TransCelerate BioPharma Member Companies Commit to Share COVID-19 Related Clinical Data via DataCelerate®

PHILADELPHIA–()–TransCelerate BioPharma Inc., a non-profit collaboration comprised of 21 of the largest global biopharmaceutical companies, today announced that it will be utilizing its DataCelerate® platform to share Member Company control arm data from ongoing and planned COVID-19 clinical studies, as well as data from past studies in related diseases or patient populations. The data will accumulate in the coming weeks and will be made available to TransCelerate Member Companies who are pursuing treatments and vaccines for this pandemic. As the COVID-19 related data accumulates from Member Companies, TransCelerate will immediately investigate providing access outside the membership.

DataCelerate® is a global cloud-based data sharing platform that allows for deidentified, anonymized pre-clinical and clinical data types to be requested, voluntarily shared and, in some instances, converted and harmonized to a uniform data model to facilitate its use. The DataCelerate® system and accompanying legal agreements provide an internationally compliant system protecting privacy rights in personally identifiable clinical data. It is a validated and fully trusted way for TransCelerate Member Companies to share data and has been utilized to power research activities since 2017.

Data can be downloaded from DataCelerate® into participating Member Company systems for customized assessments, analyses and querying through an access controlled, secured environment. Data sharing is voluntary, and Member Companies share de-identified/anonymized patient-level data collected from the control arms of clinical trials. This data has already been used to reduce the number of patients in clinical trials, improve trial design, assess safety signals, negated the need for some studies, increase knowledge of disease and treatments and improve the understanding of global patient populations.

“This is an exciting commitment,” said Dalvir Gill, Ph.D., CEO of TransCelerate BioPharma, Inc. “The quick decision to share detailed COVID-19-related patient-level data will allow us to leverage pre-existing data sharing agreements and have the data quickly available in an already operational data sharing platform.”

DataCelerate® is already in use at Member Companies, allowing this to be an immediate resource. Since its launch, the platform has already amassed individual patient data from 53 disease areas, including >40,000 vaccine patients. DataCelerate® was built with feedback incorporated from global health authorities.

“The value of this highly-curated, patient-level data is crystal clear as we work to quickly develop treatments for COVID-19,” said Michelle Rohrer, Ph.D., Chair of the TransCelerate Board of Directors and Senior Vice President, Global Head of Pharma Development Regulatory and Policy, Roche. “The TransCelerate members have committed to this endeavor and will be submitting clinical study data that may be relevant for scientists, statisticians, and clinicians who are working on developing COVID-19 interventions. This effort illustrates how biopharmaceutical companies are collaborating and sharing information in order to find treatments as quickly as possible.”

“At Amgen, we are acting quickly and collaborating with others in the interest of patients,” said Elliott Levy, M.D., Senior Vice President, Global Development, Amgen. “Our use of data from DataCelerate® has already helped Amgen plan clinical trials where the number of patients in the control arms has been reduced by half. By making available control data from patient populations affected by COVID-19, or similar populations, this effort could help accelerate clinical trials and get us that much closer to a treatment and vaccine. Time is of the essence, and control arm pooling through DataCelerate® will help safely and efficiently reduce the barriers to get these drugs tested.”

“We are immediately pivoting to investigating access for non-member organizations,” continued Gill. “This will require overcoming technical complications and addressing legal issues because the DataCelerate platform is designed for secured internal access and is governed by pre-existing Data Sharing Agreements among the Member Companies.”

For additional resources currently available to support the continuity of clinical trials visit: https://transceleratebiopharmainc.com/covid-19/.

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 organization’s mission is to collaborate across the global biopharmaceutical R&D community to identify, prioritize, design and facilitate implementation of solutions intended to drive the efficient, effective and high-quality delivery of new medicines. The vast majority of TransCelerate solutions are publicly available. Headquartered in Philadelphia, TransCelerate has 21 member companies and 30+ initiatives focused on improving the patient and site experience, enhancing sponsor efficiencies and drug safety and harmonizing process and sharing information.

Membership in TransCelerate is open to pharmaceutical and biotechnology companies with R&D operations. For more information, please visit http://www.transceleratebiopharmainc.com, https://twitter.com/TransCelerate, or https://www.linkedin.com/company/transcelerate-biopharma-inc-/.

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