Best Practices in Leveraging Phase Appropriate Expertise and Technologies to Accelerate your Product Development to Commercialization
Sponsored by: Catalent Pharma Solutions
- Oral Small Molecules
Date: 6 May
Time: 3PM London/10AM New York
The path from development to commercialization can be challenging enough, but without an experienced partner an innovator may have to deal with wholly foreseeable hurdles such as inadequate planning for downstream processes, which can result in high manufacturing costs or even batch failure. These can be avoided by a partner that adopts a holistic approach to the development process at the earliest stage. Weighing in product considerations early during development by leveraging world-class expertise and specialized technologies ensure that processes can be transferred to commercial production in a timely manner without any issues.
In this webinar, pharmaceutical scientists will present real-life examples of challenges they’ve overcome in the transfer of oral small molecules from a dedicated early-phase development site to a dedicated late-phase manufacturing site. The experts will share collaborative best practices and explain how features of Catalent’s OneXpress™ can reduce risks, accelerate timelines, and maximize utilization of resources across a global network to drive more successful outcomes.
Register for this webinar today.
Director of Pharmaceutics, Catalent, San Diego
Meredith Perry is the Director of Pharmaceutics at Catalent San Diego, where she helps clients to identify formulation strategies for small molecules and peptides in preclinical and early clinical development. Meredith believes that being strategic in early phase formulation and analytical development gives each molecule the best chance to help patients with unmet needs. She has been with the Catalent San Diego site (formerly Pharmatek Laboratories) since 2003 and has supported over 100 clients with their solubility and stability-challenged molecules. Meredith holds a BS in Chemistry and a BA in Economics from the University of California, San Diego.
Director Pharmaceutical Development, Manufacturing, Catalent, Kansas City
Todd Stutzman received his Doctor of Pharmacy degree from University of Nebraska Medical Center. He has over 30-years of experience in the industry, all in formulation development. Early in his career he worked on microencapsulation of biodegradable polymers in the treatment of osteomyelitis and biodegradable films for the treatment of gingivitis. He also worked at Sandoz OTC division for 2-years developing suspensions, syrups and chewable tablets. The remaining portion of his career has been in prescription products for new chemical entities working at Marion Merrell Dow, Hoechst Marion Roussel and Aventis. In 2000, Todd transitioned from big pharma to contract development, working for Quintiles as a group leader, followed by Aptuit as a manager and most recently Catalent Pharma Solutions as a director of Pharmaceutics. His team of a 120 scientists and technicians has currently taken 13 programs from development to commercial launch in the last 10-years. Eleven of those 13 compounds were orphan classification. Two of the programs were given breakthrough status. The 13 commercial products are distributed in over 80 countries worldwide.
Key Learning Objectives
- Approaches for lean and efficient analytical method development and transfer
- Explore challenges & opportunities in cross-functional collaboration
- Understand how an integrated approach can accelerate timelines and reduce risk
- New Product Strategy & Development
- Project Leaders & Project Management
- Product Development
- Formulation Scientists