The Bio Report

International Collaboration Seeks to Drive Breakthroughs in Progressive MS

There has been dramatic progress in the understanding and treatment of relapsing remitting multiple sclerosis, a debilitating neurodegenerative disorder. But progressive MS, a more advanced form of the disease, has remained elusive. Now, a novel collaboration has brought an international group of MS societies together to fund research. We spoke to Bruce Bebo, executive vice president of research for the National MS Society and a member of the Progressive MS Alliance, about the intractability of progressive MS, how the unusual cooperation between MS groups came about, and whether the alliance will stand as a model for groups working in other disease areas looking to get the most out of their research investments.

Will Increased FDA Regulation of Diagnostics Speed or Slow Development of Personalized Medicine

The U.S. Food and Drug Administration is moving to expand its regulatory domain by adding oversight of certain diagnostics it does not regulate today. The agency says thousands of these test are used daily to guide treatment decisions and diagnose disease, and it wants to ensure their validity and advance personalized medicine. We spoke to Nathan Beaver, a partner with Foley & Lardner, about the FDA’s efforts, the implications for diagnostics companies, and why the agency’s plans are being met with some resistance from industry and Congress.

Using Human Biology to Improve R&D

One problem with drug discovery and development is that answers about the way substances act in the human body are often not apparent early in the process. Though human cell assays have been used, they have their limitations. BioSeek’s BioMap technology seeks to improve the success rate of research and development by bringing the complexity of human biology to cell assays and incorporating that into the earliest stages of drug discovery process. We spoke to Ellen Berg, director and general manager at BioSeek, about the company’s technology, how it seeks to improve discovery and development, and other ways the technology is being used by the industry.

Reengineering Drug Discovery and Development

Drugmakers have employed new technologies to reduce the cost and time and it takes develop drugs and produce therapies that more precisely target the underlying biology driving diseases. Boston-based Berg Pharma is using artificial intelligence with a variety of other technologies to reengineer the discovery and development process. We spoke to Niven Narain, co-founder, president, and chief technology officer of Berg, about the problems with drug development today, what makes his company's approach unique, and what its pipeline can tell us about whether the approach is working.

The Year in Biotech So Far and What’s Ahead

The biotech sector surged in the first half of the year despite volatile markets. M&A and financing continued to be robust as EvaluatePharma weighed in with its Pharma & Biotech Half-Year Report. We spoke to Jonathan Gardner, deputy news editor of EP Vantage, about the trends in the first half of the year, whether 2014 will set new records for M&A activity, and the threats out there that may put an end to the good times.

Epirus Sees Opportunities for Biosimilars Outside U.S.

The regulatory pathway for biosimilars is still a work in progress at the U.S. Food and Drug Administration, but around the world the industry is growing as regulators have resolved issues that remain obstacles in the United States. We spoke to Amit Munshi, CEO of Epirus Biopharmaceuticals, about the opportunities in emerging and developed markets, his company’s strategic approach, and when we’ll see a vibrant biosimilars industry in the United States.