A CMC regulatory consultant with over 30 years of experience in the pharmaceutical industry.
Bekki is a Senior CMC Regulatory Consultant with 30 years of experience in providing strategic CMC regulatory guidance and delivery of global applications during drug development and registration across a wide variety of dosage forms, therapeutic areas and markets including direct interaction with global regulatory authorities.
The past 10 years her focus has been on CMC Regulatory Strategy, Advocacy and Intelligence driving multiple activities across complex networks.
She is an industry and agency recognized expert in both ICH and emerging markets including GMP and CMC market specific requirements for global marketing applications.
Sha was co-chair of the American Association of Pharmaceutical Scientist (AAPS) CMC Focus Group for 2014-2016. Regulatory Sciences Liaison for AAPS 2015-2017.
A recognized leader and past co-chair in International Society of Pharmaceutical Engineers (ISPE) Asia Pacific and Latin America Focus Groups.
Examples of projects completed:
Provide strategic direction and guidance to cross-functional development teams to produce approvable CMC components of global regulatory marketing applications (NDA, MAA, NDS, and IRF)
Plan and coordinate the preparation of global marketing applications (module 2 and module 3) for USP, EU, Canada and international markets.
An industry expert on country specific marketing requirements.
Advise team members on CMC content for marketing and investigational applications.
Plan and coordinate the preparation of new investigational applications (IND, IMPD, CTA) across all stages of development in support of global development programs.
Assess and implement regulatory solutions to CMC issues and prepare contingency plans.
Direct the CMC regulatory activities of multiple global development projects in one or more therapeutic areas.
Train and prepare CMC team members for scientific advice meetings with regulatory authority personnel as it relates to CMC strategy (preparation of briefing packages, identification of key questions, rehearsal, attendance of agency meetings, etc.)
Communicate directly with regulatory authority personnel (End of Phase 2 meetings, Pre-NDA meetings, response to questions) to negotiate and influence CMC project issues that are aligned with business needs.
Managed the development of the “Regulatory and Quality White Paper for Continuous Manufacturing” involving MIT, US and EU Regulators and leading industry experts. This paper was presented in May 2014 at the International Symposium on Continuous Manufacturing of Pharmaceuticals (May 2014), and will be the basis for development of an ICH Quality document for 2016. Authored the Regulatory section of the paper.