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Licensing provisions that obligate recipients of government funding to share relevant technology and know-how for scarce drugs during pandemics and epidemics can reduce shortages and overcome obstacles that intellectual property rights present.
As innovations in the biotechnology sector continue to proliferate, the traditional education of medical students, residents and fellows will need to change to incorporate innovation as a core tenet of training.
A US decision to award a set of key patents related to CRISPR–Cas9 gene editing to the Broad Institute could spell the end for a long-running dispute over inventorship with the University of California and the University of Vienna.
For the raft of new ventures developing epigenome editors, a compelling niche may be diseases of haploinsufficiency or genome imprinting that require exquisite control of gene expression.
Protective encapsulating devices and gene-editing technologies could obviate the need for antirejection drugs in stem-cell-derived therapies for diabetes.
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.