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Retrospective cohort study sought to identify similarities between response- and progression-based end points in clinical trials and weighted observational cohorts of patients.

Companies must be able to defend the fidelity and confidentiality of all records and data generated throughout a product’s entire lifecycle, starting with the earliest points in research.

Sotyktu (deucravacitinib; Bristol Myers Squibb) is an oral, selective, allosteric tyrosine kinase 2 inhibitor that produced clinically meaningful improvements in Psoriasis Area and Severity Index scores among adult patients with moderate-to-severe plaque psoriasis.

Panna Sharma, CEO of Lantern Pharma, discusses LP-284, using their RADR during testing, ensuring global use, and what the future holds.

In the fifth and final part of this video interview series, Ken Getz, executive director and research professor, Tufts Center for the Study of Drug Development, Tufts University School of Medicine and Steve Young, chief science officer, CluePoints look ahead to the future of risk-based quality management and what adoption will look like.

Once-weekly subcutaneous injection of CT-388 produced significant weight loss in healthy adults with obesity compared with placebo across 24 weeks in an early phase trial.

Promising scientific advances are pacing oncology drug development.

In part 4 of this video interview series, Ken Getz, executive director and research professor, Tufts Center for the Study of Drug Development, Tufts University School of Medicine and Steve Young, chief science officer, CluePoints touch on what risks companies leave themselves susceptible to without the adoption of risk-based approaches.

Sharing an entertaining dive into the origins, milestones, and future of behavioral economics—where lessons can be applied to clinical practice.

Expanded relationship will utilize Medidata’s artificial intelligence solutions.

The potential of PBPK modeling in answering key questions around these drugs.

In the Complete Response Letter to Dynavax, the FDA stated that the supplemental Biologic License Application based on findings from the Phase I HBV-24 trial lacked sufficient data to support a full evaluation of the efficacy or safety of a four-dose Heplisav-B regimen in adults on hemodialysis.

A forum of prominent industry stakeholders highlights the challenges for patients in navigating the multiple legal, regulatory, and ethical barriers to cross-border participation.

In part 3 of this video interview series, Ken Getz, executive director and research professor, Tufts Center for the Study of Drug Development, Tufts University School of Medicine and Steve Young, chief science officer, CluePoints discuss what could be holding stakeholders back from adopting risk-based quality management.

Blockbuster cancer therapies failed to improve progression-free survival as combination.

Trial data met the pre-specified futility criteria for the primary endpoint of recurrence-free survival with the combination of vibostolimab and Keytruda (pembrolizumab) in the adjuvant treatment of patients with resected high-risk melanoma.

In part 2 of this video interview series, Ken Getz, executive director and research professor, Tufts Center for the Study of Drug Development, Tufts University School of Medicine and Steve Young, chief science officer, CluePoints highlight what stood out to them from the results of a recent study on RBQM adoption.

The Tufts Center for the Study of Drug Development is gathering new benchmark data on the vendor qualification process including the time, cost, and resources required to qualify contract service and technology vendors.

Administrative constraints cause FDA to push back its review of data from a pivotal Phase III trial (NCT05127434), which demonstrated favorable clinical safety and efficacy for mRNA-1345, an investigational vaccine found to reduce the incidence of RSV-associated lower respiratory tract disease.

In part 1 of this video interview series with Ken Getz, executive director and research professor, Tufts Center for the Study of Drug Development, Tufts University School of Medicine and Steve Young, chief science officer, CluePoints, Getz touches on the findings from a recent study on RBQM adoption.

A survey conducted at this year’s Pistoia Alliance conference determined that although 70% of life sciences experts acknowledge artificial intelligence’s potential, many still struggle with its initiation and implementation.

A cohort study used county-level data on social determinants of health to examine their association with oncology study access.

Findings from the Phase III KEYNOTE-B21 trial show that Keytruda (pembrolizumab) plus chemotherapy as adjuvant therapy, with or without radiotherapy, administered to patients with newly diagnosed high-risk endometrial cancer following surgery with curative intent did not achieve superiority in disease-free survival over placebo.

Midpoint clinical trial data for Teal Health’s Teal Wand is promising after exceeding initial enrollment numbers in the last 6 months.

Multicentric studies on diarrhea are essential for comprehending its epidemiology, causes, and treatment outcomes.

Cell-selective, adeno-associated virus gene therapy DB-OTO restored hearing to normal levels within 24 weeks in a child born with profound genetic deafness due to variants of the otoferlin gene.

Phase Ia trial of VYN202, expected to begin this quarter, will enroll approximately 64 healthy participants.

Phase I/IIa HORNBILL trial results show Boehringer Ingelheim’s novel humanized monoclonal anti-Sema3A antibody was well tolerated and showed early signs of efficacy.