The Bio Report

Last month Otsuka Pharmaceutical and Proteus Digital Health won U.S. Food and Drug Administration approval for what’s being hailed as the first digital pill. Abilify Mycite, a drug-device combination that marries Otsuka’s Abilify, used to treat schizophrenia, with Proteus’ ingestible sensor, wearable sensor, and smartphone app intended to monitor and improve compliance. We spoke to George Savage, chief medical officer of Proteus, about the technology, other potential uses, and how it may help address the quality and cost of healthcare.

Climate change and the increasing frequency and intensity of extreme weather events carry a toll on human health. Not only do floods, hurricanes, and other similar phenomenon cause death and injury, they also create long-term health effects. Jesse Bell, a research scientist at the North Carolina Institute for Climate Studies at North Carolina State University recently examined the issues in an article in the Journal of the Air & Waste Management Association. We spoke to Bell about the health consequences of these weather events, the challenges they create for public health systems to plan and prepare, and why new research is needed to better understand the relationship between these events and human health.

Tom Frieden, after eights years of running the U.S. Centers for Disease Control and Prevention, is turning his sights to global health. Frieden has set a goal of saving 100 million lives from cardiovascular disease in low- and middle-income countries by applying proven strategies used in developed countries. His program Resolve to Save Lives, an initiative of Vital Strategies, will also work to prevent infectious disease epidemics and pandemics by strengthening public health systems in these nations. We spoke to Frieden about the initiative, whether strategies that worked in the developed world can be translated to low- and middle-income countries, and what it will take to be successful.

A public-private consortium is seeking to cut the time it takes to discover and advance new cancer therapies to the clinic to one year from the six years it takes on average today. Accelerating Therapeutics for Opportunities in Medicine, or ATOM, brings together scientists from government, academia, and industry with the ambitious goal of harnessing supercomputers to transform cancer drug discovery into a rapid process that can determine molecules that will be safe and effective before advancing them to human clinical trials. We spoke to Michelle Arkin, a member of ATOM and associate professor of pharmaceutical chemistry at the University of California, San Francisco’s school of Pharmacy, about the consortium, the approach its taking, and why it may alter the way therapies for a much broader range of diseases than cancer are developed.

Merger and acquisitions may be a path to creating value for life science companies, but talks can breakdown because of flaws in management thinking that skew their sense of the value of their company. Oded Ben-Joseph, managing director of Outcome Capital, applied behavioral economics to the M&A front to discuss how cognitive biases can derail M&A transactions in an article in the September issue of In Vivo. We spoke to Ben-Joseph about cognitive biases, why the life sciences sector is particularly prone to the problem, and what executives can do to minimize their effects.

The growing problem of bacterial resistance to antibiotics represents a significant public health threat. That’s been made worse by the dearth of new therapies that have come to market. AmpliPhi Biosciences is developing bacteriophages, viruses that infect and kill bacteria, to provide a way to target drug-resistant bugs. We spoke to Paul Grint, CEO of AmpliPhi about the health need, AmpliPhi’s approach, and why harnessing these natural killers of bacteria may provide a promising source of new therapeutics.

Bioelectronic therapies are being developed to treat a number of conditions that currently can only be addressed using pharmaceutical interventions. Thync, a bioelectronics company, believes its technology that targets the cervical and thoracic spinal nerves to modulate the autonomic nervous system, can be used to treat variety of ailments including mental health, inflammatory disorders, and skin conditions. It points to a growing body of scientific literature that demonstrates the important role the nervous system plays in regulating the body’s immune response. We spoke to Thync CEO Isy Goldwasser about the technology, how it works, and why the company’s first clinical trial of it will be as a potential treatment for psoriasis.

Despite the growing volume of electronic health records, they have so far left the recruitment of clinical trial patients, clinical trial designs, and site selection largely unchanged. The result is that drug companies are often designing clinical trials with gaps in information about the patient population they are serving, the medical issues these patients face, and where they can find them. This adds to the high cost and long timelines required to move an experimental therapy through clinical development. TriNetX is trying to address this problem through its health research platform that allows drug developers to analyze large amounts of patient data from healthcare organizations within its network. We spoke to Gadi Lachman, CEO of TriNetX, about its platform, how it works, and why he believes this could lead to more efficient drug development.

Synthetic biology is promising to harness living organisms to replace industrial processes that rely on toxic chemicals, consume large amounts of energy and water, and leave environmental degradation in their wake. One such example of a company seeking to transform an industry in this way is Colorifix, which is developing a revolutionary dyeing process to help the textile industry dramatically reduce its environmental impact in a cost-effective way using a synthetic biology based approach. We spoke to Orr Yarkoni, founder and CEO of Colorifix, about the company, how it is using synthetic biology to change the process of dyeing materials, and why he expects it to change the environmental toll of the textile industry.

Kindred Biosciences is looking to leverage the billions of dollars that others have invested in approved drugs by modifying, improving, and repurposing them for the animal market. The company believes it can formulate, develop, and win approval for these medicines for between $3 million and $5 million each in a matter of three to five years, and capture markets that range between $10 million and $100 million annually. We spoke to Richard Chin, founder and CEO of Kindred, about the business strategy, the company’s pipeline, and the opportunity created by our willingness to spend big money on our pets.

When the BIO Investor Forum convenes in San Francisco October 17 and 18, a key point of discussion will be the availability of funding for emerging life sciences companies. One of the panelist addressing that issue this year will be Asish Xavier, vice president of venture investments for Johnson & Johnson Innovation’s venture arm JJDC. We spoke to Xavier about JJDC’s approach to investing as a strategic investor, the changing landscape for venture capital, and how competitive the environment is for access to compelling technologies today.

In April 2016, the consulting firm LifeSci Advisors adopted a comprehensive action plan to advance gender diversity in the life sciences industry. It has partnered with Women in Bio and Girls Inc. of New York City to provide mentorship and advancement programs for women and girls in the STEM fields, started its own board diversity initiative, and created the LifeSci Advisory Board on Gender Diversity. We spoke to Michael Rice, LifeSci Advisors founding partner, about the state of gender diversity in biotech boardrooms, what the firm has been doing, and why it decided to focus its efforts there.

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 regulatory environment today, and whether it will ultimately be payers who are more demanding of data to convince them of the worth of a therapy.

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 Harats, CEO of VBL, about the therapy, how it works, and why it might be useful in treating a variety of cancers.

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 precision health, what gaps in the healthcare continuum need to be addressed to create a healthcare system geared toward prediction and prevention, and how companies will make a business out of this.

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 discipline, not a pill, is what’s needed. Orexigen’s solution centered on a novel approach. The company decided to make a pitch directly to patients and connect them to telehealth-based doctors, who could ensure use of the drug is appropriate and help them avoid the embarrassment they may feel when speaking to their own doctors. We spoke to Thomas Cannell, Chief Operating Officer and President of Global Commercial Products for Orexigen, about its obesity drug Contrave, its marketing strategy, and whether it represents a marketing model that others may follow.

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 through October 5. We spoke to John Cumbers, founder of SynBioBeta, about trends within synthetic biology, key drivers and challenges for the sector, and why companies in all industries today need to begin crafting their own bio strategies.

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 argue that top pharmaceutical companies, spend more of their profits on buying back their shares to boost their stock prices than they do on R&D, a move that enriches senior executives. We spoke to Lazonick about the paper, why he believes this so-called financialized business model is counterproductive to innovation, and what steps he thinks are necessary to change the landscape.

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 against resistant gonorrhea. The company last month entered into a novel partnership with the non-profit Global Antibiotic Research & Development Partnership to fund the pivotal trial and assure access to the drug in low- and middle-income countries if successful. We spoke to Manos Perros, CEO of Entasis, about Zoliflodacin, the partnership with GARDP, and whether it serves as a model for the development of a broader arsenal of new antibiotics.

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 therapies, the changing regulatory environment, and whether the institute will have a future beyond its existing funding.