At a Glance
- Status: Active Consortium
- Year Launched: 2012
- Initiating Organization: TransCelerate Biopharma
- Initiator Type: Industry
- No disease focus
- Location: North America
TransCelerate BioPharma Inc. is a non-profit organization with a mission to collaborate across the biopharmaceutical research and development
community to identify, prioritize, design and facilitate the implementation of solutions to drive efficient, effective and high-quality delivery of new medicines, improving the health of people around the world.
TransCelerate BioPharma Inc. was launched in 2012 as a non-profit organization to improve the health of people around the world by simplifying and enhancing the research and development of innovative new therapies.
TransCelerate’s diverse portfolio of initiatives focuses on the shared vision of accelerating and enhancing the research and development of innovative new therapies. These initiatives develop practical solutions to overcome inefficiencies in clinical trials and are drawn from the combined expertise of our members and industry collaborators.
Our current Initiatives:
Clinical Data Standards
- The Clinical Data Standards Initiative develops industry-wide Data Standards in priority Therapeutic Areas to support the exchange and submission of clinical research and meta-data, while improving patient safety and outcomes.
Clinical Data Transparency
The Clinical Data Transparency Initiative was formed to develop a model approach for redacting privacy information found in clinical study reports and a model approach for anonymization of patient-level data shared with the healthcare community, enhancing transparency and facilitating future research while preserving the privacy of patients, investigators and clinical trial staff.
Clinical Trial Diversification
TransCelerate's Clinical Trial Diversification Initiative has achieved its goal of developing better practice materials for Site and Sponsors to improve engagement and recruitment of minority patient populations.
Common Protocol Template
The Common Protocol Template Initiative works with industry stakeholders to create a model clinical trial protocol template containing a common structure and common language, enhancing the clinical development process across stakeholder groups.
The Comparator Network Initiative is working to establish reliable, rapid sourcing of quality products for use in clinical trials through a Comparator Supply Network, which will enable accelerated trial timelines and enhanced patient safety.
The eConsent Initiative will create a common approach for the electronic consenting of patients using an array of digital elements and process efficiencies to provide insight into patients' understanding. Successful industry adoption of eConsent will empower patients, their families and their providers, while increasing regulatory compliance and reducing quality risks.
The eLabels Initiative will establish an innovative information channel in clinical trials: electronic labels. The Initiative envisions a future where the "label" used on medicines in clinical trials can be more beneficial to patients and sponsors as a digital channel of information.
The Investigator Registry Initiative will create a shared repository of investigator contact details and some site-related data from consenting sites, accelerating the identification and recruitment of qualified investigators and reducing cost and trial length by avoiding duplication of standard site qualification.
Pediatric Trial Efficiencies
This Initiative thoroughly assessed potential solutions that would lead to faster access to new drugs for pediatric patients. Rather than continue as a standalone initiative, a decision was made to transition the focal points of pediatric populations to other TransCelerate initiatives, where appropriate.
Placebo and Standard of Care Data Sharing
The Placebo and Standard of Care Initiative was established to enable the sharing of data to maximize the value of clinical data collected historically in the placebo and standard of care control arms of a clinical trial. Our goal is to enhance clinical trial designs, develop disease models and improve patient recruitment.
Quality Management System
The Quality Management System Initiative aims to explore ways to improve quality across the industry through partnerships with health authorities and other industry stakeholders - which can enhance patient safety by improving quality, assuring data integrity, minimizing delays in clinical trials and bringing drugs to market faster.
Risk Based Monitoring
Through this Initiative, TransCelerate is creating a model approach and resource solutions for the risk-based monitoring of clinical trials, with the objective to enhance patient safety and ensure quality of clinical data.
Shared Investigator Platform
TransCelerate's Shared Investigator Platform will establish a single platform to deliver content and services to investigator sites and provide a single point of access for interaction with participating clinical trial sponsors, enabling study planning, study start-up and study conduct activities while reducing administrative burden on site staff.
Site Qualification and Training
The goal of the Site Qualification and Training Initiative is to enhance and simplify the clinical trial site qualification and training process by creating common tools and resources that reduce time spend on non-study specific tasks, allowing more focus on protocol-related work.
TransCelerate BioPharma Inc. was formed in 2012 following a discussion among executive R&D leadership, in response to pharmaceutical executives expressing the need to work together to eliminate inefficiencies in R&D.
TransCelerate's ten original members were: Abbvie, AstraZeneca, Boehringer Ingelheim, Bristol-Myers Squibb, GlaxoSmithKline, Johnson & Johnson, Eli Lilly, Pfizer, Roche and Sanofi. In January 2013 Dalvir Gill was selected as CEO.
Structure & Governance
TransCelerate BioPharma has leadership from major biopharmaceutical companies – who have dedicated their careers to medicine, science and ensuring access to life-saving medicines through efficient and safe drug research and development. TransCelerate leadership has an unwavering dedication to assessing, refining and creating processes to make the drug development environment efficient, safe and innovative.
TransCelerate supports Member Companies in selecting areas of focus and delivering results. Member Companies make all decisions regarding implementation, including if they would like to implement or adopt a TransCelerate solution.
Membership of TransCelerate is available to pharmaceutical and biopharmaceutical companies with R&D organizations who engage in the innovative discovery, development, and manufacturing of new drugs.
TransCelerate workstreams are led and powered by Member Company resources. This is why TransCelerate membership in comprised of two components; an annual membership fee and a talent contribution commitment. There is a small team of TransCelerate employees and outsourced functions that help operationalize activities across the portfolio – but member company talent is the defining characteristic that has made TransCelerate successful in delivering solutions.
There are three membership tiers that are defined by a company’s global R&D spend. Each tier has a different annual membership fee and talent contribution commitment level.
While CROs, Investigator Sites, and other stakeholder groups are not eligible for membership – TransCelerate has other avenues in which they engage.
TransCelerate owns the copyright rights in the deliverables that it has developed. TransCelerate posts many of its deliverables on its website and publishes others in journals and other media to enable industry stakeholders to benefit from and use the guidance provided in these deliverables. Nevertheless, TransCelerate retains the exclusive rights under the copyright laws to reproduce, copy, distribute, and publicly display these works and to make derivative works based on these deliverables.
TransCelerate has several Initiatives that would allow industry to share data among each other more readily and seamlessly. Those Initiatives include Clinical Data Standards, Clinical Data Transparency, Placebo/Standard of Care, Quality Management System and the Shared Investigator Platform.