Title: Pediatric Drug Development: Unique Considerations and Challenges

Date: Thursday, October 04, 2018

Time: 11:00 AM Eastern Daylight Time

Duration: 1 hour

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The need to develop improved medicines for pediatric populations is driving a greater requirement to include children in the drug development process. The focus on developing pediatric products and the number of pediatric clinical trials is increasing in response to new regulation, increased funding and scientific advances in areas of special benefit for children.

This emerging research environment creates a unique set of challenges for today’s drug development companies.

PPD and Quotient Sciences provide an innovative solution to solve these challenges that offers end-to-end support for all stages of pediatric drug development from chemistry and manufacturing through all clinical trial phases, and commercial manufacturing.

In this webinar, we will explore:

  • Product considerations when designing acceptable, palatable pediatric pharmaceutical products including formulation, clinical assessment and manufacturing
  • Clinical and operational considerations when executing and designing clinical trials for pediatric patient populations
  • Regulatory considerations for pediatric drug development including US and EMEA incentives, guidance and requirements


Timothy M. Miller, M.D.

Timothy M. Miller, M.D.
Vice President and Therapeutic Area Head, Pediatrics & Rare Diseases

Dr. Miller leads PPD’s pediatrics and rare disease functions. He joined PPD in 2018 with more than 20 years of healthcare experience in academic medical centers and the pharmaceutical and biotech industries. His research interests encompass neurologic and orphan diseases, genetic and neuromuscular disorders, and inflammatory/immune-mediated diseases of the nervous system. As a fellowship-trained neuromuscular neurologist, Dr. Miller’s work weaves together deep clinical knowledge, novel science, and an understanding of required field actions to advance the discovery of and access to therapies, addressing the needs of patients living with rare and debilitating diseases.

Jonca C. Bull, M.D.

Jonca C. Bull, M.D.
Vice President PPD Consulting and Medical Director, Ophthalmology

Dr. Bull ensures the safety of patients and the scientific integrity of studies at PPD and as a regulatory affairs expert with therapeutic expertise in ophthalmology, she guides therapeutic, protocol and safety reporting training to internal teams. Dr. Bull joined PPD in 2017 following a career with the US Food and Drug Administration and in the pharmaceutical industry. Her therapeutic expertise is in clinical regulatory development consulting for biopharmaceutical products in the areas of ophthalmology, diabetes and sub-population disparities, non-opioid pain management in osteoarthritis, and sickle cell anemia. Dr. Bull also previously served as assistant commissioner and director of the office of minority health for the FDA and is a diplomat of the American Board of Ophthalmology and the National Board of Medical Examiners.

Peter Scholes, M.D.

Peter Scholes, M.D.
Chief Scientific Officer
Quotient Sciences

Dr. Scholes has over 20 years of experience in the pharmaceutical industry. In his role at Quotient Sciences he has been instrumental in identifying and implementing the innovative and flexible benefits of integrating pharmaceutical development and clinical testing in early research. He has served as a committee member for the U.K. Controlled Release Society and APS Biopharmaceutics focus group and in 2013 set up a GastroPlus™ user group with industry colleagues as a discussion forum for PBPK modelling and simulation science. In 2010, Peter was named one of PharmaVOICE’s 100 most inspiring people in the life sciences industry. He was appointed as an Honorary Professor in Pharmaceutical Sciences at Nottingham University in August 2015.