The Bio Report

The growing problem of antibiotic-resistant bacteria and the evolution of next-generation sequencing technology is giving rise to new approaches to combat what’s become a serious global health threat. Epibiome, which describes itself as a precision microbiome engineering company, is working to develop cocktails of bacteriophages to use in animal and human health. We spoke to Nick Conley, CEO of Epibiome, about the urgent need for new therapeutics, the renewed interest in phages, and Epibiome’s unique approach to address the problem.

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 isolation platform, and its implications for changing how cancer patients

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. We spoke to Cameron Durrant, CEO of KaloBios, about his efforts to clean up the mess he inherited, turnaround the fortunes of the company, and introduce an innovate pricing model that could reshape the way industry thinks about pricing its products.

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 Betts-Lacroix, co-founder and CTO of Vium, about the company, how its hoping to change the preclinical drug development process, and why that’s essential.

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 the new report, the need for the industry to innovate pricing models for new drugs, and why as companies seeks to demonstrate the value of a product they will need to consider the unique perspective of each payer.

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 editor for EP Vantage, about the ASCO meeting, what the early abstracts say, and who will likely be making headlines at this year’s meeting.

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 so few treatments available today, and why she holds out hope for the pipeline of new therapies moving through the clinic.

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, executive director of the Campaign for Sustainable Rx Pricing, about the organization, its focus on market-based solutions, and what it will take to make them a reality.

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 samples for THC content, the presence of pesticides, and their potential effects on users. We spoke to Daniel Yazbeck, chairman and CEO of MyDx, about his handheld analyzer, how it works, and how he expects it to both enable and be fueled by changing consumer behavior in the emerging world of the quantified self.

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 School and Boston Children’s Hospital, notes that researchers follow the money and that the cancers with which we have made the least progress still seem to get the least amount of funding. We spoke to Zetter about his commentary, the opportunities being created by the Cancer Moonshot, and how he thinks cancer funding needs to change.

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.