Pharmaceutical Development of ATMPs

This In-house training course will provide a comprehensive overview of the regulatory, quality and GMP requirements to consider when developing ATMPs.

In-house training services and consultancy

This In-house programme will cover the regulatory landscape, the definition and classification of ATMPs and provide practical guidance on how to overcome quality and specific GMP challenges. Comparison of the differences between GMP for Advance Medicinal Therapeutic Product (ATMPs) and conventional therapeutics will be explored. Consideration of what is required for clinical trials and the preparation of the IMPD will also be addressed. Furthermore advice on the specific transportation requirements of these products will be included.

Your next step is to call us now on +44 (0)20 7729 6677 or email us at info@falconbury.co.uk or use our contact form and find out how we can help. There are no commitments, and if we cannot help our advice and recommendations are free of charge.

Sample programme - Day one

Quality considerations for ATMPs

  • Introduction to ATMPS
  • Definition of ATMPs and associated terms
  • Classification of ATMPs

The regulatory landscape

  • Examining the European regulatory landscape for ATMPs – detailed analysis of existing regulation 1394/2007
  • Considering factors lying outside of the regulation’s scope, e.g. combination products
  • Links to related directives, e.g. Tissues and Cells Directives (2002/98/EC and 2004/23/EC); medical devices directive (93/42/EEC) and forthcoming regulation

Strategic considerations

  • Opportunities to meet with regulators to maximise approval chances
  • ATMP-specific options in the EU: certification procedure, risk-benefit approach
    • Accelerated access opportunities in EU and US

Insight into global regulations and requirements

  • Examining key markets including Europe, US and Japan
  • Evaluate the regulatory differences between regions to help you build a strategic approval route
  • GMP requirements at Phase I in US and Europe – ramifications for your product
  • Conditional licencing in Japan – possible potential for you?
  • Practical insight into other markets: South Korea

Overcoming quality challenges

  • Overview of frequent quality concerns
  • Potency assay development
  • Determining critical quality attributes
  • Developing a successful QC strategy for short shelf-life product
  • QP release: timing and logistical challenges for ATMPs

Sample programme - Day two

GMP for ATMPs

  • What is required: examine the major differences between GMP for ATMPs and conventional therapeutics
  • Overcoming potential pitfalls when manufacturing cells
  • Current GMP interpretations
  • Multiple manufacturing sites for autologous products
  • Point-of-care preparation devices

Delivery and shipping

  • Considering stability issues
  • Challenges in transporting cell therapies/cryopreservation
  • Preparation on site

Preparation for clinical trial

  • Optimising materials for regulatory compliance – vendor qualification
  • Risk analysis for biological materials
  • The comparability concept and its importance in preparing for clinical trials
  • Introduction to GMO approval requirements

Practical considerations for the Investigational Medicinal Product Dossier (IMPD)

  • Terms and definitions
  • Guidance on IMPD content for ATMPs
  • Data requirements for first-in-human vs later clinical trials

Recommended trainer

Andrew Willis

Andrew Willis is an independent consultant providing expert advice and training on global regulatory solutions and pharmaceutical development. Previously, he worked for Catalent Pharma Solutions as VP Regulatory Affairs & Consulting Services. Catalent is the world’s leading contract manufacturer and distributor of pharmaceuticals, and he was head of a team of internal and external regulatory affairs consultants.

Andrew qualified as a Chemist from the University of Glamorgan, after which he furthered his understanding of pharmaceutical development, working as a research chemist with Parke Davis. He has 10 years manufacturing and analytical experience prior to entering regulatory affairs as a Senior Executive Officer with responsibility for submission of European MAAs and project management of development programs. He currently has a total of 28 years pharmaceutical experience with extensive knowledge in the development and manufacture of sterile, solid oral, inhalation, topical and biotech pharmaceutical products. These experiences have allowed knowledge of many Biotech products requirements with experiences of growth hormones and multiple cancer treatments, including development and clinical registration of the first genetically modified live bacterium for such treatment. He has extensive experience of major European and US regulatory projects, in the clinical and marketing authorisation stages, and has significant experience in coordinating and managing meetings with European and US Health Authorities.

Specific experience includes the project management of a large MAA requiring full clinical data, followed by Mutual Recognition of the application in all of the European Concerned Member States. The project recorded successful outcomes in all major markets (26 countries) and was viewed as highly successful by the client, meeting very stringent project timings.