Medical and Regulatory Affairs

The Regulatory Landscape for Immuno-gene Therapeutics in Hematological Malignances

Over the past few years, there has been a dramatic increase in the use of genetically modified cells for cancer immunotherapy, including chimeric antigen receptor (CAR)-T cells, recombinant T-cell receptor T cells and genetically modified CD34+ cells for the treatment of hematological malignancies. Clinical trials of immuno-gene therapeutics are becoming increasingly common, and regulatory guidelines...

Consulting

6 Reasons Why Early Oncology Drug Trials Fail (And How to Avoid Them)

Unfortunately, not all oncology trials succeed. In fact, the phase success and likelihood of approval (LOA) rates for oncology are the lowest across major therapeutic areas. Although there are many reasons for these relatively poor success rates, issues determining dose, schedule, and regimen in early phase trials are among the most prominent. Why and Where...

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 1 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...

Clinical Research: Phase 1 - Phase 4

Against the Odds: Achieving Fast Startup in a Sickle Cell Drug Trial

Even when things go pretty well, launching a clinical trial is a game of long odds. And when the deck is stacked against you the way it was when we set out to study a drug for sickle cell disease, the difficulties can add up fast. So even we were surprised by the success of...

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...