Accelerating Anticancer Agent Development and Validation Workshop

June 23-25, 2010
Bethesda North Marriott Conference Center
Bethesda, Maryland

Preliminary Agenda

Time	Topic	Presenters
Wednesday, June 23
7:15 am	Registration/Continental Breakfast
8:00 am	Welcoming Remarks	H. Kim Lyerly, MD (Duke University) Gwen Darien (Samuel Waxman Cancer Research Foundation) James Zwiebel, MD (NCI)
Session I 8:30-10:00 am	Introduction to Drug Development	Moderator: H. Kim Lyerly, MD
8:30 am	Economic View of Cancer Drug Development	Kevin Schulman, MD, MBA (Duke University)
9:00 am	Confirmation Versus Hypothesis Within General Clinical Trials	Thomas Fleming, PhD (Fred Hutchinson Cancer Research Center)
9:30 am	The Role of Advocacy in Cancer Drug Development	Gwen Darien (Samuel Waxman Cancer Research Foundation)
10:00-10:30 am	Break
Session II 10:30-12:30 pm Modules are conducted concurrently, and will be repeated on Thursday, so all learners will be able to attend two. Learners attend one module of their choice on each day.	FDA CORE CURRICULUM Module #1: Early IND Stage Drug Development	Moderator: John Leighton, PhD (FDA)
	A. FDA Regulatory Project Management and Your Drug Product Development	Erik Laughner , MS (FDA) Capt. Frank Cross, Jr. (FDA)
	B. Non-clinical Recommendations to Enable a First in Human IND • Drugs • Biologics	Haleh Saber, PhD (FDA) Anne Pilaro, PhD (FDA)
	C. Considerations for First in Human Oncology Studies/Sponsor Obligations for INDs	Albert Deisseroth, MD (FDA) Steven Lemery, MD (FDA)
	D. Special Considerations for Cellular Therapies and Tumor Vaccine INDs	Donna Przepiorka, MD, PhD (FDA)
	Module #2: Pre-NDA/BLA Drug Development	Moderator: Julie Bullock, PharmD (FDA)
	A. Clinical Pharmacology • Introductions • Drug-Drug Interactions • Food Effects • Organ Impairment • Evaluation of the drug’s potential to prolong the QT interval • Conclusions	Julie Bullock, PharmD (FDA) Gene Williams, PhD (FDA) Joe Grillo, PharmD (FDA) Sarah Schrieber, PharmD (FDA) Julie Bullock, PharmD (FDA) Bahru Habtemariam, PharmD (FDA) Julie Bullock, PharmD (FDA)
	B. In Vitro Diagnostic Co-Development	Reena Phillip, PhD (FDA)
	Module #3: Considerations for Clinical Trial Design to Support Marketing Approval	Moderator: Richard Pazdur, MD (FDA)
	A. FDA Marketing Approval Standards	Amy McKee, MD (FDA)
	B. Clinical Trial Endpoints	Amir Shahlaee, MD (FDA)
	C. Group Assignment Blinding & Unintentional Unblinding	Tatiana Prowell, MD (FDA)
	D. Patient Reported Outcomes	Ethan Basch, MD (Memorial Sloan-Kettering Cancer Center)
	E. Special Population Programs	Sandra Casak, MD (FDA)
	Module #4: Clinical Trial Statistics	Moderator: Raje Sridhara, PhD (FDA)
	A. Adaptive Designs • Non-Inferiority	Raje Sridhara (FDA)
	B. Missing Assessments	Thomas Fleming, PhD (Fred Hutchinson Cancer Research Center)
	C. Endpoint Challenges	Lori Dodd, PhD (NIH)
12:30 pm-1:30 pm	Lunch
Session III 1:30-3:00 pm	Perspectives on Cancer Drug Development	Moderator: Joseph Tomaszewski, PhD (NCI)
1:30 pm	Early Opportunities for Safety Evaluation in Anticancer Drug Discovery	Myrtle Davis, DVM, PhD (NCI)
2:00 pm	Development of Validated Laboratory Assays Early Clinical Trials	Ralph Parchment, PhD (NCI)
2:30 pm	Current Industry Approaches to Non-clinical Development of Anticancer Pharmaceuticals	Vijayapal Reddy, DVM, PhD (Eli Lilly)
3:00-3:30 pm	Break/Assemble in DRUG DEVELOPMENT CASE STUDY Rooms
Session IV 3:30–5:30 pm Case studies are conducted concurrently, and will be repeated on Friday, so all learners will be able to attend two. Learners attend one case study of their choice on each day.	Case Study Discussion Groups Afinitor (Novartis Pharmaceuticals) Alimta (Eli Lilly & Co.) Nplate (Amgen, Inc.) Taxotere (Sanofi Aventis) Tykerb (GlaxoSmithKline)
5:30 pm	Reception
6:15 pm	Dinner Dinner Panel: FDA Alumni Discuss Their Experiences	Moderator: Richard Pazdur, MD (FDA) Panelists: Josh Bilenker, MD (Aisling Capital, LLC) Isagani Chico, MD (Exelixis Inc.) Edwin Rock, MD, PhD (Otsuka Pharmaceutical Group)

Thursday, June 24
8:00–8:30 am	Continental Breakfast
Session V 8:30-10:00 am	The Role of Biomarkers in Cancer Drug Development: Fact or Fiction?	Moderator: Neil Spector, MD (Duke University)
8:30 am	Genomic-based Biomarkers	Joseph Nevins, PhD (Duke University)
9:00 am	Biomarkers Co-developed with Therapeutic Agents	Lance Liotta, PhD (George Mason University)
9:30 am	Challenges in the Use of Biomarkers as Endpoints in Phase 3 Trials	Thomas Fleming, PhD (Fred Hutchinson Cancer Research Center)
10:00-10:30 am	Break
Session VI 10:30 am-12:30 pm Case studies conducted concurrently. A repeat of Wednesday's case studies. Learners should choose one module from the list that is different from Wednesday's choice.	FDA CORE CURRICULUM (repeat of Session II) Module #1: Early IND Stage Drug Development	Moderator: John Leighton, PhD (FDA)
	A. FDA Regulatory Project Management and Your Drug Product Development	Erik Laughner, MS (FDA) Capt. Frank Cross, Jr. (FDA)
	B. Non-clinical Recommendations to Enable a First in Human IND • Drugs • Biologics	Haleh Saber, PhD (FDA) Anne Pilaro, PhD (FDA)
	C. Considerations for First in Human Oncology Studies/Sponsor Obligations for INDs	Albert Deisseroth, MD (FDA) Steven Lemery, MD (FDA)
	D. Special Considerations for Cellular Therapies and Tumor Vaccine INDs	Donna Przepiorka, MD, PhD (FDA)
	Module #2: Pre-NDA/BLA Drug Development	Moderator: Julie Bullock, PharmD (FDA)
	A. Clinical Pharmacology • Introductions • Drug-Drug Interactions • Food Effects • Organ Impairment • Evaluation of the drug’s potential to prolong the QT interval • Conclusions	Julie Bullock, PharmD (FDA) Gene Williams, PhD(FDA) Joe Grillo, PharmD (FDA) Sarah Schrieber, PharmD (FDA) Bahru Habtemariam, PharmD (FDA) Julie Bullock, PharmD (FDA)
	B. In Vitro Diagnostic Co-Development	Reena Phillip, PhD (FDA)
	Module #3: Considerations for Clinical Trial Design to Support Marketing Approval	Moderator: Richard Pazdur, MD (FDA)
	A. FDA Marketing Approval Standards	Amy McKee, MD (FDA)
	B. Clinical Trial Endpoints	Amir Shahlaee (FDA)
	C. Group Assignment Blinding & Unintentional Unblinding	Tatiana Prowell, MD (FDA)
	D. Patient Reported Outcomes	Ethan Basch, MD (Memorial Sloan-Kettering Cancer Center)
	E. Special Population Programs	Sandra Casak, MD (FDA)
	Module #4: Clinical Trial Statistics	Moderator: Raje Sridhara, PhD (FDA)
	A. Adaptive Designs • Non-Inferiority	Raje Sridhara, PhD (FDA)
	B. Missing Assessments	Thomas Fleming, PhD (FDA)
	C. Endpoint Challenges	Lori Dodd, PhD (FDA)
12:30-1:30 pm	Lunch
Session VII 1:30-3:00 pm	Complementation and Continuation of Cancer Drug Development	Moderator: Renzo Canetta, MD (Bristol-Myers Squibb)
1:30 pm	International Harmonization of Cancer Drug Development	Francesco Pignatti, MD (EMEA)
2:00 pm	Cancer Survivorship	Julia Rowland, PhD (National Cancer Institute)
2:30 pm	Post-approval Risk Management	Peter Bach, MD (Memorial Sloan Kettering Cancer Center)
3:00-3:30 pm	Break
Session VIII 3:30-5:30 pm	In-Depth Discussion Groups Discussion groups meet concurrently. Learners participate in group of their choice
	Discussion Group #1: Special Issues in Cancer Vaccine Development	Peter Bross, MD (FDA) Bindu George, MD (FDA) H. Kim Lyerly, M.D. (Duke University) Wilson Bryan, MD (FDA) Jeffrey Schlom, MD (NCI)
	Discussion Group #2: Pitfalls in Oncology Drug Development	Richard Pazdur, MD (FDA) William John, PhD (Eli Lilly & Co.)
	Discussion Group #3: Harmonization of Cancer Drug Development in the U.S and Europe	Renzo Canetta, MD (Bristol-Myers Squibb) Capt. Justina Molzon, MS, PharmD (FDA) Francesco Pignatti, MD (EMEA)
	Discussion Group #4 Issues Related to Simultaneous Approval of Two New Molecular Entities	Eric Rubin, PhD (Merck & Co.) Rachel Berman, MD, MD, MPH (FDA) James Zwiebel, MD (NCI)
	Discussion Group #5: Through the Looking Glass: An In-depth Look at the Impact of Pediatrics on Oncology Drug Development	Julie Rosenberg, MD (Bristol-Myers Squibb) Peter Adamson, MD (Children's Oncology Group) Gregory Reaman, MD (Children's Oncology Group) Jay Scott (Alex's Lemonade Stand) Jeffrey Skolnick, MD (AstraZeneca) Catherine Weil, MD (Bristol-Myers Squibb)
	Discussion Group #6 Personalized Medicine/Comparative Effectiveness	Andrew Freedman, PhD (National Cancer Institute)

Friday, June 25
Session IX 8:00 - 10:00 am Case studies conducted concurrently. A repeat of Wednesday's case studies. Learners should choose one case study from the list that is different from Wednesday's choice.	Case Study Discussion Groups #2 Case study groups meet concurrently. Learners attend case study of their choice. Afinitor (Novartis Pharmaceuticals) Alimta (Eli Lilly & Co.) Nplate (Amgen, Inc.) Taxotere (Sanofi Aventis) Tykerb (GlaxoSmithKline)
10:00 - 10:30 am	Break
Session XI 10:30 - 12:00 pm	Social Responsibilities of Drug Development • Access to Unapproved Drugs • Ethical Implications of Access • Implications for Industry	Karen McGinn, MS, CRNP (FDA) Seema Shah, JD (NCI) Judith Ochs, MD (Astra Zeneca)
12:00 pm	Adjourn/Departure


Accelerating Anticancer Agent Development and Validation Workshop	A Postgraduate Workshop for Clinical and Translational Cancer Investigations Focused on Strategic Planning to Develop and Validate New Anticancer and Cancer Prevention Agents and Pathways	June 23-25, 2010 North Bethesda, MD