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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 443 4 5 POST REPORTING SERVICE 6 HAMDEN, CT (800) 262-4102 1 2 2 1 ROCKY HILL, CONNECTICUT 2 3 4 53 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. . .6789 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 you15 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 all3 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 for7 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, I10 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 guidelines19 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 the9 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 of6 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, who17 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 this20 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, but3 Stacy and her law firm have been very much involved in the4 activities of California and the CIRM. So we invited them5 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’ve17 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 is11 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 line15 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 any21 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 to5 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 encouraged3 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 of8 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 or13 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 ground6 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 accepting12 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 technology19 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 actually3 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 have10 developed, I’m allowed to hold it close to my chest long 11 enough to get it published and long enough to get a patent12 application on file preferably before I publish it. But 13 then I have to make that data free to everyone else in the14 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 information20 -- 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-profit2 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 was5 -- 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 state9 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 and14 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 comparable3 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 comes13 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 share16 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 proposed9 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 transfer20 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 strict12 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 whether4 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 bonds7 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 research17 for embryonic stem cell research. Much less of a focus on18 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 field8 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 is12 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 broadly2 in order to pursue non commercial research period. That’s3 statement one. 4 Statement two is if you wish to pursue 5 commercial research and whether that’s directly or whether6 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 that9 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 California2 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 the6 annual fund or to further enhance research or other public7 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 the11 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 most15 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 of9 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 deep6 involvement in embryonic stem cell research and the taking7 of funds back into the stem cell agency and then giving it8 to the state without restrictions are what made that issue9 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 over21 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 out16 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 the3 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 were13 a lot of models proposed. There were models that proposed14 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 the20 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 to7 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 litigation13 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 the19 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 percent2 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 a14 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 claims11 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 parties6 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 teeing7 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 the15 APO has had a policy banning claims to embryonic stem cell16 lines for some time. And it’s considered that this WARF 17 appeal may be a vehicle to challenge the APO’s position or18 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 little4 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 with17 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 has6 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 only13 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 lot19 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 of3 doing business with patents. They’re there. You’ve got to4 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 agreements8 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 to13 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 really6 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 service8 kinds of things as opposed to back into the general fund, 9 as it did in California, then we’re less likely to have to10 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 are12 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 is5 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 whole6 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 strike10 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 for13 -- 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. Wesleyan8 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 solicit15 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, met19 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 of6 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 egg20 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 mean5 they’ve been working on it for a while, haven’t they, 6 Charles? 7 DR. JENNINGS: They were -- I mean as long8 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 as13 -- 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 a18 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 that7 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 have15 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 have19 and the public way to dispense. So I’m just wondering if 20 we shouldn’t move more forward to consideration of what we21 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 are6 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 product9 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 looking12 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 might15 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 passage20 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 of2 these issues and see where they’re going say in grant year3 next year. But meanwhile we have had, as opposed to other4 states, very clear fruitful sailing in Connecticut. And I5 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’t17 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 California20 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 that6 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 end14 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 the18 situation in California and Connecticut from a political 19 point of view are widely different. Proposition 71 passed20 60/40. Whereas our stem cell bill went through the Senate21 of the Connecticut legislature ten to one and it went past6 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 and9 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 to13 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 out17 that I don’t think anything about the Y cell agreement 18 inhibits research. It was -- it’s been a little dampening19 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 benefits10 then we have to think about the implications of our 11 policies for eventual commercialization of the research or12 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 thinking15 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 have6 to decide in August of ’06 whether or not you want to have7 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 the9 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 policy17 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 of20 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 goes19 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 it7 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 of17 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 you21 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 interpreted16 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 if20 I might, I mean we might want to then further clarify that21 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. It9 -- 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 to20 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 should4 be a separate non-lapsing account? 5 MR. SALTON: No, that addresses the fact 6 that the monies that are transferred -- that is an account7 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 it15 doesn’t re -- in an elapsing account the money that’s put 16 in the account for that spending purpose at the end of the17 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 be6 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 is7 -- 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’s13 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 -- into17 patients in the market place because the read is that this18 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 a5 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 ultimately15 as, you know, the people who put this bill into place were16 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 go3 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 up21 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 not4 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 to15 that for sure because it depends on WARF’s thinking. But I16 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 it11 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. It2 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 such9 applications except that no member shall participate in 10 the affairs of the Committee with respect to the review or11 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 not18 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 that8 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 end11 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 which14 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 just6 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 Advisory16 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 may3 make more sense just to provide ourselves a list of the 4 necessary required recusals without necessarily the entire5 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 interest13 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 a17 long time relationship with a couple of different parts of18 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 list9 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 a15 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 mean20 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 totally6 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 of13 Health have sort of evolved this as they have gone through14 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 Harvard6 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 that6 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 and16 distinguished careers would somehow scuttle someone else’s17 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 a6 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 on7 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 subjective4 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 role11 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 to18 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 this5 Committee should refrain from applying for funding because6 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 record17 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, 9057 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 passed6 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 of3 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 active18 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 comply14 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 replace5 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 where13 an application from UCONN was being considered he may sort14 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 conflict8 of interest forms -- 9 MS. HORN: -- I have them both in paper 10 form today and I also have them electronically that I will11 send out after the meeting. And I did send out an NIH form12 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 that16 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’m6 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 I6 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 peer9 review have already signed this, received their passwords 10 and they are looking at the proposals. 11 MR. MANDELKERN: Excuse me, what would the12 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 to15 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 to8 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, do20 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 is4 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 I15 have access to reviewing these grants since I’m working on16 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 thought10 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 cut6 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 going7 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 form11 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 is16 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 send6 me a computerized version of this because it would take me7 probably 24 hours to list the number of recusals if I were8 to take this literally. 9 MS. HORN: Okay. 10 DR. GENEL: I have -- I’ll talk to you off11 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 a19 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’s9 what I do. You know, they give me, Ernie, would you 10 review this and half the way I say there is a conflict and11 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 my13 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 are18 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 two7 -- 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’re16 going to destroy those applications when you’re done. I 17 mean getting rid of the application, not keeping a copy of18 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 the8 end of the conflict of interest form that says, again, 9 there is no non-disclosure. And I also agree to destroy or10 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 is18 for Nancy. 19 MS. RION: Yes. 20 DR. CANALIS: I am not going to be able to21 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 have21 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 back7 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 our10 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 confidentiality18 it will delay the work of coming to a conclusion about how19 to distribute our funds. And I think that is not our 20 purpose. I think our purpose is to efficiently, fairly and21 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 done8 with the work to distribute our funds, which we are on the9 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 put21 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’d3 would like to put forward the opposite motion so that the 4 Committee has the opportunity to consider it. I would like5 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 doing12 that. We have a meeting that is scheduled to start at 8:3013 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 obligation18 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 do2 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 our11 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 take15 it on trust that they do a perfect job. And there may be 16 reviewers and their recommendations, which we will want to17 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 the11 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 delaying19 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 would6 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 see3 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 the12 applications are played out in terms of collaborations. 13 And so I cannot sign this form until I’ve had access to at14 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 this20 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 one2 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 just6 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. Genel2 not look at my application? 3 DR. GENEL: My pleasure. 4 COMMISSIONER GALVIN: Now, for the general5 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 go16 -- 17 DR. JENNINGS: -- you go, we go. 18 COMMISSIONER GALVIN: Okay. We’re on Item19 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 I3 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 have10 the breakfast that -- linger, yes. 11 DR. CANALIS: Commissioner, upfront 12 usually the initial review committee has made some obvious13 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 going17 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 would8 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 need13 -- 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 an8 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 5013 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 we4 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 are12 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 the11 money. I mean you’ve got four categories, I think -- five.12 So it seems like this Committee is going to figure out how13 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 going19 to fund somebody 15 out of 15 or are you? 20 MR. WOLLSCHLAGER: I would think -- I mean21 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 a5 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 in16 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 to12 spend X money on cores and you’ve got ten applications for13 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 kind6 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 1712 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 been20 no attempt to codify application of the available funds to21 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 and3 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 -- that15 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 are2 some that the peer review is likely to come back and say 3 these are absolutely outstanding. Those very usually have4 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 the14 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 in19 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 as21 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 up2 so that you can have -- 3 COMMISSIONER GALVIN: -- okay. 4 MS. RION: Depend on a couple of people to5 have some real knowledge of that proposal. 6 COMMISSIONER GALVIN: Okay. I’m not trying7 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 not12 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 one20 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 out5 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 to2 fund the research. Can I then say, yes, I’m going to 3 approve the research that’s within that hybrid formula but4 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 can9 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 mandate16 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. And21 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 of4 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 we8 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 I10 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 of5 it. 6 DR. CANALIS: I’d like to address the 7 issue you brought up of starting to tease grants apart. I8 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 for6 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 or8 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 two18 categories. 19 MR. WALLACK: Henry, how do you answer 20 Ann’s remark that from what I heard from Ann, I mean we’re21 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 grant3 law you still have to be concerned with making sure that a4 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 going17 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 what10 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 -- and17 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 issued21 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 in9 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 to15 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 a19 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. The3 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 that21 the -- I think that that process as it was laid out in the6 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 the10 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 your11 -- to other people who are going to support you and ask it12 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 sign14 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 me18 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’re3 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 going12 to sit down and negotiate. The concern is with the 13 dissatisfied failing bidder who is going to come in on the14 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 me20 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 there3 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 case10 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 is21 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 for2 an NIH advisory -- 3 COMMISSIONER GALVIN: -- if you do it this4 way you’re going to get somebody who’s going to enjoin the5 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’ve10 gone for the last several meetings around this question of11 how to go the final mile of awarding the money. It’s 12 obviously not going to be done in the next 15 minutes that13 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 the13 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 is18 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 subcommittee21 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 be6 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. Which10 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 from2 the floor? And do you want it in the form of a motion? I 3 think that the Committee should be totally unencumbered by4 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 volunteer4 for that committee. Okay. 5 COMMISSIONER GALVIN: We certainly want to6 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 Committee19 meetings are covered by -- 20 COMMISSIONER GALVIN: -- they’re covered. 21 So whatever you do is not going to be private. It’s going6 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 that6 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 a3 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 going11 to cost to do gene -- so now one of the things that you 12 would do -- 13 MR. SALTON: -- so are you suggesting that14 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 is19 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 fact18 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 little8 gray areas that we could explore. But I think the black 9 and white area for me is the idea that among categories of10 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 completely2 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 it15 was not. 16 MR. SALTON: First of all, I have to raise17 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 individual8 and another section and make it a core so that that person9 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 way17 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 you12 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 of6 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 my15 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 that20 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 to3 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 plead18 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’s7 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 idea10 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 is10 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 his14 consulting fee really downplay his role in the committee. 15 He and Willy had played a critical role to draft our state16 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 what6 sort of a standard are we going to be held to in terms of 7 making our deliberations publicly available? Will we need8 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. Much7 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 as4 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 made9 by Charles, seconded, adopted. Meeting was recessed. That10 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, you17 would have to, yes, make an agenda available and that we 18 could do through Connecticut Innovations. And that agenda19 would basically say the subcommittee is meeting to discuss20 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 to17 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 you21 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 meeting20 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 retract7 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 options15 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 recommendation21 or a suitable alternative -- so the aim is to minimize the6 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 the3 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 want16 to include some public comment before we conclude. And so17 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 in3 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 to10 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 wanted15 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 that2 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 for6 you as well as accessible to the public. 7 DR. YANG: Warren has a wonderful location8 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 idea8 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 seems12 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 business19 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 to11 adjourn say aye. 12 ALL VOICES: Aye.13 (Whereupon, the meeting was concluded at 14 4:00 p.m.)156 7 8 POST REPORTING SERVICE 9 HAMDEN, CT (800) 262-4102

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