The Bio Report

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.

Dyadic Seek to Bring Disruptive Technology to Biomanufacturing

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.

Enlisting the Immune System in the Battle Against Alzheimer’s

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.

Overcoming the Delivery Challenges of Gene Therapy

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 Sparks Battle to House the EMA

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.