2014-08-14 17:41:58 - SMi is proud to announce that Peter Bach, Director from BioPharmaLogic Ltd, will be hosting the Bispecifics: From Discovery to First in Human masterclass taking place on the 13th January 2015 in Central London
This full-day 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. The masterclass aims to cover the most important aspects that should be part of the “big picture” to file an IND.
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.
Attendees will hear from Peter H Bach, as he examines options to help get the quickest First-Time in Human Study (FTIH) that is risk managed. He will then “back-fill” how these objectives can be reached and how to deal with the unexpected.
For further details please visit: www.smi-online.co.uk/2015bispecific-concepts4.asp
Alternatively contact Fateja Begum on +44 (0) 207 827 6184 or email at email@example.com
About SMi Group:
Established since 1993, the SMi Group is a global event-production company that specializes in Business-to-Business Conferences, Workshops, Masterclasses and online Communities. We create and deliver events in the Defence, Security, Energy, Utilities, Finance and Pharmaceutical industries. We pride ourselves on having access to the world’s most forward thinking opinion leaders and visionaries, allowing us to bring our communities together to Learn, Engage, Share and Network. We hold events in over 30 major cities throughout the world including London, Paris and Singapore and to date have welcomed over 200,000 participants from 80 countries. More information can be found at www.smi-online.co.uk
About BioPharmaLogic Ltd:
BioPharmaLogic Ltd works with multidisciplinary teams to expedite nonclinical development to enable first-time-in-humans and proof of concept. They deliver challenging milestones that supported start-ups, SMEs, mid-Cap and global Biopharmaceutical companies, especially in the development of biosimilars and next generation Bispecifics.