The Bio Report

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.

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 significantly lower costs than biotech processes in use today. We spoke to Mark Emalfarb, CEO of Dyadic, about its manufacturing process, the benefits it could bring, and why it may have big implications for drugmakers.

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 CNS conditions. We spoke to Ajay Verma, chief medical officer of United Neurosciences, about Alzheimer’s, the company’s platform technology, and the promise of enlisting the immune system in the fight against CNS diseases.

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 synthetic peptides that target cell suface receptors and allow DNA or RNA into the cell. We spoke to Simon Newman, director of preclinical development for Nanogenic Solutions, about the challenges of gene therapy, the LipTide technology, and what it could mean for advancing a range of RNA and DNA therapies.

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 forward, and why its viewed as an economic prize.

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. Food and Drug Administration needs to do more to improve surveillance of drugs once they are approved.

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, assistant professor of Biology at Stanford University and lead author of a recent study in PLoS Neglected Tropical Diseases that looks at how climate change may affect the spread of mosquito-borne disease. We spoke to Mordecai about the study, what it means for potential infectious disease outbreaks, and how public health officials and drugmakers in the developed world may need to think differently about neglected tropical diseases.

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 how personalized medicine has changed their lives. We spoke to SF State’s Goldman and Dan Maher, one of the alumni who drove the creation of the conference, about the state of personalized medicine, the pace of advances, and what’s surprised them most about where we are today.