YourEncore Insights - Life Sciences

Working with the FDA: Developing a Regulatory Strategy That Works (Ep. 14 of The Pharmcast)

Posted by Jim Combs on 3/2/17 4:00 PM

On this week's episode of The Pharmcast, we explore the key elements of an effective regulatory strategy and how to drive value to patient and shareholders by working with the FDA. We also cover common ways agency decisions can destroy value if not done properly.

Dr. Tim Franson and Dr. Joe Lamendola recently gave a presentation to a group of private equity and venture capital funds to outline the importance of regulatory strategy for small biopharma companies.

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Topics: Regulatory, FDA, Pharmcast

Riding the Policy Roller Coaster in 2017: A Policy Update with Dr. Tim Franson (Ep. 13 of The Pharmcast)

Posted by Jim Combs on 2/16/17 8:30 AM

We are at a time of great change and transition in the FDA. The sitting FDA chief stepped down, just when the 21st Century Cures Act passed into law; PDUFA 6 is up for renewal this year; and the new administration has signaled hiring freezes for government agencies, including the FDA.

While many of the policy and leadership changes in 2017 may not appear to make a day-to-day impact on drug developers at first, these changes can in fact have a profound impact. 

To help us understand how 21st Century Cures, PDUFA 6, and leadership changes can affect your development plans, we sit down with Dr. Tim Franson, who is not only YourEncore's Chief Medical Officer, but also Chairman of the Board  for The Critical Path Institute, the Immediate Past-President for the USP, and a key contributor to the last few PDUFAs.

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Topics: Regulatory, FDA, Pharmcast, policy, pdufa

Executive Briefing: EU Medical Device Regulation | 5 Ways EU MDR Will Impact Your Business [White Paper]

Posted by Patrice Napoda on 2/15/17 8:00 AM

The European Union has agreed on a new Medical Device Regulation meant to improve patient safety and data  transparency. The regulation is extensive and impactful – it touches many functions within the company and  companies that fail to comply will not be allowed to sell products into the EU. With the legislation expected to  publish in 2017, companies will have three years to bring medical devices into compliance and, under a separate new regulation for IVD’s, five years for these products.

With the EU finally reaching the agreement, the compliance clock is ticking. Although many functions are impacted, regulatory leaders will most likely be responsible for driving corporate compliance.  If you’re just starting the process, download Executive Briefing: EU Medical Device Regulation to learn five ways EU MDR will impact your business. 

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Topics: Regulatory, Medical Device, EU MDR

Medtech Valuation Killers: 10 Regulatory & Commercialization Traps to Avoid (Ep. 11 on The Pharmcast)

Posted by Jim Combs on 2/8/17 8:00 AM

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Topics: Regulatory, Medical Device, Med Dev, Pharmcast

Holiday Wish-Lists and Watch-Outs From Regulatory Leaders (Ep. 5 on The Pharmcast)

Posted by Jim Combs on 12/8/16 9:56 AM

 

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Topics: Pharmaceutical Industry, Regulatory, FDA, Pharmcast

Pharm-ers Almanac 2016: The Butterfly Effect

Posted by Tim Franson, MD on 9/27/16 8:30 AM

There is a saying, coined by the late Edward Lorenz, an early pioneer of the chaos theory, that “the flap of a butterfly’s wings in Brazil can set off a tornado in Texas.” This observation is known as the butterfly effect: the concept that small changes can have large downstream effects.

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Topics: Pharmaceutical Industry, Regulatory, Medical Device

Are You Ready for EU MDR?

Posted by Minnie Baylor-Henry on 9/15/16 12:47 PM

Back in 2010 when European regulators announced plans to overhaul legislation on how the European Union oversees medical devices, the industry knew that it would take time for changes to take effect. With the EU reaching agreement on the regulation, it appears that the final Medical Device Regulation (EU MDR) may take effect as early as January 2017. 

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Topics: Life Sciences, Pharmaceutical Industry, Regulatory, Medical Device

Embracing Satan's PDUFA

Posted by Peter J. Pitts on 8/19/16 8:00 AM

Monday’s public meeting on the FDA’s PDUFA VI Commitment Letter was a love-fest (mostly) – but as Theresa Mullin, Director of CDER’s Office of Strategic Programs, wisely noted, “the devil is in the details." Indeed.

The meeting was in three panels: Pre-Market Review and Post-Market Safety, Regulatory Decision Tools, and Administrative Enhancements.

A few highlights and comments.

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Topics: Pharmaceutical Industry, Regulatory, FDA

If Brexit, Whither EMA?

Posted by Peter J. Pitts on 7/14/16 9:00 AM


If Brexit, whither EMA?

Will Great Britain become like Norway and Iceland, attending committees such as the CHMP, where their views and votes are not of the same standing as those of members of the EU, or choose to follow a different route? There’s a lot at stake for the future of the MHRA and the British public health.

But what about the impact of removing MHRA expertise from EMA?

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Topics: Pharmaceutical Industry, Regulatory

Alternative Regulatory Pathways for Rare Disease: Breaking the ICE

Posted by Tim Franson, MD on 4/25/16 10:30 AM

There is a heightened sense of urgency by all stakeholders to accelerate development of therapies for rare disease.  The FDA shares this urgency, but it also must protect the public safety and follow the well-defined laws and regulations governing the process.

The challenge (or opportunity) is to develop creative approaches, which accelerate access and stay within the regulatory boundaries – or find ways to shape the boundaries.  Intermediate Clinical Endpoints, or ICE, could represent one such approach. 

I sat down with Dr. Joe Lamendola on April 7th to discuss this approach, and you can listen/watch the full converation below

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Topics: Pharmaceutical Industry, Regulatory, Rare Disease