2021 AAADV WORKSHOP SCHEDULE & AGENDA

September 28th

SEPTEMBER 28

11:30am - 1:30pm

Learners eligible to attend a Satellite or Breakout Session

- AACR-AAADV Academic Translational Science Curriculum
  Speakers: Zach Hartman, Patricia LoRusso (DO), Herbert Kim Lyerly (MD), Steven Piantadosi, Laura van 't Veer
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- IOTN Breakout Session: Clinical Trial Case Studies: Stages of Investigation
  Speakers: Lawrence Fong, Zachary Morris, Andrew Sikora (MD Anderson)
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2:00pm - 4:00pm

FDA Core Curriculum
Coordinator: Jennifer Gao (FDA)
Speakers: Erik Bloomquist (FDA), Erica Nakajima (FDA), Nicole Sunseri (FDA), Suparna B. Wedam (MD)
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4:00pm - 6:00pm

- FDA-AAADV Satellite Symposium: Patient Advocates and Cancer Drug Development
  Moderator Session 1: Patty Spears
  Speakers Session 1: Rick Bangs, Michelle Treager, Salina Miller
  Moderator Session 2: Michelle Treager
  Speakers Session 2: Mary Scoggins, Ivis Sampayo, Andrea Ferris
  
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September 29th

SEPTEMBER 29

Learners eligible to attend a Satellite or Breakout Session

9:00am - 11:00am

- CDDF-AAADV Satellite Session on Global Pediatric Neuro-Oncology Network
  Speakers: Kim Lyerly, Jaap Verweij, Roger Packer, Nicolas Gerber, Rakesh Jalali, Chitkala Kalidis, Ruth Hoffman, Greg Reaman, Dominik Karres, CS Parmesh
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10:00am - 11:30am

- IOTN Breakout Session: NIH/NCI Mechanisms and Programs Focused on Clinical Translation
  Speakers: Alan Hutson, Elad Sharon, Rosemarie Aurigemma, Shizuko Sei, Stacey Adam, Marc Ernstoff
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11:30am - 12:00pm

Keynote Speech - Strengthening the Clinical Trial Enterprise – Lessons from a Pandemic
Speaker: Janet Woodcock (Acting Commissioner, FDA)
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12:00pm - 1:30pm

- Managing uncertainty in regulatory decision-making
  Moderator: Richard Schilsky (MD)
  Speakers: Jeff Allen (PhD), Julia A. Beaver (MD), Tammy Kim (MD), Allan Safferman (MD)
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2:15pm - 3:45pm

Learners attend One of the following Four sessions

- Patient-Centric Drug Development: Lessons Learned from COVID
  Moderator: Ishwaria Subbiah (MD)
  Speakers: Alexia DiVenere, Jennifer Gao (FDA), Dr. David Hyman, Vivek Subbiah (MD)
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- Finding the treatment effect: subgroups, cut-points, and signatures
  Moderator: Lisa Meier McShane (PhD)
  Speakers: Sandra Casak (FDA), Mallorie H. Fiero (FDA), Thomas Fleming (PhD), Lisa Meier McShane (PhD)
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- Learning from Our (IO) Mistakes: Innovations in Immuno-Oncology Translational Safety Science
  Moderator: Elad Sharon (MD, MPH)
  Speakers: Seamus Cotter, David E. Kozono, Jarushka Naidoo, Kerry Lynn Reynolds
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- Development of single patient therapies
  Moderator: Ke Liu (MD, PhD)
  Speakers: Praveen Aanur, Melinda Bachini, Peter Bross (FDA), Chaohong Fan (FDA), Patrick Ott, Steven Rosenberg (MD, PhD)
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4:00pm - 5:00pm

Learners attend One of the following Four sessions

- Value of blinded independent central radiology review
  Moderator: Dr. Janet Dancey
  Speakers: Greg Goldmacher, Lawrence H. Schwartz (MD)
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- Weight/BSA based dosing of Therapeutic proteins is the Optimal Approach
  Moderator: Jaap Verweij (MD, PhD)
  Speakers: Daniel Goldstein (MD Biography), Stijn Koolen
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- Is it possible to obtain evidence of tumor agnostic drug activity?
  Moderator: Herbert Kim Lyerly (MD)
  Speakers: Ted Laetsch, Chitkala Kalidas, Susan Spinosa, Merck Eric Rubin, Leigh Marcus, Gina Hollenbeck
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- Advancing novel combinations of radiotherapy with systemic immune therapy: Is an abscopal effect a critical endpoint?
  Moderator: David Raben
  Speakers: Nicole Davarpanah (MD, JD), Silvia Formenti (MD), Amanda Walker
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September 30th

SEPTEMBER 30

Learners eligible to attend a Satellite or Breakout Session

9:00am - 11:00 am

- ASCO-ACS Satellite Session: Clinical Trials in Low- and Middle-Resource Settings - A Focus on Africa
  Speakers: Jennifer Dent, Dr. Bello Abubakar, Dr. Kassa Ayalew, Julie Gralow, Bill Cance, Gertrude Nakigudde, Dr. Folakemi Odedina, Chitkala Kalidis, Jamie Freedman, Moji Christianah Adeyeye, Dr. Lola Fashoyin-Aje, Jackson Orem, Thea Norman
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10:00am - 11:30am

- IOTN Breakout Session: Beauty is in the eye of the beholder: What does a fundable translational project look like?
  Speakers: Ananth Annapragada, Kory Hallett, Katherine Needleman, Dan Watkins, Casey Cunningham, Debra Chao
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11:30am - 12:00pm

Keynote Speech
Speaker: Dr. Robert Califf
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12:00pm - 1:30pm

- Clinical Trials in the Digital Age
  Moderator: Jaap Verweij (MD, PhD)
  Speakers: Don Dizon (MD), Dawn Hershman, Sean Khozin (MD, MPH, ASCO), Bakul Patel (MSEE, MBA)
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1:30pm - 2:00pm

- Special Lecture: NCI's Clinical Trials 2030 Strategic Plan
  Speaker: James Doroshow (MD)
  
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2:15pm - 3:45pm

Learners attend One of the following Four sessions

- Measurable Residual Disease (MRD) and pathologic Complete Response (pCR): What are they? How do we measure them? How do we use them?
  Moderator: Renzo Canetta (MD)
  Speakers: Nicole Gormley (MD), Ola Landgren, Kelly Laschinger (RN), Lisa Meier McShane (PhD), William Fraser Symmans
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- The end of the beginning of biosimilars
  Moderator: Donald R. Harvey III (PharmD)
  Speakers: Hillel Cohen, Elizabeth deVries, Gary Lyman (MD, MPH), Pam Traxel, Lee Newcomer, Stacey M. Ricci (MEng, ScD)
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- Approaches to combination therapy in anti-PD(L)1-refractory cancer
  Moderator: Eric H. Rubin (MD)
  Speakers: Marya Chaney, Matt Hellman, Kurt Schalper, Marc Theoret (MD)
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- History and possible future of companion diagnostics: How do we build forward?
  Moderator: Elizabeth Mansfield
  Speakers: Gideon Blumenthal (MD), Phillip Febbo (MD), Rasika Kalamegham, Reena Philip (PhD), Laura van 't Veer
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4:00pm - 5:00pm

Learners attend One of the following Four sessions

- How Can We Reengineer Cancer Drug Development Systems for Patient Desired Outcomes?
  Moderator: Michele Atlan
  Speakers: Christopher Booth (MD), Eliiabeth Duke (FDA), Sally Schott, Michelle Treager
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- Is there still a role for pharmacokinetics in anticancer agent development and use?
  Moderator: Donald R. Harvey III (PharmD)
  Speakers: Steffie Groenland, Atik Rahman (FDA), Mirat Shah (FDA), Karthick Vishwanathan (PhD)
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- What are we missing by not enrolling Sexual and Gender Minorities into clinical trials?
  Moderator: Mark Polizzotto
  Speakers: Jamie Brewer (MD), Nada Hamad (BSc MSc Forensic, MBBS), Sanford E. Jeames (DHA), Joel Palefsky (MD, CM, FRCP(C)), Scout, Gita Suneja
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- Why aren’t we using PROs in drug development?
  Moderator: Nicole Davarpanah (MD, JD)
  Speakers: Gita Thanarajasingam, Vishal Bhatnagar (MD), Jill Feldman, Serban Ghiorghiu
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October 1st

OCTOBER 1

Learners eligible to attend a Satellite or Breakout Session

9:00am - 11:00am

- Duke Margolis Center Satellite Session on Value in Cancer Care
  Speakers:Mark McClellan
  
  Panelist: Marianne Hamilton Lopez, Robert Saunders, Nirosha Mahendraratnam Lederer, Brent Rice, Jeff Allen
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- AACR-NCI Satellite Session Cancer Prevention
  Speakers: Phil Castle, Pat Haugan, Shizuko Sei, Eva Szabo, Worta McCaskill-Stevens, Brandy Heckman-Stoddard, Christos Patriotis, Elizabeth Mansfield, Keith Knutson, Zachary Hartman, Danielle Kroll
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10:00am - 11:30am

- IOTN Breakout Session: The IOTN: Progress and Future Directions
  Speakers: Adekunle Odunsi, Kevin Howcroft, Andrew Sikora, Alan Hutson, Ananth Annapragada, Kunle Odunsi, Kevin Howcroft
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11:30am - 12:00pm

Keynote Speech: Large-scale Randomized Evidence in the 2020’s
Speaker: Sir Richard Peto
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12:00pm - 1:30pm

- Future Clinical Trials
  Moderator: William G. Cance (MD)
  Speakers: Adrian Hernandez, Dr. Michael J. Kelley (MD), Paul Kluetz (FDA), Leanne Madre, Steven Piantados
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1:30pm - 2:00pm

- Special Lecture Dr. Ned Sharpless, Director, National Cancer Institute
  Speaker: Ned Sharpless (MD)
  
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2:15pm - 3:45pm

- FDA Case Studies: Venetoclax/azacitidine (Project Livin' Label recording)
  Speakers: Kelly Norsworthy, Lori Ehrlich, Jalaja Potluri, Courtney DiNardo, Claude Sipe
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Learners attend One of the following Four sessions

- Sacituzumab
  Speakers:Sarah Oliver, Christy Osgood, Christina Brus, Daejin Abidoye, Heather Springfield, Aditya Bardia, Catherine McQuade
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- Sotorasib
  Speakers:Nicole Drezner, Erica Nakajima, Stacy Shord, Greg Friberg, Grace Dy, Askia Dozier, John A. Szczesny
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- Trastuzumab deruxtecan
  Speakers: Amita Chaudhari, Steven Lemery (MD), Shan Pradhan (FDA)
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- Crizotinib
  Speakers: Nicole Earnhardt Aldrich, Yvette Kasamon (FDA), Margret Merino (FDA)
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4:00pm - 5:00pm

- Closing Remarks- Chasing My Cure
  Speaker: David Faigenbaum
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