Gina Burgess is Principal Scientist, Medical Writing, for the Regulatory Sciences group of Cardinal Health Specialty Solutions.
Burgess is responsible for medical writing and clinical consulting activities, with an emphasis in providing medical writing support for clinical and regulatory documents used during the conduct of clinical trials (ie, clinical protocols, investigator brochures and clinical study reports), as well as regulatory documents to be used as part of regulatory applications.
Burgess has more than 28 years of experience in the pharmaceutical industry, focusing in the areas of clinical research, regulatory affairs and medical writing for drug and biologic products. Prior to joining Cardinal Health, Gina was a senior medical writer for early development services (Phases 1 and 2) for Pharmaceutical Research Associates and Director of Clinical Pharmacology, Medical Writing, for 11 years with Quintiles. Before Quintiles, she spent 13 years with Hoechst Marion Roussel Inc. (formerly Marion Merrell Dow and Marion Laboratories), in various positions within clinical research, regulatory affairs and scientific communications.
Burgess has expertise with Phase 1 development, including preparing Phase 1 and 2 clinical protocols, clinical study reports and clinical pharmacology sections of Investigational New Drug (IND) applications, New Drug Applications (NDAs), Common Technical Documents (CTDs) and Marketing Authorization Applications (MAAs).
Burgess has been involved at various stages of the development process for several FDA-approved compounds, including Cardizem (calcium channel blocker), Carafate (anti-ulcer), Anzemet (anti-emetic), Sabril (anti-epilepsy), Allegra (non-sedating anithisatmine), Ketek (macrolide antibiotic), Orudis (osteoarthritis treatment), Pentasa (ulcerative colitis treatment), Vidaza (antineoplastic for myelodysplastic syndrome/AML), Thalidomide (antineoplastic for multiple myeloma), AndroGel (testosterone gel), Copaxone (multiple sclerosis treatment) and extended-release Luvox (anxiety disorders treatment).
Burgess received a bachelor’s of science degree from the University of Missouri-Kansas City School of Pharmacy.