The Society of Decision Professionals (SDP) is excited to collaborate with OccamPoint for our March 2025 Webinar.
"Biomarker Considerations in Optimizing Pharmaceutical Portfolios"
Featuring: Zoran Antonijevic (Chief Scientific Officer, Bioforum)
Hosted By: Lucia Mokres (Chief Fixer, Araneae Consulting)
Wednesday, March 12th 1:00 PM – 2:00 PM PT | 4:00 PM – 5:00 PM ET
Abstract:
There is an increased interest in biomarker-enriched development in the pharmaceutical industry. Predictive biomarkers have the potential to increase the benefits of investigational medicines to both patients and sponsors. Patients may receive optimized treatment, while sponsors use successful biomarker development to improve the probability of product success (POS) and better differentiate the product if it is approved. However, biomarker development can add cost, complexity, and time to drug development. Biomarkers will also reduce market size, because they are usually approved only in a subset of the population.
The presentation will evaluate the financial value of biomarker enrichment. Impacts of previously identified pros and cons will be considered and optimal solutions provided. The value will first be evaluated in the context of a single program, and then in the context of the whole portfolio, followed by an example of an adaptive enrichment design. This case study will provide an illustration of optimal development strategy and of setting up enrichment decision criteria.
Speaker Bio:
Zoran Antonijevic (Chief Scientific Officer, Bioforum)
Zoran Antonijevic is an expert in clinical trial design, pharmaceutical program strategy, and statistical consulting. Currently serving as the Chief Scientific Officer at Bioforum, he brings decades of experience by designing well over 100 clinical trials, that utilize innovative adaptive and platform designs.
Zoran has held senior leadership roles at organizations including Amgen, IQVIA, and Cytel. For over a decade, he led the Drug Information Association (DIA) Innovative Design Scientific Working Group, fostering advancements in clinical trial strategy and design. A prolific author and educator, Zoran has published more than 30 scientific papers, and delivered more than 70 presentations at scientific events . He is the editor
of books on “Platform Trials in Drug Development ” and “Optimization of Pharmaceutical R&D Programs and Portfolios ”. With a strong foundation in statistics, and decision sciences, Zoran continues to shape the future of drug development, driving innovation and improving patient outcomes.
Host:
Lucia Mokres (Chief Fixer, Araeae Consulting)
Lucia Mokres is a dynamic problem-solver and the founder of Araneae, where she specializes in resolving complex operational challenges that hinder business performance, such as missed milestones and unmet goals. With more than 15 years of experience spanning startups to Fortune 200 companies, Lucia has cultivated a rare ability to uncover patterns and connections that others often overlook. Her expertise includes executive leadership, project and program management, business solutions consulting, startup advisory, and clinical and medical regulatory affairs. A former Chief Medical Officer for an early-stage life science company, she has also delivered over a decade of public speaking and earned recognition with the Women Leaders in Action Leadership Award from Abbott Vascular.
A passionate advocate for her community, Lucia serves on the boards of two Bay Area nonprofits and has held leadership roles in over 12 volunteer organizations, supporting causes from women in science to emergency response. She combines her professional accomplishments with personal excellence as a former elite cyclist and women’s team captain for a regional bike racing team. Lucia holds a B.S. in Physiology and Neuroscience with a Minor in Spanish Literature from UC San Diego and a Doctor of Veterinary Medicine (DVM) from Colorado State University.