Knee Osteoarthritis Clinical Trial Design: An Imaging-Based Approach

Timothy J. Mosher, MD., Kenneth L. Miller Chair, Department of Radiology at Penn State University; Radiologist Consultant and Faculty Director at Medical Metrics, Inc.

Dr. Mosher is the Kenneth L. Miller Chair, Department of Radiology at Penn State University and Distinguished Professor of Radiology and Orthopaedic Surgery. He is a clinical musculoskeletal radiologist researching quantitative MRI for evaluation of articular cartilage and osteoarthritis and application of MRI in multicenter clinical trials.

Dr. Mosher is active in the field of diagnostic error in medicine, serving as a member of the Board of Directors for the Society to Improve Diagnosis in Medicine (SIDM) and representative of Penn State Health in the Coalition to Improve Diagnosis. He is also a fellow of the International Society for Magnetic Resonance in Medicine (ISMRM).  Previously, Dr. Mosher served as Deputy Editor for Magnetic Resonance in Medicine and Associate Editor for Osteoarthritis and Cartilage. He currently serves as an Associate Editor for MRI for the journal Radiology.

He is a member of the SBSR/NIH study section and served on the Scientific Advisory Board for the Canadian Arthritis Network and the Canadian Foundation for Innovation. Dr. Mosher has published 70+ books and manuscripts, with the majority in the area of musculoskeletal imaging, quantitative cartilage imaging, and MRI technical development. He also serves as an expert consultant and faculty director for Medical Metrics, Inc. (MMI).

Iman Ahmad, Senior Director, Clinical Affairs, MCRA, LLC

Ms. Ahmad is a clinical expert with 16+ years’ experience in managing pharmaceutical and device studies, including domestic US trials, and larger multinational global studies. She works closely with the Regulatory department in the development and submission of IDE, IND, 510(k), and PMA applications for IVD, wound care and orthopedic devices.

As Sr. Clinical Director, Iman leverages her knowledge of FDA regulations and ICH/GCP guidelines to design pre- and post-market clinical studies in a manner that helps drive clinical and regulatory compliance and ensures superior data quality. She has assisted with the development of clinical protocols that incorporate strategic regulatory, statistical and reimbursement objectives so that our clients can use each clinical trial to collect data required by all stakeholders. She also advises clients on the use of innovative statistical analyses that can help reduce a study’s sample size and/or allow for an early success/failure determination. She assists clients with the identification and qualification of sites that help ensure their trial’s success. Iman also provides strategic guidance to clients on how to maintain inspection readiness at research sites, and how to prepare for a BIMO inspection.

Dave McGurl, Senior Director, Regulatory Affairs, MCRA, LLC

Mr. McGurl worked for 7 years at the FDA in the premarket orthopedic devices branch prior to joining MCRA in 2016. During his time at FDA, Mr. McGurl held several positions, including acting branch chief of the orthopedics branch and senior premarket lead reviewer. Throughout his professional career, Mr. McGurl has reviewed or written hundreds of regulatory submissions, including 510(k)s, PMAs, De Novos, IDEs, HDEs, CERs, STEDs, Technical Files, and Design Dossiers.

Mr. McGurl is a seasoned regulatory expert with proficiency in US and international medical device regulations. Mr. McGurl specializes in regulatory strategy, writing of regulatory submissions, clinical protocol design and development, analysis of preclinical and clinical data, and regulatory compliance review of marketing/labeling materials for medical devices. Mr. McGurl’s work at MCRA focuses primarily on both international and US medical devices with a specialization in orthopedic arthroplasty, trauma, and sports medicine.