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AThis transcript has not been edited or corrected,
but appears as received from the commercial transcribing service. Accordingly, the FDA makes no representation
to its accuracyY@
2
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4 FOOD AND DRUG ADMINISTRATION
5 CENTER FOR BIOLOGICS EVALUATION AND RESEARCH
6
7
8
9 BIOLOGICAL RESPONSE MODIFIERS
10 ADVISORY
COMMITTEE (BRMAC)
11 Meeting 36
12 DAY TWO
13
14
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16
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19
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21 Gaithersburg, Maryland
22 Friday, October 10, 2003
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PARTICIPANTS:
2 BRMAC MEMBERS:
3 MAHENDRA S. RAO, Acting Chair
National Institute on
Aging
4
JONATHAN S. ALLAM
5 Southwest Foundation for Biomedical Research
6 BRUCE R. BLAZAR
University of Minnesota
7
DAVID M. HARLAN
8 National Institute of Diabetes and Digestive
and Kidney Disease
9
KATHERINE A. HIGH
10 University of Pennsylvania
11 JOANNE KURTZBERG
Duke University Medical
Center
12
ALISON F. LAWTON
13 Genzyme Corporation
14 RICHARD C. MULLIGAN
Harvard Medical School
15
ANASTASIOS A. TSIATIS
16 North Carolina State University
17 ALICE J. WOLFSON
Wolfson &
Schlichtmann
18
TEMPORARY VOTING MEMBERS:
19
JAMES F. CHILDRESS
20 University of Virginia
21 LYNNE L. LEVITSKY
Harvard Medical School
22
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1 PARTICIPANTS
(CONT'D):
2 TEMPORARY VOTING MEMBERS (CONT'D):
3 ABBEY S. MEYERS
National Organization for
Rare Disorders
4
CAROLE B. MILLER
5 St. Agnes Healthcare
6 W. MICHAEL O'FALLON
Mayo Clinic
7
DANIEL R. SALOMON
8 The Scripps Research Institute
9 ROBERT S. SHERWIN
Yale University School of Medicine
10
JANET H. SILVERSTEIN
11 University of Florida College of Medicine
12 CONSULTANTS:
13 JOHN J. O'NEIL JR.
LifeScan, Inc.
14
CAMILLO RICORDI
15 University of Miami School of Medicine
16 GUESTS/GUEST SPEAKERS:
17 BERNARD J. HERING
University of Minnesota
18
JAMES SHAPIRO
19 University of Alberta
20 THOMAS L. EGGERMAN
National Institute of
Diabetes and Digestive
21 and Kidney Diseases
22
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PARTICIPANTS (CONT'D):
2 GUESTS/GUEST SPEAKERS (CONT'D):
3 JAMES BURDICK
Health Resources and
4 Services Administration
5 FRANCISCA AGBANYO
Health Canada
6
FOOD & DRUG ADMINISTRATION
(FDA) PARTICIPANTS:
7
JESSE L. GOODMAN
8 Center for Biologics Evaluation
and Research
9
KATHRYN CARBONE
10 Center for Biologics Evaluation
and Research
11
RAJ PURI
12 Center for Biologics Evaluation
and Research
13
CAROLYN WILSON
14 Center for Biologics Evaluation
and Research
15
ANDREW BYRNES
16 Center for Biologics Evaluation
and Research
17
NANCY MARKOWITZ
18 Center for Biologics Evaluation
and Research
19
STEVEN BAUER
20 Center for Biologics Evaluation
and Research
21
22
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PARTICIPANTS (CONT'D):
2 FDA PARTICIPANTS (CONT'D):
3 AMY ROSENBERG
Center for Drug
Evaluation
4 and Research (CDER)
5 EMILY SHACTER
Center for Drug
Evaluation
6 and Research
7 GAIL DAPOLITO
Executive Secretary
8 Center for Biologics Evaluation
and Research
9
ROSANNA L. HARVEY
10 Committee Management Specialist
Center for Biologics Evaluation
11 and Research
12 BRMAC #36 FDA PLANNING COMMITTEE MEMBERS:
13 PHILIP NOGUCHI
Center for Biologics
Evaluation
14 and Research
15 CYNTHIA
RASK
Center for Biologics
Evaluation
16 and Research
17 DARIN WEBER
Center for Biologics
Evaluation
18 and Research
19 DWAINE RIEVES
Center for Biologics
Evaluation
20 and Research
21 KEITH M. WONNACOTT
Center for Biologics
Evaluation
22 and Research
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1
PARTICIPANTS (CONT'D):
2 BRMAC #36 FDA PLANNING COMMITTEE MEMBERS
(CONT'D):
3
NICHOLAS I. OBIRI
4 Center for Biologics Evaluation
and Research
5
RICHARD McFARLAND
6
STEPHEN GRANT
7
SUSAN LEIBENHAUT
8
JOHN ELTERMANN JR.
9
JOHN FINKBOHNER
10
SARAH KIM
11
SUSAN ELLENBERG
12
GHANSYAM GUPTA
13
ROBERT MISBIN
14
15 C O N T E N T S
16
AGENDA SESSION: PAGE
17 Current Status of Clinical Islet 7
Transplantation
18
Allocation of Pancreata for
Whole 65
19 Organ and Islet Transplantation
20 Ethical Considerations in Allogeneic 115
Islet Transplantation
21
Clinical Development of
Islet Products 151
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1 P R O C E E D I N G S
2 (8:13 a.m.)
3 DR. SHAPIRO:
Good morning. On
4
behalf of Dr. Camillo Ricordi, and
5
Dr. Bernhard Hering, and myself, and many
6
other members involved with total islet
7
transplant activity. It is a
great pleasure
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to provide this information today to the FDA
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as we consider moving forward with a
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possibility of a BLA.
11 I'd like to emphasize that we come
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to you today with a long history of research
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and progress in islet transplantation over
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now three decades. With the
first
15
successful islet transplantation and
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reversal of diabetes in rodent models by
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Dr. Paul Lacy and his colleagues back in the
18
early 1970s.
19 The success at the University of
20
Minnesota with islet auto‑transplants in
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the 1970s, and in fact it's worth mentioning
22
that today there are islet autografts that
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are functional beyond 18 years maintaining
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insulin independence with no concerns
3
regarding the health of those patients
4
receiving islet autografts ‑‑
5 (Power plug pulled)
6 DR.
SHAPIRO: As I was saying,
7
the 30 years of research and then the 18
8
years of success with islet
9
auto‑transplants, and then the development
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of the automated method by Dr. Camillo
11 Ricordi
introduced and published in 1989,
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and then the first series of patients
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receiving allo transplants using the
14
automated method in 1990; the success at
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Giessen and more recently in Minnesota by
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Dr. Bernhard Hering and his group, and also