Oncology Biologics Development Primer

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February 28-29, 2008
Gaithersburg Marriott Washingtonian Center
Gaithersburg, MD

Presentation Slides and Schedule
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Thursday, February 28
8:00 am - 8:10 am	Welcome and Introductions
8:10 am - 8:55 am	Keynote Address Regulatory Overview of Oncology Biologics Product Development from Bench to First-in-Man Raj Puri, MD, PhD - Food and Drug Administration, CBER
8:55 am - 10:25 am	Session 1: Preclinical Development
	Cell and Gene Therapy Products for Cancer Treatment Ying Huang, PhD - Food and Drug Administration, CBER
	Biological Therapeutics for Cancer Treatment Andrew J. McDougal, PhD, DABT - Food and Drug Administration, CDER
	Principles of Preclinical Development and Validation of Molecular Markers/Biomarkers of Toxicity and Efficacy for Cancer Therapies Samir Khleif, MD - National Cancer Institute, CCR
	Developing Biologics for Phase I Trials: Manufacturing and Toxicology Anthony R. Welch, PhD - National Cancer Institute
10:40 am - 12:30pm	Session 2: Clinical Development
	Phase I Design Issues: Surrogate Markers/Selecting Pts/Special Inclusion-Exclusion Criteria Susan Jerian, MD - OncoRD, Inc.
	Phase II and Beyond Issues John M. Kirkwood, MD - University of Pittsburgh
	Good Clinical Research Practice - Working in the World of Regulated Research Marta Fields - Amgen Inc.
1:30 pm - 3:30 pm	Session 3: Case Studies in Protein Therapeutics
	Cytokines: Lessons from Single Digit Cytokines IL2, IL7 Crystal Mackall, MD - National Cancer Institute, Pediatric Oncology
	Cytokines: Lessons From Double Digit Cytokines IL12, IL18 and Counting Michael T. Lotze, MD - University of Pittsburgh Cancer Institute
	Antibodies: CTLA4 Antagonist Therapy for Cancer Rachel W. Humphrey, MD - Bristol-Myers Squibb Company
	Antibodies: CD40 Agonist Development for Cancer Robert H. Vonderheide, MD, D.Phil - University of Pennsylvania, Abramson Family Cancer Rsch. Inst.
	Panel Discussion Moderator: Susan Jerian, MD - OncoRD, Inc.
3:45 pm - 5:15 pm	Session 4: Industry and Academic Relationships in Biologic Development
	Academic Drug Development: Bench to First-in-Man without Industry Elizabeth M. Jaffee, MD - Johns Hopkins University
	Industry Perspective: What Industry Expects from Academic Partnerships David Parkinson, MD - Nodality, Inc.
	Academic Perspective: Role of Tech Transfer in Academia and Common Out-Licensing Criteria Christopher Moulding - USC Stevens Institute for Innovation
4:30 pm - 5:15 pm	Panel Discussion Moderator: Robert J. Zimmerman, SD - Zimmerman Consulting
Friday, February 29
8:00 am - 8:05 am	Welcome and Overview
8:05 am - 10:15am	Session 5: Regulatory Strategies in the Global Arena
	EU Perspective on Regulatory Issues for Biologics Robert Charnas, PhD - Amgen
	Japan Perspective on Regulatory Issues for Biologics Ken Takeshita, MD - Celgene
	Clinical Trial Design Issues for Combination Products and Combination Therapies Patricia Keegan, MD - Food and Drug Administration
	Panel Discussion Moderator: Robert J. Zimmerman, SD - Zimmerman Consulting
10:30 am - 12:00 pm	Session 6: Case Studies in Vaccines
	Dendritic Cell Based Vaccines Lothar H. Finke, MD - ARGOS Therapeutics
	Cancer Vaccines Frederic Lehmann, MD - GlaxoSmithKline Biologicals s.a.
	Nucleic Acid Based Vaccines Laurence Elias, MD - Geron Corporation
	Panel Discussion Moderator: Michael T. Lotze, MD - University of Pittsburgh Cancer Institute
1:00 pm - 2:40 pm	Session 7: Case Studies in Cellular Therapeutics
	Overview of Adoptive Transfer T Cell Therapy for Cancer Nicholas P. Restifo, MD - National Cancer Center
	NK Cell Therapeutics for Cancer Jeffrey Miller, MD - University of Minnesota
	Adoptive T Cell Transfer of Regulatory T Cells for GVHD Carl H. June, MD - University of Pennsylvania
	Mesenchymal Stem Cell Therapy with ProchymalTM C. Randal Mills, PhD - Osiris Therapeutics, Inc.
	Panel Discussion Moderators: Carl H. June, MD - University of Pennsylvania                     C. Randal Mills, PhD - Osiris Therapeutics, Inc.
3:00 pm - 4:40 pm	Session 8: Case Studies in Gene Therapies
	Oncolytic Viruses: Reovirus Matt Coffey, PhD - Oncolytics Biotech, Inc.
	Gene Modified T Cell Therapy Michel Sadelain, MD, PhD - Memorial Sloan-Kettering Cancer Center
	Adenovirus Vectors Sunil Chada, PhD - Introgen Therapeutics, Inc.
	Panel Discussion Moderator: Mercedes Serabian, MS, DABT - Food and Drug Administration (CBER)
	Closing Comments

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