YourEncore Insights - Life Sciences

Bioethics in Biopharma: Lessons on Safety, Big Data and Bioethics from Dr. Don Therasse  (Ep. 7 on The Pharmcast)

Posted by Jim Combs on 1/5/17 12:26 PM

This week on The Pharmcast, we talk with Dr. Don Therasse, former VP of Global Patient Safety for Eli Lilly & Company, and current Strategic Advisor for YourEncore.

With over 26 years of experience working with Lilly, Therasse held a diverse set of roles ranging from clinical research physician, to medical director, to medical affairs leader, and finally to patient safety leader.  Beyond drug safety, Don Therasse is a thought leader in bioethics and is credited with building Lilly's internal bioethics group.

In our conversation with Dr. Therasse, we explore experiencing a major patient safety event, building a bioethics program, the promise (and limitations) of big data in patient safety, and success formulas for transitioning into new departments within a large biopharma company. 

If you have topics you would like YourEncore to explore on future episodes of The Pharmcast, please email [email protected] with feedback or suggestions.

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Topics: Pharmaceutical Industry, Quality & Safety, Pharmcast

FDA 483 Response: Four Tips to Avoid a Warning Letter

Posted by Victor Chance and Judith Meritz on 8/25/16 12:05 PM

The receipt of a 483 at the conclusion of a facility inspection notifies a company of conditions the FDA believes are in violation of the Food, Drug & Cosmetic Act. If 483s are not properly addressed, the FDA can take further enforcement action to protect the public health – including issuing Warning Letters. Warning Letters not only indicate potential risks to patients, but also bring unwanted publicity, erode patient trust, and potentially restrict the approval of future products significantly impacting revenue. Therefore, companies must know how to mount a competent response.

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Topics: Quality & Safety, Medical Device, FDA

A Biotech’s Guide to FDA’s 2016 Agenda

Posted by Peter J. Pitts on 2/17/16 10:39 AM

It is often said that the FDA loves ambiguity – because it gives the agency unlimited authority.  As a former regulator, I know that’s true. However, what’s more important to the men and women of the FDA is to be an innovation accelerator. And that means the agency has to lead through … clarity.

That wish is apparent when you study the FDA’s recently released 2016 Guidance Agenda, which outlines what the agency views as its top priorities for 2016.

The document is worth perusing in its entirety, but to save you some time, I have assembled what I view as some of the more interesting items for biotechs to watch.

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Topics: Life Sciences, Pharmaceutical Industry, Quality & Safety, Regulatory