08:00 AM - 09:30 AM | Registration/Continental Breakfast
08:30 AM - 12:00 PM | Core Curriculum
Drug Development for Early Career Investigators
MODERATOR
Tatiana Prowell, M.D. | Early Efficacy Trials, Biomarkers, and Diagnostic Tests
SPEAKER
Tatiana Prowell, M.D. | Nonclinical Testing Through IND Application
PANELISTS
Brenda Gehrke, PhD | U.S. Food and Drug Administration
Lola Fashoyin-Aje, M.D., M.P.H. | U.S. Food and Drug Administration,
Applications of Clinical Pharmacology in Oncology Drug Development
Olanrewaju Okusanya, Pharm.D | FDA
09:30 AM - 12:00 PM | In-Depth Discussion Group
Challenges with New Clinical Trial Designs
MODERATOR
Patricia LoRusso, D.O. | Yale University
Investigator Perspective
PANELIST
Howard Burris, M.D. | Sarah Cannon
Eric Rubin, M.D. | Merck Research Laboratories
The Institutional Review Board Perspective
Michele Russel-Einhorn, J.D. | Advarra
Challenges of Adaptive Trials from a GCP Perspective
Kassa Ayalew, M.D., M.P.H. | U.S. Food and Drug Administration
Novel Trial Designs: Opportunities and Challenges from the FDA Oncology Center of Excellence Perspective
Gideon Blumenthal, M.D. | U.S. Food and Drug Administration
The Patient Perspective
Hildy Dillon, M.P.H. | Cancer Support Community
Patient-Reported Outcomes (PROs) and their Use in Cancer Drug Development
MODERATORS
Paul Kluetz, M.D. | U.S. Food and Drug Administration
Thomas Fleming, Ph.D.
University of Washington
Introduction
PANELIST
Thomas Fleming, Ph.D. | University of Washington
What is Important to Patients?
Jane Perlmutter, M.B.A., Ph.D. | Gemini Group
21st Century Cures and the Current Regulatory Landscape for PROs in Cancer Trials
Paul Kluetz, M.D. | U.S. Food and Drug Administration
What PRO Measure Are we Reviewing?
Lynn Howie, M.D. | U.S. Food and Drug Administration
How do We Measure? What is a Fit for Purpose Tool?
Selena Daniels, M.S. Pharm.D. | U.S. Food and Drug Administration
How do We Analyze and Interpret Data?
Jason Schroeder, Ph.D. | U.S. Food and Drug Administration
Panel Discussion
FDARA 2017 and the Future of Cancer Drug Development in Pediatrics
MODERATOR
Gregory Reaman, M.D. | U.S. Food and Drug Administration
Background and U.S. Regulatory Framework for New Drug Development in Pediatric Populations: BPCA and PREA – Recently Enacted Changes in Their Implementation
PANELIST
Gregory Reaman, M.D. | U.S. Food and Drug Administration
Expanded Opportunities for Precision Medicine for Pediatric Medicine
Donald Parsons, M.D., Ph.D. | Baylor College of Medicine
Clinical Considerations for Evaluation of Molecularly Targeted Drugs in Children
Elizabeth Fox, M.D. | Children’s Hospital of Philadelphia
Industry Perspective on Changes to PREA
Ruchi Gupta, M.S. | Genentech, Inc.
Patient Advocate Perspective
Nancy Goodman, J.D. | Kids v Cancer
The Impact of Precision Oncology on Health Disparities
MODERATOR
Gwen Darien | Patient Advocate
National Patient Advocate Foundation
PANELISTS
Vence Bonham, Jr., J.D. | National Insitututes of Health
Jonca Bull, M.D. | PPD
The Patient Perspective
PANELIST
Everett Dodson | Patient Advocate
Georgetown/Lombardi Comprehensive Cancer Center
Access to Experimental Drugs Prior to FDA Approval
MODERATOR
Renzo Canetta, M.D. | Independent Consultant
Aspects of the Right to Try Proposed Legislations
PANELIST
Arthur Caplan, Ph.D. | New York University School of Medicine
The NCI MATCH Trial
Alice Chen, M.D. | National Cancer Institute
The Beat AML Program
John Byrd, M.D. | Ohio State University
The Industry Experience and Perspective on Expanded Access
Michelle Rashford, M.B.B.S. | Bristol-Myers Squibb
Beverly Harrison, B.S. | Johnson & Johnson
Single Patient Expanded Access
Leigh Marcus, M.D. | U.S. Food and Drug Administration
The Patient Perspective
Lisa Taylor, M.B.A. | NRG Oncology
10:45 AM - 11:15 AM | Break
12:00 PM - 01:00 PM | Lunch
01:00 PM - 03:00 PM | Plenary Session
Combinatorial Strategies in Immuno-oncology: Biologic Rationale, Statistical Design and Study Conduct Challenges
MODERATORS
Gregory Reaman, M.D. | U.S. Food and Drug Administration
Eric Rubin, M.D. | Merck Research Laboratories
Opportunities and Challenges in Combinatorial Approaches in Immuno-oncology: Biologic Rationale and Strategy
SPEAKER
Mario Sznol, M.D. | Yale University
Statistical Considerations and Study Design
Rajeshwari Sridhara, Ph.D. | U.S. Food and Drug Administration
Industry Perspective
Emmett Schmidt, M.D., Ph.D. | Merck Research Laboratories
Arvin Yang, M.D., Ph.D. | Bristol-Myers Squibb Company
The Patient Perspective
Kim Norris | Patient Advocate
Lung Cancer Foundation of America
03:00 PM – 03:30 PM
Break
03:30 PM - 05:30 PM | Case Studies I (learners attend one from this group)
Bavencio® (avelumab) | EMD Serono
PANELIST
Virginia Pappalardo, RAC | EMD Serono
Besponsa® (inotuzumab ozogamicin), Pfizer, Inc.
Alison Russell, PhD | Pfizer
Kymriah™ (tisagenlecleucel) | Novartis
Manisha Patel | Novartis Pharmaceuticals
Vyxeos™ (daunorubicin and cytarabine) | Jazz Pharmaceuticals
PANELIST – Fojan Zamanian, Ph.D. | Jazz Pharmaceuticals
05:30 PM - 07:00 PM | Reception
08:00 AM - 09:00 AM | Continental Breakfast
08:00 AM - 09:00 AM | Breakfast Discussion Groups
(Core Curriculum attendees and Patient Advocates only)
09:00 AM - 10:00 AM | KEYNOTE ADDRESS
FDA Policy Impacting the Development and
Availability of Cancer Drugs and Diagnostics
SPEAKER Anna Abram, Keynote Speaker
10:00 AM - 10:30 AM | Break
10:30 AM - 12:30 PM | In-Depth Discussion Group II
(learners attend one from this group)
Opportunities and Challenges of Using Pragmatic
Clinical Trials in Cancer Drug Development
MODERATOR – Richard Schilsky, M.D. | American Society of Clinical Oncology
Overview of Pragmatic Clinical Trials and Their Role in Drug Development
PANELIST
Adrian Hernandez, M.D., M.H.S. | Duke University
The TAPUR Study as an Example of a Biomarker-driven Pragmatic Clinical Trial
Edward Kim, M.D. | Levine Cancer Institute
Considerations in Use of Pragmatic Clinical Trials to Support Regulatory Approval of New and Expanded Indications
Sean Khozin, M.D., M.P.H. | U.S. Food and Drug Administration
Sponsor Perspective on Opportunities and Challenges of Pragmatic Clinical Trials
Mary Beattie, M.D., M.A.S. | Roche/Genentech
Patient Perspective on Opportunities and Challenges of Pragmatic Clinical Trials
Jane Perlmutter, M.B.A., Ph.D. | Gemini Group
Panel Discussion: All Speakers
International Clinical Trials in Global Cancer Drug Development
MODERATOR
Howard Fingert, M.D. | Takeda Oncology
Globalization of Clinical Trials
Ke Liu, M.D., Ph.D. | U.S. Food and Drug Administration
Cancer Immunoediting and Neoantigens
PANELIST
Jay Backstrom, M.D., M.P.H. | Celgene
Site Audit Findings
Ute Berger, M.D. | PRA Health Sciences
International Clinical Trials – A Patient Centric View
Rick Bangs, M.B.A., P.M.P. | SWOG
CDER Perspective: International Clinical Trials and Clinical Inspections
Kassa Ayalew, M.D., M.P.H. | U.S. Food and Drug Administration
Neoantigen-based Novel Cancer Therapies
Adnan Jaigirdar, M.D. | U.S. Food and Drug Administration
Neoantigen-based Peptide Vaccine
Catherine Wu, M.D. | Dana-Farber Cancer Institute
Neoantigen-based Cell Therapy
Steven Rosenberg, M.D., Ph.D. | National Cancer Institute;
Neoantigen Approach: Industry Perspective
Tal Zaks, M.D., Ph.D. | Moderna Therapeutics
The Patient Perspective
Sandra Hamilton, R.N., B.S.N., M.Ed | SWOG
Drug Development for Serious and Life Threatening Hematologic Diseases: A Lesson from Oncology
MODERATOR
Haleh Saber, Ph.D. | U.S. Food and Drug Administration
Proposal for Evaluation of Therapeutics for Severely Debilitating or Life-Threatening Indications
PANELIST
Judith Prescott, D.V.M., Ph.D., D.A.C.V.P. | Merck Research Laboratories
Novel Approach to Developing Products for SDLT Hematologic Diseases
Haleh Saber, Ph.D. | U.S. Food and Drug Administration
Sickle cell disease: Clinical perspectives on severity and current treatment options
E. Dianne Pulte, M.D. | U.S. Food and Drug Administration
Is Collaboration for Innovation in a “Crowded” Space Feasible?
MODERATOR
Tatiana Prowell, M.D. | U.S. Food and Drug Administration
Challenges and Barriers to Collaboration Between Pharmaceutical Companies
PANELIST
Josh Bilenker, M.D. | Loxo Oncology
Regulatory Perspective on Successful Examples of Industry Collaboration in Oncology Drug Development
Patricia Keegan, M.D. | U.S. Food and Drug Administration
What’s Possible in Collaborations Between Drug and Diagnostic Companies?
David Brunel, M.A. | Biodesix
The Patient Perspective
COL (ret.) James E. Williams, Jr., USA., M.S., S.P.H.R. | Pennsylvania Prostate Cancer Coalition; Intercultural Cancer Council
12:30 PM - 01:30 PM | Lunch
01:30 PM - 03:30 PM | Case Studies II (learners attend one from this group)
Zejula® (niraparib), Tesaro
PANELIST
Charles Miller, BS/BA | TESARO
Keytruda® (pembrolizumab), Merck & Co.
Brian Abbott, Ph.D. | Merck
Bavencio® (avelumab), EMD Serono
Virginia Pappalardo, RAC | EMD Serono
Besponsa® (inotuzumab ozogamicin), Pfizer, Inc.
Alison Russell, PhD | Pfizer
Kymriah™ (tisagenlecleucel), Novartis
Manisha Patel | Novartis Pharmaceuticals
03:30 PM - 04:00 PM | Break
04:00 PM - 06:00 PM
In-Depth Discussion Group III (learners attend one from this group)
Approaches to Augmenting Responses to Checkpoint Inhibitors and Risk Mitigation
MODERATORS
Elad Sharon, M.D. | National Cancer Institute
Helen Chen, M.D. | National Cancer Institute
Strategies to Augment Clinical Benefit with Immune Checkpoint Inhibition
Gwynn Ison, M.D. | U.S. Food and Drug Administration
Ravi Madan, M.D. | National Cancer Institute Center for Cancer Research
Development and Clinical Implementation of Predictive Biomarkers
Alessandro Cesano, M.D., Ph.D. | nanoString, Inc.
Risk Mitigation for Immune Checkpoint inhibitors: A Rheumatologist’s Perspective
Laura Cappelli, M.D., M.H.S. | Johns Hopkins University
Immune Checkpoint Blockade Therapy: Targets of Response and Adverse Events
Kavita Dhodapkar, M.D. | Emory University
A Walk-Through of Biomarker Discovery: Combining Next-Generation Sequencing Assessments to Improve Survival Predictions with Checkpoint Blockade
Julie Rytlewski, Ph.D. | Adaptive Biotchtechnologies
Panel Discussion: All Speakers and Alexandra Snyder, M.D.
Expanded Eligibility Criteria for Clinical Trials
PANELISTS
Harpreet Singh, M.D. | U.S. Food and Drug Administration
Joohee Sul, M.D. | U.S. Food and Drug Administration
Stuart Lichtman, M.D. | Memorial Sloan-Kettering Cancer Center
Darrel Cohen, M.D., Ph.D. | Pfizer, Inc.
Eric Rubin, M.D. | Merck Research Laboratories
Broadening Eligibility Criteria to Make Clinical Trials More Representative
Edward Kim, M.D. | Levine Cancer Institute
Modernizing Eligibility Criteria Organ Dysfunction
Nam Atiqur Rahman, Ph.D. | U.S. Food and Drug Administration
Expansion of Eligibility Criteria: Trial Design Considerations
Thomas Gwise, Ph.D. | U.S. Food and Drug Administration
The Patient Perspective
Patricia Spears, B.S. | Susan G. Komen
Circulating Free Tumor DNA in Cancer Drug Development and Clinical Use
MODERATOR
Julia A. Beaver, M.D. | U.S. Food and Drug Administration
The Power, Precision and Challenges of Plasma in NSCLC
PANELIST
Benjamin Levy, M.D. | Johns Hopkins University Sidney Kimmel Cancer Center
Triple-Negative Breast Cancer: Current Approaches in Early and Metastatic Disease
Daniel Stover, M.D. | Ohio State University James Cancer Center
Innovative Approaches to ctDNA Detection and Clinical Applications
Maximilian Diehn, M.D., Ph.D. | Stanford University
The Regulatory Perspectives on ctDNA in vitro Diagnostic Tests
Reena Philip, Ph.D. | U.S. Food and Drug Administration
The Use of ctDNA in Clinical Trials and Beyond: Patient Perspectives
Jamie Holloway, Ph.D. | Georgetown Breast Cancer Advocates; Metastatic Breast Cancer Project, Broad Institute; Science37
Real World Data: Opportunities for Potential Drug Approval Strategies
Rajeshwari Sridhara, Ph.D. | U.S. Food and Drug Administration
Assessing Bias in Real-World Data
Bill Capra, Ph.D. | Genentech, Inc.
Potential Endpoints For Evaluating Treatment Effect When Using Real World Data
Pallavi Mishra-Kalyani, Ph.D. | U.S. Food and Drug Administration
Estimation of Treatment Effect Using Real World Data
Qi Long, Ph.D. | University of Pennsylvania
Real World Data: Opportunities for Potential Drug Approval Strategies
Bettye Green, R.N. | Alliance for Clinical Trials in Oncology
Panel Discussion: Regulatory Considerations for Drug Approval Using Real World Data
Albert Kraus, Ph.D. | Pfizer, Inc
Richard Pazdur, M.D. | U.S. Food and Drug Administration
06:00 PM - 07:30 PM | Reception
08:00 AM - 09:00 AM | Continental Breakfast
08:00 AM - 09:00 AM | Breakfast Discussion Groups
(Core Curriculum attendees and Patient Advocates only)
09:00 AM - 11:00 AM | Cast Studies III
(learners attend one from this group)
Vyxeos™ (daunorubicin and cytarabine), Jazz Pharmaceuticals
PANELIST
Fojan Zamanian, Ph.D. | Jazz Pharmaceuticals
Zejula® (niraparib), Tesaro
Charles Miller, BS/BA | TESARO
Keytruda® (pembrolizumab), Merck & Co.
Brian Abbott, Ph.D. | Merck
Bavencio® (avelumab), EMD Serono
Virginia Pappalardo, RAC | EMD Serono
11:00 AM - 11:30 AM | Box Lunches
11:30 AM - 01:30 PM | Case Studies IV (learners attend one from this group)
Besponsa® (inotuzumab ozogamicin), Pfizer, Inc.
PANELIST – Alison Russell, PhD | Pfizer
Kymriah™ (tisagenlecleucel), Novartis
PANELIST –
Manisha Patel | Novartis Pharmaceuticals
Vyxeos™ (daunorubicin and cytarabine), Jazz Pharmaceuticals
Fojan Zamanian, Ph.D. | Jazz Pharmaceuticals
Zejula® (niraparib), Tesaro
PANELIST
Charles Miller, BS/BA | TESARO
01:30 PM - 01:45 PM | Adjourn