Frank Li, MD, PhD Joins GessNet Advisory Board | Regulatory Expertise

Advancing FDA and Global Regulatory Strategy Through Expert Advisory Leadership

Gaithersburg, MD (April 9, 2026) – GessNet announced today that Frank Li, MD, PhD, RAC, has joined the GessNet Advisory Board as Senior Pharmaceutical Regulatory and Clinical Advisor, further strengthening the company’s leadership in global regulatory strategy, FDA submissions, and digital regulatory solutions for the life sciences industry.

Dr. Li is the Founder and Principal Consultant of BLA Regulatory, LLC, bringing more than 20 years of global experience in regulatory strategy and execution across the biopharmaceutical, biotechnology, and medical device sectors. Throughout his career, Dr. Li has supported product development from early pre‑IND planning and first‑in‑human studies through successful global marketing applications, including NDA, BLA, MAA, and JNDA submissions across major regulatory regions.

Senior Pharmaceutical Regulatory and Clinical Leadership

With a unique combination of clinical medical training, advanced biomedical research, and hands‑on regulatory leadership, Dr. Li brings deep expertise in innovative drugs, biologics, biosimilars, medical devices, and combination products. His experience includes accelerated development programs such as Orphan Drug Designation, RMAT, Breakthrough Therapy Designation, Fast Track, and Accelerated Approval, supporting clients in addressing serious and unmet medical needs.
Dr. Li has also led regulatory strategies across a broad range of FDA regulatory pathways, including Q‑Sub, 513(g), 510(k), De Novo, IDE, and PMA, making him a valuable strategic advisor for organizations navigating complex and evolving regulatory requirements.

Advancing Digital Regulatory Submissions and Data Integration

Dr. Li, together with his firm’s team of more than 20 regulatory consultants, brings strong pharmaceutical industry expertise that enhances GessNet’s innovative digital solutions and consulting services for regulatory submissions. His background aligns closely with GessNet’s focus on integrating regulatory content with underlying engineering and scientific data, including:

• • Quality by Design (QbD)
  • Risk Management
  • Design Controls
  • Clinical and nonclinical development data

This integration supports more efficient, traceable, and high‑quality regulatory submissions across global markets.

Supporting GessNet’s Mission and Advisory Board Excellence

At GessNet, the company’s mission is to advance medical product development through first‑principles‑based digital solutions and expert consulting, enabling organizations to accelerate safe, effective, and compliant products to market with confidence. Dr. Li joins a distinguished advisory board of industry experts, reinforcing GessNet’s commitment to regulatory excellence, innovation, and client success.
GessNet looks forward to collaborating with Dr. Li as the company continues to expand its capabilities in regulatory consulting, digital regulatory platforms, and life sciences innovation.

Reference

1. LinkedIn Announcement:
   Wu, F. (2025). “Announcement of Frank Li, MD, PhD, RAC joining the GessNet Advisory Board.”
   Available at:
   https://www.linkedin.com/posts/fubin-wu-0561b96_im-excited-to-share-that-frank-li-md-phd-share-7447662999860944896