The Bio Report

What’s Driving the Booming Market for Orphan Drugs

The market for Orphan drugs is growing at more than twice the rate of other prescription medicines In 2013, a record 260 therapeutics won orphan designations in the United States alone as science, policy, and pricing are fueling the trend for drugmakers to develop expensive drugs for small patient populations. We spoke to Jon Gardner, author of a new report from EvaluatePharma, about the growth of the orphan drug market, how successful drugmakers have been at expanding the use of these drugs for non-orphan indications, and whether growing pricing pressure will lead to disruptions in the market for these products.

Why Interoperability Is Much More than a Technology Problem

A new government report finds that healthcare providers in the United States are increasing their adoption of health information technology, but their willingness to do so is tied to the incentives available. What’s more, the government is implementing a new plan to improve interoperability, a suggestion that results from past efforts have fallen short of expectations. We spoke to Joe Smith, chief medical officer and chief science officer for West Health, about the current state of health information technology, the barriers to interoperability, and what it will take to deliver on the promise of technology to improve healthcare.

The Lean Startup Takes Hold in the Life Sciences

The National Science Foundation and the National Institutes of Health, concerned about seeing the science they fund commercialized, have embraced the Lean Startup method as a way to improve the odds of success for new companies. Steve Blank, whose work launched the Lean Startup movement, has long worked with entrepreneurs, but last year began working with life sciences startups to apply the approach to an area he once thought it would not work. We spoke to Blank, entrepreneur, author, and Lean Startup guru about what startups do wrong, what he’s learned from applying the method to the life sciences, and whether there are lessons to be learned from lean startups for older, established companies.

Enlisting Monoclonal Antibodies to Combat Bacterial Resistance

There’s growing global concern about threat from antibiotic resistant pathogens. That’s leading to new interest in looking beyond traditional antibiotics to monoclonal antibodies to address the problem. We spoke to Ken Stover, senior director of infectious disease for MedImmune, about the problem, the role monoclonal antibodies could play, and why new efforts hold more promise than previous ones to enlist these powerful therapeutics, which are more often associated with cancer and autoimmune diseases.

The Forces Bringing Disruptive Change to Healthcare

Scientific breakthroughs, innovations in technology, and the changing use of data are among the forces that are driving disruptive changes to healthcare. A new report from the IMS Institute for Healthcare Informatics highlights a number of these developments and what they mean for the way healthcare is accessed and delivered. We spoke to Murray Aitken, executive director of the IMS Institute for Healthcare Informatics, about the report, how these developments are reshaping the healthcare landscape, and how they are altering the role drugs will play in advancing healthcare.

How One Foundation is Getting the Biggest Bang for Its R&D Bucks

As pressure on government and corporate research budgets grow, organizations like the Multiple Myeloma Research Foundation are playing an increasingly critical role in advancing and accelerating drug development. The foundation’s efforts, including its landmark genetic study of multiple myeloma patients, are helping advance innovative therapies in an area that had long been characterized by its lack of new treatment options. We spoke to Walter Capone, president and CEO of the Multiple Myeloma Research Foundation, about his organization’s efforts, how it’s breaking down barriers to cooperation between its partners, and what it’s doing to get the biggest bang for its research bucks.

International Collaboration Seeks to Drive Breakthroughs in Progressive MS

There has been dramatic progress in the understanding and treatment of relapsing remitting multiple sclerosis, a debilitating neurodegenerative disorder. But progressive MS, a more advanced form of the disease, has remained elusive. Now, a novel collaboration has brought an international group of MS societies together to fund research. We spoke to Bruce Bebo, executive vice president of research for the National MS Society and a member of the Progressive MS Alliance, about the intractability of progressive MS, how the unusual cooperation between MS groups came about, and whether the alliance will stand as a model for groups working in other disease areas looking to get the most out of their research investments.

Will Increased FDA Regulation of Diagnostics Speed or Slow Development of Personalized Medicine

The U.S. Food and Drug Administration is moving to expand its regulatory domain by adding oversight of certain diagnostics it does not regulate today. The agency says thousands of these test are used daily to guide treatment decisions and diagnose disease, and it wants to ensure their validity and advance personalized medicine. We spoke to Nathan Beaver, a partner with Foley & Lardner, about the FDA’s efforts, the implications for diagnostics companies, and why the agency’s plans are being met with some resistance from industry and Congress.