CureSearch Pediatric Early Development Symposium 

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2024 PEDS


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

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Uniting stakeholders to drive real change in pediatric cancer drug development

PEDS brings together key experts and stakeholders in the field of pediatric cancer drug development to address timely challenges and emerging opportunities in the field, facilitating critical conversations that propel new treatments towards regulatory approval and commercialization. 2024 PEDS will unite experts in entrepreneurship, regulatory navigation, investment strategies, academic research, and collaborative partnerships to discuss challenges and opportunities within the field. 

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

This year's can't-miss topic will explore how the regulatory landscape in pediatric cancer is rapidly evolving, and how this change presents significant challenges in translating novel discoveries from the lab into commercially available treatments for children with cancer. With obstacles encompassing the regulatory approval process, lack of funding, and the difficulty of conducting pediatric clinical trials, the journey to bring pediatric oncology drugs to market remains exceedingly complex and new business models are emerging. Stakeholders will identify essential strategies - such as utilizing innovative funding models and fostering collaborative partnerships that harness global expertise - to expedite the process of bringing transformative therapies to pediatric cancer patients.

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


PEDS Featured Speaker Sam Blackman
PEDS Featured Speaker Catherine Bollard
PEDS Featured Speaker Crystal Mackall
PEDS Featured Speaker James Olson


 PEDS Day 1 | Wednesday, Oct. 9th


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


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


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, Oct. 10th


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


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


Event concludes by 3:15 PM EST

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

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