Clinical Research: Phase 1 - Phase 4

Achieving the Promise of Gene Therapy: New Pathways to Overcome Patient Enrollment and Safety Challenges, Upcoming Webinar

TORONTO (PRWEB) SEPTEMBER 15, 2020 Though gene therapy has been around for decades, it continues to pose extraordinary challenges in the areas of R&D, clinical development, and operation of clinical trials. Sponsors and CROs face shifting operational and regulatory demands amid rapid advances in the science of precision medicine. This webinar will examine the evolving...

PREMIER VOICES #14: Setting a Real-World Strategy in an Evolving Clinical Research Environment

Featured Guests Stacy WeilSenior Vice President,Clinical Data Operations, Strategic Business Optimization Stacy Weil translates Premier Research’s strategy into actionable data initiatives that enable internal and external customers to achieve the highest level of performance and success. Prior to joining Premier Research, Ms. Weil was Vice President of Clinical Data Operations at PatientiP.Read More Nach Davé,...

ASIST: Advanced Study Integrity Services Team

How has COVID-19 impacted your clinical study? Get the insights. The analysis. And the plan. The COVID-19 pandemic has altered the clinical trial landscape around the world. Keep your study on track with expert help from the Premier Research Advanced Study Integrity Services Team (ASIST). Premier developed ASIST to help biopharma companies like yours adapt...

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...

Expert Reaction to a Study Looking at Caffeine and Pregnancy

A study, published in BMJ Evidence Based Medicine, looked at caffeine use and pregnancy. At Science Media Center, Dr. Adam Jacobs, Associate Director of Biostatistics, Premier Research, said: “I note the author has published 2 books on the dangers of coffee which in my opinion should have been included in declarations of interest for the journal article....

A New Era in Dermatology: Study Design, Regulatory Strategies, and Patient Participation, Upcoming Webinar

TORONTO (PRWEB)AUGUST 28, 2020 New treatment options for moderate to severe dermatological diseases and areas of high unmet need are driving a revolution in clinical development of dermatology drugs. But questions remain: What indications should be pursued? How to design a study that targets the right endpoints? And how will environmental constraints affect the research?...

Setting a Real-World Strategy in an Evolving Clinical Research Environment

Presented byStacy Weil, Senior Vice President, Clinical Data Operations, Strategic Business Optimization & Nach Dave, RPh., MSc, Vice President, Development Strategy Related Resources Real-World Data and Real-World Evidence: What Is Their Value as a Synthetic Control Arm? Data Driven: How Electronic Patient-Reported Outcomes (ePROs) Provide a Vital Opportunity to Capture Key Data Beyond the COVID-19...

Considerations for Applying Adaptive Design Approaches to Early Oncology Studies

By utilizing accumulating data to modify the operating characteristics of an active trial in accordance with pre-specified rules, adaptive designs can make clinical trials more flexible, efficient, and informative than fixed-sample designs.[1] Adaptive design approaches can be applied across all phases of clinical development, including early oncology studies. These designs introduce real-time flexibility while a...

Minimizing Early-Stage Oncology Failures with Adaptive Design Approaches

Despite advances in our understanding of the complex genetic, molecular, and immunological factors which lead to cancer, the success and likelihood of approval rates for oncology remain low. According to a recent study performed by the Biotechnology Innovation Organization (BIO), nearly one-third of drugs entering phase 2 studies between 2006 and 2015 failed to progress....

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...