December 2018
How to Optimize your Pre-IND Meeting (Registration Required)
For emerging biotech companies, the importance of the Pre-IND Meeting cannot be overstated. This meeting is the first encounter with FDA. The difference between a mediocre and a great Pre-IND Meeting is measured in years of time and millions of dollars in development. We have conducted hundreds of successful Pre-IND Meetings on behalf of our clients.Join us for breakfast on Friday, December 7th as we discuss the ways to optimize your time with the Agency. Please see link below to…
Find out more »September 2021
Modular Facility Session at ISPE Facilities of the Future Conference
This session will explore novel ways to reduce project time lines and demonstrate how PODular manufacturing will increase facility flexibility to meet potential future changing business needs. The presentation is directly applicable to flexible manufacturing facilities and responsiveness of drug supply. It will address key lead time challenges in traditional manufacturing and offer an option for manufacturing closer to the customer. Session Moderator Mark A. Butler - President and Managing Director, IPS Genentech's New Clinical Supply Center: A manufacturing template…
Find out more »Reducing the Cost of Vaccine Delivery at ISPE Facilities of the Future Conference
This Session will look at new technological advancements and innovations to accelerate the development and commercialization of vaccines to address the threat of future epidemics. Speakers from the Bill & Melinda Gates Foundation and Apiject will provide an overview of how each working to provide low cost, high reliability vaccine manufacturing. Session Moderator Mark A. Butler - President and Managing Director, IPS Speaker Philippe-Alexander Gilbert, Ph.D. Senior Program Officer CMC Bill & Melinda Gates Foundation
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