Dermatology

Patient and Stakeholder Engagement

Essential Strategies for Patient-Focused Dermatology Clinical Trials

Dermatology clinical research is undergoing a rapid transformation in response to new demands for clinical trials that are more justifiable, safer, and less burdensome for patients. In dermatology, a patient-focused approach can be applied to all phases of the research process, from the earliest stages of discovery and pre-clinical testing to clinical trials, regulatory approval,...

Study Design

Establishing Competitive Advantage in Dermatology Trials: Critical Study Design and Operational Considerations for a New Age

Skin diseases are the fourth leading cause of health afflictions, affecting nearly 900 million people worldwide.1,2 At the same time, there has been a remarkable increase in dermatology drug development activity in recent years. For conditions such as atopic dermatitis, psoriasis, and melanoma, there are hundreds of ongoing or planned clinical trials.3 In this new...

Clinical Research: Phase 1 - Phase 4

Drug and Device Development Secrets in the World of Medical Aesthetics, Upcoming Webinar

TORONTO (PRWEB) NOVEMBER 09, 2020 New treatment options for aesthetic indications are in record-high demand, fueled by an aging population, and a growing focus on aesthetic issues related to nutritional habits, sedentary lifestyles, the complex stresses of 21st-century life and rising awareness about aesthetic solutions in all adult age groups. The search for more effective,...

Clinical Research: Phase 1 - Phase 4

Essential Strategies in Dermatology Clinical Trials: The Convergence of Patients, Regulations, and Study Design

Competition for patients among sponsors in the field of dermatology drug development has never been as intense as it is now — so much so that it’s becoming difficult to meet project timelines, attract and retain patients, and achieve comprehensive study results. Patients are in high demand, and making studies appealing to them — convenient,...

Clinical Research: Phase 1 - Phase 4

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

Explore dermatology trials from the vantage point of study design, patient access, data quality, regulatory considerations, and more This webinar explores the latest changes in dermatology trials in the areas of study design, patient access, data quality, regulatory considerations, and more. Learn what’s required to understand the disease burden, patients’ treatment goals, and other critical...

Consulting

The State of Cell Therapies in Dermatology

Skin contains essential stem cell populations and other cell types that are critical for renewing and maintaining its structural integrity and function.1 Of the many types of skin stem cells that have been identified, epidermal stem cells — primarily keratinocyte stem cells — are recognized to play the key role in tissue repair and skin...

Consulting

The State of Gene Therapy in Dermatology

When it comes to dermatologic conditions, gene therapy is still in its very early stages. However, we are seeing promising potential solutions for some rare genetic dermatology diseases, as well as ongoing research in more common skin conditions. The success of gene-based therapies relies on three critical elements:1 A well-defined disease geneA therapeutic geneAn efficient...

Consulting

Gene Therapy in Dermatology: Transfer Techniques and Delivery Systems

Gene therapy holds the potential of long-term efficacy or even a cure for diseases with an underlying genetic basis, offering hope to patients with currently incurable diseases. The use of gene therapy for dermatologic conditions is attractive for many reasons:1 As the largest organ of the human body, skin is easily accessible for gene deliveryThe...

Medical and Regulatory Affairs

FDA Releases Draft Guidance for Transdermal Product Development

Transdermal and topical delivery systems (TDS) are important dosage forms that allow delivery of a drug to local tissue or provide systemic delivery through the skin. These drug products provide a number of advantages for patients, but can be challenging to develop. In November 2019, the FDA issued a draft guidance entitled Transdermal and Topical...

Data Management & Biostatistics

Establishing Risk-Based Monitoring within a Quality-Based System as ‘Best Practice’ for Clinical Studies

Risk-Based Monitoring (RBM) makes an impact. The US Food and Drug Administration (FDA) requires that clinical trial sponsors “provide oversight to ensure adequate protection of the rights, welfare, and safety of human subjects and the quality of the data submitted to FDA.” [US FDA 2019] This has traditionally been accomplished through onsite monitoring visits and...