Disrupting the FDA: industry insiders offer up a wish list and highlight challenges

9:36 pm by | 2 Comments

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Stephanie Baum

By Stephanie Baum

Stephanie Baum is the East Coast Innovation Reporter for MedCityNews.com. She enjoys covering healthcare startups across health IT, drug development and medical devices and innovations deployed to improve medical care. She graduated from Franklin & Marshall College in Pennsylvania and has worked across radio, print and video. She's written for The Christian Science Monitor, Dow Jones & Co. and United Business Media.
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Rather than do away with RTCs, do them more efficiently. A core team of five people just used crowdsourcing and telemonitoring to design a Phase 2a drug study for $1.4 million: 180 patients, 12 months, biometric telemonitoring, ePROs, virtual study visits with 2-way video, medication adherence monitoring and activity monitoring. Patients will go to a study site at enrollment and completion only-- all other data collected in the home. Less burden on patients = easier recruitment & better retention. FDA is open to this-- the industry is dragging its heels.


 @johnkmholland That sounds really interesting and I'd like to hear more. Please let me know the best way to contact you to follow up. [email protected]