Perspective

Drugmakers launch TransCelerate BioPharma to speed testing

Ten biopharmaceutical companies announced Sept. 19 the formation of TransCelerate BioPharma Inc., a nonprofit intended to accelerate new medication development.

Abbott, AstraZeneca, Boehringer Ingelheim, Bristol-Myers Squibb, Eli Lilly and Company, GlaxoSmithKline, Johnson & Johnson, Pfizer, Genentech and Sanofi will pool finances, personnel and other resources to improve the quality of clinical studies, address challenges related to drug development and to quickly and efficiently release a larger number of new drugs to the public, according to a press release.

“There is widespread alignment among the heads of R&D at major pharmaceutical companies that there is a critical need to substantially increase the number of innovative new medicines, while eliminating inefficiencies that drive up R&D costs,” acting TransCelerate CEO Garry Neil, MD, partner at Apple Tree Partners and former corporate vice president of science and technology at Johnson & Johnson, said in the release. “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.”

The initial focus for the organization will be the execution of clinical studies, with early projects including the development of a comparator drug supply model and standards for clinical data and site monitoring, as well as mutual recognition of training and site qualification across member companies.

“We applaud the companies in TransCelerate BioPharma for joining forces to address a series of longstanding challenges in new drug development,” said Janet Woodcock, MD, director of FDA’s Center for Drug Evaluation and Research. “This collaborative approach in the pre-competitive arena … 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.”

Ten biopharmaceutical companies announced Sept. 19 the formation of TransCelerate BioPharma Inc., a nonprofit intended to accelerate new medication development.

Abbott, AstraZeneca, Boehringer Ingelheim, Bristol-Myers Squibb, Eli Lilly and Company, GlaxoSmithKline, Johnson & Johnson, Pfizer, Genentech and Sanofi will pool finances, personnel and other resources to improve the quality of clinical studies, address challenges related to drug development and to quickly and efficiently release a larger number of new drugs to the public, according to a press release.

“There is widespread alignment among the heads of R&D at major pharmaceutical companies that there is a critical need to substantially increase the number of innovative new medicines, while eliminating inefficiencies that drive up R&D costs,” acting TransCelerate CEO Garry Neil, MD, partner at Apple Tree Partners and former corporate vice president of science and technology at Johnson & Johnson, said in the release. “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.”

The initial focus for the organization will be the execution of clinical studies, with early projects including the development of a comparator drug supply model and standards for clinical data and site monitoring, as well as mutual recognition of training and site qualification across member companies.

“We applaud the companies in TransCelerate BioPharma for joining forces to address a series of longstanding challenges in new drug development,” said Janet Woodcock, MD, director of FDA’s Center for Drug Evaluation and Research. “This collaborative approach in the pre-competitive arena … 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.”

    Perspective

    This joint venture between major pharmaceutical companies seems to have a goal of reducing the costs of pharmaceutical research by streamlining and standardizing the process. This has the potential for encouraging physician and patient participation in clinical trials. I hope this actually translates into real benefits for cancer patients.

    • Lisa K. Lohr, PharmD, BCPS, BCOP
    • HemOnc Today Editorial Board member
    Perspective
    Edward A. Bell

    Edward A. Bell

    The formation of this new and innovative entity, TransCelebrate BioPharma, Inc., appears to be a step in the right direction for new drug development.

    Lack of newly introduced medications for some areas of medical practice, such as antibiotics and other infectious disease pharmacotherapies, has been well recognized. As bacterial resistance to our current antibiotic armamentarium continues, development of new antibiotic agents and new antibiotic classes has not kept pace. Short-course antibiotics are not as profitable to pharmaceutical companies as medications that patients are prescribed for years, such as therapies for hyperlipidemia.

    How the formation of TransCelebrate BioPharma Inc. will translate into development of new medications for infants and children, which are FDA-labeled for such use, is not known. This represents an additional area that has long concerned pediatric clinicians. So, while this new and innovative organization is a step forward, what real and useful applications develop for infants and children remain to be seen.

    • Edward A. Bell, PharmD, BCPS
    • Infectious Diseases in Children Editorial Board member

    Disclosures: Bell reports no relevant financial disclosures.