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