TransCelerate: a global collaboration across biopharmaceutical R&D to accelerate and simplify new medicines development
DOI:
https://doi.org/10.18063/jmds.v1i1.121Keywords:
clinical trials, research and development, risk-based monitoring, clinical data transparency, comparator drugs, quality management system, qualification and training, site, GCP trainingAbstract
As the economic pressures increase on healthcare systems around the world due to aging populations, chronic
diseases, expanding patient populations in emerging markets and advances in medical technology, it is crucial that we
focus on developing and delivering innovative and quality medicines with true medical value to patients around the
world in a more collaborative, quality-focused and cost-effective manner.
An important component to this mission across the biopharmaceutical industry is identifying and solving common issues that compromise the success of a clinical development program – the shared pathway to safer and more clinically
meaningful medicines. However, subject recruitment challenges, data collection and follow-up issues, identification of
high-quality trial sites, and lack of successfully achieving study timelines continue to stress clinical trial operations
teams across companies. Although there has been progressing across this range of roadblocks by individual companies,
the underlying economics continue to threaten the research and development (R&D) business model.
Failure to solve these key issues will affect all parties involved in the clinical trial enterprise: patients, clinical investigators, health authorities, academia, tax-payers and the sponsor companies. The question remains whether a deep and
broad collaborative effort that stretches across the clinical development arena—one that is charged with a common goal
of improving quality, enhancing the investigator and patient experience, reducing costs and sharing data—can be a
catalyst for success. With encouraging signs already realised, the operation of TransCelerate BioPharma Inc., a
non-profit organisation created to improve the health of people around the world by accelerating and enhancing the
R&D of innovative new therapies will test this premise.
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