TransCelerate BioPharma Reports Impact In The Way Clinical Trial Information Was Shared Among The Biopharmaceutical Industry In 2016

PHILADELPHIA--(BUSINESS WIRE)--2016 was a pivotal year for TransCelerate BioPharma Inc., demonstrating a clear evolution in the way the biopharma industry aims to streamline efficiencies through the sharing of data, and harmonizing on critical challenges. TransCelerate’s core initiatives reflect long-felt procedural pain points, and over the last year it has seen measurable progress in its mission to help drive the efficient, effective and high-quality delivery of new medicines for patients. In addition, TransCelerate committed substantial effort in 2016 building true foundations for its patient-facing initiatives, invigorating the organization’s focus on the patient experience during clinical trials.

“In just four years, TransCelerate has demonstrated what we’re capable of, if we work together,” reflects TransCelerate CEO Dalvir Gill, PhD. “We serve as a platform for multi-stakeholder collaboration, while bringing together some of the best minds in biopharmaceutical research and development. We continue to pioneer pragmatic and transformational improvements to the drug development process. After another great year in 2016, I can confidently say that TransCelerate will remain a real agent of change in the coming years.”

New Insights from Information Sharing & Harmonization Initiatives

On two core Initiatives, TransCelerate uncovered results that communicate significant progress in the journey to improve patient safety and efficiency in clinical trials.

• The Comparator Network executed end-to-end operations on updated technology, enabling access to top global comparator products, and eliminating the chance for counterfeit drugs to enter the investigational supply chain. The Network has exceeded transaction volume of $120M and saves members approximately 10 to 12% per transaction. By providing detailed stability data, the Network has avoided wasting substantial quantities of investigational product. Most importantly, avoiding drug loss due to potential temperature excursions has prevented delays in getting lifesaving products to patients who participate in clinical trials.
• TransCelerate has made significant progress in the Placebo & Standard of Care Data Sharing Initiative. Thus far, preliminary results indicate that use of such well-defined historical data can reduce study time significantly, and reduce the number patients in the placebo/standard of care arm.

Reinforced Commitment to Patients in Clinical Research

Recognizing the patient as the most important stakeholder in clinical development, TransCelerate launched many new initiatives dedicated to improving the patient experience in clinical research.

• TransCelerate made progress on the goal to empower and engage patients, launching a new initiative dedicated to understanding patient burden, and use of technology in clinical trials – Patient Experience & Technology, and solidifying the Initiative centered on supporting better informed patients – Clinical Research Awareness & Access.
• The eConsent Initiative released its draft Implementation Guidance, aimed at evolving the informed consent practice toward increased efficiency, compliance and patient understanding, supported by electronic consent tools. An updated guidance paper will be made available in 2017.
• The eLabels Initiative continued to work towards laying the foundation for digitally-enabled, patient-centric labels on clinical trial medicines, propelling the needle forward on patient and site utility.

Through a collaboration with the Center for Information and Study on Clinical Research Participation (CISCRP), TransCelerate is working with international Patient Advisory Boards to gather patient feedback on our key patient engagement initiatives that will help us inform recommendations for new approaches and best practices.

Preparing for an Exciting 2017

With the support, passion and knowledge of hundreds of industry experts from 18 biopharmaceutical companies, and collaborative efforts with over 40 global health authorities and industry organizations, TransCelerate has transformed the industry’s approach to clinical trial monitoring through the Risk Based Monitoring Initiative, reduced duplication in investigator site training through the Site Qualification Training Initiative and created value where there were serious redundancies in clinical operations related forms, templates and processes. In 2017, TransCelerate will continue fulfilling its pledge to bring innovation to the drug development process.

Elliott Levy, M.D., Senior Vice President of Global Development at Amgen, and the newly appointed Vice Chair of the TransCelerate Board of Directors, states, “Since TransCelerate was launched, our industry has seen unprecedented collaboration and accomplishments, and I am incredibly optimistic about what’s next. We are all eager to continue innovating together to address drug development challenges and deliver meaningful change for patients.”

By working with global health authorities to integrate feedback into initiatives, TransCelerate will reinforce its commitment to the international health and R&D community. The consortium plans to increase engagement with patients, sites and CROs from the ground-level in the development of solutions to improve trial awareness, access, and experience. A few anticipated milestones in 2017 include:

• Enhance the value of the Shared Investigator Platform for both sites and sponsors by delivering new capabilities, enhanced functionality, and adoption from more TransCelerate Member Companies.
• Increase the use of and value of the Common Protocol Template across stakeholders (sponsors, sites, regulators), and identify a pathway to automation and traceability from protocol to data collection.
• Launch a new data sharing platform through its subsidiary, BioCelerate, which will initially be used for toxicology and animal control data, and offers the potential to store, visualize and analyze a multitude of preclinical and clinical data types.
• Identify technology, and process changes to optimize the use of eSources and provide proof of concept to demonstrate viability of using eSource technologies for regulated clinical trials.

About TransCelerate BioPharma, Inc.

TransCelerate BioPharma Inc. is a non-profit organization dedicated to improving the health of people around the world by simplifying and accelerating the research and development (R&D) of innovative new therapies. The organizations' mission is to collaborate across the global biopharmaceutical R&D community to identify, prioritize, design and facilitate implementation of solutions designed to drive the efficient, effective and high quality delivery of new medicines. TransCelerate evolved from conversations at various forums for executive R&D leadership to discuss current issues facing the industry, and examine solutions for addressing common challenges. The founding member companies are AbbVie, AstraZeneca, Boehringer Ingelheim, Bristol-Myers Squibb, Eli Lilly and Company, GlaxoSmithKline, Johnson & Johnson, Pfizer, the Roche Group, and Sanofi. Additional members that have joined since the inception of TransCelerate include Allergan, Inc., Amgen, Astellas Pharma Inc., EMD Serono, Inc. (a subsidiary of Merck KGaA, Darmstadt, Germany), Merck & Co., Inc., Novo Nordisk, Shionogi & Co., Ltd. and UCB.

Membership in TransCelerate is open to pharmaceutical and biotechnology companies with Research & Development operations. Executive offices are located in Philadelphia, PA. For more information, please visit http://www.transceleratebiopharmainc.com.

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