The RACE for Children Act: Early Global Impact and Ensuring Success with Pediatric Champions

Life Sciences, Clinical Trials, Pharmaceutical Regulation, Drug Discovery & Development,
  • Thursday, December 17, 2020

After three years of hard work by multiple diverse stakeholders and with much anticipation, the RACE for Children Act became effective August 18th, 2020. This landmark legislation aims to dramatically shift the global landscape of clinical research in pediatric oncology and intends to bring new molecularly targeted cancer therapeutics to children, who have not been as greatly impacted by precision medicine over the past few decades compared to adults. Whether the RACE for Children Act leads to the development of more drugs for children with cancer in the USA and globally remains to be seen. What can we learn about the global impact of the RACE for Children Act in the first few months since its implementation? What is needed to ensure its ongoing success?

Regulators, researchers, industry and patient advocates have come together to focus on not only curing childhood cancer but reducing long term side effects. Please join us in hearing from them on what the early global impact of the RACE for Children Act looks like, and what is needed to ensure its success, including the critical function of pediatric champions.

Speakers

http://Dr.%20Gregory%20Reaman,%20U.S.%20Food%20and%20Drug%20Administration,%20Silver%20Spring,%20MD,%20USA

Dr. Gregory Reaman, Associate Director for Pediatric Oncology, Oncology Center of Excellence, Office of the Commissioner / Associate Director for Pediatric Oncology, Office of Oncologic Diseases, Office of New Drugs, Center for Drug Evaluation and Research at U.S. Food and Drug Administration, Silver Spring, MD, USA

Dr. Gregory Reaman is the Associate Director for Pediatric Oncology in the FDA’s Oncology Center of Excellence, Office of the Commissioner and Associate Director for Pediatric Oncology in the Office of Oncologic Diseases, Center for Drug Evaluation and Research. He is the Executive Director emeritus of the Center for Cancer and Blood Disorders and senior attending physician at Children’s National, Washington, D.C. He has held numerous leadership positions in clinical trial groups and professional organizations. He was the Inaugural Chair of the Children’s Oncology Group and previously served as the Associate Chair for New Agent Studies and Vice Chair for Scientific Affairs of the Children’s Cancer Group. He served on the national Board of Directors of the American Cancer Society and chaired its Task Force on Cancer in Children and on the Board of Directors of the American Society of Clinical Oncology and is currently a member of the Board of Directors of the International Society of Pediatric Oncology. He was the first pediatrician member of the FDA’s Oncologic Drugs Advisory Committee and the first chair of its Pediatric Subcommittee. He is a professor emeritus of pediatrics at the George Washington University School of Medicine and Health Sciences. His research interests are in the immunobiology and therapy of acute leukemia and the development of new cancer therapeutics for children. He has authored more than 350 peer-reviewed publications.

Message Presenter
http://Prof.%20Gilles%20Vassal,%20Gustave%20Roussy/Université%20Paris-Saclay,%20Villejuif,%20France

Prof. Gilles Vassal, Head of Pediatric Research Program at Gustave Roussy/Université Paris-Saclay, President ITCC, Chair of ACCELERATE, Villejuif, France

Prof. Gilles Vassal is trained as a paediatric oncologist. He got his PhD in pharmacology. He is Professor of Oncology in University Paris-Saclay and Head of Pediatric Research Program at Gustave Roussy, a large comprehensive cancer center in France. For the last 20 years, he has dedicated his research, clinical and training activities to the development of new drugs for children and adolescents with cancer and precision pediatric oncology. He is past President of SIOPE, the European Society of Paediatric Oncology (https://www.siope.eu) and currently President of the EU academic Consortium for Innovative Therapies for Children with Cancer (http://www.itcc-consortium.org). He is chairing the ACCELERATE international mutlistakeholder platform (www.accelerate-platform.eu) to speed up innovation in paediatric oncology. As a SIOPE representative, he is co-leading workpackage 4 of the IMI2 Conect4Children network (https://conect4children.org/) and coordinates the development of Multistakehoder meetings to best address unmet pediatric needs. Author of more than 250 publications in peer-reviewed journals, he is member of several scientific councils.

Message Presenter

Dr. Anjali Sharma, Pediatric Oncology Development Lead and Early Oncology Development lead, Amgen, Malibu, California, USA

Dr. Anjali Sharma received her medical degree from Lady Hardinge Medical College, New Delhi, India and completed her pediatric internship and residency at University of Illinois, Chicago. She completed her fellowship in adult bone marrow and stem cell transplantation as well as pediatric hematology and oncology at Stanford University, CA. Dr. Sharma became an Attending Physician in 2006 where her research and clinical focus had been on pediatric oncology/solid tumors as well as bleeding disorders. In 2015 she joined Amgen Medical Affairs and in 2017 transitioned to Global Development as a Clinical Research Medical Director where she has been involved in pediatric filing as well as medical monitoring for several late stage studies. In 2019 Dr. Sharma assumed the role of Pediatric Oncology Development Lead for all Oncology programs in view of the impact of the RACE for Children Act and she consults on all early and late stage molecules. Dr. Sharma continues as an early Oncology development lead and currently leads two adult hematology-oncology programs. Dr. Sharma has been elected as the PhRMA rep for ACCELERATE in 2019, and is a member of CureSearch for Children’s Cancer industry advisory council.

Message Presenter
http://Dr.%20Beth%20Anne%20Baber,TigoHealth,%20San%20Diego,%20California,%20USA

Dr. Beth Anne Baber, Founder & President, TigoHealth, San Diego, California, USA

Dr. Beth Anne Baber is the founder and President of TigoHealth, an early-stage medical software company that connects patients to care, services and health data they need to manage their healthcare delivery. Empowering patients with easy access improves their outcomes and significantly reduces expenditures for their providers.

Dr. Baber worked closely with Congress on personalized medicine and pediatric medical research initiatives. In addition to generating over $60M in funding for cancers of children, adolescents and young adults in the Department of Defense, she was instrumental in establishing a $126M NIH pediatric research genomics initiative aimed at understanding the link between childhood cancers and structural birth defects. Dr. Baber received her Ph.D. from The Scripps Research Institute and continued cancer research studies at the Salk Institute. While at the Salk, she obtained an MBA from University of California – San Diego Rady School of Management.

Message Presenter

Who Should Attend?

  • Research and Development
  • Clinical Research
  • Medical Affairs
  • Scientific Affairs
  • Regulatory Affairs
  • Clinical Affairs
  • Project Management
  • Clinical Operations
  • Risk Management
  • Executives
  • Health Care Professionals
  • Patient Advocacy Groups and Their Members
  • Anyone who has an Interest in the Future of Pediatric Oncology

What You Will Learn

In this webinar, participants will learn about:

  • The impact of the RACE for Children Act since it went into effect, from a regulatory, health care professional and industry point of view, both in the USA and globally
  • What a pediatric champion is and why they are needed
  • The experience of a parent and child of a molecularly targeted therapy

Xtalks Partner

PRA Health Sciences

PRA Health Sciences delivers innovative drug development solutions that improve patients’ lives. Our people are passionate about clinical research, working tirelessly to provide quality results. We offer exceptional experience across all phases and therapeutic areas and a broad spectrum of solutions, ranging from full-service clinical development to a pioneering embedded model.

With 16,000+ employees covering 90+ countries, we bolster an impressive global presence with keen local insights. Our project teams harness their understanding of local regulations, standards of care and cultural customs to effectively align our approaches with each study’s unique goals.

At PRA, we love what do because we are making a difference in the lives of patients and their family members worldwide. Over the years, we have contributed to the development of numerous drugs now available to countless patients. From our scientific and medical experts to therapeutically aligned project managers and monitors, we provide the commitment and expertise needed for today’s complex studies.

You Must Login To Register for this Free Webinar

Already have an account? LOGIN HERE. If you don’t have an account you need to create a free account.

Create Account