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BIOGRAPHIES

John Moscariello

John Moscariello currently serves as Senior Director of Viral Vector and Gene Editing Process Development at Bristol-Myers Squib (BMS). At BMS, John’s group develops viral vector processes that enable rapid timelines to generate clinical viral vectors as well as the development and characterization of commercial viral vector processes. Prior to his work at BMS, John was the Vice President of Process Development at AGC Biologics where his team was responsible cell line development, upstream and downstream process development, analytical and formulation development, and technical support for AGC Biologics’ commercial manufacturing facility and supported development activities from generating processes for Toxicology/Phase 1 supply up to and including commercialization and post-approval process support. John is very active in the biotechnology community. He is on the Scientific Advisory Board for various conferences, including the BioProcess International conference series, and the CBI conference series on achieving efficient facilities and the next frontier of single-use technologies. John obtained his Ph.D. in Chemical and Biological Engineering from the University of Wisconsin-Madison, and his B.Eng. in Chemical Engineering from the University of Delaware.

Michael Brewer

Michael Brewer is the Director, Global Principal Consultant, Regulatory for the BioProduction Division (BPD) at Thermo Fisher Scientific. In this role, Michael is responsible for providing global support to BPD customers and serving as the regulatory thought leader and expert across all technology areas within BPD. Prior to moving to this role, he led the team responsible for product applications including microbiology, analytical sciences, and quality control. The products are fully integrated solutions for glycan profiling, bacterial and fungal identification, mycoplasma and viral detection, and host cell DNA and protein quantitation. Michael has over 30 years’ experience in the biopharma industry, including Scios, Synergen, and Amgen in a variety of roles including discovery research, analytical sciences, and quality control. Prior to joining Thermo Fisher Scientific, he led a group at Amgen that developed qualified, validated,/ and implemented molecular methods for host cell DNA quantitation, contaminant (mycoplasma, virus, and bacteria) detection, contaminant identification, strain typing, and genotypic verification of production cell lines.

Christine Le Bec

Christine Le Bec joined Sensorion Pharma in early 2020 as Head of CMC Gene Therapy. She is responsible for all CMC activities, including pre-clinical development, CMC transfer to CMOS, manufacturing and supplying of Phase 1 and 2 clinical trails. Before joining Sensorion Pharma, she worked for more than 20 years at Genethon in the field of Gene Therapy vectors (AAV, Lentivirus, Baculovirus) for rare diseases. She has a strong expertise in the development, qualification, validation of analytical methods for product characterization, release testing of gene therapy products and in stability studies. She has also a solid knowledge of International regulations and reviewing CMC documents for clinical trial applications.

Claire Davies

After obtaining her PhD from the University of London in 2001, Claire Davies performed her postdoctoral work at the William Harvey Research Institute (WHRI) at Bart’s and The London, Queen Mary’s School of Medicine and Dentistry and Joslin Diabetes Center, Harvard Medical School, Boston. Over the last 18 years, Dr Davies has led analytical and CMC teams in product development and analytical method development and validation. Currently, Dr Davies leads Bioanalytics, a group responsible for developing methods and strategies to support process development, product characterization and release and stability testing for therapeutic proteins and gene therapy products in preclinical and clinical development.

Authorship & Conflict of Interest

Contributions: All named authors take responsibility for the integrity of the work as a whole, and have given their approval for this version to be published.

Acknowledgements: None.

Disclosure and potential conflicts of interest: The authors declare that they have no conflicts of interest. MB is an employee of Thermo Fisher Scientific.

Funding declaration: The authors received no financial support for the research, authorship and/or publication of this article.

Article & copyright information

Copyright: Published by Cell and Gene Therapy Insights under Creative Commons License Deed CC BY NC ND 4.0 which allows anyone to copy, distribute, and transmit the article provided it is properly attributed in the manner specified below. No commercial use without permission.

Attribution: Copyright © 2020 Moscariello J, Brewer M, LeBec C & Davies C. Published by Cell and Gene Therapy Insights under Creative Commons License Deed CC BY NC ND 4.0.

Article source: Invited.

Interview conducted: 22 Sep 2020; Publication date: November 6 2020.

 

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