The Bio Report

For people with type I diabetes, the day-to-day management of the disease can be a full-time job involving the monitoring blood glucose levels and injection of insulin. The medical device giant Medtronic has been working toward the development of what it’s called an artificial pancreas, a steady improvement of pump and sensor technology to free type I diabetes patients and allow them to think less about the management of their disease. We spoke to Fran Kaufman, chief medical officer of Medtronic Diabetes, about the progress the company has made, its newest technology that is moving towards the market, and how close it is to realizing its vision of an artificial pancreas.

By using data from routine testing about the genetic evolution of the HIV /AIDS virus in the Canadian province of British Columbia, researchers have shown they are able to identify emerging outbreaks of the disease in near real-time and intervene to control its spread. The first-of-its-kind system is the focus of a study in an April edition of The Lancet HIV. We spoke to Art Poon, Associate Research Scientist for the British Columbia Centre for Excellence in HIV/AIDS and lead author of the study, about the monitoring system, the impact it has had, and whether such an approach is transferable to other regions and other disease outbreaks.

As pricing pressure grow on the pharmaceutical industry, a recent article in Invivo argues that drugmakers must look to a variety of new pricing models built around collaborations with payers and providers. Such an approach, the authors argue, would minimize conflicts between stakeholders, close the information gap about the real-world value of new drugs, and allow for a more evidence-based approach to pricing. We spoke to Susan Garfield, a principal in EY's Life Sciences Advisory Services practice and co-author of the Invivo article, about the need for new approaches to pricing, why the existing unit price approach is too one-dimensional, and what’s at stake for the industry if it fails to innovate new models.

The France-based biotech Gensight Biologics is developing gene therapy treatments for rare, mitochondrial, and neurodegenerative diseases of the eye. Its lead therapeutic candidate is in late-stage trials for Leber’s Hereditary optic neurophathy, a sudden condition that afflicts young adults and leaves almost all of them blind. We spoke to Gensight’s CEO Bernard Gilly about the company, the challenges and promises of gene therapy, and why eye disease is a particularly attractive target for this emerging area of treatment.

Nearly $3 billion a year is wasted on cancer drugs because of the way they are packaged, according to a study in BMJ. These expensive drugs that are injected or infused come in fixed size vials and patients often require less drug than what is sold as a single dose. Because of restrictions on the ability to use leftover drug, the result is that it is usually thrown out. Nevertheless, drugmakers have little incentive to do things differently because the waste enhances their profitability. We spoke to Leonard Saltz, an oncologist with Sloan Kettering Memorial Cancer Center and coauthor of the study, about the findings, why Europe doesn’t have the same problem, and what can be done to stop the waste.

The walking dead live, but it's value, not brains, they are eating. So-called zombie funds, life sciences venture capital funds that are fully invested and unable to raise new money, still maintain their board seats. But Outcome Capital’s Managing Directors Oded Ben-Joseph and Arnie Freeman say their divergent interest from their fellow board members often lead to disputes that can end the life of promising technologies and lead to acquisitions that leave much value on the table. We spoke to Ben-Joseph and Freeman about the boardroom dynamics were zombies lurk, the consequence of this board misalignment, and how acquirers may seek to leverage the situation

Last month, the Senate confirmed Robert Califf, a cardiologist and clinical researcher from Duke University, as commissioner of the U.S. Food and Drug Administration. Though he was overwhelming confirmed, some expressed concerns about his ties to the pharmaceutical industry. Others used the confirmation process to protest the FDA’s handling of opioid painkillers as the problem of addiction to these drugs have become a growing concern. We spoke to Peter Pitts, a former FDA associate commissioner and president of the Center for Medicine in the Public Interest, about Califf, why he’s well suited for the job, and the challenges he will face in his new role.

Bird Rock Bio, a small, San Diego-based biotech, is planning to take aim at some of the biggest biologics on the market with an antibody in development to treat rheumatoid arthritis that it says it expects to market at an annual cost of just $2,000 a year. That compares to around $30,000 a year for drugs such as Humira, Remicade, and Enbrel that are TNF inhibitors. The experimental therapeutic known as Gerilimzumab targets IL-6. We spoke to Paul Grayson, president and CEO of Bird Rock Bio about the company, the benefits of targeting IL-6, and how the company expects to be able to offer the drug at such a disruptive price point.

The embattled pharma executive Martin Shkreli, whether intentional or not, has ignited a long smoldering public policy discussion about the pricing of pharmaceuticals. As there are growing calls for steps to restrain drug prices, there are also industry concerns about the effect such actions would have on the ability to attract investment and pursue the development of high-risk, innovative therapies. We spoke to Denis Corin, CEO of Q BioMed, an acceleration and development company, for a perspective on the fallout from Shkreli, how to balance innovation with affordability, and whether he expects any lasting impacts on small drug developers.

The California Institute for Regenerative Medicine, California’s voter-established stem cell agency, is thinking about its future. The institute recently issued a strategic plan for the next five years that it says represents a “radical overhaul of the way the institute conducts business” and emphasizes “coordination, speed, partnerships, and patients.” We spoke to Randy Mills, president of the California Institute for Regenerative Medicine, about the strategic plan, the ambitious goal it has set for the next five years, and whether CIRM will have a life beyond the $3 billion voters approved for its funding.

About 1.3 million people in the United States have type 1 diabetes, which requires constant monitoring and regular injections of insulin. The autoimmune disease attacks the insulin producing beta cells in the pancreas and replacement of those cells has long been viewed as an ideal approach to treating the disease. The problem, though, has been finding a reliable supply or replacement cells and protecting them from the body’s immune system while allowing them to recieve needed nutrients, as well as deliver insulin to the body. San Diego-based ViaCyte is now in human clinical trials with a promising approach to treating the disease. We spoke to Paul Laikind, president and CEO of ViaCyte, about the company’s cell therapy, its critical financial support from the California Institute for Regenerative Medicine and JDRF, and why its investigational product may represent a functional cure.

Non-steroidal anti-inflammatory drugs are the most widely used medications in the world. They are used to treat pain resulting from diseases such as arthritis, but these drugs can raise blood pressure and cause serious problems including heart attacks, strokes, and death. We spoke to Paul Waymack, founder, chairman, and chief medical officer of Kitov Pharmaceuticals about its efforts to bring to market a combination therapy that addresses these safety concerns. Waymack discussed the issues surrounding pain medications, his company’s approach, and how the company’s smart FDA strategy is significantly cutting its cost and time to market.

The American Association for Cancer Research, with seven leading cancer research centers, has launched Project GENIE to determine how to better tailor treatments to patients’ individual cancers. The effort will take tumor genomic profiling data from the various institutions and aggregate it into a single database for researchers to harness. We spoke to Barrett Rollins, chief scientific officer at the Dana-Farber Cancer Institute, about the project, how far down the path of precision medicine we have travelled, and how he expects it to reshape cancer care in the years to come.

As medical device makers are building network connectivity and intelligence into their products, they are adding new vulnerabilities and risks as well. The U.S. Food and Drug Administration has just issued draft guidance for postmarket management of cybersecurity of medical devices. It follows previous guidance on premarket submissions for management of cybersecurity in medical devices. We spoke to Russell Jones, partner with Deloitte & Touche, cyber risk leader for the firm’s State of California Practice and co-leader of the firm’s medical device safety and security practice, about the FDA actions, how these connected devices can be exploited by hackers, and what medical device makers can learn from industries that have already faced these issues.

The pharmaceutical industry appears to have lost ground in 2015 on the ongoing debate around drug pricing, a problem that Christopher Bowe sees in part as a failure of leadership within the industry. In a recent guest column in Forbes, Bowe, who advises industry CEOs on communicating their strategies and ideas, argued that the industry needs CEOs capable of reframing the discussion with fresh ideas, forging new alliances, and disrupting existing business models. We spoke to Bowe about this leadership vacuum, why it is critical for the industry to move beyond its tired arguments, and what it needs to do to rebuild trust and credibility with the public.

As 2015 came to a close, Congress passed a package of tax extenders that among other things expanded the Research and Development Tax Credit and made it permanent. The move represents a big win for innovation-based industries, but the life sciences in particular, which will benefit from a new provision that allows companies to capitalize on the credit ahead of producing revenue. We spoke to Dan Mennel, California Market Leader of Strategic Federal Tax Services for Grant Thorton and Matt Gardner, CEO of the California Technology Council, about the R&D tax credit, what it does, and what it means for the life sciences.

The year 2015 was another big one for biotech with record dealmaking, big drug approvals, and solid performance, but it somehow didn’t feel as good as it looks on paper. Pricing concerns that garnered big attention are expected to grow in intensity in the new year with the presidential election and negotiations for the renewal of the Prescription Drug User Fee Act. We spoke to Adam Feuerstein, senior columnist for TheStreet.com, about the year in biotech, the highs and lows, and what’s ahead in the new year.

Growing costs pressures, the integration of technology, and the transformation of the patient into a healthcare consumer is giving rise to a new health economy. In its report on the top health industry issue for 2016, PwC highlights the forces expected to have the most impact on the industry in the coming year. We spoke to Karla Anderson, principal of U.S. pharmaceuticals and life sciences for PwC, about the report, how an increasing emphasis on value is reshaping the sector, and what’s in store for 2016.

Despite a record number of new drug approvals this year, the return on R&D investment for the largest pharmaceutical companies continues to fall, according to a new report from the Deloitte Centre for Health Solutions and Deloitte’s R&D services group. In fact, the report finds R&D returns for this group of companies have fallen to their lowest point since Deloitte began tracking them in 2010. We spoke to Neil Lesser, principal with Deloitte Consulting in the Life Sciences strategy practice and a leader in the Research & Development strategy practice, about the report, the pressures on the industry that are hurting returns, and what R&D strategies companies can pursue that might reverse the trend.

Retail prices for more than 100 widely used specialty drugs rose nearly 11 percent in 2013, according to a new report from AARP Public Policy Institute. The report found that the average annual cost of a specialty drugs used to treat chronic diseases rose to more than $53,000 — greater than the U.S. median income and more than twice the $23,500 median income of people on Medicare. We spoke to Leigh Purvis, director of health services research in AARP’s Public Policy Institute about the report, trends that are fueling demand for these drugs, and whether there are public policy solutions to rein in rising drug prices that can be implemented without harm to innovation.