Pauline McEwan, PhD

Pauline McEwan, PhD

Senior Consultant

Dr. McEwan joined Biologics Consulting as a Senior Consultant in April, 2017 with more than 12 years of consulting experience in drugs, biologics, devices and combination product development. Prior to joining Biologics Consulting, she served as a senior consultant toxicologist at Aclairo PDG and IND Consulting where she was involved in all aspects of nonclinical development of gene and cell therapies, small molecule, biosimilars, and viral therapeutics, as well as drug and device development and safety programs. The nonclinical development activities included writing and submissions of eCTD’s, IND’s, 505b(2), BLA’s, NDA’s, IDE’s, position papers and toxicological safety assessments for impurities, leachables and extractables.

Dr. McEwan has also worked closely with sponsors to outsource GLP and non-clinical GLP studies to nonclinical CRO’s and is involved closely with nonclinical study design, implementation, monitoring and auditing of GLP study facilities.

Dr. McEwan works with clients/sponsors to provide regulatory strategy and to assist in FDA meetings on behalf of clients for combination (drug-drug, drug-device, biologics-device) products at CBER, CDER and CDRH divisions.

For several years, Pauline served as Principal Consultant to Celladon Corporation and was responsible for the nonclinical development of a gene therapy program for congestive heart failure, working in conjunction with FDA on developing guidance documents for industry.
Prior to her consulting career, Pauline held industry positions as senior manager and director of research and development at Miravant Medical Technologies for cardiovascular drug/device combinations and served as a Steering Committee Member at Guidant Corporation.

Pauline’s early career was sponsored by British Heart Foundation and Wellcome Trust initiatives. Pauline received her Ph.D. in experimental pathology from the University of Glasgow Department of Pathology and MRC Blood Pressure Unit. Her thesis focused on the role of growth factors in the pathophysiology of endocrine and cardiovascular disease. She held post-doctoral fellowships in pharmacology and cardiovascular genetics at Edinburgh and Harvard Medical School, respectively. Her work has culminated in several publications in peer-reviewed journals and book chapters.