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...
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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...
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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...
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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...
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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...
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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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