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  • Kirk Hartley

The Pace of Science and Business – More Speed

Velocity continues to increase for turning cutting edge molecular biology into businesses and new treatments. On March 14, the UK announced fast advancing plans to emulate the US FDA’s approach to fast-tracking "breakthrough" drugs for "early access" for serious medical conditions with unmet medical needs. E.g. Alzheimer’s, Lou Gerigh’s disease, diabetes, and most cancers. The pharma industry of course is pleased (except for increased costs), and has been pushing for greater speed. An article from FierceBiotech explains:

"Impressed by the success of the FDA’s breakthrough therapy designation, U.K. regulators are considering a similar effort to speed the path for promising drugs, according to an industry group.

The nation’s government is in the midst of "active discussion across Whitehall" on a plan that would fast-track certain treatments, according to the trade group U.K. BioIndustry Association. Under the proposal, U.K. regulators would consider licensing drugs for marketing in the country and making them available to National Health Service patients before they’re approved by the European Medicines Agency, association CEO Steve Bates said in a post on the group’s website.

The FDA has approved 37 of the more than 140 applications received since launching the breakthrough designation program in 2012, according to EvaluatePharma, promising a prioritized review process that could shave months off a drug’s path to market. But a U.K. analog, dubbed the "promising innovation medicine" designation, could prove even more valuable to the industry, according to Bates, as it could be coupled with fast-track reimbursement for new treatments."

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About Kirk

Since becoming a lawyer in 1983, Kirk’s over 30 years of practice have focused on advising a wide range of corporations, associations, and individuals (as both plaintiffs and defendants) on both tort and commercial law issues centered around “mass torts.”

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