Getting Your Biologic to Clinic Faster and More Efficiently
Sponsored by: Catalent
- Clinical Trial
- Biologic Development
Date: 22 May
Time: 5PM London/12PM New York
Accelerating Commercialization Through Dose Form Development, Manufacturing and Clinical Supply
Biopharma companies constantly struggle with the time that it takes to get a drug through the regulatory approval process and into the market. It can take up to seven years or longer before a drug finally enters the market and becomes accessible for health care providers and patients. Much of this time is driven by the clinical trial process—developing protocols, recruiting patients, analyzing data, etc. The rules guiding these specific clinical trial activities give companies limited opportunity to reduce the approval timeline.
However, there are multiple opportunities for companies to speed time to clinic, which impacts the speed to market. Processes such as dose form development and clinical trial planning can be started earlier to reduce issues and delays. In addition, adopting pre-qualified and/or single-use manufacturing equipment can help speed up manufacturing timelines.
When there is a need to outsource development and manufacturing, there is clear benefit to choose a partner that has end-to-end capabilities and can perform these parallel processes. Information gathered during formulation development or other typically later stage processes can enable companies to make adjustments sooner and avoid costly rework and delays.
During this webinar, experts will discuss considerations for biologic development and strategies to remove steps from the critical path to clinic. Register today to learn how these tools and solutions can be leveraged to quickly move a product from Phase 1 through Phase 3 and on to process qualification and commercial production.
Fellow Manufacturing Technology Specialist
Jo Anne Jacobs is a Fellow in the Drug Product Manufacturing Science and Technology group at Catalent Biologics’ Bloomington, Indiana site. Ms. Jacobs has been in the pharmaceutical industry for over twenty years, having worked in academic and commercial settings. She began her career in the pharmaceutical industry doing formulation development and small-scale manufacturing of solid dosage forms. Ms. Jacobs has extensive experience in the manufacturing of parenteral products, and she has additional experience with dry blending, wet granulation, fluid bed drying, tablet coating, etc. At Catalent she works closely with the business development, project management, process development and manufacturing operations groups to ensure the successful technical transfer of both clinical and commercial products. Ms. Jacobs is also a Registered Pharmacist with hospital and community pharmacy experience. She has been active in BPOG, PDA, AAPS, ISPE and the South Carolina Pharmaceutical Association over the course of her career.
Customer Service Excellence Manager
Ann McMahon is Manager, Customer Service Excellence for Catalent’s Clinical Supplies Services business unit and has over 17 years of experience in the pharmaceutical industry. Prior to Catalent, Ann was a Manager, New Product Launch at West-Ward Pharmaceuticals and Boehringer Ingelheim. Ann’s areas of expertise include project management, packaging and labelling, technical transfer, scale up and commercialization, supply chain management, operational and supplier management, and analytical services. Ann holds a B.S. in Biology/Biochemistry from Ohio Northern University and a M.S. in Clinical Pharmacology from the Ohio State University.
Key Learning Objectives
- Learn how companies can use early development data to efficiently design a clinical manufacturing program to decrease the standard Phase 1 to approval timeline
- Identify ways that manufacturing can make an impact to improve timelines
- Uncover the most efficient ways to get drugs through clinic and to market
- Understand the importance of clinical trial planning early during development
- Chief Scientific Officer
- Process Development Scientist
- CMC Engineer
- Bioprocessing Engineer
- Upstream Development Scientist
- Downstream Development Scientist
- VP of Biologic Development
- VP of Bioprocessing
- VP of Process Development
- VP of Biomanufacturing
- Director of Biologic Development
- Director of Bioprocessing
- Director of Process Development
- Director of Biomanufacturing
- VP of Bioproduction
- Director of Bioproduction
- Director of Biologics
- Clinical supply Management
- Clinical Supply
- Clinical Supplies
- Supply Chain
- Clinical Logistics
- Clinical Operations
- Clinical Trial Operations
- Vendor Management