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Preclinical Considerations in Cell and Gene Therapy Product Development

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Contributors

  • Vatsala Naageshwaran; Chief Business Officer, Absorption Systems

    Vatsala Naageshwaran is Chief Business Officer at Absorption Systems. She was instrumental in driving internal reviews of all service offerings working with cross functional teams resulting in an enhanced scientific and commercial portfolio. She collaboratively helped drive research and expansion of CellPort™, Absorption Systems’ exclusive drug transporter technology and played a key role in the effort to establish the commercialization of drug-transporter assays to fulfill FDA and EMA requirements for in vitro drug-drug interaction studies. She has worked on numerous projects in support of NDA submissions that have received FDA and EMA approvals as well as with several leading generic companies to support successful ANDA submissions and market approvals of generic drugs since 2009 to date. Prior to joining Absorption Systems, she has worked for several biotechnology / pharmaceutical companies as a research scientist with experience in drug discovery, assay validation, and product development. Her research has been featured at national conferences such as AAPS, SOT, AACR and EORTC and she has authored many publications submitted to peer-reviewed journals. She has spoken at numerous AAPS and other forums and conducted workshops on clinically relevant drug transporters and non-clinical methods for establishing bioequivalence of oral and complex drug products. Vatsala has a Master’s degree in Biochemistry from Mt Holyoke College, MA, a Master’s degree in Pharmacometrics from the University of Maryland Baltimore and completing her PhD in Ocular Modelling and Simulations through the University of Eastern Finland. Her research interests are in the areas of ophthalmology, pharmacokinetics and bioequivalence.

September 29, 2020
Tue 12:30 PM EDT

Duration 1H 30M

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