In this episode, we are honored to welcome Ana Palijan, the esteemed Director of Early Phase and Translation Research at Innovaderm. Our journey takes us into the complex realm of early phase trial study designs. We start by demystifying the distinct features that set apart early and late phase trials. Next, we turn our attention to the role of data quality in early phase clinical research and its far-reaching implications on study results. We then delve into the unique dermatology techniques utilized in early phase trials and their importance. Embark on this captivating exploration with us alongside Ana Palijan!

Join us in this episode as we welcome Dr. Robert Bissonnette, the Founder and CEO of Innovaderm. We will explore the fascinating world of placebo response rates in atopic dermatitis, discussing key considerations, strategies to mitigate placebo response, and interpreting higher-than-expected rates of placebo responses. Do not miss this chance to learn from a dermatology research pioneer.

Join us in our latest episode as we look into the intricate world of clinical research with our esteemed guest, Valerie Paolella, Associate Director in Clinical Trial Management at Innovaderm. In this enlightening episode, we explore the complex topic of risk-based monitoring (RBM), a critical component in clinical trials. Our conversation begins by exploring the various forms of clinical monitoring, each with its unique characteristics and applications. We then navigate through the best practices in RBM and discuss the challenges that arise, offering insights on how to effectively manage these hurdles. The discussion culminates with an in-depth look at the process of assembling the RBM A-Team, where we highlight the key roles and skills required for successful RBM implementation.

Join us for a special episode of our podcast, hosted by Janet Overvelde, Innovaderm’s Senior Director in Project Management, live from the 2024 AAD in San Diego, CA. Janet interviews Staci Ellis, the Vice President and Head of Regulatory Affairs at RegDev Inc., a seasoned leader with a wealth of experience in Regulatory Affairs. They explore the guidelines for a successful Investigational New Drug (IND) filing in the US, discussing early engagement, strategic planning, aligning dose data with FDA safety assessments, and the importance of compliant Chemistry, Manufacturing, and Controls (CMC). Do not miss this episode packed with expert advice and valuable insights.

We welcome Edith Siméon, Innovaderm’s Associate Director of Biostatistics, who brings over 20 years of industry experience. We dive into the critical role of estimands in clinical trials and data analysis, focusing on their purposes and requirements, cross-functional responsibility, and impact on statistical analyses. This episode promises to enlighten and inspire.

In this episode, Innovaderm’s Chief Operating Officer, Cedric Burg, an expert in clinical trial management delves into the significance of prior indication experience in clinical trials, focusing on site proficiency, protocol insight, and focused monitoring. Gain valuable insights from Cedric’s extensive experience in the field.

We welcome Innovaderm’s seasoned Project Director, Fadi Achkar, with more than 15 years of experience in the field. This episode covers the complexities of multicenter studies in AA. We explore how to account for patient AA severity during recruitment, the subjective nature of the Severity of Alopecia Tool (SALT) and the unmet needs in AA. Gain valuable insights from Fadi’s extensive experience in the field.