Event Schedule

Welcome from CCC President

Barry Stein (CCC)

8:30 - 8:35

Opening & Conference Objectives

Anne Marie Wright (Elements Strategy Inc)

8:35 - 8:40

KEYNOTE

International Regulatory Collaboration in the Era of Precision Medicine

8:45 - 9:45
International Regulatory Collaboration
Dr. Steven Lemery (FDA)
Health Canada's Experience with Project Orbis
Melissa Hunt (Health Canada)
Followed by Panel Discussion –
Designing Clinical Trials of the Future
Project Orbis - A New Way Forward
Dr. Steven Lemery (FDA)
Melissa Hunt (Health Canada)
Barry Stein (CCC) - Discussant
Anne Marie Wright (ESI) - Conference Facilitator

Envisioning the Future of Cancer Clinical Trials

Rethinking Clinical Trials for the Next Generation of Cancer Drugs –
The World of Precision Medicine

9:45 - 10:45
Rethinking Clinical Trials in the Era of Precision Medicine
Dr. Lillian Siu (UHN)
TBC
Dr. Josep Tabernero (VHIO)
Followed by Panel Discussion –
Designing Clinical Trials
in the Era of Personalized Medicine
Dr. Lillian Siu (UHN)
Dr. Josep Tabernero (VHIO)
Dr. Winson Cheung (U of Calgary) - Discussant
Anne Marie Wright (ESI) - Conference Facilitator

Frameworks for RWE and Recommendations
for Real World Endpoints

10:55 - 11:55
Opportunities to Support Advancements in Care for Patients with Cancer
Dr. Margaret McCusker (Flatiron)
Impacting Patients with Innovative Data Products
Dr. James Creeden (Foundation Medicine)
Followed by Panel Discussion -
Combining Data to Advance Personalized Healthcare
Dr. James Creeden (Foundation Medicine)
Dr. Margaret McCusker (Flatiron)
Dr. Michael Duong (Roche) - Discussant
Anne Marie Wright (ESI) -Conference Facilitator

Digital Health Technology in Modernizing Clinical Trials

11:55 - 1:15
Artificial Intelligence: Turning Data into Knowledge
Dr. Kam Kafi (Imagia AI)
Novel Approaches to Precision Medicine - Data Collection in the Wild
Dr. Mackenzie Wildman (Evidation Health)
Pentavere
Aaron Leibtag (Pentavere AI)
Followed by Panel Discussion –
The Use of AI in Clinical Trial Data and RWE
Building data to benefit patient and
support regulatory decisions.
Dr. Kam Kafi (Imagia AI)
Dr. Mackenzie Wildman (Evidation Health)
Aaron Leibtag (Pentavere AI)
Stephen Sundquist (3CTN) - Co-Discussant
Barry Stein (CCC) - Co-Discussant
Anne Marie Wright (ESI) -Conference Facilitator

Lunch and Poster and Video Session

1:15 to 1:45

Clinical Trial Considerations and using RWD/RWE

To Help Inform Value-Based Agreements

1:45 - 3:05
Advancing RWE Use in Support of Precision Medicines
Murray Aitken (IQVIA)
Using RWE to Inform Value-Based Agreements: European Experience & Opportunities for Canada
Dr. Michael Seewald (AstraZeneca)
Value by Design: The Potential of RWE in Sustainable Patient Access
Dr. Christopher McCabe (Institute of Health Economics)
Followed by Panel Discussion –
Value Based Agreements and RWE Frameworks
Murray Aitken (IQVIA)
Dr. Michael Seewald (AstraZeneca)
Dr. Christopher McCabe (Institute of Health Economics)
Leigh Funston (AstraZeneca) - Discussant
Anne Marie Wright (ESI) - Conference Facilitator

The CTTI Model

The Canadian Cancer Clinical Trials Stakeholder Charter

3:05 - 4:20
Patient Group Pathway Model to Accessing Cancer Clinical Trials
Stephen Sundquist (3CTN)
Judy Needham (Canadian Cancer Trials Group)
Followed by Panel Discussion -
Implementation and Adoption of the Charter
Stephen Sundquist (3CTN)
Judy Needham (Canadian Cancer Trials Group)
Vatche Bartekian (Vantage Biotrials)
Martine Elias (Myeloma Canada
Dr. Stephanie Michaud (BioCanRx) - Discussant
Anne Marie Wright (ESI) - Conference Facilitator

Closing Remarks and Meeting Summary Wrap-up

Barry Stein and Anne Marie Wright

4:20