BioPharma group to boost efforts to use analytics

An organization working to streamline and accelerate research of new therapies is building an initiative to modernize the use of analytics.

The initiative is one of three announced late last week by the TransCelerate BioPharma, as part of a three-pronged expansion of its clinical and drug safety portfolio.

TransCelerate BioPharma is a not-for-profit organization that aims 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 analytics initiative aims to analyze methods for considering and validating novel statistical computing platforms to better enable support from health authorities.

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A laboratory specialist uses a microscope to check cells during the last phase of vaccine manufacture inside a clean laboratory at the Sotio AS biotechnology company in Prague, Czech Republic, on Wednesday, July 20, 2016. Czech Republic’s richest man, billionaire Petr Kellner's Sotio biotech company, which is seeking to develop active cellular immunotherapy for treatment of prostate, ovarian and lung cancer, has invested "billions of koruna" into research and clinical development, the unit's spokesman, Richard Kapsa, said without elaborating. Photographer: Martin Divisek/Bloomberg

The organization says the analytics effort aims to leverage the most advanced and innovative data analytical capabilities available, aiming to boost both time savings and quality in generating results. The long-term aim is to enable higher-level research in the future and support reproducible research.

In addition to efforts to modernize data analytics for clinical development, TransCelerate is also increasing efforts in two other initiatives.
In one, the Common Clinical Serious Adverse Events Fields Initiative intends to develop best practices for identifying the most critical serious adverse events fields to both increase data quality and create better efficiencies for sites, contract research organizations and regulators.

The other is the Interpretation of Guidances and Regulations Initiative, which is expanding its scope to include clinical guidance’s and regulations.

The 20-member organization’s clinical and drug safety portfolio now consists of 30 initiatives supported by significant in-kind resource contributions from TransCelerate members. Membership in TransCelerate is open to pharmaceutical and biotechnology companies with R&D operations.

TransCelerate’s drug safety team recently met with several health authorities to inform thinking for upcoming deliverables, among them the U.S. Food and Drug Administration.

The organization expects deliverables from the new initiatives “to enhance our prior investments and to deliver quick and tangible value to our members and other stakeholders,” says Janice Chang, executive vice president of TransCelerate BioPharma. “Furthermore, as multiple stakeholders adopt our work globally, we have significantly ramped up our engagement with health authorities who are increasingly eager to collaborate with TransCelerate to solve common problems.”

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