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Cole Werble

Washington, DC
Cole Werble is the former owner and editorial director of FDC Reports, Inc., the publisher of The Pink Sheet, The Gray Sheet, and other leading news publications for the health care industry. He has more than 35 years of experience analyzing business critical developments affecting the biopharma sector and developing world class information products for the sector.
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Latest From Cole Werble

Senate Gene Editing Hearing: Trust In US FDA On Display

Discussion on cutting edge medical technology demonstrates the strong reputation FDA has built as a regulator. Witnesses in the gene editing field said FDA is doing a good job – and Congress is likely to leave it at that.

Regulation Regenerative Medicine

CVS/Aetna Deal Faces Challenge of Appeasing Current PBM Clients

Big, revolutionary, vertical deals to change structure of health industry are dramatic but tough to pull off. Will CVS PBM customers worry about funding a competitor?

Pharmacy Benefit Management Private Payers

Real-World Evidence: Advice, Principles And Examples Emerge From FDA

Biopharma sponsors are eagerly awaiting guidance on how to apply 'real-world evidence' to drug development and regulatory decisions. Recent workshops provide some clues about what is likely to be included in the first drafts.

Review Pathway Clinical Trials

Orphan Drug Development May Be Well-Suited To Digital/Wearables

Pfizer feels that orphan products may present a particularly good area for testing wearable monitors and other digital devices as research tools. The small patient populations and fine distinctions in functional improvement or delay of disease progression may be ideally suited for the digital collection of data.

Rare Diseases Digital Health

Reagan-Udall Expanded Access Navigator Ready To Launch

Web tool to help patients find expanded access program should go live in early June, focusing initially on oncology. That timing should help deflect efforts to enact “Right to Try” legislation.

Clinical Trials Policy

Patient Input Comes Full Circle: Ex-FDAer Gives Feedback To FDA

US agency's April 6 patient-focused drug development meeting on sarcopenia sent two very divergent messages about the status of measuring patient engagement on new drug development: both delivered by an unexpected messenger, former FDAer Ray Lipicky.

Regulation Drug Approval Standards
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