Monthly Archives: March 2018

DURHAM, N.C., March 30, 2018 — Fourteen Premier Research employees have been named finalists for PharmaTimes magazine’s Clinical Researcher of the Year awards. The finalists are three clinical trial managers, two project managers, and nine members of two project teams. Competition continues through to April 27, when the awards are announced. Finalists in the Clinical TrialRead more

DURHAM, N.C., March 30, 2018 — Predicting the cost of clinical trials is a complex task, and more CROs are providing grant forecasting as a service to produce more accurate projections and give customers greater visibility. A grant forecasting expert from Premier Research will discuss new approaches to predicting trial costs in April at theRead more

Immuno-gene therapeutics are transforming the therapeutic landscape of hematological malignancies. The recent approvals of two chimeric antigen receptor (CAR)-T cell therapies—tisagenlecleucel (marketed as Kymriah™) and axicabtagene ciloleucel (marketed as Yescarta™)—mark the beginning of the next revolution in cancer treatment. However, along with demonstrated efficacy in hematologic malignancies, CAR-T cells have the capacity to elicit seriousRead more

Over the past few years, there has been a dramatic increase in the use of genetically modified cells for cancer immunotherapy, including chimeric antigen receptor (CAR)-T cells, recombinant T-cell receptor T cells and genetically modified CD34+ cells for the treatment of hematological malignancies. Clinical trials of immuno-gene therapeutics are becoming increasingly common, and regulatory guidelinesRead more

Days before Christmas 2017, a nationwide call went out requesting nominations of patients and caregivers to join a new public/private-sponsored Patient Engagement Collaborative. Among the promised duties for this yet-to-be-filled body of 16 patient community representatives: Propose new collaboration models in which patients and patient advocates are partners in healthcare product development and U.S. FoodRead more

Experts describing recent advances in drug development often drift into hyperbole — but really, can you blame them? Gene therapies and drugs that weaponize the immune system against tumor cells are among recent breakthroughs that were unthinkable even a decade ago. But therapies for central nervous system disorders have been a stubborn exception. “We recognizeRead more

Forecasting the cost of clinical drug and medical device trials has never been easy, and as trials become more complex, estimating (and re-estimating) these costs becomes even more challenging. Lack of accurate forecasts has serious schedule and cost implications. By impeding effective cash management, inaccurate projections can lead to disruptions and delays that cost sponsorsRead more

After years in development, the final version of the Medical Device/In Vitro Diagnostic Medical Device Regulations was published in the Official Journal of the European Union on May 5, 2017. These regulations superseded the previous Directives for the European market and will be implemented over the next few years. In our last post, we went overRead more

DURHAM, N.C., MARCH 2, 2018 — You know that well-worn advice about picking investments: that past performance doesn’t guarantee future results. The same can be said of selecting clinical trial sites, as Premier Research’s top analgesia expert will explore at the American Pain Society’s 2018 Scientific Summit on March 6 in Anaheim. Michael Kuss, ViceRead more

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