Date: Wednesday, May 22, 2019
Time: 12:00PM EST
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.
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
Jo Anne Jacobs
Fellow Manufacturing Technology Specialist
Customer Service Excellence Manager
Catalent Pharma Solutions