Clinical Research: Phase 1 - Phase 4

Clinical Research: Phase 1 - Phase 4

Oncology Trials in the Time of COVID-19: Expert Insights

Best practices for managing ongoing cell and gene therapy trials Personalized medicine is radically changing how the world looks at cancer therapy. Having completed more than 170 hematology and oncology trials, we know what it takes to optimize studies for these next-generation biotherapies with expertise ranging from small dose-finding studies to large multinational trials. In...

Clinical Research: Phase 1 - Phase 4

Addressing a Critical Unmet Need: Considerations for Designing and Conducting Neonatal Clinical Trials

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,...

Clinical Research: Phase 1 - Phase 4

Neonatal Research Insights: Conducting Clinical Trials in the Smallest Patients

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...

Clinical Research: Phase 1 - Phase 4

Med Ad News – Optimizing Early Oncology Studies Through Adaptive Trial Designs

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...

Clinical Research: Phase 1 - Phase 4

Understanding New FDA Guidance for Pediatric Oncology Studies: A Sponsor’s Guide to the FDA RACE for Children Act

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...

Clinical Research: Phase 1 - Phase 4

Premier Insight 272: Delivering the Global Expertise Required to Coordinate a Pediatric Gene Therapy Trial

With their potential for long-term or even curative efficacy, gene therapies are of great interest to researchers, clinicians, patients and caregivers alike. But coordinating and conducting a global, multi-center gene therapy trial is a complex, high-risk undertaking. Beyond the usual protocols and procedures required to ensure patient safety and data quality, gene therapy studies must...

Clinical Research: Phase 1 - Phase 4

Contract Pharma – Realizing the Full Potential of Precision Medicine in Oncology

Innovation in oncology drug development is being driven by “precision medicine.” Precision medicine promises a new paradigm in oncology where every patient receives truly personalized treatment. This approach to disease diagnosis, treatment and prevention utilizes a holistic view of the patient—from their genes and their environment to their lifestyle—to make more accurate decisions. Growing at...

Clinical Research: Phase 1 - Phase 4

Applied Clinical Trials – Patient Engagement and Advocacy: Advancing the Cause of Clinical Drug Research

Duchenne muscular dystrophy (DMD) patients almost universally lose the ability to walk as the disease progresses. Patients generally understand that loss of ambulation is to be expected, and as was learned from a patient preference study, they tend to put greater priority on maintaining use of their hands. Yet for many years, DMD drug trials...

Clinical Research: Phase 1 - Phase 4

Unlocking the Full Potential of Personalized Medicine in Oncology

Related Webinar: The Role of Adaptive Trial Designs in Early Oncology Studies Personalized oncology promises a new standard of care where therapies are tailored to the molecular profile of a specific tumor. For the full potential of personalized medicine to be realized, regulatory, technical, clinical, and economic frameworks will need to evolve to the nuances...

Clinical Research: Phase 1 - Phase 4

PharmaVoice – Small Pharma Driving Big Pharma Innovation

“Big pharma’s new role in this is to partner and fund the innovation that it so sorely needs to bulk up its dwindling pipelines. This is a cost-effective move for larger drug companies to leverage outside scientific talent to gain access to breakthrough discoveries. “‘This is a dominant trend in the industry,’ says Nach Davé,...