CureSearch Pediatric Early Development Symposium (PEDS)

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JOIN US FOR

2024 PEDS

A VIRTUAL CONFERENCE | OCT. 9-10, 2024

Reality Check: Entrepreneurship and Regulatory Navigation in Pediatric Cancer Drug Development

CureSearch_PEDS logo- black subtext-03

PEDS Co-Chairs

Brenda Weigel

Brenda Weigel, MD

Director, Division of Pediatric Hematology/Oncology
University of Minnesota’s Masonic Cancer Center

CureSearch Scientific Advisory Council Chair

Jeffrey Skolnik

Jeffrey Skolnik, MD

Vice President, Clinical Development
Inovio Pharmaceuticals Inc.

CureSearch Industry Advisory Council Chair

WHAT ARE PEOPLE SAYING ABOUT PEDS?

“This was truly a one-of-a-kind effort that's invaluable to our community!”

“The pediatric oncology community (academia, industry, regulatory, advocacy) is made up of a very special set of dedicated experts working diligently to improve pediatric drug development.”

“There are many people working very hard to figure out how to advance drugs for children. On the other hand, companies aren't really geared up for the process yet.”

“Collaboration/partnership/Communication. The sessions reinforced the importance of these concepts across all of Peds Oncology development. The better and more efficient that industry, regulators and academia can be at working together, the faster that new and better drugs will become available for pediatric cancer patients.”

"There are lots of moving parts to PIPs/PSPs but with the right knowledge and support, that can be done in a way that supports drug development in pediatric oncology."

“I really wanted to thank the organizers for allowing for enough time for substantive discussions. The Q&A sessions were brilliant.”

FULL AGENDA

Subject to change*

 PEDS Day 1 | Wednesday, October 9th, 2024

OPENING REMARKS

Event begins at 10:00 AM EST

Led by: Kay Koehler, CEO and PEDS Co-Chairs, Brenda Weigel, MD and Jeffrey Skolnik, MD

SESSION 1: Charting the Regulatory Landscape in Pediatric Cancer Drug Development

Experts will present and discuss key topics such as Priority Review Vouchers, the Creating Hope Act reauthorization, Accelerated Approval, Project Optimus, and Real-World Evidence.

Session begins at 10:30 AM EST

Session Chair:

Elizabeth Fox, MD, St. Jude Children’s Hospital

Featured Speakers:

Nicole Drezner, MD, Food and Drug Administration

Kimberly Lindstrom, PhD, Day One Biopharmaceuticals

Sean Khozin, MD, MPH, CEO Roundtable on Cancer (CEORT), Project Data Sphere (PDS), Phyusion

BREAK FOR LUNCH

12:30 to 1:15 PM EST

SESSION 2: “If You Build It, Will They Come?” How Can We Build the Case for Investing in Pediatric Cancer Drug Development?

A dynamic panel discussion exploring the evolving biotech investment landscape, the impact of the Inflation Reduction Act on rare disease and pediatric oncology investments, and future outlooks for fostering investment in pediatric cancer drug development.

Session begins at 1:15 PM EST

Session Chair:

Sam Blackman, MD, PhD, Day One Biopharmaceuticals

DAY 1 CLOSING REMARKS

3:15 to 3:30 PM EST
Led by Co-Chairs: Brenda Weigel, MD and Jeffrey Skolnik, MD

Day 1 concludes by 3:30 PM EST

Led by: Co-Chairs, Brenda Weigel, MD and Jeffrey Skolnik, MD

PEDS Day 2 | Thursday, October 10th, 2024

OPENING REMARKS

Day 2 begins at 10:00 AM EST

Led by: Co-Chairs, Brenda Weigel, MD and Jeffrey Skolnik, MD

SESSION 3: From Bench to Boardroom: The Journey of Academic Innovators in Pediatric Cancer Drug Development

Academic researchers who have successfully launched spin-off companies will share valuable lessons, successes, challenges, and new strategies for future innovation.

Session begins at 10:15 AM EST

Session Chair:

David Largaespada, PhD, Masonic Cancer Center, University of Minnesota

Featured Speakers:

Crystal Mackall, MD, Stanford University School of Medicine

Catherine Bollard, MD, Children’s National Hospital, George Washington University

Jim Olson, MD, PhD, Seattle Children’s Hospital, Fred Hutchinson Cancer Center, University of Washington

BREAK FOR LUNCH

12:30 to 1:00 PM EST

SESSION 4: Partnering for Progress: Strategies for Engaging Investors in Pediatric Cancer Public-Private Partnerships

A panel discussion focused on enhancing community support and investor engagement in major pediatric cancer trial initiatives, featuring insights from national and international leaders.

Session begins at 1:00 PM EST

Session Chair:

Peter Adamson, MD, Sanofi

Featured Speakers:

Stacey Adam, PhD, Foundation for the NIH

Andy Kolb, MD, Leukemia & Lymphoma Society

Kirk Tanner, PhD, National Brain Tumor Society

Douglas Hawkins, MD, Seattle Children’s Hospital, Children's Oncology Group

Tommy Rennison, PhD, Cancer Research Horizons

Pamela Kearns, MD, University of Birmingham

CLOSING REMARKS

Event concludes by 3:15 PM EST

Led by: Co-Chairs, Brenda Weigel, MD and Jeffrey Skolnik, MD

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