Bioanalysis Zone

Gene therapy: an interview with Hugh Davis

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Hugh M. Davis, Chief Business Officer, Frontage Laboratories, Inc., Exton, Pennsylvania (PA, USA)

As CBO for Frontage Laboratories, Dr Davis oversees all aspects of business development, sales, marketing, strategic partnerships and alliances. Hugh has over 30 years of experience in the pharmaceutical industry in R&D. His most recent position was with Johnson & Johnson (NJ, USA) where he served as VP and Head of Biologics Development Sciences in the Janssen BioTherapeutics division of Janssen R&D, LLC since 2001. In this role, Hugh participated in the development and approval of many biologic therapies. Prior to J&J, Hugh led the Pharmacodynamics & Exploratory Research Laboratory in the Clinical Pharmacology Unit at GlaxoSmithKline (NJ, USA) from 1996 to 2001.

Hugh has published over 75 manuscripts in refereed journals, book chapters and invited review articles in areas of therapeutic drug discovery, clinical pharmacology and development in immunology, oncology, metabolic disease, bone metabolism and cardiovascular medicine. He obtained his PhD from Villanova University (PA, USA) and completed his Post-doctoral Fellowship at Centocor, Inc. (PA, USA) where he patented the characterization of the CA 125 cancer antigen.


Questions

1 Could you introduce yourself and explain your interest in gene therapy? [Time – 00:34]
2 How has the bioanalytical laboratory kept up with the complexity of oligonucleotide-based and gene therapies? [Time – 01:43]
3 What are the challenges in the design of a clinical development program? How does CROs, such as Frontage, consult with companies to help them get to more efficient answers? [Time – 04:23]
4 Compared to small molecule and biologics research, what is the timeframe for bringing an oligonucleotide-based therapy to market? [Time – 08:23]
5 What bioanalytical considerations should be taken into account when developing bioanalytical assays to address downstream goals? (such as: determining the safety index, the therapeutic window, the maximum recommended starting dose and potential toxicities) [Time – 12:49]
6 With gene therapies providing a potential cure rather than attenuation of symptoms, where do you hope this field will be in 5–10 years’ time? [Time – 16:02]
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