Tuesday 9th December, 2014
10:00am to 4:45pm
This Masterclass will provide the top view for all disciplines and functions including discovery, manufacturing, nonclinical, regulatory and clinical.
ADCs and next generation drug conjugates are the most exciting advances in therapeutic drug development. Progressing development is complex process as targeting molecule, linker and war head all have to be assessed for safety. This depends on using different approaches to find the best options and progress quickly to first-time in human studies (FTIH). The risks needs to be managed to reach objectives and plans set in place to deal with the unexpected. The outcome is to provide an agency with a credible CMC package, demonstrable efficacy and safety to support a risk management plan for FTIH. The Masterclass aims to cover the most important aspects that should be part of the "big picture" to file an IND.
This Masterclass will provide the top view for all disciplines and functions including discovery, manufacturing, nonclinical, regulatory and clinical to provide each with the challenges faced by the other disciplines.
Peter Bach trained in chemistry, biochemistry, pharmacology and toxicology. His academic focus contributed to the understanding of target selective injury (and hence human risk assessment), research that attracted support from industry, and national and international research funders. He advised WHO, IPCS, IARC, ILO, IUPAC, EU and other agencies on Chemical Safety.
Masterclass Price: GBP 599
Category : Conferences | Science, Health and Medicine | Pharmaceuticals
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