Paul Papagni

Adjunct Faculty

Paul Papagni is a Senior Executive/Attorney with an operations/compliance career track with medical industry leaders. He has extensive experience in reorganizing and streamlining complex infrastructures while identifying and addressing multi-tier regulatory compliance issues.

Paul currently serves as Assistant Vice President Center for Research and Grants responsible for overseeing strategic objectives and operational plans for Baptist Health Research Programs. In this role, he provides vision and leadership to integrate operational efficiency, clinical quality, patient safety and compliance in the support of research across multiple sites and collaborative efforts with other research institutions. He also serves as content expert for clinical research compliance, clinical operations and assists in representing Baptist Health with key federal, state and private regulators and constituencies.

Education

Suffolk University School of Law, Boston, MA - Juris Doctor
University of Massachusetts - Bachelor of Arts, Political Science

Courses Taught

Human Subjects Protection 2022- 2025

Publications/Research Listings

Publications: NCCN Molecular Testing White Paper: Effectiveness, Efficiency, and Reimbursement, J Natl Compr Canc Netw 2011;9:S-1-S-16 Paul F PF Engstrom, Mara G MG Bloom, Paul Papagni, JD Stuck

Between a Scalpel and a Rock, or Molecular Pathology and Legal-Ethical Issues in Use of Tissues for Clinical Care and Research: What Must a Pathologist Know? Am J Clin Pathol 137(3):346-55 (2012), PMID 22338046 Sarah Dry, Wayne W. Grody, and Paul Papagni

PRESENTATIONS:
“FDA Inspections: Always Be Ready and What to Do When They Actually Come Knocking on Your Door!” MAGI Conference October 2024
“AI and Machine Learning: When is it Research and What Do IRB Members Need to Know” HCCA Conference June 2024 New Orleans LA
“Clinical Research Innovation and Best Practices: Embracing Innovation Before Regulatory Guidance/Demand” Arrives Magi 2022
“Ready, Set, Go! Accelerating Research Site Startup Best practices for quick site startups” Magi October 2021
“Lessons Learned from Doing Research During COVID-19 Pandemic” SOCRA Sept. 2021
"Improvements in the FDA Expanded Access Program Compared to Growing Demand for Right To Try Laws – Operational View" PRIMR Dec2020 "Right to Try Laws vs. FDA Expanded Access: What You Need to Know and What You Need to Do" HCCA Compliance Institute June 2020
Panel Member for FDA "Project Facilitate" Public Workshop: Oncology Center of Excellence-Envisioning Oncology Product Development for 2020
"Building Models for Hospital and Practice-Based Research Programs—Agony and Ecstasy" (AER19), November 18-20 2019 Boston, MA
"Mining the Sunshine Data: Finding Potential Conflicts of Interest" HCCA Research Compliance Institute" Orlando June 2019
" Integrating Community Hospital Based Research in a System Wide Network" HCCA Research Compliance Institute Orlando June 2019