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Roundtable: Driving Down Healthcare Costs
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...
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Understanding and Maximizing Interactions with the Califf FDA
image source: fda.govDoes 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...
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FDA Gets Out In Front on Single Source Problem
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....
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Transparency Isn't a One-Way Proposition
Transparency in medicine isn't a one-way street.
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Alternative Regulatory Pathways for Rare Disease: Breaking the ICE
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...
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[Recording] EU Medical Device Regulation Presentation
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...
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[Watch] No Surprises: Improving Medical Devices Due Diligence
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...
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Getting Real World About Outcomes Data
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...
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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,...
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Real World Evidence: Times They Are a (Slowly) Changin'
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 –...
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Embracing Satan's PDUFA
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...
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FDA 483 Response: Four Tips to Avoid a Warning Letter
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...
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Drug Pricing – What’s the Answer to High Cost Off-Patent Medicines?
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...
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Are You Ready for EU MDR?
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....
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Pharm-ers Almanac 2016: The Butterfly Effect
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...
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Considering Biosimilars – 3 Key Areas to Assess in Your Strategy
Innovators simply cannot afford to ignore biosimilars. These products have the potential to create significant clinical and financial advantages for both patients and payers.
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Navigating Drug-Device Combination Product Approval
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...
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Leading the Bristol-Myers Transformation: An Executive Roundtable (Part 2)
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...
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Leading the Bristol-Myers Transformation: An Executive Roundtable (Part 1)
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...
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The Pharmcast: 9 Biotech Valuation Killers
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,...
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