The Bio Report

The cost of drug development, a metric that underlies discussions ranging from investment in startups to drug pricing, is a matter of great interest and controversy within the pharmaceutical industry. The Tufts Center for the Study of Drug Development recently completed a new estimate of the cost of developing a new prescription drug and raised it to $2.6 billion, up from $802 million in 2003. We spoke to Joe DiMasi, director of economic analysis at the Tufts center for the Study of Drug Development and principal investigator for the study, about the findings, why there’s been dramatic growth in cost despite efforts to reinvent drug development, and whether there’s reason to think the trend will reverse itself anytime soon.

News last month of the Cystic Fibrosis Foundation’s $3.3 billion sale of royalty rights to Kalydeco and other Vertex Pharmaceuticals drugs it helped fund served as a bold statement to the growing prominence and power of venture philanthropy. We spoke to Margaret Anderson, executive director of FasterCures, about the transaction, the role new funding and collaboration models are playing in accelerating drug development, and what traditional investors and disease groups are learning from each other.

While many may think of telemedicine as an example of digital health technologies that will reshape the future landscape of medicine, a new survey from the law firm Foley & Lardner shows it is very much part of healthcare’s here and now. We spoke to Monica Chmielewski, special counsel to Foley & Lardner, about the survey’s findings, how the Affordable Care Act is fueling growing use of telemedicine, and why reimbursement concerns remain the biggest barrier to wider adoption.

IBM’s Watson Group recently announced an investment in Pathway Genomics, part of a $100 million initiative by the computing giant to spur innovation in entrepreneurial companies that seek to leverage its cognitive computing platform Watson. Pathway Genomics will develop an app that will use Watson to provide health and wellness guidance customized to a user’s genetics. We spoke to Lauri Saft, director of IBM Watson Partner Programs, about the agreement, the things Watson can do better than doctors, and how this cognitive wonder promises to transform healthcare.

Brittany Maynard, a 29-year-old woman with terminal brain cancer who chose to end her own life with a lethal dose of medication, sparked a renewed discussion of so-called death with dignity laws. Maynard had become visible on social and traditional media in her final weeks as she campaigned for legislation now pending in several states. We spoke to Alan Meisel, professor of law and bioethics at the University of Pittsburgh and founder and director of the university's Center for Bioethics and Health Law, about the Maynard case, the state of existing and pending legislation, and whether Americans are becoming more willing to discuss the need to balance technological interventions with quality of life issues when considering their own deaths.

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.

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 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.

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.

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.