Tag: oncology

Clinical Research: Phase 1 - Phase 4

Empowering Oncology Patients to Maximize Study Outcomes: Strategies and Considerations for Sponsors

TORONTO (PRWEB) OCTOBER 27, 2021 — Patient recruitment comprises one of the most significant initial challenges in any oncology study but engaging and retaining these patients throughout the clinical trial can ultimately be the challenge requiring the most upfront planning and coordination. However, during initial planning, the focus is usually placed predominately on recruitment and not...

Phase 1 Trials: Strategies for Site Selection and Dose-Escalation

Introduction Designing and executing an effective Phase 1 trial for a novel investigational oncology product can be challenging. Every facet of the process, from site selection and recruitment rate analysis to trial design and start-up, is interconnected. A nuanced approach is important, and early, careful planning is critical. This white paper explores key considerations for...

Build A Better Oncology Patient Experience: Supporting Participants Throughout A Study

Patient recruitment comprises one of the most significant initial challenges in any oncology study, but engaging and retaining patients throughout the trial can prove to be the challenge requiring the most up-front planning and coordination. However, during the initial planning stages of clinical trial implementation, the intensity of focus is usually placed predominately on speedy...

Premier Research Acquires Camargo Pharmaceutical Services

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...

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...

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....

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...

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...