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DURHAM, N.C., March 19, 2019 — Chimeric antigen receptor (CAR) T-cell therapy shows enormous potential for treating many forms of cancer, including lymphoma, acute myeloid leukemia, and myelodysplastic syndromes. Oncology experts Brian Marks, BSc, DC, Senior Director and Ashley Jones, MSc, Project Lead will discuss these emerging therapies and their potential to unleash the body’s defensesRead more

Decades of painstaking research have recently begun to yield gene therapy products that are delivering meaningful benefits to human health. The approvals of voretigene neparvovec-rzyl (Luxturna) for inherited vision loss, tisagenlecleucel (Kymriah) for lymphoblastic leukemia, and axicabtagene ciloleucel (Yescarta) for lymphoma have ushered in a new era of therapeutics. With the rapid evolution of theRead more

As medical device regulations evolve and global, multi-center studies become increasingly common, a growing number of sponsors are turning to independent committees such as Data Monitoring Committees (DMCs) or Clinical Endpoint Committees (CECs) for assistance with clinical trial oversight. However, given that neither the U.S. Food and Drug Administration (FDA) nor the European Medicines AgencyRead more

DURHAM, N.C., February 26, 2019 — The European Union’s new Medical Device Regulation will mean a lot of changes for device makers when it takes effect in May 2020. Now’s the time to prepare, and Premier Research will discuss how at a live webinar on Tuesday, March 12. Topics will include: When device makers needRead more

Months before Britons voted narrowly to leave the European Union (EU) in June 2016, then-U.K. Prime Minister David Cameron called a vote to withdraw from “the gamble of the century” and warned of dire political and economic repercussions. More than two-and-a-half years later, Cameron’s warning sounds more prescient than ever. Countless unanswered questions confront BritishRead more

The assignment sounded simple enough: Recruit 24 patients for a Phase I proof-of-concept study of inflammatory bowel disease. The first CRO that received the assignment showed how difficult it really was: They were able to recruit only nine patients in a year and a half. At that point, the sponsor asked Premier Research to stepRead more

In a fast-paced digital world, healthcare has had to adapt to better serve consumers who increasingly prefer or rely on web- or app-based services. Telehealth (or e-health) solutions are providing increased access to care, making it easier not only for patients to receive care, but also for healthcare professionals to deliver that care. For healthcare professionalsRead more

 Clinical research certainly has evolved over the past three decades. There are more trials crossing a broader spectrum of indications, and advances in study design and execution have dramatically changed the way drugs and medical devices are evaluated and sold. But perhaps no change has been more significant than the growth in engagement onRead more

This episode, we’re proud to share the first part of our conversation with Alan Thomas, patient advocate and founder of Ataxia & Me, ahead of International Ataxia Awareness Day on September 25. Alan talks about his personal journey with ataxia and how he first got started with patient awareness. Follow Alan and Ataxia & MeRead more

The European Union’s new Medical Device Regulation (MDR) and In Vitro Diagnostics Regulation (IVDR) are putting a lot of pressure on the medical device industry. These are big changes with far-reaching implications, and if there’s a common denominator among them, it can be summed up in one word: more. In this episode of Premier Voices,Read more

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