Jae Sly

Pathway Preclinical Partners (Path2P) provides strategic consulting services for BioPharma and Medtech companies across the full spectrum of drug development—from early-stage discovery to global clinical trial readiness. Whether you're a start-up building your first roadmap or an established company expanding into new markets, we bring deep expertise and global reach to support your success. Our team of over 35 cross-functional specialists—including former FDA officials, regulatory strategists, and legal and IP experts—collaborates with clients to design effective, efficient preclinical programs and clinical strategies tailored to U.S., EU, and Asian regulatory landscapes. With strong global alliances through our sister companies, PVR and Oximio, we ensure seamless execution from IND-enabling studies to trial launch and beyond. Our services include: 📊 Preclinical study design, toxicology strategies, and regulatory alignment 📄 IND/CTA strategy, submission management, and publishing 🌍 Clinical study design in the U.S. and EU, and CRO identification in the U.S., EU, and Asia 🧠 IP strategy, licensing, spin-out company support, and economic impact analysis 🤝 Strategic partnerships and commercialization pathways At Path2P, we chart the path so you can reach the summit—navigating complexity, carrying the load, and accelerating your journey to patients.