Clinical Research: Phase 1 - Phase 4

A Primer on Cancer Immunotherapy Part 1: Goals & Major Approaches

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. The U.S. Food and Drug Administration (FDA) has approved six immunotherapies across 19 cancer types and two tissue-agnostic conditions. But widespread...

Top Physician to Lead Cell-Based Therapy Panel at Clin Ops West

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 cancer...

Clinical Research: Phase 1 - Phase 4

Untapped Potential: Asia-Pacific’s Growing Role in Biotech Drug Research

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 of...

Medical and Regulatory Affairs

Draft Guidance: Hematologic Malignancies: Regulatory Considerations for Use of Minimal Residual Disease in Development of Drug and Biological Products for Treatment

The FDA has released a new draft guidance for sponsors planning to use minimal residual disease (MRD) as a biomarker in clinical trials conducted under an investigational new drug application (IND) or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

Patient and Stakeholder Engagement

The Art and Science of Selecting Patients for Phase 1 Oncology Studies

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 using toxicity-based endpoints may not be suitable for phase I studies of...

Clinical Research: Phase 1 - Phase 4

Key Considerations When Designing a Phase 1 Oncology Trial

Traditionally, phase 1 oncology trials have relied on a standard 3+3 dose escalation design to achieve the objective of defining a recommended phase 2 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 raised...

Study Design

Premier Voices #1: Rare Oncology w/ Colin Hayward & Peter Larson

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 defined biomarkers and baseline...

Advancing Drug Development: Join Us at Clin Ops in Oncology West

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....

Clinical Research: Phase 1 - Phase 4

Boosting Immuno-Oncology’s Effectiveness Against Cancer

Immuno-oncology continues to be an exciting frontier in the fight against cancer. Researchers continue to develop drugs that allow the body to weaponize its own immune system against the growth of new tumors. Most uses of immunotherapies have been limited to cancers, like those in the lungs or pancreas, that produce a strong immune response. In his article...

Clinical Research: Phase 1 - Phase 4

CAR T-cell Therapies: Safety Considerations and Toxicity Management

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 serious...