Expert Roundtable: getting a gene therapy product to market: pitfalls and how to prevent them

Cell & Gene Therapy Insights 2020; 6(6), 1237–1247

10.18609/cgti.2020.137

Published: 22 September 2020
Expert Roundtable Video
Hetal Brahmbhatt, Thomas Guarinoni, Elizabeth Simmons

Hetal Brahmbhatt

Principal Investigator - Science and Technology Team, Pharma Services, Viral Vector Services, Thermo Fisher Scientific

Dr Hetal Brahmbhatt is a Principal Investigator in the Science and Technology Team, Pharma Services, Viral Vector Services at Thermo Fisher Scientific. She has a PhD in Biochemistry and Biomedical Sciences from McMaster University where she characterized small molecule modulators of apoptotic proteins. In her present role, she contributes to the development of platform processes and technologies for the manufacturing of viral gene transfer vectors.

Elizabeth Simmons

Associate Director QC Analytics, Homology Medicines Inc

Beth has a Master’s degree from Lehigh University in Analytical Chemistry and Regulatory Affairs with 13 years of industry experience. She has managed small and large Quality Control laboratories including method transfer, qualification and validation teams in both small pharma and CMO settings. During that time Beth has supported 2 facility start ups (Commercial and Clinical) and managed technical teams focusing on small molecule, oligonucleotides, and now gene therapy.

Thomas Guarinoni

Manager, Downstream Process team, Viralgen

Thomas Guarinoni, MSc was recruited in January 2017 as manager of the Downstream Process team at Viralgen. He was successful in transferring the entire purification process from Askbio to Viiralgen in record time. Thomas Guarinoni obtained his MSc in 2011 at ENSTBB (National Superior College of Biotechnology) in Bordeaux, France.