Overview of Mouse Models for Drug Development
Nikhil Joshi, PhD – Yale School of Medicine

State-of-the-Art Multicellular Models
Russell Jenkins, MD, PhD – Massachusetts General Hospital

Toxicology Models
Lois Lehman-McKeeman, PhD – BMS

FDA Perspectives on Preclinical Models
Tiffany Ricks, PhD – FDA

Break
10:55–11:10 a.m.

Session II: IO Clinical Protocol Development
11:10 a.m.–12:40 p.m.
Moderator: Jon Wigginton, MD – Bright Peak Therapeutics

Early-stage IO Drug Development
Jon Wigginton, MD – Bright Peak Therapeutics

Lessons Learned in Development of CD-3-based Bispecifics
Stan Frankel, MD – Vagelos College of Physicians and Surgeons

Late-stage IO Drug Development (Cell Therapy)
Kristen Hege, MD

Lunch
12:40–1:40 p.m.

Session III: Clinical Trial Design and Terminology, Endpoints, Etc.
1:40–3:20 p.m.
Moderator: Amy McKee, MD – AstraZeneca

Dose Finding in Early Phase Oncology : Getting it right at the start
Dinesh de Alwis, PhD – Generate Biomedicines

Evolving Approach to Endpoints in CAR T Studies
Lynn Navale, MS – Allogene

Novel biomarkers to drive developmental and regulatory drug development
Amy McKee, MD – AstraZeneca

Panel Discussion
Dinesh de Alwis, PhD – Generate Biomedicine
Lynn Navale, MS – Allogene
Amy McKee, MD – AstraZeneca
Lola Fashoyin-Aje, MD, MPH – FDA

Break
3:15–3:30 p.m.

Session IV: FDA Initiatives
3:30–5 p.m.
Moderator: Amy McKee, MD – AstraZeneca

Project Optimus
Nicole Gormley, MD – FDA

Accelerated Approval
Nicole Verdun, MD – FDA, Center for Biologics Evaluation and Research

FrontRunner
Laleh Amiri-Kordestani, MD – FDA

Panel Discussion
Laleh Amiri-Kordestani, MD – FDA
David Feltquate, MD, PhD – iTeos Therapeutics
Nicole Gormley, MD – FDA
Nicole Verdun, MD – FDA, Center for Biologics Evaluation and Research
Bill Grossman, MD, PhD – Gilead Sciences

Networking Reception
5:15–6:45 p.m.

Investor Perspective
Jakob Dupont, MD – Sofinnova Investments

Panel Discussion
Christiana Bardon, MD, MBA – MPM BioImpact 
Jason Ruth, PhD – MRL Ventures 
Daina Graybosch, PhD – Leerink Partners
Jakob Dupont, MD – Sofinnova Investments
Asish Xavier, PhD, MBA – Johnson & Johnson Innovation - JJDC

Break
9:35–9:55 a.m.

Session VI: Chimeric Antigen Receptors
9:55–11:35 a.m.
Moderator: Pedro Romero, MD – Novigenix

Where We've Been and Where We're Going
Marcela Maus, MD, PhD – Massachusetts General Hospital

In Vivo Methods of Delivery
Chris Ramsborg – Flagship Pioneering

Acute and Long-Term Neurological Safety
Denis Migliorini, MD – University of Geneva, Switzerland

Panel Discussion
Marcela Maus, MD, PhD – Massachusetts General Hospital
Chris Ramsborg – Flagship Pioneering
Denis Migliorini, MD – University of Geneva, Switzerland

Lunch
11:35–12:35 p.m.

Session VII: Artificial Intelligence
12:35–2:15 p.m.
Moderator: Alexandra Synder, MD – Generate Biomedicines

Target Discovery
Philip Tagari (CSO) – insitro

Creating Drugs (Large Molecules)
Heather Van Epps, PhD – Generate Biomedicines

Creating Drugs (Small Molecules)
Guido Lanza – Valo Health

Clinical Trial Execution

Zhiyong Lu, PhD – National Center for Biotechnology Information

Break
2:15–2:30 p.m.

Session VIII: Immune Cell Engagers
2:30–4:40 p.m.
Moderator: Pedro Romero, MD – Novigenix

T cell Engagers for Liquid Tumors
Patrick Baeuerle, PhD – Cullinan Therapeutics, Inc.

Different Approaches to Engage T Cells for Solid Tumors
Lawrence Fong, MD – Fred Hutchinson Cancer Center/UCSF

Lessons Guiding Future and Next Gen T Cell Engagers for Solid Tumors
Danielle Townsley, MD, MSc – Amgen

Panel Discussion
Moderator: Jessica Kirshner, PhD – Regeneron Pharmaceuticals 
Patrick Baeuerle, PhD – Cullinan Therapeutics, Inc.

Lawrence Fong, MD – Fred Hutchinson Cancer Center/UCSF
Danielle Townsley, MD, MSc – Amgen

Closing Remarks