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Bispecifics: From discovery to first time in human
13 January 2015
Bispecifics: From discovery to first time in human

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.
 

Masterclass agenda

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10:00

Registration & Coffee

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10:30

Welcome and Introduction

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11:00

Top level Regulatory Strategy

  •  Biology and building the regulatory arguments
  • Manufacturing for nonclinical development
  • Manufacturing for clinical use
  • Building the full CMC package
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    11:45

    Morning Coffee

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    12:00

    Taking it into the clinic...

  • Geographical differences
  • Finding clinical leverage
  • Staging the test item supply to speed the development
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    13:00

    Networking Lunch

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    14:00

    Non clinical efficacy testing

  • Models
  • Service providers
  • Interpretation
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    14:30

    In vitro safety assessment

  • LiBRA (Literature Based Risk Assessment)
  • IHC
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    15:00

    Afternoon Tea

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    15:30

    In vivo safety assessment

  • CRO selection
  • Design and CROs management
  • Bioanalytical considerations
  • Agency interactions
  • The regulatory package
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    16:00

    Group Discussion and Q&A

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    16:30

    Closing Remarks and Close of Masterclass

    MSE Meeting Rooms

    103a Oxford Street
    London
    United Kingdom

    MSE Meeting Rooms

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    WHAT IS CPD?

    CPD stands for Continuing Professional Development’. It is essentially a philosophy, which maintains that in order to be effective, learning should be organised and structured. The most common definition is:

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