Join our complimentary lunch & learn seminar at our new Garnet Valley, PA facility
Title: The Past, Present and Future of Pediatric Drug Development: Meeting regulatory and patient expectations in developing acceptable pediatric formulations
Wednesday, October 9th, 2019
|Quotient Sciences - Garnet Valley Facility|
11:00am - 11:30am - Registration & Lunch (will be provided)
11:30am - 1:00pm - Seminar
1:00pm - 2:00pm - Q&A and Facility Tour
3080 McCann Farm Drive
*There will be plenty of self-parking spaces available for all attendees
The number of approved pediatric drug treatments on the market for children remains substantially less than those for adults. Over the last decade, global regulatory bodies have placed a greater priority on the pharmaceutical and clinical development of pediatric dosage forms in order to improve and protect child health. A combination of these unmet patient needs and regulatory incentives (and potential penalties) has driven a significant increase in industrial research to develop age-appropriate, acceptable pediatric medicines.
There are many important considerations to keep in mind when developing a pediatric dosage form and the requirements can greatly differ from drug products designed for adult use. Development scientists must take into account the route of administration, the safety profile, overall taste and palatability, the child’s age, weight, physiologic condition and the treatment plan’s requirements. All of these key factors must be balanced appropriately in order to successfully develop a pediatric product that garners clinical, regulatory and commercial success. Arguably the greatest industry challenge however remains a lack of knowledge and guidance on how these development objectives can be successful met.
This seminar will review past experiences, current industry standards and future expectations for pediatric drug development. We will look at EU and US regulatory landscapes for the development and approval of pediatric drug products, describe today’s standard practices in industry and some of the barriers to success, then look at trends and emerging ideas on the future direction for pediatric medicines. There will be a focus on the unique considerations and requirements for pediatric drug product design in order to develop palatable, acceptable drug products for a variety of target age groups. Strategies and case studies will be shared illustrating how key challenges can be overcome.
Key Discussion Topics:
- What is our final destination – how best can the needs of pediatric patients be embedded within industrial drug development?
- Regulatory considerations for pediatric drug development including US and EU incentives, guidance and requirements
- Patient-centric dosage forms for pediatric populations – what factors influence formulation design to ensure acceptability?
- The importance of taste masking, taste modification and alternate dosage forms
- The use of clinical testing to optimize the taste and pharmacokinetic performance of new pediatric drug products
- Adaptive clinical manufacturing and product supply strategies for global pediatric trials