Challenges in development of Cell/Gene Therapy Products (ATMPs) – Intellectual Property Do’s and Don’ts
Regulated as pharmaceuticals with a requirement for market approval, ATMPs (cell and/or gene therapy products) need to have a strong business model to survive costs of high-risk development, GMP manufacture and clinical trials. Partnering with commercial entities can often assist in your GMP translation, CMC, device and clinical trials development, but your partners need confirmation of protection for the commercial...