The Bio Report

Sprout Pharmaceuticals earlier this week won a controversial U.S. Food and Drug Administration approval of Addyi, the first drug approved in the United States to treat female sexual dysfunction. Following the news, Valeant Pharmaceuticals said it would acquire Sprout for $1 billion. We spoke filmmaker Liz Canner, director of the documentary Orgasm, Inc., about Addyi, the drug industry’s long standing pursuit of a female Viagra, and why its approval is troubling to many people.

Earlier this month in a preemptive challenge from Amarin Pharma against the U.S. Food and Drug Administration a federal judge ruled that the FDA cannot prohibit a drugmaker from promoting the off-label use of a drug if it does so through the dissemination of truthful and non-misleading information. The decision about the First Amendment Rights of a pharmaceutical company is seen as a significant ruling in a long-standing battle between the agency and the industry that has played out over the past 20 years. We spoke to John Kamp, executive director of the Coalition for Healthcare Communication, about the case, the issues behind it, and its implications for how the industry and agency will act going forward.

Drugmakers about 10 percent of the time fail to report serious adverse events to the U.S. Food and Drug Administration within the time required, according to a recent study in the Journal of the American Medical Association. We spoke to Pinar Karaca-Mandic, study co-author and associate professor of Health Policy and Management at the School of Public Health at the University of Minnesota, about the study, the concerns it raises, and whether regulators need to rethink the way adverse events are reported.

A growing problem with drug resistant infections acquired in hospitals is catching the eye of Consumer Reports, which has added the incidence of two common and deadly infections to their hospital ratings. The ratings come in the second part of a three-part investigation in the antibiotic crisis. We spoke to Doris Peter, director of Consumer Reports’ Health Ratings Center, about the study, what the highest rated hospitals are doing that the lower rated ones are not, and things patients can do to safeguard themselves when they face a hospital stay.

The controversy over the high price of new drugs and the question of the value they provide will come under increased scrutiny thanks to a grant to a Boston-based nonprofit that works to get at these questions. The Laura and John Arnold Foundation this week announced it is providing $5.2 million to the Institute for Clinical and Economic Review aimed at transforming the way new drugs are evaluated and priced. We spoke to Sarah Emond, COO of the institute, about the work it does, what this new grant will do to expand that work, and how to get a the question of the value of new drugs.

Researchers at the University of California, Berkeley and the Gladstone Institutes have grown beating cardiac tissue from stem cells in work that may lead to new ways to quickly screen for drugs likely to cause birth defects in the heart and identify drugs that may be dangerous during pregnancy. We spoke to Bruce Conklin, a senior investigator at the Gladstone Institute of Cardiovascular Disease, about the work, which was published in the journal Nature Communications, the promise it has for providing more accurate insights than animal models, and whether the approach could be expanded to other cell types to screen for drug toxicity to other organs.

For many patients with rare and difficult to diagnose conditions, it can take many years and many doctors to find a correct answer. CrowdMed is trying to offering an alternative to patients by allowing them to tap the wisdom of crowds and letting medical detectives who sign on to the site try to find the right answer. We spoke to Jared Heyman, founder and CEO of CrowdMed, about the problem with the traditional way doctors diagnose patients, the wisdom of crowds, and the case for making medicine a team sport.

Last year, the biotechnology industry set records across the board for financial metrics, a reflection of product success, new drug approvals, and free-flowing investment capital. Despite the record performance, concerns continue about growing pricing pressure and maturing pipelines that represent challenges with which the industry must contend. We spoke to Glen Giovannetti, EY’s Global Life Sciences Leader about his firms recently released Beyond Borders report, what the numbers tell us, and what the industry will need to do to keep the good times rolling.

A detailed view of funding of emerging therapeutic companies over the past ten years shows despite a rebound in venture financing, companies continue to struggle to find early-stage money. Nevertheless, the report shows the overall health of investment in the sector is thriving. We spoke to Dave Thomas, senior director of industry research and analysis for the Biotechnology Industry Organization and co-author of the report, about BIO’s findings, what therapeutic areas attracted the most financing, and what impact the capital markets have had on partnering and licensing activity.

To improve the long-term value of biopharmaceutical companies, management should learn to think more like activist investors, according to a new report from EY. The report argues that capital allocation and strategic decision-making could benefit from company leaders setting aside their assumptions and challenging themselves by thinking more like outsiders. We spoke to Jeff Greene, Global Life Sciences Transaction Advisory Services Leader for EY, about the report, what industry executives could learn from activists, and whether shareholder activists indeed have a track record worth emulating.

Bernard Muller was a successful businessman in the maritime and oil industry, but when he was diagnosed with the neurodegenerative disease ALS in 2010, he turned his entrepreneurial skills toward developing new therapies to treat the disease. Muller co-founded the world’s largest genetic research project for ALS, project MinE, and launched Treeway, a biotech company developing new therapies for ALS. As the Biotechnology Industry Organization kicks off its BIO 2015 International Convention in Philadelphia June 15, Muller is a finalist as one of the organization’s Everyday Superheroes in the pharma/biotech category. We spoke to Muller about his decision to launch Treeway, the active role he sees for patients, and why he thinks traditional approaches to drug development and clinical trial design have not served ALS patients well.

Sleep researchers and clinicians will be gathering in Seattle June 6 - 10 for SLEEP 2015, a joint meeting of the American Academy of Sleep Medicine and the Sleep Research Society. It is the largest gathering of sleep medicine physicians, sleep and circadian researchers, and health professionals in the sleep field. We spoke to Chris Winter, a fellow of the American Academy of Sleep Medicine and a board-certified sleep specialist with a background in neurology, about our understanding of sleep today, how genetics and digital health technologies may be altering our understanding of sleep, and what we should do to get a decent night’s rest.

Wall Street’s attention will turn to Chicago as the annual meeting of the American Society of Clinical Oncology runs from May 29 to June 2. Some 5,000 abstracts became available mid-month and investors have been sifting through them to gain insights into which drugmakers will rise and fall on news from the meeting. We spoke to Adam Feuerstein, senior columnist for TheStreet, about the ASCO meeting, what the early abstracts say, and who will likely be making headlines at the meeting this year.

A recent article in Nature Chemical Biology that shows it is possible to convert sugar into morphine with genetically engineered yeast has sparked public attention over the potential illicit use of the technology and the need for regulation. The work, though, also opens up significant possibilities for producing a wide range of drugs and the discovery of new ones to treat everything from cancer to infectious diseases. We spoke John Dueber, assistant professor of bioengineering at the University of California, Berkeley and one of the authors of the study, about the work, its implications, and what role biologists need to play in regulating themselves.

Universities are moving away from a passive approach to technology transfer to engage with industry in new partnerships, put a greater emphasis on translational research, and nurturing technologies so they can give rise to new products and companies. We spoke to Eric Tomlinson, chief innovation officer of Wake Forest Baptist Medical Center, about these changes, the approach Wake Forest is taking, and how it is forging new relationships with industry and the regional economy.

With the mapping of the human microbiome, a new understanding is emerging of the complex relationship between the microorganisms that live in the human gut, skin, and elsewhere on the body, and the role they play both in disease and in maintaining health. Along with growing concerns about drug resistant bacteria, this is giving rise to opportunities for narrow spectrum antibiotics. We spoke to David Martin, founder and CEO of AvidBiotics, about the problems of antibiotic resistance, the benefits narrow spectrum therapies offer, and how the sequencing of the microbiome is leading to new approaches to not only treat infectious diseases, but other diseases not traditional thought of as being driven by microorganisms.

AgeneBio is developing drugs to treat the pre-dementia stage of Alzheimer’s disease, and other neurological and psychiatric conditions. The company announced encouraging mid-stage results for its lead therapeutic, which works by quieting hyperactivity in the hippocampus portion of the brain, which plays a critical role in the formation of memory. We spoke to Jerry McLaughlin, CEO of AgeneBio about the company’s efforts, why this approach holds promise in delaying the onset of dementia in Alzheimer’s patients, and whether this approach may have implications for other neurological and psychiatric diseases.

In April, the IMS Institute released a new report that U.S. drug spending in 2014 rose 13.1 percent to $373.9 billion, the largest single year increase in spending since 2001. A number of factors drove the increase including the launch of innovative new therapies such as Gilead’s hepatitis C drug Sovaldi. We spoke to Murray Aitken, executive director of IMS Institute for Healthcare Informatics, about the new report, the confluence of factors that drove spending higher, and what the outlook is for 2015 and beyond.

AARP, the advocacy group serving people over the age of 50, is taking steps to ensure that digital health technologies best serve its membership. The organization has embarked on an initiative to test the design and functionality of digital health devices for older people and provide feedback to the marketplace. It’s enlisted partners United Healthcare and Pfizer as part of its effort. We spoke to Jeff Makowka, director of thought leadership for AARP, about its efforts, how it’s going about testing devices, and what it hopes to accomplish. We had some technical difficulties on this podcast that were not apparent during the interview. We’ve done our best to clean it up, but you will hear some static early in the recording. We apologize to our listeners and our guest, who we think you’ll find nonetheless interesting.

A newly discovered archive of documents reveal the sugar industry’s efforts to shape the national research agenda away from the effects of sugar on tooth decay and push for programs to focus on alternatives to reducing consumption. We spoke to Cristin Kearns, a University of California, San Francisco postdoctoral scholar who discovered the papers, about her research, how the agenda of the National Institute of Dental Health became aligned with the sugar industry’s, and how industry can subvert research agendas to protect their economic interests at the expense of public health.