Janssen R&D LLC
Division of Johnson & Johnson
Latest From Janssen R&D LLC
The SARS-CoV-2 outbreak has the federal government working not only on a vaccine candidate specifically targeted at the novel coronavirus but also thinking more broadly about ways to head off future potential pandemics with emerging pathogens.
A deputy center director position remains open and four new associate director positions were added over the last year.
It may be easier to use observational study data to replicate randomized controlled trial results in certain therapeutic areas or where drugs were studied against each other instead of placebo, the US FDA’s David Martin says; the agency-funded DUPLICATE real-world evidence demonstration project has completed replication work on the first five trials, all of which are diabetes drug cardiovascular outcomes studies.
Only a culture shift can move sponsors away from traditional monitoring to risk-based approaches, a transition being slowed by fear of change as well as confusion resulting from too many ‘flavors’ of risk-based monitoring strategies, stakeholders say; FDA tries to clarify what risk-based monitoring is, and is not.
- Therapeutic Areas
- RW Johnson Pharmaceutical Research Institute
- Johnson & Johnson Pharmaceutical R&D LLC
- North America
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- Johnson & Johnson
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- Per Peterson, Pres.
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Janssen R&D LLC
Phone: (800) 526-7736
920 Rte. 202
P.O. Box E1756 Raritan, NJ 08869
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