Progressing bispecifics depends on early strategic clarity, and understanding what is possible by using different approaches in different regions of the world. The masterclass will examine these options to help get the quickest First-Time in Human study (FTIH) that is risk managed. It will then "back-fill" how these objectives can be reached and how to deal with the unexpected. Each of the steps required to provide an agency with a credible manufacturing package, demonstrable efficacy and safety assessment, supporting a risk management plan for a FTIH study.
Why you should attend:
The masterclass aims to cover the most important aspects that should be part of the "big picture" to file an IND. It 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. The content is especially aimed to help small companies develop Bispecifics.
About the Masterclass Leader:
Peter Bach was trained in chemistry, biochemistry, pharmacology and toxicology. His academic focus contributed to the understanding of target selective renal injury research that attracted support from industry, national and international research funders.
In the CRO sector Peter supported global virtual teams, SMEs and major Pharmaceutical companies to fast-track novel biologicals (including bispecific) and NCEs out of discovery, through safety assessment and into first-time-in-human studies and through clinical phase I-III programmes and licensed, following interactions with US, EU and other Regulatory Agencies.
In the BioPharma Sector Dr Bach has lead nonclinical strategy and operations, and been responsible for global outsourcing and its implementation, the development of multiple products across a wide range of therapeutic areas and been responsible for post marketing safety stewardship of multiple licensed products.
Venue Details: Holiday Inn Bloomsbury, Coram Street, London, WC1N 1HT, United Kingdom
Standard Rate: £599+VAT
Speakers: Peter H Bach, Director, BioPharmaLogic Ltd