The Bio Report

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.

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 spoke to Barry McDonough, senior vice president of business development for TruTag, about the technology, how it works, and how it can address a global health concern.

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 to insecticides that are broad acting, can cause harm to humans and other animals, and may be unable to effectively reach their intended targets in urban environments. We spoke to Hadyn Parry, CEO of Oxitec, about how the company breeds billions of mosquitos that can’t reproduce, how it delivers them to where they are needed, and how the company is addressing the regulatory barriers to demonstrate its technology is safe and effective.

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 evaluate pharma, about the new report, the outlook for the sector and the potential for a new patent cliff with the advent of biosimilars.

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 response. We spoke to Adam Simpson, president and CEO of PvP Therapeutics, about the interesting history behind Kumamax, how it works, and why it will be the only drug PvP ever develops.

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 Giovannetti, Global Biotechnology Leader for EY, about the new Beyond Borders report, what the numbers tell us, and ongoing efforts for the industry to adapt to a healthcare world moving from volume to value.

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 expertise, R&D infrastructure, and a collaborative environment, COI is providing promising startups with a way to accelerate their development in a capital efficient way. We spoke to Jay Lichter, president and CEO of COI Pharmaceuticals, about the COI model, the challenges of cost-effective innovation, and what can be learned from COI’s experience.