Welcome to Katherine Kacena Consulting
kk@kkstats.com
001-508-808-4383
Biostatistical Consulting in Drug and Device Development
Katherine Kacena is a Statistical Consultant with 25 years of research experience, across industry, academia, and in collaborations with non-governmental and governmental institutions. Katherine received her PhD at the Johns Hopkins School of Hygiene and Public Health, now the Bloomberg School of Public Health, in the Department of International Health, in the challenging Disease Control track, which was equally weighted in the studies of biostatistics, epidemiology, and molecular biology with applications to international health. In addition, she has completed a two-year Visiting Fellowship in the Statistics Department, Harvard University (Cambridge, MA) studying causal inference and multiple imputation.
Therapeutic or Functional Area of Expertise
Oncology, Cardiovascular Diseases, Autoimmune Diseases, Medical Devices, Infectious Diseases, Enzyme Deficiencies, in vitro Diagnostics, and Radiotherapeutics
Peer-Reviewed COVID
Pajon R, Paila YD, Girard B, Dixon G, Kacena K, et al. Initial analysis of viral dynamics and circulating viral variants during the mRNA-1273 Phase 3 COVE trial. Nat Med 2022: 1- 17.
Peer-Reviewed Oncology
Richardson K, Castillo JJ, Sarosiek S, Branagan AR, Flynn C, Meid KE, Gutine J, Liu X, Kofides A, Liu S, Wolf JL, Kacena KA. Identification of robust predictors for ibrutinib response by multi-omics in MYD88 mutated Waldenstrom Macroglobulinemia. Blood Advances. 2024: 1-13.
Peer-Reviewed Osteoarthritis
Bowes MA, Kacena K, Alabas OA, et al. Machine-learning, MRI bone shape and important clinical outcomes in osteoarthritis: data from the Osteoarthritis Initiative. Ann Rheum Dis 2021; 80:502–508.
Development Phases
Preclinical to Post-approval
Clinical Trial Designs
Application of innovative trial designs
Education
2004-2006: Visiting Fellow, Department of Statistics, Harvard University, Cambridge, MA, USA
1998-1999: Postdoctoral Fellow, Department of Adult Infectious Disease, School of Medicine, Johns Hopkins University, Baltimore, MD, USA
1995-1998: PhD, Disease Control, International Health, School of Public Health, Johns Hopkins University, Baltimore, MD, USA (degree conferred 1999)
Coursework/dissertation equally weighted in biostatistics, epidemiology, and molecular biology (Advisor: Thomas C. Quinn, MS, MD)
1991-1995: BS, Double Major in Cellular and Molecular Biology, and Psychology, University of Michigan, Ann Arbor, MI, USA
Junior Year abroad: St. Edmund Hall, Oxford University, Oxford, England, U.K.
Hobbies
- Eco-tourism (SCUBA, Snorkel, Land)….Especially with Tiger Sharks, Great Hammerheads, Humpback Whales, Orcas, Spotted Dolphins, Whale Sharks, Lemon Sharks, and Nurse Sharks
- Languages, Swimming, Surfing, Vinyasa Yoga, Walking Jacky and Buddy