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