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Additional changes could make the registries of drug patents published by the FDA, called the Orange and Purple Books, more useful and reduce barriers to effective competition from generic and biosimilar drugs.
The complicated and labor-intensive manufacturing of novel cell and gene therapies requires efforts to improve workforce development programs for the nascent cell therapy industry broadly, and for cell manufacturing more specifically.
Commercializing research is fraught with pitfalls, but a thoughtful checklist can ensure you set off on the right path and give your fledgling business the best chance of success.
Advances in technology and changes to healthcare during the pandemic may finally realize the vision of patient-centric blood testing espoused by disgraced Theranos CEO Elizabeth Holmes.