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NYT – Drug Makers Join Efforts in Research

NYT – Drug Makers Join Efforts in Research


Ten of the world’s largest pharmaceutical companies said on Wednesday that they would cooperate on research aimed at accelerating drug development, starting with streamlining clinical trials.

Pharmaceutical companies have collaborated before on areas considered not directly competitive, like finding variants in the human genome and biomarkers to predict disease and the effectiveness of drugs. But the people behind the new effort said it would be the largest of its kind.

“There’s never been anything like this to take on these big challenges,” said Garry Neil, the interim chief executive of the new nonprofit organization, TransCelerate BioPharma, which has been formed to carry on the work.

Mr. Neil, a former corporate vice president for science and technology at Johnson & Johnson, offered no details on the size of the effort, saying only that the budget would be in the millions of dollars.

The pharmaceutical industry has been struggling to come up with new drugs, despite a vast increase in spending on research and development over the last decade. In the meantime, sales from many big-selling drugs are evaporating as patents expire and generic competition kicks in.

Mr. Neil said that TransCelerate would initially take on five projects aimed at making clinical trials more efficient. Clinical trials are the most costly part of bringing a drug to market.

One project would be to standardize the way data from clinical trials are recorded. That would make it easier for clinical trial investigators to enter data without having to remember each company’s format and to compare data from clinical trials.

Similarly, TransCelerate will work on a common Internet portal that investigators can use to communicate with all drug companies, and also on standardizing efforts to qualify clinical trial sites and to train investigators. It will also work on a way for companies to easily procure one another’s already marketed drugs for use in comparative clinical trials.

“We started with things we think are important and also doable,” Mr. Neil said, saying the goal is to make significant progress on each project by the middle of next year. He said that TransCelerate might eventually expand to collaborations on drug discovery research.

The 10 initial members are Abbott, AstraZeneca, Boehringer Ingelheim, Bristol-Myers Squibb, Eli Lilly, GlaxoSmithKline, Johnson & Johnson, Pfizer, Roche’s Genentech division, and Sanofi. The heads of research and development at these companies sit on the board of TransCelerate.

Other companies, including smaller ones, will be able to join, Mr. Neil said.

The companies will contribute money and personnel to work on the various projects. While TransCelerate will have a headquarters in Philadelphia, the employees from different companies will not all work together at that location, instead meeting as necessary, Mr. Neil said.

TransCelerate said it would work with other organizations. At least two nonprofit organizations, each with pharmaceutical company participation, are already working on accelerating clinical trials and standardizing data. Just last week, those two organizations — the Clinical Data Interchange Standards Consortium and the Critical Path Institute — announced that they would form the Coalition for Accelerating Standards and Therapies.

Mr. Neil said TransCelerate had been in the formative stage for about a year and had been in discussions with regulators.

“We applaud the companies in TransCelerate BioPharma for joining forces to address a series of longstanding challenges in new drug development,” Dr. Janet Woodcock, the director of the drug division at the Food and Drug Administration, said in a statement issued by TransCelerate.