1. Teaching Contributions:
   1. PharmD Teaching: Pharmaceutics-I, Pharmacy Lab-I
   2. Graduate Teaching: Physical Pharmacy, Pharmaceutical Unit Operations
   3. Thesis Chair for Sharon Jiang, Nicole Damour, and Robert Tuohy
   4. Other Teaching Roles: Developed GMPs for the 21^st Century Certificate program, Revised the Masters in Regulatory Sciences Program, Initial chair for the Ph.D. in Regulatory Affairs and Quality Assurance. 
2. Research Overview:

My research area is Regulatory Affairs.  Key projects are direct-to-consumer genetic Testing and Orphan Drug Approvals.  Additionally, mechanisms of orphan drug approvals, clinical study size, and development timelines are being evaluated for the efficacy of research programs.

Other work includes the evaluation of topical, transdermal, and transungual formulations with emphasis on solubility enhancement.

1. Research Interests:

Regulatory filing mechanisms, Quality Systems, Quality by Design Approaches.

1. Current CGMP Studies

Jan 2025 to Dec 2029       Metformin to Attenuate ProgressiVe Respiratory deCline in IPF (MAVRIC-IPF), F. Martinez, PI, UNC, DCC, Dept of Defense

July 2023 to June 2026    Metformin IN Asthma for overweight and obese individuals (MINA), David Wu PI, Baylor, Johns Hopkins DCC, National Heart Lung Blood Health Institute, NHLBI

Apr 2022 to March 2026   Phase 1 study of oral epigallocatechin-3-gallate (EGCG) in IPF patients, Hal Chapman, PI, SABER (Michigan), DCC, National Heart Lung Blood Health Institute, NIH

Oct 2021 to Sep 2025       A Phase II, Randomized, Double-Blinded, Placebo-Controlled Trial of Doxycycline to Reduce Progression of Emphysema in HIV, NHLBI

Oct. 2019 to Sept. 2025    “Prospective tReatment EffiCacy in IPF uSIng genOtype for Nac Selection (PRECISIONS) trial” Martinez, F. PI, Weil Cornell, National Heart Lung Blood Health Institute, NHLBI

1. Key Publications:

Public Perspectives on Direct‑to‑Consumer Testing Oversight, Sharon Jiang, David Lebo, Thomas Schultz, https://doi.org/10.1007/s43441-024-00685-8

ICH Q9: Attaining a Quality-Business Synergy through Quality Risk Management, ROI Analysis, and Highly Capable Facilities, Rick Friedman David Lebo, Lawrence Liberti, G.K. Raju, Pharmaceutical Technology, 2024, Issue 1, 30-45

“Antipruritic Effect of Topical Acetaminophen Gel in Histaminergic and Non-histaminergic Itch Provocation: A Double-blind, Vehicle controlled Pilot Study”, Leigh A. NATTKEMPER, Kaining ZHI, Kaeli E. ROMERO, Serena M. SHAH, Teresa JU, Kayla FOURZALI, Rachel Shireen GOLPANIAN, Flor MACQUHAE, Yiong Huak CHAN, David B. LEBO and Gil YOSIPOVITCH, Advances in Dermatology and Venereology, 102, Jan, 2022

1. Administrative & Service Roles: Curriculum Committee
2. Collaboration Interests & Opportunities:

Clinical supplies for multi-center NIH and DOD sponsored clinical trials.

Currently training students in CGMP, Developing a Continuous Manufacturing program in QA/QA

1. Professional Profiles:

http://www.ncbi.nlm.nih.gov/myncbi/browse/collection/48029361/?sort=date&direction=ascending

Explore research activity.