All for one, one for all

Ten leading pharmas form nonprofit organization dedicated to alleviating clinical trial bottlenecks

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PHILADELPHIA—Reaching across borders, time and competitiveforces, 10 top pharmaceutical companies from around the world have formed anonprofit consortium dedicated to accelerating the development of newmedicines.
The organization, which is called TransCelerate BioPharmaInc., is the largest ever initiative of its kind and will focus—at leastinitially—on eliminating some of the bottlenecks that cause inefficiencies inclinical 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., RocheGroup member Genentech and Sanofi, who met at several industry forums "where wediscussed issues that have been a bottleneck in the R&D space for a numberof years," says Dr. Garry Neil, former corporate vice president of science andtechnology at Johnson & Johnson and acting CEO of TransCelerate. 
"We figured we are at the point now where maybe we shouldput a little focus on this issue," says Neil, who is now a partner at AppleTree Partners. "We all know what the problems are and what the solutions mightbe, so why don't we roll up our sleeves and get down to it?"
Clinical trials are the "lowest-hanging fruit with thebiggest short-term payoff," Neil adds. "This really is about accelerating innovationin drug development and getting more drugs to patients. What we are trying todo is shorten that timeline and make sure products are properly tested."
Although TransCelerate's participants came up with a list of30 potential problems to tackle, they quickly narrowed that list down to aninitial set of five tasks to fund and tackle: development of a shared userinterface for investigator site portals; mutual recognition of study sitequalification and training; development of risk-based site monitoring approachand standards; development of clinical data standards; and establishment of acomparator drug supply model.
"Many people are surprised at this, but the developmentprocess we have today is not an efficient system," says Neil. "I have argued withsome of my R&D colleagues who say it takes 20 to 30 years to get from benchdiscovery 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 newtreatments accept that, either. Imagine if you could define the standards for aseries of diseases, and your membership says, 'we are going to adopt these datastandards and then accelerate it as the industry standard.'"
TransCelerate also has a prioritized list of diseases to focuson, says Neil.
"We have a list of about 2,000 diseases that we are in theprocess of prioritizing, but what is most important right now from a clinicalstudy point of view are diseases like Alzheimer's, cancer, heart disease anddiabetes. This work will never really end, because we are learning more aboutdiseases all the time," he says.
Each of the 10 founding companies will contribute funds andother resources, including personnel. TransCelerate is also looking to expandits founding collection of 10 companies. Membership is open to allpharmaceutical and biotechnology companies that can contribute to and benefitfrom these shared solutions.
According to Neil, TransCelerate has had interactions withregulators from both the U.S. Food and Drug Administration and the EuropeanMedicines Agency, as well as academic institutions, small biotech firms andcontract research organizations, and received a "warm and enthusiasticresponse."
"We're putting a lot of resources behind this, most of whichinvolve people. We have a lot of industry muscle and experts behind this, butwe 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 forcollecting information about diseases in clinical trials. We want to come upwith a better, risk-based way to monitor clinical trials, and an intelligentapproach to ensuring data integrity and subjects of clinical trials."
For now, TransCelerate is working remotely, but will have aphysical location in Philadelphia at GSK's Navy Yard headquarters. Neil willcontinue to lead TransCelerate for now, but he says the organization isactively recruiting a new CEO with hopes of hiring an individual by the end ofthe year.
Although some in the industry have expressed skepticism thatthese competing companies can work together on a common goal, Neil stressesthat TransCelerate is "not anticompetitive, but procompetitive."
"We are going to stimulate a lot more competition, and wereally need that. This is a very lucrative, vibrant industry, and wedesperately need to continue to be. Innovation is part of the solution, and italso ought to be at the center of healthcare reform, not just in the UnitedStates, but around the world," he says.

TransCelerate'sfounding board members
John Leonard, SVP Global Pharmaceutical R&D,Abbott

Anders Ekblom
, Head of Science & Technology,AstraZeneca
Klaus Dugi
, Corporate SVP Medicines,Boehringer-Ingelheim

Brian Daniels
, SVP Global Development & MedicalAffairs, Bristol-Myers Squibb
Lynn Marks, SVP Medicines Development Centre forInfectious 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
Garry Neil, Former Corporate VP, Science & Technology, Johnson & Johnson
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