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In this interview, Michael J. Graziano, PhD, DABT, Vice-President, Drug Safety Evaluation for Bristol-Myers Squibb and leader of the BioCelerate Toxicology Data Sharing Initiative, provides more details about the DataCelerate platform.
TransCelerate BioPharma recently launched a clinical data sharing platform, DataCelerate. The platform incorporates preclinical toxicology data from the company’s subsidiary, BioCelerate, supporting toxicology data sharing amongst member companies. The platform provides access to numerous data types, which can then be visualized and downloaded for analysis. In this interview, Michael J. Graziano, PhD, DABT, Vice-President, Drug Safety Evaluation for Bristol-Myers Squibb and leader of the BioCelerate Toxicology Data Sharing Initiative, provides more details.
Moe Alsumidaie: What is DataCelerate?
Mike Graziano: DataCelerate is a data sharing platform, launched in July, aimed at integrating clinical and preclinical data sets into one repository. The platform currently houses toxicology data to help companies gain insight on target toxicity and is integrating historical, de-identified clinical data under TransCelerate’s Placebo and Standard of Care (PSoC) data sharing initiative, which includes data collected from the placebo and standard of care control arms of clinical trials. Through the sharing of data, member companies can help one another increase the efficiency of the drug development process and better design clinical trials. Currently, there are 16 TransCelerate member companies using DataCelerate.
MA: Can you describe the technology platform DataCelerate is using? What does BioCelerate’s data sharing agreement require from member companies?
MG: DataCelerate's technology can support both structured and unstructured data, is built on Accenture’s Insight Platform and is shared only between member companies. Within the platform, users are equipped with tools that allow them to search for and visualize anonymized data. Users can also extract some or all of this data and download it into their own systems for customized data assessments and queries. BioCelerate member companies are in the process of sharing user experience and assessing the efficiency of the platform to identify opportunities for future system enhancements. The toxicology data sharing component of DataCelerate is focused on enabling member companies to make internal decisions on compounds in early clinical development. Although DataCelerate is in its early phases, more TransCelerate member companies are looking to join the toxicology data sharing initiative. This will increase the amount of data in the system and build greater value for all member companies involved.
The data sharing agreement for BioCelerate member companies is minimal and requires member companies to share only one compound or one set of studies from a compound per year. Additionally, the data sharing agreement states that publishing any of the data is prohibited, and companies cannot share this information with health authorities.
MA: How will DataCelerate maintain confidence with two companies that are competing for the same target?
MG: It’s in their best interest. The member companies are willing to share data early on in hopes of better understanding toxicity profiles. Since they will likely have a different chemical structure, you can gain insights into on- or off-target toxicity. If the toxicity is due to the chemical structure, you may decide to redesign a better molecule. We have also realized that more and more biopharmaceutical companies are acknowledging that greater transparency and sharing of anonymized, toxicology data can transform the design of clinical studies and better facilitate the delivery of clinical therapies. Without data sharing, otherwise hidden unused historical data would go undiscovered.
MA: How do you envision the DataCelerate initiative changing in the future?
MG: TransCelerate also hopes to integrate additional data types, like pharmacology data collected in earlier preclinical development or genomic data, as well as link to data from other groups that have different data sets. Other opportunities to link to other data sharing initiatives will also be considered. We hope to better facilitate the research and development process by allowing member companies to more efficiently share, search, and access data than ever before.
Moe Alsumidaie, MBA, MSF is Chief Data Scientist at Annex Clinical, and Editorial Advisory Board member for and regular contributor to Applied Clinical Trials.