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Alliance for Regenerative Medicine (ARM)

Making ATMPs a reality for rare disease patients

28 February 2024 | By Paolo Morgese (Alliance for Regenerative Medicine)

Advanced therapy medicinal products (ATMPs) will be among the first to undergo joint clinical assessments at EU level in 2025 and these will form the basis for national value assessments and pricing negotiations. Here, Paolo Morgese from the Alliance for Regenerative Medicine discusses how methodologies for joint clinical assessments (JCAs)…

article

European Pharmaceutical Review Issue 5 2023

9 November 2023 | By European Pharmaceutical Review

EPR Issue 5 includes articles on microbiological testing of ATMPs, the use of inline Raman spectroscopy for bioprocess control, paediatric drug formulation, and more.

article

The evolution of AAVs in cell and gene therapy

20 July 2023 | By Catherine Eckford (European Pharmaceutical Review)

AAV development for cell and gene therapy in 2023 is being impacted by manufacturing and regulation challenges, however advancing technologies offer opportunity, according to leaders in the field.

news

Pharma responds to proposed EU pharmaceutical legislation reform

28 April 2023 | By Catherine Eckford (European Pharmaceutical Review)

Industry bodies EPFIA and the Alliance for Regenerative Medicine and law firm Pinsent Masons have responded to the recent proposed revision of the EU pharmaceutical legislation.

article

Realising the potential of AAV gene therapies

27 April 2023 | By Dr Rajiv Vaidya (Andelyn Biosciences)

In this article, Dr Rajiv Vaidya, Head of Manufacturing Science & Technology at Andelyn Biosciences, explores strategies for improving the scalability and cost‑effectiveness of AAV production while maintaining regulatory compliance.

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Recommended

Alliance for Regenerative Medicine (ARM)

Making ATMPs a reality for rare disease patients

European Pharmaceutical Review Issue 5 2023

The evolution of AAVs in cell and gene therapy

Pharma responds to proposed EU pharmaceutical legislation reform

Realising the potential of AAV gene therapies