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1 1 2 1 VERBATIM PROCEEDINGS 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 CONNECTICUT STEM CELL RESEARCH ADVISORY COMMITTEE 17 18 19 20 21 AUGUST 15, 2006 22 23 1:05 P.M. 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 CONNECTICUT ECONOMIC RESOURCE CENTER 42 43 200 CORPORATE PLACE 44

3 4 5 POST REPORTING SERVICE 6 HAMDEN, CT (800) 262-4102 1 2 2 1 ROCKY HILL, CONNECTICUT 2 3 4 5

3 4 5 POST REPORTING SERVICE 6 HAMDEN, CT (800) 262-4102 1 3 2 MEETING RE: STEM CELL RESEARCH ADVISORY COMMITTEE 3 AUGUST 15, 2006 4 5 1 . . .Verbatim Proceedings of the meeting

2 of the Connecticut Stem Cell Research Advisory Committee,

3 held August 15, 2006, at 1:05 P.M., at the Connecticut

4 Economic Resource Center, 200 Corporate Place, Rocky Hill,

5 Connecticut. . .

6

7

8

9 COMMISSIONER ROBERT GALVIN: We have one

10 item to attend to before our invited guests will discuss

11 intellectual -- our intellectual property for us. The

12 item is, of course, approval of the minutes of the July

13 18, 2006 meeting. And would you all, if you have not

14 reviewed those minutes, would you review them and when you

15 have make any suggestions, additions or deletions. And

16 subsequent to that we’ll entertain a motion to accept

17 them.

18 Is everybody okay with the minutes?

19 Warren?

20 MR. WARREN WOLLSCHLAGER: Mr. Chair, on

21 behalf of Dr. Landwirth, he did submit just today an e-

6 7 8 POST REPORTING SERVICE 9 HAMDEN, CT (800) 262-4102 1 4 2 MEETING RE: STEM CELL RESEARCH ADVISORY COMMITTEE 3 AUGUST 15, 2006 4 5 1 mail to Marianne and to myself with a couple of

2 suggestions about -- first of all, “I apologize to you all

3 for not being able to make the meeting”. But he had a

4 couple of comments on the minutes. One is the report on

5 the Toronto meeting. I guess if the Chair would like the

6 Ethics subcommittee to comment on the ISSCR guidelines for

7 conduct of human research he’s happy to organize a review

8 of that document. And I think that’s specifically

9 addressed in some of the -- in the draft. And I’m sorry, I

10 just got this handed to me.

11 And secondly is that Dr. Landwirth’s

12 departure was noted correctly in terms of the time of his

13 departure from the meeting. But he did participate in the

14 discussion that follows in the minutes regarding how the

15 peer review process should take place. So I think we may

16 need to just relocate that particular discussion.

17 COMMISSIONER GALVIN: His first offer to

18 summarize the International Stem Cell Committee guidelines

19 have we accepted that or -- I’m not quite sure what he

20 wanted to do.

21 MR. WOLLSCHLAGER: In our discussion of

6 7 8 POST REPORTING SERVICE 9 HAMDEN, CT (800) 262-4102 1 5 2 MEETING RE: STEM CELL RESEARCH ADVISORY COMMITTEE 3 AUGUST 15, 2006 4 5 1 the ISSCR -- let me withdraw that -- that No. 1 issue,

2 Commissioner. Just go -- just go to No. 2 on the minutes

3 about his time of departure.

4 COMMISSIONER GALVIN: Sure.

5 MR. WOLLSCHLAGER: Being reflected after

6 the discussion on the peer review.

7 COMMISSIONER GALVIN: I see no problem

8 with that. Are there any other deletions or changes to the

9 minutes? If so, I’ll entertain a motion to accept the

10 minutes with the one amendment about Dr. Landwirth’s time

11 of departure.

12 MR. KEVIN RAKIN: So moved.

13 COMMISSIONER GALVIN: Second?

14 A VOICE? Second.

15 COMMISSIONER GALVIN: All in favor?

16 VOICES: Aye.

17 COMMISSIONER GALVIN: Opposed? Thank you.

18 We are -- yes, sir.

19 MR. ROBERT MANDELKERN: I have to ask

20 everyone to speak up loudly because I’m very hard of

21 hearing in spite of hearing aids and I am loosing a lot of

6 7 8 POST REPORTING SERVICE 9 HAMDEN, CT (800) 262-4102 1 6 2 MEETING RE: STEM CELL RESEARCH ADVISORY COMMITTEE 3 AUGUST 15, 2006 4 5 1 the comments, which I don’t want to do. So I would

2 appreciate it if everyone could speak up a little more

3 loudly than usual. Thank you.

4 COMMISSIONER GALVIN: Okay. That also

5 helps the transcriptionist to be clearer if you speak up

6 and it also helps me because my hearing isn’t the best in

7 the world because of my misspent youth.

8 MR. MANDELKERN: That’s what happens.

9 COMMISSIONER GALVIN: Yes. Okay. Warren,

10 would you introduce our two guests?

11 MR. WOLLSCHLAGER: Yes. I’m happy to do

12 that, Commissioner. I’ve -- some of us had the pleasure

13 of spending a bit of this morning with two partners from

14 the law firm of Foley and Lardner. And one is Stacy

15 Taylor, who came to us -- flew in from California last

16 night. And the other is Mark Waxman, not Max Warkman, who

17 comes out of the Boston office. And they’re here at our

18 invitation and remember we discussed this at the last

19 meeting, you approved inviting them. And this -- and this

20 relationship came about actually because of a connection

21 that Dr. Yang made with Ms. Taylor out in a conference in

6 7 8 POST REPORTING SERVICE 9 HAMDEN, CT (800) 262-4102 1 7 2 MEETING RE: STEM CELL RESEARCH ADVISORY COMMITTEE 3 AUGUST 15, 2006 4 5 1 San Francisco.

2 And just, again, not to talk too long, but

3 Stacy and her law firm have been very much involved in the

4 activities of California and the CIRM. So we invited them

5 here to give us an overview on lessons learned and, you

6 know, pitfalls to watch out for. So I turn it over to

7 Stacy.

8 MS. STACY TAYLOR: Very good. Well, for

9 some of you folks who were here this morning this is

10 treading over old ground, but we will tread over it again

11 and maybe I can answer some new questions. As Warren

12 indicated we are involved in CIRM in California.

13 COURT REPORTER: Can you speak into that

14 microphone right in front of you, please?

15 MS. TAYLOR: Oh, thank you. We’ve been

16 involved with them and have been observers of what they’ve

17 done in the course of developing their policies. In

18 particular for me, since I’m an intellectual property

19 attorney, I’ve been interested in what they’ve done with

20 their IP policies, who is going to own the intellectual

21 property, what kind of money they’re going to generate

6 7 8 POST REPORTING SERVICE 9 HAMDEN, CT (800) 262-4102 1 8 2 MEETING RE: STEM CELL RESEARCH ADVISORY COMMITTEE 3 AUGUST 15, 2006 4 5 1 from it, what kind of restrictions are going to be placed

2 on the funds that go out to grantee organizations and so

3 forth.

4 And there are some things that CIRM has

5 done very well with their policies. There are some things

6 that have drawn quite a bit of criticism and there are

7 even more things that remain to be decided both in terms

8 of policies that have been adopted and policies that have

9 not yet been adopted.

10 What we know about what CIRM’s thinking is

11 on intellectual property comes primarily from the policy

12 that was adopted for intellectual property owned by non-

13 profit organizations. That is as far as CIRM got. They

14 were on a roll developing these policies and first in line

15 was the policy for training grants, which they have

16 already issued. Not released, they’ve already allowed a

17 number of them. They haven’t actually funded those

18 grants, but they have identified the potential grantees.

19 Then next in line for CIRM was to develop

20 an intellectual property policy for non-profit

21 organizations. And they were in line to begin developing

6 7 8 POST REPORTING SERVICE 9 HAMDEN, CT (800) 262-4102 1 9 2 MEETING RE: STEM CELL RESEARCH ADVISORY COMMITTEE 3 AUGUST 15, 2006 4 5 1 a policy for for-profit organizations. They actually got

2 so far as a draft with the latter before they received a

3 claim from WARF. WARF’s position being that based on the

4 Thompson patents owned by WARF that the generation of

5 revenue -- of revenue stream from the grantees of CIRM

6 funds back to CIRM, which funds would then go into

7 California state’s general fund not earmarked for

8 research, not earmarked for health care, back into the

9 general fund to be used by the state as it saw fit, made

10 CIRM -- put CIRM in the commercial camp.

11 WARF has licenses for non-profit entities

12 and licenses for for-profit entities. Different royalty

13 structures, different terms of agreement under their

14 licenses for the Thompson patents depending on which one

15 of those camps you fall in. In their view the revenue

16 stream back to CIRM put CIRM in the commercial camp as a

17 for-profit agency.

18 Those discussions are continuing. It is

19 at the discussion level. It has not reached the point of

20 litigation. It has certainly not reached the point of any

21 decision between those two entities. But the immediate

6 7 8 POST REPORTING SERVICE 9 HAMDEN, CT (800) 262-4102 1 10 2 MEETING RE: STEM CELL RESEARCH ADVISORY COMMITTEE 3 AUGUST 15, 2006 4 5 1 impact of WARF’s announcement that it would make such a

2 claim on CIRM’s income was that CIRM stopped working on

3 its for-profit intellectual property policy.

4 The WARF claims then was stimulated, so to

5 speak, by the portion of the non-profit organization IP

6 policy, which has been adopted by CIRM and which provides

7 for grantees to own intellectual property in any research,

8 products of that research, research tools, anything that

9 they develop that spins off intellectual property from

10 CIRM funded research. The grantees will own the

11 intellectual property. They can patent it as they see fit

12 although CIRM obviously and strongly encourages those

13 patents to be applied for. And then they can license

14 those patents. CIRM has a voice in how those patents are

15 licensed.

16 But at the point if when maybe in the

17 future those licenses bear fruit and the grantee

18 organizations get a royalty stream from their own

19 licensees than 25 percent of that royalty stream net has

20 to be returned to CIRM and put into the state’s general

21 fund coffers. That policy has been adopted. It is being

6 7 8 POST REPORTING SERVICE 9 HAMDEN, CT (800) 262-4102 1 11 2 MEETING RE: STEM CELL RESEARCH ADVISORY COMMITTEE 3 AUGUST 15, 2006 4 5 1 rethought, to say the least, in terms of in response to

2 WARF’s claim that that turned CIRM into a commercial

3 entity even though CIRM itself was not doing any research.

4 They put the money out, the money comes back to them, it

5 goes to the state. CIRM, in terms of money, is sort of a

6 classic middleman. But from WARF’s point of view that

7 turned them into a commercial entity.

8 And there was a lot of debate in a number

9 of different respects as to how intellectual property

10 would be treated for CIRM funded for-profit entities. But

11 all of that debate has essentially been put on hold

12 pending some further developments on the WARF patent

13 claim.

14 Another aspect of the intellectual

15 property policy CIRM developed for non-profit

16 organizations requires that when I, as a CIRM grantee,

17 receive CIRM funds and I develop intellectual property, I

18 get my patent. I go to license it out to the community,

19 I’m encouraged very strongly to license it out on a non-

20 exclusive basis rather than an exclusive basis. I am

21 strongly discouraged, if not outright told, not to sell

6 7 8 POST REPORTING SERVICE 9 HAMDEN, CT (800) 262-4102 1 12 2 MEETING RE: STEM CELL RESEARCH ADVISORY COMMITTEE 3 AUGUST 15, 2006 4 5 1 that technology unless I sell my company lock stock and

2 barrel. I can’t sell it to a third party. I’m encouraged

3 to license it.

4 From the non-exclusive -- non-exclusive

5 license basis the licensees have to have -- there have to

6 be milestones in place for those non-exclusive licensees

7 to meet certain commercial goals within certain periods of

8 time.

9 But perhaps more importantly, at least,

10 from the grantee organization and the licensee’s point of

11 view is that anybody who is in the stream of receiving

12 money from CIRM, whether it is the grantee organization or

13 the grantee’s organizations licensees downstream, is

14 subject to an obligation to share the wealth, so to speak.

15 The intellectual property that develop, whether it be

16 tangible or intangible, that’s data that’s research tools,

17 that’s actual products has to be made available to other

18 California research institutions at no cost to that

19 institution. There is a lot of question marks obviously

20 with that. What I just said is a paraphrase of what’s in

21 the IP policy, but it pretty much covers all of the ground

6 7 8 POST REPORTING SERVICE 9 HAMDEN, CT (800) 262-4102 1 13 2 MEETING RE: STEM CELL RESEARCH ADVISORY COMMITTEE 3 AUGUST 15, 2006 4 5 1 that the IP policy covered.

2 And it left a lot of ground uncovered.

3 For example, what is a California research institution?

4 An entity that has a research division in California but

5 has most of its presence outside of the State of

6 California or California research institution, that’s an

7 example of the kind of definitional questions that have

8 been left open by the policy as its been adopted.

9 But the sharing requirement has drawn

10 quite a bit of fire from the academic and the research

11 community because they feel that in exchange for accepting

12 whatever limited amount of money they may receive from

13 CIRM it puts them in the position, a competitive

14 disadvantage with respect to their colleagues outside of

15 the State of California. Essentially, the mechanism by

16 which this sharing occurs is that if I, grantee

17 organization, have a patent all of my colleagues and

18 competitors in California are allowed to use my technology

19 free of cost for research. They’re granted an exemption

20 from infringement. Similar in scope to the federal

21 research exemption, which can take you all the way up

6 7 8 POST REPORTING SERVICE 9 HAMDEN, CT (800) 262-4102 1 14 2 MEETING RE: STEM CELL RESEARCH ADVISORY COMMITTEE 3 AUGUST 15, 2006 4 5 1 through FDA trials.

2 At the point, of course, that you actually

3 get approval for commercialization, then your research

4 exemption may expire because you’re not longer doing

5 research. But it could take you pretty far down the path

6 towards commercialization and that is all free of

7 obligation to the patentee who patented technology based

8 on CIRM funded research.

9 If I have data, that I as a scientist have

10 developed, I’m allowed to hold it close to my chest long

11 enough to get it published and long enough to get a patent

12 application on file preferably before I publish it. But

13 then I have to make that data free to everyone else in the

14 state. The same with research tools, the same with --

15 everything that the CIRM money has touched in essence has

16 to be made available to everyone in the state. Whereas

17 someone whose doing this outside of the state has a, what

18 is perceived as something of a competitive advantage

19 because they can maintain more of that kind of information

20 -- proprietary secret and not be obliged to make it

21 available to everyone. That -- I say that’s one of the

6 7 8 POST REPORTING SERVICE 9 HAMDEN, CT (800) 262-4102 1 15 2 MEETING RE: STEM CELL RESEARCH ADVISORY COMMITTEE 3 AUGUST 15, 2006 4 5 1 areas that has been highly controversial in the non-profit

2 IP policy that was developed.

3 The other has to do with the Prop 71 that

4 resulted in the Stem Cell Research Fund for California was

5 -- had two goals in mind. One was to make stem cell

6 research happen and to make therapies available

7 particularly for patients within the State of California

8 similar to the goals being sought by the Connecticut state

9 fund. But also they had -- Prop 71 was more or less sold

10 to the voters or so says the proponents of the revenue

11 sharing as a means to generate revenue to the state.

12 The -- on the revenue generating side

13 there is a number of different ways that Prop 71 could and

14 will eventually, if it’s successful in funding research,

15 result in financial benefits to the state. One, of course,

16 would be this 25 percent back from the licensing of any

17 intellectual property, assuming that it would happen with

18 that kind of burden on the grantee organization. Another

19 would be bringing -- recruiting scientists and businesses

20 to the state.

21 And the third is making the therapies, if

6 7 8 POST REPORTING SERVICE 9 HAMDEN, CT (800) 262-4102 1 16 2 MEETING RE: STEM CELL RESEARCH ADVISORY COMMITTEE 3 AUGUST 15, 2006 4 5 1 whenever they result from this funded research, available

2 at a cost no greater than the Medicare price or comparable

3 technologies. And that’s another aspect of the

4 intellectual property policy. If I receive CIRM funds I

5 have to insure that I, as a grantee organization, if I

6 develop therapies or my licensees if they develop

7 therapies that they set -- they make sure that however

8 they’re commercialized, however they’re made available to

9 the patient population that they are made available to

10 California patients at no greater than the Medicare price

11 for a comparable technology.

12 Again, a definition, which you left,

13 rather untouched by the scope and breadth of the IP

14 policy, what is -- what is a comparable technology by

15 which you determine that price point. That’s left

16 relatively unaddressed by the policy.

17 It’s also -- all of these things in

18 combination are -- make up the core of the core five

19 features of the IP policy that was adopted by CIRM. I

20 don’t think even though the non -- the for-profit policy

21 has been more or less stalled pending resolution of --

6 7 8 POST REPORTING SERVICE 9 HAMDEN, CT (800) 262-4102 1 17 2 MEETING RE: STEM CELL RESEARCH ADVISORY COMMITTEE 3 AUGUST 15, 2006 4 5 1 some resolution, some discussion of the issue raised by

2 WARF with respect to whether WARF is entitled to some

3 share of the revenues. I don’t -- these seem to be

4 benchmarks. These five core principles in the IP policy

5 seem to be benchmarks that were arrived at somewhat

6 painfully through a very extensive political process,

7 through the input of a lot of interest, a lot of very

8 diverse interest in the state, through a lot of

9 legislative pressure particularly from Senator Deborah

10 Ortiz, who advocated the passage of Prop 71 and has been

11 very involved in the implementation of that process.

12 And it seems unlikely that when CIRM comes

13 out with its next IP policy for for-profit agencies that

14 it will go backwards for many of these benchmarks. It

15 seems unlikely, for example, that it will reduce the share

16 of revenues that it is requesting out of licensee

17 royalties, out of the licensee royalty stream. It’s very

18 unlikely because this was a very core feature of Prop 71

19 that it won’t do anything to allow a different pricing

20 structure once therapy is made available in California

21 using CIRM money.

6 7 8 POST REPORTING SERVICE 9 HAMDEN, CT (800) 262-4102 1 18 2 MEETING RE: STEM CELL RESEARCH ADVISORY COMMITTEE 3 AUGUST 15, 2006 4 5 1 So these, even though there is a cloud so

2 to speak, over where CIRM is going with IP at this point,

3 these seem to be features that they’re going to have to

4 live with going forward. And there has been a lot of

5 concern expressed -- there is some very good features

6 about the IP policy. Certainly from CIRM’s perspective it

7 saves the organization from having to establish a tech

8 transfer office, had CIRM insisted as many people proposed

9 on keeping ownership of IP resulting from state funded

10 research, they would have had to have a model probably,

11 possibly similar to what’s in a lot of universities.

12 Establish a tech transfer office, find it -- licensees,

13 monitor those licenses, manage the money coming out of

14 them.

15 So from CIRM’s perspective not having to

16 have a tech transfer office was a good thing. From the

17 grantee’s perspective certainly being able to own and

18 control the creation of this intellectual property was a

19 good thing. To some extent the grantees own tech transfer

20 policies in terms of what it shares with the -- with its

21 inventors, what kind of cost incurs are left within its

6 7 8 POST REPORTING SERVICE 9 HAMDEN, CT (800) 262-4102 1 19 2 MEETING RE: STEM CELL RESEARCH ADVISORY COMMITTEE 3 AUGUST 15, 2006 4 5 1 control. So for grantees that’s a very positive

2 development.

3 But by the same token it puts a

4 significant burden on the researchers who accept these

5 funds in California in terms of the intellectual property

6 that they have to share and what their ultimate profit

7 stream is going to be down the road. And that concern has

8 led some observers, particularly of the Denver capital

9 community, to say that accepting CIRM funding is not

10 really a viable vehicle in and of itself for

11 commercialization of products because it’s just too strict

12 a means of getting money for that research particularly

13 for the --

14 MR. RAKIN: -- what has been the reaction

15 of the tech transfer offices like Stanford and the UC

16 system? You made one reference to it, but are they

17 accepting it and are comfortable with it?

18 MS. TAYLOR: Well, that’s a good question.

19 There are some Stanford, UCSF both have very substantial

20 stem cell research efforts underway. They have accepted

21 training grants. They are both recipients of training

6 7 8 POST REPORTING SERVICE 9 HAMDEN, CT (800) 262-4102 1 20 2 MEETING RE: STEM CELL RESEARCH ADVISORY COMMITTEE 3 AUGUST 15, 2006 4 5 1 grants from CIRM. And the training grants don’t have,

2 obviously, any of these IP implications.

3 There is a big question mark as to whether

4 or not any of these organizations will apply for the full

5 funding. For CIRM right now is essentially an unfounded

6 mandate. The litigation has stopped, the selling of bonds

7 that was going to fund it. They do have -- the state did

8 just commit to loaning a 150 million dollars from some

9 unnamed source to CIRM. Whether or not that money will

10 ever materialize, I don’t know. So we don’t really know

11 what those institutions are going to do.

12 Word on the street though is that they’re

13 not interested. They haven’t -- the -- CIRM was or Prop

14 71’s mission, which differs a bit from the Connecticut

15 state mission. Their primary mission was to fill in the

16 gap created by the restrictions on federal funded research

17 for embryonic stem cell research. Much less of a focus on

18 adult stem cell research and other stem cell technologies.

19 And so, you know, there is sort of a built in market

20 because those institutions that rely very heavily on

21 federal funds for a lot of their research have fewer

6 7 8 POST REPORTING SERVICE 9 HAMDEN, CT (800) 262-4102 1 21 2 MEETING RE: STEM CELL RESEARCH ADVISORY COMMITTEE 3 AUGUST 15, 2006 4 5 1 alternatives to get that kind of research funded.

2 But the big institutions, the ones that

3 have a lot of market power, the scientists are leaving.

4 They’re going overseas. The institutions are getting

5 private donations. They’re looking -- they’re being

6 creative. They’re looking for other sources. And it’s

7 very possible that some of the bigger players in the field

8 in California will not apply.

9 MR. MARK WAXMAN: Okay. Maybe just talk

10 -- I’d like to offer a couple of observations on what

11 Stacy said going back to the beginning. For anyone who is

12 involved in this needs to give some consideration to the

13 role that Wisconsin Alumni Research Foundation or WAFT

14 patents play in the commercialization process. You know,

15 the WARF and their related anti-Y cell who actually

16 they’ve empowered to do their negotiating for them, have

17 created a template which in essence is in two parts. One

18 says that based upon their patents and their patents

19 essentially claim embryonic stem cells, whether it’s the

20 derivation of them, the licensing -- I mean the isolation

21 of them, and they say we have patented that and we will

6 7 8 POST REPORTING SERVICE 9 HAMDEN, CT (800) 262-4102 1 22 2 MEETING RE: STEM CELL RESEARCH ADVISORY COMMITTEE 3 AUGUST 15, 2006 4 5 1 allow you to use our patented technology, use that broadly

2 in order to pursue non commercial research period. That’s

3 statement one.

4 Statement two is if you wish to pursue

5 commercial research and whether that’s directly or whether

6 that’s by letting someone else pursue commercial research

7 and you share in the rights, the royalties or some other

8 way then WARF basically says you can’t do that unless that

9 other player is licensed by us and we get our cut. So

10 that’s the WARF wall, if you will. And there are various

11 attempts that are starting up to attack that wall. But at

12 the end of the day that’s a decision that people make,

13 we’re either going to accept the wall and dedicate

14 ourselves primarily to non-commercial research. Or we’re

15 going to hope that the third parties negotiate an

16 acceptable license with WARF so that we can work together.

17 So that’s kind of the WARF thing. There

18 are early discussions. I think I expressed the view that

19 the heck with whatever WARF is doing I think it’s

20 important that people move ahead with their own programs

21 or nothing will happen. So that’s part one.

6 7 8 POST REPORTING SERVICE 9 HAMDEN, CT (800) 262-4102 1 23 2 MEETING RE: STEM CELL RESEARCH ADVISORY COMMITTEE 3 AUGUST 15, 2006 4 5 1 Part two is a comment about the California

2 situation. What California has done is what worked, or

3 doesn’t work as Stacy said, balancing a wide variety of

4 interest for California. Those interests are political,

5 scientific, commercial, and a number of other interests

6 that had to be balanced in a certain stew. And the stew

7 continues to swirl as the heat comes up from various

8 places. That particular balance may or may not work here

9 because the stew is very different. Both -- for all the

10 reasons that one might say Connecticut is different from

11 California, which we could spend a lot of time at.

12 But at the end of the day, Connecticut

13 will need to strike its own balance looking at a variety

14 of sort of core issues which is to what extent does it

15 want to further commercialization as opposed to non

16 commercial research and what does the community think

17 about that. To what extend does Connecticut want to tilt

18 the benefits towards its own citizens in comparison with

19 citizens at large or in other states. California has

20 struck, as Stacy said, a certain balance.

21 To what extent does Connecticut want to

6 7 8 POST REPORTING SERVICE 9 HAMDEN, CT (800) 262-4102 1 24 2 MEETING RE: STEM CELL RESEARCH ADVISORY COMMITTEE 3 AUGUST 15, 2006 4 5 1 have a quote, “simple program” as opposed to a complex

2 program because all the bells and whistles add degrees of

3 complexity that may also impact the ability to just run

4 the program on a day to day basis. To what extent is

5 Connecticut interested in creating a fund to replenish the

6 annual fund or to further enhance research or other public

7 health values and industrial values of more benefit or

8 that will lead to another balancing on this table of the

9 various issues. And there are a few more. But these, I

10 think, are the major ones that need to be addressed in the

11 development of your own policy.

12 So a California, New Jersey, other states

13 have their own models. I suspect they’re -- you’ve seen

14 one, you’ve seen one. You only hope you’ve addressed most

15 of the issues to avoid big open questions later and say,

16 gee, we wish we would have thought of that. And to that

17 extent for better or worse I think the experience in

18 California is a good model because they’ve been kind of

19 dragged through a lot of issues relatively early.

20 MS. TAYLOR: It’s true we’ve been under a

21 microscope. And add the WARF factor, if you want to call

6 7 8 POST REPORTING SERVICE 9 HAMDEN, CT (800) 262-4102 1 25 2 MEETING RE: STEM CELL RESEARCH ADVISORY COMMITTEE 3 AUGUST 15, 2006 4 5 1 it that, is more of an issue perhaps for California than

2 it is likely to be for Connecticut. Two things triggered

3 it’s application in California. One California’s fund is

4 devoted to embryonic stem cell research and that’s what

5 the WARF patents cover are embryonic stem cell lines. Two,

6 California by virtue of the political process, you know,

7 there is a lot of factors you can identify by virtue of

8 the promises it made when Prop 71 was passed, by virtue of

9 a lot of things, has -- is requiring that money come back

10 to the states that is not designated for further research.

11 Now, interestingly California requires

12 that its grantees to use the portion of money that they

13 obtain from licensing state funded stem cell research to

14 put that money back into research. So as the grantee

15 organization I have to take my profits, after I pay my

16 inventors, and put it back into research. But the state

17 doesn’t do that. The money goes back to CIRM and it goes

18 into the general fund and it fills potholes and it fills

19 -- builds streets, it does what have you. And it’s that

20 latter factor that really triggers WARF’s interest.

21 Now, that -- whether or not that’s

6 7 8 POST REPORTING SERVICE 9 HAMDEN, CT (800) 262-4102 1 26 2 MEETING RE: STEM CELL RESEARCH ADVISORY COMMITTEE 3 AUGUST 15, 2006 4 5 1 ultimately going to be a problem for Connecticut -- I

2 mean for California, who knows. There is a lot of

3 discussions going on. The WARF patents are in for

4 reexamination as of several weeks ago. They could end up

5 going away. We don’t know. But those two factors, the deep

6 involvement in embryonic stem cell research and the taking

7 of funds back into the stem cell agency and then giving it

8 to the state without restrictions are what made that issue

9 ripe for California and neither one of those factors,

10 depending on what you do here, may be issues for

11 Connecticut.

12 MR. MILTON WALLACK: Stacy, that’s not

13 totally accurate. The second part, which we discussed

14 earlier, is probably going to be more -- you know, right

15 on the mark that we can get dedicated funds. But our

16 Chairman keeps reminding us that we’re to fill in where

17 the federal government is falling down relative to

18 embryonic stem cell research. So that of the 70 grants

19 that we have had presented to us that we’ll fund 20

20 million hopefully by the end of December. 10 million over

21 the next eight years, it’s I think the intent to channel

6 7 8 POST REPORTING SERVICE 9 HAMDEN, CT (800) 262-4102 1 27 2 MEETING RE: STEM CELL RESEARCH ADVISORY COMMITTEE 3 AUGUST 15, 2006 4 5 1 and focus on the embryonic stem cell part. And as the

2 relationship develops between you and all of us that’s

3 something I think that you ought to really be aware of.

4 MS. TAYLOR: And that makes sense because

5 that really is what the state initiatives are designated

6 to address for the most part. For California it was a

7 part of the actual legislative mandate. But I would

8 expect that states who are getting involved in this

9 initiative are going to have an interest in funding

10 embryonic stem cell research because that’s by and large

11 why these state funds exist in the first place. And it’s

12 a product of the unavailability of the federal funds.

13 But it’s what you do -- just with respect

14 to the WARF factor, which as Mark said, is really a very

15 small part of the equation. And a part that could play out

16 in a lot of different ways. But just with respect to that

17 factor and those patents covering the embryonic stem cell

18 research whether or not you have an obligation or your

19 licensees have an obligation to WARF will depend a lot on

20 whether or not you fall into that commercial camp versus

21 non-commercial camp.

6 7 8 POST REPORTING SERVICE 9 HAMDEN, CT (800) 262-4102 1 28 2 MEETING RE: STEM CELL RESEARCH ADVISORY COMMITTEE 3 AUGUST 15, 2006 4 5 1 MR. WALLACK: Another quick question. In

2 order to make those funds as universally accessible in the

3 therapy side to the citizens of the state, they use the

4 Medicare formula.

5 MS. TAYLOR: Um, hmm.

6 MR. WALLACK: Was there any reason they

7 chose the Medicare as opposed to the Medicaid? Because

8 wouldn’t then it be even more universally accessible if

9 they had chosen to use the Medicaid?

10 MS. TAYLOR: Why they ended up with

11 Medicare in particular I think -- and I know that there

12 were a lot of discussions on this point because there were

13 a lot of models proposed. There were models that proposed

14 a percentage reduction over the commercial price. There

15 were models that proposed Medicaid as being the sort of

16 standard and then Medicare. I think it may have been or

17 what I’ve heard is that it may have been in part because

18 there was a sense that people were more comfortable with

19 the Medicare model. That they had more experience with the

20 Medicare model. That it was perhaps some better defined.

21 You know, what -- how the price points were arrived at in

6 7 8 POST REPORTING SERVICE 9 HAMDEN, CT (800) 262-4102 1 29 2 MEETING RE: STEM CELL RESEARCH ADVISORY COMMITTEE 3 AUGUST 15, 2006 4 5 1 the Medicare model. But that’s what they ended up with at

2 the end of the day.

3 DR. ANN KIESSLING: Are you familiar with

4 the relationship between Geron and WARF?

5 MS. TAYLOR: Yes.

6 DR. KIESSLING: Could you describe that to

7 us a little bit because that’s the first commercial

8 company that I know of that’s had to come up with some,

9 you know, therapeutic use and some kind of license with

10 WARF.

11 MS. TAYLOR: They have a license with

12 WARF. It was a result -- it was a settlement of litigation

13 that occurred between the two companies.

14 DR. KIESSLING: Right.

15 MS. TAYLOR: It went on for several years.

16 I don’t know, Mark, if you’ve actually looked at the

17 agreement itself between the two companies. As I

18 understand it, it -- they ended up sort of dividing up the

19 pie. I mean Geron clearly falls into the commercial camp

20 in terms of the royalties that they pay and the royalties

21 can -- the part of the revenue stream that comes back to

6 7 8 POST REPORTING SERVICE 9 HAMDEN, CT (800) 262-4102 1 30 2 MEETING RE: STEM CELL RESEARCH ADVISORY COMMITTEE 3 AUGUST 15, 2006 4 5 1 WARF can be pretty substantial. It can go up to 40 percent

2 of net for Geron or any other company that falls under

3 that commercial camp.

4 But Geron has exclusive rights within a

5 field of use for particular kinds of therapies from WARF.

6 That’s --

7 DR. CHARLES JENNINGS: Isn’t under what

8 those fields are? My recollection was that one was beta

9 cells and diabetes and another was cardio --

10 MS. TAYLOR: -- it’s not neuro cells.

11 DR. JENNINGS: But it’s three at the most

12 --

13 MS. TAYLOR: -- there are three. I have a

14 copy of the agreement. I don’t have the details off the

15 top of my head. But I have excerpts of it I’d be happy to

16 send to you.

17 DR. JENNINGS: Okay. And this is even

18 though Geron funded the original work.

19 MR. WAXMAN: Yes. That’s what the -- the

20 essence of the litigation was to establish whether that

21 funding would create a freedom to practice or not. And it

6 7 8 POST REPORTING SERVICE 9 HAMDEN, CT (800) 262-4102 1 31 2 MEETING RE: STEM CELL RESEARCH ADVISORY COMMITTEE 3 AUGUST 15, 2006 4 5 1 resulted in a settlement after, as you noted, some

2 expensive litigation, which carved out where the freedom

3 to practice would be. It retained the rest for WARF as a

4 resolution of the dispute. If it hadn’t funded any of it

5 to begin with it would haven’t have been a dispute.

6 MS. TAYLOR: They wouldn’t have gotten to

7 the table in the first place.

8 MR. WAXMAN: Right.

9 DR. KIESSLING: It’s a tough group, isn’t

10 it, WARF.

11 COMMISSIONER GALVIN: Well, I think that

12 the very -- Stacy and I and Mark discussed it a little

13 bit, but the very real risk of this is to drive -- drive

14 the embryonic stem cell research efforts out of country

15 and overseas. If you make it that difficult for people --

16 I mean the obvious thing is why don’t you -- why don’t I

17 go to Belgium or to Valencia, Spain or to the United

18 Kingdom. And I think that’s a very real risk to have a

19 net out flow of the best science, which is distressing.

20 DR. JENNINGS: My understanding is some

21 major biotech companies in California, and Bertram being

6 7 8 POST REPORTING SERVICE 9 HAMDEN, CT (800) 262-4102 1 32 2 MEETING RE: STEM CELL RESEARCH ADVISORY COMMITTEE 3 AUGUST 15, 2006 4 5 1 one example, are conducting all of their human embryonic

2 stem cell work outside of the country where WARF doesn’t

3 have patent rights.

4 MS. TAYLOR: That’s right.

5 DR. JENNINGS: Is that correct?

6 MS. TAYLOR: The work patent in Europe --

7 it just went to the enlarged Board of Appeals which is a

8 step up beyond the APO patent office itself. And it is

9 considered -- that patent is considered to tee up the

10 issue of whether or not the APO will allow any hard claims

11 to embryonic stem cells. Right now the APO flatly refuses

12 to accept them. And Germany -- as does Germany and France

13 and Ireland, but the UK is all over them.

14 DR. JENNINGS: Yes.

15 MS. TAYLOR: And so you’ve got this sort

16 if dichotomy and it’s the WARF patent that may break that

17 dichotomy because --

18 DR. WILLIAM LENSCH: -- so if I could

19 clarify, my understanding of the WARF patent situation in

20 Europe was not necessarily from within the patent office,

21 but because the process allowed outside interested parties

6 7 8 POST REPORTING SERVICE 9 HAMDEN, CT (800) 262-4102 1 33 2 MEETING RE: STEM CELL RESEARCH ADVISORY COMMITTEE 3 AUGUST 15, 2006 4 5 1 to contest the awarding of a patent.

2 MS. TAYLOR: That’s right.

3 DR. LENSCH: And so it’s not the European

4 union problem per say. It’s that other people can

5 petition against it much as they have done in California.

6 MS. TAYLOR: That’s true, but it is teeing

7 off the issue -- in Europe -- third parties can also get

8 the patents here, but not until they’ve actually issued.

9 And once a patent issues in the United States it’s

10 entitled to presumption of validity making it that much

11 harder to challenge. In Europe before the thing actually

12 issues they publish it and everybody can pile on with

13 their objections. And you’re right, that was the

14 procedure by which the WARF patent got challenged. But the

15 APO has had a policy banning claims to embryonic stem cell

16 lines for some time. And it’s considered that this WARF

17 appeal may be a vehicle to challenge the APO’s position or

18 maybe soften it somewhat.

19 Whether or not that’s realistic, I don’t

20 know. I mean the APO has just changed its position a bit

21 in terms of what it will fund on the research side, but

6 7 8 POST REPORTING SERVICE 9 HAMDEN, CT (800) 262-4102 1 34 2 MEETING RE: STEM CELL RESEARCH ADVISORY COMMITTEE 3 AUGUST 15, 2006 4 5 1 whether or not that will affect the patent position I

2 don’t know.

3 DR. JENNINGS: If I can come back a little

4 bit to what this might mean for us in Connecticut by

5 analogy with what you know to be happening in California

6 and elsewhere. So my understanding is a number of major

7 research universities have had a problem in signing

8 agreements with WARF not because of the -- they’re

9 uncomfortable with the price but because it severely

10 restricts their ability to do collaborative research with

11 industry. I know, for instance, that was a real sticking

12 point with many of the Harvard affiliated institutions.

13 MS. TAYLOR: Um, hmm.

14 DR. JENNINGS: And what’s been happening

15 in California and elsewhere, do you have a sense of how

16 many big research universities have reached agreement with

17 WARF and are they comfortable with their -- or have they

18 just resigned themselves to the fact that they can’t

19 collaborate with industry if their industry collaborators

20 don’t have WARF licenses? And does anybody know where the

21 major Connecticut institutions are at in this? I mean has

6 7 8 POST REPORTING SERVICE 9 HAMDEN, CT (800) 262-4102 1 35 2 MEETING RE: STEM CELL RESEARCH ADVISORY COMMITTEE 3 AUGUST 15, 2006 4 5 1 either UCONN or Yale signed an agreement with WARF?

2 MR. WOLLSCHLAGER: Yale has not.

3 DR. JERRY YANG: UCONN has not either.

4 DR. JENNINGS: Has not. So neither Yale

5 nor UCONN.

6 MS. TAYLOR: There seems to be a

7 difference between the public position and the reality.

8 The public position is that WARF has until the patent

9 office or somebody else decides otherwise WARF -- it is

10 part of the cost of doing business. The reality is that

11 people are not staying in health wanting to do the

12 science. And WARF is a factor in that. It’s not the only

13 factor, but it is a factor in that because it limits your

14 ability to do this sort of collaborations that are really

15 critical to this research. It limits the ability to

16 distribute your cell lines. To -- what you can do with

17 those cell lines, what you can derive from those cell

18 lines. It -- they really get their fingers in an awful lot

19 of pots through those licenses.

20 I don’t -- I honestly don’t know how many

21 institutions have actually taken the licenses versus not

6 7 8 POST REPORTING SERVICE 9 HAMDEN, CT (800) 262-4102 1 36 2 MEETING RE: STEM CELL RESEARCH ADVISORY COMMITTEE 3 AUGUST 15, 2006 4 5 1 taken the licenses. But I have heard statements to the

2 effect of, well, you know it’s just part of the reality of

3 doing business with patents. They’re there. You’ve got to

4 deal with them if you want to do this kind of research.

5 But, you know, a lot of people are voting defeat too.

6 DR. LENSCH: So recently WARF reduced the

7 price that was required under material transfer agreements

8 to do academic research with their lines. Has there been

9 any movement or change for the commercial side?

10 MS. TAYLOR: I don’t know.

11 DR. JENNINGS: Increased it to compensate.

12 MS. TAYLOR: Yes. I don’t know. I have to

13 say too, Charles knows this I think, that we represent

14 WARF, but not in the stem cell field. And so we’re -- as

15 we can comment on a lot of what WARF does and we follow a

16 lot of what WARF does, we do tread a little bit on thin

17 ice in doing sort of digging into their agreements and

18 digging into their intellectual property in advance of

19 somebody really needing us to do that. And so we know --

20 we’re informed in terms of how it’s affected our clients,

21 but it’s not -- it’s not something that -- we don’t really

6 7 8 POST REPORTING SERVICE 9 HAMDEN, CT (800) 262-4102 1 37 2 MEETING RE: STEM CELL RESEARCH ADVISORY COMMITTEE 3 AUGUST 15, 2006 4 5 1 have a program in place to dig into what WARF is doing

2 with non clients.

3 MR. WALLACK: Stacy, let me try this on.

4 What I understand from what you’ve said before also as

5 long as our funds that we get back vis a vie IP fall into

6 a dedicated fund that can be either for additional

7 research or for therapies, whatever -- some social service

8 kinds of things as opposed to back into the general fund,

9 as it did in California, then we’re less likely to have to

10 contend with litigation vis a vie WARF. Is that accurate?

11 MS. TAYLOR: In my opinion, yes, and less

12 likely is the critical phrase there because I don’t think

13 any -- I think WARF took a lot of people by surprise in

14 making their claim against the CIRM for a lot of reasons

15 that they were characterizing was being thought of as a

16 non-profit institution, as a state institution, as being

17 commercial. And that they were asking for the money to

18 come from CIRM and not CIRM’s grantees. So that -- that

19 announcement, so to speak -- I won’t even characterize it

20 as a claim because they’re not in litigation and WARF

21 hasn’t actually entered into an agreement with CIRM. But

6 7 8 POST REPORTING SERVICE 9 HAMDEN, CT (800) 262-4102 1 38 2 MEETING RE: STEM CELL RESEARCH ADVISORY COMMITTEE 3 AUGUST 15, 2006 4 5 1 the announcement that WARF would consider CIRM to be a

2 commercial entity that had to pay WARF was a surprise.

3 And, you know, we don’t know exactly what -- under what

4 circumstances WARF would not make that claim to a state

5 agency that is receiving revenues back from its grantees.

6 But I think it’s fair to -- or a

7 reasonable estimate at any rate that if you were getting

8 the money back from grantees and folding it back into

9 research, in other words, acting like a non-profit

10 institution more than as a revenue generating arm of the

11 state to raise money for general purposes, I think you are

12 less likely to fall into that camp.

13 MR. WALLACK: So just a quick follow up

14 then, so it would pay then for us to persist in what’s

15 already in fact in our bill and not deviate from that

16 because it probably would be -- it would be less

17 problematic as we go down the road vis a vie WARF.

18 MS. TAYLOR: I think it is likely to be

19 less problematic.

20 MR. WALLACK: Okay.

21 MR. WAXMAN: Just to be -- put a fine

6 7 8 POST REPORTING SERVICE 9 HAMDEN, CT (800) 262-4102 1 39 2 MEETING RE: STEM CELL RESEARCH ADVISORY COMMITTEE 3 AUGUST 15, 2006 4 5 1 point on it that the WARF license agreement says

2 institutions shall not require commercial grant back of

3 rights. What you have done is said it’s not a commercial

4 grant back of rights, it’s a grant back of rights which is

5 reinvigorating the research and we’re not a commercial

6 entity anyway, we’re an arm of the state.

7 MR. WALLACK: Right. It’s one

8 interpretation.

9 MR. RAKIN: But by extension would you

10 recommend talking to them?

11 MS. TAYLOR: That’s a strategic question.

12 MR. RAKIN: Because if we’re one of the

13 first states and it clearly is not for profit in terms of

14 our goal. Maybe there is a clarification or a very --

15 MS. TAYLOR: -- it depends.

16 MR. RAKIN: -- beneficial deal to be

17 struck.

18 MR. WAXMAN: I think it -- I think it’s

19 premature to answer the question because until there is a

20 program that you said this is a program that we want to

21 pursue, this is how we’ve struck the balance among a whole

6 7 8 POST REPORTING SERVICE 9 HAMDEN, CT (800) 262-4102 1 40 2 MEETING RE: STEM CELL RESEARCH ADVISORY COMMITTEE 3 AUGUST 15, 2006 4 5 1 range of things to sit down at a table and be unable to

2 answer questions, what is your whole program, where are

3 you going, I think would be premature.

4 DR. JENNINGS: But it is likely that by --

5 that by January we will be starting to fund research

6 activities some of which will be directed towards --

7 MR. RAKIN: -- I guess I’m just a big

8 believer in you sit down, you say this is our perspective,

9 this is what our lawyers think and we don’t have to strike

10 any agreement, because we think we’re in a perfectly fine

11 situation. But we’re still developing a policy.

12 MS. TAYLOR: There is a lot to be said for

13 --

14 COMMISSIONER GALVIN: -- Bob, do you have

15 a question?

16 MR. MANDELKERN: Yes. I have a question

17 through you. Since 90, almost five percent of our grant

18 applications are from UCONN and Yale would it not be

19 helpful to us to hear from the Yale and UCONN

20 representatives if this represents a problem to them or

21 not because for the first two years basically the state

6 7 8 POST REPORTING SERVICE 9 HAMDEN, CT (800) 262-4102 1 41 2 MEETING RE: STEM CELL RESEARCH ADVISORY COMMITTEE 3 AUGUST 15, 2006 4 5 1 funds are going to be allocated unless the five other

2 grants are considered all the money will be going to Yale

3 and UCONN. So their input on this, I think, with their

4 representatives here in a sense would be helpful to us.

5 COMMISSIONER GALVIN: I think that’s a

6 fair statement and that we would want to obtain opinions

7 from the -- at least the major entities involved. Wesleyan

8 University is also involved. It certainly appears that

9 the two major players are Yale University and the

10 University of Connecticut. They are, of course, two very

11 different types of organizations in terms of their

12 management, their tradition, their -- one belongs to the

13 State of Connecticut. One of them is an international

14 university. I would certainly think that we would solicit

15 opinions from their -- from their legal armamentarium of

16 attorneys of patent law and health care and the like.

17 I think that as Mark and Stacy and I

18 discussed there is a very real possibility that you can

19 drive the research off shore if this is not handled

20 correctly. And I’m not speaking for anybody at Yale

21 University, but I’m not -- I would venture a guess that

6 7 8 POST REPORTING SERVICE 9 HAMDEN, CT (800) 262-4102 1 42 2 MEETING RE: STEM CELL RESEARCH ADVISORY COMMITTEE 3 AUGUST 15, 2006 4 5 1 they would not be too tolerant of being told what exactly

2 they’re going to do and that they would -- I would also

3 venture a guess that it would not be terribly difficult

4 for them to go off shore. And I think we would loose a

5 tremendous amount of energy and a tremendous amount of

6 scientific acumen, but we also would loose that very

7 special relationship we have with scientists from the two

8 -- two of the major entities collaborating. And I would

9 -- I have some real fears that that could happen and it

10 doesn’t seem to be an unlikely conclusion or an unlikely

11 conclusion given if the facts are true then this may be --

12 that that institution may come to the conclusion of we’ll

13 just do it with Dr. Wilmont’s lab in Scotland.

14 Warren?

15 MR. WOLLSCHLAGER: Thank you,

16 Commissioner. Just a point of clarification for Board

17 members who may not know this is that Stacy and Mark, at

18 the invitation of the Department and the Commissioner, met

19 with representatives of our major research institutions

20 this morning during a morning session that ran about an

21 hour and a half. It included the legal representatives of

6 7 8 POST REPORTING SERVICE 9 HAMDEN, CT (800) 262-4102 1 43 2 MEETING RE: STEM CELL RESEARCH ADVISORY COMMITTEE 3 AUGUST 15, 2006 4 5 1 both Yale and UCONN.

2 COMMISSIONER GALVIN: Yes, I don’t think

3 we came to -- I think that they’re digesting this

4 information.

5 MR. WOLLSCHLAGER: Right.

6 COMMISSIONER GALVIN: And that there will

7 be a further reaction from the two of them not in concert,

8 but perhaps individually because they have very different

9 charters, very different governance, and very different

10 long term outlooks.

11 MR. WOLLSCHLAGER: And I do also,

12 Commissioner, suggest that perhaps it might be worthwhile

13 for the state to get together with interested parties,

14 both externally and from within the state, to put on a

15 full day legal symposium including representatives of our

16 Office of the Attorney General.

17 COMMISSIONER GALVIN: Yes. We did some

18 talking about that issue about presenting a seminar and

19 discussing this issue and also other issues germane to egg

20 donation and to -- and to freedom of information, all of

21 which are very deeply involved here.

6 7 8 POST REPORTING SERVICE 9 HAMDEN, CT (800) 262-4102 1 44 2 MEETING RE: STEM CELL RESEARCH ADVISORY COMMITTEE 3 AUGUST 15, 2006 4 5 1 MR. WALLACK: As part of the symposium,

2 the International Symposium in ’07 also.

3 DR. KIESSLING: My question was hasn’t

4 Harvard University reached an agreement with WARF? I mean

5 they’ve been working on it for a while, haven’t they,

6 Charles?

7 DR. JENNINGS: They were -- I mean as long

8 as I was at Harvard they were working on it. And the last

9 that I heard was that they had basically turned off their

10 hands in despair unable to reach agreement. I don’t know

11 how that has evolved over the last few months. So I’m not

12 completely up to date on that. I believe Howard Hughes as

13 -- and of course -- Harvard is one of the most prominent

14 and he’s funded by -- he’s a Hughes employee.

15 DR. KIESSLING: Right.

16 DR. JENNINGS: But how that affects

17 Harvard I’m not clear. Harvard was trying to coordinate a

18 united front among all of its various affiliates and

19 that’s -- that’s not a fast process.

20 MR. MANDELKERN: Dr. Galvin.

21 COMMISSIONER GALVIN: Yes, sir.

6 7 8 POST REPORTING SERVICE 9 HAMDEN, CT (800) 262-4102 1 45 2 MEETING RE: STEM CELL RESEARCH ADVISORY COMMITTEE 3 AUGUST 15, 2006 4 5 1 MR. MANDELKERN: Just a point of

2 information, do you think that this issue would cause

3 UCONN and Yale to withdraw their grant applications for

4 the first few years?

5 COMMISSIONER GALVIN: Well, I might --

6 listening to our distinguished visitors today I think that

7 one of the things is that early grants may very well be

8 training grants, which would not be applicable to these

9 commercial legal encumbrances. But what I do hear is that

10 this prospect has very inhibitory qualities and is, I

11 think, inhibiting the submission of some grants. But also

12 I think more important than the grants are it’s driving

13 the scientists out of California and to other --

14 MR. MANDELKERN: At the time being we have

15 more requests for grants than we have money available by

16 three to one. So even if two out of three withdraw their

17 applications and the other third are worthwhile and

18 meritorious we still have recipients for the funds we have

19 and the public way to dispense. So I’m just wondering if

20 we shouldn’t move more forward to consideration of what we

21 have on the table that is the grant application process,

6 7 8 POST REPORTING SERVICE 9 HAMDEN, CT (800) 262-4102 1 46 2 MEETING RE: STEM CELL RESEARCH ADVISORY COMMITTEE 3 AUGUST 15, 2006 4 5 1 conflict of interest, all of which are on the agenda so

2 that we can move forward rationally as a committee to the

3 consideration of what we have to do within the next few

4 months.

5 COMMISSIONER GALVIN: Well, I think we are

6 going to move forward in that direction. And I think

7 there are probably none of us who are here who feel that

8 there is the imminent production of a license or a product

9 or a procedure that would be subject to these types of --

10 to these types of legal quandaries. I think that my

11 concern and hearing Stacy speak about is if I were looking

12 long term and I felt that the long term atmosphere or

13 milieu where I was going to operate would be one

14 constrained by litigation or fees to another party I might

15 very well put my long term planning into someplace else

16 other than the United States.

17 MR. MANDELKERN: Just in response to that,

18 Dr. Galvin, so far we’ve been fortunate that we have been

19 able to move reasonably smoothly forward since the passage

20 of the law in June of 2005. I can understand the long

21 term point of view, but I think short term the sooner we

6 7 8 POST REPORTING SERVICE 9 HAMDEN, CT (800) 262-4102 1 47 2 MEETING RE: STEM CELL RESEARCH ADVISORY COMMITTEE 3 AUGUST 15, 2006 4 5 1 move the more likely it is that everyone can digest all of

2 these issues and see where they’re going say in grant year

3 next year. But meanwhile we have had, as opposed to other

4 states, very clear fruitful sailing in Connecticut. And I

5 think we should move forward on that basis.

6 COMMISSIONER GALVIN: I agree and we

7 certainly have no feelings about dampening down our

8 efforts or curtailing anything that we do. However, I

9 look at it from the point of view as if, you know, if

10 you’re on a boat out on the ocean you can only see,

11 depending on how big your boat is, you can only see about

12 13 miles, 10 miles to the horizon. And if you’re really

13 smart you’ll send somebody to shinny up the mast and see

14 what’s ahead of you, you know, 25 five miles out.

15 And I think that we need to look at it

16 from that standpoint about, you know -- we certainly don’t

17 want to become aware of this as an -- at an inopportune

18 time. We also would like to learn the lessons that I

19 think have been relatively painfully learned in California

20 so we don’t have -- so we move along at different

21 pathways. And I think that’s why these inputs are so

6 7 8 POST REPORTING SERVICE 9 HAMDEN, CT (800) 262-4102 1 48 2 MEETING RE: STEM CELL RESEARCH ADVISORY COMMITTEE 3 AUGUST 15, 2006 4 5 1 valuable.

2 MS. TAYLOR: And if I could, Commissioner,

3 I think that the lessons to take from CIRM is not really

4 to do what CIRM did or not do what CIRM did. What

5 happened in California played out a number of factors that

6 may or may not be present in Connecticut. You have a

7 different law. You have a somewhat different mandate. You

8 have a different political environment. You can end up

9 with a different result.

10 I think what’s really instructive at the

11 end of the day about what happened with CIRM is not that

12 they ended up with a policy that necessarily drives

13 researchers out of the state. But that they wanted to end

14 up with a policy that gave researchers motivation to stay

15 within the state and they didn’t quite get there.

16 COMMISSIONER GALVIN: Well said.

17 MR. MANDELKERN: I would also say that the

18 situation in California and Connecticut from a political

19 point of view are widely different. Proposition 71 passed

20 60/40. Whereas our stem cell bill went through the Senate

21 of the Connecticut legislature ten to one and it went past

6 7 8 POST REPORTING SERVICE 9 HAMDEN, CT (800) 262-4102 1 49 2 MEETING RE: STEM CELL RESEARCH ADVISORY COMMITTEE 3 AUGUST 15, 2006 4 5 1 the House three to one. It was widely supported by the

2 people, by a two to three margin -- three to two margin.

3 And the Governor couldn’t act quickly enough to sign the

4 bill. So there is a completely different political

5 environment, which hopefully will lead to other science

6 results for us also that might not be quite so

7 contentious.

8 COMMISSIONER GALVIN: Well, we hope so and

9 we hope that this -- that this gubernatorial and

10 legislative initiative leads to the state becoming more

11 involved in other types of science and scientific

12 investigation with the -- with some future applications to

13 medicine and the well-being of the population. So I

14 certainly agree with your remarks.

15 Ann, did you have a statement?

16 DR. KIESSLING: I just wanted to point out

17 that I don’t think anything about the Y cell agreement

18 inhibits research. It was -- it’s been a little dampening

19 to venture capitalists. In the CIRM guidelines also I

20 don’t think it inhibited any of the research in

21 California. It simply dampened the enthusiasm of

6 7 8 POST REPORTING SERVICE 9 HAMDEN, CT (800) 262-4102 1 50 2 MEETING RE: STEM CELL RESEARCH ADVISORY COMMITTEE 3 AUGUST 15, 2006 4 5 1 California venture capitalists to jump in at the very

2 beginning because the state is going to take back a

3 significant amount of the money. And they have to have

4 predisclosure. So I don’t -- I don’t know of anything

5 that is on the books right now that actually inhibits the

6 research.

7 DR. JENNINGS: I think on the one hand

8 we’re here to stimulate research. On the other hand, if

9 the long term strategic plan is to deliver health benefits

10 then we have to think about the implications of our

11 policies for eventual commercialization of the research or

12 it seems our aim is not merely to fund excellent science

13 in Connecticut. It goes beyond that. And my understanding

14 of our mandate is that we are also supposed to be thinking

15 about commercial benefits to Connecticut and health

16 benefits to Connecticut most of which won’t happen simply

17 as a result of the academic research we have without for

18 profit investment coming in somewhere down the road. And

19 I think we’ve been remiss about how our decisions now

20 might increase or decrease the likelihood of that

21 happening.

6 7 8 POST REPORTING SERVICE 9 HAMDEN, CT (800) 262-4102 1 51 2 MEETING RE: STEM CELL RESEARCH ADVISORY COMMITTEE 3 AUGUST 15, 2006 4 5 1 COMMISSIONER GALVIN: Oh, I certainly

2 agree with your remarks and your remarks. And during the

3 morning session I harkened back to some of my military

4 years where if you want to build an aircraft carrier you

5 have to be -- you won’t have it for ten years. So you have

6 to decide in August of ’06 whether or not you want to have

7 a brand new aircraft carrier in August of ’16. And in

8 order to do that you have to try to look out as far in the

9 future as you reasonably can and decide what you want to

10 do whether you want this at all or in some form. So I

11 think we’re -- I think we’re saying the same things that

12 we have to look out as far as we can reasonably

13 anticipate. And I agree with your remarks entirely.

14 Mike.

15 DR. MYRON GENEL: If I may make one

16 observation, which I think is relevant. We do have policy

17 as to the request for applications. Until amended that

18 represents our policy. The policy is that institutions --

19 that applicants are to describe their plans for sharing of

20 revenues, which at a minimum should be 5 percent. The --

21 that represents our policy because we haven’t gone any

6 7 8 POST REPORTING SERVICE 9 HAMDEN, CT (800) 262-4102 1 52 2 MEETING RE: STEM CELL RESEARCH ADVISORY COMMITTEE 3 AUGUST 15, 2006 4 5 1 further at this point.

2 What we do with those applications and

3 what we do with the -- with what the applicants have

4 proposed is something that we have yet to determine. I

5 think we probably need to do something or come to some

6 conclusion on that before the fall, I would guess.

7 COMMISSIONER GALVIN: Okay. Are there any

8 more questions for Stacy and Mark? If not, I would like

9 to -- Henry?

10 MR. HENRY SALTON: I would like just to

11 make one observation and make it clear that under the

12 current statutes that govern this Committee revenue

13 generated in the applications, as Myron indicated, are

14 required to address, you know, a generation of revenue

15 from patents and royalties and similar types of

16 intellectual property. But if revenue does come in it

17 goes to the general fund in Connecticut.

18 MR. WALLACK: No, it doesn’t.

19 MR. SALTON: Yes, it does.

20 COMMISSIONER GALVIN: Yes.

21 MR. SALTON: There is donations and gifts

6 7 8 POST REPORTING SERVICE 9 HAMDEN, CT (800) 262-4102 1 53 2 MEETING RE: STEM CELL RESEARCH ADVISORY COMMITTEE 3 AUGUST 15, 2006 4 5 1 can be given to the stem cell fund, but it does not talk

2 about revenue stream.

3 MR. WALLACK: The way I’ve read it, Henry,

4 is that there is a dedicated -- where is it?

5 MR. SALTON: There is a dedicated fund

6 that’s funded by the tobacco settlement trust fund on an

7 annual basis. And then it’s for -- then it can be

8 supplemented with contributions, gifts, grants, donations,

9 requests and devises. I don’t think that contemplates

10 revenue stream off of a patented rights.

11 MR. WALLACK: I know that you have the

12 legal background rather than myself, but the way I read

13 this that the account will be within the general fund.

14 Now to me that implies that there will be an account. An

15 account meaning a dedicated account --

16 MR. SALTON: -- no, the general rule in

17 Connecticut is that unless the legislature has directed

18 revenue streams to go in a particular account that it goes

19 to the general fund and all accounts are within the

20 general fund. But if, for example, monies that may come

21 in from, at one point we have gas tax -- gas taxes,

6 7 8 POST REPORTING SERVICE 9 HAMDEN, CT (800) 262-4102 1 54 2 MEETING RE: STEM CELL RESEARCH ADVISORY COMMITTEE 3 AUGUST 15, 2006 4 5 1 certain amount of that is dedicated to highway repair,

2 inspection, monitoring of bridges. There is specific

3 statutory instruction as to how those funds are

4 streamlined into the specific uses and accounts.

5 If there isn’t a specific dedication --

6 and not all the gasoline tax goes there -- a portion of it

7 goes, which is not so dedicated, just goes into the

8 general fund. So it’s something that we could look at as

9 far as future legislation goes. If you want to, you know,

10 go to the legislature and say, listen, you know, one of

11 the things that might undermine our ability to move

12 forward with those whole project would be the fact that

13 you don’t have an instruction that allows for revenue

14 streams to go into this account. And the legislature may

15 say, heh, it’s worthwhile because in years 8, 9 and 10 we

16 might have to reduce -- we could literally look at ways of

17 maybe keeping some tobacco money and not sending it in

18 here because you earned a couple of million dollars along

19 the way.

20 But right now, this bill does not give you

21 the anchor to drive revenue from these kind of financial

6 7 8 POST REPORTING SERVICE 9 HAMDEN, CT (800) 262-4102 1 55 2 MEETING RE: STEM CELL RESEARCH ADVISORY COMMITTEE 3 AUGUST 15, 2006 4 5 1 benefits into this special account.

2 MR. WALLACK: Mr. Chairman, if that -- if,

3 in fact, Henry from his legal perspective is correct, and

4 he probably is, then perhaps at some point at your

5 convenience you might want to look at a discussion about

6 how we can proceed in the next legislative session to get

7 some specific -- more specific wording and instructions

8 about where those monies can go. To me that makes a

9 tremendous amount of sense because it also addresses the

10 problem that the had in California when it went into the

11 general fund and it became therefore viewed as a

12 commercial effort or undertaking.

13 But now and in the previous meeting if --

14 it was at least clear to me, maybe I didn’t understand it,

15 that if in fact California had -- WARF had not interpreted

16 the money as being partially a commercial venture, vis a

17 vie going to the general fund -- so it makes a tremendous

18 amount of sense on every level for the security of

19 research institutions, for our efforts and so forth. So if

20 I might, I mean we might want to then further clarify that

21 as an agenda item. To me it’s critical.

6 7 8 POST REPORTING SERVICE 9 HAMDEN, CT (800) 262-4102 1 56 2 MEETING RE: STEM CELL RESEARCH ADVISORY COMMITTEE 3 AUGUST 15, 2006 4 5 1 COMMISSIONER GALVIN: Well, it -- it is

2 certainly an item of criticality. Henry has been around

3 the -- you’ve been around the scene much longer than I

4 have and my impression is --

5 MR. SALTON: -- this scene.

6 COMMISSIONER GALVIN: My impression is

7 that to attempt to earmark funds from collected monies of

8 -- within the general fund is exceptionally difficult. It

9 -- you get into the issues of an executive branch agency

10 telling the legislatures what to do with their money,

11 which they guard -- as I found that they guard very

12 zealously. That there is almost nothing there that’s

13 earmarked.

14 We talked earlier today about all our

15 license fees going there. And when we asked for some

16 money to upgrade our computer systems so we can issue

17 licenses electronically that’s their money. The minute

18 they collect the money it becomes theirs and not ours.

19 MR. MANDELKERN: A question through you to

20 Henry, the language -- I’m reading from the bill, the 205

21 bill, “there is established a stem cell research fund,

6 7 8 POST REPORTING SERVICE 9 HAMDEN, CT (800) 262-4102 1 57 2 MEETING RE: STEM CELL RESEARCH ADVISORY COMMITTEE 3 AUGUST 15, 2006 4 5 1 which shall be a separate non-lapsing account within the

2 general fund”. Doesn’t that imply, without maybe the

3 language that satisfies you, that what is generated should

4 be a separate non-lapsing account?

5 MR. SALTON: No, that addresses the fact

6 that the monies that are transferred -- that is an account

7 within the general fund which at the end of the bill is

8 funded through tobacco trust monies that come into the

9 state.

10 COMMISSIONER GALVIN: It’s an outflow.

11 MR. SALTON: It’s -- and so it’s an

12 outflow account and it’s -- the important part about non-

13 lapsing is that if you don’t spend it this year the money

14 remains in the account for this particular purpose. So it

15 doesn’t re -- in an elapsing account the money that’s put

16 in the account for that spending purpose at the end of the

17 fiscal year lapses back into the general fund and the

18 account balances turns to zero.

19 MR. MANDELKERN: What about the separate?

20 Where it says, “shall be a separate”?

21 MR. SALTON: None of that language will be

6 7 8 POST REPORTING SERVICE 9 HAMDEN, CT (800) 262-4102 1 58 2 MEETING RE: STEM CELL RESEARCH ADVISORY COMMITTEE 3 AUGUST 15, 2006 4 5 1 satisfactory in determining that the revenue stream from

2 research royalties will go into an -- outside the general

3 fund. That is really just a place within the budget that

4 holds for these funds -- a separate location for these

5 funds to be held and utilized by the Committee in making

6 grants. It does not talk about revenue stream. And this is

7 -- I mean this is not atypical of the legislative process.

8 We see these kind of dedicated accounts and in those same

9 agencies they have revenue streams, not withstanding the

10 fact that they have a spending account, the revenue goes

11 into the general fund.

12 And it may or may not be -- you know, it’s

13 a matter of bringing the policy back to the legislature

14 and saying, you know, as intellectual property experts

15 have said, you know, we may face a great obstacle and an

16 impediment to getting these therapies out into the -- into

17 patients in the market place because the read is that this

18 is a commercial use and we’re going to have -- the state

19 is going to have to address that problem. Or we just, you

20 know, draw a pipeline between this particular revenue

21 stream and this account and that’s all we need to do to

6 7 8 POST REPORTING SERVICE 9 HAMDEN, CT (800) 262-4102 1 59 2 MEETING RE: STEM CELL RESEARCH ADVISORY COMMITTEE 3 AUGUST 15, 2006 4 5 1 get past that impediment.

2 And the legislature may say, that’s fine,

3 but we might shave off our funds feeding into it based on

4 whatever you guys earn in revenue. And our base will be a

5 zero sum game for the legislature in that circumstance.

6 And that would take care of this problem and the

7 legislature wouldn’t feel like -- they would just say,

8 well, fine, we’ll just put a little less in every year.

9 COMMISSIONER GALVIN: Yes, we get two

10 million they’re going to give -- they’ll give us eight.

11 MR. SALTON: Right.

12 COMMISSIONER GALVIN: It will always add

13 up to ten.

14 MR. SALTON: Right. But I think ultimately

15 as, you know, the people who put this bill into place were

16 very successful in demonstrating the need for it, this is

17 something that, you know, if the legislature is still

18 behind the policy they should appreciate the need to make

19 this fix as a layperson, not as a politician.

20 MR. WALLACK: Henry -- on donated funds?

21 MR. SALTON: Yes.

6 7 8 POST REPORTING SERVICE 9 HAMDEN, CT (800) 262-4102 1 60 2 MEETING RE: STEM CELL RESEARCH ADVISORY COMMITTEE 3 AUGUST 15, 2006 4 5 1 MR. WALLACK: How would that --

2 MR. SALTON: -- donated funds are -- do go

3 into this account. So for example, if we got money from

4 the Ford Foundation, if they’re still in existence, that

5 money would -- any donated funds go into the account.

6 MR. WALLACK: So that would not roll over

7 into --

8 MR. SALTON: -- no.

9 MR. WALLACK: Okay.

10 MR. SALTON: And that’s what that second

11 sentence in the section provides that you can take

12 contributions, gifts, donations and bequests.

13 MR. MANDELKERN: I could quote it, I have

14 the longer --

15 COMMISSIONER GALVIN: -- okay, we need to

16 move on. Go ahead, one last question.

17 DR. LENSCH: If I may ask a question of

18 our guest just so to see if I’ve understood you correctly,

19 WARF has directed their attention not at the State of

20 California but at CIRM, this interest that they brought up

21 of late. Connecticut has not formed an institute. All of

6 7 8 POST REPORTING SERVICE 9 HAMDEN, CT (800) 262-4102 1 61 2 MEETING RE: STEM CELL RESEARCH ADVISORY COMMITTEE 3 AUGUST 15, 2006 4 5 1 us on this Committee act as public officials just in

2 furtherance of benefit to the State of Connecticut. Is

3 there something unique about how CIRM is set up? Is it not

4 a public entity, a public non-profit entity? And are we

5 insulated in some way because we lack an institute?

6 MS. TAYLOR: That’s guessing to some

7 extent on what WARF’s thinking is on that issue. They’re

8 following the money is my impression not the entity

9 structure. And to some extent CIRM has a similar

10 structure at the committee level. The peer review

11 committee, they’ve taken them from office, they serve as

12 fiduciaries of the state.

13 DR. LENSCH: I see.

14 MS. TAYLOR: So I don’t know the answer to

15 that for sure because it depends on WARF’s thinking. But I

16 wouldn’t think the entity difference would come into play

17 that much.

18 DR. LENSCH: Thank you.

19 COMMISSIONER GALVIN: Thank you very much

20 for your input and your long trip out from lovely San

21 Diego. Mark, that’s for coming down from the City of the

6 7 8 POST REPORTING SERVICE 9 HAMDEN, CT (800) 262-4102 1 62 2 MEETING RE: STEM CELL RESEARCH ADVISORY COMMITTEE 3 AUGUST 15, 2006 4 5 1 big dig. We shall see you all, I’m sure, in the future.

2 Our next item is Item 4, an overview on

3 conflict of interest and Attorney Horn will speak to that

4 issue.

5 MS. MARIANNE HORN: I will. This came up

6 at our last meeting and I promised that I would do an

7 update and overview for the Committee on the conflict of

8 interest. I have prepared a conflict of interest form,

9 which I’ll send out to you all electronically. But I have

10 a copy of it here today if you’d like to take a look at it

11 and you will be asked to fill out, as you review a grant,

12 to determine whether you have a conflict of interest.

13 Let me just take a minute here to update

14 everybody on the -- on the new law. As you know it was

15 amended in April of this year. And it does provide two

16 key provisions, I think, that clarify the language that

17 was in there prior to this. And this is -- this is a

18 fairly unique conflict of interest provision.

19 It says that it is not a conflict of

20 interest --

21 DR. CANALIS: What page are we on?

6 7 8 POST REPORTING SERVICE 9 HAMDEN, CT (800) 262-4102 1 63 2 MEETING RE: STEM CELL RESEARCH ADVISORY COMMITTEE 3 AUGUST 15, 2006 4 5 1 MS. HORN: I am on -- yes, you all got a

2 new copy of the bill. And I’m looking at Connecticut

3 General Statute 19a-32f(d). Page three of four at the top.

4 DR. CANALIS: “Not withstanding the

5 provisions of any other law”, is that it?

6 MS. HORN: Yes.

7 DR. CANALIS: Page two.

8 DR. GENEL: It also says --

9 MS. HORN: -- yes.

10 DR. GENEL: Yes, it’s actually page three

11 of four, if that helps.

12 MS. HORN: Okay? “So it shall not

13 constitute a conflict of interest for a trustee, director,

14 partner, officer, stockholder, proprietor counsel or

15 employee of any eligible institution or for any other

16 individual with a financial interest in any eligible

17 institution to serve as a member of the Committee”. So

18 that was a clarification that was put into the new

19 legislation. So while you may hold a role in any -- one

20 of those roles with an eligible institution it does not

21 preclude you from serving on the -- this Committee and

6 7 8 POST REPORTING SERVICE 9 HAMDEN, CT (800) 262-4102 1 64 2 MEETING RE: STEM CELL RESEARCH ADVISORY COMMITTEE 3 AUGUST 15, 2006 4 5 1 carrying out the affairs of this Committee. It

2 says that all members shall be public officials and shall

3 adhere to the Code of Ethics for public officials set

4 forth in Chapter 10.

5 And then this is another new part.

6 “Members may participate in the affairs of the Committee

7 with respect to reviewer consideration of grant and aid

8 applications including the approval or disapproval of such

9 applications except that no member shall participate in

10 the affairs of the Committee with respect to the review or

11 consideration of any grant in aid application filed by

12 such member or by any eligible institution in which such

13 member has a financial interest or with whom such member

14 engages in any business, employment, transaction or

15 professional activity”. So if you have a relationship of

16 the nature described in that last sentence of the bill or

17 if you have filed an application for the grant you are not

18 allowed to participate in the review or consideration of

19 that application.

20 Yes.

21 DR. LENSCH: I’m just wondering, at what

6 7 8 POST REPORTING SERVICE 9 HAMDEN, CT (800) 262-4102 1 65 2 MEETING RE: STEM CELL RESEARCH ADVISORY COMMITTEE 3 AUGUST 15, 2006 4 5 1 point should such declarations be made as we sit at the

2 table in consideration of those applications or do you

3 anticipate a disclosure in advance?

4 MS. HORN: I’m thinking I could do the

5 form today and people can start filling them out.

6 DR. LENSCH: I see.

7 MS. HORN: Based -- I’m understanding that

8 they may change somewhat. They would need to be updated

9 for the reasons we didn’t do it a year ago when the

10 Committee started. But that if anything changes at the end

11 of the grant that should be brought to the attention of

12 the -- but I think it’s going to be a complicated process

13 and I think the sooner we know who has a conflict on which

14 grant the better.

15 DR. JENNINGS: May -- can I just clarify?

16 So in definition of institution, does this -- so for

17 example, is UCONN one institution or is the University

18 distinct from the medical school and similarly for Yale?

19 Does that mean that everybody with an affiliation to Yale

20 must recuse themselves from any application from Yale and

21 conversely for UCONN or is it more granular than that?

6 7 8 POST REPORTING SERVICE 9 HAMDEN, CT (800) 262-4102 1 66 2 MEETING RE: STEM CELL RESEARCH ADVISORY COMMITTEE 3 AUGUST 15, 2006 4 5 1 MS. HORN: We have --

2 DR. JENNINGS: -- and will we have a

3 quorum?

4 MS. HORN: We have looked at that fairly

5 broadly that UCONN, as an institution, there was no basis

6 for separating that off into divisions. If you have an

7 association and this is an employed -- an employed

8 association with UCONN or with Yale that you do have a

9 conflict.

10 DR. JENNINGS: Right. And so I should --

11 you know, in my particular case I’ve done some consulting

12 for Jerry’s center at UCONN in my practice as a private

13 consultant. So I don’t know whether that would mean that

14 I would need to recuse myself from -- I mean I have no

15 involvement with UCONN as a whole, but I -- there might

16 need to be a determination as to what --

17 MS. HORN: -- we would need to make a

18 determination about how far out that would go and what --

19 DR. JENNINGS: -- and there may be other

20 people with similarly sort of marginal affiliations with

21 institutions. I think it would be -- sorry, if I can just

6 7 8 POST REPORTING SERVICE 9 HAMDEN, CT (800) 262-4102 1 67 2 MEETING RE: STEM CELL RESEARCH ADVISORY COMMITTEE 3 AUGUST 15, 2006 4 5 1 finish that thought. I think it probably would be helpful

2 for all of us to receive the comprehensive list of each

3 other’s disclosures just so that we know, you know, what

4 we have around the table and how that’s going to play out

5 in terms of who can sit in on what decision making.

6 MS. HORN: Yes.

7 DR. JENNINGS: Is that the plan to share

8 the -- this -- the disclosures at our next meeting or

9 sometime forward?

10 MS. HORN: We can certainly discuss that.

11 We can -- we hadn’t gotten that far. We developed a

12 mechanism where we’ve got the disclosure form and would

13 ask you to send it back to the Department where we can

14 review any questions that you may have in terms of -- on

15 behalf of the Commissioner as the Chairman of the Advisory

16 Committee. But we have not worked out anything beyond

17 that whether we would share it. We do have an item on the

18 agenda here for developing the actual process of the

19 review of the grant.

20 DR. JENNINGS: Right.

21 MS. HORN: And I think that may fall

6 7 8 POST REPORTING SERVICE 9 HAMDEN, CT (800) 262-4102 1 68 2 MEETING RE: STEM CELL RESEARCH ADVISORY COMMITTEE 3 AUGUST 15, 2006 4 5 1 within -- within that scope.

2 DR. GENEL: If I may, Mr. Chairman, it may

3 make more sense just to provide ourselves a list of the

4 necessary required recusals without necessarily the entire

5 forms.

6 MS. HORN: The --

7 DR. GENEL: -- I mean I think really what

8 you’re asking for is some sort of an assessment of who is

9 going to be available.

10 DR. JENNINGS: Yes, that’s right.

11 DR. GENEL: And I think when the

12 determination is made about what the conflicts of interest

13 are if you could provide a list of required recusals that

14 would be very helpful.

15 COMMISSIONER GALVIN: And just one second,

16 Warren. Just to focus some down to earth things, I have a

17 long time relationship with a couple of different parts of

18 the University of Connecticut and therefore I will not

19 vote on any grant that involves the University of

20 Connecticut. I think that if one would be a devil’s

21 advocate could you not say that if I voted against

6 7 8 POST REPORTING SERVICE 9 HAMDEN, CT (800) 262-4102 1 69 2 MEETING RE: STEM CELL RESEARCH ADVISORY COMMITTEE 3 AUGUST 15, 2006 4 5 1 something that came from Yale University would I not be

2 voting for the -- taking out a competitor and making

3 things more advantageous for the University of

4 Connecticut. I don’t think I would and if I thought I

5 would I wouldn’t vote at all.

6 But it is a problem and the problem is

7 that we’re in a small state and the law stated and the

8 legislative intent was to get -- we submitted a large list

9 of people, but the intent of the appointing officials was

10 to get people who were involved in Connecticut, that it

11 was a Connecticut based program. And if you read the

12 descriptions of what they were looking for for scientists

13 and bio-ethicists and business people it’s very hard to

14 select a panel like this of distinguished individuals in a

15 state with three and a half million people and two major

16 universities without getting a lot of people from one or

17 the other.

18 I mean where else would they come from

19 unless we got -- I’ll get to you in a minute, Ann. I mean

20 where else would we get them from? I mean we don’t want

21 to get people sitting on a panel like this who are totally

6 7 8 POST REPORTING SERVICE 9 HAMDEN, CT (800) 262-4102 1 70 2 MEETING RE: STEM CELL RESEARCH ADVISORY COMMITTEE 3 AUGUST 15, 2006 4 5 1 unacquainted with the subject matter. I mean we could

2 have, I suppose, found 15 or 18 or 20 people who were --

3 who had doctorates in philology or in Mesopotamia pottery

4 or whatever you will and who were very smart people and

5 held full professorships, but had no idea of the subject

6 matter. So the very design of the project is the one that

7 makes it difficult for us to deal with it now because the

8 kinds of people who need to make the kinds of decisions

9 within the confines of a small state automatically

10 includes people who have conflicts of interest or may

11 have. Go ahead, Ann.

12 DR. KIESSLING: The National Institutes of

13 Health have sort of evolved this as they have gone through

14 their peer review committees. And 20 years ago anybody

15 from Harvard couldn’t review any other Harvard grant. It

16 isn’t like that anymore because you run out of qualified

17 people to review. So for places like Stanford and you

18 have medical schools and undergraduate campuses and large

19 faculties, it depends on what your faculty base is. So

20 now each of the Harvard teaching hospitals can review --

21 those faculty can review grants submitted by other Harvard

6 7 8 POST REPORTING SERVICE 9 HAMDEN, CT (800) 262-4102 1 71 2 MEETING RE: STEM CELL RESEARCH ADVISORY COMMITTEE 3 AUGUST 15, 2006 4 5 1 teaching hospitals.

2 Otherwise you run out of people with

3 expertise, as you’ve said.

4 MS. HORN: Um, hmm.

5 DR. KIESSLING: So it’s very possible that

6 people from your medical school could review applications

7 from your undergraduate school without there being a real

8 conflict of interest if those were, as Charles -- if they

9 were defined as separate institutions. So there is

10 precedent for that at NIH.

11 COMMISSIONER GALVIN: Okay, I’ll get to

12 your question in just a moment. I think one of the

13 personal quandaries I find -- and something that’s

14 personally a bit unpleasant to me is to consider the fact

15 that someone like Milt or Dr. Genel, who have had long and

16 distinguished careers would somehow scuttle someone else’s

17 grant in order or move something ahead that was not

18 worthwhile. I mean particularly in Dr. Genel’s case it

19 would be a repudiation of his whole career. What’s he

20 going to get out of it? That he tanked a grant from UCONN

21 and encouraged one from Yale that wasn’t quite -- it was a

6 7 8 POST REPORTING SERVICE 9 HAMDEN, CT (800) 262-4102 1 72 2 MEETING RE: STEM CELL RESEARCH ADVISORY COMMITTEE 3 AUGUST 15, 2006 4 5 1 half point less worthy. I mean we’re not -- we’re

2 --sitting around this table, we’re not the kind of people

3 who do things like that.

4 DR. GENEL: I thank you for that vote of

5 confidence.

6 MR. WALLACK: Can we please have a vote on

7 that though?

8 COMMISSIONER GALVIN: Okay, we had a

9 question in the back of the room.

10 A VOICE: Yes, in terms of peer review of

11 grant proposals does the law preclude having experts from

12 outside of the State of Connecticut sitting on the panel?

13 COMMISSIONER GALVIN: We have several.

14 A VOICE: So in terms of having a quorum

15 if you have a -- I don’t see the problem with having

16 individuals review the grants --

17 COMMISSIONER GALVIN: -- that’s why we

18 enlarged the -- we enlarged the Board. We have three new

19 members and we have several out of state members

20 anticipating more. We just did that so we would have an

21 appropriate number of reviewers because of our -- we have

6 7 8 POST REPORTING SERVICE 9 HAMDEN, CT (800) 262-4102 1 73 2 MEETING RE: STEM CELL RESEARCH ADVISORY COMMITTEE 3 AUGUST 15, 2006 4 5 1 a structural problem which is inherent in where we live

2 and how this Committee was constructed and the newness of

3 the material and the rareness of people who are subjective

4 experts.

5 I think Dr. Canalis has a statement.

6 DR. CANALIS: Commissioner, I do agree

7 with all these statements you have made. On the other

8 hand, this goes one step beyond and the step beyond is it

9 is allowing members of this Committee to apply for funds.

10 And members of this Committee have played an integral role

11 in designing the types of applications that are going to

12 be funded. They have also had a very personal, positive

13 or negative relationship with other members of the

14 Committee. Furthermore, the role of this Committee is to

15 monitor the funds and members of this Committee should be

16 totally independent -- members that monitor these funds.

17 So to me for a member of this Committee to

18 apply for funding is not congruent with lack of conflict.

19 To me that is a conflict. It went one step beyond that I

20 personally find acceptable. One of the criteria that we

21 established was funding should -- one of the criterias of

6 7 8 POST REPORTING SERVICE 9 HAMDEN, CT (800) 262-4102 1 74 2 MEETING RE: STEM CELL RESEARCH ADVISORY COMMITTEE 3 AUGUST 15, 2006 4 5 1 funding besides scientific merit was of the highest

2 ethical standards. And I think we’re going to be

3 questioned. And I think it’s going to be a serious

4 problem in the future. And in my opinion, members of this

5 Committee should refrain from applying for funding because

6 the perception is going to be of a conflict.

7 DR. JERRY YANG: Do you want me to resign

8 from the Committee?

9 DR. CANALIS: I didn’t ask for that. I’m

10 just --

11 DR. YANG: -- I will apply. When I was

12 appointed, no. Other the students are no, I was applying.

13 I’m a committee member, I’m applying. If you want me to

14 resign, I’ll resign. Okay?

15 COMMISSIONER GALVIN: I don’t think we

16 need to entertain resignations --

17 DR. YANG: -- the statement of -- why are

18 you starting at this time?

19 DR. CANALIS: I have the right to make --

20 DR. YANG: -- at this time?

21 DR. CANALIS: -- the statements that I

6 7 8 POST REPORTING SERVICE 9 HAMDEN, CT (800) 262-4102 1 75 2 MEETING RE: STEM CELL RESEARCH ADVISORY COMMITTEE 3 AUGUST 15, 2006 4 5 1 believe -- at this time is the first time that this

2 conflict of interest has been brought up to attention of

3 this Committee. Consequently, at this time is the time

4 that I find appropriate to voice my opinion. My opinion

5 may be unacceptable. It is my opinion.

6 DR. YANG: You are --

7 DR. CANALIS: -- I stated that clearly.

8 COMMISSIONER GALVIN: Okay.

9 MS. HORN: Dr. Canalis, in the law that I

10 just read it does say that the -- it does contemplate a

11 member of the Committee applying for --

12 DR. CANALIS: -- I’m not disputing that.

13 MS. HORN: Okay. And recusing themselves

14 from voting on that application.

15 DR. CANALIS: I’m not disputing the law.

16 I’m just voicing my opinion. And I wanted to go on record

17 with my opinion.

18 COMMISSIONER GALVIN: Okay.

19 DR. YANG: Thank you, that’s your opinion.

20 DR. CANALIS: Because in the future when

21 we’d be under public scrutiny I want to make certain that

6 7 8 POST REPORTING SERVICE 9 HAMDEN, CT (800) 262-4102 1 76 2 MEETING RE: STEM CELL RESEARCH ADVISORY COMMITTEE 3 AUGUST 15, 2006 4 5 1 I voiced this opinion on August 15th.

2 COMMISSIONER GALVIN: So noted. I would

3 have to say that I have great respect for Dr. Canalis and

4 his opinions and his ability to be forthright in

5 expressing them. I think it’s an almost inescapable bit

6 of conclusion or outcome that with the 70 some grants, 905

7 percent of which are either from the University of

8 Connecticut or Yale University or the two medical schools

9 that I think if we sat down and took all of the Yale

10 grants we’d probably find somebody who, you know, was the

11 Wallack golf buddy or knew somebody else or -- you know,

12 it’s just -- it’s just too small a world for these things

13 not to -- not to happen. And for people connected to

14 various people within either institution not to have some

15 sort of a connection.

16 It’s a very -- it’s a very -- and it’s

17 permitted by and was considered and discussed by the

18 Ethics Committee and by both -- by the leaders of both

19 parties and that’s the law we operate underneath, you

20 know. I know that there are other organizations who might

21 do it differently. We operate underneath the law as passed

6 7 8 POST REPORTING SERVICE 9 HAMDEN, CT (800) 262-4102 1 77 2 MEETING RE: STEM CELL RESEARCH ADVISORY COMMITTEE 3 AUGUST 15, 2006 4 5 1 by the elected representatives and by -- as directed by

2 the Chief Magistrate, Chief Executive. And that’s kind of

3 the way it is.

4 Jerry.

5 DR. YANG: Thank you, thank you -- and

6 have -- I would like to request Dr. Canalis does not

7 review my proposal because certainly it is a conflict of

8 interest. We hold --

9 COMMISSIONER GALVIN: -- that’s all right.

10 That’s okay. Mike, are you going to tell me that you’ve

11 tanked one of the grants already?

12 DR. GENEL: No, but I’d like to point out

13 I understand where Dr. Canalis is coming from and I share

14 the concern about the perception. But the problem

15 basically with those is the law, which states that

16 appointments to the Committee should include a nationally

17 -- one of whom shall be nationally recognized as an active

18 investigator in the field of stem cell research. And in

19 fact that is a requirement for both the, I believe the

20 Senate majority leader who appointed me despite the fact

21 that I am not an expert -- international expert -- known

6 7 8 POST REPORTING SERVICE 9 HAMDEN, CT (800) 262-4102 1 78 2 MEETING RE: STEM CELL RESEARCH ADVISORY COMMITTEE 3 AUGUST 15, 2006 4 5 1 expert in stem cell research -- and the House of

2 Representatives.

3 So the law is very explicit in terms of

4 defining the qualifications of the members of this

5 Committee. And that the -- the dilemma is, I think,

6 reflected in the law.

7 COMMISSIONER GALVIN: I agree. But it’s --

8 but that’s -- that’s the way it is. We don’t make --

9 DR. CANALIS: -- I do not agree with that.

10 The dilemma is not in the law, the dilemma is with

11 ourselves also. My laboratory works on -- and I could

12 have applied. And I wouldn’t apply because I find that is

13 a conflict. I’m not suggesting at any point not to comply

14 with the law. That was not suggested. What I’m

15 suggesting is to use judgment on this.

16 COMMISSIONER GALVIN: Okay.

17 MR. WALLACK: I’d like to comment. I’m a

18 little bit distressed by the fact that you feel that you

19 would recuse yourself. Of all the reasons you’ve stated,

20 No. 1, about the integrity of the group. No. 2, I think

21 that -- and I think there has been references before all

6 7 8 POST REPORTING SERVICE 9 HAMDEN, CT (800) 262-4102 1 79 2 MEETING RE: STEM CELL RESEARCH ADVISORY COMMITTEE 3 AUGUST 15, 2006 4 5 1 of your associations with these groups are in non paid

2 capacities from what I understand. And this modification,

3 which happened, I guess, in June to the law specifically

4 talks in terms of with financial interest, which I don’t

5 think from what I understand, that you have. So I would

6 hope that you could see yourself clear to in fact vote on

7 these rather than recusing yourself.

8 COMMISSIONER GALVIN: Well, I’m a

9 Director, a Board of Director member at the medical

10 school, which is -- puts a little different spin on it.

11 I’m also a graduate student and I’d probably be afraid

12 they wouldn’t give me my degree in May if I --

13 MR. WALLACK: -- no, you understand.

14 COMMISSIONER GALVIN: Yes, the

15 relationship for me is too close. I’ve been a faculty

16 member, paid, non-paid for more than a quarter of a

17 century. I’m a committee chair. I’m a Director. You know,

18 and I am a student at the school of business and also on

19 their advisory committee. It’s too close a relationship

20 for me.

21 MR. MANDELKERN: Dr. Galvin, Milt picked

6 7 8 POST REPORTING SERVICE 9 HAMDEN, CT (800) 262-4102 1 80 2 MEETING RE: STEM CELL RESEARCH ADVISORY COMMITTEE 3 AUGUST 15, 2006 4 5 1 up the point that was in my mind if you are to recuse

2 yourself based on your own conscience and interpretation

3 of the laws and so on, don’t we have to put into place a

4 procedure, even though it’s an impossible task, to replace

5 you as Chair during that period of time that you’re

6 recused. Somebody has to chair the meeting.

7 MR. SALTON: The practice would be that

8 the Commissioner could chair the meeting for purposes of

9 presiding over motions and calling motions. But he would

10 not participate in discussions on any applications and/or

11 to -- nor would he obviously vote on any application. But

12 in the sense of presiding over the meeting as far as where

13 an application from UCONN was being considered he may sort

14 of be the manager of the meeting in a non-participatory

15 way. And so he could sit as Chair in that capacity, but

16 he would not participate in the sense of reviewing,

17 discussions, criticism or anything else. So he would

18 basically sort of be the school master.

19 MR. MANDELKERN: He would not have to be

20 replaced.

21 MR. SALTON: He would not have to be

6 7 8 POST REPORTING SERVICE 9 HAMDEN, CT (800) 262-4102 1 81 2 MEETING RE: STEM CELL RESEARCH ADVISORY COMMITTEE 3 AUGUST 15, 2006 4 5 1 replaced for that purpose.

2 MR. MANDELKERN: Okay.

3 COMMISSIONER GALVIN: Are we all set and

4 ready to move on or do we have some further comments? Mr.

5 Wollschlager.

6 MR. WOLLSCHLAGER: I just want to make

7 sure I understand. So the intent is to distribute conflict

8 of interest forms --

9 MS. HORN: -- I have them both in paper

10 form today and I also have them electronically that I will

11 send out after the meeting. And I did send out an NIH form

12 basically for purposes of if people have questions about

13 what that -- how they should define some of the terms.

14 They can look to the NIH for some guidance on how another

15 group does it. We are not identical to NIH, but I think

16 it’s a helpful form. And then I will put a cover memo on

17 that about if you have any questions to contact me.

18 MR. WALLACK: Can we take care of that

19 today, if we want to?

20 MS. HORN: Yes. That’s it.

21 COMMISSIONER GALVIN: Okay, No. 5, are we

6 7 8 POST REPORTING SERVICE 9 HAMDEN, CT (800) 262-4102 1 82 2 MEETING RE: STEM CELL RESEARCH ADVISORY COMMITTEE 3 AUGUST 15, 2006 4 5 1 ready to move on? Nancy.

2 MS. NANCY RION: Certainly. I have an

3 additional form for you to sign. This is the non-

4 disclosure form, which simply states that if you are

5 choosing to read the proposals, which I understand that

6 you are all interested in doing, that you will not share

7 any of the information which is exempted by -- you will

8 note that on the proposal what is exempted. And you will

9 only talk to other members of the Committee regarding

10 these.

11 DR. CANALIS: Ms. Rion?

12 MS. RION: I’m sorry.

13 DR. CANALIS: I missed. Could you repeat?

14 I missed it.

15 MS. RION: It’s a non-disclosure form that

16 simply says you will not disclose either in writing or

17 orally any information designated in such proposals as

18 trade secrets or commercial --

19 DR. CANALIS: -- okay, got it, fine. We

20 had discussed that.

21 MS. RION: And then once you decide -- I’m

6 7 8 POST REPORTING SERVICE 9 HAMDEN, CT (800) 262-4102 1 83 2 MEETING RE: STEM CELL RESEARCH ADVISORY COMMITTEE 3 AUGUST 15, 2006 4 5 1 not sure what your decision is going to be. If you would

2 like to have access to all of the proposals what I would

3 need to have prior to that is to have this signed form

4 from you and then I would send you passwords so that you

5 can access those on our web. But I cannot do that until I

6 have a signed form from you. So I will send these around.

7 If you have any questions let me know, but I think it’s

8 pretty straightforward. The -- all the members of the peer

9 review have already signed this, received their passwords

10 and they are looking at the proposals.

11 MR. MANDELKERN: Excuse me, what would the

12 password let us enter into? What would the password --

13 MS. RION: -- all of the proposals are on

14 the Connecticut Innovations website. But you can’t get to

15 them until you have this special password. So this

16 special password, which I will give to you after you have

17 given this to me, I will e-mail that to you is only

18 available to the five peer reviewers and to each of you.

19 And it’s not --

20 MR. MANDELKERN: -- when was the decision

21 made that the members of the advisory committee after

6 7 8 POST REPORTING SERVICE 9 HAMDEN, CT (800) 262-4102 1 84 2 MEETING RE: STEM CELL RESEARCH ADVISORY COMMITTEE 3 AUGUST 15, 2006 4 5 1 signing the non-disclosure and getting the password could

2 look at all the grant proposals?

3 MS. RION: Well, I’m not -- I do not --

4 I’m not sure that that decision has been made and --

5 MR. MANDELKERN: -- neither do I.

6 MS. RION: And I think that is up to your

7 discussion today. But eventually you are going to want to

8 see some proposals. So maybe we’re doing something now

9 that we wouldn’t have to do later.

10 MR. MANDELKERN: It was discussed at the

11 last meeting with no conclusion reached.

12 MS. RION: That’s what I understand.

13 MR. MANDELKERN: There was a question of

14 the original grant proposals and the summary submitted by

15 Laura, I guess, by the peer review. I think there should

16 be clarity on that before we go forward.

17 MS. RION: That would be helpful to me as

18 well, so thank you.

19 COMMISSIONER GALVIN: Mr. Wollschlager, do

20 you have --

21 MR. WOLLSCHLAGER: -- yes, I had a

6 7 8 POST REPORTING SERVICE 9 HAMDEN, CT (800) 262-4102 1 85 2 MEETING RE: STEM CELL RESEARCH ADVISORY COMMITTEE 3 AUGUST 15, 2006 4 5 1 question actually.

2 MS. RION: Yes.

3 COMMISSIONER GALVIN: I think your name is

4 a lot harder to pronounce than Mark’s, by the way.

5 MR. WOLLSCHLAGER: I think so too.

6 COMMISSIONER GALVIN: Yes, okay.

7 MR. WOLLSCHLAGER: Thank you for pointing

8 that out to me.

9 COMMISSIONER GALVIN: You’re welcome.

10 MR. WOLLSCHLAGER: On the record, so

11 noted. I do have a question though and it’s for you,

12 Nancy, I guess. Is -- to the extent that other folks in

13 the Department, for instance me, are providing support to

14 the Commissioner in his role as Chair, then why couldn’t I

15 have access to reviewing these grants since I’m working on

16 things like, well, I don’t know -- a lot of things that I

17 need to look at the grant then in order to get a sense of

18 the playing field. So I heard you say this is only

19 available to the five peer reviewers and the members of

20 this Committee. I guess I would then say, well, are

21 Connecticut Innovations staff looking at these

6 7 8 POST REPORTING SERVICE 9 HAMDEN, CT (800) 262-4102 1 86 2 MEETING RE: STEM CELL RESEARCH ADVISORY COMMITTEE 3 AUGUST 15, 2006 4 5 1 applications?

2 MS. RION: I think it was implied by this

3 that the Connecticut Innovations Department of Public

4 Health staff and their legal representation would have

5 access.

6 MR. WOLLSCHLAGER: So actual staff --

7 that’s really all I’m looking for.

8 MS. RION: Yes.

9 MR. WOLLSCHLAGER: Okay, great. I thought

10 it was just the Committee. I hadn’t read it yet. Thanks.

11 COMMISSIONER GALVIN: You’re welcome.

12 MS. RION: This is partly we want to keep

13 track of who has access.

14 MR. RAKIN: Mr. Commissioner, can I ask

15 her I guess it’s a legal question about this

16 confidentially form -- conflict of interest form to

17 Marianne.

18 MS. HORN: Yes.

19 MR. RAKIN: Is this -- when they’re

20 talking about engages in any business transaction, okay,

21 is that past transactions, future, I mean where is the cut

6 7 8 POST REPORTING SERVICE 9 HAMDEN, CT (800) 262-4102 1 87 2 MEETING RE: STEM CELL RESEARCH ADVISORY COMMITTEE 3 AUGUST 15, 2006 4 5 1 off? So for instance, I’m a director of companies that

2 have license agreements with Yale.

3 MS. HORN: Um, hmm.

4 MR. RAKIN: That may still be in place

5 does that fall into this, it seems to me it would. Or --

6 MS. HORN: -- I’m looking at the NIH

7 guidelines here, professional associate, and it talks

8 about professional associate means a colleague -- mentor

9 or student with whom the peer reviewer is currently

10 conducting research or other significant professional

11 activities or with whom the member has conducted

12 activities within three years of the date of review. Not

13 the commercial situation you’re talking about, but it

14 might provide some guidance there.

15 MR. RAKIN: Well, anyway, maybe we can

16 talk about it off line rather than take the whole

17 Committee’s time.

18 DR. KIESSLING: The intent is to not be

19 more rigorous than the NIH guidelines.

20 MS. HORN: No. And -- this is just

21 because there were some terms in the Connecticut law that

6 7 8 POST REPORTING SERVICE 9 HAMDEN, CT (800) 262-4102 1 88 2 MEETING RE: STEM CELL RESEARCH ADVISORY COMMITTEE 3 AUGUST 15, 2006 4 5 1 really are not defined and the NIH provides some guidance.

2 So to the extent that it’s useful I throw that out there.

3 To the extent that it doesn’t speak to it we’ll have to

4 come up with something that is more creative.

5 MR. WOLLSCHLAGER: And absent to Chair, I

6 would just say that I think this body, your body, is going

7 to decide do we want it more rigorous than NIH, yes or no.

8 It’s not specified in the law, it’s really up to you.

9 MS. HORN: And, again, in terms of this

10 form, the confidentiality or the conflict of interest form

11 is drafted off a NIH form. So I look to the scientists

12 around the room to say if I have a professional or

13 business relationship I typically would say it’s only if

14 it’s current. I don’t -- it’s not usually required that

15 we go back. So you can provide us some guidance on what is

16 usual and customary in the scientific field.

17 MS. RION: If I could just make a

18 suggestion, I think it would be easiest for staff if when

19 you list the applications that you might have conflict

20 with if you would do the code number, dash the PI, the

21 main PI. I think you’ll notice when you go to the website

6 7 8 POST REPORTING SERVICE 9 HAMDEN, CT (800) 262-4102 1 89 2 MEETING RE: STEM CELL RESEARCH ADVISORY COMMITTEE 3 AUGUST 15, 2006 4 5 1 all of them are identified that way. So if we could

2 consistently refer to these proposals by the code number

3 and the PI then we can be clear which one you have to be

4 -- you don’t have to write out the whole proposal name.

5 DR. GENEL: May I ask then if you can send

6 me a computerized version of this because it would take me

7 probably 24 hours to list the number of recusals if I were

8 to take this literally.

9 MS. HORN: Okay.

10 DR. GENEL: I have -- I’ll talk to you off

11 line about what I would suggest we do.

12 MS. HORN: Okay.

13 MS. RION: I also think that there may be

14 -- it may -- it may well happen that you begin to read a

15 proposal and realize that there are collaborations in it

16 and so forth that you did not anticipate and that you do

17 have a conflict and that you would have to -- have to add

18 that to your conflict of interest list because there are a

19 lot of -- in some of these group projects and so forth

20 there are a lot of different individuals involved and you

21 might find something that concerns you.

6 7 8 POST REPORTING SERVICE 9 HAMDEN, CT (800) 262-4102 1 90 2 MEETING RE: STEM CELL RESEARCH ADVISORY COMMITTEE 3 AUGUST 15, 2006 4 5 1 MS. HORN: And we’ll establish some kind

2 of a reasonable deadline for this to be done so that we

3 can -- whoever is putting together the process for this

4 group to handle the grants we’ll have some idea of what --

5 how many different kinds of hats to order so that we can

6 keep track of who is able to vote on which grant.

7 DR. CANALIS: So the applications will be

8 available. I mean the only way to determine whether one --

9 whether one is an additional conflict or not is to review

10 the application or at least sit down and -- so that is

11 appropriate.

12 MR. MANDELKERN: That has not been

13 decided.

14 DR. CANALIS: But how do you know you’re

15 in conflict or not unless you examine the application?

16 MR. MANDELKERN: You can’t do it from a

17 summary?

18 DR. CANALIS: You need to see the

19 investigators and whether you have had any recent

20 affiliation with any of them. And sometimes from the

21 principle investigator you know it, but sometimes there

6 7 8 POST REPORTING SERVICE 9 HAMDEN, CT (800) 262-4102 1 91 2 MEETING RE: STEM CELL RESEARCH ADVISORY COMMITTEE 3 AUGUST 15, 2006 4 5 1 could be enlarged programs unless you see who else is

2 involved how do I know.

3 MS. HORN: So when you’re doing a grant

4 for another organization, a grant review, how would you

5 handle that?

6 DR. CANALIS: If I find during the review

7 process that I am in conflict I’ll call the executive

8 secretary and I’d tell him or her I am in conflict. That’s

9 what I do. You know, they give me, Ernie, would you

10 review this and half the way I say there is a conflict and

11 I return it. I mean that’s the norm in the world that I

12 have lived under today. So, you know, I mean obviously my

13 world is changing. But -- so I would have to have access

14 to an application to know whether or not I am in conflict.

15 I’ll do as I’m told, I don’t care.

16 DR. JENNINGS: But if I can just clarify,

17 the applications, Nancy, they’re all available -- they are

18 all on the website now and technologically, at least,

19 pending a policy decision they could be accessible to all

20 of us.

21 MS. RION: That’s correct.

6 7 8 POST REPORTING SERVICE 9 HAMDEN, CT (800) 262-4102 1 92 2 MEETING RE: STEM CELL RESEARCH ADVISORY COMMITTEE 3 AUGUST 15, 2006 4 5 1 DR. JENNINGS: Okay.

2 MR. WOLLSCHLAGER: They’ve been -- all

3 peer reviewers have access at this point.

4 DR. KIESSLING: Is it helpful to review

5 what current practice is in -- would that be helpful? So

6 now -- you’re sent their grants on a disc and there is two

7 -- there is two parts of study section and review so we --

8 one is that you make sure that you don’t have a conflict.

9 A conflict, you know, Commissioner Galvin would not be a

10 conflict under NIH guidelines right now. Only if he were

11 much more closely related to some of the research than

12 simply being part of the administration of that

13 institution. So you have to just make sure that you don’t

14 have a conflict that’s real.

15 But you also have to guarantee that you’re

16 going to destroy those applications when you’re done. I

17 mean getting rid of the application, not keeping a copy of

18 the application you are encouraged over and over. This is

19 for this room only and period. When the review process is

20 over any information that you talk about that application,

21 including your own telling statements, you’re encouraged

6 7 8 POST REPORTING SERVICE 9 HAMDEN, CT (800) 262-4102 1 93 2 MEETING RE: STEM CELL RESEARCH ADVISORY COMMITTEE 3 AUGUST 15, 2006 4 5 1 to destroy.

2 MS. HORN: Um, hmm.

3 DR. KIESSLING: So that’s a big part of

4 grant review at NIH. Part of it is conflict of interest,

5 but part of it is maintaining the confidentiality of

6 what’s reviewed in that room.

7 MS. HORN: There is a certification at the

8 end of the conflict of interest form that says, again,

9 there is no non-disclosure. And I also agree to destroy or

10 return all material, not to disclose or discuss, and not

11 to disclose procurement information and to refer all

12 inquiries concerning the review back to Connecticut

13 Innovations.

14 DR. KIESSLING: Right.

15 DR. CANALIS: Attorney Horn?

16 MS. HORN: Yes.

17 DR. CANALIS: On request, actually this is

18 for Nancy.

19 MS. RION: Yes.

20 DR. CANALIS: I am not going to be able to

21 access the applications on the web because of the request

6 7 8 POST REPORTING SERVICE 9 HAMDEN, CT (800) 262-4102 1 94 2 MEETING RE: STEM CELL RESEARCH ADVISORY COMMITTEE 3 AUGUST 15, 2006 4 5 1 of Dr. Yang. So you are going to have to devise a

2 different method for me to access the applications.

3 MR. MANDELKERN: It has not been decided

4 by the Committee that there will be access to the

5 applications as you --

6 DR. CANALIS: -- if there were to be

7 access to the applications, in my case, I’m requesting to

8 abide by Dr. Yang’s request that I do not go near his

9 application which I agree. So if we are in that -- in

10 that vein, we have just signed, you know, some documents

11 here and what I’m requesting is that a method be devised

12 -- can I finish? When I finish I’ll tell you. That a

13 method that be devised that I have no access to his

14 application.

15 DR. YANG: Can I clarify?

16 COMMISSIONER GALVIN: Jerry?

17 DR. YANG: I’d like to clarify what I

18 stated in the request. It is not your looking at my

19 proposals, that’s not --

20 DR. CANALIS: -- my request is that I have

21 no access to Dr. Yang’s application.

6 7 8 POST REPORTING SERVICE 9 HAMDEN, CT (800) 262-4102 1 95 2 MEETING RE: STEM CELL RESEARCH ADVISORY COMMITTEE 3 AUGUST 15, 2006 4 5 1 DR. YANG: That is your request.

2 DR. CANALIS: In that case it is my

3 request.

4 COMMISSIONER GALVIN: All right, we can --

5 there is a way to fix that.

6 MR. MANDELKERN: I would like to step back

7 and consider as a Committee whether it is in the interest

8 of the Committee to open all the grant proposals to all

9 the Committee members. I see a process that encumbers our

10 work rather than moves it forward. There is now a whole

11 process of destroying 70 grants by each one of us. What

12 if it’s not done? What does that open us to? I’m not a

13 scientist, but I don’t doubt my ability to evaluate the

14 worth of a grant, given a rank, given a score and given a

15 summary statement by five peer reviewers.

16 I think that if we go through getting the

17 password after signing non-disclosures and confidentiality

18 it will delay the work of coming to a conclusion about how

19 to distribute our funds. And I think that is not our

20 purpose. I think our purpose is to efficiently, fairly and

21 equitably move forward and allow the peer review

6 7 8 POST REPORTING SERVICE 9 HAMDEN, CT (800) 262-4102 1 96 2 MEETING RE: STEM CELL RESEARCH ADVISORY COMMITTEE 3 AUGUST 15, 2006 4 5 1 committee’s work to stand on its own feet, which is to

2 give us summaries, ranks and scores that we can take

3 forward to make decisions, as we have decided, at a

4 previous meeting in one day.

5 If we are all to access 70 grant

6 proposals, read them between the 4th and the 17th, and

7 evaluate them I don’t see how we’re ever going to get done

8 with the work to distribute our funds, which we are on the

9 verge of doing if we do not open up pitfalls for

10 ourselves. I think the opening of a password to all the

11 grant proposals is one that I do not support. And I would

12 like to see it put to a vote and so that it’s on the

13 record as such.

14 COMMISSIONER GALVIN: Is that a motion to

15 that effect?

16 MR. MANDELKERN: Well, there’s no motion

17 to open it. I’m not going to put a motion up that I don’t

18 support.

19 COMMISSIONER GALVIN: Okay.

20 MR. MANDELKERN: Unless you want me to put

21 a motion that I’ll speak against. That’s not probably

6 7 8 POST REPORTING SERVICE 9 HAMDEN, CT (800) 262-4102 1 97 2 MEETING RE: STEM CELL RESEARCH ADVISORY COMMITTEE 3 AUGUST 15, 2006 4 5 1 parliamentary, is it?

2 DR. JENNINGS: Mr. Chairman, if I may, I’d

3 would like to put forward the opposite motion so that the

4 Committee has the opportunity to consider it. I would like

5 to propose a motion that the grants should be made

6 available to this Committee. And I completely agree with

7 Mr. Mandelkern that we should not be obliged to look at

8 them, but that we should have the opportunity to do so if

9 we wish. I think we have a -- as you absolutely rightly

10 state, we have an obligation, which is to move this

11 process forward quickly. I think we have a plan for doing

12 that. We have a meeting that is scheduled to start at 8:30

13 on, from memory, October the 15th.

14 COMMISSIONER GALVIN: Yes, you’re brining

15 breakfast, don’t you recall?

16 DR. JENNINGS: I’m bringing breakfast,

17 right. I’ll supply the donuts. But we have an obligation

18 to come to that meeting as prepared as we see fit and

19 reach decisions by the end of that day. And I think if

20 individual members feel that it would be helpful to look

21 at the whole text of any particular application for

6 7 8 POST REPORTING SERVICE 9 HAMDEN, CT (800) 262-4102 1 98 2 MEETING RE: STEM CELL RESEARCH ADVISORY COMMITTEE 3 AUGUST 15, 2006 4 5 1 whatever purpose my view is that they should be free to do

2 so. I completely agree with Ernie Canalis’ point that

3 there are cases in which you may have a conflict of

4 interest that will not become apparent until you look at

5 the application in its entirety. We are also under an

6 obligation to assess the implications not only

7 scientifically, but also to advance the general purpose

8 that benefits the State of Connecticut. And I think that

9 may not be apparent from the short notes of the reviewers

10 who are not under any mandate to consider that. That’s our

11 mandate. It’s not theirs.

12 And frankly we don’t know exactly what

13 we’re going to hear from them. We don’t know how good a

14 job they will do of summarizing. We can’t necessarily take

15 it on trust that they do a perfect job. And there may be

16 reviewers and their recommendations, which we will want to

17 go back and compare with the original to make sure that

18 we’ve understood correctly. I think there are a number of

19 reasons why we might benefit from having the option,

20 although I would reiterate not the obligation to look at

21 any grant that --

6 7 8 POST REPORTING SERVICE 9 HAMDEN, CT (800) 262-4102 1 99 2 MEETING RE: STEM CELL RESEARCH ADVISORY COMMITTEE 3 AUGUST 15, 2006 4 5 1 COMMISSIONER GALVIN: -- would it be fair

2 to say that your motion is to allow --

3 DR. JENNINGS: -- that was a unwieldy

4 motion.

5 COMMISSIONER GALVIN: Would it be fair to

6 say that your motion would be to allow members of this

7 Committee to have an access code so that they can review

8 any of the applications that they choose with the

9 exception that Dr. Canalis does not want to review --

10 DR. JENNINGS: -- yes, I might not use the

11 word review. I don’t want to create ambiguity.

12 COMMISSIONER GALVIN: Peruse.

13 DR. JENNINGS: Peruse, thank you.

14 MR. WALLACK: I’ll second the motion.

15 COMMISSIONER GALVIN: Okay. Any

16 discussion?

17 MR. MANDELKERN: Well, I would talk

18 against it as I did before. I think it would be a delaying

19 process particularly on the day when we make decisions if

20 people come in venting the proposals as opposed to what

21 the peer review committee has ranked and scored that would

6 7 8 POST REPORTING SERVICE 9 HAMDEN, CT (800) 262-4102 1 100 2 MEETING RE: STEM CELL RESEARCH ADVISORY COMMITTEE 3 AUGUST 15, 2006 4 5 1 open up the whole process all over again and prevent us

2 from a decision. I am opposed to the motion because I see

3 it as delaying not as expediting.

4 COMMISSIONER GALVIN: Dr. Lensch.

5 DR. LENSCH: I’ve heard Mr. Mandelkern’s

6 concerns and I think they’re valid concerns. Personally,

7 it comes down to a single issue in my mind and that is

8 that I am not in good faith, though I sit here today

9 having no relationship to any Connecticut institution and

10 I should be able to disclose that I do not. But I have no

11 direct knowledge of that until I have reviewed the way the

12 applications are played out in terms of collaborations.

13 And so I cannot sign this form until I’ve had access to at

14 least review that aspect of the application. And I must

15 support the motion and particulate only that one point to

16 do so.

17 COMMISSIONER GALVIN: Thank you. Any

18 further discussion? We’ll have a vote. All in favor of

19 the motion. The motion, again, is to allow members of this

20 assembly to have, and selected others, to have an access

21 code to peruse the applications once they have returned

6 7 8 POST REPORTING SERVICE 9 HAMDEN, CT (800) 262-4102 1 101 2 MEETING RE: STEM CELL RESEARCH ADVISORY COMMITTEE 3 AUGUST 15, 2006 4 5 1 from the International Review Committee. Is that -- no?

2 DR. JENNINGS: No, that’s not necessarily.

3 MS. HORN: Before that.

4 COMMISSIONER GALVIN: To peruse them at

5 any time.

6 DR. JENNINGS: We do not want to delay

7 things.

8 COMMISSIONER GALVIN: Okay. So the motion

9 is to --

10 DR. JENNINGS: -- as soon as technically

11 feasible.

12 COMMISSIONER GALVIN: That members of the

13 Committee and other officials who need to access them for

14 more -- for technical reasons should be provided with the

15 code to allow them access to all of the grants with the

16 exception of Dr. Canalis and Dr. Yang have agreed that Dr.

17 Canalis does not want to see Dr. Yang’s particular

18 document. That is the motion that’s on the floor. All in

19 favor?

20 VOICES: Aye.

21 COMMISSIONER GALVIN: Opposed? The vote

6 7 8 POST REPORTING SERVICE 9 HAMDEN, CT (800) 262-4102 1 102 2 MEETING RE: STEM CELL RESEARCH ADVISORY COMMITTEE 3 AUGUST 15, 2006 4 5 1 is carried. I think we can find a way to exclude that one

2 document from the set given to Dr. Canalis.

3 MS. RION: Sure.

4 COMMISSIONER GALVIN: If we can’t do it

5 easily with the network and with the technology we’ll just

6 have to make copies of everything save that one.

7 MS. RION: If I may, the website you’re

8 going to have to click on each proposal and you can look

9 at whatever proposals you choose.

10 COMMISSIONER GALVIN: Okay.

11 MS. RION: You can choose not to look at

12 one or more, that’s fine.

13 COMMISSIONER GALVIN: That’s fine. But I

14 think what Dr. Canalis wants is to make sure it’s not in

15 his set of things to look at. And so we may want to

16 provide him with a --

17 DR. CANALIS: -- I’ll work with you,

18 Nancy.

19 MS. RION: Okay.

20 COMMISSIONER GALVIN: Yes, I don’t think

21 it’s an impossibility to exclude that one document.

6 7 8 POST REPORTING SERVICE 9 HAMDEN, CT (800) 262-4102 1 103 2 MEETING RE: STEM CELL RESEARCH ADVISORY COMMITTEE 3 AUGUST 15, 2006 4 5 1 MR. WALLACK: Can I request that Dr. Genel

2 not look at my application?

3 DR. GENEL: My pleasure.

4 COMMISSIONER GALVIN: Now, for the general

5 good of the audience, I have to leave at quarter till the

6 hour. I have a downstate appointment and now what does

7 that mean? Can I appoint someone to chair in my absence,

8 Henry?

9 MR. SALTON: Yes. You’re meaning --

10 COMMISSIONER GALVIN: -- 15 minutes.

11 MR. SALTON: 15 minutes?

12 COMMISSIONER GALVIN: Yes.

13 MR. SALTON: If the Committee wishes to

14 remain in session.

15 COMMISSIONER GALVIN: Okay. Then let’s go

16 --

17 DR. JENNINGS: -- you go, we go.

18 COMMISSIONER GALVIN: Okay. We’re on Item

19 6, I believe. Okay. Let me make a remark that -- I’ll

20 say this as nicely as I can. I don’t have a clue of how

21 to go in and review all of these things. I don’t do this.

6 7 8 POST REPORTING SERVICE 9 HAMDEN, CT (800) 262-4102 1 104 2 MEETING RE: STEM CELL RESEARCH ADVISORY COMMITTEE 3 AUGUST 15, 2006 4 5 1 So I will have to have people like Dr. Yang and Dr.

2 Canalis and the scientists who do these -- it’s not that I

3 don’t’ have a clue about lots of things. I have clues of

4 -- lots of clues about lots of things, but my career has

5 been all primary care. So I don’t know how you get 70

6 applications and in eight hours decide what you’re going

7 to do. So I’d have to -- perhaps Dr. Lensch, Dr. Canalis

8 and others can -- I mean physically what do you do? You

9 go in and you sit down and then what happens after we have

10 the breakfast that -- linger, yes.

11 DR. CANALIS: Commissioner, upfront

12 usually the initial review committee has made some obvious

13 recommendations and in general terms, you know, the lower

14 50 percent of applications receive little discussion. So

15 if you follow the NIH system there are ways to sort out

16 applications that upfront everybody believes are not going

17 to get funded. Of course, this Committee may not find

18 that approach acceptable. But a way, you know, to sort

19 out is you have applications that have scored in the

20 extremely poor range, you know, the summary statement of

21 the peer review should guide us in that sense, you know.

6 7 8 POST REPORTING SERVICE 9 HAMDEN, CT (800) 262-4102 1 105 2 MEETING RE: STEM CELL RESEARCH ADVISORY COMMITTEE 3 AUGUST 15, 2006 4 5 1 COMMISSIONER GALVIN: Based on your

2 experience when we get these back --

3 DR. CANALIS: -- I haven’t done study

4 session for a while, I’m too old, they don’t ask me any

5 longer. But --

6 COMMISSIONER GALVIN: -- don’t talk to me

7 about being too old. But would we expect that these would

8 come back and they would fall out in some order. I mean

9 one would get 98, one would get 97, one would get --

10 DR. CANALIS: -- you should ask the peer

11 review committee that that’s what you would like to see,

12 Commissioner. If that’s what you want, you know, you need

13 -- my assumption is there are going to score the

14 applications with a numerical number.

15 COMMISSIONER GALVIN: Okay.

16 DR. CANALIS: Numerical can’t be not a

17 number, I guess. And then they can rank them for you or

18 Nancy can rank them for you, if that’s what you want.

19 COMMISSIONER GALVIN: Okay, I was just

20 sort of concerned are they going to come back and say,

21 pretty good, not so good and not good at all.

6 7 8 POST REPORTING SERVICE 9 HAMDEN, CT (800) 262-4102 1 106 2 MEETING RE: STEM CELL RESEARCH ADVISORY COMMITTEE 3 AUGUST 15, 2006 4 5 1 DR. CANALIS: My understanding is that

2 they were going to be scored. Is that correct, Nancy?

3 MS. RION: Yes.

4 DR. JENNINGS: Can somebody clarify the

5 details of the instructions that they’ve received so far?

6 COMMISSIONER GALVIN: Yes.

7 MR. WOLLSCHLAGER: Yes, again, it’s not an

8 instructional process because like this body they can

9 choose their own process. But what they’ve committed to

10 is to follow NIH as closely as possible including not

11 providing -- and we’re looking at this right now -- not

12 providing a numerical score or a ranking for the bottom 50

13 percent, which Dr. Canalis referenced. But -- so they’re

14 looking at, you know, the -- I always get this backwards.

15 So if they’re looking at the 1 to 2.5 they’re going to

16 provide those scores and then provide an ordinal ranking

17 within the categories of the applications. So if you have

18 20 applications that they’ve looked at maybe the bottom --

19 those that fall out of the bottom 50 percent may not have

20 a score or a ranking. Those other ten will have a score

21 and a ranking within the category.

6 7 8 POST REPORTING SERVICE 9 HAMDEN, CT (800) 262-4102 1 107 2 MEETING RE: STEM CELL RESEARCH ADVISORY COMMITTEE 3 AUGUST 15, 2006 4 5 1 COMMISSIONER GALVIN: Okay, I understand

2 what you said and I’m used to my military background. We

3 get 20 applicants and we get -- ten of them were people we

4 really didn’t think had the juice or the academic

5 qualifications. And we sort of put them in a pile and say,

6 well, we’ll look at these if something happens and we

7 can’t -- we can’t pick five out of the top ten. But they

8 really didn’t get very much attention.

9 So if I’m -- and, Jerry, you were -- or

10 Ernie can correct me, it sounds like we’re going to get a

11 series of applications that are basically unranked and are

12 just going to be there. And then we’re going to spend our

13 time with about half of the applications and sort them

14 out. Is that a fair assumption, Jerry?

15 DR. YANG: Yes. That’s normally the way

16 --

17 DR. KIESSLING: -- the mission of this

18 Committee is to decide how to spend the money not rank --

19 we’re not --

20 DR. CANALIS: -- it is a funding

21 committee.

6 7 8 POST REPORTING SERVICE 9 HAMDEN, CT (800) 262-4102 1 108 2 MEETING RE: STEM CELL RESEARCH ADVISORY COMMITTEE 3 AUGUST 15, 2006 4 5 1 DR. KIESSLING: So this is -- so we’re

2 sort of functioning like council.

3 DR. CANALIS: That is correct.

4 DR. KIESSLING: At NIH not --

5 DR. CANALIS: -- that is correct.

6 DR. KIESSLING: Not peer review.

7 DR. CANALIS: Right.

8 DR. KIESSLING: And the council at NIH is

9 the one that decides, okay, this is how they ranked them

10 and this is the money and this is how we want to spend the

11 money. I mean you’ve got four categories, I think -- five.

12 So it seems like this Committee is going to figure out how

13 these applications fall out relative to how you want to

14 spend the money not whether you agree with the ranking

15 system. Correct?

16 DR. CANALIS: That’s correct.

17 COMMISSIONER GALVIN: Yes, but you’re not

18 going to give somebody ranked -- you’re probably not going

19 to fund somebody 15 out of 15 or are you?

20 MR. WOLLSCHLAGER: I would think -- I mean

21 it’s up to the Committee, but --

6 7 8 POST REPORTING SERVICE 9 HAMDEN, CT (800) 262-4102 1 109 2 MEETING RE: STEM CELL RESEARCH ADVISORY COMMITTEE 3 AUGUST 15, 2006 4 5 1 DR. KIESSLING: -- it depends on how you

2 want to --

3 MR. WOLLSCHLAGER: -- that you would not

4 be looking at -- even if this Committee wanted to invest a

5 100 percent in start up research, you know, the new

6 investigators, if in fact the proposals lacked scientific

7 and/or ethical merit you may want to change your decision

8 on where you’re going to invest.

9 DR. KIESSLING: Right.

10 MR. WOLLSCHLAGER: So you’re not going to

11 invest in poor science or poor -- you know, ethically

12 challenged science just because you think that’s the

13 algorithm that best fits the State of Connecticut.

14 DR. CANALIS: And it would be unusual for

15 council to fund -- they fund out of sequence, but to go in

16 the bottom 50 percent would --

17 MR. WOLLSCHLAGER: -- yes.

18 DR. CANALIS: Would be rather unusual.

19 MR. WOLLSCHLAGER: I guess that’s better

20 stated.

21 DR. CANALIS: And that’s basically --

6 7 8 POST REPORTING SERVICE 9 HAMDEN, CT (800) 262-4102 1 110 2 MEETING RE: STEM CELL RESEARCH ADVISORY COMMITTEE 3 AUGUST 15, 2006 4 5 1 DR. KIESSLING: -- but it’s not unheard

2 of.

3 DR. CANALIS: I didn’t say it’s

4 impossible, I said it would be rather unusual.

5 COMMISSIONER GALVIN: Yes, let me clarify

6 something, Jerry. If something comes back unranked and --

7 are we going to say, well, we better look at all the

8 unranked ones because maybe we’re missing something?

9 DR. KIESSLING: No.

10 COMMISSIONER GALVIN: No, okay. Okay.

11 DR. KIESSLING: But if you say you want to

12 spend X money on cores and you’ve got ten applications for

13 core grants.

14 MR. MANDELKERN: No, you have two.

15 DR. KIESSLING: Well, I know, but I was

16 just giving an example. And eight of those ended up in

17 that bottom pile, but you still think that investing in

18 cores is going to speak to some of the issues for some of

19 the other applications, you might dig down into the ones

20 that they didn’t think were so great so you can have as

21 many cores as you think Connecticut needs. That’s the kind

6 7 8 POST REPORTING SERVICE 9 HAMDEN, CT (800) 262-4102 1 111 2 MEETING RE: STEM CELL RESEARCH ADVISORY COMMITTEE 3 AUGUST 15, 2006 4 5 1 of decision I thought this Committee was making. Big

2 picture decisions, not which application -- I think this

3 Committee wants to figure out -- you want so much in new

4 investigator, established investigator, core facilities.

5 COMMISSIONER GALVIN: Bob, you had a

6 comment.

7 MR. MANDELKERN: yes, I think if you

8 looked at the distribution of the grant requests you will

9 get a logical approach because if half of them, for

10 example, are dropped off for no merit. They get no rank,

11 no score from the peer review. That means you will have 17

12 seeds left, for example. You will have 13 investigators,

13 two groups, one core possibly and two hybrids. That will

14 be refine because there is in the application there is a

15 limit, if memory serves me, of a 100,000 -- no, 200,000

16 for a seed, a million for experienced investigator,

17 etcetera. You will have very logical parameters that fall

18 into place.

19 So I think that even though there has been

20 no attempt to codify application of the available funds to

21 the categories inherently we can see it that way if we

6 7 8 POST REPORTING SERVICE 9 HAMDEN, CT (800) 262-4102 1 112 2 MEETING RE: STEM CELL RESEARCH ADVISORY COMMITTEE 3 AUGUST 15, 2006 4 5 1 approach it from a logical point of view. They will fall

2 that way because if it’s maximum for a seed is 200,000 and

3 you do ten, you’re only spending two million dollars.

4 COMMISSIONER GALVIN: Okay. So we go into --

5 and I know Charles and Nancy have a comment. So we go

6 into our room and there is a bunch of these applications.

7 Then what happens?

8 MS. RION: If I could tell you the

9 experience that I have had. I have had a group such as

10 yourselves.

11 COMMISSIONER GALVIN: Um, hmm.

12 MS. RION: Review to make funding

13 decisions on as many as a 130 proposals in one day. You

14 spend very, very little time on those that are not -- that

15 do not get a good score from your peer reviewers.

16 COMMISSIONER GALVIN: Okay.

17 MS. RION: In the process that I’ve run

18 we’ve always addressed each one so that just because the

19 panel felt that that was important.

20 COMMISSIONER GALVIN: Got you.

21 MS. RION: To address it. But it doesn’t

6 7 8 POST REPORTING SERVICE 9 HAMDEN, CT (800) 262-4102 1 113 2 MEETING RE: STEM CELL RESEARCH ADVISORY COMMITTEE 3 AUGUST 15, 2006 4 5 1 take more than a minute or two to do that. Then there are

2 some that the peer review is likely to come back and say

3 these are absolutely outstanding. Those very usually have

4 a very fairly quick discussion because everyone has read

5 it and said, wow, this is fabulous.

6 The top -- most of the time has been

7 spent, in my experience, on those --

8 COMMISSIONER GALVIN: -- in between.

9 MS. RION: Sort of, maybes and I always

10 have newsprint all over the wall with each one of the --

11 one of these up there with the information that’s needed.

12 And correct me if I’m wrong, but it seems to me that the

13 directions to the peer review were for them to look at the

14 scientific and technical merit and ethical merit as well.

15 You all on those maybes, it seems to me, look at the rest

16 of your criteria, financial benefits to the state, the

17 potential for collaboration, the alignment with the

18 funding priorities and the commitment of the host

19 institution and collaborators that’s where you would look

20 at those pieces that you have established as criteria to

21 make the -- this final decision on those maybes. And I

6 7 8 POST REPORTING SERVICE 9 HAMDEN, CT (800) 262-4102 1 114 2 MEETING RE: STEM CELL RESEARCH ADVISORY COMMITTEE 3 AUGUST 15, 2006 4 5 1 think it’s very possible to do this within a day.

2 COMMISSIONER GALVIN: Okay. Are we going

3 to have a score sheet?

4 DR. JENNINGS: I think we’ll need one.

5 MS. RION: A score sheet for each one of

6 you? I don’t think you need that.

7 COMMISSIONER GALVIN: For the various --

8 you mentioned five different categories here now. How do

9 we figure out maybe one has outstanding cooperation and

10 outstanding --

11 MS. RION: -- excuse me.

12 COMMISSIONER GALVIN: Yes, go ahead.

13 MS. RION: I apologize. What tends to be

14 -- I would recommend you considering, some of you,

15 choosing to focus on one or another kinds of proposals so

16 that some of you can speak specifically. So that when we

17 come up to Proposal A that Mike Genel is going to say I

18 read this thoroughly. There is a fabulous collaboration in

19 here, dah, dah, dah, dah. And then you all sort of say,

20 okay, and then go on. So you may want to consider just as

21 the peer review has chosen two people for it to focus on

6 7 8 POST REPORTING SERVICE 9 HAMDEN, CT (800) 262-4102 1 115 2 MEETING RE: STEM CELL RESEARCH ADVISORY COMMITTEE 3 AUGUST 15, 2006 4 5 1 each proposal, maybe you all would want to divide those up

2 so that you can have --

3 COMMISSIONER GALVIN: -- okay.

4 MS. RION: Depend on a couple of people to

5 have some real knowledge of that proposal.

6 COMMISSIONER GALVIN: Okay. I’m not trying

7 to be difficult. I’m just trying to figure out the -- how

8 many chairs do we need, how many -- how do we do this.

9 Because it’s -- it may have been a long time since Dr.

10 Canalis has done this. I’ve done it with selecting people,

11 senior officers for promotion and you get 20 people and

12 you know the bottom ten and you know the top three or

13 four. And then you get these ones in the middle that you

14 -- finally somebody says, you know, I’m acquainted with

15 this situation and I know the schooling this guy has had

16 and I think he’s an outstanding -- it appears he’s an

17 outstanding candidate. So it’s kind of the same thing

18 you’re saying.

19 MS. RION: Right.

20 COMMISSIONER GALVIN: Yes. I’m just -- I

21 don’t want to mill around in there for a couple of hours

6 7 8 POST REPORTING SERVICE 9 HAMDEN, CT (800) 262-4102 1 116 2 MEETING RE: STEM CELL RESEARCH ADVISORY COMMITTEE 3 AUGUST 15, 2006 4 5 1 looking for --

2 MS. RION: -- you can’t do that.

3 COMMISSIONER GALVIN: Yes. Dr. Yang.

4 DR. YANG: Yes. I’ve been thinking of

5 adding a comment on the national model. It’s certainly a

6 good one. I think that one we -- the bottom 50 percent

7 there is really no need to discuss, only the top ranking

8 ones that tend to go for discussion. And I think Nancy

9 directions were clear too that the -- I think Nancy also

10 stated clearly that the Committee -- the review

11 committee’s job is really for scoring and ranking, but not

12 necessarily making which one is funded and which one is

13 not funded. You can be a top ranked but still not be

14 funding and that could be more like the Natural Science

15 Foundation, they said, sorry, you are -- into the Natural

16 Science Foundation category because -- the same for our

17 Committee decision we -- but the decision making whether

18 to fund or not you’re going to -- the No. 1 ranking and --

19 so the Committee is really the final decision on which one

20 we are funding.

21 COMMISSIONER GALVIN: Okay, I’m good.

6 7 8 POST REPORTING SERVICE 9 HAMDEN, CT (800) 262-4102 1 117 2 MEETING RE: STEM CELL RESEARCH ADVISORY COMMITTEE 3 AUGUST 15, 2006 4 5 1 MR. WALLACK: I have a question. We have

2 Harvard applications. Say I love the research that’s

3 going to be done by the senior investigator, but I’m also

4 committed to having two cores. Can I then extrapolate out

5 and say I want to fund the researcher? Can I make that

6 decision at that point or does it have to go back to the

7 researcher with the idea that, you know, for his approval

8 that we can disassociate the two? How does that work?

9 COMMISSIONER GALVIN: I don’t know.

10 DR. KIESSLING: It’s just -- that’s the

11 hard part. You’ve only got so much money and you’ve got

12 to figure out --

13 MR. WALLACK: -- let me give you a real

14 life thing. Say I have an application for five million

15 dollars.

16 DR. KIESSLING: Right.

17 MR. WALLACK: I’ve already made my

18 commitment, as you indicated before, to my two cores.

19 DR. KIESSLING: Right.

20 MR. WALLACK: But my hybrid is going to

21 fund a million dollars to a senior researcher, four or

6 7 8 POST REPORTING SERVICE 9 HAMDEN, CT (800) 262-4102 1 118 2 MEETING RE: STEM CELL RESEARCH ADVISORY COMMITTEE 3 AUGUST 15, 2006 4 5 1 five million dollars to basically another core. I want to

2 fund the research. Can I then say, yes, I’m going to

3 approve the research that’s within that hybrid formula but

4 I’m going to assign that senior investigator to do his

5 research or recommend that he does at another core. It’s

6 his option about whether or not he wants to accept that

7 recommendation. Can I do that?

8 DR. KIESSLING: I think this Committee can

9 do anything it decides it can do. The mandate is to make

10 the best use of the money.

11 MR. WALLACK: Okay. So I can do that.

12 DR. KIESSLING: But if you decided that’s

13 the best use of the money. I mean there are times when

14 grants go back out council saying the only part of this

15 application which scored well that really fits our mandate

16 right now is aims two and three. So --

17 MR. WALLACK: -- okay.

18 DR. KIESSLING: Their budgets are cut. I

19 think the mandate to this Committee is to make the very

20 best use of the funds that you have at your disposal. And

21 I think --

6 7 8 POST REPORTING SERVICE 9 HAMDEN, CT (800) 262-4102 1 119 2 MEETING RE: STEM CELL RESEARCH ADVISORY COMMITTEE 3 AUGUST 15, 2006 4 5 1 MR. MANDELKERN: -- well, I would like to

2 make a point of view from an overall point of view if it

3 is stated by those who are experienced in this awarding of

4 the funds at the final bottom line that 50 percent of the

5 grants will be found not meritorious. If that happens to

6 equate with 50 percent of the money we will have

7 eliminated 30 odd thousand dollars worth of grants. So we

8 would be left with 30 odd thousand and we have 20 million.

9 Excuse me, I meant the opposite. I didn’t mean to. What I

10 mean to say is we’ll be left with 30 odd million dollars

11 worth and we have 20 million dollars, which means that

12 it’s not such a momentous task.

13 Dr. Galvin, I wanted to make this point

14 and I wanted you to hear it because it may answer some of

15 the quandary you had. If 50 percent of the grants are not

16 meritorious and at the bottom, and they equate with 50

17 percent of the money then we’re only dealing with 30 odd

18 million and we have 20 million, which wouldn’t be an

19 insurmountable task.

20 COMMISSIONER GALVIN: But I don’t know

21 which ones, you know, I can’t tell that.

6 7 8 POST REPORTING SERVICE 9 HAMDEN, CT (800) 262-4102 1 120 2 MEETING RE: STEM CELL RESEARCH ADVISORY COMMITTEE 3 AUGUST 15, 2006 4 5 1 MR. MANDELKERN: It’s possible that it

2 might fall in that pattern.

3 COMMISSIONER GALVIN: It’s possible.

4 That’s rather more geometric than I would like to think of

5 it.

6 DR. CANALIS: I’d like to address the

7 issue you brought up of starting to tease grants apart. I

8 do have difficulties with that unless that is decided

9 beforehand and in what kinds of situations. I think the

10 rules need to be stated upfront otherwise it’s going to

11 become arbitrary. You are entitled to do that. As Ann

12 said, the problem is that we’re under scrutiny and it’s

13 going to be, you know, you’re going to be called

14 arbitrary. And I think that the rules need to be stated

15 upfront.

16 Investigators have the opportunity to

17 decide for what type of funds apply and if they made the

18 wrong strategic decision that is life. You know, that’s

19 what happens to all of us.

20 MR. SALTON: I think that there is a

21 concern that when you issued the Request For Proposals for

6 7 8 POST REPORTING SERVICE 9 HAMDEN, CT (800) 262-4102 1 121 2 MEETING RE: STEM CELL RESEARCH ADVISORY COMMITTEE 3 AUGUST 15, 2006 4 5 1 applications if you did not put out front that hybrids

2 could be split up and give applicants the notice that you

3 could submit a hybrid and at the same time you’re really

4 going for a hybrid or we could be -- a research -- okay,

5 then people may not have said, well, look I don’t have --

6 I didn’t realize I had that option. And so I put all my

7 eggs in putting it into this pool of type of categories or

8 grants in order to make sure it was -- my first priority

9 to make sure my research was funded and I wasn’t pursuing

10 an opportunity to collaborate between a hybrid.

11 If -- and some people may have covered

12 both eggs, both categories. I put in a hybrid and I put

13 in a separate stand alone application for research. So I

14 don’t think at this point in time in light of the way you

15 structured the request for proposal that you could start

16 taking a category and splitting that application so that

17 really it fits into -- one application so it fits into two

18 categories.

19 MR. WALLACK: Henry, how do you answer

20 Ann’s remark that from what I heard from Ann, I mean we’re

21 here to do the best we possibly can.

6 7 8 POST REPORTING SERVICE 9 HAMDEN, CT (800) 262-4102 1 122 2 MEETING RE: STEM CELL RESEARCH ADVISORY COMMITTEE 3 AUGUST 15, 2006 4 5 1 MR. SALTON: Yes. But in generic -- in

2 general applicable state contracting and request for grant

3 law you still have to be concerned with making sure that a

4 process is fair and appropriate. You can’t just, for

5 example, say we -- unless you’re going to withdraw the

6 request for proposal in total, okay, because we are a

7 state agency and we have to play by state fairness rules

8 in a way.

9 You can’t say, for example, well, we got

10 all the applications now we’re going to change all the

11 rules as far as how an application will be weighed. We’re

12 going to throw out the factors because the bottom line is

13 we want to what’s right for stem cell research

14 generically. And so I think that at this point I would

15 have a concern and would advice the Committee to be very

16 cautious of taking a hybrid and deciding that you’re going

17 to kind of carve out the facility portion of the hybrid

18 and just look at -- and -- without having anyone knowing

19 that this was an opportunity in advance when they

20 submitted their applications.

21 COMMISSIONER GALVIN: I think Henry is

6 7 8 POST REPORTING SERVICE 9 HAMDEN, CT (800) 262-4102 1 123 2 MEETING RE: STEM CELL RESEARCH ADVISORY COMMITTEE 3 AUGUST 15, 2006 4 5 1 entirely true. It’s patently unfair to do that. And

2 without -- you can’t, it would never -- we would never be

3 able to justify expending public funds on a selection

4 process that wasn’t totally open and announced beforehand

5 and something that we decided to do because we thought it

6 was a good thing. We’d never be able to sustain -- you

7 can’t do business that way.

8 Nancy.

9 MS. RION: If I may, I think probably what

10 would happen is that the peer review might come back and

11 say, this -- this portion of the proposal is just really

12 outstanding. This other part might not and recommend

13 funding it half as much as they request. Then in my

14 experience what happens is you go back to the PI and say,

15 this is the -- we would be willing to consider funding it

16 up to two million instead of five million. Show us -- and

17 these -- this is what the peer review said. Now, you give

18 us what the plan would be --

19 MR. SALTON: -- well, that would be okay

20 if you had put those set of rules in place when you issued

21 the RFP. If you had said to people when you submit a

6 7 8 POST REPORTING SERVICE 9 HAMDEN, CT (800) 262-4102 1 124 2 MEETING RE: STEM CELL RESEARCH ADVISORY COMMITTEE 3 AUGUST 15, 2006 4 5 1 request we may do partial grants or we may split out

2 portions on the basis of what we think is -- because a

3 hybrid in particular would -- an applicant has kind of an

4 opportunity to make a decision based on the rules of the

5 game that says, I can go into category -- this category,

6 this category or maybe work out a deal with someone else

7 and go for the hybrid. There may be some applicants, I

8 don’t know, who said, yes, I’m going to cut -- I’ve put in

9 a hybrid. I’m going to take first bite of the apple at

10 the hybrid and I’ll put a second bite of the apple by

11 putting in a standalone research grant. And other people

12 would say, gee, in light of the -- the only -- my first

13 priority is to get the research done so I’m going to put

14 all my eggs into that one application and I’m not going to

15 expend, in a very short period of time, the effort

16 necessary to put a hybrid together even though there may

17 be very few hybrids.

18 DR. GENEL: Commissioner, we’re spending a

19 lot of time on the speculation. I think within the

20 scientific community it’s well recognized that review

21 committees and advisory committees will negotiate grants

6 7 8 POST REPORTING SERVICE 9 HAMDEN, CT (800) 262-4102 1 125 2 MEETING RE: STEM CELL RESEARCH ADVISORY COMMITTEE 3 AUGUST 15, 2006 4 5 1 based on the available money. And our job is going to be

2 to determine how we’re going to distribute the money. The

3 reality is that the peer review process is likely to be --

4 very well eliminate a lot of the numbers on the smaller

5 grants. And we’re going to be sitting here faced with

6 major decisions on the large three categories, the group

7 project, core facility and hybrid grants. I added it up,

8 39 million dollars requested here in those three

9 categories. And they’re a small number of grants.

10 And the reality is we’re going to -- that

11 is the area where we’re going to have to try and make the

12 tough decisions. And I think we need to preserve, for

13 ourselves, the flexibility of going back to investigators

14 and saying we have X amount of money and that’s -- you

15 come back with the budget.

16 COMMISSIONER GALVIN: No, you can’t do

17 that not with state funds, can you, Henry? As far as I

18 understand.

19 MR. SALTON: Well, perhaps we should wait

20 and cross that bridge when we get to it. But I think that

21 the -- I think that that process as it was laid out in the

6 7 8 POST REPORTING SERVICE 9 HAMDEN, CT (800) 262-4102 1 126 2 MEETING RE: STEM CELL RESEARCH ADVISORY COMMITTEE 3 AUGUST 15, 2006 4 5 1 RFP we would be on safe ground at this -- that process is

2 not laid out in the RFP.

3 COMMISSIONER GALVIN: It’s not laid out.

4 MR. WALLACK: Henry, can I ask a quick

5 question? What about if we voted a motion today that said

6 that we have decided that --

7 MR. SALTON: -- I think that would be too

8 late because the applications have been submitted.

9 COMMISSIONER GALVIN: You can’t change the

10 rules.

11 DR. KIESSLING: But do you think that

12 everybody who submitted a grant feels that they’re either

13 going to get all or nothing?

14 DR. JENNINGS: That’s certainly not what

15 happens --

16 MR. SALTON: -- I’m not saying as far as

17 the amount of funding, but I’m talking about splitting up

18 an application. So for example, if someone submitted an

19 application --

20 DR. KIESSLING: -- maybe this is just

21 semantics.

6 7 8 POST REPORTING SERVICE 9 HAMDEN, CT (800) 262-4102 1 127 2 MEETING RE: STEM CELL RESEARCH ADVISORY COMMITTEE 3 AUGUST 15, 2006 4 5 1 MR. SALTON: No, it’s not semantics.

2 DR. LENSCH: So could you, please, state

3 specifically -- speak to the question of if a --

4 MR. SALTON: -- if the Committee chose --

5 if the Committee got an application and someone said, the

6 application is for two million dollars to do this

7 following work and the Committee said, we think this work

8 is valid and it’s valuable, but in light of our funding

9 demands we feel that we’re only going to put a million

10 dollars into it. And you may go off and have to go to your

11 -- to other people who are going to support you and ask it

12 and make up that missing million. But this is all we can

13 put on the table and if you’re willing to take it you sign

14 the grant contract. If you’re not wiling to take the

15 million, that’s fine.

16 But what -- for example, if someone said

17 to you, I have a three part project and it will include me

18 buying equipment and me hiring these people and me doing

19 some very specific kind of research in -- that I’m

20 describing substantively. And you said, all we want at

21 this point in time is to say to you the only thing you’re

6 7 8 POST REPORTING SERVICE 9 HAMDEN, CT (800) 262-4102 1 128 2 MEETING RE: STEM CELL RESEARCH ADVISORY COMMITTEE 3 AUGUST 15, 2006 4 5 1 going to be able to do is to do the substantive research

2 and we’re not going to -- or just buy the equipment. We’re

3 not going to do anything else. And that, I think, is

4 where you have a problem.

5 DR. JENNINGS: That’s a problem partly

6 because these are --

7 DR. KIESSLING: -- that’s standard

8 operating procedure.

9 MR. SALTON: But the problem you have is

10 this is -- this is a state contracting process where you

11 -- the concern is not so much with the person you’re going

12 to sit down and negotiate. The concern is with the

13 dissatisfied failing bidder who is going to come in on the

14 process and go, if I had known, if it had been told to me

15 before that I could have segregated in my application

16 certain components and then maybe had a shot at

17 negotiating this component as opposed to aggregating

18 everything, then now I’m going to bring a challenge

19 legally to the whole process because it did not provide me

20 notice that this --

21 DR. JENNINGS: -- they could always have

6 7 8 POST REPORTING SERVICE 9 HAMDEN, CT (800) 262-4102 1 129 2 MEETING RE: STEM CELL RESEARCH ADVISORY COMMITTEE 3 AUGUST 15, 2006 4 5 1 segregated the components because there was no limit to

2 the number of applications from any institutions and there

3 was no compulsion, for example, to combine --

4 MR. SALTON: -- you’re taking -- you’re

5 not saying, I took a separate application from the same

6 person and where -- you’re talking about taking a single

7 application, a hybrid, for example.

8 DR. JENNINGS: Um, hmm.

9 MR. SALTON: That’s I think the worst case

10 is the hybrid where you split out the researcher from the

11 other components and you pay him off and you say, you

12 never even applied. The other people in the research

13 component say, he never even applied for a research grant.

14 DR. GENEL: Henry, I have taken an

15 entirely different view. I mean this -- these are not

16 state contracts. These are grant applications.

17 COMMISSIONER GALVIN: No, they’re state

18 contracts.

19 DR. GENEL: And the mentality that exists

20 within the scientific community in terms of NIH funding is

21 exactly, I think, what we’re talking about. And I don’t

6 7 8 POST REPORTING SERVICE 9 HAMDEN, CT (800) 262-4102 1 130 2 MEETING RE: STEM CELL RESEARCH ADVISORY COMMITTEE 3 AUGUST 15, 2006 4 5 1 see why that is just as applicable here as it would be for

2 an NIH advisory --

3 COMMISSIONER GALVIN: -- if you do it this

4 way you’re going to get somebody who’s going to enjoin the

5 whole process and we’ll be in Superior Court for a couple

6 of years to straighten it out.

7 DR. GENEL: Not from this community.

8 COMMISSIONER GALVIN: Go ahead, Bob.

9 MR. MANDELKERN: It seems to me that we’ve

10 gone for the last several meetings around this question of

11 how to go the final mile of awarding the money. It’s

12 obviously not going to be done in the next 15 minutes that

13 we have. And we have to get moving on that question of

14 how the review process is going to work.

15 I would like to make a motion that we in

16 the next 15 minutes appoint a subcommittee to come in to

17 the September meeting and with a clear process of how

18 we’re going to do the review and get to the final vote on

19 October 17th. That is my proposal that a subcommittee of

20 this Committee be appointed with the sole purpose of

21 coming in with a clear cut review process.

6 7 8 POST REPORTING SERVICE 9 HAMDEN, CT (800) 262-4102 1 131 2 MEETING RE: STEM CELL RESEARCH ADVISORY COMMITTEE 3 AUGUST 15, 2006 4 5 1 COMMISSIONER GALVIN: I’m sorry, if I’m

2 going to -- but I want to -- I think we need to close --

3 get a little closer on what Henry and I are saying that

4 with respect this is -- to change any of the rules or to

5 internally rearrange any of the grants will undoubtedly

6 result in a legal challenge to the dispersement of any of

7 the funds. And that will be very difficult to resolve.

8 DR. CANALIS: I support that furthermore.

9 NIH posts its guidelines upfront, you know. They tell you

10 in a program project the rules are set upfront. You know,

11 you need three -- a minimum of three fundable projects,

12 all this is stated upfront. And we did not do this in the

13 beginning.

14 COMMISSIONER GALVIN: We didn’t do it. No.

15 DR. CANALIS: We didn’t do it. We failed.

16 That’s the process of rushing, we failed.

17 COMMISSIONER GALVIN: Okay. Now, there is

18 a motion on the floor. Would you repeat your --

19 MR. MANDELKERN: -- the motion is that we

20 appoint in the next 15 minutes that we have a subcommittee

21 of this Committee as a whole to come in for the September

6 7 8 POST REPORTING SERVICE 9 HAMDEN, CT (800) 262-4102 1 132 2 MEETING RE: STEM CELL RESEARCH ADVISORY COMMITTEE 3 AUGUST 15, 2006 4 5 1 meeting with a clear process of review of the grant

2 applications and how we can get to the final vote to

3 disperse the 20 million dollars. So that we have a

4 starting -- a clear starting point and a clear ending

5 point for the September meeting.

6 COMMISSIONER GALVIN: Do I hear a second?

7 DR. JENNINGS: Yes, I will second that.

8 COMMISSIONER GALVIN: Okay, seconded by

9 Mr. Jennings. Is there any further discussion? Then,

10 I’ll call a vote. All in favor of this -- does everybody

11 understand the -- what we’re voting on? Okay. All in

12 favor.

13 DR. KIESSLING: We’re voting on a

14 subcommittee.

15 DR. JENNINGS: To create a subcommittee.

16 COMMISSIONER GALVIN: Right. Any

17 discussion?

18 DR. LENSCH: I actually have one question

19 that I’d like to ask. Is it your intention that this

20 subcommittee bring forward a single plan or that they

21 bring forward a couple of options for our discussion?

6 7 8 POST REPORTING SERVICE 9 HAMDEN, CT (800) 262-4102 1 133 2 MEETING RE: STEM CELL RESEARCH ADVISORY COMMITTEE 3 AUGUST 15, 2006 4 5 1 MR. MANDELKERN: A couple of options that

2 will lead to decision, yes. A couple of options that will

3 lead to decision not to endless points that move us away

4 from what we must do. So I think it’s not necessary to

5 come with one plan, but as many creditable plans as can be

6 put forth to the whole committee so that votes can be

7 taken. This is the process we will follow. There will be

8 no more introduction of extraneous because we’ve covered

9 them all in the subcommittee and here is A, B and C. Which

10 do you think is the way to go for the whole committee, A

11 or B or C?

12 I take your point very well that it

13 shouldn’t be an arbitrary introducing by the subcommittee,

14 but a meaningful one.

15 DR. LENSCH: Thank you, sir.

16 MR. MANDELKERN: Thank you.

17 COMMISSIONER GALVIN: Does everybody

18 understand what we’re voting on? All in favor?

19 Aye.

20 COMMISSIONER GALVIN: Opposed? The ayes

21 have it.

6 7 8 POST REPORTING SERVICE 9 HAMDEN, CT (800) 262-4102 1 134 2 MEETING RE: STEM CELL RESEARCH ADVISORY COMMITTEE 3 AUGUST 15, 2006 4 5 1 MR. WALLACK: Can I make a suggestion from

2 the floor? And do you want it in the form of a motion? I

3 think that the Committee should be totally unencumbered by

4 any kinds of relationships and so forth. And have

5 relatively easy access to each other for what it’s worth.

6 I’m going to suggest that Ann and Willie be at least two

7 parts of this committee. I have no problems with Charles

8 also. He’s got -- if the Yang relationship would be an

9 encumbrance. But if the Chairman felt that -- that group

10 out of state and so forth and so on, no relationships, to

11 me would come back and they’ve heard the whole discussion.

12 I would be very comfortable with the result that they

13 would get out of this kind of discussion.

14 DR. JENNINGS: I would certainly be happy

15 to participate in that. I don’t see that as a consulting

16 relationship with --

17 MR. WALLACK: -- that’s fine. But my

18 suggestion would include Charles -

19 DR. JENNINGS: -- and the committee can

20 bear my potential conflict in mind when it looks at the

21 recommendations.

6 7 8 POST REPORTING SERVICE 9 HAMDEN, CT (800) 262-4102 1 135 2 MEETING RE: STEM CELL RESEARCH ADVISORY COMMITTEE 3 AUGUST 15, 2006 4 5 1 COMMISSIONER GALVIN: So we have three

2 proposed members.

3 MR. MANDELKERN: I would like to volunteer

4 for that committee. Okay.

5 COMMISSIONER GALVIN: We certainly want to

6 be as inclusive as possible for the committee. So there

7 are four perspective members. Now --

8 MR. WOLLSCHLAGER: -- not too inclusive.

9 COMMISSIONER GALVIN: What?

10 MR. WOLLSCHLAGER: Not too inclusive or

11 else we start having --

12 COMMISSIONER GALVIN: -- to what extent

13 does four members -- where do we go with Freedom of

14 Information on that?

15 MR. SALTON: That would be covered by

16 Freedom of Information.

17 COMMISSIONER GALVIN: Yes.

18 MR. SALTON: Subcommittee of the Committee

19 meetings are covered by --

20 COMMISSIONER GALVIN: -- they’re covered.

21 So whatever you do is not going to be private. It’s going

6 7 8 POST REPORTING SERVICE 9 HAMDEN, CT (800) 262-4102 1 136 2 MEETING RE: STEM CELL RESEARCH ADVISORY COMMITTEE 3 AUGUST 15, 2006 4 5 1 to be public.

2 DR. KIESSLING: I would like to know a

3 little bit more about Henry’s concerns.

4 MR. SALTON: I think there is a quorum on

5 the subcommittee. It’s going to make formal

6 recommendations, the subcommittee.

7 COMMISSIONER GALVIN: It’s going to be

8 FOIable stuff.

9 MR. SALTON: We’ll double check that when

10 we go back to the office.

11 COMMISSIONER GALVIN: Okay.

12 DR. KIESSLING: Henry, I wanted to know a

13 little bit more about your concerns then with respect to

14 state funds. So say you have a grant that has a 100

15 thousand dollar budget. And the -- reviewing the budget

16 is part of submission of the peer review hopefully. And

17 they come back and they say, gee, you know, they think

18 they can do this for a 100 thousand dollars. But we’re

19 sure they cannot. So we can’t fund -- but we can’t fund

20 this entire proposal because they can’t do this amount of

21 work for a 100 thousand dollars. What do you do with that

6 7 8 POST REPORTING SERVICE 9 HAMDEN, CT (800) 262-4102 1 137 2 MEETING RE: STEM CELL RESEARCH ADVISORY COMMITTEE 3 AUGUST 15, 2006 4 5 1 information?

2 MR. SALTON: To me that sounds like that a

3 merit rejection.

4 DR. KIESSLING: No.

5 MR. SALTON: You’re saying that --

6 DR. KIESSLING: -- no, not at all.

7 DR. JENNINGS: It’s not a scientific

8 merit, but it’s a logistical merit.

9 DR. KIESSLING: The science is great. The

10 young investigator didn’t understand how much it was going

11 to cost to do gene -- so now one of the things that you

12 would do --

13 MR. SALTON: -- so are you suggesting that

14 you’re going to offer them more money than beyond the --

15 what they requested?

16 DR. KIESSLING: That’s a possibility.

17 MR. SALTON: I think that’s a problem.

18 DR. KIESSLING: What happens more often is

19 that they are --

20 MR. SALTON: -- I would probably say

21 reject and come back next year. We’ve got another ten

6 7 8 POST REPORTING SERVICE 9 HAMDEN, CT (800) 262-4102 1 138 2 MEETING RE: STEM CELL RESEARCH ADVISORY COMMITTEE 3 AUGUST 15, 2006 4 5 1 million.

2 DR. KIESSLING: That holds the work up.

3 That is --

4 MR. SALTON: -- well, you’re not going to

5 -- I mean I don’t know from a practical point of view you

6 guys know the number of applications you have and, Larry,

7 you have a sense of where your priorities are going to be.

8 I’m not so certain that we really know how much money

9 you’re going to have available for that kind of a project

10 anyways.

11 DR. KIESSLING: Well, what would that do

12 within the framework of your concerns about state bidding?

13 I mean --

14 COMMISSIONER GALVIN: -- I think, Ann,

15 that our concerns are with state bidding it has to be

16 completely transparent and everyone involved has to know

17 in the beginning and it has to be stated as such. The fact

18 that they may be familiar with NIH or NIS or anybody else

19 doesn’t count. We have to say, here are exactly the

20 playing rules. And --

21 DR. KIESSLING: -- so what were they told

6 7 8 POST REPORTING SERVICE 9 HAMDEN, CT (800) 262-4102 1 139 2 MEETING RE: STEM CELL RESEARCH ADVISORY COMMITTEE 3 AUGUST 15, 2006 4 5 1 about how their budgets were to be reviewed?

2 MR. SALTON: It’s in the RFP.

3 COMMISSIONER GALVIN: That’s all they’ve

4 been told.

5 MR. SALTON: That’s all they were told.

6 But the issue is that people are -- I think it’s a

7 different issue, Ann. There are probably a million little

8 gray areas that we could explore. But I think the black

9 and white area for me is the idea that among categories of

10 funding since you have -- especially with hybrid, where

11 you’re saying a hybrid shall be combined -- this category

12 and that category or these categories and that category,

13 that where people can choose what slot to put their bid

14 into and they’re told these are the limitations of the

15 categories, once you take a combined category and start

16 splitting it up the people who only thought the single

17 application in one of the subcategories are disadvantaged

18 and that would violate general state fair contracting

19 laws.

20 And that’s where the Commissioner and I

21 are on the same line. Whether or not the community feels

6 7 8 POST REPORTING SERVICE 9 HAMDEN, CT (800) 262-4102 1 140 2 MEETING RE: STEM CELL RESEARCH ADVISORY COMMITTEE 3 AUGUST 15, 2006 4 5 1 this way or not, you might find someone who has completely

2 submitted a totally merit less claim, application by the

3 peer review and they’re going to seize on that to hammer

4 back on the Committee because you did that. And any first

5 year generic lawyer is going to look at that and go, wow,

6 this is -- this is a big trip wire.

7 COMMISSIONER GALVIN: Excuse me, I need to move on

8 and with permission I will ask Dr. Lensch to chair the

9 remainder of the meeting or referee as you see.

10 DR. KIESSLING: So if we got an

11 application and it was a hybrid and the peer review -- if

12 we got an application and it was a hybrid and the peer

13 review was as Nancy described. The peer review decided

14 that part of this application was wonderful and part of it

15 was not.

16 MR. SALTON: First of all, I have to raise

17 the question is peer review -- is the peer review

18 committee going to give an overall score to the

19 application as a whole or are they going to give a score

20 based on subcomponents of the application? I’m not sure

21 that’s in keeping with what their charge is. I think

6 7 8 POST REPORTING SERVICE 9 HAMDEN, CT (800) 262-4102 1 141 2 MEETING RE: STEM CELL RESEARCH ADVISORY COMMITTEE 3 AUGUST 15, 2006 4 5 1 their charge is to give a ranking of the application as a

2 whole and a score to the application as a whole. Is that

3 right, Warren?

4 MR. WOLLSCHLAGER: That’s my

5 understanding, Henry. And, again, to go to your point if

6 somebody has submitted a hybrid, but was also clever

7 enough to pull out some sections and make it an individual

8 and another section and make it a core so that that person

9 now is covered in three or four different places. Well,

10 but in fact if you look at the list you’ll see multiple

11 names. I don’t know content yet, but I wouldn’t be

12 surprised if some folks have done that. That certainly

13 puts folks who didn’t think they could do that at a

14 disadvantage.

15 DR. LENSCH: And so, chair prerogative

16 here, if I understand this correctly these grants in a way

17 are bids to the state and that it seems that we have the

18 ability to negotiate the overall amount of the bid, but

19 not to take out sections of the bid.

20 DR. KIESSLING: But do we have the right

21 to negotiate the overall bid?

6 7 8 POST REPORTING SERVICE 9 HAMDEN, CT (800) 262-4102 1 142 2 MEETING RE: STEM CELL RESEARCH ADVISORY COMMITTEE 3 AUGUST 15, 2006 4 5 1 DR. JENNINGS: It’s up to the applicants

2 to adjust it in whatever way they see fit in order to

3 match the amount of the funding that we’re willing to --

4 MR. SALTON: -- I think the thing --

5 DR. KIESSLING: -- I think Henry is

6 saying, no, we can’t do that.

7 MR. SALTON: I think the thing I’m trying

8 to say is this. There are -- again, there are

9 differences. For example, you may have a bid where the

10 overall bid is, as I say, it’s one million dollars and

11 they have their money in different little buckets. And you

12 may say, listen, we’re willing to give you one million

13 dollars, but we think that some of your overhead exceeds

14 -- it -- while it doesn’t exceed the cap, it’s a little

15 bit high and we think you should -- that overhead is

16 something that should come down and we could -- otherwise

17 the person is still at the top -- one of the top bids in

18 their category. But you can negotiate to adjust some of

19 their -- they way they’ve aligned their budget. Okay?

20 But that’s different than saying, for

21 example, you know what you’re missing a major component of

6 7 8 POST REPORTING SERVICE 9 HAMDEN, CT (800) 262-4102 1 143 2 MEETING RE: STEM CELL RESEARCH ADVISORY COMMITTEE 3 AUGUST 15, 2006 4 5 1 your research. You should be hiring a genobiologist and

2 you don’t have that and it was never part of your

3 application. The rest of this will work if you hired this

4 person, add as a staff member. Well, now you’re really

5 putting -- you’re really -- you’re going beyond the scope

6 of their application by suggesting to them, a, an

7 advantage that they didn’t put in and that other bidders

8 would have said, you know, I did use that guy. I did hire

9 such a person and I was rejected. I don’t understand why

10 this is taking place.

11 So --

12 DR. GENEL: -- I really don’t like the

13 analogy to a bid process. This is a grant application

14 process. I mean I know the legalities of this. I mean my

15 model to this is the classic NIH funding mechanism. And

16 irrespective of state contract precedent or so forth, I

17 think we have to establish a different precedent. This is

18 a grant application.

19 MR. SALTON: And respectfully I think that

20 if we wanted to depart from that -- from the general

21 principles then we needed to put that up front in the RFP.

6 7 8 POST REPORTING SERVICE 9 HAMDEN, CT (800) 262-4102 1 144 2 MEETING RE: STEM CELL RESEARCH ADVISORY COMMITTEE 3 AUGUST 15, 2006 4 5 1 You may do that for next year and say, these are -- these

2 are -- this is the evaluative technique and we’re going to

3 reserve the right to do these things with these bids.

4 DR. GENEL: Well, perhaps so. But, you

5 know, my feeling from the very beginning was the RFP was

6 going out to scientists who spoke the same language that

7 I’m speaking now.

8 MR. MANDELKERN: Yes, but you can’t make

9 an assumption that there is not somebody waiting to stop

10 the process, Mike, that’s been moving along very smoothly

11 since June 15th of 2005. And counsel is suggesting that

12 we are wandering from state law and we will be wandering

13 into severe litigation. We’ve seen it in California.

14 DR. GENEL: Oh, I know.

15 MR. MANDELKERN: Where a three million

16 dollar fund has gone nowhere. We’ve seen it in Jersey

17 where ambitious plans have gone nowhere. I ardently plead

18 that we don’t follow that road in Connecticut.

19 DR. GENEL: I won’t belabor the point. I

20 think when we really get to specifics on October 15th I

21 think some of these issues are going be a lot more

6 7 8 POST REPORTING SERVICE 9 HAMDEN, CT (800) 262-4102 1 145 2 MEETING RE: STEM CELL RESEARCH ADVISORY COMMITTEE 3 AUGUST 15, 2006 4 5 1 apparent than they are now in theory.

2 MR. MANDELKERN: I would think we should

3 move to some formalization of the subcommittee which was

4 passed almost unanimously, which has four members, as to

5 how we’re going to proceed and so on.

6 DR. LENSCH: That seems appropriate. Let’s

7 take one quick comment from Jerry.

8 DR. YANG: Thank you. I think this

9 discussion can take us forever. So it would be a good idea

10 for Henry to discuss it with the subcommittee once the

11 committee is formed. I would like to make two

12 announcements/clarifications, clear to the committee.

13 One, I am involved in promoting international consortium

14 for stem cell research. My dream is to promote quick

15 outcomes from stem cell research -- I just went to Taiwan,

16 China and this Saturday I’m going to Brazil to give talks

17 about our stem cell reprogramming research. This

18 December, I will attend the first international stem cell

19 consortium meeting in UK as the meeting co-coordinator --

20 so I’ll be there and you are certainly welcome to join. I

21 also want to tell you for Charles to join that

6 7 8 POST REPORTING SERVICE 9 HAMDEN, CT (800) 262-4102 1 146 2 MEETING RE: STEM CELL RESEARCH ADVISORY COMMITTEE 3 AUGUST 15, 2006 4 5 1 subcommittee with no competing interest within it.

2 The second clarification I want to make,

3 is that the center for regenerative biology had recruited,

4 months ago, the former executive director of the Harvard

5 Stem Cell Institute, Charles, to serve as the Center’s

6 Stem Cell Research Consultant for consulting in stem cell

7 research policy, federal and state regulations and

8 oversight for our protocols and application guidance for

9 institutional committee e.g., escrow approval. Charles is

10 also involved in our plans for stem cell research

11 international consortium for research oversight. We are

12 not sure where the headquarters will be. You are welcome

13 to advice for the headquarters’ location. I don’t want his

14 consulting fee really downplay his role in the committee.

15 He and Willy had played a critical role to draft our state

16 stem cell research program proposal guidelines. I think

17 the subcommittee’s role is to really discuss the review

18 process and again, he can play a critical role in this

19 subcommittee. I do not want to say anything about the

20 review process because I want to leave that up to the

21 subcommittee. Thank you.

6 7 8 POST REPORTING SERVICE 9 HAMDEN, CT (800) 262-4102 1 147 2 MEETING RE: STEM CELL RESEARCH ADVISORY COMMITTEE 3 AUGUST 15, 2006 4 5 1 DR. LENSCH: Thank you, Jerry. So may I

2 ask Henry one more question before we decide what this

3 committee is going to be made of? Regarding the

4 transparency and Freedom of Information Act, if we do not

5 have a quorum of this Committee for this subcommittee what

6 sort of a standard are we going to be held to in terms of

7 making our deliberations publicly available? Will we need

8 to have a transcription or just have our notes available

9 if someone wants them?

10 MR. SALTON: Well, first of all, assuming

11 that the FOI applies you would never have to have

12 transcription. You would have to just merely have someone

13 take minutes on the meeting and -- if it’s considered to

14 be a meeting under the FOI you just merely have to have

15 minutes taken.

16 DR. LENSCH: All right.

17 MR. SALTON: And those minutes need to be

18 then made available to the public and adopted at some

19 point later as being the official minutes of the

20 subcommittee.

21 DR. LENSCH: Is there some rule for the

6 7 8 POST REPORTING SERVICE 9 HAMDEN, CT (800) 262-4102 1 148 2 MEETING RE: STEM CELL RESEARCH ADVISORY COMMITTEE 3 AUGUST 15, 2006 4 5 1 certification of those minutes or just that they be

2 submitted?

3 MR. SALTON: It’s just that the

4 subcommittee would all agree at some point, yes, this is

5 accurate and this is what happened at the meeting and

6 these are the minutes that are accurate. That’s all. Much

7 like we do here. We don’t have anyone who is an

8 independent person certify the minutes.

9 DR. JENNINGS: I mean, Mr. Chairman, I

10 mean perhaps the recommendation of the Committee would be

11 punch the minutes themselves would be the recommendation,

12 I mean the primary output of the discussion will be a

13 recommendation to this larger committee as to --

14 MR. SALTON: -- I mean the minutes would

15 merely have to say --

16 DR. JENNINGS: -- who is involved in the

17 discussion and this is what we recommend.

18 MR. SALTON: First of all, while I’m

19 fairly certain, I’m not absolutely certain that the FOI

20 applies to subcommittees. But I’m fairly certain it does.

21 Assuming that I’m right, then I think the minutes merely

6 7 8 POST REPORTING SERVICE 9 HAMDEN, CT (800) 262-4102 1 149 2 MEETING RE: STEM CELL RESEARCH ADVISORY COMMITTEE 3 AUGUST 15, 2006 4 5 1 have to say, much if you look at our draft minutes, the

2 meeting was held on such and such a date. The following

3 members were present. The first topic of discussion was as

4 follows, dah, dah, dah, dah. This is what the people,

5 various things were said and discussed and generically as

6 these minutes do. They’re not word for word. There was a

7 motion to say, we’re going to adopt this process and

8 recommend it to the larger committee. The motion was made

9 by Charles, seconded, adopted. Meeting was recessed. That

10 would be basically --

11 DR. JENNINGS: -- that’s not onerous.

12 MR. SALTON: That’s not onerous.

13 DR. LENSCH: One final question in terms

14 of public announcement of the meeting. Is that a

15 requirement of the subcommittee?

16 MR. SALTON: Assuming the FOI applies, you

17 would have to, yes, make an agenda available and that we

18 could do through Connecticut Innovations. And that agenda

19 would basically say the subcommittee is meeting to discuss

20 the advisory review process. It would be one line and it

21 would be just -- they would do the necessary filing and

6 7 8 POST REPORTING SERVICE 9 HAMDEN, CT (800) 262-4102 1 150 2 MEETING RE: STEM CELL RESEARCH ADVISORY COMMITTEE 3 AUGUST 15, 2006 4 5 1 that’s it.

2 DR. LENSCH: Okay.

3 MR. SALTON: Unless you guys want to add

4 to the agenda, you know.

5 DR. LENSCH: No, I think we would want it

6 to be as easy as possible and if we have to set up a

7 conference call and all that type of stuff I don’t have

8 the facilities available.

9 MR. MANDELKERN: Should we formalize a

10 committee and elect a chair and then move from there?

11 DR. LENSCH: So three of us have been

12 mentioned. Ann has been mentioned. I’ve been mentioned

13 Charles has been mentioned.

14 MR. MANDELKERN: And I volunteered.

15 DR. LENSCH: And Bob. And so --

16 DR. KIESSLING: -- I think Robert wants to

17 come. I think you want to come.

18 MR. MANDELKERN: Yes, I certainly do.

19 DR. LENSCH: And so you’re willing to

20 participate. Are you willing to participate, Ann, and you

21 Charles?

6 7 8 POST REPORTING SERVICE 9 HAMDEN, CT (800) 262-4102 1 151 2 MEETING RE: STEM CELL RESEARCH ADVISORY COMMITTEE 3 AUGUST 15, 2006 4 5 1 MR. SALTON: So I would suggest that

2 someone make a motion that the following main members be

3 appointed to the subcommittee --

4 MR. WALLACK: -- I’ll move that Charles

5 and Willy and Bob and Ann be appointed to it. How do you

6 want to handle the motion though to the Chair?

7 MR. SALTON: Well, why don’t we first

8 appoint the committee and they can elect the chair among

9 themselves.

10 DR. JENNINGS: I will second it.

11 MR. WALLACK: I recommend that those are

12 the four people.

13 DR. JENNINGS: I will second that.

14 MR. SALTON: And so all those affirming

15 say aye.

16 VOICES: Aye.

17 MR. SALTON: All those opposed?

18 MR. WALLACK: Would the four people be

19 more comfortable if we recommended a chair or -- I mean

20 the peer review people choose their own chair.

21 MS. RION: They can choose the chair.

6 7 8 POST REPORTING SERVICE 9 HAMDEN, CT (800) 262-4102 1 152 2 MEETING RE: STEM CELL RESEARCH ADVISORY COMMITTEE 3 AUGUST 15, 2006 4 5 1 DR. KIESSLING: Henry, in this section

2 where it says -- is this the RFP where it says proposal

3 instructions?

4 MS. RION: Yes.

5 DR. KIESSLING: Is this all I need? Is

6 this exactly what it says in the RFP?

7 MS. RION: Yes.

8 MR. MANDELKERN: On the subcommittee, I

9 would propose Willy act as chair and take that

10 administratively in relation to CI so that we can get

11 together and move along.

12 MR. WALLACK: I’ll second that.

13 DR. LENSCH: All those affirming say aye.

14 VOICES: Aye.

15 DR. LENSCH: All those opposed? And I’ll

16 abstain.

17 MR. SALTON: I thought you would oppose.

18 DR. LENSCH: I’m not that smart. And so

19 it looks like we have a task to return to the next meeting

20 with a small cohort of proposals for how the funding is

21 going to be divided amongst the categories, if I’ve

6 7 8 POST REPORTING SERVICE 9 HAMDEN, CT (800) 262-4102 1 153 2 MEETING RE: STEM CELL RESEARCH ADVISORY COMMITTEE 3 AUGUST 15, 2006 4 5 1 summarized that correctly. And then it --

2 DR. JENNINGS: -- the procedure, the

3 decision making --

4 MR. MANDELKERN: -- the motion was not

5 within the categories unfortunately.

6 DR. JENNINGS: Could somebody just retract

7 the original motion so we’re absolutely clear as to what

8 the mission is.

9 MR. MANDELKERN: Somebody goes to the

10 verbatim a hundred and fifty pages and boils it down to

11 six pages. I assume that that’s the procedure.

12 MR. WOLLSCHLAGER: No, we have a separate

13 meeting --

14 MS. RION: -- my notes were create options

15 for the -- for how the process is going to work.

16 DR. JENNINGS: I think we all understand

17 that.

18 DR. YANG: The review process.

19 DR. JENNINGS: Yes. And we will bring

20 back to this Committee a -- either a single recommendation

21 or a suitable alternative -- so the aim is to minimize the

6 7 8 POST REPORTING SERVICE 9 HAMDEN, CT (800) 262-4102 1 154 2 MEETING RE: STEM CELL RESEARCH ADVISORY COMMITTEE 3 AUGUST 15, 2006 4 5 1 amount of further debate.

2 MR. MANDELKERN: That was the point of the

3 motion, which was passed almost unanimously.

4 DR. KIESSLING: Is there a meeting place

5 or do you need a --

6 DR. LENSCH: We’ll figure it out as soon

7 as possible, something that’s maximally convenient for

8 everyone involved.

9 MR. MANDELKERN: Yes.

10 MR. SALTON: You can have a telephonic

11 meeting.

12 DR. LENSCH: So Charles brings up the

13 point that we would like to include public commentary.

14 Item No. 7 is lengthy and unfortunately it doesn’t look

15 like we’re going to have time to cover it today if we want

16 to include some public comment before we conclude. And so

17 if that’s all right with the Committee, we will move

18 forward to the second seven on the list.

19 DR. YANG: Just on the schedule, October

20 17th is 8:30 to --

21 MS. RION: -- I apologize, my mistake,

6 7 8 POST REPORTING SERVICE 9 HAMDEN, CT (800) 262-4102 1 155 2 MEETING RE: STEM CELL RESEARCH ADVISORY COMMITTEE 3 AUGUST 15, 2006 4 5 1 8:30.

2 MS. HORN: And we’re definitely meeting in

3 September.

4 MR. MANDELKERN: The last meeting there

5 was a question of the British delegation coming in for

6 September. We voted approvingly that we would meet with

7 them. Has that been changed, Warren?

8 MR. WOLLSCHLAGER: No.

9 MR. MANDELKERN: So therefore there has to

10 be a meeting. We don’t want them to come to an empty room.

11 MS. RION: I apologize. I added that

12 discuss whether or not to meet in September knowing that

13 we have at least three people who come from Boston. If we

14 do not have a lot of -- a lot on the agenda, I just wanted

15 to make sure that there is a reason. We clearly have the

16 -- to discuss the review process so it seems to me --

17 DR. JENNINGS: - -and we have a clear

18 agenda. If I may, Mr. Chairman, we also have the items on

19 7, Part 1, which are standing items, which we never get

20 to.

21 DR. LENSCH: Never, ever.

6 7 8 POST REPORTING SERVICE 9 HAMDEN, CT (800) 262-4102 1 156 2 MEETING RE: STEM CELL RESEARCH ADVISORY COMMITTEE 3 AUGUST 15, 2006 4 5 1 DR. JENNINGS: Perhaps we should move that

2 they should be higher on the agenda for the next meeting.

3 MS. RION: That sounds good. May I also

4 ask how you found this room and this place? We keep

5 searching for a little larger room, that’s comfortable for

6 you as well as accessible to the public.

7 DR. YANG: Warren has a wonderful location

8 where you had the conference meeting that the state --

9 MR. WOLLSCHLAGER: -- oh, that’s in the

10 LOB.

11 DR. YANG: The LOB. Would that be

12 possible? I mean it’s a good location there.

13 MR. WOLLSCHLAGER: I mean it was some

14 thought when we first started out maybe we didn’t want to

15 go to the LOB while they were in session. They’re not

16 currently in session. I think it is comfortable parking

17 and it’s free. But that’s something that we could

18 certainly investigate for you.

19 DR. YANG: It’s less traffic than this

20 one. The other one you just turn off into the parking lot.

21 It’s so close.

6 7 8 POST REPORTING SERVICE 9 HAMDEN, CT (800) 262-4102 1 157 2 MEETING RE: STEM CELL RESEARCH ADVISORY COMMITTEE 3 AUGUST 15, 2006 4 5 1 MR. WALLACK: Which room did you use,

2 Warren, at the LOB?

3 DR. KIESSLING: I don’t care as long as

4 the instructions are clear.

5 MR. WOLLSCHLAGER: 2C or one like that.

6 Do you want us to check that out?

7 DR. YANG: I think it would be a good idea

8 to check it out.

9 DR. JENNINGS: I would like to suggest

10 that we probably need slightly more microphones than we

11 have. We’ll see how the transcripts come out, but it seems

12 all of us are not really within convenient reach of

13 microphones. And I’d also like to request more water and

14 more diet coke.

15 DR. YANG: Thank you.

16 MS. RION: I got that.

17 DR. YANG: Thank you. I need more water.

18 DR. LENSCH: If there is no other business

19 from the Committee, I’d like to invite anyone else in

20 attendance to voice opinions or make comments if they

21 would like. All right.

6 7 8 POST REPORTING SERVICE 9 HAMDEN, CT (800) 262-4102 1 158 2 MEETING RE: STEM CELL RESEARCH ADVISORY COMMITTEE 3 AUGUST 15, 2006 4 5 1 DR. JENNINGS: Do you need a motion to --

2 DR. LENSCH: -- yes, so absent that I will

3 entertain a motion to adjourn.

4 MR. MANDELKERN: Motion to adjourn.

5 DR. JENNINGS: Second.

6 DR. LENSCH: Dr. Jennings has seconded.

7 Those affirming?

8 VOICES: Aye.

9 DR. JENNINGS: Actually I oppose.

10 DR. LENSCH: Those affirming the motion to

11 adjourn say aye.

12 ALL VOICES: Aye.

13 (Whereupon, the meeting was concluded at

14 4:00 p.m.)

15

6 7 8 POST REPORTING SERVICE 9 HAMDEN, CT (800) 262-4102

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