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Biosimilar Workshop 2015

Preliminary Pogramme
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Preliminary Programme

Biosimilar monoclonal antibodies - Practical considerations for their development

TBC, 2015

Munich, Germany


Dr. Diane Seimetz, Biopharma Excellence

Dr. Tilo Netzer, PharmaLex

DAY 1 

11.30 - 13.00 Registration and welcome snacks and refreshments
13.00 - 14.30 Workshop
14.30 - 15.00 Coffee break
15.00 - 17.30 Workshop
17.30 End of the day
18.00 Transfer to the venue of the social event
18.30 Social event

SESSION 1: Overview on current regulatory expectations on the development of biosimilar mAbs. (Diane Seimetz)

  • The current environment of biosimilar mAbs
  • Where do we stand currently in the biosimilar regulation in the ICH region – EU, US and Japan
  • Development strategies to assemble the CMC, non-clinical and clinical data package for the EU and US
  • Q & A / Discussion

SESSION 2: Practical considerations to set up and use the similarity approach

  • The definition of the similarity approach
  • The continuous similarity testing during development - preliminary similarity testing versus final similarity exercise
  • Definition of the QTPP (Quality Target Product Profile) throughout the development
  • Differences in the EU and US in the similarity approach definition
  • Changes in the manufacture for a biosimilar mAb – the comparability exercise built into the similarity package
  • How to handle differences - the step-wise approach to confirm similarity throughout the development
  • Q & A / Discussion

SESSION 3: The RMP (Reference Medicinal Product)

  • Which RMP needs to be sourced - strategic considerations for the identification of the sourcing strategy
  • What information do agencies want to see?
  • How many batches of the RMP need to be tested finally?
  • The use of the RMP throughout the development
  • Determination of the similarity ranges
  • Q & A / Discussion

DAY 2 

08.30 - 09.00 Welcome Coffee
09.00 - 10.30 Workshop
10.30 - 11.00 Coffee break
11.00 - 13.00 Workshop
13.00 - 14.00 Lunch break
14.00 - 16.30 Workshop
16.30 End of the workshop

SESSION 4: Practical considerations in setting up the manufacturing and analytical testing approach

  • Criterias for the selection of an adequate expression systems
  • Manufacturing process development for biosimilar mAb
  • Formulation development for a biosimilar mAb
  • The comparability package for process changes during the development of a biosimilar mAb
  • Quality parameters for characterization and analytical testing
  • Regular stability determination and investigation of similarity by forced degradation studies
  • Selection of suitable methods for characterisation, release and similarity testing
  • Sample preparation, stability and storage considerations
  • Specific case studies on analytical investigation of similarity and how to handle differences
  • Q & A / Discussion

SESSION 5: Clinical design and development of biosimilar mAbs (Paul Chamberlain)

  • Interpretation of regulatory requirements in designing the clinical development program
  • How to justify extrapolation?
  • PK and immunogenicity sampling strategy for the Phase I study, Immunogenicity determination and data interpretation
  • Pitfalls to avoid in preparing the Phase I study
  • Study population selection
  • Design and statistical considerations for the Phase I and Phase III studies
  • Expectations of prescribers, patients and payers
  • Q & A / Discussion

SESSION 6: What other considerations needed for non-clinical investigation of biosimilar mAbs? (Diane Seimetz)

  • The EU step-wise approach for the determination of the appropriate non-clinical program
  • Selection of the in vitro assay portfolio
  • Are there any animal studies to be considered?
  • Expectations of the FDA
  • Q & A / Discussion

SESSION 7: The CTD for biosimilar mAbs

  • Regulatory dossier requirements
  • Risk management plans and regulatory considerations after approval
  • Q & A / Discussion