Category Archives: Hematology & Oncology

In recent years, immunotherapy has led to substantial advances in cancer therapy. In particular, the immune checkpoint inhibitors — PD-1/PD-L1 and CTLA-4 inhibitors — have revolutionized treatment for certain hematologic malignancies and solid tumors. To date, the U.S. Food and Drug Administration (FDA) has approved immunotherapies for more than 15 cancer indications. However, widespread useRead more

DURHAM, N.C., April 25, 2019 — Premier Research will moderate a panel on cell-based therapies on Tuesday, April 30, at the Clinical Operations in Oncology Trials West Coast meeting in Burlingame, Calif. Colin Hayward, the company’s chief medical officer, will lead a discussion about how researchers are overcoming the challenges inherent in creating cell-based cancerRead more

Of the 350 million to 400 million people infected with the hepatitis B virus worldwide, one in three lives in China. The country is home to 130 million carriers of the disease and 30 million who are chronically infected.[1][2] Some rural parts of China have an especially high incidence of tuberculosis,[3] and across Asia, prevalence ofRead more

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

The FDA has released a new draft guidance for sponsors planning to use minimal residual disease (MRD) as a biomarker in clinical trials conducted under an investigational new drug application (IND) or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. Read the full guidance here or clickRead more

Meet Premier’s oncology experts at ASCO booth #24153 May 31-June 4! The primary purpose of early-stage clinical trials is to determine the recommended dose and toxicity profile of an investigational drug or multi-drug combination therapy. Since molecularly targeted agents (MTAs) and immunotherapies have toxicities that are distinct from cytotoxic chemotherapies, traditional dose escalation methods usingRead more

Traditionally, phase I oncology trials have relied on a standard 3+3 dose escalation design to achieve the objective of defining a recommended phase II dose (RP2D). However, statistical simulations have shown that as few as one in three trials using the 3+3 design succeed in identifying the maximum tolerated dose.[1] Concerns have also been raisedRead more

The inaugural edition of Premier Voices focuses on rare oncology drug development and takes a looks at: * Using adaptive design to limit patient exposure to ineffective treatments and increase the overall likelihood of success * Making the most of small and geographically dispersed patient populations * Dealing with limitations such as a lack of definedRead more

This weekend, just in time for ASCO’s annual meeting in Chicago, we’re launching our new podcast, Premier Voices! Hosted by our own Paul Mirek, marketing manager at Premier, the podcast is aimed at sharing viewpoints and insights of our clinical research experts around the network and beyond. It’s our chance to get inside their headsRead more

DURHAM, N.C., APRIL 20, 2018 — A Premier Research oncology expert will discuss advances in the development of cancer drugs at Clinical Operations in Oncology Trials West Coast in Burlingame, California. Brian Huber, Executive Director for Oncology Strategic Development, will present Transforming the Oncology Drug Development Process on Tuesday, April 24, at 10 a.m. Mr.Read more

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