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Roundtable: Driving Down Healthcare Costs

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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.


Understanding and Maximizing Interactions with the Califf FDA

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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.

FDA Gets Out In Front on Single Source Problem

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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:

Transparency Isn't a One-Way Proposition

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

Alternative Regulatory Pathways for Rare Disease: Breaking the ICE

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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

[Recording] EU Medical Device Regulation Presentation

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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.

[Watch] No Surprises: Improving Medical Devices Due Diligence

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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. 

Getting Real World About Outcomes Data

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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.


If Brexit, Whither EMA?

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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?

Real World Evidence: Times They Are a (Slowly) Changin'

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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.)

Embracing Satan's PDUFA

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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.

FDA 483 Response: Four Tips to Avoid a Warning Letter

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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.

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

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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: 

Are You Ready for EU MDR?

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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. 

Pharm-ers Almanac 2016: The Butterfly Effect

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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.


Considering Biosimilars – 3 Key Areas to Assess in Your Strategy

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Innovators simply cannot afford to ignore biosimilars. These products have the potential to create significant clinical and financial advantages for both patients and payers.

Navigating Drug-Device Combination Product Approval

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The popularity of drug-device combination products has been soaring. These products — which comprise combinations of drugs, biologics and devices — had sales reaching $22 billion in 2014, and the market is expected to grow to $31 billion by 2019.1

However, growth in this sector is threatened by a lack of alignment within the FDA, which is slow to approve drug-device combination products.  For those considering developing a combination product, I thought it helpful to provide an FDA primer to help people navigate the approval process and understand where the challenges are.    

Leading the Bristol-Myers Transformation: An Executive Roundtable (Part 2)

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A continuation of our maiden voyage of the Pharmcast, we talk with a trio of former Bristol-Myers Squibb executives, who developed and delivered BMS’ “String of Pearls” strategy, that delivered first-class medicines to patients and positioned BMS as a clear leader in the immuno-oncology space.

In part 2 of the roundtable, we start off with John Celentano, who was responsible for delivering a large organizational transformation to fund reinvestment in their innovation pipeline.

With the "string of pearls" strategy in place, it was time to figure out how BMS was going to pay for their acquisitions, and continue to fund the development of new products.

Knowing they needed to fundamentally change how they ran the business, the BMS board set out with something they referred to as "the productivity transformative initiaitive."

After restructuring the way the company ran, by shrinking the company and increasing productivity, the board members of BMS set their sites on investing in innovative products and technologies - primarily biologics. At the time, only about 6-7% of major drus were biologics. But, the BMS executives estimated that in the future, the biologic market would near 25%.

In what was, at the time, a make-or-break decision, the BMS executives made a leap-of-faith, $2.3 billion acquisition of a small company called "Medarex," a company that focused on immuno-oncology medicines.

Despite originally being heavily criticized by leaders in the oncology field for the alliance, BMS was well on their way to becoming a leader in the immuno-oncology space. 

Leading the Bristol-Myers Transformation: An Executive Roundtable (Part 1)

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We are pleased to announce that YourEncore has officially joined the podcasting ranks with the launch of the YourEncore Pharmcast, your weekly dose of wisdom from top life science minds.   Each week we will speak with top industry experts in our network or beyond about hot industry topics, leadership, and the path to success. 

For our maiden voyage of the Pharmcast, we talk with a trio of former Bristol-Myers Squibb executives, who developed and delivered BMS’ “String of Pearls” strategy that delivered first-class medicines to patients and positioned BMS as a clear leader in the immuno-oncology space.

What follows is a tremendous case study on leadership, portfolio decisions, organizational transformation, and most importantly, developing life-changing medicine for patients.

The Pharmcast: 9 Biotech Valuation Killers

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This week in the Pharmcast, we discuss "9 Biotech Valuation Killers" with Dr. Brian Daniels, the former SVP of Global Development for Bristol-Myers Squibb and now Venture Partner with 5AM Ventures, and Dr. Don Therasse, former VP of Global Patient Safety and Medical Affairs for Eli Lilly & Company.  

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