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...
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....
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...
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....
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...
Featured Guests Luke Gill, B.Sc., M.Sc., MBAVice President, Oncology Luke Gill is the head of Oncology Clinical Development Services at Premier Research. He works collaboratively with biotech sponsors, the scientific community, and other stakeholders to develop and implement strategic approaches to early phase oncology development and CAGT trials. As a drug development expert, Gill has...
Introduction Due to the challenges associated with studying investigational medical products in neonates, healthcare professionals must often resort to administering drugs in neonatal intensive care units (NICUs) off-label. While numerous pediatric legislative initiatives have been passed worldwide, neonates are still largely treated with medicines that have not been specifically studied or approved in this young,...
Despite the passage of various legislative initiatives aimed at increasing the frequency and quality of pediatric clinical trials, neonates continue to be treated with medicines that have not been studied or approved in this population.1 Historically, sponsors may have felt that the ethical and logistical challenges limited the opportunities for neonatal research. Our experience has...
Despite advances in technology and our understanding of the genetic and molecular underpinnings of cancer, making a meaningful impact on the survival and quality of life of patients with cancer remains a significant challenge. In fact, a recent review revealed that, among 59 cancer drugs approved by the U.S. Food and Drug Administration (FDA) based...
Summary The Research to Accelerate Cures and Equity (RACE) for Children Act The Research to Accelerate Cures and Equity (RACE) for Children Act aims to improve and expand treatment options for pediatric cancer patients by mandating that all new adult oncology drugs also be tested in children when the molecular targets are relevant to a...