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714.444.4100 Fax: 714.444.4411 Email: Depo@Depo1.Com Barristers' Reporting Service BARRISTERS' REPORTING SERVICE BEFORE THE SCIENTIFIC AND MEDICAL ACCOUNTABILITY STANDARDS WORKING GROUP TO THE CALIFORNIA INSTITUTE FOR REGENERATIVE MEDICINE ORGANIZED PURSUANT TO THE CALIFORNIA STEM CELL RESEARCH AND CURES ACT REGULAR MEETING LOCATION: KABUKI HOTEL 1625 POST STREET SAN FRANCISCO, CALIFORNIA DATE: FEBRUARY 28, 2008 9 A.M. REPORTER: BETH C. DRAIN, CSR CSR. NO. 7152 BRS FILE NO.: 80559 1 1072 BRISTOL STREET, SUITE 100, COSTA MESA, CALIFORNIA 92626 PHONE: 714.444.4100 FAX: 714.444.4411 EMAIL: [email protected] BARRISTERS' REPORTING SERVICE I N D E X ITEM DESCRIPTION PAGE NO. CALL TO ORDER 3 ROLL CALL 10 STAFF REPORT 11 SCIENTIFIC PRESENTATIONS: CLINICAL TRIALS 16 IPS EXPERIMENTS 53 REPORT ON CIRM GUIDELINES FOR 154 OOCYTE DONATION DISCUSSION REGARDING PLAN 186 GOING FORWARD ADJOURNMENT 250 2 1072 BRISTOL STREET, SUITE 100, COSTA MESA, CALIFORNIA 92626 PHONE: 714.444.4100 FAX: 714.444.4411 EMAIL: [email protected] BARRISTERS' REPORTING SERVICE 1 SAN FRANCISCO, CALIFORNIA 2 THURSDAY, FEBRUARY 28, 2008 3 9 A.M. 4 5 CHAIRMAN LO: LET'S GET STARTED. WE 6 HAVE A FULL AGENDA, AND I THINK THERE WILL BE A 7 LOT OF INTERESTING DISCUSSIONS AND LOOKING FORWARD 8 TO THE DAY. 9 FIRST, I WANT TO WELCOME EVERYBODY TO 10 SAN FRANCISCO. WE PARTICULARLY ARRANGED GOOD 11 CALIFORNIA WEATHER FOR THOSE OF YOU FROM THE EAST 12 COAST TO KNOW WHAT YOU ARE MISSING. AND IF ANYONE 13 IS THINKING OF RELOCATING TO CALIFORNIA, IT'S LIKE 14 THIS 364 DAYS A YEAR. I'M NOT IMMUNE FROM A 15 LITTLE BIT OF WHAT WE CALL CREATIVE EXAGGERATION, 16 ALTA. BUT I WANT TO WELCOME EVERYBODY. IT'S 17 GREAT TO SEE EVERYBODY AGAIN, AND HOPE THAT YOU 18 ALL HAVE BEEN WELL SINCE OUR LAST MEETING. 19 A LOT HAS HAPPENED SINCE OUR LAST 20 MEETING. AND PART OF WHAT WE'RE GOING TO DO TODAY 21 IS TO SORT OF GET CAUGHT UP WITH SOME SCIENTIFIC 22 ADVANCES. TWO OF OUR MEMBERS, JOHN WAGNER AND 23 KEVIN EGGAN, HAVE ACTUALLY BEEN INVOLVED WITH SOME 24 VERY EXCITING, VERY IMPORTANT SCIENTIFIC WORK, AND 25 THEY'VE VERY GRACIOUSLY AGREED TO SORT OF GIVE US 3 1072 BRISTOL STREET, SUITE 100, COSTA MESA, CALIFORNIA 92626 PHONE: 714.444.4100 FAX: 714.444.4411 EMAIL: [email protected] BARRISTERS' REPORTING SERVICE 1 SORT OF A THUMBNAIL SKETCH OF SOME OF THE EXCITING 2 DEVELOPMENTS. 3 THERE'S BEEN ADMINISTRATIVE CHANGES. 4 ALAN TROUNSON WAS LURED HERE FROM THE DISMAL 5 WEATHER IN AUSTRALIA TO TAKE OVER AS THE PRESIDENT 6 AND CEO OF CIRM. THIS IS OUR FIRST CHANCE TO ALL 7 MEET HIM, AND WE CERTAINLY WELCOME ALAN. AND HE'S 8 GOING TO PROVIDE DYNAMIC LEADERSHIP AND HAS SOME 9 IDEAS FOR US TO THINK ABOUT IN TERMS OF THE 10 STRATEGIC PLAN FOR CIRM AND HOW SWG MIGHT BE ABLE 11 TO HELP WITH SOME NEW INITIATIVES THAT HE'S 12 THINKING ABOUT AT CIRM. 13 BUT I WANT TO ASK SHERRY TO ADD HER 14 WELCOME. 15 MS. LANSING: WELL, AGAIN, I ALSO WANT 16 TO WELCOME EVERYBODY AND SAY HOW HAPPY I AM TO SEE 17 EVERYBODY AGAIN. I MISSED, I GUESS, TWO MEETINGS, 18 AND I WANT TO APOLOGIZE; BUT WHEN WE TOOK THE 19 VOTE, I WAS THE ONLY ONE THAT HAD A PROBLEM ON 20 THOSE DAYS. SO RELUCTANTLY I WAS NOT ABLE TO 21 ATTEND. PLEASE DON'T INTERPRET THAT AS A LACK OF 22 PASSION OR ENTHUSIASM FOR THE WORK THAT WE'RE 23 DOING BECAUSE LITERALLY IT WAS 15 TO 1 WHO 24 COULDN'T ATTEND THAT DAY. 25 I TOO WANT TO SAY THAT THIS MEETING 4 1072 BRISTOL STREET, SUITE 100, COSTA MESA, CALIFORNIA 92626 PHONE: 714.444.4100 FAX: 714.444.4411 EMAIL: [email protected] BARRISTERS' REPORTING SERVICE 1 REPRESENTS WHAT WE'VE ALWAYS TALKED ABOUT, THAT WE 2 ARE A CONSTANT WORK IN PROGRESS, AND THAT WHAT WE 3 DECIDE TODAY, DUE TO THE SCIENCE MOVING SO FAST, 4 WE MAY CHANGE, YOU KNOW, IN TWO OR THREE MONTHS, 5 THAT QUICKLY, BECAUSE THE SCIENCE IS MOVING SO 6 QUICKLY AND THINGS THAT HAVE HAPPENED WITH THE 7 CHEEK CELL AND ALL THESE THINGS ARE THINGS WE 8 DIDN'T KNOW ABOUT TWO YEARS AGO WHEN WE BEGAN OUR 9 WORK. 10 AND SO, ONCE AGAIN, I GUESS I SAY WHAT I 11 ALWAYS SAY IS WE'LL BE MEETING, AND FOR ME HAPPILY 12 BECAUSE I LIKE SEEING ALL OF YOU, UNTIL THE LAST 13 PATIENT IS CURED IS HOW I LIKE TO THINK OF IT. DO 14 YOU KNOW? 15 AGAIN, I ALSO WANT TO WELCOME ALAN AND 16 SAY HOW LUCKY WE ALL FEEL AT CIRM TO HAVE HIM AS 17 OUR NEW LEADER AND THAT HE BRINGS A FRESH 18 PERSPECTIVE. AND SO I THINK YOU'RE GOING TO SEE 19 THROUGH OUR AGENDA THAT WE HAVE A LOT OF ISSUES 20 THAT WE NEVER HAD BEFORE BECAUSE OF HOW FAST THE 21 SCIENCE IS MOVING. AND THAT'S WHAT'S GREAT ABOUT 22 OUR GROUP, THAT THEY CAN HAVE AN OPEN AND HONEST 23 DISCUSSION, A TRANSPARENT DISCUSSION, AND PERHAPS 24 COME TO SOME CONCLUSIONS OR, EVEN MORE LIKELY, 25 CONTINUE TO HAVE SUBCOMMITTEES EXPLORING THEM AND 5 1072 BRISTOL STREET, SUITE 100, COSTA MESA, CALIFORNIA 92626 PHONE: 714.444.4100 FAX: 714.444.4411 EMAIL: [email protected] BARRISTERS' REPORTING SERVICE 1 COME BACK TO US. SO, AGAIN, THANK YOU FOR YOUR 2 TIME. THANK YOU FOR YOUR EXPERTISE. AND I'M JUST 3 HONORED TO BE PART OF IT. 4 CHAIRMAN LO: GREAT. I THINK SHERRY, AS 5 SHE ALWAYS DOES, SORT OF HIT THE NOTE THAT I THINK 6 IS THE KEYNOTE FOR OUR MEETING TODAY, AND THAT'S 7 HAVING FINISHED OUR MES REGULATIONS, OUR JOB IS 8 NOT DONE. THE SCIENCE HAS PROGRESSED. THERE HAVE 9 BEEN POLICY CHANGES IN OTHER COUNTRIES AROUND THE 10 WORLD, AND WE'RE GOING TO NEED TO REVISIT SOME 11 ISSUES THAT WE'VE DISCUSSED BEFORE. AND I'M NOT 12 SURE HOW WE'RE GOING TO COME OUT, BUT I THINK WE 13 ARE ALL COMMITTED TO CONSIDERING ISSUES IN LIGHT 14 OF NEW SCIENTIFIC DEVELOPMENTS, NEW POLICY 15 DEVELOPMENTS, AND MAKING SURE OUR ETHICAL 16 STANDARDS ARE AS UP TO DATE AS THE SCIENCE. 17 I WANT TO QUICK, IF SOMEONE CAN PUT THE 18 NEXT SLIDE ON, SORT OF GIVE YOU AN OVERVIEW OF 19 WHAT I HOPE TO ACCOMPLISH TODAY, SORT OF HOW THE 20 MEETING WILL BE SET OUT. SO THE FIRST THING WE'RE 21 GOING TO DO IS TO HAVE SOME PRESENTATIONS THAT 22 REALLY GIVE THE SWG SORT OF A BACKGROUND ON ALL 23 THAT'S BEEN GOING ON. AND SO FIRST GEOFF IS GOING 24 TO GIVE US SOME UPDATES ON REGULATORY 25 CONSIDERATIONS, AND THEN WE'RE GOING TO HAVE TWO 6 1072 BRISTOL STREET, SUITE 100, COSTA MESA, CALIFORNIA 92626 PHONE: 714.444.4100 FAX: 714.444.4411 EMAIL: [email protected] BARRISTERS' REPORTING SERVICE 1 PRESENTATIONS TO HELP US GET UP TO DATE ON THE 2 SCIENCE. 3 JOHN WAGNER IS GOING TO TALK ABOUT SOME 4 WORK HE HAS DONE WITH SORT OF MOVING IMPORTANT 5 SCIENTIFIC DISCOVERIES IN THE LAB INTO CLINICAL 6 TRIALS IN AN EXPEDITIOUS MANNER, BUT DOING THESE 7 TRIALS IN A WAY THAT ALLOW HIM TO EVALUATE THE 8 EFFECTIVENESS AND THE SAFETY OF THE INTERVENTION. 9 I THINK IT'S A REAL MODEL FOR SORT OF MOVING 10 QUICKLY TO CLINICAL TRIALS AND YET PROVIDING 11 RIGOROUS DATA FROM THOSE RESULTS. 12 AND THEN KEVIN EGGAN, WHO WITH HIS LAB 13 HAS BEEN IN THE FOREFRONT OF SORT OF DISCOVERIES, 14 NEW WAYS TO DERIVE PLURIPOTENT CELL LINES, WILL 15 SORT OF PRESENT THAT TO US. I THINK ONE OF THE 16 THINGS WE'RE GOING TO THINK ABOUT IS HOW THESE NEW 17 DEVELOPMENTS WITH WAYS TO DERIVE PLURIPOTENT CELLS 18 MAY OR MAY NOT CHANGE OUR WAY OF THINKING ABOUT 19 SOME OF THE ETHICAL POLICY ISSUES. 20 WE'RE ALSO GOING TO HEAR A LITTLE ABOUT 21 WHAT OTHER GROUPS THAT ARE TRYING TO SET 22 GUIDELINES AND POLICY ARE DOING. SO THERE'S A 23 MEETING OF THE INTERNATIONAL STEM CELL FORUM, 24 INTERSTATE ALLIANCE FOR STEM CELL RESEARCH, AND 25 THE NATIONAL ACADEMIES PANEL, WHICH ALTA IS THE 7 1072 BRISTOL STREET, SUITE 100, COSTA MESA, CALIFORNIA 92626 PHONE: 714.444.4100 FAX: 714.444.4411 EMAIL: [email protected] BARRISTERS' REPORTING SERVICE 1 CO-CHAIR, HEAR A LITTLE BIT ABOUT WHAT SOME OF THE 2 ISSUES THEY'RE THINKING ABOUT ARE. 3 AND THEN THERE'S SOME SPECIFIC ISSUES 4 THAT I THINK WE NEED TO THINK ABOUT AFRESH. ONE 5 IS THE USE OF STEM CELL LINES, PLURIPOTENT STEM 6 CELL LINES, DERIVED IN OTHER JURISDICTIONS UNDER 7 CONDITIONS WHICH MAY NOT HAVE BEEN ACCEPTABLE FOR 8 CIRM FUNDING IN CALIFORNIA. MAY CIRM-FUNDED 9 RESEARCHERS USE THOSE LINES? IT'S GOING TO BE AN 10 INCREASINGLY IMPORTANT ISSUE THAT WE NEED TO MAKE 11 SURE WE'VE THOUGHT THROUGH CAREFULLY. 12 AND THEN ALAN TROUNSON IS GOING TO TALK 13 TO US ABOUT THE ISSUE OF OOCYTE DONATION OR 14 SHARING FOR RESEARCH PURPOSES, AND HE'S GOING TO 15 TALK ABOUT HOW HE FEELS THAT IT'S VERY IMPORTANT 16 FOR SCIENTIFIC PURPOSES TO BE ABLE TO DERIVE FRESH 17 NEW PLURIPOTENT LINES USING FRESH OOCYTES AND HOW 18 OUR CURRENT REGULATIONS MAKE THAT DIFFICULT.
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