Clinical Research: Phase 1 - Phase 4

Clinical Research: Phase 1 - Phase 4

Medical Design & Outsourcing: Software as a Medical Device: Here’s How the Regulatory Landscape is Changing

Software as a medical device (SaMD) has emerged as a class of devices for collecting, processing and analyzing healthcare data to manage disease. Powered by analytics, SaMD accelerates the diagnosis and treatment of a wide range of medical conditions and is automating certain aspects of patient care, saving time and improving health outcomes. Because the...

Clinical Research: Phase 1 - Phase 4

Introduction to CAR T-Cell Therapy Part 2: Additional Considerations & Future Opportunities

Beginning in 2017 with the approvals of tisagenlecleucel (Kymriah™) and axicabtagene ciloleucel (Yescarta™), chimeric antigen receptor (CAR) T-cell therapies have changed the treatment paradigm for patients with certain hematologic malignancies. Since those initial approvals, three other CAR T-cell therapies have been approved for various hematologic malignancies, but many challenges still limit the therapeutic efficacy of...

Clinical Research: Phase 1 - Phase 4

Introduction to CAR T-Cell Therapy Part 1: Background & Current Development Landscape

Chimeric antigen receptor (CAR) therapies use CAR T cells, a patient’s own immune cells that are programmed to recognize and kill cancer cells throughout the body. Beginning in 2017 with the approvals of tisagenlecleucel (Kymriah™) and axicabtagene ciloleucel (Yescarta™), CAR T-cell therapies have changed the treatment paradigm for patients with certain hematologic malignancies. Since those...

Clinical Research: Phase 1 - Phase 4

PM360: How COVID Has Reshaped the Clinical Trial Regulatory Landscape

The concept of patient centricity is hardly new, but in recent months it has assumed new urgency as industry and regulators have had to adapt to an evolving landscape. The evolution is spurring substantial changes in how clinical trials are developed and implemented, as regulators revise their processes and issue updated guidance documents to encourage...

Clinical Research: Phase 1 - Phase 4

Gene Therapy for Parkinson’s Disease: Strategies and Operational Requirements

Introduction Gene therapy holds great promise as a potential treatment for Parkinson’s disease, a disorder for which currently available medications do not causally treat the underlying disease mechanisms. However, given the early stage of gene therapy research in this therapeutic area, questions abound regarding its utility and practicality in treating Parkinson’s disease. Those questions have...

Clinical Research: Phase 1 - Phase 4

ContractPharma: Gene Therapy Trials

Since the first gene therapy trial in 1990, the regulatory landscape has shifted from broad, loosely defined guidance with little variation between different cell and gene therapies to a more robust collection of guidelines and directives focused on testing and manufacturing considerations for these products in specific disease states and therapeutic settings. This article will...

Clinical Research: Phase 1 - Phase 4

PharmaTimes: Keeping Pace

In recent years, the gene therapy regulatory landscape has evolved from a broad, general guidance to a narrower focus on testing and manufacturing considerations in specific disease states. This article explores how factors such as environmental risk assessment and biosafety can impact gene therapy clinical study start-up as well as the continuing evolution of guidances...

Clinical Research: Phase 1 - Phase 4

5 Key Takeaways: Drug and Device Development Secrets in the World of Medical Aesthetics

New treatment options for medical aesthetic indications are in record-high demand, fueled by growing awareness of the effects of physiological and environmental aging and the influence of lifestyle on skin health. By 2025, the global aesthetic medicine market is projected to be $22.8 billion, nearly one-third of which is expected to be dermal fillers. Premier...

Clinical Research: Phase 1 - Phase 4

TrialSite News: Joining the Revolution in Dermatology Drug Development: Tips for Successful Clinical Trials

Skin diseases are the fourth leading cause of health afflictions, affecting nearly 900 million people worldwide. It’s not surprising, then, that there has recently been a noticeable increase in dermatology drug development. There are currently thousands of dermatology clinical trials planned or already launched, including a variety of programs investigating innovative, targeted therapies. Much of...

Clinical Research: Phase 1 - Phase 4

TrialSite News: Going Virtual: How to Implement mHealth and Remote Monitoring in Your Clinical Trials

In the year since COVID-19 brought all normal activity to a halt, clinical trial professionals around the world have been forced to re-examine their strategies. What happens when neither patients nor clinical research associates can visit trial sites? How can data collection and data monitoring occur — and critically, how can researchers deliver clean, concise...