Dr. Kathryn J. Lucchesi (Kathy) is a retired senior clinical research administrator and senior medical writer. She was a senior clinical research administrator for Mass General Brigham [MGB]) in the Division of Nephrology until 2018. Prior to her retirement in 2019, she was a clinical research consultant to the MGB’s Chief of Nephrology and Vice Dean for Research at Cedars-Sinai Medical Center. At the onset of the Covid-19 pandemic in 2020, Kathryn continued to consult for MGB, participating in the development of a longitudinal research study to track Covid-19 antibodies.
Prior to her joining the Board in 2023, Kathy served on the MDIH Planning Committee since 2017 and Steering Committee overseeing the forthcoming MDIH renovation and expansion. She resides full time in Bar Harbor and recently also joined MDIH’s Credentialing Committee.
In addition to her work at MGB, Kathy was a medical writer for nearly 20 years. She has been a consultant for various clients in the pharmaceutical industry with 25+ years combined academic and industry experience in pharmaceuticals, pre-clinical investigation, drug information, pharmacovigilance, regulatory affairs, and clinical research. She has written scientific publications from original data, review articles, educational materials, and drug information, and regulatory documents (clinical study reports, research protocols, investigator brochures), and has helped prepare New Drug Applications for FDA and regulatory documents for European and Canadian Regulatory Agencies.
Areas of therapeutic focus have been in hematology and oncology, anemia and blood management, hormone replacement therapy, anti-infectives, reproductive health, diabetes and metabolism. Kathy has broad methodological experience related to pharmacology, clinical and basic research, drug safety, and pharmacoeconomics. She has held the position of Director of Clinical Science at Wyeth Research, focusing on recombinant therapy for hemophilia patients. Her work involved writing and implementing clinical research protocols and development of clinical investigator brochures, study reports, and responses to inquiries by regulatory authorities. Prior to that, she directed the Drug Information group at Genetics Institute (GI), where her charge was to provide scientifically credible information to healthcare professionals and to train internal staff about hematopoietic cytokines and coagulation factors manufactured by GI’s proprietary recombinant technology. Kathy and the group she supervised also handled all aspects of post-marketing drug safety and product quality reporting.
Formerly a registered pharmacist, Kathy spent several years at the University of Pennsylvania and the Lahey Clinic coordinating investigational drug services and serving on their Institutional Review Board. She received her doctorate in Pharmacology from Dartmouth College in Hanover, New Hampshire, where the topic of her thesis research was transport mechanisms of hydrophilic solutes across the blood-brain barrier. Kathy completed a 3-year post-doctoral fellowship at Yale School of Medicine, investigating the biophysics, electrophysiology, and biochemistry of ion channels derived from mammalian skeletal muscle tissue.
Kathy has published several research articles in peer-reviewed journals on subjects as varied as the clinical effects of immune therapy for acute myeloid leukemia, a device used to treat preeclampsia, and the pharmacology of snake and insect venoms related to neurotransmission.