How the RACE for Children Act impacts Pediatric Oncology Drug Development
Sponsored by: Covance
- Pediatric Oncology
- Drug Development
Date: 17 March
Days to go: 23
Time: 2PM London/10AM New York
Understanding current regulations and enhancing your global strategy
While several innovative oncology treatments have been approved in the last decade for adults, the dearth of clinical research in the pediatric populations often means that children and adolescents still have limited treatment options. In fact, many medications given to pediatric patients have never been formally researched in a clinical trial setting.
Over the last 20 years, legislative acts such as Best Pharmaceuticals for Children Act (BPCA) and Pediatric Research Equity Act of 2003 (PREA) have aimed to break down some of the barriers in the pediatric drug development landscape. PREA was updated with the RACE for Children Act (Research to Accelerate Cures and Equity for Children Act) and the proposed reauthorization of the Creating Hope Act and its pediatric priority review voucher program may also continue to make a difference.
Join us for an educational webinar to hear insights from thought leaders in this area, spanning expertise in rare diseases, regulatory strategy, oncology and pediatric drug development. They will discuss the current pediatric oncology drug development landscape and give an in-depth, industry-focused view of the applicable regulations.
Along with practical advice for setting up a successful pediatric oncology trial, you will learn about the RACE for Children Act, how it differs from operating under PREA and/or orphan drug exemptions and how to best navigate these regulations. The presenters will also share their industry strategies to consider when designing a global development program.
Kathleen A. Neville, MD, MS, MBA, FAAP, FCCP,
Sr. Director, Child Health Innovation Leadership Department, Johnson & Johnson
Dr. Kathleen Neville is board certified in pediatrics, pediatric hematology/oncology and clinical pharmacology. Dr. Neville earned her Doctor of Medicine at SUNY HSC-Brooklyn and she holds a Master of Science degree in Clinical Research from Indiana University and a Master’s in Business administration from the Henry W. Bloch School of Management at the University of Missouri-Kansas City in Kansas City, MO.
Dr. Neville has served as Director of Experimental Therapeutics for several Nationally known programs as well as Chief of the Section of Clinical Pharmacology and Toxicology and Co-Director of Precision Medicine at Arkansas Children’s Hospital. She has also served on the pediatric subcommittee of the FDA’s Oncologic Drugs Advisory Committee, the FDA’s Pediatric Advisory Committee and on several special emphasis committees. In addition, Dr. Neville has served as Chair for the American Academy of Pediatrics (AAP) Committee on Drugs. She served as lead author of the AAP’s policy statement on the off-label use of drugs and she has collaborated with investigators across the US and internationally for new agents in pediatric early phase trials.
In September of 2018, Dr. Neville joined Johnson and Johnson’s Child Health Innovation Leadership Department (CHILD) as Senior Director, Pediatric Drug Development. In this role, Dr. Neville provides pediatric support to products in development across business sectors. The majority of her work is focused on advancing the pediatric portfolio across Janssen, specifically within oncology.
Dr. Neville has significant clinical trials expertise (e.g., study design, execution, data analysis, holding an IND) as well as translational research experience as it relates to the use of medications in children. She is an expert in pediatric drug development with a focus on early phase trials in pediatric oncology and hematology. She has also maintained an interest in rare diseases and the treatment of pain in children.
Geoffrey S. Kannan, PhD, MD,
Medical Director, Oncology, Covance
Geoffrey Kannan, PhD, MD is a Medical Director in Oncology Clinical Drug Development Services at Covance. His clinical specialty is pediatric hematology/oncology and pediatric neuro-oncology. Dr. Kannan received his undergraduate degree in Biochemical Sciences with honors at Harvard University, where he first became interested in oncology. He completed a PhD in Cancer Biology at the University of Texas M.D. Anderson Cancer Center in Houston, TX, where his research focused on the interface between cell cycle regulation and apoptosis in Ewing’s sarcoma. After medical school and a residency in pediatrics at the University of Miami in Miami, FL, Dr. Kannan returned to the University of Texas M.D. Anderson Cancer Center for a fellowship in Pediatric Hematology/Oncology. Dr. Kannan’s research interests in fellowship included NK-cell adaptive cell therapy for medulloblastoma. Dr. Kannan’s interest in pediatric neuro-oncology led to further training in pediatric neuro-oncology at Dana-Farber Cancer Institute/Boston Children’s Hospital. Dr. Kannan also served as Instructor in Pediatrics at Harvard Medical School, where he was responsible for administration of the robust clinical trial program at Dana-Farber Cancer Institute. Dr. Kannan then entered private practice at Pediatric Specialists of Virginia in Northern Virginia, serving as the only fellowship-trained pediatric neuro-oncologist in Northern Virginia, administering clinical trials for the neuro-oncology program at Children’s National Medical Center in Washington, DC. Dr. Kannan brings a wealth of scientific and clinical experience in oncology to clinical trial development now as a Medical Director at Covance.
Alicia M. Baker McDowell, DRSc, MS,
Executive Strategist, Head of Biosimilars Center of Excellence, Strategic Product Development Consulting, Covance
Alicia Baker McDowell is an executive strategist and the head of the Biosimilars Center of Excellence based in Princeton, NJ. Alicia has over 23 years of drug development experience including over 20 years in global regulatory strategy. Alicia has registered multiple products across the globe in over 90 countries in therapeutic areas such as oncology, diabetes, pain and CNS, and is experienced in direct agency interactions including FDA, EMA, MHRA, NMPA, PMDA, KFDA, TGA, and others. Her experience spans small molecules and biologics. Alicia has a BS in Biology from St. Joseph’s University, a MS in Regulatory Affairs/Quality Assurance from Temple University, a MS in Regulatory Science from the University of Southern California and a Doctorate in Regulatory Science from the University of Southern California.
Cindy Jackson, DO, FAAP,
Vice President and General Manager, Rare Disease and Pediatrics, Covance
Cynthia R. Jackson, DO, FAAP, is Vice President and General Manager of the Rare Diseases and Pediatrics Therapeutic Area at Covance. She has over 19 years’ experience in clinical development for both rare disease and pediatric indications and prior to her work in the CRO setting, was a clinical investigator and academic pediatric infectious diseases consultant. She maintains an adjunct faculty appointment in the Department of Pediatrics, Division of the Pediatric Infectious Diseases at Duke University.
Key Learning Objectives
- Learn about the challenges facing pediatric oncology drug development
- Understand the legislative and regulatory history to incentivize drug development
- Gain insights on developing a global clinical trial strategy
- Hear about best practices for engaging regulatory agencies
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