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All for one, one for all
PHILADELPHIA—Reaching across borders, time and competitive forces, 10 top pharmaceutical companies from around the world have formed a nonprofit consortium dedicated to accelerating the development of new medicines.
The organization, which is called TransCelerate BioPharma Inc., is the largest ever initiative of its kind and will focus—at least initially—on eliminating some of the bottlenecks that cause inefficiencies in clinical trials.
Joining forces in the consortium are leaders from Abbott, AstraZeneca PLC, Boehringer Ingelheim, Bristol-Myers Squibb Co., Eli Lilly & Co., GlaxoSmithKline PLC (GSK), Johnson & Johnson, Pfizer Inc., Roche Group member Genentech and Sanofi, who met at several industry forums "where we discussed issues that have been a bottleneck in the R&D space for a number of years," says Dr. Garry Neil, former corporate vice president of science and technology at Johnson & Johnson and acting CEO of TransCelerate.
"We figured we are at the point now where maybe we should put a little focus on this issue," says Neil, who is now a partner at Apple Tree Partners. "We all know what the problems are and what the solutions might be, so why don't we roll up our sleeves and get down to it?"
Clinical trials are the "lowest-hanging fruit with the biggest short-term payoff," Neil adds. "This really is about accelerating innovation in drug development and getting more drugs to patients. What we are trying to do is shorten that timeline and make sure products are properly tested."
Although TransCelerate's participants came up with a list of 30 potential problems to tackle, they quickly narrowed that list down to an initial set of five tasks to fund and tackle: 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.
"Many people are surprised at this, but the development process we have today is not an efficient system," says Neil. "I have argued with some of my R&D colleagues who say it takes 20 to 30 years to get from bench discovery to the marketplace. My answer to that is this is the data we have, but I don't accept that. I don't think the patients who are waiting for new treatments accept that, either. Imagine if you could define the standards for a series of diseases, and your membership says, 'we are going to adopt these data standards and then accelerate it as the industry standard.'"
TransCelerate also has a prioritized list of diseases to focus on, says Neil.
"We have a list of about 2,000 diseases that we are in the process of prioritizing, but what is most important right now from a clinical study point of view are diseases like Alzheimer's, cancer, heart disease and diabetes. This work will never really end, because we are learning more about diseases all the time," he says.
Each of the 10 founding companies will contribute funds and other resources, including personnel. TransCelerate is also looking to expand its founding collection of 10 companies. Membership is open to all pharmaceutical and biotechnology companies that can contribute to and benefit from these shared solutions.
According to Neil, TransCelerate has had interactions with regulators from both the U.S. Food and Drug Administration and the European Medicines Agency, as well as academic institutions, small biotech firms and contract research organizations, and received a "warm and enthusiastic response."
"We're putting a lot of resources behind this, most of which involve people. We have a lot of industry muscle and experts behind this, but we can't do it on our own. We need help from the drug development ecosystem," he notes. "In addition, we are working with CDISC to define the standards for collecting information about diseases in clinical trials. We want to come up with a better, risk-based way to monitor clinical trials, and an intelligent approach to ensuring data integrity and subjects of clinical trials."
For now, TransCelerate is working remotely, but will have a physical location in Philadelphia at GSK's Navy Yard headquarters. Neil will continue to lead TransCelerate for now, but he says the organization is actively recruiting a new CEO with hopes of hiring an individual by the end of the year.
Although some in the industry have expressed skepticism that these competing companies can work together on a common goal, Neil stresses that TransCelerate is "not anticompetitive, but procompetitive."
"We are going to stimulate a lot more competition, and we really need that. This is a very lucrative, vibrant industry, and we desperately need to continue to be. Innovation is part of the solution, and it also ought to be at the center of healthcare reform, not just in the United States, but around the world," he says.
TransCelerate's founding board members
John Leonard, SVP Global Pharmaceutical R&D, AbbottGarry Neil, Former Corporate VP, Science & Technology, Johnson & Johnson
Anders Ekblom, Head of Science & Technology, AstraZeneca
Klaus Dugi, Corporate SVP Medicines, Boehringer-Ingelheim
Brian Daniels, SVP Global Development & Medical Affairs, Bristol-Myers Squibb
Lynn Marks, SVP Medicines Development Centre for Infectious Disease, GlaxoSmithKline
Jan Lundberg, EVP Science and Technology, Lilly
Mikael Dolsten, President of Worldwide R&D, Pfizer
Corsee Sanders, Global Head of Development Innovation & Clinical Operations, Roche
Elias Zerhouni, President of Global R&D, Sanofi