Rachel Smith Executive Director Rare Disease Center of Excellence Parexel International Ms. Smith brings more than a decade of experience in every development phase of rare disease and cell and gene ...

Head of Technology Auditing & Compliance, UCB Pharma ...

Results from the Phase III BRUIN CLL-314 trial (NCT05254743) showed that Jaypirca (pirtobrutinib) achieved superiority in overall response rates compared to Imbruvica (ibrutinib) in patients with ...

In this video interview, Kate Gallin Heffernan, life sciences attorney at Epstein Becker Green, explains how clinical research teams can accurately report on diversity-related grant work while ...

In this video interview, Kate Gallin Heffernan, life sciences attorney at Epstein Becker Green, advises clinical research organizations to assess their portfolios, diversify funding sources, and ...

In this video interview, Kate Gallin Heffernan, life sciences attorney at Epstein Becker Green, advises clinical research teams to closely scrutinize federal fund certifications and document ...

In this video interview, Kate Gallin Heffernan, life sciences attorney at Epstein Becker Green, outlines how even unenforced executive orders can influence federal funding decisions, prompting ...

FDA cites trial design concerns in Complete Response Letter (CRL) to Replimune: The agency rejected the RP1 Biologics License Application (BLA) due to issues with the IGNYTE trial’s control and ...

A new myTomorrows survey of physicians in the United States highlights the need for smarter, AI-driven tools to overcome inefficiencies in clinical trial access and improve patient care timelines.

Despite ambitions to streamline regulatory review, FDA’s Elsa platform has been prone to hallucinations, prompting internal scrutiny and questions about AI reliability and governance.

The Phase III INDEPENDENCE trial (NCT04717414) failed to meet its primary endpoint of achieving transfusion independence in patients with myelofibrosis-associated anemia treated with Reblozyl ...

Shipra Patel, global therapeutic area section head, endocrinology, global head, pediatrics, Parexel, discusses the importance of long-term patient retention, data accuracy, and AI-driven compliance ...