A group of 10 big pharma companies are collaborating in a move that could change the way clinical trials are done. One goal of the nonprofit will be to provide better information on the risks and benefits of drugs and therapeutics more efficiently, according to a company statement.
TransCelerate BioPharma, based in Philadelphia, will involve GlaxoSmithKline (NYSE:GSK), Pfizer (NYSE:PFE), Johnson & Johnson (NYSE:JNJ), Bristol-Myers Squibb (NYSE:BMY), Eli Lilly (NYSE:LLY) , Abbott Laboratories (NYSE: ABT), AstraZeneca (NYSE: AZN), Sanofi (NYSE: SFY), Boehringer Ingelheim and Genentech, a unit of The Roche Group.
The initial focus will be on carrying out clinical studies starting with these five projects:
Development of a shared user interface for investigator site portals
Mutual recognition of study site qualification and training
Development of risk-based site monitoring approach and standards
Development of clinical data standards
Establishment of a comparator drug supply model
Each of the drug development companies will contribute funding and staff from their research and development divisions. The seed for the nonprofit originated from the Hever Group, a forum for pharmaceutical executive R&D leadership to talk about issues facing the industry.
The acting CEO for TransCelerate is Dr. Garry Neil, a partner with Apple Tree Partners. He previously served as corporate vice president, for Science & Technology at J&J. he’s also held senior positions at Astra Zeneca and Merck KGaA.
Although the 10 companies made the initial commitment, membership is open to any pharmaceutical and biotechnology company, according to a spokesperson for the group. “The intent is to expand membership in 2012 and 2013 to include other large companies, as well as small and mid-sized companies who can benefit from TransCelerate’s work,” the spokesperson said.
A Deep-dive Into Specialty Pharma
A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.
The move is particularly interesting because the drug development cycle from its earliest stages to approval and commercialization can cost billions of dollars. If the drug development process could be shortened in a standardized format, it could have huge implications for the cost of drug development, the investment decisions made by life science investors, the kinds of drugs that get developed and the price of pharmaceuticals.
The companies will work with regulators like The U.S. Food and Drug Administration, the European Medicines Agency, the Clinical Data Interchange Standards Consortium, Critical-Path Institute, Clinical Trials Transformation Initiative, the Innovative Medicines Initiative and contract research organizations.
Pharmalot noted that the move seemed to reflect recommendations made in an Ernst & Young biotechnology report earlier this year that pharmaceutical companies should work with academic institutions and nonprofits to share noncompetitive data to improve drug development.
Ernst & Young Global Lifesciences Leader Glen Giovannetti commented in the Pharmalot blog post that it welcomed the move and took it as a positive sign that the industry is embracing the kinds of changes called for in the E&Y report.
“We haven’t seen one quite like this before where 10 pharmaceutical companies paired up of sort of their own volition in a way,” he says. “They join other consortia. This seems to be more of a real commitment of their resources and their effort. I think it’s great. They’re going to concentrate on getting some standardization around the clinical trial process. Perhaps more important in the long term, how data is gathered and assembled it really could move toward greater standardization of data so that trial results downstream could be more easily pooled and shared and investigated for insights.”
Giovannetti noted that big data will play an increasingly significant role in the clinical trial process, but it will take some time before the pharmaceutical and healthcare industries can use big data “holistically” within the healthcare ecosystem.
