The Bio Report

Partnership Drives Development of Antibiotic to Combat Resistant Gonorrhea

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.

CIRM-Funded Pipeline of Regenerative Therapies Advances

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.

Technology Allows Drugmakers to Tag and Authenticate Individual Pills

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.

Harnessing Mosquitoes to Fight the Spread of Infectious Disease

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.

Biotech Industry Moves Towards a Patent Cliff

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.

PvP Takes a Unique Approach to Treating an Autoimmune Disease

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.

Uncertainty Hangs over the Biotech Sector

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.

What Others Can Learn from COI’s Approach to Cost-Efficient Drug Development

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.