Program |
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Wednesday, June 17
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7:15 a.m.
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Registration and Continental Breakfast
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8:15 a.m.
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Welcoming Remarks
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H. Kim Lyerly, M.D.
Program Chair |
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Musa Mayer, M.S., M.F.A.
Program Committee Member |
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Session I
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Phase I Trials and Pharmacology/Toxicology
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Moderator:
John Leighton, Ph.D. U.S. Food & Drug Administration |
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8:30 a.m.
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When Must You Submit an IND?
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Virginia Kwitkowski, MS, RN, ACNP-BC
U.S. Food & Drug Administration |
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8:55 a.m.
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How to Enable a First in Human IND--Non-Clinical Requirements
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Haleh Saber, Ph.D.
U.S. Food & Drug Administration |
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9:20 a.m.
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Special Considerations for Cellular Therapies and Tumor Vaccine INDs
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Donna Przepiorka, M.D., Ph.D.
U.S. Food & Drug Administration |
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9:45 a.m.
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Panel Discussion
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All Speakers
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10:20 a.m.
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Break
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Session II
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Biomarkers to Accelerate Drug Development
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Moderator:
H. Kim Lyerly, M.D. Duke University |
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10:45 a.m. |
How are Biomarkers Used to Select Appropriate Patients for Your Agent? |
H. Kim Lyerly, M.D. |
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11:05 a.m.
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What is the Role of Post-Trial Biomarker Analysis to Identify a Responsive (Resistant) Patient Population?
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Richard Simon, D.Sc.
National Cancer Institute |
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11:25 a.m.
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Panel Discussion
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Laurence Baker, D.O.
Jane Perlmutter, Ph.D. Richard Simon, D.Sc. |
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12:00 p.m.
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Lunch
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Session III
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What are the Signals that Lead to the Next Step in Development?
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Moderator:
Renzo Canetta, M.D. Bristol-Myers Squibb |
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1:00 p.m.
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What are the Anti-Cancer Molecules Designed to Do and Are They Successful in Early Clinical Trials?
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Robert Mook, Jr., Ph.D.
Duke University |
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1:20 p.m.
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Is the Magnitude of the Clinical Outcome Sufficient to Perform Pivotal Phase III Studies?
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Jeffrey Abrams, M.D.
National Cancer Institute |
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1:40 p.m.
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Panel Discussion
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Jeffrey Abrams, M.D.
Robert Hershberg, M.D., Ph.D. Robert Mook, Jr., Ph.D. |
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2:10 p.m.
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Break
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Session IV
3:00 - 5:30 p.m. |
Case Study Discussion Groups #1
Discussion groups meet concurrently. Learners attend session of their choice. |
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Agent #1: Alimta (Eli Lilly & Co.)
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Lilly Team:
William John, M.D. Colleen Mockbee, R.Ph. FDA Team: Martin Cohen, M.D. Shenghui Tang, Ph.D. Patient Advocate: Mark Gorman |
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Agent #2: Nplate (Amgen)
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Amgen Team:
Monica Batra, M.S., R.A.C. Dietmar Berger, M.D., Ph.D. FDA Team: R. Dwaine Rieves, M.D. Brian Booth, Ph.D. Claudia Karwoski, Ph.D. Angela Men, Ph.D. Patient Advocate: Robert Erwin, M.S. |
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Agent #3: Sprycel (Bristol-Myers Squibb)
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BMS Team:
Eric Bleickardt, M.D. David Shapiro, M.D. FDA Team: Michael Brave, M.D. Xiaoping Jiang, Ph.D. Haleh Saber, Ph.D. Patient Advocate: Karl Schwartz |
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Agent #4: Taxotere (Sanofi Aventis)
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Sanofi Aventis Team:
Linda Gustavson, Ph.D. Abebe Haregewoin, M.D. Mark Moyer, M.S. Martin Roessner, M.Sc. Jean-Francois Tamby, M.D. FDA Team: Qin Ryan, M.D. Patient Advocate: Musa Mayer, M.S., M.F.A. |
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Agent #5: Tarceva (OSI Pharmaceuticals)
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OSI Team:
Karsten Witt, MD FDA Team: Patricia Cortazar, M.D. Qi Liu, Ph.D. Patient Advocates: Gwen Darien James Omel, M.D. |
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Agent #6: Tykerb (GlaxoSmithKline)
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GSK Team:
Leanne Cartee, Ph.D. Ronald Fleming, Pharm.D. Kevin Koch, Ph.D. Julie Maltzman, M.D. Alaknada Preston, Ph.D. Richard Swenson, Ph.D. FDA Team: Amna Ibrahim, M.D. Gene Williams, Ph.D. Patient Advocates: Virginia Mason, B.S.N., R.N. Jane Perlmutter, Ph.D. |
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5:30 p.m.
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Reception and Dinner
Dinner Panel: FDA Alumni Discuss their Experiences |
Moderator:
Richard Pazdur, M.D. U.S. Food and Drug Administration Panelists: Ramzi Dagher, M.D. Pfizer Pharmaceuticals Edwin Rock, M.D., Ph.D. GlaxoSmithKline Adrian Senderowicz, M.D. AstraZeneca |
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Thursday, June 18
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8:00 a.m.
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Continental Breakfast
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Session V
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Peri- and Post-marketing Studies
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Moderator:
Robert Justice, M.D. U.S. Food & Drug Administration |
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8:30 a.m.
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Clinical Pharmacology/QT
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Julie Bullock, Pharm.D.
U.S. Food & Drug Administration |
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8:50 a.m.
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What Does "Quality by Design" Bring
to Your Drug Development Program? |
Sarah Pope, Ph.D.
U.S. Food & Drug Administration |
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9:10 a.m.
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Safety
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Robert Kane, M.D.
U.S. Food & Drug Administration |
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9:30 a.m.
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Panel Discussion
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All Speakers
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10:00 a.m.
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Break
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Session VI |
Clinical Trials Development |
Moderator:
Patricia Keegan, M.D. U.S. Food & Drug Administration |
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10:30 a.m.
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Endpoints and Types of Approvals
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Katherine Fedenko, M.S. CRNP-BC
U.S. Food & Drug Administration |
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10:50 a.m.
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How Can Patient-Reported Outcomes Demonstrate Clinical Benefit?
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Paivi Miskala, M.S.P.H., Ph.D.
U.S. Food & Drug Administration |
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11:10 a.m. |
Providing Clinical Evidence of Effectiveness |
Amna Ibrahim, M.D.
U.S. Food & Drug Administration |
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11:30 a.m.
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Panel Discussion
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All Speakers
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12:00 p.m.
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Lunch
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Session VII
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Statistical Design Challenges
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Aloka Chakravarty, Ph.D.
U.S. Food & Drug Administration |
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1:00 p.m.
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Basics of Clinical Trial Design
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Aloka Chakravarty, Ph.D.
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1:20 p.m.
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Possible Pitfalls When Designing Non-Inferiority Trials
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David Harrington, Ph.D.
Harvard University |
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1:40 p.m.
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What Have We Learned from Past Failures?
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Rajeshwari Sridhara, Ph.D.
U.S. Food & Drug Administration |
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2:10 p.m.
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Panel Discussion
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All Speakers
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2:30 p.m.
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Break
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Session VIII
2:45 - 4:15 p.m. |
In-Depth Discussion Groups
Discussion groups meet concurrently. Learners attend session of their choice. |
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Discussion Group #1:
How to Avoid Going on Clinical Hold |
Robert Kane, M.D.
U.S. Food and Drug Administration Susan Krivacic, M.P.A. Cancer Anonymous Kevin Shannon, M.D. U.S. Food and Drug Administration Richard Swenson, M.D. GlaxoSmithKline |
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Discussion Group #2:
a) Why Phase III Trials Fail b) Novel Phase II Trial Designs to Avoid a Phase III Trial Failure |
Aloka Chakravarty, Ph.D.
U.S. Food and Drug Administration David Harrington, Ph.D. Harvard Medical School James Omel, M.D. International Myeloma Foundation Jane Perlmutter, Ph.D. Gemini Group Rajeshwari Sridhara, Ph.D. U.S. Food and Drug Administration |
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Discussion Group #3:
Pitfall and Progress in Cancer Vaccine Development |
Peter Bross, M.D.
U.S. Food and Drug Administration Mark Gorman National Coalition for Cancer Survivorship H. Kim Lyerly, M.D. Duke Cancer Center Robert Hershberg, M.D., Ph.D. VentiRx Pharmaceuticals Jeffrey Schlom, M.D. National Cancer Institute Karl Schwartz Patients Against Lymphoma |
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Discussion Group #4:
How to Get your Drug Through FDA |
Gwen Darien
American Association for Cancer Research William John, M.D. Eli Lilly & Co. Musa Mayer, M.S., M.F.A. AdvancedBC.org Richard Pazdur, M.D. U.S. Food & Drug Administration |
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Discussion Group #5:
Pharmacology/Toxicology |
Robert Erwin, M.S.
Marti Nelson Cancer Foundation Ronald Fleming, Pharm.D. GlaxoSmithKline Anne Pilaro, Ph.D. U.S. Food & Drug Administration Virginia Mason, B.S.N., R.N. Inflammatory Breast Cancer Research Foundation Mercedes Serabian, Ph.D. U.S. Food & Drug Administration Leigh Verbois, Ph.D. Food and Drug Administration |
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Session IX
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What are the Social Responsibilities
of Drug Development? |
Moderator:
Robert Erwin, M.S. Marti Nelson Cancer Foundation |
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4:30 p.m.
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Why Access to Unapproved Drugs
Must Not Alter the FDA Approval Standards |
Richard Pazdur, M.D.
U.S. Food and Drug Administration |
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4:35 p.m.
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Access to Unapproved Drugs
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Ann Farrell, M.D.
U.S. Food and Drug Administration |
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5:00 p.m.
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What Knowledge Can be Gained in Developing Drugs to Treat Rare Diseases?
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Southwest Oncology Group/University of Michigan |
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5:25 p.m.
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Ethical Implications of Access to Unapproved Drug
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Seema Shah, J.D. |
| 5:50 p.m. | Why Creative Clinical Trial Designs are Necessary for Getting Agents to Children with Cancer in a Timely Fashion |
Eugenie Kleinerman, M.D. MD Anderson Cancer Center |
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6:15 p.m.
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Panel Discussion
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All Speakers
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6:35 p.m.
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Reception
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Friday, June 19
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7:30 a.m.
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Continental Breakfast
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Session X
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Case Study Discussion Groups #2
Discussion groups meet concurrently. Learners attend session of their choice. |
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Agent #1: Alimta (Elil Lilly & Co.)
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Lilly Team:
William John, M.D. Colleen Mockbee, R.Ph. FDA Team: Martin Cohen, M.D. Shenghui Tang, Ph.D. Patient Advocates: Gwen Darien American Association for Cancer Research Susan Krivacic, M.P.A. Cancer Anonymous |
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Agent #2: Nplate (Amgen)
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Amgen Team:
Monica Batra, M.S., R.A.C. Dietmar Berger, M.D., Ph.D. FDA Team: R. Dwaine Rieves, M.D. Brian Booth, Ph.D. Claudia Karwoski, Ph.D. Angela Men, Ph.D. Patient Advocate: Mark Gorman National Coalition for Cancer Survivorship |
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Agent #3: Sprycel (Bristol-Myers Squibb)
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BMS Team:
Eric Bleickardt, M.D. David Shapiro, M.D. FDA Team: Michael Brave, M.D. Xiaoping Jiang, Ph.D. Haleh Saber, Ph.D. Patient Advocates: James Omel, M.D. Jane Perlmutter, Ph.D. |
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Agent #4: Taxotere (Sanofi Aventis)
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Sanofi Aventis Team:
Linda Gustavson, Ph.D. Abebe Haregewoin, M.D. Mark Moyer, M.S. Martin Roessner, M.Sc. Dalila Sellami, M.D. FDA Team: Qin Ryan, M.D. Patient Advocates: Virginia Mason, B.S.N., R.N. (Inflammatory Breast Cancer Research) Karl Schwartz (Patients Against Lymphoma) |
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| Agent #5: Tykerb (GlaxoSmithKline) |
GSK Team: |
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| 10:30 a.m. | Break |
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| 11:00-12:00 p.m. |
Comparative Effectiveness: Implications for Cancer Drug Development |
William Lawrence, M.D., M.S. Agency for Healthcare Research and Quality Introduction by: Renzo Canetta, M.D. |
| 12:00 p.m. |
Adjourn/Departure |
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| 12:00 p.m. |
CLOSED SESSION (Faculty Only); Summation and Course Evaluation |
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