2022 AAADV WORKSHOP SCHEDULE & AGENDA

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Wednesday, September 14

Pre-Workshop: Fundamentals of Global Cancer Drug Development

8:45am (EST) Sept 14

Welcome and Introduction

Keynote Address

9:00am (EST) Sept 14

9:45am (EST) Sept 14

Q and A, Discussion

Session 1: Global Clinical Research Methods

10:00am (EST) Sept 14

Global Clinical Research Methods: Scientific Issue
Martin Stockler, Professor of Oncology and Clinical Epidemiology, University of Sydney, Oncology Director at the NHMRC Clinical Trials Center.

10:20am (EST) Sept 14

Global Clinical Research Methods: Regulatory Issues

Speaker: Chitkala Kalidas, Global Head, Oncology & In Vitro Diagnostics Regulatory Affairs and Oncology Sustainability, Bayer

10:40am (EST) Sept 14

Global Clinical Research Methods: Translational Research Issues
Speaker: Jian Wang, Head of Translational, Oncology Regulatory Science, Strategy & Excellence, AstraZeneca

11:00am (EST) Sept 14

Andrew J Martin

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

Global Clinical Research Methods: Trial Group Capability

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

Moderator: Martin Stockler Speakers: Chitkala KalidasJian Wang, Andrew Martin, Lesley Seymour

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

Speaker: Vassilis Golfinopoulos, European Organization for Research and Treatment of Cancer (EORTC) Headquarters Director

1:25pm (EST) Sept 14

Data Supporting Regulatory Action from Academic Trials: An Academic Perspective

Speaker: Martin Stockler, Professor of Oncology and Clinical Epidemiology, University of Sydney, Oncology Director at the NHMRC Clinical Trials Center.

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

Speaker: Lesley Seymour, Professor and Medical Oncologist Queens University, Canadian Cancer Trials Group Deputy Director, and IND Program Director

2:25pm (EST) Sept 14

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

NCI’s NExT Program: Supporting the next generation of global cancer therapeutics

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

The AAADV-ASCO-CDDF Global Cancer Drug Development Workshop

8:45am (EST) Sept 15

Welcome and Introduction

Moderator: Julie Gralow, Chief Medical Officer, American Society of Clinical Oncology (ASCO)

Keynote Address

9:00am (EST) Sept 15

Richard Sullivan
Keynote Address: Global Cancer Drug Development: Opportunities and Value to Society

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

Speaker: Sir Richard Peto, Emeritus Professor of Medical Statistics and Epidemiology at the University of Oxford

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

Global Access to Cancer Therapies Post-Approval

Speaker: Cary Adams, Chief Executive Officer, Union for International Cancer Control (UICC)

11:05am (EST) Sept 15

Q and A, Discussion

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

Current Models of MRCT- PedAL
Speaker: Gwen Nichols, Chief Medical Officer, Leukemia and Lymphoma Society (LLS)

1:45pm (EST) Sept 15 A

Industry Challenges of MRCT
SpeakerAndrew Lee, Senior Vice President, Head of Global Clinical Trial Operations at Merck

2:15pm (EST) Sept 15 A

Patricia Keegan

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

Andrew Lee
Patricia Keegan
Q and A, Discussion

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

Challenges and Opportunities for Dose Optimization in Oncology: Introduction

1:00pm (EST) Sept 15 B

Challenges and Opportunities for Dose Optimization in Oncology: Introduction

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

Designing More Efficient First in Human Dose-Finding Studies
Speaker: Lillian Siu, Director of the Phase I Program and Co-Director of the Bras and Family Drug Development Program at Princess Margaret Cancer Centre, BMO Chair in Precision Genomics, University of Toronto

2:00pm (EST) Sept 15 B

Endpoints to Define the Optimal Dose and How to Measure Them

Speaker: Julie Bullock, Senior Vice President and Global Head of Clinical Pharmacology & Translational Medicine, Certara

2:30pm (EST) Sept 15 B

Lillian Siu
Julie Bullock

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

Peter H. O’Donnell

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

Randomized Dose Finding Studies
Speaker: Elizabeth Garrett-Mayer, Vice President Center for Research and Analytics (CENTRA), American Society of Clinical Oncology (ASCO)

4:00pm (EST) Sept 15 B

Lori Minasian
Patient Reported Outcomes to Define Tolerance vs Toxicity and Impact on Adherence
Speaker: Lori Minasian, Deputy Director Division of Cancer Prevention US National Cancer Institute National Institutes of Health

4:30pm (EST) Sept 15 B

Peter H. O’Donnell
Lori Minasian
Panel Discussion: Patient Heterogeneity and Defining the Optimal Dose

Moderator: Richard Schilsky

Speakers: Peter H. O’Donnell, Elizabeth Garrett-Mayer, Lori Minasian

Invited Discussant: Larissa Higgins, HPRA

In Depth Discussion Groups in Global Drug Development

8:45am (EST) Sept 16

Terrell Baptiste
Welcome and Introduction

ModeratorTerrell 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

ctDNA for Cancer Detection, Prognostication and Monitoring Efficacy: Introduction

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

Mark Stewart
Patient Advocate Perspective

Speaker: Mark Stewart, Vice President Science Policy, Friends of Cancer Research (FOCR)

9:50am (EST) Sept 16 A

Chaudhuri Aadel
Academic Perspective

Speaker: Aadel Chaudhuri, Assistant Professor, Washington University, St. Louis MO

10:05am (EST) Sept 16 A

Megan Hall
Industry Perspective

Speaker: Megan Hall, Vice President, Medical Affairs, Grail

10:20am (EST) Sept 16 A

Carla Herberts
Regulatory Perspective

Speaker: Carla Herberts, European Medicines Agency (EMA)

10:35am (EST) Sept 16 A

Mark Stewart
Megan Hall
Carla Herberts

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

Innovative Diagnostics Use of Computational Pathology and Proteomics for Target Quantification: Potential to Inform Decision Making in Precision Oncology

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

Jochen Lennerz
Digital/Computational Pathology- Academic Perspective
Speaker: Jochen Lennerz, Associate Professor of Pathology, Harvard Medical School, Medical Director, Center for Integrated Diagnostics, Massachusetts General Hospital

11:20am (EST) Sept 16 A

Digital/Computational Pathology- Industry Perspective
Speaker: Joseph Oakley, Medical Director for Biomarker Development, Paige

11:35am (EST) Sept 16 A

amanda paulovich
Proteomics- Academic Perspective
Speaker: Amanda Paulovich, Professor and Aven Foundation Endowed Chair, Director, CLIA Targeted Proteomic Laboratory, Clinical Research Division, Fred Hutchinson Cancer Center

11:50am (EST) Sept 16 A

Innovative Diagnostics

SpeakerMatthew Ellis, Senior Vice President, Early Oncology, Oncology Research & Development, AstraZeneca

12:05pm (EST) Sept 16 A

Session 1 Track B Sept. 16th

9:30am (EST) Sept 16 B

Adapting to the New Normal:: Introduction

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

Differing Priorities/objectives and EDI in (Global/MR) Clinical Trials

Speaker: Patricia Keegan, Chief Medical Officer, TopAlliance

9:45am (EST) Sept 16 B

Principles of Considering EDI in (Global) Cancer Trials

Speaker: Janet Dancey, Director, Canadian Cancer Trials Group

10:00am (EST) Sept 16 B

Autologous Cellular Therapies and Regulatory Issues

Speaker: Ke Liu, Chief Development Officer, Marengo Therapeutics

10:15am (EST) Sept 16 B

Judy Needham
Renate Haidinger
Leslie Gilham

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

Patty Spears
Patricia Keegan
Vernal Branch

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

Adam Dicker
Academic Perspective

Speakers: Adam Dicker, Professor and Chairman, Department of Radiation Oncology, Sidney Kimmel Medical College at Thomas Jefferson University

11:45am (EST) Sept 16 B

Matt Bryant
Industry Perspective

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

Dose Optimization to Improve Risk/Benefit Profiles | Therapeutic Drug Monitoring: Introduction

Moderators: Sarah Oliver, Executive Director – Global Regulatory Oncology Head- Gilead Sciences

1:10pm (EST) Sept 16 A

Julia Maues
Patient Advocacy Perspective

Speaker: Julia Maues, Patient Centered Dosing Initiative

1:20pm (EST) Sept 16 A

Divya Samieni

Industry Perspective

Speaker: Divya Samieni, Senior Scientist, Genentech

1:30pm (EST) Sept 16 A

Sarah Oliver
Divya Samieni
Q and A, Discussion Dose Optimization to Improve Risk/Benefit Profiles

Moderator: Sarah Oliver

Speakers: Julia Maues, Divya Samieni

Invited Discussants: Jian Wang, AstraZeneca | Gary Wilkinson, Bayer

1:50pm (EST) Sept 16 A

Therapeutic Drug Monitoring

Moderator: Donald Harvey, Professor Hematology and Medical Oncology, Pharmacology and Chemical Biology, Emory University

1:55pm (EST) Sept 16 A

Jan Beumer

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

K.P. Haresh

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

Patient Advocacy Perspective

Speaker: David Arons, Chief Executive Officer of the National Brain Tumor Society (NBTS)

1:25pm (EST) Sept 16 B

Daniel Landi
Academic Perspective

Speaker: Daniel Landi, Pediatric Neurooncologist, Duke University

1:40pm (EST) Sept 16 B

Industry Perspective

Speaker: Chitkala Kalidas, Global Head, Oncology & In Vitro Diagnostics Regulatory Affairs and Oncology Sustainability, Bayer

1:55pm (EST) Sept 16 B

Kenneth Buetow

Improving Patient Care Using Digital Twins in Neurooncology

Speaker: Kenneth Buetow, Professor, Arizona State University, Director, Computational Sciences and Informatics, Center for Evolution and Medicine, Bioinformatics and Data Management for the National Biomarker Development Alliance.

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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