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Preliminary Program
Accelerating Anticancer Agent Development and Validation Workshop
Bethesda North Marriott Hotel and Conference Center
May 16-18, 2012
Wednesday, May 16 |
| 7:00-8:00 am |
Registration/Continental Breakfast |
| 8:00-8:30 am |
Opening Remarks
- H. Kim Lyerly, M.D.
- Gregory Reaman, M.D.
- Elizabeth Thompson
- Gregory Curt, M.D.
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| 8:30-10:00 am |
Session I: Lessons from Successes in Oncology
Moderator: Sandra Swain, M.D.
- Success in the approval of oncology agents
Speaker: Anthony Murgo, M.D.
- Potential strategies to accelerate the process: Industry perspective
Speaker: C. Glenn Begley, M.D., Ph.D.
- Pre-competitive cooperation using existing databases to develop knowledge
Speaker: Gregory Curt, M.D.
|
| 10:00-10:30 am |
Break |
| 10:30-12:30 pm |
Session II: Core Curriculum
Modules are conducted concurrently, and will be repeated on Thursday, May 17. Learners attend one module of their choice on each day (total of two).
- Module 1: Early IND stage drug development: Clinical and non-clinical considerations
Moderator: John Leighton, Ph.D.
Speakers: Haleh Saber, Ph.D. and Marc Theoret, M.D.
- Module 2: Clinical pharmacology expectations for drug development
Moderator: Nam Atiqur Rahman, Ph.D.
Speakers: Stacy Shord, Pharm.D., Gene Williams, Ph.D.
- Module 3: Considerations for clinical trial design to support marketing approval
Moderator: Gregory Reaman, M.D.
- Clinical trial endpoints, SPA, approval mechanisms
Speaker: Paul Kluetz, M.D.
- Pitfalls in drug development
Speaker: Tatiana Prowell, M.D.
|
| 12:30-1:30 pm |
Lunch |
| 1:30-3:00 pm |
Session III: Pictures of Success in the Development of Drugs with Companion Diagnostics: Panel Discussion
Moderator: Shakun Malik
- Xalkori
Speakers: Shakun Malik, M.D.; Karen Bijwaard, M.D.
- Zelboraf
Speakers: Geoffrey Kim, M.D.; Donna Roscoe, Ph.D.
Panelists: Robert Becker, Jr., M.D., Ph.D.; Elizabeth Mansfield, Ph.D.;
Robert Justice, M.D.; Patricia Keegan, M.D.; Richard Pazdur, M.D.
|
| 3:00-3:30 pm |
Break |
| 3:30-5:30 pm |
Session IV: Case Studies
Case studies are conducted concurrently, and will be repeated on Friday, May 18. Learners attend one case study of their choice on each day (total of two)
- Halaven (Eisai Pharmaceuticals)
| Eisai Team |
FDA Team |
- Annmarie Petraglia, R.Ph.
|
- Martha Donoghue, M.D.
- Steven Lemery, M.D.
- Anne Pilaro, Ph.D.
- Stacy Shord, Ph.D.
- Weishi Yuan, Ph.D.
|
- Jakafi (Incyte Corporation)
| Incyte Team |
FDA Team |
- Ronald Falcone, Ph.D.
- Thomas Hare
- Victor Sandor, M.D.
- Kim Solomon, Ph.D.
- Lothar Tremmel, Ph.D.
- William Williams, M.D.
- Swamy Yeleswaram, Ph.D.
- Kris Vaddi, Ph.D.
- Neil Wummer, M.D.
|
- Wei Chen, Ph.D.
- Albert Deisseroth, M.D.
- Kyung Lee, Ph.D.
- Satjit Brar, Ph.D.
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- Xalkori (Pfizer Pharmaceuticals)
| Pfizer Team |
FDA Team |
- Erling Donnelly, Ph.D.
- Diane Matsumoto, Ph.D.
- Hakun Sakul, Ph.D.
- Patrick Schnell, M.D.
- Paulina Selaru, M.S.P.H.
- Weiwei Tan, PhD
- Keith Wilner, PhD
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- Karen Bijwaard, M.D.
- Brenda Gehrke, Ph.D.
- Shakun Malik, M.D.
- Pengfei Song, Ph.D.
- Shenghui Tang, Ph.D.
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- Zelboraf (Roche Pharmaceuticals)
| Roche Team |
FDA Team |
|
|
- Robeena Aziz, Ph.D.
- Jeanne Fourie Zirkelbach, Ph.D.
- Geoffrey Kim, M.D.
- William McGuinn, Ph.D.
- Donna Roscoe, Ph.D.
- Qiang Xu, Ph.D.
|
- Zytiga (Janssen Biotech)
| Janssen Team |
FDA Team |
- Kelly Johnson Reid, M.S., R.A.C.
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- Robeena Aziz, Ph.D.
- Paul Kluetz, M.D.
- Yangmin Ning, M.D.
- Elimika Pfuma, Ph.D.
- Haleh Saber, Ph.D.
- Howard Soule, Ph.D.
- Lijun Zhang, Ph.D.
|
|
| 5:30-8:00 pm |
Reception/Dinner/Dinner Panel
“Financing Oncology Drug Development: The Changing Landscape”
Panelists: Josh Bilenker, M.D.; Anthony Fiorino, M.D., Ph.D.; Donald Light, M.S., Ph.D. |
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Thursday, May 17 |
| 7:30-8:00 am |
Continental Breakfast |
| 8:00-9:30 am |
Session V: Monitoring Success
Moderator: Gregory Curt, M.D.
- Limiting patient access to new agents based on emerging safety and efficacy profiles
Speaker: Scott Patterson, M.D., Ph.D.
- Access and expanded access
Speaker: Gerard Kennealey, M.D.
- Post Hoc Pharmacogenomics
Speaker: TBN
|
| 9:30-10:00 am |
Break |
| 10:00 am -12:00 pm |
Session VI: Core Curriculum
A repeat of Wednesday’s modules. Learners should choose one module from the following list that is different from Wednesday’s choice.
- Module 1: Early IND stage drug development: Clinical and non-clinical considerations
Moderator: John Leighton, Ph.D.
Speakers: Haleh Saber, Ph.D. and Marc Theoret, M.D.
- Module 2: Clinical pharmacology expectations for drug development
Moderator: Nam Atiqur Rahman, Ph.D.
Speakers: Stacy Shord, Pharm.D., Gene Williams, Ph.D.
- Module 3: Considerations for clinical trial design to support marketing approval
Moderator: Gregory Reaman, M.D.
- Clinical trial endpoints, SPA, approval mechanisms
Speakers: Paul Kleutz, M.D., Tatiana Prowell, M.D.
- Pitfalls in drug development
Speaker: Tatiana Prowell, M.D.
|
| 12:00-1:00 pm |
Lunch |
| 1:00-2:30 pm |
Session VII: Critical Issues for Pivotal Trials
Moderator: Jeffrey Abrams, M.D.
- Assuring the applicability of foreign clinical trials to U.S. patients
Speaker: TBN
- Accrual of under-represented minorities
Speaker: Worta McCaskill-Stevens, M.D., M.S.
- The engagement of U.S. NCI-supported cooperative groups: Update on structure/reorganization
Speaker: Meg Mooney, M.D., M.B.A.
|
| 2:30-3:00 pm |
Break |
| 3:00-5:00 pm |
Session VIII: In-depth Discussion Groups
- Developing active immunotherapy agents
Discussion Leader: Peter Bross, M.D.
- The co-development of companion diagnostics
Discussion Leader: Elizabeth Mansfield, M.D.
- Drug development in rare cancers
Discussion Leaders: Katherine DeLorenzo, M.D.;
Speakers: Ann Pariser, M.D.; Gwenn Ison, M.D.; Albert Deisseroth, M.D.
- Innovative trial designs and endpoint considerations for pediatric cancer drug development
Discussion Leader: Frank Balis, M.D.
- How patient-reported outcomes are used in oncology drug development
Discussion Leaders: Elizabeth Thompson, Ethan Basch,
M.D.; Brandon Hayes-Lattin, M.D.; Lori Minasian, M.D.; Howard Soule,Ph.D.
- Challenges in global oncology drug development
Discussion Leadrs: Toshio Miyata, M.D., Iordanis Gravanis
|
| 5:00-6:30 pm |
Reception |
| |
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Friday, May 18 |
| 7:30-8:00 am |
Continental Breakfast |
| 8:00-10:00 am |
Session IX: Case Studies
A repeat of Wednesday’s case studies. Learners should choose one case study from the following list that is different from Wednesday’s choice.
- Halaven (Eisai Pharmaceuticals)
| Eisai Team |
FDA Team |
- Annmarie Petraglia, R.Ph.
|
- Martha Donoghue, M.D.
- Steven Lemery, M.D.
- Anne Pilaro, Ph.D.
- Stacy Shord, Ph.D.
- Weishi Yuan, Ph.D.
|
- Jakafi (Incyte Corporation)
| Incyte Team |
FDA Team |
- Ronald Falcone, Ph.D.
- Thomas Hare
- Victor Sandor, M.D.
- Kim Solomon, Ph.D.
- Lothar Tremmel, Ph.D.
- William Williams, M.D.
- Swamy Yeleswaram, Ph.D.
- Kris Vaddi, Ph.D.
- Neil Wummer, M.D.
|
- Wei Chen, Ph.D.
- Albert Deisseroth, M.D.
- Kyung Lee, Ph.D.
- Satjit Brar, Ph.D.
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- Xalkori (Pfizer Pharmaceuticals)
| Pfizer Team |
FDA Team |
- Erling Donnelly, Ph.D.
- Diane Matsumoto, Ph.D.
- Hakun Sakul, Ph.D.
- Patrick Schnell, M.D.
- Paulina Selaru, M.S.P.H.
- Weiwei Tan, PhD
- Keith Wilner, PhD
|
- Karen Bijwaard, M.D.
- Brenda Gehrke, Ph.D.
- Shakun Malik, M.D.
- Pengfei Song, Ph.D.
- Shenghui Tang, Ph.D.
|
- Zelboraf (Roche Pharmaceuticals)
| Roche Team |
FDA Team |
|
|
- Robeena Aziz, Ph.D.
- Jeanne Fourie Zirkelbach, Ph.D.
- Geoffrey Kim, M.D.
- William McGuinn, Ph.D.
- Donna Roscoe, Ph.D.
- Qiang Xu, Ph.D.
|
- Zytiga (Janssen Biotech)
| Janssen Team |
FDA Team |
|
|
- Robeena Aziz, Ph.D.
- Paul Kluetz, M.D.
- Yangmin Ning, M.D.
- Elimika Pfuma, Ph.D.
- Haleh Saber, Ph.D.
- Howard Soule, Ph.D.
- Lijun Zhang, Ph.D.
|
|
| 10:00-10:30 am |
Break |
| 10:30 am-12:00 pm |
Session X: Surrogate Endpoints to Predict “Clinical Benefit”
Moderator: Thomas Fleming, Ph.D.
- Challenges in the use of biomarkers as endpoints in phase 3 trials
Speaker: Thomas Fleming, Ph.D.
- Pathological CR in the neoadjuvant setting
Speaker: Patricia Cortazar, M.D.
- Changing the landscape of progression-free survival as a primary endpoint
Speaker: Rajeshwari Sridhara, Ph.D.
|
| 12:00 pm |
Adjourn |
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