BiSpecifics: Concept to clinic

Dec 10, 2013, 9:00AM to 5:00PM

Location Coram Street
London WC1N 1HT, UK
Cost £599
Details BiSpecific biologicals take the selectivity and versatility of therapeutic antibodies to a higher level.

Getting these novel molecules into the clinic requires a detailed understanding of their biology, the effects they may produce, their manufacture and potential quality issues and then undertaking efficacy and safety testing. Each of these aspects offers new and untried challenges to the sponsor, CMOs/CROs and Agencies as there are few guidelines, and limited development experience.

SMi's masterclass hosted by BioPharmaLogic and Épée Services, will examine considerations required to develop a global strategy for progression of bispecifics from bench to the clinic. It will explore the steps required to provide an agency with a credible manufacturing package, demonstrable efficacy and safety assessment, to assist in getting the quickest first-time in human study (FTIH).

Benefits of Attending:
• Understand the major considerations for developing a global development plan
• Discuss first-hand experiences in developing New Generation Biologics with experts in the field
• Explore requirements to interact with multiple agencies
• Learn how you can maximise the potential of your product

Contact Fateja Begum
Tel: +44 (0) 20 7827 6184
Email: fbegum@smi-online.co.uk

Keywords:
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literature based risk assessment, ihc, chemistry manufacturing and control, new generation biologics, adcs, antibody drug conjugates, biologicals, monoclonal, therapeutic antibodies, antibodies, bispecific, cmc, workshop, masterclass

Artists / Speakers: BioPharmaLogic Ltd, Peter Bach, Épée Services Ltd, Mairead Duke.
Venue Holiday Inn Bloomsbury
RSVP http://atnd.it/1eI4McJ

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