In this exclusive interview, Dr. Robert Bissonnette shares insights from Indero’s internally-led study, which introduces a novel approach to early phase topical drug evaluation. By leveraging quantitative gene expression analysis and non-invasive tape strip sampling, this method promises to transform the assessment of new chemical entities (NCEs), offering rapid, cost-effective, and patient-friendly solutions for advancing dermatological therapies.
Scientific and Clinical Foundations
1- Could you share what inspired you to look at those early time points, what gaps were you hoping to fill with this study?
RB: Traditionally, proof of concept studies in clinical research involve administering treatments to patients over a period of 2 to 3 months before evaluating whether the primary endpoint has been achieved. This lengthy timeframe can delay critical insights into a drug’s efficacy and slow down the overall development process. My goal was to establish a more efficient approach that allows us to detect meaningful early signals of efficacy within just a few days of initiating treatment.
2- How does this choice build on earlier research about microdosing and early gene activity?
RB: We developed an approach that could be compatible with the FDA and EMA strategy for early phase 1 trials, specifically regarding the total amount of drug administered and the duration of treatment.
3- How were tape strips and RNA-seq utilized in this research, and what considerations guided the selection of biomarkers and the development of bioinformatics methods?
RB: We collaborated with Dr. Emma Guttman from Mount Sinai, NY, leveraging her expertise in gene expression analyses. Dr. Guttman applied her established methodology with tape strips for Atopic Dermatitis (AD), which involves measuring gene expression using RNA. The analysis focused on sets of biomarkers that play crucial roles in AD pathology. These included Th2, Th22, and Th17 cytokine pathways, which are central to the inflammatory processes underlying AD, as well as genes related to skin barrier function.
Broader Implications and Applications
4- Could this research model be applicable to other skin conditions, and what disease characteristics make it suitable for short-duration evaluation?
RB: The tape strips methodology has demonstrated versatility and effectiveness in studying a range of skin diseases beyond atopic dermatitis. For instance, it has yielded valuable insights when applied to conditions such as psoriasis and hidradenitis suppurativa, where non-invasive sampling of skin allows for detailed molecular profiling and monitoring of disease activity. The core advantage of this approach lies in its ability to collect epidermal samples rapidly and painlessly, making it practical for repeated measures in both clinical trials and routine research settings.
5- Is there potential to compare different drugs, concentrations, or formulations within the same patient using this methodology, and what logistical challenges might arise?
RB: One of the advantages of this new method is that it is possible to compare various concentrations of the same drug, various vehicles for a fixed drug concentration, or compare a new drug to an approved topical drug and get data after only 3 days of treatment. By applying different formulations or concentrations to distinct skin sites on the same patient, direct observation of gene expression changes and biomarker responses can be achieved within a very short period. This design not only facilitates head-to-head comparisons between new and existing treatments but also allows for the assessment of how different vehicles may affect drug delivery and efficacy.
Business, Strategy, and Collaboration
6- What are the advantages that microdose or early phase 1 screening offers regarding timelines, costs, and decision-making in topical drug development, and how does this approach alter the traditional early phase development timeline?
RB: Microdose and early phase 1 screening streamline topical drug development by enabling rapid, low-risk human studies with less preclinical toxicology. These methods yield early efficacy and pharmacodynamic data, drastically reducing timelines. Early molecular and clinical readouts can accelerate strategic decisions and bolster funding or partnership opportunities. Overall, this model offers efficient progression and resource optimization in the early clinical phase.
7- Could microdose or early phase 1 screening become standard practice in topical drug development?
RB: Microdose and early phase 1 screening are showing promising potential as future approaches in topical drug development.
By enabling rapid, low-risk human evaluation with less preclinical requirements, these approaches accelerate timelines, reduce costs, and support earlier, data-driven decisions. Non-invasive methods like tape stripping allow for efficient, direct comparisons of multiple formulations or drugs within the same patient. As the industry seeks greater efficiency, these strategies are well positioned to streamline development and facilitate faster delivery of new therapies, provided regulatory alignment continues.
8- In what ways could this new process impact funding opportunities?
RB: This streamlined process can enable sponsors to obtain preliminary evidence of a treatment’s effectiveness much earlier, which may strengthen their case when seeking additional funding for larger, subsequent clinical trials.
Dr. Bissonnette’s research marks a major change in how early-stage topical drugs are tested. Using gene expression analysis and tape stripping, researchers can quickly run proof of concept studies and directly compare treatments, different concentrations or vehicles within the same patient. These advances help speed up clinical development, cut costs, simplify regulatory steps, and make it easier to get funding, moving new treatments to patients faster.
About the Author
Indero is a dual-focus CRO for dermatology and rheumatology, with over 25 years of experience in clinical research and trial delivery. Our full-service approach which includes everything from protocol design and patient recruitment to trial monitoring and biometrics provides biotech and pharmaceutical sponsors with the rigorous scientific foundation and tailored expertise their studies need to reach the finish line efficiently and effectively. With capabilities in North America, Europe, Latin America, and Asia-Pacific; vast, continuously growing relationships with investigators and patients; and a dedicated research clinic through which we design and execute our own studies, Indero is the ideal partner for clinical needs at global scale.
