Articles
ClinPage: Why JNJ Frets About ‘Big Data’
Big data was a theme at this week’s 2012 Post-Approval Summit. For eight years, the meeting has been organized by academic surgeon Richard Gliklich and hosted on his turf, the Longwood portion of Harvard’s medical empire.
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PharmExec.com: Post-Approval Regulatory Priorities: Progress or Pile-Up?
An enduring falsehood about the pharmaceutical industry is that the heavy lifting ends with a successful new drug registration. What comes after is the equivalent of a well-funded retirement, where providers embrace the therapy, payers meet the price, and patients push the boundaries of clinical practice toward lucrative new indications.
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The Pink Sheet: REMS Assessment Is As Challenging As Initial Design, Regulators Acknowledge
Regulators on both sides of the Atlantic are grappling with how to measure whether risk management programs imposed on pharmaceuticals are having the desired effect.
The Pink Sheet: FDA's New Interest: Identifying Latent Risks
FDA is taking a closer look at how to identify risks that present spontaneously by modestly. "There is new and growing interest in this kind of event." said Bob Temple, Associate Director for Medical Policy, CDER. "A real change in focus."
Applied Clinical Trials: Observations from the Post-Approval Summit
We are moving to an age of active surveillance and this will create new issues, but also solutions,” said Richard Gliklich, MD, Harvard Medical School and president and chief executive officer of Outcome Sciences.
BIO-IT World: CDER Stresses 'Active' Post-Approval Surveillance
Speakers at the recent Post-Approval Summit* left no doubt that we are entering a new era of active surveillance of post-approval drugs. Richard Gliklich, chairman of the conference, said a number of forces have recently changed the role of post-approval research from “what had been an afterthought to something far more intrinsic” to the delivery and evaluation of health products.
BIO-IT World: McClellan Envisions Lifecycle Approach to Drug Surveillance
Rising drug development costs and public frustration about major drug recalls highlight the need for an active, post-market drug surveillance system, Mark McClellan told attendees at the recent Post-Approval Summit.
SCRIP: Implications of the FDA’s increased focus on post-approval safety
The passage of the Food and Drug Administration Authorization Act (FDAAA) in September 2007 represents a sweeping overhaul of the US system for ensuring the safety of approved drugs.
CWWeekly: CDER’s Woodcock Details Expanded Authority, Sentinel Concept at Post-Approval Summit
Opening the Post-Approval Summit at Harvard, keynote speaker Janet Woodcock, M.D., Director of the Center for Drug Evaluation and Research (CDER), Food and Drug Administration (FDA), outlined her agency’s expanded authorities in the area of post-approval research oversight brought about by the passage of the FDA Amendments Act (FDAAA) into law at the end of March.
ClinPage: FDA’s Woodcock On FDAAA
Last week, we quoted Wyeth’s Joseph Camardo on the renewed user fee legislation known as FDAAA. He’s not sure the new post-marketing environment is starkly different from the old one. In thinking of the still-murky FDAAA regulatory landscape, we were reminded of a lyric from The Who: “Meet the new boss, same as the old boss.”
ClinPage: Wyeth on FDAAA
Because of the random sighting of Ira Spector at one conference or another, we’ve always had a soft spot for Wyeth. We don’t know Spector—no need to fret he has been consorting with the news media.
ClinPage: Post-Approval? Or Pre-Apocalypse?
Maybe it’s the medical school ambiance. Or the end of a long Boston winter. But every year, for mysterious reasons, the Post Approval Summit feels a bit different than other meetings.
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CWWeekly: PDUFA Revitalization Act to Boost Post-Approval Sector
Congress' recent reauthorization of the U.S. Food and Drug Administration's (FDA) Prescription Drug User Fee Act (PDUFA) included a series of changes that will no doubt have profound effects on the clinical trials industry.
ClinPage: Post-Approval Summit Politician Serono Speak at Meeting
Mark Uehling, Editor, ClinPage
The Post-Approval Summit at Harvard, now in its third year, is the most cerebral conference on our calendar. It is also the meeting most larded with VIP speakers, including a preponderance of physicians who run a) large swaths of international companies or b) big slices of a regulatory bureaucracy in the U.S. or Europe.
CWWeekly: A CenterWatch Publication - May 2006
The recent, 2nd Annual Post-Approval Summit held at Harvard Medical School included two days of indepth sessions focusing on the evaluation of marketed treatments in real-world patient outcomes.
BIO-IT World: eCliniqua
Mark Uehling, Senior Science Editor
Last year, we recounted some of the Post Approval Summit's outstanding speeches by multiple FDA people, an ex-FDA boss and a dozen thought leaders from Pfizer, Genentech, and other companies. We thought it would be hard to top that meeting at the Harvard Medical School. We were wrong.
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GCPJ: RiskMAPs - A Route to Drug Safety
Based on a presentation by Anne Trontell, MD, MPH, Deputy Director of the FDA's Office of Pharmacoepidemiology and Statistical Science
As the public calls for better tracking of adverse events and swifter action when a problem is identified the pharma industry must raise its game. Trontell discusses the FDA guidance designing a risk minimization action plan (RiskMAP). The article focuses on utility and design in three types of RiskMAPs: targeted education and outreach, patient reminder systems, and performance-linked access systems.
Get with the Guidelines for Cardiovascular Secondary Prevention
Kenneth LaBresh, MD, et al.
Research shows that Web-based quality initiatives demonstrably improve patient outcomes. Using a Web-based Patient Management Tool as part of a collaborative quality improvement initiative enhanced adherence to prevention guidelines in hospitalized patients with coronary artery disease.
ClinPage: Woodcock at Harvard
Mark Uehling, Editor, ClinPage
Like those who work in quarries and mines, journalists covering the pharmaceutical industry wear special ear protection while on the job. It's all required by OSHA and has greatly advanced over the years. Certain terms that (for those in the life sciences) are oxymoronic or their own antonyms never reach the battered ears of journalists. Other words, which tend to have highly convoluted meanings (think "governance," "real-time," "proactive"), are automatically back translated into English.
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Life Science Leader: A Review of the 2011 Post-Approval Summit
Sara Gambrill, Contributing Editor, Life Science Leader
There is an enormous amount of data generated by post-approval research, but one of the nagging questions is: how can researchers get even more, better data and refine it into information that plays a role in decision-making by regulators, biopharma, physicians, insurers, and patients, ultimately improving health outcomes? Speakers at the two-day Post-Approval Summit in Boston (www.postapproval.com) shared a myriad of ways in which they were already embarking on this quest, and some of the highlights are shared below.
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