REUTERS - Ten top pharmaceutical companies from the United States and Europe said they have formed a nonprofit organization to accelerate the development of new drugs, a risky and expensive undertaking for companies of any size.
Abbott Laboratories Inc, AstraZeneca Plc, Boehringer Ingelheim, Bristol-Myers Squibb Co, Eli Lilly and Co, GlaxoSmithKline Plc, Johnson & Johnson, Pfizer Inc, Roche Holding AG’s Genentech and Sanofi SA have launched TransCelerate BioPharma Inc, headquartered in Philadelphia, the companies said on Wednesday.
Each company will contribute financial and other resources to meet specific objectives and established guidelines for sharing information and expertise.
“There are a number of problems we want to solve. Some are related to cost, but we’re just as concerned about other factors — the quality and the time it takes to enroll patients and complete clinical studies,” TransCelerate Chief Executive Dr Garry Neil said in a telephone interview.
“What we’ve seen over the last few years is that costs have risen and the success rates have gone down through all of the phases of drug development, and we’re trying to address that,” said Neil, formerly Corporate Vice President, Science & Technology, Johnson & Johnson.
The goal, he said, is to create an infrastructure by establishing a single portal for all clinical investigators to use for all clinical studies, as well as a common language and standards aimed at increasing efficiency and cutting errors. Streamlining the training of investigators is another objective, he said.
“We want to simplify, standardize and also raise quality,” he said. “We worry about potentially promising drugs which might not get studied unless we can increase the overall efficiency of the system. I think it will make it easier for all companies.”
Neil said companies will pursue individual studies on their own, so there are no competitive threats.
He said he wants and expects more companies, including smaller ones, to join TransCelerate.
“We wanted to make this manageable at first. We’re getting a lot of interest from others. The goal is not to make this exclusive,” he said, adding that the cost of membership is based on how much a company spends on R&D. He declined to be more specific, but noted that the more participants, the lower the fees will be.
“This will be affordable for small companies,” he added.
TransCelerate also plans alliances with industry groups, such as the Clinical Data Interchange Standards Consortium, Critical-Path Institute, Clinical Trials Transformation Initiative, Innovative Medicines Initiative, European Medicines Agency, and Contract Research Organizations, it said, adding that this model provides a new approach for the industry.
Neil said the idea has been well-received by regulators, including the Food and Drug Administration and European Medicines Agency.
“As an industry, we’re not able to address the unmet needs as fast as stakeholders want and patients want,” he said. “The questions we’re asking are more and more complicated. We’re going into more difficult diseases — Alzheimer’s, congestive heart failure, advanced cancer, diabetes, obesity — and as we try to study these diseases, we need a more robust infrastructure.”
Reporting by Debra Sherman in Chicago; Editing by Jeffrey Benkoe, Lisa Von Ahn and Jim Marshall