Orlando M.

WORK HISTORY

EDUCATION

ABOUT ORLANDO M.

Most clinical trials don’t miss timelines because teams lack expertise.They miss them because critical decisions were made with incomplete visibility.After years in biotech business development and clinical research partnerships, I’ve learned that the difference between a trial that moves forward and one that stalls often comes down to one thing:The quality of decisions made before the first patient is enrolled.I’ve spent my career working with biotech companies, sponsors, and research partners to help bring therapies to patients faster by aligning strategy, operations, and the right partners early in the process.From leading U.S. and international business development initiatives to building strategic partnerships across the clinical research ecosystem, my focus has remained the same:Help sponsors move faster without increasing risk.Today, I work with biotech teams navigating the complexities of clinical development, particularly around IRB strategy, study startup, regulatory review, and operational readiness.The goal is simple:Help teams reduce friction so their science can move forward.How I operate:• Study Startup & Regulatory Strategy – Supporting sponsors through IRB review, compliance requirements, and early trial planning so studies launch efficiently.• Clinical Trial Risk Visibility – Identifying operational blind spots early before they become delays, amendments, or enrollment issues.• Strategic Partnerships – Connecting sponsors with the right expertise across regulatory, ethical review, and study execution.At the end of the day, clinical trials aren’t just timelines and milestones.They represent patients waiting for new therapies.If you’re preparing for a clinical study and want to pressure-test your strategy early, feel free to reach out.