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

Abstract

<div class="authors authors-lg"><div class="author"><div class="authors authors-lg"><div class="author"><div class="author-img"><img src="https://bioinsights.blob.core.windows.net/uploads/5665fd4b0e0d43fd9457b130647e8679.png" data-image="1"></div><div class="author-det"><h3 class="author-name" style="color:#5D538A;">Hetal Brahmbhatt</h3><h5 class="author-title" style="color:#5D538A;"><strong><strong>Principal Investigator - Science and Technology Team, Pharma Services, Viral Vector Services, Thermo Fisher Scientific</strong></strong></h5> 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. </div></div></div></div></div><div class="authors authors-lg"><div class="author"><div class="author-img"><strong><strong><img src="https://bioinsights.blob.core.windows.net/uploads/119afb6b1b5b4b119cd918769348eab8.jpg" data-image="1"></strong></strong></div><div class="author-det"><h3 class="author-name" style="color:#00A795;"><strong><strong>Elizabeth Simmons</strong></strong></h3><h5 class="author-title" style="color:#00A795;"><strong><strong>Associate Director QC Analytics, Homology Medicines Inc</strong></strong></h5> 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. </div></div></div><div class="authors authors-lg"><div class="author"><div class="author-img"><strong><strong><img src="https://bioinsights.blob.core.windows.net/uploads/thomas.png" data-image="1"></strong></strong></div><div class="author-det"><h3 class="author-name" style="color:#007589;"><strong><strong>Thomas Guarinoni</strong></strong></h3><h5 class="author-title" style="color:#007589;"><strong><strong>Manager, Downstream Process team, Viralgen</strong></strong></h5> 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. </div></div></div>