Transcript Slide 1

CALIFORNIA STEM CELL
RESEARCH AND CURES ACT
REGULATORY AFFAIRS PROFESSIONALS SOCIETY
WEST COAST CONFERENCE & EXHIBITION
March 23, 2005
Michael A. Swit, Esq.
Vice President, Life Sciences
Proposition 71 -- Basics
• Established "California Institute For Regenerative
Medicine" To Regulate Stem Cell Research And Provide
Funding, Through Grants And Loans, For Such Research
And Research Facilities.
• Created Constitutional Right To Conduct Stem Cell
Research – Adds Article Xxxv To California Constitution
– “Medical Research”
• Prohibited Institute's Funding Of Human Reproductive
Cloning Research.
• Established Oversight Committee To Govern Institute.
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Proposition 71 – Basics …
• Provides General Fund loan up to $3 million for
Institute's initial administration/implementation
costs.
• Authorizes issuance of general obligation bonds
to finance Institute activities up to $3 billion
subject to annual limit of $350 million.
• Appropriates monies from General Fund to pay
for bonds.
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Proposition 71 -- Specifics
• The institute shall have the following purposes:
– (a) To make grants and loans for stem cell research, for
research facilities, and for other vital research opportunities to
realize therapies, protocols, and/or medical procedures that
will result in, as speedily as possible, the cure for, and/or
substantial mitigation of, major diseases, injuries, and
orphan diseases.
– (b) To support all stages of the process of developing cures,
from laboratory research through successful clinical trials.
– (c) To establish the appropriate regulatory standards and
oversight bodies for research and facilities development.
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Stem Cell Research
• Stem cell research -- includes research involving adult stem
cells, cord blood stem cells, pluripotent stem cells, and/or
progenitor cells.
– Pluripotent stem cells –
• cells capable of self-renewal
• have broad potential to differentiate into multiple adult cell types
• may be derived from somatic cell nuclear transfer or from surplus
products of in vitro fertilization treatments when such products are
donated under appropriate informed consent procedures.
– Progenitor cells -- multipotent or precursor cells that are
partially differentiated, but retain the ability to divide and give rise
to differentiated cells.
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Covered Research
• Per “Purpose & Intent” – scientists at California
universities and other advanced medical research
facilities
• Maximize the use of research funds by giving priority to stem cell
research that has the greatest potential for therapies and cures,
specifically focused on pluripotent stem cell and
progenitor cell research among other vital research
opportunities that cannot, or are unlikely to, receive
timely or sufficient federal funding, unencumbered by
limitations that would impede the research.
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California Institute For Regenerative
Medicine -- CIRM
• Established in early 2005 with the passage of
Proposition 71 – to administer Prop. 71
• The Independent Citizens Oversight Committee
("ICOC") –
– 29-member governing board for the Institute; represent:
• California's leading public universities
• Non-profit academic and research institutions
• Patient advocacy groups – specifically -- spinal cord injury and
Alzheimer’s Disease, type II diabetes, multiple sclerosis or amyotrophic
lateral sclerosis, type I diabetes and heart disease, : cancer and
Parkinson’s disease, mental health disease, and HIV/AIDS
• Biotechnology industry
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CIRM …
• ICOC Chairs
– Chair -- Robert Klein, Klein Financial Group
– Vice Chair -- Ed Penhoet, Ph.D. President, Gordon & Betty
Moore Foundation
• Interim President – Zach Hall – ex-associate dean of
medical research, USC
• Working Groups:
– Scientific and Medical Research Funding Working Group.
– Scientific and Medical Accountability Standards Working
Group.
– Scientific and Medical Research Facilities Working Group.
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Key Issues Facing CIRM
• Sunshine on process –
– Meetings
• Two public meetings per year required
• Subject to Bagley-Keene Open Meeting Act for all meetings – although
some meetings can be closed – specific examples:
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Patient confidentiality
Trade secret information
Prepublication scientific information
Personnel actions involving CIRM employees
• Grants and loans must be adopted in open meetings
– Records –
• California Public Records Act applies
• Some restrictions – similar to those under public meeting
– Must use competitive bidding for services
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Key Issues Facing CIRM …
• Location of CIRM – candidates include:
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San Francisco
San Diego
Los Angeles
Sacramento
• Can non-stem cell research be supported – see
Slide 4 -- “for other vital research opportunities”
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Key Issues Facing CIRM …
• What can be funded
– Preference – ensure funding does not duplicate or supplant
existing funding, high priority shall be placed on funding
pluripotent stem cell and progenitor cell research that cannot, or
is unlikely to, receive timely or sufficient federal funding,
unencumbered by limitations that would impede the research
– “Vital research opportunity” -- scientific and medical research
and technologies and/or any stem cell research not actually
funded by the institute under [first bullet point] which provides a
substantially superior research opportunity vital to advance
medical science as determined by at least a two-thirds vote of a
quorum of the members of the Scientific and Medical Research
Funding Working Group and recommended by WG to ICOC
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Key Issues Facing CIRM …
• What Can Be Funded
– Restrictions on what therapies can be covered
• Text says -- to realize therapies, protocols, and/or medical
procedures that will result in, as speedily as possible,
the cure for, and/or substantial mitigation of, major
diseases, injuries, and orphan diseases.
– “major” – appears to modify diseases and injuries?
– Are “minor” diseases and injuries eligible for support?
– Are improvements that are incremental, but not substantial,
eligible even if for “major diseases, injuries, and orphan diseases”
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Key Issuing Facing CIRM …
• What Can Be Funded
– Restrictions on what therapies can be covered …
• But, see Slide #6 – from Purposes & Intents Section of
Prop. 71 – makes clear CIRM should maximize its dollar;
but does that also require outcomes be used in “triage” of
proposals?
– Won’t fund anything funded by NIH
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Key Issues Facing CIRM …
• What Can Be Funded –
– Research funding -- any distinctions based on:
• For profit vs. not-for-profit research?
• In California or not – can part benefit a non-California
firm?
– Facilities and Equipment Funding -• Grantee must be a not-for-profit
• Remember -- must be in California to get $
– Split between research and facilities – 90/10
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Key Issues Facing CIRM …
• Revenues from products developed with CIRM
funds
– The Law – “ICOC shall establish standards that require that
all grants and loan awards be subject to intellectual property
agreements that balance the opportunity of the State of California to
benefit from the patents, royalties, and licenses that result from basic
research, therapy development, and clinical trials with the need to assure
that essential medical research is not unreasonably hindered by the
intellectual property agreements. “
– Open Issues
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How much goes to state?
Form of payment?
Will CIRM seek joint ownership of inventions?
Can outsiders share in process?
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Key Issues Facing CIRM …
• California – location, location, location
– Preference for California Suppliers
• ICOC shall establish standards to ensure that grantees
purchase goods and services from California suppliers to
the extent reasonably possible, in a good faith effort to
achieve a goal of more than 50 percent of such purchases
from California suppliers.
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Key Issues Facing CIRM …
• Standards to be set on variety of subjects
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Informed Consent
Patient Privacy
Protection of Human Subjects
No “compensation” to donors; can reimburse expenses
Paying for cell lines to cover a number of expenses to obtain,
but (implicitly) not to pay a “profit”
– Time Limits for Obtaining Cells -- on time during which cells
may be extracted from blastocysts
• initially -- 8 to 12 days after cell division begins, not counting any time
during which the blastocysts and/or cells have been stored frozen.
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Key Issues Facing CIRM …
• Conflicts of Interest – Sen. Deborah Ortiz and Sen.
George Runner – last week proposed constitutional
amendment would require CIRM, its board and any
outside members of the board's working groups to
adhere to strict conflict-of-interest guidelines based on
those used in the state government and the federal
National Institutes of Health.
• Open meetings -- It also would force the board, its
working groups and the institute to hold all meetings in
accordance with California's open-meeting laws.
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Key Issues Facing CIRM …
• Was Proposition 71 Legal? – two lawsuits
– Allegedly violates requirement that an initiative cover
just a single subject
– Allegedly can not exempt certain members from
government conflicts of interest laws
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How to Contact CIRM
P.O. Box 99740
Emeryville, CA 94622-9740
Phone: (510) 450-2419
Fax: (510) 450-2435
Web Address: www.cirm.ca.gov
E-Mail: [email protected]
Street address: 5858 Horton Street, Emeryville,
CA 94608
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Questions?
Call, e-mail, fax or write:
Michael A. Swit, Esq.
Vice President, Life Sciences
THE WEINBERG GROUP INC.
336 North Coast Hwy. 101
Suite C
Encinitas, CA 92024
Phone 760.633.3343
Fax 760.633.3501
Cell 760.815.4762
D.C. Office 202.730.4123
[email protected]
www.weinberggroup.com
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About the speaker …
Michael A. Swit, Esq., who is Vice President, Life Sciences at THE WEINBERG GROUP
INC., has extensive experience in all aspects of FDA regulation with a particular emphasis on
drugs and medical device regulation. In addition to his private legal and consulting
experience, Mr. Swit also served for three and a half years as vice president and general
counsel of Pharmaceutical Resources, Inc. (PRI) a prominent generic drug company and,
thus, brings an industry and commercial perspective to his representation of FDA-regulated
companies. While at PRI from 1990 to late 1993, Mr. Swit spearheaded the company’s
defense of multiple grand jury investigations, other federal and state proceedings, and
securities litigation stemming from the acts of prior management. Mr. Swit then served from
1994 to 1998 as CEO of Washington Business Information, Inc. (WBII) a premier publisher
of FDA regulatory newsletters and other specialty information products for the FDA
publishing company. Before joining THE WEINBERG GROUP, he served in the FDA
Regulatory Law Practices at both Heller Ehrman and McKenna & Cuneo, first in that firm’s
D.C. office and then in its San Diego office. He first practiced FDA regulatory law with the
D.C. office of Burditt & Radzius from 1984 to 1988. Mr. Swit has taught and written on a
wide variety of subjects relating to FDA law including, since 1989, co-directing a three-day
intensive course on the generic drug approval process, serving on the Editorial Board of the
Food & Drug Law Journal, and editing a guide to the generic drug approval process, Getting
Your Generic Drug Approved, published by WBII. Mr. Swit holds an A.B., magna cum
laude, with high honors in history, in 1979, from Bowdoin College, and earned his law
degree from Emory University in 1982. He is a member of the California, Virginia and
District of Columbia bars.
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For more than twenty years, leading companies have depended on
THE WEINBERG GROUP when their products are at risk. Our
technical, scientific and regulatory experts deliver the crucial results
that get products to market and keep them there.
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