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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.

Latest From Cole Werble

COVID-19 Clinical Trial Disruptions: A Real-World Test Of De-Centralized Techniques

US FDA asks oncology drug sponsors for information on the impact of modifications to clinical trials during the pandemic – with close attention to remote monitoring and data collection.

Clinical Trials Coronavirus COVID-19

AstraZeneca COVID Monoclonal Combination Headed To Clinic ‘Within Weeks’

AstraZeneca devoted a surprisingly large piece of its testimony at the recent House vaccine hearing to its therapeutic work. The company appears to be anticipating another shift in public attention back to the mAB cocktail as a way to treat and prevent COVID-19.

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Re-Wiring US FDA’s Regulatory Thinking

The efforts to upgrade FDA’s information technology infrastructure may be opening up into an opportunity to reinvent its processes for regulatory decision making.

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Re-Wiring US FDA’s Regulatory Thinking

The efforts to upgrade FDA’s information technology infrastructure may be opening up into an opportunity to reinvent its processes for regulatory decision making.

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Vaccines After COVID: Catch-Up Watch Under Way

There has been a dramatic drop-off in routine immunization rates in the US and around the world amid the COVID-19 outbreak. The catch-up effort may complicate the pandemic response efforts.

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Turning Vaccine Priority Upside Down: Applying H1N1 Lessons To COVID-19

A successful COVID-19 vaccine candidate will create a critical challenge: who receives the first doses of what is bound to be a constrained supply? Vaccine developers see useful lessons from the 2009 H1N1 outbreak – but a very different priority order.

Vaccines Distribution
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