The Bio Report

At the end of January, after nearly a year of hearings, roundtables, and white papers, the House Energy and Commerce Committee’s Subcommittee on Health released a draft of the much anticipated 21st Century Cures Act. The draft, nearly 400 pages long, addresses a broad range of issues in the drug and device development and review process. We spoke to Nick Manetto, principal with the national advisory and advocacy firm FaegreBD, about the legislation, where the points of controversy lay, and whether despite its bipartisan birth political brawling is ahead.

There’s no shortage of data created in the world of healthcare, but harnessing it to improve care and reduce costs remains a challenge. Apervita, backed with $18 million recent venture investment from GE Ventures, Baird Capital, and others is a marketplace for people to buy and sell their healthcare analytics. We spoke to Paul Magelli, CEO of Apervita, about the pressures on healthcare providers today, the challenges to integrating analytics into practice, and how Apervita hopes to change that.

President Obama unveiled the details of his $215 million precision medicine initiative, the centerpiece of which is a 1 million person study that seeks to correlate genetic data, with health records, lifestyle information, and more to better understanding wellness and disease and fuel the development of new therapies. We spoke to Amy Miller, executive vice president of The Personalized Medicine Coalition, about the initiative, if the funding for it will match its ambition, and whether concerns about privacy will stand as a barrier to its success.

CAR-T cell immunotherapies seek to harness the body’s immune system to fight tumor cells. The promise of this new class of therapies has ignited investor’s imaginations, but a new report from EP Vantage argues that the enthusiasm that has driven valuations of CAR-T companies should be tempered by an eye towards the risks. We spoke to Jacob Plieth, report author and senior reporter for EP Vantage, about the promise of these therapies, what we know about their safety and efficacy, and why the muddy intellectual property landscape is a concern.

Investment in biomedical research in the United States is declining at a time when other countries have been increasing their spending. While this is raising concerns about the threats this poses to the nation’s economic competitiveness, a new study in the Journal of the American Medical Association suggests new strategies will be necessary to fund research and development if the clinical value of past investments and opportunities to improve care are to be fully realized. We spoke to study co-author Ray Dorsey, Professor of Neurology and Co-Director of the Center for Human Experimental Therapeutics at the University of Rochester Medical Center, about the findings, what strategies can be employed to reverse the trends, and why new investment alone is not the answer.

It was an unprecedented year for M&A activity in the life sciences, but even though Big Pharma returned to dealmaking after largely spending 2013 on the sidelines, it’s been unable to close its growth gap through acquisitions. Specialty Pharmaceutical and Big Biotech have been building muscle and key acquisitions that could address growth for Big Pharma continue to be snapped up by competitors. We spoke to Jeff Greene, EY’s Global Life Sciences Transaction Advisory Services Leader, about his firm’s new M&A report, at what point the growing price of assets becomes too rich, and what the outlook is for 2015.

Ron Cape, co-founder, chairman and CEO of Cetus, the first biotechnology company, died earlier this month at 82. Cetus, which developed PCR technology, as well as Betaseron and Interleukin-2,has faded from the minds of industry watchers, but its impact has been lasting. The company not only provided scientific, but financial and cultural innovations that helped shaped the industry. Chiron acquired the company in 1991. We spoke to Mark Jones, director of research for the Life Sciences Foundation about Cape, the innovations he made, and his lasting contributions.

The rapidly growing area of regenerative medicine is promising to replace chronic therapies with cures. As the biotechnology industry gathers in San Francisco for a big week of meetings, the Alliance for Regenerative Medicine is readying to deliver its annual State of the Industry Briefing. We spoke to Edward Lanphier, president and CEO of Sangamo Biosciences and the newly elected chairman of the alliance, about the transformation of medicine that’s underway, the particular excitement among investors and industry over gene therapy, and why he’s confident payers are ready to embrace the new technology.

As the biotech industry ramps up for the JPMorgan Healthcare conference, we continue our conversation with TheStreet.com’s Adam Feuerstein. In part two of our conversation, we look ahead to what’s in store for the biotech industry in 2015. We get Feuerstein’s thoughts on who and what to watch in the new year, what Big Pharma company may be the target of a takeover, and whether fights over drug pricing will put an end to biotech’s bull market.

The year 2014 was one for the record books for the biotech industry. In part one of a two-part podcast, we take a look back at the year that was with Adam Feuerstein, senior columnist for TheStreet.com. Feuerstein discusses the growing controversy over drug pricing, the newsmakers of 2014, and lessons from the Dendreon bankruptcy.

Two-thirds of Americans say they are willing to anonymously share their health information with researchers, but only about 1 in 5 is willing to provide their purchase history or social media activity, according to a recent Truven Health Analytics-NPR Health Poll. The findings suggests that while there is growing comfort with electronic health records, privacy concerns may hinder the ability of Big Data to deliver on its full promise to improve the health of individuals. We spoke to Michael Taylor, chief medical officer of Truven Health Analytics, about the survey, the level of theft and misuse of health data, and who people trust the most with their information.

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.