The Bio Report

Will Policy Triumph Over Politics in 21st Century Cures Act

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.

Democratizing the World of Healthcare Analytics

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.

Will Funding for Obama’s Precision Medicine Initiative Match Its Ambition

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.

Should Investors Temper Their Enthusiasm for CAR-T Therapies

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.

What to Do About the United States’ Declining Investment in R&D

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.

Why Big Pharma Hasn’t Been Able to Fix Its Revenue Gap with M&A

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.

Remembering Industry Pioneer Ron Cape

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.

Moving from Chronic Therapies to Cures

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.