Merry Christie, Ph.D.

As Director in CMC Biologics, Merry is responsible for advising clients on technical subjects and providing regulatory strategy to support the development and registration of biologicals, cell and gene therapies, and combination products. She is also responsible for the authoring and review of regulatory submissions. Her regulatory experience includes both the US and EU markets. In addition, as the Head of Expertise in Biosimilars, Merry uses her biosimilars expertise to lead a multidisciplinary Global Biosimilars Regulatory team. 

Merry brings to the role more than 14 years of combined experience gained working in the US regulatory arena, together with a history of CMC technical experience with all aspects of the manufacturing and development of biologicals. Her technical expertise includes analytical method development and validation, formulation development, quality control, manufacturing changes, comparability studies and stability studies. 

Prior to joining VCLS, Merry worked in the Office of Biotechnology Products in the Office of Product Quality at FDA, where she was responsible for a variety of biotechnology products in all stages of their lifecycle, from early development to post-approval. Products included biosimilars, enzymes, monoclonal antibodies, antibody-drug conjugates, pegylated proteins, fusion proteins, NDA-to-BLA transition products, combination products, and products to treat COVID-19. In addition, Merry has experience with products granted under Priority Review and with Orphan Drug designations.  

Whilst at the FDA, Merry was also involved in the review of meeting packages, original INDs, 351(a) and 351(k) BLAs, IND amendments and BLA supplements, and in providing regulatory guidance and scientific advice to Sponsors as part of formal meetings at FDA and at public meetings. Lastly, she participated in pre-approval/pre-licensing/cGMP, biosimilar and for-cause inspections. 

Merry continues to serve as a member of the Editorial Advisory Board for the Journal of Pharmaceutical Sciences. Her responsibilities include advising the Editors on the scope, direction and possible topics/authors for the journal. In addition, she regularly peer reviews scientific manuscripts and commentaries submitted for publication. Merry is also an active member of the Alliance for Regenerative Medicine (ARM) and the American Association of Pharmaceutical Scientists (AAPS). 

Merry completed her Ph.D. in Pharmaceutical Sciences at the University of Colorado and as a graduate student, she published a number of peer-reviewed journal articles on CMC considerations for biosimilars development, the immune response to protein aggregates, and pharmacogenomics. 

Merry is based at the VCLS Cambridge, MA office.