PDA Pacific NW: The Commercialization of Gene and Cellular Therapies Dinner

Kimberley Buytaert-Hoefen, PhD, Director of Pre-Clinical Consulting of Azzur Group  has 20 years of experience in research and development (7 years) commercial pharmaceutical, gene and cellular therapy and medical device industry involvement (13 years).  Currently, she works closely with gene and cellular therapy companies to develop and implement effective regulatory compliance solutions. Specifically, Buytaert-Hoefen’s experiences include

1. cGMP Manufacturing site assessments for FDA 21 CFR Parts 11, 210 and 211 and Q7A.
2. Clinical site assessments for multiple cell collection, processing and infusion sites.
3. Regulatory preparations including INTERACT and BLA FDA submissions.

Buytaert-Hoefen’s has developed an expertise in performing pharmaceutical and medical device inspections with an emphasis on sterile processing.  She was a former FDA investigator trained at performing surveillance, for cause, pre-approval establishment and post-marketing adverse drug experience reporting inspections.  Buytaert-Hoefen is highly skilled at laboratory data review both in chemistry and microbiology, data integrity assessments, and process validation.  She is qualified in the authoring, review and coordination of regulatory documentation.