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UNITED STATES OF AMERICA

FOOD AND DRUG ADMINISTRATION

CENTER FOR BIOLOGICS EVALUATION AND RESEARCH

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VACCINES AND RELATED BIOLOGICAL

PRODUCTS ADVISORY COMMITTEE

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MEETING

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WEDNESDAY,

MAY 16, 2001

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The Advisory Committee met in the Grand Ballroom, Holiday Inn Gaithersburg, 2 Montgomery Village Avenue, Gaithersburg, Maryland, at 9:00 a.m., Dr. Robert S. Daum, Acting Chair, presiding.

PRESENT:

ROBERT S. DAUM, M.D., Acting Chair

C. ESTUARDO AGUILAR-CORDOVA, M.D., Ph.D.

DONALD BLAIR, Ph.D.

JOHN COFFIN, Ph.D.

JAMES COOK, M.D.

MICHAEL DECKER, M.D.

PAMELA S. DIAZ, M.D., Member

PRESENT (Continued):

ALEX J. VAN DER EB, Ph.D.

WALTER L. FAGGETT, M.D., Member

BARbARA LOE FISHER, Member

JUDITH D. GOLDBERG, Sc.D., member

DIANE E. GRIFFIN, M.D., Ph.D., Member

STEPHEN HUGHES, Ph.D.

SAMUEL L. KATZ, M.D., Member

KWANG SIK KIM, M.D., Member

STEVE KOHL, M.MD., Member

PAMELA McINNES, D.D.S., Msc.(Dent.)

PHILIP MINOR, Ph.D.

LAWRENCE MOULTON, Ph.D.

MARTIN MYERS, M.D.

SUZETTE PRIOLA, Ph.D.

DAVID S. STEPHENS, M.D., Member

SIDNEY WOLFE, M.D.

NANCY CHERRY, Executive Secretary

C-O-N-T-E-N-T-S


Conflict of Interest Statement 4

Introductions 4

Introduction to the Session on Designer Cell

Substrate, Dr. Andrew Lewis 16


Designer Cell Substrates for Vaccine

Development: Concepts and Issues,

Dr. Steve Hughes 35


Adenovirus Biology as Related to Development

and Use of Adenovirus Vectors, Dr.

Estuardo Aguilar-Cordova 54


Adenovirus Transformation of Human Cells and the

Development of 293 and PER.C6 for the

Manufacture of Defective Adenovirus Vectors,

Dr. Alex van der Eb 77


Adenovirus Transformed Cell Tumorigenicity and

Transformed Cell-Host Interaction that

Determine their Tumor Forming Capability,

Dr. James Cook 100


Quantitative Assessment of the Risks of

Residual DNA, Dr. Keith Peden 131


Introduction to Adventitious Agent Issues,

Dr. Philip Krause 161


Transmissible Spongiform Encephalopathy Agents

as an Issue in the Use of Neoplastic Cell

Substrates, Dr. Sue Priola 168


Adventitious Agent Testing of Neoplastic Cell

Substrates, Dr. Philip Krause 196


Review of OVRR-CBER Issues with the Use of

Adenovirus-vectored Vaccines and their

Complementing Designer Cell Substrates,

Dr. Hana Golding 228


Committee Discussion 239

P-R-O-C-E-E-D-I-N-G-S

(9:01 a.m.)

ACTING CHAIRMAN DAUM: Good morning. We will begin our session with turning the floor over to Nancy Cherry, who will read the conflict of interest statement.

MS. CHERRY: First of all, I'd like to welcome you all to this meeting, and then I will read the statement.

The following announcement addresses conflict of interest issues associated with this Session 2 of the Vaccines and Related Biological Products Advisory Committee meeting on May 16th, 2001.

This open session is focused on discussion on adventitious agent testing, tumorigenicity testing, and issues related to residual cell substrate DNA of novel and neoplastic cell substrates used to manufacture viral vaccines.

No temporary voting members have been appointed for this session.

To determine if any conflicts of interest existed, the agency reviewed the submitted agenda and all financial interests reported by the meeting participants. As a result of this review, the following disclosures are being made regarding the discussion May 16th.

Drs. Griffin, Aguilar-Cordova, and Ketner have each been granted a waiver in accordance with 18 USC 208(b)(3), which permits them to participate fully in the discussions.

Also, in accordance with Section 2635.502 of the Standards of Conduct, Drs. Coffin and Moulton have been granted appearance determinations which permit them to participate fully in the discussions.

Drs. Daum, Goldberg, Griffin, Kim, Stephens, Blair, Priola, Hughes, Cook, McInnes, and Minor have associations with firms that could be or appear to be affected by the Committee discussions. However, in accordance with 18 USC 208 and with the section I referenced above of the Standards of Conduct, it has been determined that none of these associations is sufficient to warrant the need for a waiver, for a written appearance determination or for exclusion.

The agency has determined that the services of Dr. van der Eb as a non-voting guest are essential. Dr. van der Eb has reported that he received a consulting fee for scientific advice on Crucell's human cell line.

In addition, the agency has determined that the services of Dr. Michael Decker as a non-voting guest from industry are also essential. Dr. Decker is employed by Aventis Pasteur as the Vice President of Medical and Scientific Affairs. He reported a financial interest in a firm that could be affected by the committee discussion.

In addition, Dr. Decker's employer has associations with university researchers and with major vaccine manufacturers.

In the event that the discussions involve specific products or firms not on the agenda and for which FDA's participants have a financial interest, the participants are reminded of the need to exclude themselves from the discussions. Their recusals will be noted for the public record.

With respect to all other meeting participants, we ask in the interest of fairness that you state your name and affiliation and any current or previous financial involvement with any firm whose products you wish to comment on.

Copies of all waivers and appearance determinations addressed in this announcement are available by written request under the Freedom of Information Act.

And I do have one other announcement. The Committee management specialists that did so much work to put this meeting together are, I guess, both sitting out at the front desk now. Denise Royster is being assisted today by Rosanna Harvey, and if you have any problems, please see them.

ACTING CHAIRMAN DAUM: Thank you very much, Nancy.

There's a peculiar microphone feedback in the room that seems to be resonating around when anyone is speaking. It sounds like someone whispering, and I realize after a while that it's me and it's my echo going around. We had it when Dr. Patriarca was speaking last time also.

Can you give it a thought? Maybe I'm just sitting at the funnel here.

PARTICIPANT: Are you hearing it now?

ACTING CHAIRMAN DAUM: When I speak I am.

Also, cell phones, beepers, all the things you can't use on airplanes, please don't use them here either. Different reason. They really distract the tone of the discussion and the Committee deliberations, and I'd very much be grateful if everybody now thought about whether they have a beeper or cell phone that could ring and disrupt the Committee.

I would like to take a few minutes to go around the table and have people introduce themselves this morning, and I would like to ask that there be a slight discrimination in the process, unless the way we usually do it, and that is we'll start with Dr. Griffin and come down as far as Ms. Fisher, which are the standard Committee members, and then I'm going to ask everybody else, starting with Dr. Myers and working our way around, to not only say who they are and what their affiliation is, but sort of explain how that affiliation gets them here in one sentence or two. Why are they consulting to our Committee for in general or for this particular issue.

I think that would be helpful in terms of orienting everyone toward the discussion. So, Dr. Griffin, would you start us off, please?

DR. GRIFFIN: So I am Diane Griffin from Johns Hopkins. I'm the chair of the Molecular Microbiology and Immunology Department in the School of Public Health, and I'm going to explain a little bit about myself.

I'm interested in the pathogenesis of viral infections.

ACTING CHAIRMAN DAUM: Perfect.

DR. STEPHENS: I'm David Stephens from Emory University, Director of the Division of Infectious Diseases. I'm a bacteriologist, not a virologist. So I'll pass to the next person.

ACTING CHAIRMAN DAUM: Committee members need to be less explicit in this regard.

(Laughter.)

ACTING CHAIRMAN DAUM: This is not a total expose, but rather an opportunity for the Committee to understand why the consultants that are here today, in fact, are.

Dr. Goldberg.

DR. GOLDBERG: Hi. Judy Goldberg. I'm the Director of Biostatistics at New York University, School of Medicine.

DR. KATZ: I'm Sam Katz, a pediatric infectious disease person from Duke who's spent most of his career studying vaccines.

DR. DIAZ: I'm Pamela Diaz, pediatric infectious disease person and the Director of Infectious Diseases for the Chicago Department of Health.

DR. KOHL: I'm Steve Kohl, pediatric infectious diseases and at the Argonne Health Science University, with an expertise in viral immunology.

DR. KIM: I'm Kwang Sik Kim. I'm head of pediatric infectious diseases at Johns Hopkins School. My work has been primarily on the pathogenesis of infectious diseases, primarily on bacterial infections in pediatrics.

MS. FISHER: Barbara Loe Fisher, President of the National Vaccine Information Center, a nonprofit organization that's concerned about vaccine safety.

DR. MYERS: I'm Martin Myers. I'm the Director of the National Vaccine Program Office. Background: pediatrician in infectious diseases interested in pathophysiology, particularly animal models of Herpes viral infections; former Chairman of Pediatrics.

MS. McINNES: I'm Pamela McInnes, Deputy Director, Division of Microbiology and Infectious Diseases, National Institute of Allergy and Infectious Diseases. NIAID is, of course, an important funder through public money, expenditure on basic, applied, and clinical research in infectious diseases.

DR. VAN DER EB: I am Alex van der Eb, emeritus professor at the University of Leiden, with expertise in viral transformation and cancer in general. I'm still active in the lab and scientific advisor to Crucell, a member of the Scientific Advisory Committee.

DR. DECKER: I'm Dr. Michael Decker. I'm a member of the Departments of Preventive Medicine and Infectious Diseases at Vanderbilt University, where for, oh, ten or 15 years I've been actually involved in clinical research and vaccines. Recently I've joined Aventis Pasteur as Vice President for Scientific and Medical Affairs, and I'm here because through a typical federal process, I am the vaccine industry representative to VerPAC.

DR. AGUILAR-CORDOVA: I'm Estuardo Aguilar. I'm with the Harvard Gene Therapy Initiative, and I've been asked to come here primarily because of my work in antiviral vectors and their use in gene therapy applications.

DR. COFFIN: John Coffin. I'm a professor in the Department of Molecular Biology and Microbiology at Tufts University and also part-time Director of the NCI's HIV Drug Resistance Program and also part-time cranberry grower. And I'm here, I guess, because my research over quite a number of years has been engaged in understanding how retroviruses work and how they transform cells and issues related to that.

DR. COOK: I'm Jim Cook. I'm Chief of Infectious Disease at the University of Illinois, and my research interest is adenoviral early gene expression, especially E1A and how it affects the cell's response to the inflammatory response in host..

DR. BLAIR: I'm Don Blair. I'm Chief of the Oncogene Mechanism Section of the Center for Cancer Research at the NCI and have a long history of interest in DNA biological activity and tumorigenesis.

DR. MOULTON: Larry Moulton. I'm a biostatistician at Johns Hopkins University, and I spend the majority of my time working on vaccine safety and vaccine efficacy studies.

DR. KETNER: I'm Gary Ketner from the Department of Molecular Microbiology at the Johns Hopkins University now Bloomberg School of Public Health, and I'm an adenovirus geneticist.

DR. MINOR: I'm Philip Minor. I'm from the National Institute of Biological Standards and Control in the United Kingdom. We're concerned with quality control and quality issues and regulation of viral vaccines, and we also get involved in viral contamination, issues of biological products.

DR. WOLFE: I'm Sid Wolfe. I'm a general internist by clinical training, and since leaving NIH 30 years ago, I've spent most of my time at the Public Citizens Health Research Group in activities that relate to the FDA, drugs, biologics, and I think I'm here because we've worked closely, sometimes in an antagonist way, but closely with the FDA for 30 years to try and sort through problems.

This is certainly one of the most interesting and important issues that's come at least to my attention, and I'm glad to be asked to participate.

DR. PRIOLA: I'm Sue Priola from the Rocky Mountain Laboratories, which is an off, off, off campus branch of National Institutes of Health, and I'm here to provide information about infectivity TSE infection, and tissue culture cells and the risks involved.

DR. HUGHES: I'm Steve Hughes. I'm from the HIV Drug Resistance Program of the NCI, and I have a longstanding interest in retroviruses and retroviral vectors.

ACTING CHAIRMAN DAUM: And I'm Robert Daum. I'm from -- I'm with parainfluenza virus infection.

(Laughter.)

ACTING CHAIRMAN DAUM: I'm from the University of Chicago. I'm head of the Section of Pediatric Infectious Diseases there. My interests include antimicrobially induced stress in Gram positive bacteria, and that's my day job, and my closet research concerns clinical evaluation of vaccines and strategies for improving immunization rates in inner city children.

And so with that, I welcome everybody, members and guests, to our meeting. We have obviously a very distinguished panel of consultants today to help us with these important issues.

And at this point I'd like to move on with the body of the meeting and call on Dr. Andrew Lewis from the FDA, who will introduce us to this session on so-called designer cell substrates.

While Dr. Lewis is walking up to the podium, could the FDA folks tell us who they are also and just in the same kind of brief, USA Today format?

DR. PEDEN: Yes, my name is Keith Peden. I'm in the Division of Viral Products in the Office of Vaccines at CBER. We're involved in the regulation of vaccines, and as a nighttime job we do some research on HIV.

DR. KRAUSE: Phil Krause in the Laboratory of DNA Viruses. I'm interested in viral latency and in viral detection.

DR. GOLDING: I'm Hana Golding. I'm the Chief of the Laboratory of Retrovirus Research in Division of Viral Product. I'm very much involved in regulation of HIV vaccine, and my scientific world has been focused on HIV cell entry and HIV vaccine development.

ACTING CHAIRMAN DAUM: Thank you very kindly.

DR. GRIFFIN: I am Diane Griffin from Johns Hopkins.

DR. STEPHENS: I'm David Stephens from Emory University.

DR. GOLDBERG: Judy Goldberg from New York University.

DR. KATZ: Sam Katz from Duke University.

DR. DIAZ: Pamela Diaz, Chicago Department of Health.

DR. KOHL: Steve Kohl, Argonne Health Science University.

DR. KIM: Kwang Sik Kim, Johns Hopkins School of Medicine.

MS. FISHER: Barbara Loe Fisher, National Vaccine Information Center.

DR. MYERS: Martin Myers, National Vaccine Program Office.

DR. COFFIN: John Coffin, Tufts University and sometimes NCI.

DR. COOK: Jim Cook, University of Illinois.

DR. BLAIR: Don Blair, NCI.

DR. MOULTON: Larry Moulton, Johns Hopkins University.

DR. KETNER: Gary Ketner, Johns Hopkins.

DR. MINOR: Philip Minor from the National Institute of Biological Standards in the U.K.

DR. WOLFE: Sid Wolfe, Public Citizens Health Research Group.

DR. HUGHES: Steve Hughes, NCI.

ACTING CHAIRMAN DAUM: And I'm Robert Daum from the University of Chicago.

DR. LEWIS: And by way of introduction, I'm Andrew Lewis, as it says on this slide. Maybe we need to cut the lights down a bit. Can people see this better now?

I'm the Chief of the Laboratory of DNA Viruses, Division of Viral Products. I came to the FDA about a little over five years ago, having spent basically a 30-year career at the National Institutes of Health studying adenoviruses and adenovirus transformed cells.

My role in introducing today's session is twofold. The first is to review the status of the Office of Vaccines' approach to the use of neoplastic cell substrates for viral vaccine development and, second, to introduce the topic of designer cell substrates and the issues associated with their use for vaccine manufacture.

Is this better? Keith, could you see about focusing this slide? Is that better?

Okay. Thank you.

Several of the topics for discussion today have evolved from studies of viral oncology, using
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