J Lee pharmaceutical Consulting

Dr. Lee offers strategic regulatory consulting to pharmaceutical, biotechnology, and academic institutions in areas including:

• Pre-IND and IND strategy - study design, endpoint selection, and FDA meeting preparation
• NDA/BLA submission strategy – readiness assessments, review of submission packages, and addressing FDA questions
• Pediatric development planning - pediatric study plan (PSP) development and extrapolation strategies
• FDA guidance interpretation - practical application of FDA guidance documents to development programs
• Post-approval support - supplements and label expansion strategies

Dr. Lee's deep understanding of the FDA process, combined with her scientific rigor, gives clients a strategic advantage in navigating complex regulatory pathways.

In addition, Dr. Lee offers consulting services to professional societies and patient organizations to support the design and implementation of multistakeholder forums aimed at identifying knowledge gaps and potential solutions to advance drug development in gastroenterology.

As Division Director of Gastroenterology at the FDA's Center for Drug Evaluation and Research (CDER), Dr. Lee held signatory authority for Investigational New Drug (IND) applications, New Drug Applications (NDAs), and Biologics License Applications (BLAs) across a wide range of gastrointestinal indications, including:

• Inflammatory bowel disease (Crohn's disease and ulcerative colitis)
• Eosinophilic gastrointestinal diseases
• Celiac disease
• Short bowel syndrome
• Irritable bowel syndrome
• GERD, erosive esophagitis
• Constipation, bowel cleansing for colonoscopy
• Rare diseases affecting the GI tract
• Biosimilar programs including GI indication(s)

Dr. Lee supervised the development of 11 indication-specific FDA guidance documents and played a central role in stakeholder engagement, regulatory innovation, and cross-disciplinary team leadership.

Stakeholder Engagement

Throughout her FDA career, Dr. Lee demonstrated a strong track record in collaborative leadership:

• Co-developed with the American Gastroenterological Association (AGA) annual FDA Town Hall sessions at Digestive Disease Week
• Organized and chaired public workshops with patient organizations and professional societies
• Led hundreds of FDA meetings on study design, endpoint selection, and pediatric drug development
• Developed a visiting fellowship program with the American College of Gastroenterology (ACG) to help educate the next generation of GI researchers on drug development and regulatory science

Dr. Jessica J. Lee is a regulatory consultant with 14 years of FDA experience and a strong scientific background in gastroenterology and pediatric drug development. From 2020 to 2025, she served as Division Director of Gastroenterology at the FDA's Center for Drug Evaluation and Research (CDER), where she oversaw regulatory decisions and led multiple initiatives shaping the future of GI drug development.

Clinical & Scientific Background

Dr. Lee brings rigorous academic and clinical credentials to her regulatory work:

• B.S. - Massachusetts Institute of Technology
• M.D. - SUNY Upstate Medical University
• M.M.Sc. - Harvard Medical School
• Fellowship in Pediatric Gastroenterology - Boston Children's Hospital/Harvard Medical School
• Board Certified in General Pediatrics and Pediatric Gastroenterology

Dr. Lee's clinical and translational research focused on inflammatory bowel disease, including NIH- and foundation-funded studies. Prior to joining the FDA, she served on faculty at Boston Children's Hospital and Harvard Medical School. From 2017 to 2018, Dr. Lee served as Deputy Division Director and Senior Scientific Advisor for Clinical and Translational Research in the Division of Digestive Diseases and Nutrition, NIDDK, NIH.

If you're seeking strategic regulatory guidance grounded in FDA experience and scientific insight, Dr. Lee welcomes the opportunity to speak with you. Whether you are planning an early-stage meeting, preparing a regulatory submission, or seeking clarity on FDA expectations, Dr. Lee offers practical, expert advice to help you move forward with confidence.

Please email at jessica@jleepharmaconsulting.com to explore how Dr. Lee may be able to support your development program. A 30-minute introductory call may be scheduled for qualified inquiries.