Practical Aspects of Formulation, Analytical, Project Management & Clinical Packaging to get your product to market faster
Driving more efficient timelines is key to bringing a product to market when you are on an accelerated track. Expedited program designations and approaches are available from FDA of which break though therapy designation is the latest. If you do not have the pharmaceutical, analytical, packaging and project management resources and infrastructure in-house, maintaining a development program at a rate that takes full advantage of the benefits of receiving an expedited designation from FDA may be challenging.
Join the webinar and hear from industry experts on how an integrated development program approach can be used to mitigate risk and reduce timelines to get maximum benefit from receiving expedited or orphan designations for your drug.
Presented by
Richard J. Holl, PhD,
Director, Pharmaceutical Science, Catalent Pharma Solutions
Richard J. Holl, PhD, is Director Pharmaceutical Science at Catalent Pharma Solutions in Kansas City, Missouri, where he manages a pharmaceutical development and manufacture group. He has been at his current position for 5 years, having been previously employed at several large and small pharmaceutical companies throughout his over 20-year career.
Benjamin Porter,
Senior Manager, Small Molecule and Analytical Chemistry at Catalent Pharma Solutions
Benjamin Porter, is a Senior Manager in Small Molecule Analytical Chemistry at Catalent Pharma Solutions in Kansas City, Missouri, where he manages an analytical group of scientists. He has over 15 years of industry experience with analytical testing to support pharmaceuticals throughout the development and commercial process.
Jean Heier,
Senior Project Manager, Catalent Pharma Solutions
Jean Heier is a Senior Project Manager at Catalent Pharma Solutions in Kansas City, Missouri. She has over 20 years experience in the pharmaceutical business. She has been with (legacy) Catalent for 15 years serving in a Project Management role for the last 10 years and previously as a bioanalytical chemist.
Phillip Zemler,
Senior Manager Operations, Catalent Pharma Solutions
Philip Zemler is Sr. Manager Operations at Catalent Pharma Solutions in Kansas City, Missouri, where his operation delivers clinical and niche commercial packaging services to worldwide markets. He has been onsite in KC for seven years, having served the business through multiple roles in Project Management, Compliance, Continuous Improvement, and Operations management.
