Summary

I am a biopharmaceutical drug development expert with 15+ years of experience in oncology, immunology, and neurosciences, who lead several INDs/CTAs and regulatory approvals across geographies. With a proven track record of successfully charting the nonclinical development of small molecules and biologics, my expertise spans the critical areas of toxicology and risk assessment, pharmacodynamics/pharmacokinetics, and regulatory submissions. I am adept at implementing lean yet robust development plans, navigating the complexities of nonclinical studies in all standard species, across all standard routes of administration, and leading projects from initial concept through IND submission and beyond. I focus on high-quality data and insightful analysis to inform the path forward; which combined with my deep understanding of the regulatory landscape allows me to anticipate potential pitfalls and offer strategic solutions to mitigate risks and maximize the likelihood of a successful journey. My commitment to collaboration and communication with your team guarantees a tailored approach, ensuring our deliverables align with your objectives. Together, we will work diligently towards achieving ambitious milestones to pave the way for your drug's entry in the clinic and eventual registration.