Tag: oncology

Clinical Research: Phase 1 - Phase 4

The Importance of Site Selection and Dosing Strategies in Early-Phase Oncology Studies

TORONTO (PRWEB) NOVEMBER 02, 2020 Setting up an effective phase 1 trial for a novel investigational oncology product is rife with challenges. Every aspect, from site identification to estimation and coordination of enrollment and safety review, is interrelated to ensure a timely dose determination that is nimble and allows flexibility. What factors can affect, or...

Clinical Research: Phase 1 - Phase 4

Regulatory Challenges in Global CAR-T Cell Therapy Development

When exploring the complex and rigorous regulatory landscape for CAR-T cell therapies, sponsors may encounter challenges in their efforts to bring products to market Since the historic approval of Kymriah® (tisagenlecleucel) in 2017, research on chimeric antigen receptor (CAR) T cell therapy has accelerated. There are more than 230 regenerative medicine companies in Europe and...

Clinical Research: Phase 1 - Phase 4

Adaptive Trial Designs in Early Oncology: Minimizing Risk & Accelerating Timelines

Introduction Over the past decade, significant advances have improved our understanding of the genetic and molecular mechanisms that lead to cancer. And yet, a recent review of the oncology drugs approved by the U.S. Food and Drug Administration (FDA) on the basis of response rate showed only 10 percent of these therapies demonstrate an overall...

Clinical Research: Phase 1 - Phase 4

Novel Trial Approaches for Rare Cancer Patients, Upcoming Webinar

TORONTO (PRWEB) AUGUST 4, 2020 Join Rupa Doshi, Ph.D., Executive Director –Program Strategy, Oncology, Premier Research and Sameena Sharif, Ph.D., Senior Vice President, Product Strategy, Premier Research in a live webinar on Monday, August 24, 2020 at 11am EDT (4pm BST/UK). Rare cancers account for 22 percent of cancer diagnoses worldwide, yet there is no...

Premier Research Adds to Diverse Team of Oncology Experts

Oncology Expert Dr. Cassandra Matney Joins Global CRO DURHAM, N.C., August 3, 2020 — Premier Research continues to build its oncology expertise with the addition of Cassandra Matney, M.D., as Senior Medical Director. Matney joins a diversely talented team of oncology experts who have managed more than 170 oncology trials over the past five years....

Clinical Research: Phase 1 - Phase 4

Principles Of CAR T-Cell Therapy And The Pathway To Regulatory Approval

For many years, the primary forms of cancer treatment have been chemotherapy, radiation and surgery, but the toughest forms of cancer demand breakthrough therapies. Advances in immuno-oncology have led to the advent of Chimeric Antigen Receptor T (CAR T) cell therapy, which combines a patient’s own T cells with engineered T cell receptors known as...

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

Finding the Fast Track in Early-Phase Oncology Trials

Put yourself in this scenario: Your compound is a newly validated mutated receptor that is present in only a limited number of cancer patients, and there is no approved diagnostic test. Your product, an antibody-like molecule that inhibits the receptor’s activity, also stimulates a potent immune response. Further complicating things, much of the preclinical data...

Patient and Stakeholder Engagement

The Art and Science of Selecting Patients for Phase I 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...