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Riding the Policy Roller Coaster in 2017: A Policy Update with Dr. Tim...
We are at a time of great change and transition in the FDA. The sitting FDA chief stepped down, just when the 21st Century Cures Act passed into law; PDUFA 6 is up for renewal this year; and the new...
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Working with the FDA: Developing a Regulatory Strategy That Works (Ep. 14 of...
On this week's episode of The Pharmcast, we explore the key elements of an effective regulatory strategy and how to drive value to patient and shareholders by working with the FDA. We also cover common...
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The Future is Here: Using Big Data and Artificial Intelligence in Oncology...
On this week's episode of The Pharmcast, we talk with YourEncore Expert, Philippe Barzin, on the future of big data and artificial intelligence in oncology. Based off Philippe's article, Artificial...
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7 Best Practices in Biologics Launch Communications (Ep. 16 of The Pharmcast)
On this episode of The Pharmcast, Heidi Youngkin shares seven best practices for successful biologic launch communication.When it costs over $2.5B dollars to develop a drug, according to the most...
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Welcome to the Real World: A Reality Check for Digital Health with Dr. Ron...
This week on The Pharmcast, we tackle one of the hottest topics in the life sciences and healthcare industry: digital health. The promise of digital health is enticing, and a logical evolution of the...
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YourEncore Announces Addition of Michelle DeJonge and Dr. James Wood as...
INDIANAPOLIS, IN--YourEncore (www.yourencore.com), a company that helps firms in the life sciences, consumer products and food sciences industries solve complex innovation, compliance and productivity...
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The Frontiers of Rare Disease Development: Advances in Regulatory Science...
This week on The Pharmcast, we catch up with Dr. Tim Franson to discuss the leading edge of rare disease drug development. Dr. Franson has been actively helping Parent Project Muscular Dystrophy, a...
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State of the Industry: U.S. Regulatory Policy Improvements (Ep. 19 of The...
In this episode of The Pharmcast, we share a recording from our May 5th webinar, State of the Industry: U.S. Regulatory Policy Overview. Parthenon-EY and YourEncore recently conducted a nationwide...
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Ten Tips for Enterprise Technology Adoption in Pharma
The RFP processes are robust, the ROI models are compelling, the software is best of breed, and the expectations are high. So, why do so many software deployment programs in Pharma fail to deliver...
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How Blockchain is Revolutionizing the World and Changing Healthcare as We...
In this episode of The Pharmcast, we join YourEncore Expert, Darryl Glover, to discuss one of the hottest technologies on the market today: blockchain.We've heard some people say that if the internet...
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Transparency vs. Smoke and Mirrors: Clinical Trials Debate
The debate around clinical trial transparency is certainly nothing new. But is the answer, as some call for, "more transparency and oversight?"I say it’s just not that simple.As the former senior...
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6 Must-Ask Questions Before Adding New Biomarkers to Your Clinical Trial...
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...
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YourEncore Insights Greatest Hits of 2015
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...
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FDA and NBCDs: Do Not Pass GAO
GAO Asked to Assess Viability of FDA’s Complex Generics PathwayThe FDA has begun approving generic versions of non-biologic complex drugs (NBCDs) using the same regulatory approval pathway used for...
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Regulatory R.A.N.T. - Biomarkers, Pediatrics, Benefit-Risk - Oh my!
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...
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A Biotech’s Guide to FDA’s 2016 Agenda
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...
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From Snake Oil to Fish Oil: The Need for a New Approach to Off-Label...
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...
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FDA's Abuse-Deterrent Commissioner
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...
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FDA Advisory Committee Mistakes to Avoid
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...
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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.The transparent truth is that the prices patients actually pay aren't set by drug manufacturers — they're determined by pharmacy benefit managers,...
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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.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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Improving R&D Productivity with Activity Based Costing
Today’s prevailing wisdom is that R&D costs are on the rise while ROI on those investments are down. The Tufts Center for the Study of Drug Development puts the total costs of new drug around $2.7B...
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