Wed May 8th 2019
8:00am - 9:30am
Registration for AAADV Workshop; Continental Breakfast
9:30 am – 12:00 pm
Moderator
Lola Fashoyin-Aje, M.D., M.P.H. ; U.S. Food and Drug Administration
Core Curriculum For New Learners
Faculty from U.S. Food and Drug Administration:
9:30 AM - 12:00 PM
IN-DEPTH DISCUSSION GROUP I
Learners attend One of the following Five sessions.
1.
Histology Agnostic Drug Development
9:30 AM - 12:00 PM
Moderator
Leigh Marcus, M.D., U.S. Food and Drug Administration
Martha Donoghue, M.D.., U.S. Food and Drug Administration
Speakers
Janaki Veeraraghavan, Ph.D. U.S. Food and Drug Administration
Brittany Avin, Patient Advocate PhD Candidate, John’s Hopkins University
Panelist
David S. Hong, M.D.MD Anderson Cancer Center
Nicolas Llosa, M.D.Johns Hopkins University
Joshua H. Bilenker, M.D.Loxo Oncology, Inc.
2.
Liquid Biopsy - State of the Science and Future Directions
9:30 AM - 12:00 PM
Moderator
Gary Kelloff, M.D., National Cancer Institute
Description
- Liquid Biopsy Overview and Novel Considerations:
Gary Kelloff, M.D., National Cancer Institute - Standards Development for Liquid Biopsy:
P. Mickey Williams, Ph.D.; Frederick National Laboratories for Cancer Research - Liquid Biopsy NGS Considerations:
Soma Ghosh, Ph.D.; U.S. Food and Drug Administration - Liquid Biopsy Clinical Validation:
Robert McCormack, Ph.D.; Independent Consultant - Clinical Utility and Advances in Liquid Biopsy: Geoffrey Oxnard, M.D.; Dana-Farber Cancer Institute, Harvard University
- Panelist: Carl. Barrett, Ph.D., Astrazeneca
Speakers
Geoffrey R. Oxnard, M.D. Dana-Farber Cancer Institute, Harvard University
Robert McCormack, Ph.D. Independent Consultant
P. Mickey Williams, Ph.D. Frederick National Laboratories for Cancer Research
Soma Ghosh, Ph.D. U.S. Food and Drug Administration
Panelist
J. Carl Barrett, Ph.D. AstraZeneca
Laurel Pracht Gynecologic Oncology Group / NRG Oncology Cooperative Group
Justin Odegaard, M.D., Ph.D. Guardant Health
3.
Nonclinical Strategies to Support Emerging Complex Biologic Oncology Therapeutics
9:30 AM - 12:00 PM
Moderator
Aaron Moss, Ph.D., Certara
Description
- Supporting FIH in the Absence of an “Appropriate” Species for Bispecific Molecules: Ezio Bonvini, M.D., Macrogenics
- Nonclinical Programs to Support Complex Biologic Development: Christopher Scull, Ph.D., Biologics Consulting
- How to Fill in the Gaps in a Nonclinical Program in the Absence of an Appropriate Efficacy Model: Aaron Moss, Ph.D., Certara
- Translational Systems Modeling to Increase the Therapeutic Index of Mosunetuzumab (CD20/CD3 Bispecific Antibody) in Phase 1 Trials: Chi-Chung Li, Ph.D., Genentech and Iraj Hosseini, Ph.D., Genentech
- Nonclinical Development of Complex Biologics and Cell Therapies: A Regulatory Perspective: Whitney Helms, Ph.D.; U.S. Food and Drug Administration
Speakers
Ezio Bonvini, M.D. MacroGenics, Inc.
Chris Scull Biologics Consulting
Whitney Helms, Ph.D. U.S. Food and Drug Administration
Chi-Chung Li Genentech Roche
Iraj Hosseini, Ph.D. Genentech
4.
NGS - Clinical Utility and Regulatory Considerations
9:30 AM - 12:00 PM
Moderator
Reena Philip, Ph.D., U.S. Food and Drug Administration
Panelist
Ahmet Zehir, Ph.D. Memorial Sloane Kettering Cancer Center
Katherine Szarama CMS
Donna Roscoe, Ph.D. U.S. Food and Drug Administration
Jane Perlmutter, Ph.D., M.B.A., Patient Advocate Gemini Group, Patient Advocate
5.
Roadmaps, Recommendations and Partnerships for Radiation Drug Development
9:30 AM - 12:00 PM
Moderator
David Raben, M.D., University of Colorado Denver
Sana Karam, M.D., Ph.D., University of Colorado Denver
Description
- Outside the Big Four — Why Gyn and Breast Cancers are a Great Way Forward for Radiation and I-O or Small Molecule Combinations: Christine Fisher, M.D., M.P.H., University of Colorado
- Radiation and I-O Combinations — Does the Clinical Match the Pre-Clinical Discoveries: Silvia Formenti, M.D., Weill Cornell Medicine
- Early Phase Radiation Drug Combinations — a UK Perspective: Tim Illidge, MBBS, Ph.D, University of Manchester, UK
- Window of Opportunity Radiation Studies to Develop Drugs and Get Signals: Sana Karam, M.D., Ph.D., University of Colorado Cancer Center
- NRG Phase 1 Radiation Drug Development Efforts — Why Pharma Should Come to Our Door: Steven Lin, M.D., Ph.D., MD Anderson Cancer Center
- Panelist: Jason Dixon, M.A., RT (T), Patient Advocate
Speakers
Christine Fisher University of Colorado
Sana Karam, M.D., Ph.D.University of Colorado Cancer Center
Silvia Formenti, M.D.Weill Cornell Medicine
Tim Illidge, MBBS, Ph.D. University of Manchester, U.K.
Steven Lin, M.D., Ph.D. MD Anderson Cancer Center
Jason Dixon, M.A., RT (T), Seattle Cancer Care Alliance
10:45am - 11:15am
BREAK
12:00 PM - 1:00 PM
Network Lunch
1:00 PM - 3:00 PM
Moderator
Plenary Session: Real World Evidence 2.0
Speakers
Aneesh Chopra CareJourney
Kenneth Mandl, M.D., M.P.H. Boston Children’s Hospital
Andy Coravos Elektra Labs
Panelist
| Patty Spears | UNC Lineberger Comprehensive Cancer Center |
3:00pm - 3:30pm
BREAK
3:30pm - 5:30pm
Case Studies of Approved Agents | Learners attend 1 of the 4
Yescarta (axicabtagene ciloleucel), Kite Pharma
Vitrakvi (larotrectinib), Loxo Oncology / Bayer
Kisqali (ribociclib), Novartis
Xospata (gilteritinib), Astellas
Thur May 9th 2019
8:00am - 9:00am
Ballroom foyer
CONTINENTAL BREAKFAST
8:00 – 9:00 am
Salon D
INFORMAL BREAKFAST DISCUSSION GROUPS
9:00 – 10:00 am
Salon E–H
KEYNOTE ADDRESS
FDA Policy Impacting the Development and Availability of Cancer Drugs and Diagnostics
Anna Abram, Deputy Commissioner for Policy, Planning, Legislation and Analysis, U.S. Food and Drug Administration
10:00 – 10:30 am
Foyer E–H
BREAK
10:30 am – 12:30 pm
Salons E–H
PLENARY SESSION
DECENTRALIZED CLINICAL TRIALS: THE FUTURE IS NOW
Moderators:
Tatiana Prowell, MD; U.S. Food and Drug Administration
Richard Schilsky, MD; American Society of Clinical Oncology
PART 1: RATIONALE FOR DECENTRALIZED TRIALS (DR. PROWELL)
Speaker
Johnathan Cotliar, MD; Science 37
Panelists
Gail Adinamis, BS; GlobalCare Clinical Trials, LLC
Leonard Sacks, MD; U.S. Food and Drug Administration
Ching Tian, MS; Novartis
Pamela Tenaerts, MD; Clinical Trials Transformation Initiative
Kelly Shanahan, MD; Patient Advocate
PART 2: CHALLENGES AND OPPORTUNITIES OF DECENTRALIZED TRIALS FOR ONCOLOGY DRUG DEVELOPMENT (DR. SCHILSKY)
Panel Discussion
Brian Alexander, MD, MPH; Foundation Medicine
Asha Collins, PhD; Roche/Genentech
Edward Kim, MD; Levine Cancer Institute
Nisha Nanda, BSc, PhD; Loxo Oncology
Isaac Rodriguez-Chavez, PhD, MHSc, Msc; U.S. Food and Drug Administration
Nikhil Wagle, MD; Dana-Farber Cancer Institute
Matthew B. Wiener, PharmD, Pharmatech, Inc.
Kelly Shanahan, MD; Patient Advocate
12:30 – 1:30 pm
Salon D
NETWORKING LUNCH
1:30 – 3:30 pm
CASE STUDIES OF APPROVED AGENTS II
Learners attend one from this group.
Yescarta® (axicabtagene ciloleucel), Kite Pharma
Salon E
Vitrakvi® (larotrectinib), Loxo Oncology/Bayer A.G.
Salon F
Kisquali® (ribociclib), Novartis
Salon G
Xospata® (gilteritinib), Astellas
Salon H
3:30 – 4:00 pm
Foyer E–H
BREAK
4:00 – 6:00 pm
IN-DEPTH DISCUSSION GROUP II
Learners attend one of the following five sessions.
1.
PATIENT-REPORTED OUTCOMES IN ONCOLOGY CLINICAL TRIALS: CLINICAL TRIAL DESIGN AND OPERATIONAL ISSUES TOWARD REGULATORY GRADE CLINICAL EVIDENCE
Brookside A & B
Moderators:
Paul Kluetz, MD; U.S. Food and Drug Administration
Thomas Fleming, PhD; University of Washington
Introduction:
Thomas Fleming, PhD; University of Washington
A Patient’s View on Use of PRO to Inform Tolerability
Lee Jones, MBA; Patient Advocate
Current and Future Opportunities to Assess Symptoms and Function
Paul Kluetz, MD; U.S. Food and Drug Administration
Measures of Symptoms and Function in Recent FDA Applications
Vishal Bhatnagar, MD; U.S. Food and Drug Administration
Operational Challenges with Collecting PRO in International Trials
Elisabeth Piault-Louis, PharmD; Genentech
Opportunities and Challenges for ePRO and Other Electronic Clinical Outcomes Collection
Stacie Hudgens, MSc; Clinical Outcomes Solutions
2.
MRD AS DRUG DEVELOPMENT TOOL FOR DRUGS FOR HEMATOLOGICAL MALIGNANCIES
Salon F
Moderators:
Nicole Gormley, MD; U.S. Food and Drug Administration
Speakers
Christopher Hourigan, MD; National Heart, Lung, and Blood Institute
Bindu Kanapuru, MD; U.S. Food and Drug Administration
Sharon McBain, BSc; Johnson & Johnson
Aaron Schetter, PhD, MPH; U.S. Food and Drug Administration
Qian Shi, PhD; Mayo Clinic
3.
DEFINING AND MONITORING FOR SAES IN TRIALS OF I-O AGENTS
Salon G
Moderators:
Elad Sharon; MD; National Cancer Institute
Speakers
Daniel Barber, PhD; National Institute of Allergy and Infectious Diseases
Meredith Chuk, MD; U.S. Food and Drug Administration
Nicole LeBoeuf, MD, MPH; Dana-Farber Cancer Institute
Kelly Walkovich, MD; University of Michigan
Blake Warner, DDS, PhD, MPH; National Institute of Dental and Craniofacial Research
Panelist
Hildy Dillon, MPH; Cancer Support Community, Patient Advocate
4.
COMPANION VS. COMPLEMENTARY DIAGNOSTICS
Salon H
Moderators:
Reena Philip, PhD; U.S. Food and Drug Administration
Panel Discussion
Meijuan Li, PhD; U.S. Food and Drug Administration
Christine Vietz, PhD, Foundation Medicine
Xiaolei Xu, MD, PhD; Agilent Technologies
5.
Endpoints Beyond ORR in IO Drug Development
Salon E
Moderators:
Jeffrey Weber, MD, PhD.; New York University Langone Medical Center
Panel Discussion
Marc Theoret, M.D., U.S. Food and Drug Administration
Jean Charles Soria, AstraZeneca
Kim Norris, Lung Cancer Foundation Of America
6:00 – 7:30 pm
Foyer E–H
NETWORKING RECEPTION
Fri May 10th 2019
8:00 – 9:00 am
Ballroom foyer
CONTINENTAL BREAKFAST
8:00 – 9:00 am
Moderator
Salon D
INFORMAL BREAKFAST DISCUSSION GROUPS
For New Learners and Patient Advocates
9:00 am – 11:00 am
IN-DEPTH DISCUSSION GROUP III
Learners attend one of the following five sessions.
1.
INITIATING MASTER PROTOCOLS BY ADVOCACY GROUPS TO SUPPORT DRUG DEVELOPMENT
Brookside A & B
Moderators:
Renzo Canetta, MD; Independent Consultant
Common Tumors: Precision Promise Trial (Pancreatic Cancer)
Diane Simeone, MD; New York University Langone Health
Rare Tumors: GBM AGILE Trial (Glioblastoma)
Brian Alexander, MD, MPH; Foundation Medicine
Experimental Use of Approved Drugs: TAPUR Trial (Solid Tumors and Lymphomas)
Richard Schilsky, MD; American Society of Clinical Oncology
Pediatric Malignancies: Pedal Trial (Acute Myeloid Leukemias in Children/Adolescents)
Gwen Nichols, MD; Leukemia and Lymphoma Society
Hematologic Malignancies: MyDRUG Trial (Multiple Myeloma)
Daniel Auclair, PhD; Multiple Myeloma Research Foundation, Patient Advocate
2.
DEVELOPING DRUGS THAT REDUCE THE BURDEN OF CANCER
Salon H
Moderators:
Mary Scroggins, MA; International Gynecologic
Cancer Society
Bellinda King-Kallimanis; PhD, U.S. Food and Drug Administration
Integrating PROs into Clinical Care: Benefits and Challenges
Allison Leahy, MD; Children’s Hospital of Philadelphia
Drug Development and Palliative Care
Michael L. Pearl, MD, Stony Brook Medicine
Drug Cost and Availability
Yousuf Zafar, MD; Duke University
Patient and Community Engagement in Clinical Research and Drug Development
Lisa Taylor, MBA; Patient Advocate
3.
EXTERNAL CONTROLS IN CLINICAL TRIALS IN RARE DISEASES: OPPORTUNITIES AND CHALLENGES
Salon F
Moderator:
Rajeshwari Sridhara, PhD; U.S. Food and Drug Administration
Speaker
Jingjing Ye, PhD; U.S. Food and Drug Administration
Abby Sandler, PhD; MyPART, National Cancer Institute
Panel Discussion, all speakers plus:
Larissa Higgins, MB, BCh, MSc; Health Products Regulatory Authority, Ireland
Laura Johnson, PhD; U.S. Food and Drug Administration
Richard Pazdur, MD; U.S. Food and Drug Administration
Richard Simon, DSc; R Simon Consulting Annie Ellis; Patient Advocate
4.
NOVEL THERAPEUTIC INTERVENTIONS EARLY IN THE DISEASE TRAJECTORY
Salon G
Moderator:
Patricia LoRusso, DO; Yale University
Speaker
Elizabeth Fox, MD; Children’s Hospital of Philadelphia
Hope Rugo, MD; University of California San Francisco
Margaret Tempero, MD; University of California San Francisco
Panelist
Desiree Walker, Young Survival Coalition, Patient Advocate
5.
REVISITING ELIGIBILITY CRITERIA FOR CANCER CLINICAL TRIALS
Salon E
Moderator:
Gwynn Ison, MD; U.S. Food and Drug Administration
Panel Discussion
Edward Kim, MD; Levine Cancer Institute Performance Status
Elizabeth Garrett-Mayer, PhD; American Society of Clinical Oncology
Harpreet Singh, MD; U.S. Food and Drug Administration Drug Washout/Con Meds
Vishal Bhatnagar, MD; U.S. Food and Drug Administration
Scot Ebbinghaus, MD; Merck Prior Therapies
Wayne Rackoff, MD; to Janssen Research Development Lab Reference Range/Test Intervals
Alexander Spira, MD, PhD; Virginia Cancer Specialists
Abhi Nair, MD; U.S. Food and Drug Administration
Patient Advocate
Everett Dodson; Georgetown Lombardi Comprehensive Cancer Center
11:00 am
AAADV WORKSHOP ADJOURN
Boxed lunches to go