Kelly Lancaster

• Supported a Phase I clinical program by conducting a comprehensive risk assessment of the sample management plan and collaborating with the clinical team to implement effective mitigation strategies. • Supported program management activities for clinical development program, maintaining integrated timelines, tracking clinical samples, managing risk assessments, coordinating stakeholder communications, and contributing to budget and resource planning initiatives. • Revitalized and maintained the integrated program plan, ensuring all key activities and milestones were documented and tracked through the pivotal trial and BLA submission. • Facilitated weekly core team meetings, preparing and distributing detailed summaries to stakeholders and executive leadership to ensure alignment and informed decision-making.

• Directed all preclinical in vivo pharmacology efforts across early- and late-stage discovery programs, leading two programs into Phase I/II clinical trials, and accelerating clinical readiness through robust scientific and operational leadership. • Designed and executed efficacy and PK/PD studies in clinically relevant CDX and PDX models, establishing minimally efficacious doses (MEDs) and exposure-based therapeutic indices (TIs) in collaboration with Nonclinical Development to support clinical strategy. • Recruited and led a high-performing pharmacology team, mentoring two direct reports, managing resources across three clinical-stage and eight discovery programs, and cultivating leadership growth. • Oversaw the acquisition of a local vivarium rental space, supervising site evaluations, protocol assessments, cost management, and contract negotiations to expand in vivo capabilities. • Developed and implemented a Smartsheet database to streamline study timelines, budget tracking, and program activities, significantly enhancing operational efficiency and resource visibility. • Owned and forecasted pharmacology budgets, later expanding to manage quarterly budgeting and materials resource planning (MRP) for the entire biology function in alignment with corporate goals. • Instituted process improvements, introducing new SOPs, enhancing material inventory practices, and driving data integrity initiatives to support regulatory filings, including INDs and BLAs. • Collaborated cross-functionally with development teams, leading weekly updates, strategy meetings, and alignment discussions, and contributing to nonclinical toxicology study designs and protocol reviews for rat and NHP studies. • Played a key role in authoring scientific and regulatory documents, including INDs, BLAs, IBs, DSURs, posters, manuscripts, and patents; recognized for speed, efficiency, and detail orientation critical to high-demand research settings.

Led in vivo pharmacology efforts across modalities including ADCs, bispecific antibodies, and small molecules, driving critical decision-making and program advancements. • Collaborated closely with discovery, DMPK, toxicology, and translational research teams, aligning study designs with overarching program strategies to accelerate clinical candidate selection. • Conducted complex in vivo and ex vivo analyses using advanced methodologies, including humanized mouse models, multicolor flow cytometry, qPCR, and MSD, significantly enhancing biomarker-driven decision-making. • Acted as Principal Investigator for orthotopic models IACUC protocol, ensuring compliance and maintaining high standards of ethical animal research. • Mentored junior scientists and postdoctoral researchers, elevating scientific capabilities and productivity within the team.

• Designed and executed extensive xenograft model studies to evaluate the efficacy, pharmacokinetics, and pharmacodynamics of novel small-molecule inhibitors. • Performed detailed pharmacodynamic analyses utilizing advanced techniques such as western blot, immunohistochemistry, and flow cytometry, contributing to data-driven development decisions. • Participated actively in early- and late-stage preclinical project teams, delivering key insights that advanced programs into clinical development phases. • Supervised and mentored summer interns and COOP students, fostering a supportive and enriching research environment.

• Conducted research on tumor suppressor genes and oncogenes using transgenic mouse models, providing foundational data critical for subsequent drug discovery. • Performed advanced molecular biology techniques, including PCR, DNA extraction, gel electrophoresis, immunohistochemistry, and in situ hybridization, significantly contributing to published research.

Graduate-level Coursework