The Bio Report

Regenerative medicine is rapidly moving from the lab to the clinic, but as life-saving therapies advance to the marketplace, there are questions about whether the U.S. Food and Drug Administration needs to modernize its regulatory approach to gene and cell therapies. We spoke to Michael Werner, executive director of the Alliance for Regenerative Medicine, about the state of the industry, the regul...

Glioblastoma is a devastating and fatal brain cancer that progresses rapidly. Median time from diagnosis to death is 12 to 15 months. In recurrent cases, treatment consists of both symptomatic and palliative therapies, but the disease remains fatal. VBL Therapeutics is developing a targeted anti-cancer gene-based therapy that is in late-stage testing for recurrent glioblastoma. We spoke to Dror Ha...

The promise of precision health is to transform a healthcare system that is today based on treating sickness to harnessing a range of technologies to predict and prevent illness. Health 2.0’s Technology for Precision Health Summit in San Francisco October 24 will explore the state of precision health and what’s needed to make it a reality. We spoke to Linda Molnar, chair of the summit, about preci...

Winning regulatory approval for a drug to treat obesity would seem like a great accomplishment, but for Orexigen Therapeutics, that’s when the hard work began. After its marketing partner Takeda ended their agreement because of disappointing sales, the company found itself in the position of having to market a drug to doctors who often don’t consider obesity an illness and believe willpower and di...

Though breakthroughs in the ability to read, write, and edit DNA have broad implications for healthcare, they are also fueling a far-reaching transformation of industries and laying the foundation for a new bioeconomy. The SynBioBeta conference, which has developed into a critical annual event for innovators and investors within the synthetic biology sector, will be held in San Francisco October 3...

The pharmaceutical industry has long argued that high drug prices are necessary to incentivize investment in and fund high-risk research and development of innovative new therapies. In a working paper published by the Institute for New Economic Thinking, William Lazonick, professor of Economics at the University of Massachusetts Lowell, and his colleagues challenge the industry’s premise. They arg...

Gonorrhea is a common sexually-transmitted infection, but the growth of an antibiotic-resistant strain of the disease is creating what the U.S. Centers for Disease Control and Prevention has called an urgent public health threat that requires aggressive action. Entasis Therapeutics is launching a pivotal study of Zoliflodacin, a new class of oral antibiotic that has demonstrated potent activity ag...

A number of clinical successes and the U.S. Food and Drug Administration’s granting of designations that provide accelerated pathways to experimental therapies speaks to the progress of research funded by the California Institute for Regenerative Medicine. We spoke to Kevin McCormack, ‎senior director of public communications and patient advocate outreach for CIRM, about the growing pipeline of th...

The problem of counterfeit and falsified medicines is not just an economic problem for the pharmaceutical industry, but also a threat to public health. TruTag Technologies is seeking to address the problem with its nano-scale technology that allows drugmakers to encode information on individual doses of medication to authenticate a drug and provide details on its origin and intended market. We spo...

Mosquitoes are more than just pesky. Certain types of insect serve as efficient vectors for infectious diseases that pose great harm to humans. Oxitec, a subsidiary of Intrexon, has developed a genetically altered male of the Aedes aegypti mosquito designed to mate with wild females to produce offspring that die before becoming adults. The effort is meant to provide a highly targeted alternative t...

Scrutiny of drug prices around the globe is expected to exert growing pressure on the biopharmaceutical sector. EvaluatePharma, in its recently issued World Preview 2017, Outlook to 2022 says that despite consensus forecasts for worldwide drug sales hitting more than $1 trillion in 2022, it does reflect a drop from the same period last year. We spoke to Antonio Iervolino, head of forecasting for e...

Celiac disease, an autoimmune disorder that has helped to drive the gluten-free food craze, can carry serious complications. There’s no treatment for the disease, which afflicts an estimated 2.4 million people in the United States. PvP Biologics is taking a unique approach to treating celiac disease with its Kumamax, a synthetic enzyme that degrades the parts of gluten that trigger an immune respo...

The lack of clarity over healthcare reform, changes to tax policy, and concerns about new pricing pressures are creating uncertainty over the future health of the biotech industry. EY, in its just released annual report on the industry, looks at the effect the growing uncertainty has had on the performance of the biotech companies and strategies for contending with what’s ahead. We spoke to Glen G...

The high cost of drug development, the challenge of translational research, and continuing concerns with R&D efficiency has had entrepreneurs, investors, and drugmakers open to experimenting with new models of innovation. COI Pharmaceuticals, born out of a collaboration between the pharmaceutical giant GlaxoSmithKline and Avalon Ventures, is one such model that is showing traction. With management...

The production of biologics is costly and takes time. Dyadic International has developed a proprietary manufacturing process that replaces the use of Chinese hamster ovary cells, long used to produce protein therapeutics, with a fungus that has a long history in industrial biotechnology applications. The company believes its process can produce drugs faster, in greater volumes, and at significantl...

Alzheimer’s disease is the sixth leading cause of death and it continues to rise. Today it is costing the U.S. healthcare system $200 billion a year and there are no therapies that prevent, halt, or reverse the disease’s progression. United Neuroscience is taking a new approach to the disease with its endobody vaccines, a class of synthetic biologics it is developing to treat Alzheimer’s and other...

Gene therapy represents an expanding area of potential to correct and modulate the activities of genes driving diseases. One of the major challenges these groundbreaking technologies face, though, is delivering them to where they need to go within the body to be effective. Nanogenic Solutions believes its solved the problem with its LipTide technology that marries a payload carrying-lipid with syn...

Brexit, the United Kingdom’s plan to withdraw from the European Union, carries a long list of unintended consequences, one of which is the relocation of the European Medicines Agency. As many as 20 cities are competing to become the new home of the drug regulator. We spoke to Rory Mullen, International Investment Executive for IDA Ireland, about Dublin’s efforts to woo the EMA, the process going f...

Nearly one in three drugs has a postmarket safety event, according to a study published earlier this month in JAMA. The study looked at 222 novel therapies approved between 2001 and 2010. We spoke to Nicholas Downing, clinical fellow in the Department of Medicine at Brigham and Women's Hospital and lead author of the study, about the findings, the limits of clinical trials, and whether the U.S. Fo...

Climate change is not often viewed as a public health threat, but it can have unexpected consequences on the spread of infectious diseases. As changing temperatures make new areas more hospitable to mosquitos, its can raise the risk of mosquito-borne diseases, such as dengue, chikungunya, and zika in areas not usual thought as prone to outbreaks of tropical disease. We spoke to Erin Mordecai, assi...

Ten years ago, a group of San Francisco State University alumni working at Genentech got together with the Michael Goldman, the university’s chairman of the biology department, to establish the school’s annual Personalized Medicine Conference. This year, the conference will revisit topics from its past ten years as well as exploring the future of personalized medicine ask speakers to reflect on ho...

The promise of precision medicine to provide more effective and safer cancer therapies that target the genetics driving each patient’s disease has been hindered by the lack of understanding of the specific genetic alterations underlying many cancers. Elana Fertig thinks math can solve that problem. Fertig, with a nod to the algorithm Netflix uses to help recommend movies users might like, is worki...

For anyone who has ever sought to find the price of healthcare services before obtaining them it will come as little surprise that information is not readily available. A recent study from Public Agenda, with support from the Robert Wood Johnson Foundation and the New York State Health Foundation, set out to find how Americans seek and use healthcare price information. We spoke to David Schleifer...

As the Trump Administration calls for significant increases in military spending, it is also seeking steep cuts to the National Institutes of Health, the Centers for Disease Control and Prevention and programs used to address issues of global health. Michael Osterholm director of the Center for Infectious Disease Research and Policy at the University of Minnesota, in a recent op-ed in The New York...

Recent mumps outbreaks are raising questions about strategies to combat the spread of the virus. One issue of concern is that the current vaccine is designed to protect against a different strain of the virus than the one that is sparking the outbreaks. Though the vaccine can help prevent some people from getting the disease or minimize its effects, the outbreaks have raised questions about whethe...