Regulatory Focus™ > News Articles > Major Pharmaceutical Companies Join Together to Address Regulatory Challenges

Major Pharmaceutical Companies Join Together to Address Regulatory Challenges

Posted 19 September 2012 | By

Ten of the world's largest biopharmaceutical companies have banded together to find ways to solve what the group is calling, "common drug development challenges," including the improvement of the quality of clinical studies.

The companies-Abbott, AstraZeneca, Boehringer Ingelheim, Bristol-Myers Squibb, Eli Lilly and Company, GlaxoSmithKline, Johnson & Johnson, Pfizer, Genentech a member of the Roche Group, and Sanofi-announced the formation of a nonprofit entity called TransCelerate BioPharma Inc, which they called the, "Largest ever initiative of its kind."

Under the terms of the agreement, each company will contribute financial, personnel and intellectual resources to TransCelerate, with the goal of solving common problems that currently drive up research and development costs.

"Our mission at TransCelerate BioPharma is to work together across the global research and development community and share research and solutions that will simplify and accelerate the delivery of exciting new medicines for patients," said the new CEO of the venture, Garry Neil, MD.

The project will initially focus on the execution of clinical studies by funding five projects: 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.

Clinical trials are historically one of the largest consumers of time and money during the process of drug development, with some trials costing well in excess of $100 million for just a single Phase 3 trial. By cutting down on inefficiencies in the process, TransCelerate says it hopes to be able to both reduce costs and get products to market more quickly.

Collaboration with Regulators and Other Organizations

The group also said it hopes to work closely in the near future with regulators, including the US Food and Drug Administration and the European Medicines Agency (EMA), other contract research organizations, and regulatory groups such as the Clinical Data Interchange Standards Consortium (CDISC), the Critical-Path Institute (C-Path), the Clinical Trials Transformation Initiative (CTTI) and the Innovative Medicines Initiative (IMI).

FDA already seems to be supporting the measure, with the group quoting the Director of the Center for Drug Evaluation and Research (CDER) as saying the agency, "Applaud[s] the companies in TransCelerate BioPharma for joining forces to address a series of longstanding challenges in new drug development."

"This collaborative approach in the pre-competitive arena, utilizing the collective experience and resources of 10 leading drug companies and others to follow, has the promise to lead to new paradigms and cost savings in drug development, all of which would strengthen the industry and its ability to develop innovative and much-needed therapies for patients," Woodcock added.

The measures come just months after similar efforts were launched by the National Institute of Health's (NIH) National Center for the Advancement of Translational Science (NCATS) announced the formation of its own drug development acceleration program, dubbed the Discovering New Therapeutic Uses for Existing Molecules program, to focus on repurposing failed late-stage compounds for new uses. Another NCATS program, the Cures Acceleration Network (CAN), is similarly aimed at accelerating the development of new pharmaceutical products, but instead does so with an emphasis on developing regulatory tools that can be used to accelerate clinical trials and the review of new products.


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