News & Views

|
News, Views
|
Category: News, Views

A Learning System, Deriving Value from Products Previously Studied

Many investigational products previously pursued by biopharmaceutical industry have value for small patient groups.  It is as important to glean value from existing products and knowledge as it is to pursue new treatments.  At a minimum, this could help the industry proactively face the issue of diminishing returns.  Drew Smith’s article on rising cost and declining discovery rates being the…
|
News, Views
|
Category: News, Views

We Have Reached Peak Pharma. There’s Nowhere to Go But Down, argues Drew Smith

The dynamics of the decline of pharmaceutical drugs are precisely those of a gold mine. The fist-sized nuggets have all been found, the gravel and sand is getting more expensive to recover, and soon there will be nothing but dust. We may have reached peak pharma — and there is nowhere to go but down. To read Drew’s article in…
|
News, Views
|
Category: News, Views

Creating a Learning Healthcare System (Part 1)

The successful practice of medicine requires a harnessing of collective wisdom.  Translational research (often used interchangeably with translational medicine) is a way of thinking about and conducting scientific research in a way that makes results of basic research applicable to patients.  When translational research happened mostly within academic centers, conveying new results into practice was easy.  Today, answers to problems…
|
News, Views
|
Category: News, Views

FDA’s Janet Woodcock: The Clinical Trials System is ‘Broken’

The clinical trials system is “broken” and there needs to be new ways to collect and utilize patient data, Janet Woodcock, director of FDA’s Center for Drug Evaluation and Research, told a workshop at the National Academies of Sciences, Engineering, and Medicine today.  Click here to read the full article published by Endpoints News in September 2017.
|
News, Views
|
Category: News, Views

The Generic Drug Industry has Brought Huge Cost Savings. That May be Changing.

Published by The Washington Post on 1 August 2017, this article discusses the changing cost of generic drugs. A decade ago, physicians who treat epilepsy got what seemed like a piece of good news: Eight companies had received federal approval to sell a generic version of an injectable lifesaving drug. Doctors liked the brand-name drug Cerebyx because it was safer…
|
News, Views
|
Category: News, Views

Libertarians Score Big Victory in ‘Tight-to-Try’ Drug Bill

Published by Politico on 3 August 2017, discusses the Senate Bill passing ‘Right to Try’ legislation would let very sick patients seeks unapproved treatments. The Senate unanimously approved a bill Thursday that would allow people facing life-threatening diseases access to unapproved experimental drugs, providing a victory for libertarian advocates who see government regulators thwarting patients’ rights. Click here to access…
|
News, Views
|
Category: News, Views

Senate Passes ‘Right-to-Try’ Bill to Help Terminally Ill Patients get Experimental Drugs

First published on 3 August 2017, this article in the Washington Post discusses recently passed ‘Right to Try’ legislation, aiding access to treatments for terminally ill patients. The Senate on Thursday passed by unanimous consent a measure designed to make it easier for terminally ill patients to get access to experimental treatments without oversight from the Food and Drug Administration.…
|
News, Views
|
Category: News, Views

A Rush for Immunotherapy Cancer Drugs Means New Bedfellows

Published in August 2017 by The Economist, this article discusses how once fierce rivals in Pharma are co-operating with an open innovation development model. THE modern pharmaceutical firm lives or dies on the strength of its drug portfolio. As patents expire on lucrative medicines, they must replace the income that has been lost by inventing new drugs, or buying them…
|
News, Views
|
Category: News, Views

FDA Calls for Master Protocols to Study Multiple Therapies, Multiple Diseases, or Both.

In this article published in the New England Journal of Medicine, July 2017, Janet Woodcock, M.D. et al, discuss the need for master protocols to enable the scaling of studies retaining high quality clinical evidence particularly in the conduct of “precision medicine” trials. Access the full article at http://www.nejm.org/doi/full/10.1056/NEJMra1510062#t=article
|
News, Views
|
Category: News, Views

Equipoise Lost: Ethics, Cost and the Regulation of Cancer Clinical Research

This paper by David J. Stewart, et al, first published in the Journal of Clinical Oncology: Volume 28, Number 17 (June, 2010), discusses how current approaches squander research resources and discourage research participation, and the marked imbalance between potential life-years lost versus saved renders the regulatory burden potentially unethical.  Stewart, et al. discuss suggested solutions. Access the full article at…

Register today, connect your research network, 
and accelerate your research program.

Up arrow