The Bio Report

The ability to find and tumor cells and DNA fragments shed by tumors circulating in the blood has given rise to liquid biopsies. This emerging area of diagnostics promises to improve cancer care, better monitor patient response to a therapy, personalize care, and provide earlier evidence of recurrence. We spoke to Andre de Fusco, CEO of Cynvenio, about the company’s liquid biopsy rare cell isolati...

KaloBios, a biotech best known for a series of disastrous events including failed clinical trials, a bankruptcy filing, lawsuits, and the arrest of its CEO, is being reborn. In the process, it may provide a valuable contribution to the ongoing discussion over drug pricing. In April, the development-stage company unveiled a pricing plan based on transparency, affordability, and reasonable profit. W...

Despite a rapid advance of technology there’s been little change in the preclinical drug development process. Vium is hoping to change that by using sensors, automation, and bioinformatics to change the way data is gathered in the preclinical process to fuel better and faster decisions about the potential value of an experimental drug. We spoke to Tim Robertson, co-founder and CEO of Vium and Joe...

The biotechnology industry continued to post record numbers, attract significant investment, and won approval for a solid number of new drugs in 2015. Nevertheless, EY in its new Beyond Borders report warns that there’s a deceleration within the industry that points to threats that could undermine the robust growth it has enjoyed. We spoke to Glen Giovannetti, EY Global Biotechnology Leader, about...

Wall Street’s attention will turn to Chicago as the annual meeting of the American Society of Clinical Oncology gets underway June 3 to June 7. Though this is a scientific conference, it is one closely watched by investors, who have been pouring through the abstracts that have been available and keeping an eye open for late-breakers that could move stocks. We spoke to Jon Gardner, deputy news edit...

Lupus is an often misunderstood and misdiagnosed autoimmune disease. While some 1.5 million people—mostly women—have lupus, it can take years for someone with the disease to get a correct diagnosis. We spoke to Susan Manzi, medical director of the Lupus Foundation of America and Co-founder and director of the Lupus Center of Excellence at Allegheny Health Network, about the disease, why there are...

Global innovation activity experienced broad gains across industry sectors last year, according to Thompson Reuters newly released 2016 State of Innovation report. We spoke to Anthony Trippe, senior patent analyst for Thomson Reuters about the report, its upbeat outlook, and what it says about the direction of innovation in the biotechnology, pharmaceutical, and medical device sectors.

The Campaign for Sustainable Rx Pricing, a coalition of healthcare stakeholders, thinks that the rising cost of prescription drugs can be addressed through a series of market-based solutions that will strike a balance between preserving innovation and ensuring affordability. Its recently released plan outlines steps to increase transparency, competition, and value. We spoke to John Rother, executi...

The emergence of smartphones at the center of a growing universe of digital health devices is giving rise to new ways to monitor and measure our bodies in real time. MyDx, one of the latest entrants into this area, is working to enable consumers to test the food they eat, the water they drink, and the air they breathe to ensure they’re safe. Its first offering allows cannabis users to analyze samp...

The Obama Adminstration’s Cancer Moonshot initiative is a boost to cancer researchers, but Bruce Zetter says in order for it be as effective as possible, it must not repeat the same funding priorities of the past and instead should support innovative projects and research against the deadliest cancers. In a recent commentary in Politico, Zetter, a professor of cancer biology at Harvard Medical Sch...

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...

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 Resear...

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 approa...

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 challe...

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 ha...

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...

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 thes...

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 kno...

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 therapi...

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 Ca...

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 pro...

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 m...

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...

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 t...

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 idea...