Pre-Conference Focus Day
Taking place on Tuesday January 28, 2020 - Pre-conference
This focus day will encompass short presentations on regulatory affairs, CMC and continuous manufacturing business decisions. Through group discussions, you will be able to understand how to lead a successful CM project. Delegates must select this option additionally on registration for the CCP Summit (not included in the conference only option).
8:30 am Registration & Welcome Coffee
9:00 am US Pharmacopeia and ICH Q13 Quality Draft Guidance Updates
- Atul Dubey Director, Pharmaceutical Continuous Manufacturing, US Pharmacopeia
• Status update on draft guidance
• The importance of defining a common quality framework globally to help promote CM development
• The next phase and Q&A
9:30 am A Discussion of Selected Regulatory Feedback Ahead of and After Filing a Multistage Continuous Process to API
- Malcolm Berry Founder, mbchemistryconsulting
• The value of the pre-operational visit
• Observations of common themes and differences between agencies
• Feedback post file
10:00 am Ice Breaking Session
10:30 am Coffee Break
11:00 am Continuous Bio-Processing – How to Turn this into a Reality?
- Thomas Ransohoff Managing Director, BDO USA, LLP
- Tech development – where to start?
- Should you do it in-house or outsource or through partnership model to mitigate risks?
- The end game – how to commercialize continuous bioprocessing? Making the business case for continuous process implementation
11:30 am Continuous Manufacturing – Go or No Go?
- Jana Spes Head of Pharmaceutical Development & Manufacturing Sciences, Ironwood Pharmaceuticals
• From product type to costs of goods – how do you draw up the business case to decide on manufacturing approach?
• Pros and cons of batch vs CM
• Scalability and investment requirements
• Risks and timeline
• The final steps of making the go/no go decision