It isn’t difficult to see how technology has changed our lives for the better over the last century. From self-driving cars to smartphones, numerous innovations have made our lives safer and much more convenient. Of course, one of the most robust categories where the quality of life has improved is medicine thanks to ongoing technological...
The FDA has released a new draft guidance for sponsors planning to use minimal residual disease (MRD) as a biomarker in clinical trials conducted under an investigational new drug application (IND) or to support marketing approval of drugs and biological products for the treatment of specific hematologic malignancies.
DURHAM, N.C., November 2, 2018 — Premier Research’s Chief Medical Officer will discuss bridging the regulatory engagement gap from pre-clinical to first patient in at Outsourcing in Clinical Trials New England, November 6, in Boston. Dr. Colin Hayward will address strategic and practical considerations for engaging with regulatory bodies on the opening day of the annual...
Small and mid-size biopharma companies in the U.S. and Europe are under intense pressure to find more efficient and cost-effective ways to commercialize their products. In an increasingly competitive clinical trial environment, sponsors have begun to shift their focus to the Asia-Pacific (APAC) region for their studies. In fact, the number of clinical trials in...
DURHAM, N.C., September 20, 2018 — Implementation of Europe’s new medical device regulations in 2017 started a transition that gives device companies up to five years to fully comply with strict new quality standards. But exactly what is changing, and why? And how will the new MDR and IVDR rules affect the players in this...
Small- to mid-sized biotech and pharma companies face many challenges when planning and executing an early-phase oncology trial, from performing a regulatory gap analysis and developing a target product profile to identifying the right patients and selecting efficacy endpoints. Sponsors of first-in-human trials of novel oncology compounds face significant challenges. Beyond the typical circumstances of limited budget,...
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,...
If the United Kingdom’s plan to exit the European Union evokes thoughts of a perilous road of steep grades and switchbacks, you’re pretty well attuned to the politically and commercially fraught process known as Brexit. More than two years after British voters elected to split from the EU, it often seems more questions than answers...
CAR-T cells are complex products, and translating them from basic and preclinical research to clinical trials and commercialization can be challenging. Understanding the regulations and developing a protocol that puts safety first—at every stage of development—are important first steps in bringing promising CAR-T cell therapies to the patients who need them most. CAR-T Cell Therapies:...
If you sell medical devices in Europe and haven’t made plans to comply with the EU’s new Medical Device Regulation (MDR) and In Vitro Diagnostics Regulation (IVDR), it’s time to step things up. The new MDR and IVDR rules adopted a little over a year ago do have generous phase-in periods — three years for...