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TransCelerate: a global collaboration across biopharmaceutical R&D to accelerate and simplify new medi-cines development

Lynn Marks

Abstract

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 inves-tigators, 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.


Keywords

clinical trials; research and development; risk-based monitoring; clinical data transparency; comparator drugs; quality management system; site qualification and training; GCP training

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References

AbbVie n.d., viewed April 2, 2015,

Allergen n.d., viewed April 2, 2015,

Amgen n.d., viewed May 26, 2015,

AstraZeneca n.d., viewed April 2, 2015,

Astellas Pharma US n.d., viewed April 2, 2015,

Biogen n.d., viewed April 2, 2015,

Boehringer Ingelheim n.d., viewed April 2, 2015,

Bristol-Myers Squibb n.d., viewed April 2, 2015,

EMD Serono, Inc. n.d., viewed April 2, 2015,

GlaxoSmithKline n.d., viewed April 2, 2015,

Johnson & Johnson n.d., viewed April 2, 2015,

Eli Lilly and Company n.d., viewed April 2, 2015,

Medgenics n.d., viewed April 2, 2015,

Merck & Co. n.d., viewed April 2, 2015,

Novo Nordisk n.d., viewed April 2, 2015,

Pfizer n.d., viewed April 2, 2015,

Roche n.d., viewed April 2, 2015,

Sanofi n.d., viewed April 2, 2015,

Shionogi n.d., viewed April 2, 2015,

UCB Pharma n.d., viewed April 2, 2015,

Tufts Center for the Study of Drug Development, Cost to Develop and Win Marketing Approval for a New Drug Is $2.6 Billion, November 18, 2014, viewed June 1, 2015,

TransCelerate BioPharma Inc., Clinical Data Standards n.d., viewed April 27, 2015,

TransCelerate BioPharma Inc., Site Qualification and Training (SQT) n.d., viewed April 27, 2015,

TransCelerate BioPharma Inc., Risk-Based Monitoring n.d., viewed April 27, 2015,

TransCelerate BioPharma Inc., Clinical Data Standards n.d., viewed April 27, 2015,

Clinical Data Interchange Standards Consortium (CDISC) n.d., viewed April 27, 2015,

Critical Path Institute n.d., viewed May 29, 2015,

National Cancer Institute – Enterprise Vocabulary Ser-vice n.d., viewed May 29, 2015,

Food and Drug Administration n.d., viewed May 29, 2015,

Coalition for Accelerating Standards and Therapies (CFAST) n.d., viewed April 27, 2015,

TransCelerate BioPharma Inc., Comparator Drugs n.d., viewed April 27, 2015,

TransCelerate BioPharma Inc., Shared Investigator Platform n.d., viewed April 27, 2015,

TransCelerate BioPharma Inc., Risk-Based Monitoring n.d., viewed April 27, 2015,

TransCelerate BioPharma Inc., RBM's Volume 3 Moni-toring Update n.d., viewed April 27, 2015,

TransCelerate BioPharma Inc., Site Qualification and Training (SQT) n.d., viewed April 27, 2015,

TransCelerate BioPharma Inc., GCP Training Mutual Recognition n.d., viewed April 27, 2015,

ICH, The Principles of ICH GCP n.d., viewed June 1, 2015,

TransCelerate BioPharma Inc., GCP Training Minimum Criteria n.d., viewed April 27, 2015,

TransCelerate BioPharma Inc., GCP Training Mutual Recognition n.d., viewed April 27, 2015,

Institute of Medicine of the National Academies, "Shar-ing Clinical Trial Data: Maximizing Benefits, Minimiz-ing Risk" January 2015, viewed April 27, 2015,

TransCelerate BioPharma Inc., Clinical Data Standards n.d., viewed April 27, 2015,

TransCelerate BioPharma Inc., Shared Investigator Platform n.d., viewed April 27, 2015,

TransCelerate BioPharma Inc., Placebo/Standard of Care Data-Sharing n.d., viewed April 27, 2015,

TransCelerate BioPharma Inc., Clinical Data Transpa-rency n.d., viewed April 27, 2015,

TransCelerate BioPharma Inc., elabels n.d., viewed May 26, 2015,

Applied Clinical Trials. TransCelerate’s eLabeling Initi-ative, April 22, 2015, viewed June 3, 2015,

Deloitte. Beyond M&A: Alternative arrangements ap-pear to be reshaping the life sciences landscape n.d., viewed May 26, 2015

TransCelerate BioPharma Inc., Strategic Priorities n.d., viewed April 27, 2015,


DOI: http://dx.doi.org/10.18063/jmds.v1i1.121
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Copyright (c) 2016 Lynn Marks

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