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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.Originator firms must...
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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 Squibb Transformation (Part 1) (Ep. 1 of The...
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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Leading the Bristol-Myers Squibb Transformation (Part 2) (Ep. 2 of The...
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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9 Biotech Valuation Killers (Ep. 3 of The Pharmcast)
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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Billion Dollar Bets: Lessons on Innovation from a BMS Chief Scientific...
Each week in The Pharmcast, we talk with top industry experts from our network or beyond about hot industry topics, leadership, and the path to success. This week in The Pharmcast, we catch up with...
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Holiday Wish-Lists and Watch-Outs From Regulatory Leaders (Ep. 5 on The...
This week in The Pharmcast, we asked two of our top regulatory policy Experts to give us their holiday wish-lists and top things to watch for in 2017.Leading the discussion is Dr. Tim Franson, who is...
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From Big Pharma to Biotech C-Suite: Industry and Career Insights from Dr....
This week on The Pharmcast, we talk with Dr. June Almenoff, former President, Chief Medical Officer and Board Member of a biotech, which was recently acquired in 2014 by Actavis for $1.2 billion.With...
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Bioethics in Biopharma: Lessons on Safety, Big Data and Bioethics from Dr....
This week on The Pharmcast, we talk with Dr. Don Therasse, former VP of Global Patient Safety for Eli Lilly & Company, and current Strategic Advisor for YourEncore.With over 26 years of experience...
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FDA 483 Responses: Avoiding Common Pitfalls and Deficiencies (Ep. 8 on The...
This week on The Pharmcast, we explore best practices and common pitfalls in FDA 483 Responses. In 2015, there were an average of 175 inspections and 10 warning letters issued per month by the Center...
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No Surprises: Improving Medical Devices Due Diligence (Ep. 9 on The Pharmcast)
This week on The Pharmcast, we discuss 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...
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Patient Engagement: Putting Rare Disease Patients First (Ep. 10 on The...
This week on The Pharmcast, we turn our attention to the topic of rare disease, and more specifically: how to engage and educate rare disease patients to advance development. It's estimated that nearly...
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Medtech Valuation Killers: 10 Regulatory & Commercialization Traps to Avoid...
This week on The Pharmcast, we talk with Dr. Janet Vargo and Minnie Baylor-Henry on medtech valuation killers, and the 10 regulatory and commercialization traps to avoid. Dr. Vargo penned an article on...
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NDA Mistakes to Avoid: An Interview with Dr. Joseph Lamendola (Ep. 12 on The...
This week on the Pharmcast, we talk with Dr. Joseph Lamendola on four New Drug Application (NDA) mistakes to avoid.Dr. Lamendola is the former VP of U.S. Regulatory Affairs for Bristol-Myers Squibb...
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Executive Briefing: EU Medical Device Regulation | 5 Ways EU MDR Will Impact...
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...
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