YourEncore Insights - Life Sciences

Getting Real World About Outcomes Data

Posted by Peter J. Pitts on 6/1/16 1:00 PM

I’ve just returned from a cold, blustery and wet London where I attended the annual Pharma Access Leaders Forum.

But the meeting was hot.

In fact, piping hot when you consider the tectonic changes being felt in the world of healthcare technology assessment (HTA) and their implications on both patient access and innovation. And the linkages couldn’t be more profound.

Wither HTA in the EU? A key red thread through a series of potent discussions was real world evidence (aka, “outcomes data”). Head honcho HTA officials from across Europe (including England and Scotland – both still in Europe as of last report) returned again and again to the value of outcomes not just for the evolving world of Risk Sharing Agreements, but for the acceleration of reimbursement science.

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Topics: FDA, R&D

[Watch] No Surprises: Improving Medical Devices Due Diligence

Posted by Minnie Baylor-Henry on 5/11/16 9:30 AM

Donna Godward and Dr. Janet Vargo recently presented a lunch briefing on improving medical devices due diligence.

Acquiring and selling innovative medical devices or diagnostics is standard business for small and large device companies – but doing it well is not standard business.

In this session, Donna Godward and Dr. Janet Vargo discussed the areas often overlooked in due diligence efforts that can lead to expensive or even show-stopper surprises once the acquisition is complete and later development and commercial efforts are underway. Understanding what to look for (or present) during due diligence will reduce risks and lead to a better evaluation for the transaction. 

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Topics: Medical Device, FDA

[Recording] EU Medical Device Regulation Presentation

Posted by Tim Franson, MD on 5/4/16 8:30 AM

How has your company been preparing for EU MDR?

Minnie Baylor-Henry and Jon Lange discussed this topic during one of our most well attended webinars last month. If you missed the live event, you can now watch the recorded presentation below.

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Topics: Med Dev, FDA

FDA Gets Out In Front on Single Source Problem

Posted by Peter J. Pitts on 3/29/16 11:00 AM

National Public Radio’s Marketplace program reports:

The Food and Drug Administration recently said it’s going to prioritize any generic drug application when there’s currently just one manufacturer.

Here’s why:

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Topics: Pharmaceutical Industry, Regulatory, FDA