YourEncore Insights - Life Sciences

Drug Pricing – What’s the Answer to High Cost Off-Patent Medicines?

Posted by Jim Combs on 9/13/16 11:00 AM

In the wake of the Turing, Valeant, and Mylan EpiPen pricing controversies, YourEncore Insights coordinated a conversation with two top experts to discuss potential solutions to some drug pricing dilemmas.  I interviewed Peter J. Pitts, former FDA Associate Commissioner and President of the Center for Medicine in the Public Interest, and Dr. Tim Franson, YourEncore’s Chief Medical Officer and former VP of Global Regulatory Affairs for Eli Lilly and Company.

The transcript is provided below: 

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Topics: Pharmaceutical Industry, FDA, Drug Pricing

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

Transparency Isn't a One-Way Proposition

Posted by Peter J. Pitts on 4/13/16 11:00 AM

Transparency in medicine isn't a one-way street.

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Topics: Life Sciences, Pharmaceutical Industry, Regulatory

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

Understanding and Maximizing Interactions with the Califf FDA

Posted by Peter J. Pitts on 3/17/16 9:36 AM

image source:

Does it really matter who sits in the corner office at the FDA?

Isn’t PDUFA VI already a done deal?

Can one person really change the direction of an agency that is almost entirely staffed by career civil servants?

Why bother with a new Commissioner with only one year left in the Administration?

These are all good questions, and the right answers depend on specifically who is leading the FDA.  Thanks to his recent confirmation, we now know that man is Dr. Robert Califf.

For some answers, insights, and prognostications to the questions above, I sat down with Dr. Tim Franson, Chief Medical Officer of YourEncore, to discuss what industry can expect and how to maximize future FDA interactions. 

Listen to the 40 minute discussion.  It’ll be 40-minutes well spent.

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Topics: Pharmaceutical Industry

From Snake Oil to Fish Oil: The Need for a New Approach to Off-Label Communication

Posted by Peter J. Pitts on 2/25/16 1:23 PM

As you well know, off label communications is on my short list of regulatory policy and public health issues that keep me up at night.  

Why?  There is a leadership vacuum on the topic, and absent clear leadership, federal judges are starting to dictate regulatory policy through the Amarin case and others.  If existing policy has evolved to protect the public from snake oil, the recent Amarin decision is precarious precedent for communications about fish oil – and beyond.   

To help find better solutions to this important issue, on February 18th the new Duke-Margolis Center for Health Policy held a conference titled, “Off Label Communication in 2016: Meeting Information Needs through New Policy Options.”

Those new options are detailed in an important new paper:
Policy Options for Off-Label Communication: Supporting Better Information, Better Evidence, and Better Care

I am honored to be one of the co-authors and to have had the opportunity to speak at the event. 

Just about every speaker pointed to the need for FDA leadership though bold action and … clarity.  The paper lays out what we refer to as Guiding Principles for Lasting Solutions. They are:

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Topics: Life Sciences, Pharmaceutical Industry, Regulatory

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

Regulatory R.A.N.T. - Biomarkers, Pediatrics, Benefit-Risk - Oh my!

Posted by Peter J. Pitts, Tim Franson M.D. on 2/11/16 11:44 AM

To protect sustainable innovation, it is vital to look beyond present conditions and develop proactive interventions for anticipated environmental changes. With development times for new biomedical medicines and devices now spanning years (and sometimes over a decade), regular audits (at least yearly) are essential in recognizing and adapting to key "climate changes."

Given the importance of both identifying new trends and their impact on the development and commercialization of every product and process, YourEncore gathered an eclectic entourage of experts with deep experience in regulatory and industry leadership after the recent RAPS meeting in Baltimore. We call these sessions R.A.N.T.s - Relevant Assessments, New Trends.  We turned the panel discussion into a white paper, full of insider insights on the changing face of biomarkers, pediatric studies and benefit-risk, all of which are integral factors in development planning that exist in a state of constant flux.

The discussion is particularly timely if you've read the FDA's recently released 2016 Guidance Agenda.  We trust you will find this material useful in preparing for the upcoming guidance season as well as informing your product/portfolio management and regulatory strategies.

Download the white paper now. 

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Topics: Life Sciences, Pharmaceutical Industry, Regulatory, Rare Disease, Pharmacovigilance