Introducing Path2P, your guide from discovery to patients.
Get expert-designed preclinical programs and global clinical strategies to accelerate your drug development pathway.
We Chart the Course.
You Reach the Summit.
Our Approach
At Path2P, we take a collaborative, strategic approach to drug development—built on deep regulatory expertise and real-world industry experience. From preclinical study design to global clinical strategy, we tailor each plan to your scientific goals, regulatory requirements, and market realities.
Our team of 35+ specialists—including former FDA officials, regulatory strategists, and legal experts—works alongside you to design efficient, fit-for-purpose programs that accelerate your path to patients. Whether you’re navigating U.S., EU, or Asian markets, we help you make confident, informed decisions at every stage.
We don’t just advise—we guide, carry the load, and clear the path forward.
Globally Connected
Headquartered in Delaware, U.S., Path2P leverages strategic partnerships to serve clients around the world. Through our alliances with partners that specialize in clinical trial logistics and CRO—we extend our reach across the U.S., EU, and Asia.
Our Services
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Preclinical & Regulatory Strategy
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Commercialization & IP Strategy
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Global Networking
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Business Development Strategy
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Project & Portfolio Management
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Technical Writing & Assessments
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Study Support
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Consulting On-Demand
Meet Our Team
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Jae Sly, MBA, PhD.
Chairman & CEO
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Steve Wolpe, PhD.
Chief Scientific Officer
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Haley Lassiter, BSE
Marketing Director
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Derya Aslantas, BS
Project Manager
In today’s rapidly evolving biopharma landscape, regulatory scrutiny, supply-chain complexity, and quality expectations continue to intensify across both the United States and Europe. As FDA resumes and expands inspection activity post-pandemic, and European regulators reinforce harmonized GMP oversight through EMA and national authorities, including the UK MHRA, proactive quality and compliance strategies have shifted from “nice to have” to strategic necessities for any drug developer.
Organizations are no longer preparing for each individual regulator. They’re preparing for converging expectations across FDA, EMA, and UK frameworks, where inspection readiness, data integrity, and supplier oversight must withstand scrutiny on both sides of the Atlantic.