Readers of The IN VIVO Blog and The RPM Report's First Take responded to a post on whether proponents of personalized medicine can also be supporters of comparative effectiveness research. We asked readers to weigh in on that question. Their emails initiated a lively discussion on the future of health care so we've picked excerpts from the most noteworthy responses to share.
Ramsey Baghdadi
So now, even Ted Kennedy is talking about personalized medicine.
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Replimune's RP1 oncolytic immunotherapy became the third regenerative medicine to receive an FDA complete response letter this month as the agency appears to re-visit previous agreements about accelerated approval.
The UK drug regulator acknowledges that technology will “move on” and, as such, has designed its decentralized manufacturing regulation to be as “enduring” as possible. Experts from the MHRA explain what products are covered by the new framework and how it has been future-proofed.
Sarepta's rAAVrh74 vector, used in the marketed Duchenne muscular dystrophy gene therapy Elevidys and across the company's limb girdle muscular dystrophy pipeline, earned a platform designation as the lead LGMD candidate prepares for BLA filing.
Cellares’ fully automated cell therapy manufacturing platform is the first system to receive an Advanced Manufacturing Technology designation from US FDA
A new 10-year, government-supported R&D program in China will focus on new targets and emerging technologies which can be translated into first-in-class drugs and give birth to top players in the global pharma industry.
The ARPA-H program is making individualized genetic therapies a new research priority, including the “THRIVE” grant program, which will seek genetic platforms beyond AAV and CRISPR, and “GIVE,” which will support bedside manufacturing for RNA therapies.
The FDA cannot “rest on its laurels” when it comes to advancing cell and gene therapy regulatory advances, the acting head of the Office of Therapeutic Products said. Leveraging knowledge across programs could be a key.
