Avoiding Potential Pitfalls: Phase Appropriate CMC Development and Regulatory Considerations

Incorporation of phase appropriate development strategies is becoming increasingly essential to manage the balance between speed, cost and completeness during development. The possibilities for both Chemistry Manufacturing and Control (CMC) development and filing approaches range from the minimalist style to a continuously supported style. The minimalist style is preparing only the things necessary for the next filing to save money and time. The continuously supported style is keeping a development program up-to-date and fully current  so filings are ready to go. There are pros and cons to both styles, and while there is no right answer, there probably is a “best answer” to suit each company’s culture, funding runway, and the ultimate goal for the project.

In this webinar, development and regulatory experts will discuss the phases of solid oral dosage form development from a CMC perspective. At each phase, they will identify the minimal expectations for CMC development and filing, as well as other considerations to address, thereby setting the stage for later success. In addition, they will present key learnings and past experiences of issues that came up, how they were resolved and how they could have been avoided or mitigated by taking certain strategic actions earlier in development.

This webinar will touch on several case studies that will alert drug developers to (and help them avoid) potential pitfalls and late-stage gaps in their CMC development.

Speakers

R. Wayne Wiley, RPh, Senior Director, Regulatory Affairs, Recro Gainesville

R. Wayne Wiley brings more than 30 years of experience in pharmaceutical regulatory affairs to Recro Gainesville, serving as the site’s senior director of regulatory affairs.

Wiley is an experienced manager with broad experience and success providing support for regulatory agency meetings in addition to IND, NDA, ANDA, DMF, and ROW filings and approvals. Wiley has a strong understanding of regulatory, clinical, development, and life cycle management filing requirements, including post approval support for phase IV, pharmacovigilance, and supplemental approvals. Prior to joining Recro, Wiley held various positions of increasing responsibility at Alkermes, Elan Drug Technologies, and Solvay Pharmaceuticals.

Wiley is a registered pharmacist, graduating from the Mercer University School of Pharmacy. He has delivered lectures in regulatory affairs and pharmacovigilance for the University of Georgia School of Pharmacy MS in Regulatory Affairs program and serves on the curriculum and admissions committees. He has also provided support for the Mercer School of Pharmacy Doctor of Pharmacy Preceptor training program. He is a member of RAPS, DIA, and AAPS.

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Richard Sidwell, PhD, Vice President and Chief Scientific Officer, Recro Gainesville

Richard Sidwell serves as vice president and chief scientific officer for Recro Gainesville. Sidwell is responsible for Recro’s overall scientific strategy for the CDMO business. He has worked at the Gainesville site since 2003, experiencing the site’s evolution from Elan Drug Technologies to Alkermes in 2011 and finally to Recro in 2015. While at Recro, Sidwell has been instrumental in leading and building the CDMO’s product development team, which focuses on bringing innovative solutions to its clients.

With 25 years of pharmaceutical development experience, Sidwell is recognized as a thought leader in pharmaceutical formulation and process development for oral solid dosage forms, multi-particulate controlled release formulations, and abuse-deterrent formulations for controlled substances. Sidwell holds multiple patents and publications in these areas.

Sidwell earned his Ph.D. in pharmaceutics from the University of Georgia; master’s of science degree in health physics from the Georgia Institute of Technology; and bachelor’s of science degree in physics from Oglethorpe University. Sidwell is an active member of the American Association of Pharmaceutical Scientists (AAPS).

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