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Social Media & Postmarketing Surveillance - Signal vs. Noise
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...
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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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