Thursday, October 1, 2020

Welcome by Symposium Co-Chairs

Samuel C. Blackman, MD, PhD, Chief Medical Officer & Co-Founder, Day One Biopharmaceuticals

Brenda Weigel, MD, Director of the Division of Pediatric Hematology/Oncology, University of Minnesota's Masonic Cancer Center

Clinical Development Considerations: Lessons Learned from PIPs and PSPs

Session Chair: Jeffrey Skolnik, MD, Vice President, Clinical Development, Inovio Pharmaceuticals, Inc

Advancing promising agenda into the clinic: What is an "acceptable" preclinical data package? 

Session Chair: Lou Stancato, PhD, Research Fellow, Pediatric Capabilites, Eli Lilly and Company

Lunch: CureSearch State of the Union

Kay Koehler, Chief Executive Officer, CureSearch

Tastes Great, Less Filling: Formulation Consideration for Pediatrics

Session Chair: Don Corson, PhD, DTC Consulting

To COG And Beyond: Evolution of Cooperative and Collaborative Groups

Session Chair: To Be Determined

 

Friday, October 2, 2020

Networking Sessions

Book direct 1:1 meetings with others, join conversations in virtual lounges, and/or hold group video calls

Global P(a)ediatric Development: How to Engage Internally and Enable External Alignment

Session Chair: Davy Chiodin, PharmD, Senior Vice President of Product Development, Day One Biopharmaceuticals

Where The Rubber Meets The Road: Nuts And Bolts Of Writing and Negotiating Successful PIPs and PSPs

Session Chair: Anne Borgman, MD, Vice President & Head of Hematology-Oncology Clinical Development, Jazz Pharmaceuticals

Lunch Plenary: Things We Love and Things We Hate - Regulators Dish on PIP/PSPs

Session Speakers: Greg Reaman, FDA

PIP/PSP Development and Implementation: Encompasses Coordinating With Cooperative Groups; Working With CROs; Syncing US/EU.

Session Chair: Mark Kieran, MD, PhD, Senior Director, Global Drug Development, Pediatric Oncology, Bristol-Myers Squibb

Closing Remarks