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Key discussion points:

COVID-19 is affecting us all in a way none of us could have imagined possible just a month ago. Work from home, social distancing and being in quarantine seem to be the new normal. Every company and individual is struggling to adapt to this reality.
 
In such a scenario,  enabling collaboration and unfettered exchange of ideas becomes all the more important. With that in mind, we decided to launch a Live-Chat series. The chat involves a 45 minutes discussion on topics that are of importance to scientists and the scientific community at large, to help them move forward in these difficult times.

About Syngene's Live-Chat series

Syngene reserves the right, at its discretion, to change, modify, add, or remove participation.

  • Relevance of PK and ADA data in a clinical setting

  • Impact of neutralizing antibodies on PK

  • Mending gaps between BA and Clinical teams for smoother data interpretation

© Syngene International Ltd.
Syngene International Ltd. Biocon Park, SEZ, Bommasandra Industrial Area - Phase - IV, Bangalore 560099 India

Host: Ashu Tandon | Chief Commercial Officer, Syngene

Ashu has 20 years experience in the global biopharmaceuticals industry which includes Sales and Account Management leadership across consulting, and outsourcing services in Research & Development. He has a successful track record of building multi-million dollar deals across multiple industry verticals and geographies.

As a member of Syngene's Executive Committee, he plays an important role in driving strategy related to Commercial activities. Prior to joining Syngene, Ashu was with IQVIA (formerly QuintilesIMS), Infosys and Accenture.

Panelist: Aparna Kasinath | Head-Large Molecule Bioanalytical Laboratory, Syngene

Aparna has over 18 years of drug development Bioanalytical assay experience which includes more than a decade of experience in Immunoassay Development/Transfer, Validation and Sample analysis in support of PK and Immunogenicity studies for novel biologics and biosimilars. She has a PhD from Sardar Patel University, Gujarat, India and was selected as a UNESCO fellow to the Czech Academy of Sciences, Prague- as a part of her PhD program.

She is an active member of various global scientific groups and works not only to synchronize Indian Bioanalytical practices with global regulatory  requirements, but also strives to bring out the Indian Bioanalytical perspective on to a global platform for effective  harmonization. Aparna is responsible for Good Laboratory Practices (GLP) of her laboratory to ensure scientific and regulatory compliance of generated data.

Panelist: Dr. Vibha Jawa | Director-Clinical and predictive Immunogenicity PPDM, Merck and Co

Dr. Vibha is the recipient of the 2015 Ebert Prize from the American Pharmacists Association for her work on assessing risk of critical quality attributes in a humanized mouse model system. She has published over 50 papers and her articles in the Nature Genetics, Annals of Hematology and Clinical Immunology journals have been cited over 2500 times.

At Merck & Co., Dr. Vibha is responsible for developing strategy,  providing insights and  managing scientific programs for discovery, development and optimization of biologics and vaccines. She also partners with discovery and development groups to design better molecules. Her current research interests include evaluating immune response biomarkers for early drug development and efficacy, immunogenicity prediction using in silico, in vitro and in vivo technologies, modelling impact of immunogenicity on PK and PD and their application to a systems based approach, antigen processing and presentation, and the role of T cells in immune response to drug products.

This episode of the Live Chat series is a panel discussion around a key topic in the Bio Analytical space – Clinical relevance of Immunogenicity data. It features experts from leading Pharma companies and CRO who will share their experience and insights in the field of Predictive and Clinical Immunogenicity. This includes understanding the immunological mechanisms that drive the development of Pharmacokinetic  (PK) and Anti-Drug Antibodies (ADA) and their relevance in a clinical setting.