BiSpecifics 2015
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SMi MASTERCLASS SERIES 2015 www.smi-online.co.uk/2015bispecificsmc.asp Register online and receive full information on all of SMi’s conferences Alternatively fax your registration to +44 (0) 870 9090 712 or call +44 (0) 870 9090 711 GROUP DISCOUNTS AVAILABLE MC446 2015 7th Central London Hosted by: Dr Peter H Bach MSc., PhD., MBA., Director, BioPharmaLogic Ltd Bispecifics: From discovery to first in human DEC SMi presents its 2015 masterclass on About the Masterclass: 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. The Masterclass aims to cover the most important aspects that should be part of the “big picture” to file an IND. Why you should attend: 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 REGISTER BY 30TH SEPTEMBER AND RECEIVE A £100 DISCOUNT REGISTER BY 31ST OCTOBER AND RECEIVE A £50 DISCOUNT
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Transcript of BiSpecifics 2015
SMi MASTERCLASS SERIES 2015
www.smi-online.co.uk/2015bispecificsmc.aspRegister online and receive full information on all of SMi’s conferences
Alternatively fax your registration to +44 (0) 870 9090 712 or call +44 (0) 870 9090 711GROUP DISCOUNTS AVAILABLE
MC446
2015
7th
Central London
Hosted by: Dr Peter H Bach MSc., PhD., MBA., Director, BioPharmaLogic Ltd
Bispecifics: From discoveryto first in human DECSMi presents its 2015 masterclass on
About the Masterclass:
Progressing bispecifics depends on early strategic clarity, and understanding what ispossible by using different approaches in different regions of the world. The Masterclasswill examine these options to help get the quickest first-time in human study (FTIH) that is riskmanaged. It will then “back-fill” how these objectives can be reached and how to deal withthe unexpected.
Each of the steps required to provide an agency with a credible manufacturingpackage, demonstrable efficacy and safety assessment, supporting a risk managementplan for a FTIH study.
The Masterclass aims to cover the most important aspects that should be part of the “bigpicture” to file an IND.
Why you should attend:
This Masterclass will provide the top view for all disciplines and functions includingdiscovery, manufacturing, nonclinical, regulatory and clinical to provide each with thechallenges faced by the other disciplines
REGISTER BY 30TH SEPTEMBER AND RECEIVE A £100 DISCOUNTREGISTER BY 31ST OCTOBER AND RECEIVE A £50 DISCOUNT
www.smi-online.co.uk/2015bispecificsmc.asp
Register online and receive full information on all of SMi’s conferencesAlternatively fax your registration to +44 (0) 870 9090 712 or call +44 (0) 870 9090 711
GROUP DISCOUNTS AVAILABLE
Bispecifics: From discovery to first in human
8.30 Registration & Coffee
9.00 Chairman's Opening Remarks
9.10 Developing the strategy - the big picture - the endgame
• Top level Regulatory Strategy • Biology and building the regulatory arguments • Manufacturing for non clinical and clinical use
9.50 Building the CMC package • Taking it into the clinic • Geographical differences • Finding clinical leverage • Staging the test item supply to speed the
development
10.30 Morning Coffee
11.00 Staging the test item supply to speed thedevelopment
11.40 Nonclinical efficacy testing • Models • Service providers • Interpretation
12.20 Networking Lunch
1.50 In vitro safety assessment I
• LiBRA (Literature Based Risk Assessment)
• IHC
2.30 In vivo safety assessment II
• CRO selection
• Design and CROs management
3.10 Afternoon Tea
3.40 Bioanalytical considerations
• Agency interactions
• The regulatory package
4.20 Chairman's Closing Remarks and Close of Day One
MASTERCLASS AGENDA
About your masterclass leader:
Dr Bach was trained in chemistry, biochemistry, pharmacology and toxicology. His academic focus contributed to theunderstanding of target selective renal injury (and hence human risk assessment), research that attracted support fromindustry, and national and international research funders. He advised WHO, IPCS, IARC, ILO, IUPAC, EU and otheragencies on Chemical Safety.
In the CRO sector Peter supported global virtual teams, SMEs and major Pharmaceutical companies to fast-track novelbiologicals (including bispecific) and NCEs out of discovery, through safety assessment and into first-time-in- humanstudies and through clinical phase I-III programmes and licensed, following interactions with US, EU and other RegulatoryAgencies.
In the BioPharma Sector Dr Bach has lead nonclinical strategy and operations, and been responsible for globaloutsourcing and its implementation, the development of multiple products across a wide range of therapeutic areasand been responsible for post marketing safety stewardship of multiple licensed products.
About BioPharmaLogic Ltd BioPharmaLogic Ltd works with multidisciplinary teams in the EU, Eastern Europe, US, Canada, Asia, Australia and SouthAfrica to expedite nonclinical development to enable first-time-in-humans and proof of concept. They deliverchallenging milestones that supported start-ups, SMEs, mid-Cap and global Biopharmaceutical companies, especially inthe development of biosimilars and next generation Bispecifics.
BISPECIFICS: FROM DISCOVERY TO FIRST IN HUMAN7th December 2015, Central London
4 WAYS TO REGISTER
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