News Notes


Applied Clinical Trials

Applied Clinical TrialsApplied Clinical Trials-06-01-2019
Volume 28
Issue 6

A compilation of recently released news briefs that pertain to the clinical trials industry.

Transcelerate Launches Three New Initiatives

TransCelerate BioPharma Inc., the non-profit collaboration made up of 20 biopharmaceutical companies, recently unveiled new initiatives in efforts to expand on the group’s clinical and drug safety portfolio. They include:

  • The Common Clinical Serious Adverse Events (SAE) Fields Initiative intends to conduct a feasibility assessment, develop best practices relating to identifying the most critical SAE fields, and work with an industry standard-setting organization to promulgate standards in this area, all with the intent of increasing the quality of what is reported and creating efficiencies for sites, CROs, and regulators.

  • The Modernization of Data Analytics for Clinical Development Initiative aims to analyze methods for considering and validating novel statistical computing platforms to propose to health authorities and better enable them to support these platforms.

  • The Interpretation of Guidances and Regulations Initiative has expanded in scope from strictly pharmacovigilance to include clinical guidances and regulations. For its first deliverable, the workstream is creating a quality tolerance limits framework to help facilitate clinical trial compliance. The framework will propose interpretations of clinical regulations and seek to foster harmonization across health authorities by sharing recommendations that reduce the amount of duplicative efforts and audit findings.

Big pharmas partner with Verily

Verily, Alphabet’s life sciences unit, has formed strategic alliances with Novartis, Otsuka, Pfizer, and Sanofi to develop digitally innovative, patient-centered clinical research programs using Verily’s Project Baseline’s evidence generation platform and tools. The Baseline platform is designed to engage more patients and clinicians in research, increase the speed and ease of conducting studies, and collect more comprehensive, higher quality data.

Over the coming years, the four drugmakers each plan to launch clinical studies leveraging the platform across therapeutic areas such as cardiovascular disease, oncology, mental health, dermatology, and diabetes.

Gilead forms pact in kidney disease

Gilead Sciences and Goldfinch Bio Inc., a biotechnology company focused on developing precision therapies for patients with kidney diseases, have established a strategic collaboration to discover, develop, and commercialize a pipeline of therapeutics for diabetic kidney disease (DKD) and certain orphan kidney diseases. Under the multi-year deal, Gilead has exclusive options to license worldwide rights to certain products directed toward targets emerging from Goldfinch’s proprietary Kidney Genome Atlas™. Goldfinch will also apply its biology platform of human induced pluripotent stem cell-derived kidney cells and kidney organoids to validate potential drug targets.

NIH awards NJ antibiotics grant

Hackensack Meridian Health, New Jersey’s largest health network, announced that the NIH has awarded Dr. David S. Perlin, the chief scientific officer of the network’s Center for Discovery and Innovation, a $33.3 million grant to develop new antibiotics to overcome deadly bacteria in hospitals that have become resistant to current treatments.

ICON boosts reach in Europe, Africa

ICON plc has acquired a majority shareholding in MeDiNova Research, a site network with research sites in key markets in Europe and Africa, and has the right to acquire the remaining shares in the company by the third quarter of 2020. Headquartered in Coventry, UK, MeDiNova Research is a network of 33 active clinical research sites in the UK, Spain, South Africa, Poland, and Romania.


-Staff and Wire reports



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