i3 Innovus Biographies

Cyndi Verst, PharmD, MS

Senior Vice President, Global Late Phase

Dr. Verst has more than fifteen years of experience designing and conducting clinical trials, in particular Phase IIIB/IV clinical studies. Nearly half of this experience was gathered while working within the pharmaceutical industry as a Scientist and Section Head of Medical Affairs, while supporting marketed and periapproval products. While in this role, Dr. Verst developed the necessary acumen to design robust clinical programs to appropriately blend scientific and commercial objectives into the Phase IIIB/IV study design and operational conduct, while achieving regulatory compliance.

Before joining i3 Innovus, Dr. Verst served as the Global Vice President for Kendle International, a global CRO, and was responsible for the quality design and conduct of all global Phase IIIB/IV clinical studies, including registries. Dr. Verst provided line management for over 300 Late Phase associates (Senior Directors, Directors, Associate Directors, Project Leaders, LCRAs, CRAs, Project Assistants, etc.). In this role, Dr. Verst provided executive level oversight of over 30 Phase IIIB/IV trials (>26,000 patients; >1,300 sites), 13 pregnancy and product registries (>38,000 patients; >6,000 sites) and 60 Health Economic and Outcome Research programs. Executive level oversight included ensuring quality operations, on time and on budget project deliverables, frequent review of study milestones and budget targets, issue escalation and resolution internally and externally with Sponsors, ensuring appropriate study staffing and addressing any internal hurdles to allow project teams to focus on the Sponsor.

Through this vast Late Phase experience, Dr. Verst has developed a deep appreciation of the operational requirements for the successful design and implementation of Late Phase studies. As such, Dr. Verst will be available to provide expert consultation to the Sponsor and the i3 Innovus Late Phase team during the study design and implementation.