Tag: oncology

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...

Study Design

6 Early Phase Dose-Finding Trial Designs for Oncology Therapeutics

Phase I and II trials may have different overall goals (i.e., demonstrating safety vs. efficacy), but the two both struggle with a major challenge in oncology study design: finding the right dose. Luckily, decades of data and innovations have given researchers the tools necessary to plan a successful dose-finding trial. Read on for a look...

Clinical Research: Phase 1 - Phase 4

Where Do We Start?: A Look at Dosing in Phase I Trials

Early oncology trials have changed for the better over the last few years thanks to novel investigational agents, innovations in trial design, and changes to regulatory practices. Among other improvements, these changes have helped to perfect the way study designers plan early phase dosing. Dosing strategies in Phase I trials First-in-human trials When an investigational agent is administered...

Chief Medical Officer Discussing Immuno-Oncology Molecules at OCT Southern California

DURHAM, N.C., SEPTEMBER 25, 2017 — Premier Research’s Chief Medical Officer will discuss development of immuno-oncology molecules at Outsourcing in Clinical Trials Southern California, September 27-28 in La Jolla. Dr. Colin Hayward will address strategic and practical considerations for molecule development on the opening day of the annual gathering of pharma, biotech, and medical device leaders....

Clinical Research: Phase 1 - Phase 4

4 Potential Advantages of Adaptive Design

Adaptive design is a type of clinical trial methodology that incorporates prospectively planned opportunities for modification of one or more aspects of a study’s design or its hypotheses based on interim analysis of study data. Explicitly planning these pre-specified changes helps to maintain scientific integrity while also introducing greater flexibility in the clinical research environment. The major...

Clinical Research: Phase 1 - Phase 4

Target Product Profiles: Turning Discoveries into Companies

One of the first steps in the development process is to create the target product profile (TPP) that defines the projected marketed product label. The TPP helps rule out any pharmacodynamic effects that are no more beneficial than current therapeutic treatments. Developing a TPP is also an opportunity to evaluate intellectual property and ensure that the product has an...

Clinical Research: Phase 1 - Phase 4

5 Essential Factors for Navigating Early Stage Trials

Bringing a novel drug to market can be a long, perilous journey down the clinical testing pipeline, taking upwards of 10 to 15 years. Maintaining research and development productivity while navigating the ever-changing regulatory landscape, the choppy waters of today’s reimbursement environments, and the rising tide of clinical trial costs is increasingly challenging. Medicines that fail...

Consulting

Biomarker Trends: Advancing the Body’s Ability to Fight Cancer

As researchers seek to harness the human immune system to fight cancer, they’re looking at several emerging opportunities to expand use of biomarkers. Among them: Human leukocyte antigen typing. Microbiome analysis for determining risk of inflammatory complications with immune therapeutics. Tumor mutation burden, measured via whole genome sequencing, whole exome sequencing, or comprehensive gene panel...

Clinical Research: Phase 1 - Phase 4

Why Have Cancer Treatment Vaccines Fallen Short?

Vaccines were once thought to have great potential for combating some types of cancer, but reality has failed to match those expectations. To date, vaccines have failed to play a major role in the pursuit of immune response for oncology patients. There have been two notable successes — sipuleucel-T (marketed as Provenge) is approved to...