| Oncologic Drugs Advisory
Committee Meeting
March
13, 2006
(Nonclinical requirements and phase 1 trial design
issues for the development
Of oncology
drug products)
Slides Presented at
Meeting
Morning Session |
| Welcome and Introductory Comments
|
Richard
Pazdur, M.D., Director
Office of Oncology Drug Products,
CDER |
| Preclinical
Safety Data for First in Human (FIH) Clinical Trials
in Healthy Volunteer Subjects
(PPT) (HTM) |
David
Jacobson-Kram, Ph.D., DABT
Associate Director for Pharm. &
Tox.
Office of New Drugs, CDER |
| Nonclinical Perspective on Initiating
Phase 1 Studies for Small Molecular Weight Compounds
(PPT) (HTM) |
John
Leighton, Ph.D., DABT
Supervisory Pharmacologist
DDOP, CDER, FDA
|
| Industry Perspective: Preclinical Development
Considerations for Biologics – Oncology Focus
(PPT) (HTM)
|
James
D. Green, Ph.D., DABT
Preclinical and Clinical Development
Sciences, Biogen Idec, Inc. |
| Nonclinical Perspective on Initiating
Studies for Biological Oncology Products
(PPT) (HTM)
|
Martin
David Green, Ph.D.
Supervisory Pharmacologist
DBOP, OND, CDER |
| Nonclinical Perspective on Initiating
Phase 1 Studies for Biological Oncology Products –
Case Examples
(PPT) (HTM)
|
Anne M. Pilaro, Ph.D.
Expert Toxicologist
DBOP, OND, CDER |
| Nonclinical Studies for Initiating Phase
1
Studies in Oncology: Small Molecules
vs.
Biologics
(PPT) (HTM) |
David
Ross, M.D., Ph.D.
Associate Director for Regulatory
Science
OODP, OND, CDER |
| Questions for the Committee
(PPT) (HTM) |
|
|
Afternoon Session
|
| Sponsor Presentations – Eli Lilly & Co. (PPT)
(HTM)
|
| Introduction and Objectives |
Richard Gaynor, M.D.
Vice-President, Oncology
|
| Management of Ovarian Cancer |
Robert Ozols, M.D.
Sr.
Vice President, Medical Science
Fox Chase Cancer Center |
| Clinical Efficacy of Gemzar/Carboplatin |
Allen Melemed, M.D.
Associate
Medical Director – Oncology
|
| Safety
Results and Patient Benefit |
Richard Gralla, M.D.
Multinational
Association of Supportive Care in Cancer
|
| Robustness
of Efficacy Results |
Daniel Sargent, Ph.D.
Director, Cancer Center Statistics
Mayo Clinic |
| Risk/Benefit
Overview |
Tate Thigpen, M.D.
Professor
of Medicine
University
of Mississippi School
of Medicine |
| FDA Presentations:
|
| Gemzar plus Carboplatin
Treatment of Late Relapsing Ovarian Cancer
(PPT) (HTM)
(PPT) (HTM) |
Martin Cohen, M.D., Medical Officer
DDOP,
OODP, OND, CDER
and
John R. Johnson, M.D. Medical Team
Leader
DDOP,
OODP, OND, CDER
|
| The
Role of Covariates in Clinical Trials
Analyses
(PPT) (HTM) |
Ralph D’Agostino, Sr., Ph.D.
Boston University |
| Open
Public Hearing Speakers
(PPT) (HTM)
|
|
| Questions for
the Committee
(PPT)
|
|
