Wednesday, September 14
Pre-Workshop: Fundamentals of Global Cancer Drug Development
8:45am (EST) Sept 14
Keynote Address
9:00am (EST) Sept 14
Introduction: H. Kim Lyerly
Keynote Speaker:Denis Lacombe, Chief Executive Officer, European Organization for Research and Treatment of Cancer (EORTC)
9:45am (EST) Sept 14
10:00am (EST) Sept 14
10:20am (EST) Sept 14
Global Clinical Research Methods: Regulatory Issues
10:40am (EST) Sept 14
11:00am (EST) Sept 14
Global Clinical Research Methods: Statistical Consideration
Speaker: Andrew J Martin, Associate Professor Principal Research Fellow and Senior Biostatistician NHMRC Clinical Trials Centre, University of Sydney
11:20am (EST) Sept 14
Speaker: Lesley Seymour, Professor and Medical Oncologist Queens University, Canadian Cancer Trials Group Deputy Director, and IND Program Director
11:40pm (EST) Sept 14
Q and A,
Discussion
12:30pm (EST) Sept 14
30Min Break
Session 2:
Data Supporting Regulatory Action from Academic Trials
1:00pm (EST) Sept 14
Data Supporting Regulatory Action from Academic Trials: Introduction
Moderator: Chitkala Kalidas, Global Head, Oncology & In Vitro Diagnostics Regulatory Affairs and Oncology Sustainability, Bayer
1:05pm (EST) Sept 14
Data Supporting Regulatory Action from Academic Trials: An Academic Perspective
1:25pm (EST) Sept 14
Data Supporting Regulatory Action from Academic Trials: An Academic Perspective
1:45pm (EST) Sept 14
Data Supporting Regulatory Action from Academic Trials: A Pharma Perspective
Speaker: Serban Ghiorghiu, Vice President, Late Oncology, AstraZeneca
2:05pm (EST) Sept 14
Data Supporting Regulatory Action from Academic Trials: An Academic Perspective
2:25pm (EST) Sept 14
Q and A, Discussion
Session 3:
Supporting the Future of Global Cancer Drug Development
3:00pm (EST) Sept 14
Supporting the Future of Global Cancer Drug Development: Introduction
Moderator: H. Kim Lyerly, Professor, Duke University
3:05pm (EST) Sept 14
Speaker: James H. Doroshow, M.D. Deputy Director, US National Cancer Institute, National Institutes of Health
3:45pm (EST) Sept 14
St. Jude Global: To improve survival rates of children with cancer and other life-threatening diseases around the world
Speaker: Carlos Rodriguez-Galindo, Executive Vice President, Chair, Department of Global Pediatric Medicine, Director, St. Jude Global
4:30 pm (EST) Sept 14
Training/Education in Global Drug Development
Moderator/Speaker: Wendy L. Clemens, Vice President, Research and Early Development, Sr. Early Development Program Lead, Oncology, Bristol Myers Squibb
Invited Discussants: H. Kim Lyerly
Thursday, September 15
The AAADV-ASCO-CDDF Global Cancer Drug Development Workshop
8:45am (EST) Sept 15
Moderator: Julie Gralow, Chief Medical Officer, American Society of Clinical Oncology (ASCO)
Keynote Address
9:00am (EST) Sept 15
Keynote Speaker: Richard Sullivan, Professor of Cancer and Global Health at King’s College London, and Director of the Institute of Cancer Policy (ICP) and co-Director of the Conflict and Health Research Group
9:30am (EST) Sept 15
Introduction of Plenary Speakers
Co-Moderators: Julie Gralow, Chief Medical Officer, American Society of Clinical Oncology (ASCO) | Thomas Fleming, Professor, University of Washington, Seattle
9:35am (EST) Sept 15
Learnings from Infectious Disease in Global Drug Development: COVID, HIV, Vaccines
10:05am (EST) Sept 15
Assessing Africa’s Readiness to Participate in Global Cancer Drug Development
Speaker: Bello Abubakar, Immediate Past President, African Organization for Research and Training in Cancer (AORTIC)
10:25am (EST) Sept 15
Assessing Latin America’s Readiness to Participate in Global Cancer Drug Development
Speaker: Gustavo Werutsky, Chairman, Latin American Cooperative Oncology Group (LACOG)
10:45am (EST) Sept 15
Speaker: Cary Adams, Chief Executive Officer, Union for International Cancer Control (UICC)
11:05am (EST) Sept 15
Moderators: Julie Gralow and Thomas Fleming
Speakers: Richard Peto, Bello Abubakar, Gustavo Werutsky
Invited Discussant: Gilberto Lopes, Professor, University of Miami
11:38am (EST) Sept 15
Regulatory and Health System Perspectives of Global Drug Development- A Panel Discussion
Moderator: Agnes Saint-Raymond
Discussants: Iordanis Gravainis – European Medicines Agency (EMA)
Reiko Yanagihara – Japan Pharmaceutical and Medical Devices Agency (PMDA)
Beeta Bak – Health Canada
Mojisola Adeyeye – Director General, National Agency for Food and Drug Administration and Control (NAFDAC) Nigeria
Andre Ilbawi – World Health Organization (WHO)
Stephen O’Brien – National Institute for Health and Care Excellence (NICE)
BREAK
12:35pm (EST) Sept 15
Session 2 Track A Sept. 15th
Multi-Regional Clinical Cancer Trials (MRCT)
1:00pm (EST) Sept 15 A
Multi-Regional Clinical Cancer Trials: Introduction
Co-Moderators:
Renzo Canetta, Independent, Former Head of Global Oncology Clinical Research at Bristol Myers Squibb (BMS) | Jaap Verweij, Executive Director, Cancer Drug Development Forum (CDDF)
1:15pm (EST) Sept 15 A
1:45pm (EST) Sept 15 A
2:15pm (EST) Sept 15 A
Practical Implementation of MRCT
Speaker: Patricia Keegan, Chief Medical Officer, TopAlliance
2:45pm (EST) Sept 15 A
Regulatory Perspectives of MRCT
Speaker: Fergus Sweeney
3:15pm (EST) Sept 15 A
Moderators: Renzo Canetta and Jaap Verweij
Speakers: Gwen Nichols, Andrew Lee, Patricia Keegan, Fergus Sweeney, Renzo Canetta, Jaap Verweij
Session 2 Track B Sept. 15th
1:00pm (EST) Sept 15 B
Moderator: Donald Harvey, Professor Hematology and Medical Oncology, Pharmacology and Chemical Biology, Emory University
Speaker: Mark Ratain, Leon O. Jacobson Professor of Medicine, University of Chicago
1:30pm (EST) Sept 15 B
2:00pm (EST) Sept 15 B
Speaker: Julie Bullock, Senior Vice President and Global Head of Clinical Pharmacology & Translational Medicine, Certara
2:30pm (EST) Sept 15 B
Panel Discussion: Improving Precision and Efficiency of Phase I Trials in Oncology
Moderator: Donald Harvey
Speakers: Mark Ratain, Lilian Siu, Julie Bullock.
Invited Discussant: Larissa Higgins, Health Products Regulatory Authority (HPRA), SAWP Alternate Member.
3:00pm (EST) Sept 15 B
Patient Heterogeneity and Defining the Optimal Dose: Introduction
Moderator: Richard Schilsky, University of Chicago
Lecture: Patient Heterogeneity and Defining the Optimal Dose
Speaker: Peter H. O’Donnell, Associate Professor of Medicine, University of Chicago
3:30pm (EST) Sept 15 B
4:00pm (EST) Sept 15 B
4:30pm (EST) Sept 15 B
Moderator: Richard Schilsky
Speakers: Peter H. O’Donnell, Elizabeth Garrett-Mayer, Lori Minasian
Invited Discussant: Larissa Higgins, HPRA
Friday, September 16th
In Depth Discussion Groups in Global Drug Development
8:45am (EST) Sept 16
Moderator: Terrell Baptiste, Associate Director, Regulatory Policy and Intelligence, Gilead Sciences
9:00am (EST) Sept 16
Keynote Address
Keynote Address: Accelerating Innovation to Transform Cancer Care
Introduction: Martin Stockler, Professor of Oncology and Clinical Epidemiology, University of Sydney, Oncology Director at the NHMRC Clinical Trials Centre
Keynote Speaker: Susan Galbraith, Executive Vice-President, Oncology Research & Development, AstraZeneca
Session 1 Tack A Sept. 16th
9:30am (EST) Sept 16 A
Co-Moderators: Axel Glasmacher, Professor of Medicine, University of Bonn, CDDF | Jacques Mascaro, Senior Vice President, Global Head of Oncology Regulatory Science & Strategy AstraZeneca
9:35am (EST) Sept 16 A
Speaker: Mark Stewart, Vice President Science Policy, Friends of Cancer Research (FOCR)
9:50am (EST) Sept 16 A
Speaker: Aadel Chaudhuri, Assistant Professor, Washington University, St. Louis MO
10:05am (EST) Sept 16 A
Speaker: Megan Hall, Vice President, Medical Affairs, Grail
10:20am (EST) Sept 16 A
Speaker: Carla Herberts, European Medicines Agency (EMA)
10:35am (EST) Sept 16 A
Q and A, Discussion
Moderators: Axel Glasmacher and Jacques Mascaro
Speakers: Megan Hall, Carla Herberts
Invited Discussant: Scott Patterson, Gilead Sciences
Session 2 Tack A Sept. 16th
11:00am (EST) Sept 16 A
Co-Moderators: Richard Schilsky, University of Chicago | Carl Barrett, Vice-President of Translational Science in the Oncology Innovative Medicines Division, AstraZeneca
11:05am (EST) Sept 16 A
11:20am (EST) Sept 16 A
11:35am (EST) Sept 16 A
11:50am (EST) Sept 16 A
Innovative Diagnostics
Speaker: Matthew Ellis, Senior Vice President, Early Oncology, Oncology Research & Development, AstraZeneca
12:05pm (EST) Sept 16 A
Q and A, Discussion
Moderators: Richard Schilsky and Carl Barrett
Speakers: Jochen Lennerz, Joseph Oakley, Amanda Paulovich, Matthew Ellis
Session 1 Track B Sept. 16th
9:30am (EST) Sept 16 B
Co-Moderators: Martin Stockler, Professor of Oncology and Clinical Epidemiology, University of Sydney, Oncology Director at the NHMRC Clinical Trials Center | Patty Spears, Patient Advocate, University of North Carolina
9:32am (EST) Sept 16 B
Speaker: Patricia Keegan, Chief Medical Officer, TopAlliance
9:45am (EST) Sept 16 B
Speaker: Janet Dancey, Director, Canadian Cancer Trials Group
10:00am (EST) Sept 16 B
Speaker: Ke Liu, Chief Development Officer, Marengo Therapeutics
10:15am (EST) Sept 16 B
Patient Advocate Perspective
Speakers: Judy Needham, Patient Advocate | Renate Haidinger, Patient Advocate | Leslie Gilham, Patient Advocate | Eva Schumacher, Patient Advocate
10:30am (EST) Sept 16 B
Q and A, Discussion
Moderators: Martin Stockler and Patty Spears
Speakers: Patricia Keegan, Janet Dancey, Ke Liu, Vernal Branch
Session 2 Tack B Sept. 16th
11:00am (EST) Sept 16 B
Digital Patient Solutions: A Strategy for Decentralized Care
Moderator: Alicyn Campbell, Head of Digital Health Across Oncology R&D, AstraZeneca
11:15am (EST) Sept 16 B
Digital Patient Solutions A Strategy for Decentralized Care
Speaker: Sean Connolly, Senior Vice President & General Manager, Life Sciences Solutions Medable
11:30am (EST) Sept 16 B
Speakers: Adam Dicker, Professor and Chairman, Department of Radiation Oncology, Sidney Kimmel Medical College at Thomas Jefferson University
11:45am (EST) Sept 16 B
Speakers: Matt Bryant, Head of Technology & Innovation, Founder/Co-lead Design Studio at Gilead Sciences
12:00pm (EST) Sept 16 B
Q and A, Discussion
Moderator: Alicyn Campbell
Speakers: Sean Connolly, Adam Dicker, Matt Bryant
Invited DiscussantS: Andrea Ferris, CEO and Founder, Lungevity | Elisabeth Piault-Louis, AstraZeneca
BREAK
12:30pm (EST) Sept 16
Track A Sept. 16th
1:00pm (EST) Sept 16 A
Moderators: Sarah Oliver, Executive Director – Global Regulatory Oncology Head- Gilead Sciences
1:10pm (EST) Sept 16 A
Speaker: Julia Maues, Patient Centered Dosing Initiative
1:20pm (EST) Sept 16 A
Industry Perspective
Speaker: Divya Samieni, Senior Scientist, Genentech
1:30pm (EST) Sept 16 A
Moderator: Sarah Oliver
Speakers: Julia Maues, Divya Samieni
Invited Discussants: Jian Wang, AstraZeneca | Gary Wilkinson, Bayer
1:50pm (EST) Sept 16 A
Moderator: Donald Harvey, Professor Hematology and Medical Oncology, Pharmacology and Chemical Biology, Emory University
1:55pm (EST) Sept 16 A
Thereapeutic Drug Monitoring and Dose Optimization
Speaker: Jan Beumer, Professor of Pharmaceutical Sciences, University of Pittsburgh
2:15pm (EST) Sept 16 A
Academic Perspective
Speaker: Steffie Groenland, Clinical Pharmacologist, Netherlands Cancer Institute
2:35pm (EST) Sept 16 A
Q and A, Discussion
Moderator: Donald Harvey
Speakers: Jan Beumer, Steffie Groenland
Track B Sept. 16th
1:00pm (EST) Sept 16 B
Improving Global Capacity To Develop Medicines and Improve Care: Targeting Pediatric Brain Tumors
Co-Moderators: K.P. Haresh, All India Institute Of Medical Sciences, New Delhi| Jeff Buchsbaum, National Cancer Institute, National Institutes of Health
1:10pm (EST) Sept 16 B
Speaker: David Arons, Chief Executive Officer of the National Brain Tumor Society (NBTS)
1:25pm (EST) Sept 16 B
Speaker: Daniel Landi, Pediatric Neurooncologist, Duke University
1:40pm (EST) Sept 16 B
Speaker: Chitkala Kalidas, Global Head, Oncology & In Vitro Diagnostics Regulatory Affairs and Oncology Sustainability, Bayer
1:55pm (EST) Sept 16 B
Improving Patient Care Using Digital Twins in Neurooncology
2:10pm (EST) Sept 16 B
Q and A, Discussion
Moderators: K.P. Haresh and Jeff Buchsbaum
Speakers: David Arons, Daniel Landi, Chitkala Kalidas, Kenneth Buetow
Invited Discussant: H. Kim Lyerly
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