Lukas Makris, PhD

Senior Vice President and Chief Statistician

lukas.makris@unitedbiosource.com

Lukas Makris, PhD, is responsible for clinical data and biostatistics service offering, including protocol development, statistical regulatory representation, due diligence assessments, data management, statistical programming and analysis and medical writing for Phase I-IV studies. In 1998, he founded BioCor LLC, acquired in 2006 by UBC.

With over 15 years of industry and CRO experience in biostatistics and clinical development – including numerous interactions with the FDA, EMEA and local European regulatory authorities – Dr. Makris has offered statistical regulatory guidance to biotech and pharmaceutical companies.

He serves as the statistical representative in IND, end-of-Phase II and III and NDA review meetings, as well as in discussions and negotiations on the content and format of electronic submissions. In addition, as the statistical consultant to the Medical Imaging Contract Agent Association (MICAA), Dr. Makris drafted the statistical response to the FDA Draft Guidance Document to the Medical Imaging Industry.

He has also managed clinical development programs spanning a wide variety of therapeutic areas, including asthma, cardiology, depression, metabolic disorders, oncology, pain and schizophrenia, as well as medical devices and diagnostics in several areas.

Previously, he served as Senior Director of Clinical Information Management & Biostatistics for Bracco Diagnostics Inc. and Senior Biometrician Manager for Merck Research Laboratories. Dr. Makris was also a Project Statistician for the School of Public Health and a Statistical Consultant and Instructor for the School of Statistics, both at the University of Minnesota.

A frequent presenter at international industry conferences who has co-authored numerous publications, Dr. Makris earned his bachelor’s degree in Mathematics from the University of Patras School of Sciences in Patras, Greece and his doctorate in Statistics and Bayesian Inference from the University of Minnesota School of Statistics.