Age-Appropriate Formulation Development for Pediatric Trials: Challenges and Considerations

Life Sciences, Clinical Trials, Pharmaceutical, Drug Discovery & Development,
  • Wednesday, January 29, 2020

In 2018, the US Food and Drug Administration (FDA) released updated guidelines on Drug Development¹. That same year, the European Medicines Agency (EMA) also took the initiative to implement additional regulations supporting drug development in Europe². Since the release of these guidelines, overlooking factors such as acceptability, excipient considerations and caregiver instructions are no longer an option. In this complimentary webinar, experts will discuss the recent advances, challenges and considerations in drug development. Real-life examples presented by the experts will illustrate the impact of age-appropriate dose forms for pediatrics and highlight insights into the caregiver perspectives. Register for the webinar to learn about a case study on real-world medications and acceptability assessment. The experts will walk through solutions that address the challenges in pediatric drug development and have the potential to improve patient outcomes.

Key takeaways from this webinar include:

  • Developing age-appropriate dose forms
  • Factors in excipient decision-making
  • Insights from a caregiver’s viewpoint
  • Technologies for creating ideal dose forms

Take part in this webinar to learn more about new technologies for developing and delivering optimal dosage forms that address adherence and acceptability in pediatric populations.

¹https://www.fda.gov/science-research/pediatrics/pediatric-science-and-research-activities
²https://www.ema.europa.eu/en/human-regulatory/overview/paediatric-medicines-overview 

Speakers

Matt Ling, Ph. D., Director of Scientific Services, Catalent

Dr. Matt Ling has over 20 years’ experience in the pharmaceutical industry, much of this gained in big pharma, with roles in analytical, formulation development, advanced drug delivery and project leadership spanning all phases of discovery and development. He has a Ph.D. in Organic Chemistry from the University of Nottingham.

Matt has a keen interest in the application of drug delivery technologies to address the challenges of modern pharmaceutical agents with experience in approaches to enhancing the bioavailability of poorly soluble drugs, developing nanomedicine technologies and developing products for pediatric administration. 

He is currently director of scientific services and a member of the site leadership team at Catalent Nottingham.

Message Presenter

Rachel Meyers, Pharm.D., BCPS, BCPPS, FPPA, Clinical Associate Professor, Ernest Mario School of Pharmacy, Rutgers University & Pediatric Clinical Pharmacist, Saint Barnabas Medical Center

Dr. Rachel Meyers completed her undergraduate degree at the University of Mary Washington and her Doctor of Pharmacy degree at the University of Connecticut. After graduation, she completed a PGY-1 residency at the University of Wisconsin Hospital and Clinics in Madison, Wisconsin, and a PGY-2 residency in Pediatric Pharmacotherapy at the University of North Carolina Children’s Hospital in Chapel Hill, North Carolina. In her current position, Dr. Meyers provides both didactic and experiential education in pediatric pharmacotherapy for pharmacy students and residents. She practices in the pediatric intensive care unit and the general pediatric unit at Saint Barnabas Medical Center. Her research interests include pediatric critical care, infectious diseases and dosage forms for children.

Message Presenter

Who Should Attend?

This webinar will appeal to individuals working at companies with molecules in late Phase 1 or Phase 2, or in need of advanced dose form for life cycle management purposes. Specific job titles include:

  • Senior/Director, New Product Strategy & Development
  • Project Leaders/Project Management
  • Senior/Director, Product Development
  • Head/Senior/Director, CMC
  • Senior/Director, Strategic Sourcing
  • Senior/Director, R&D
  • Formulation Scientists
  • Consultants

What You Will Learn

Attendees will gain insights into:

  • Developing age-appropriate dose forms
  • Factors in excipient decision-making
  • Insights from a caregiver’s viewpoint
  • Technologies for creating ideal dose forms

Xtalks Partner

Catalent

Catalent is the leading global provider of advanced delivery technologies, development, and manufacturing solutions for drugs, biologics, gene therapies and consumer health products. With over 85 years serving the industry, Catalent has proven expertise in bringing more customer products to market faster, enhancing product performance and ensuring reliable global clinical and commercial product supply. Catalent employs nearly 13,000 people, including approximately 2,400 scientists and technicians, at more than 35 facilities, and in fiscal year 2019 generated over $2.5 billion in annual revenue. Catalent is headquartered in Somerset, New Jersey. For more information, visit www.catalent.com.

Media Partner

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