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Excipient Innovation and Its Impact on Drug Development Part I

Speakers:

Nigel Langley (Director Technical Service and Scientific Affairs, BASF Pharma Solutions)

Joe Zeleznik (Manager of Technical Affairs, MEGGLE USA)

Date: Wednesday, April 25

Time: 9:45am - 10:30am

Pass Type: Conference Pass, VIP Attendee - Get your pass now!

Track: Drug Manufacturing

Vault Recording: TBD

Excipient innovation is becoming increasingly important as the current available pharmaceutical excipients will not be able to adequately address formulation and manufacturing challenges in drug development in the future. Formulation challenges include the anticipated increase in poorly water soluble, poorly permeable and bitter tasting active pharmaceutical ingredients (APIs) as well as the inherent instability of biologics drug products. Excipient innovation will also be critical in order to improve drug product manufacturing processes such as continuous manufacturing and new technologies such as 3 D printing.

This presentation will define the types of novel excipients and highlight the role of co -processed excipients in drug development. Examples of co- processed excipients will be given and their functionality and utility supported by case studies. The current regulatory landscape for the adoption of novel excipients in drug development will be reviewed and challenged. The presentation will conclude by providing an update on how the pharmaceutical Industry is aiming to accelerate excipient innovation by engaging with the FDA to define a more appropriate regulatory pathway in the future; a joint initiative by the IQ Pharmaceutical Consortium and IPEC Americas.

Session takeaways:

  • Develop an understanding of why there is a pressing need for various types of novel excipients to solve difficult drug development problems, facilitate new manufacturing methods, lower costs and what regulatory hurdles appear to exist

  • Identify how each participant can contribute to further development and use of novel excipients at their companies and throughout the pharmaceutical industry

  • Become confident in using novel excipients to resolve unique formulation and manufacturing problems rather than simply utilize existing excipients that may not create the best drug possible from a quality and performance perspective