Under the Microscope: Science, Operations, and Regulation in Dermatology Trials
Placebo response has long challenged dermatology trials, often making it difficult to distinguish actual treatment effect from perceived improvement.
The problem is magnified in niche indications and rare diseases, where patient numbers are small and outcomes rely heavily on subjective or visible assessments.
This webinar examines why placebo rates are disproportionately high in dermatology studies and how to address them effectively.
In today’s research environment, the discussion around placebos has changed.
As regulatory transparency increases, sponsors now face not only the scientific and operational challenge of managing placebo response but also the obligation to provide apparent, compliant oversight. The EMA’s CTIS portal has broadened public access to trial data and documentation, and the FDA’s compliance letters highlight how study design and implementation are being carefully scrutinized. These changes have reshaped expectations for how sponsors document, communicate and justify their trial strategies.
This webinar bridges the scientific, operational and regulatory perspectives behind placebo response in dermatology. Attendees will gain a deeper understanding of what drives placebo variability, how to identify and mitigate risk early and how transparency is transforming accountability across the research ecosystem. From trial design and site training to documentation and regulatory interaction, this session offers practical insights for ensuring study integrity and protecting the credibility of results in an increasingly visible world.
Register for this webinar to learn how to manage placebo risk effectively in dermatology trials.
Speakers
Mesfin James, Head of Regulatory Affairs, TFS HealthScience
Mesfin is a seasoned regulatory affairs professional with an extensive career spanning over 18 years in the clinical research sector. His invaluable expertise has facilitated multinational clinical trials across all phases of development and diverse therapeutic domains. His profound knowledge is particularly notable in oncology and rare diseases, and he has played a pivotal role in advancing regulatory activities across various regions, including the EU, the Americas, Asia Pacific, North Africa and the Middle East.
His rich experience spans a broad spectrum, including pharmaceuticals, small and large molecules, GMO-based vaccines and Gene Therapy products. He is well-versed in the meticulous compilation, review and collation of regulatory dossiers and adept at forging meaningful connections with regulatory authorities and external vendors. Mesfin’s collaborative spirit and keen insight extend to his pivotal role in supporting clinical development activities, providing invaluable regulatory strategy and guidance to cross-functional teams and sponsors across various product types and therapeutic areas.
Message Presenter
Mihály Imre, MD, PhD, Senior Medical Director, TFS HealthScience
Mihály Imre is a Senior Medical Director with over 15 years of experience spanning internal medicine, clinical research and global drug development. He has led medical monitoring and scientific oversight for Phase I–III trials across immunology, oncology, rare immune-mediated diseases and other chronic conditions, ensuring patient safety, data integrity and regulatory compliance. His expertise covers study design, protocol development, risk-mitigation strategies, pharmacovigilance and regulatory interactions (FDA, EMA), as well as medical writing and training. Multilingual (English, Romanian, Hungarian and German), he combines a strong academic background (MD, PhD) with hands-on investigator and sponsor experience. He brings a strong background in biostatistics and clinical data management, allowing him to integrate robust statistical methodology into study design, protocol development and data review.
Message Presenter
Sonja VanWye, RN, MSN, Project Director, Dermatology, TFS HealthScience
Sonja VanWye is a highly experienced Executive Director with 34+ years of experience in the clinical trial environment, focusing on strategic planning, operational delivery, project management, quality assurance, business development and consulting services.
She excels at leading cross-functional teams and navigating the complexities of balancing operational needs with financial considerations to deliver strategic options for sponsor programs. Her comprehensive knowledge spans all phases of clinical trials and includes experience across diverse global markets, including APAC, Europe and North America. Her 23 years of dermatology expertise span a broad range of therapeutic indications across medical, aesthetic and rare dermatology.
Message PresenterWho Should Attend?
This webinar will appeal to senior professionals from biotech and specialty pharma companies conducting dermatology trials including:
- Clinical Operations Leads
- Medical Directors
- Regulatory Affairs professionals
- Senior decision makers such as Chief Medical Officers, VPs or Heads of R&D and Clinical Development
Plus
- Project Directors
- Biostatisticians
- Quality and Compliance Managers
- VP or director-level leaders overseeing study design, oversight and documentation
What You Will Learn
Attendees will gain insight into:
- The scientific factors that lead to higher placebo response in dermatology studies
- Practical operational strategies to minimize placebo risk through design, site training and patient management
- How new levels of regulatory transparency from EMA and FDA affect oversight and accountability
- Best practices for documentation and communication that reinforce compliance and study integrity
- Frameworks to evaluate and reduce placebo variability from planning to closeout
Xtalks Partner
TFS HealthScience
TFS HealthScience is a full-service, global Contract Research Organization (CRO) that supports biotechnology and pharmaceutical companies throughout their entire clinical development journey. In partnership with customers, we build solution-driven teams working towards a healthier future. Bringing together nearly 800+ professionals, TFS delivers tailored clinical research services in more than 40 countries with flexible clinical development and strategic resourcing solutions across key therapeutic areas, including Dermatology, Immunology & Inflammatory Diseases, Internal Medicine, Neuroscience, Oncology & Hematology, and Ophthalmology.
Detailed information about TFS and its business offerings can be obtained through www.tfscro.com.
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