The Bio Report

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.