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Life Sciences Insights from YourEncore

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    New technologies that support postmarketing patient communication and safety surveillance can produce a mountain of data.  But are these new tools creating value or just more noise?

    YourEncore recently convened a panel of experts to discuss this topic after the 2015 Regulatory Affairs Professional Society (RAPS) Convergence conference in Baltimore, Maryland. To watch the panel discussion, click here.

    YourEncore Executive Partners, Peter J. Pitts, former FDA Associate Commissioner, and Dr. Don Therasse, former VP of Global Patient Safety and Global Medical Affairs at Eli Lilly & Co., shed some light on the topic.


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    The debate around clinical trial transparency is certainly nothing new. But is the answer, as some call for, "more transparency and oversight?"


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    During my 18 years at a major pharmaceutical company I initiated and managed the introduction of many new technologies into both pre-clinical and clinical project teams. One of my greatest challenges was translating new biomarker discoveries into assays that could be used successfully to support clinical trials.

    Discovery of new clinical biomarkers is occurring at a furious pace, which is encouraging to both drug developers and patients hoping to shorten clinical study and approval timelines. However, qualification of these new biomarkers has just begun and, while the FDA has recently outlined a proscriptive qualification process, it is unclear what biomarkers will ultimately receive regulatory approval (or how long it will take).

    So, you may find yourself in the situation where you are aware of a new biomarker that could be a significant improvement over existing assays used to support clinical trials but the data to support that contention is not yet available. Under these circumstances, what is the best way to proceed?

    I recommend you answer the following six questions before adding a new biomarker to your clinical trial protocol:


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    Billboard recently released its “Hot 100 Songs of 2015,” and it inspired me to think about YourEncore Insights' list of greatest hits. For those playing along at home, “Uptown Funk!” by Mark Ronson and  featuring Bruno Mars won top honors from Billboard.

    While Bruno Mars is not a part of the YourEncore expert network, we are humbled to have our own rock stars as 2015 YourEncore Insights contributors, who include:

    • Former FDA Associate Commissioners and Deputy Commissioners
    • Presidents of the US Pharmacopeial, Regulatory Affairs Professional Society, and Critical Path Institute
    • VPs of Development, Regulatory Affairs, Global Patient Safety, and Medical Affairs for large pharma companies
    • Founding President and CEO of Parent Project Muscular Dystrophy
    Even though we just formed this band in August, we’ve been on tour, developed a following, and produced some interesting work.  To quote Bruno, “Don’t believe me, just watch (or read on) - Hay!”

    Here are our most popular Insights of 2015:


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    GAO Asked to Assess Viability of FDA’s Complex Generics Pathway

    The FDA has begun approving generic versions of non-biologic complex drugs (NBCDs) using the same regulatory approval pathway used for small molecule drugs. However, the House Energy & Commerce Committee is asking the Government Accountability Office (GAO) to evaluate if this approach is sufficient.


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    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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    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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    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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    Yesterday the FDA Science Board discussed the agency’s approach to opioids.

    FDA presenters included agency point-man Doug Throckmorton (Deputy Director for Regulatory Programs, CDER), Janet Woodcock (Director, CDER), Sharon Hertz (Division Director, Division of Anesthesiology, Analgesia and Addiction Products), Gerald Dal Pan (Director, Office of Surveillance and Epidemiology) – and newly confirmed FDA Commissioner Rob Califf.

    Califf was there at the beginning of the meeting (expected) and stayed through the entire length of the day-long affair (unexpected). An important signal that he intends to be a hands-on leader.

    I was chosen to speak during the open public comment part of the hearing, and spoke about using real-world information to provide providers and patients with information beyond the limited world of pivotal trials. Here are my brief remarks:


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    Advisory Committee meetings are an incredibly intense and high stakes endeavor within the drug development process. Millions in R&D costs, potential revenue, and patients served can come down to an eight hour meeting. When the FDA ultimately sides with the Advisory Committee’s recommendation approximately 85% of the time, these meetings have to go well.

    Over the course of my 25+ year regulatory career, I’ve participated in numerous Advisory Committee meetings across a variety of therapeutic areas. Some went smoothly, and others didn’t. In my experience, when things don’t go well, it’s usually because of three main problems.


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    Everybody wants to lower healthcare costs, but nobody agrees on the best way to do so. And what about those pesky unintended consequences?

    I was asked by Healthcare Sales & Marketing Magazine to lead a panel of three experts on this timely/thorny topic. My co-conspirators include Ben Locwin (President, Healthcare Science Advisors), Bill Soucie (Vice President of Market Access at Xenoport), and Matt Wallach (Co-Founder and President, Veeva Systems).

    As the lead-in to the the panel says, "Something needs to be done."

    Read the full article to hear the panel’s take on the causes and possible cures for rising healthcare costs.


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    image source: fda.gov

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


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    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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    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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    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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    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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  • 07/14/16--06:00: If Brexit, Whither EMA?

  • 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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    Per the FDA’s PDUFA VI "commitment letter," the agency will face some real world deadlines to advance the use of real world evidence. But, since we’re dealing with the real world, let’s get real – guidance is unlikely until the end of 2022 at the earliest. (That's the timeline agreed to via the PDUFA VI negotiations.)


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