EXPERIENCE
June 2014 – Present: Toxicology Consultant to Achillion Pharmaceuticals Drug Safety & Toxicology Group, New Haven, CT
• Study Monitor for Discovery and GLP studies at CROs: subchronic through chronic
rodent and large animal studies with neurobehavioral, respiratory, and EEG and ERG
assessments; Developmental and Reproductive Toxicology studies (EFD, FEED,
PPND), genetic toxicology (Ames, in vitro and in vivo micronucleus), CV/Respiratory SP
studies in the dog, and ocular (intravitreous and suprachoroidal administration) studies
• Writing and review of IB, IND, PIP (Pediatric Investigational Plan), and CAC (FDA
Carcinogenicity Assessment Committee) documents
Sept 2013 – Oct 2014: Toxicology Consultant to Novartis Pharmaceuticals Pre-Clinical Safety Scientific Monitoring Group, East Hanover, NJ
• Study Monitor for CRO toxicology studies; responsible for protocol and study design, on-site
monitoring of studies, review and interpretation of data, and finalization of reports; scope of
studies ranged from single-dose and two-week non-GLP studies to GLP chronic studies in
multiple species
EXPERIENCE 1989 – 2011 MERCK RESEARCH LABORATORIES (Schering-Plough Research Institute from 1989 - 2010), LAFAYETTE/SUMMIT, NJ
• Compound Leader for early Discovery through late Development programs. Responsible for all aspects of toxicology program design; harmonization with Chemistry, Formulations, and Clinical program timelines. Coordination with drug metabolism/toxicokinetic colleagues on the establishment of preclinical toxicology programs and selection of dose levels.
• Familiarity with design and interpretation of genetic toxicity and developmental/ reproductive toxicology studies.
• Leadership and guidance on submission documents (IB, CTD, IND, IMPD); response to
US and international regulatory agency questions on submissions; participated in
meetings with US FDA and Canadian HPB
• Toxicology Study Director for acute and subchronic studies in rodents, dogs, and
primates, chronic/carcinogenicity studies in rodents, and toxicokinetic studies;
experience with small molecules as well as biologics (monoclonal antibodies);
mentoring of junior Study Directors; review of toxicology packages for potential in-
licensing candidates.
• Evaluation of impurities/contaminants/degradation products in drug substances/drug
products.
1986 – 1989 HOECHST CELANESE CORPORATION, SUMMIT/BRIDGEWATER, NJ
Toxicology representative to Chemicals Group and Specialty Chemicals Group business
units. Monitored toxicity testing programs at contract labs, conducted written hazard
evaluations of products, and represented the corporation at trade association forums.
PUBLISHED ARTICLES
Development of Hibernomas in Rats Dosed with Phentolamine Mesylate During the 24-Month
Carcinogenicity Study, F.M. Poulet, M. R. Berardi, W. Halliwell, B. Hartman, C. Auletta, and
H. Bolte. Toxicol Pathol 32: 558-566, 2004.
Renal Changes Associated with Naproxen Sodium Administration in Cynomolgus Monkeys,
M.W. Leach, D.W. Frank, M.R. Berardi, E.W. Evans, R.C. Johnson, D.G. Schuessler,
E. Radwanski, and M.E. Cartwright. Toxicol Pathol 27(3): 295-306, 1999.
Assessing Equivalence of Innovator and Generic Formulations of Betamethasone Dipropionate
Cream and Ointment, J Sequeira, M Berardi, T-M Chan, J Letarte, R Malchow, B Pramanick,
and HN Wolkoff. Clin Therapeutics 13: 687-694, 1991.
Monochloroacetic Acid Toxicity in the Mouse Associated with Blood-Brain Barrier Damage,
MR Berardi, R Snyder, RS Waritz, and KR Cooper. Fundam Appl Toxicol 9: 469-479, 1987.
Effect of Chlorine and Monochloramine in Drinking Water on the Developing Rat Fetus,
MS Abdel-Rahman, MR Berardi, and RJ Bull. J Applied Toxicol 2: 156-159, 1982.
PATENTS
Patent No. US 6,569,872 B1. Use of Neurokinin Receptor Antagonists to Treat Androgen-
Dependent Diseases. Michael W. Leach, Mark R. Berardi, Elmer J. Mirro, Dineshwar Sinha,
Jonathan A. Pachter, Mark E. Cartwright, and Gregory A. Reichard. May 27, 2003.
|
