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
Julia Beaver, M.D. , U.S. Food and Drug Administration
Gary Kelloff, M.D., National Cancer Institute
Description
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
Julia Beaver, M.D., Certara
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
Sean Khozin, M.D., M.P.H., U.S. Food and Drug Administration
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 SpearsUNC 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
For New Learners and Patient Advocates
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


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