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Public Workshop:
Scientific Considerations Related to Developing Follow-On Protein
Products, September 14-15, 2004
September 14, 2004
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Case Study for
Comparability and Efficacy – rec FIX versus Plasma derived, Bob
Adamson Ph.D., Wyeth BioPharma. [HTML]
or [PPT]
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Pre-Clinical and
Clinical And Potency and Surrogates for Efficacy and Safety, Carole
Ben-Maimon, M.D., Duramed Research Inc. [HTML]
or [PPT]
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Scientific
Considerations Related to Developing “Follow-On Protein” Products,
Joseph A. Carrado, M.Sc., R.Ph., Duramed Research, Inc. [HTML]
or [PPT]
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Structural Signatures for Comparability, Arnon Chait, Ph.D., ANALIZA, Inc. Cleveland, Ohio. [HTML]
or [PPT]
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Characterization of
Protein Pharmaceutical Products, Charles E. DiLiberti, Barr
Laboratories, Inc. [HTML] or
[PPT]
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The Manufacturing Process is a Significant
Determinant of the Therapeutic Protein Product, John
Dingerdissen, Johnson & Johnson [HTML]
or [PPT]
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Scientific Considerations Related to Developing
Follow-On Protein Products, Linda Fryklund PhD, Pfizer
Inc. [HTML] or [PPT]
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Scientific Considerations for the Development of Follow-On
Protein Products, Robert L. Garnick, Ph.D., Genentech. [HTML]
or [PPT]
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Scientific Considerations Related to Developing
Follow-On Protein Products, Walter W. Hauck, Ph.D.
Statistical Consultant, USP, Professor, Thomas Jefferson
University. [HTML] or [PPT]
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Manufacture of Follow-on Protein Products,
Jacob Hartman, Ph.D., Bio-Technology General (Israel) Ltd. [HTML]
or [PPT]
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Comparability Exercises Limitations for Follow-On Biologics (FOBs)
The European Perspective, Christopher J. Holloway, Ph.D., ERA Consulting Group. [HTML] or [PPT]
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Statement of Mathias Hukkelhoven, Ph.D.,
Novartis Pharmaceuticals Corp. [PDF]
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Terminology Considerations: Scientific
Considerations Related to Developing Generic Biopharmaceutical
Products FDA Workshop, Gordon Johnston, R.Ph.,
M.S., Generic Pharmaceutical Association. [HTML]
or [PPT]
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Use of Analytical and Characterization Technology for the
Development of Follow-On Protein Products, Andy Jones, Ph.D., Genentech,
Inc. [HTML] or [PPT]
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Scientific Considerations Related to Developing
Follow-On Protein Products: Manufacturing Issues, Art LeBlanc,
MS, Secor Pharmaceuticals, Inc.
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Testifying on behalf of the Biotechnology
Industry Organization Before the Food and Drug Administration,
HHS, Sara Radcliffe, Scientific and Regulatory Affairs. [PDF]
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Human Growth Hormone A case study of a
biopharmaceutical generic, Suzanne M. Sensabaugh, MS,
MBAVP, Sicor Inc.
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Pre-Clinical Development for Biopharmaceutical Generics,
Doron
M. Shinar, Ph.D, Teva Pharmaceutical Industries.
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Biopharmaceutical Generics Clinical Development
Plan, Yafit Stark, Ph.D., Teva. Pharmaceutical Industries, Ltd.
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Relevant Terminology, Keith Webber, Ph.D., CDER.
[HTML] or [PPT]
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Hydrogen/Deuterium Exchange to Quantitate Protein Structure Similarity,
Patricia C Weber, Ph D., ExSAR Corporation [PDF]
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Structure-Activity Relationships (SAR): Uses and
Limitations in Follow-On Biologics, Robert L. Zeid, TLI
Development. [HTML] or
[PPT]
September 15, 2004
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Immunogenicity of Therapeutic Proteins: A Case
Report, Fred Bader, PhD, Johnson & Johnson. [HTML]
or [PPT]
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Draft PPTA Follow-on Protein Products
Presentation, Don Baker, Ph.D., Baxter BioScience. [HTML]
or [PPT]
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Do “Follow-On” Proteins Need to Undergo Thorough
Clinical Testing? Hal Barron, M.D. F.A.C.C., Genentech, Inc. [HTML] or [PPT]
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What may be needed
in terms of clinical studies for a follow-on protein product?,
Murray P. Ducharme, PharmD, MDS Pharma. [HTML]
or [PPT]
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Scientific Considerations Related to Developing
Follow-On Protein Products, Theresa L. Gerrard,
Ph.D., TLG Consulting Inc.
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Product Life Cycle, James D. Green, Biogen Idec, Inc. [HTML] or [PPT]
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Scientific Considerations Related to Developing
Follow-On Protein Products,
John Greenwood, GeneMedix plc. [HTML]
or [PPT]
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Enabling drug discovery development and
manufacture realizing the future, Johanna Griffin, ProCognia, Inc. [HTML]
or [PPT]
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Scientific Considerations
Related to Follow-On Biologics, Kenneth B. Seamon, Ph.D., Amgen. [HTML]
or [PPT]
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Follow-on Protein Products Meeting
Date created: September 27, 2004, updated
October 13, 2004  |
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