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Biotech & Pharmaceutical Consulting

gene therapy

These selected case studies illustrate the scope of our work, the level of expertise we’re able to offer, and our consistent record of successful engagements.

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Case Studies
gene therapy

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Expert Witness

CMC and regulatory affairs gene therapy support

Challenge: A biotech company developing novel gene therapy approaches for in vivo cell trans-differentiation had lead programs in IND-enabling studies for two indications. The client requested...

Due Diligence of Late Stage Gene Therapy Asset

Challenge: Our client, a global pharmaceutical company, was facing a short deadline to making an offer for a late stage gene therapy asset and was under considerable competitive deal pressure. This...

Pipeline strategy for gene therapy company

Challenge: A leading biotechnology company with a focus on development and commercialization of gene therapies for bleeding and other debilitating disorders had developed a next-generation AAV gene...

Development plan for beta thalassemia gene therapy

Challenge: A leading European university identified a gene therapy for the treatment of haemoglobinopathies. Alacrita was asked to support the Principal Investigator (PI) in developing a Commercial...

Gene therapy manufacturing license negotiation

Challenge A private biotech company developing gene therapy products for several orphan diseases was in the process of initiating CMC development for their pipeline products. In order to move...

Assessment of an AAV gene therapy for an ophthalmic indication

Challenge: Alacrita conducted an assessment of an AAV gene therapy for an ophthalmic indication, focusing on market potential, technical and regulatory issues and identification of key risks.

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