By Kate Rawson
The Food & Drug Administration thinks it is winning converts for its vision of personalized medicine.
There's no question the pharmaceutical industry is desperate for a more efficient R&D machine, and FDA thinks it has one answer: personalized medicine. But for Big Pharma, the idea runs counter to the commercial reality: no one has yet demonstrated a viable model for making personalized medicine pay off. Knowing where and how to invest in personalized medicine--and taking advantage of FDA's interest the area--will increase the chances of commercial success.
By Kate Rawson
The Food & Drug Administration thinks it is winning converts for its vision of personalized medicine.
The UK’s research-based pharma industry and medical research charities have set out clear action points to drive greater diversity and inclusion in clinical trials.
The whole contract research organization industry is being impacted by the current volatility in the pharmaceutical industry.
The UK government has acknowledged that sponsors of clinical trials for rare diseases face challenges around patient recruitment and trial design, which will be addressed in its clinical trials reform, a lawyer says.
Clinical trial sponsors in the rare disease space face “big safety demands” from regulators, which can be challenging for those with limited resources. A CRO founder makes the case for “embedding automation” into the clinical trial process to keep pace with regulatory requirements.
The developers of the ChAdOx1 NipahB vaccine will be able to benefit from the early and enhanced support that the European Medicines Agency offers through its priority medicines scheme.
The termination of the HHS Secretary’s Committee on Human Research Protections closed an important forum for discussing pediatrics and pregnancy in clinical trial design, a former SACHRP chair said.
A 26 June deadline looms for the final guidance even though a draft guidance was removed from the agency’s website to comply with President Trump’s gender ideology executive order. The concepts underpinning the guidance are still relevant, legal experts say.