Ten big drug companies shared today that they have created a non-profit organization to help speed up the R&D of new drugs. These companies are Abbott, AstraZeneca, Boehringer Ingelheim, Bristol-Myers Squibb, Eli Lilly and Co., GlaxoSmithKline, Johnson & Johnson, Pfizer, Roche, and Sanofi. Together, they are unveiling TransCelerate BioPharma Inc. This is the largest initiative of its kind, and it is designed to identify and resolve common issues that can delay R&D. Read the release here. By participating in TransCelerate, each of these companies will combine financial and other resources, such as personnel, to work out industry wide challenges in a team work atmosphere. Back in June, Ernst & Young released its "Beyond Borders: Global Biotechnology Report 2012," which addressed some of the problems in R&D and suggested that companies, academia, and nonprofit groups should strive to share noncompetitive data in networks called HOLnets to improve drug development.
Glen Giovannetti, Ernst & Young Global Biotechnology, Leader says today's announcement is encouraging because it is unique. "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."
Giovanetti said in the HOLnet concept detailed by E&Y, these networks would help create standards and pool data around those standards so there could be greater sharing.
"If I were to relate back to directly to what we were writing about, this is a step in the direction of what we were putting out there," he says. "I wouldn’t expect it to be fully implemented immediately. What we were putting out there was that medicine in general is entering the world of big data. There’s a lot more data out there, both with the data that companies have traditionally credited in R&D and clinical trials, and also data that will be increasingly gathered through the delivery of healthcare….electronic health records, social media. I think that we’re a ways from seeing a true holistic network of being able to bring in data from multiple sources in the health ecosystem." According to a report by the Battelle Organization and the E&Y "Beyond Borders" report, both released in June at the annual BIO Convention in Boston, R&D spending and revenue are up, when adjusting for some large acquisitions, but financing remains tough. Though the employment picture has improved, it remains soggy when compared with the world before the Great Recession began in 2008. Battelle's study found that biotech, which was defined to also include medical devices, research and testing, and agricultural chemicals and feedstocks, gained 96,000 total jobs in the U.S. from 2001 to 2010. But how are biotechs doing? According to E&Y, those in established biotech centers – the U.S., Europe, Canada and Australia – generated revenue of $83.4 billion in 2011, a 10 percent increase from 2010 on a normalized basis, after adjusting for the acquisition of three large, U.S.-based biotechs by non-biotech buyers. After slashing R&D spending in 2009 and increasing this expenditure by just 2 percent in 2010, the industry grew R&D by a 9 percent, on a normalized basis, last year. (Read more here.) As for TransCelerate, newly appointed acting CEO Garry Neil, M.D., said, “There is widespread alignment among the heads of R&D at major pharmaceutical companies that there is a critical need to substantially increase the number of innovative new medicines, while eliminating inefficiencies that drive up R&D costs." Dr. Neil is also a partner at Apple Tree Partners and formerly corporate VP, Science & Technology, Johnson & Johnson. Members of TransCelerate have pinpointed clinical study execution as the initiative's initial focus area. Five projects have been selected by the group for funding and development. These areas include 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, and establishment of a comparator drug supply model.
TransCelerate was incorporated in early August 2012 and will file for non-profit status this fall. The board of directors includes R&D heads of the ten member companies. Membership in TransCelerate is open to all pharmaceutical and biotechnology companies who can contribute to and benefit from these shared solutions. TransCelerate's headquarters will be located in Philadelphia, PA.