Michael J. Klepper, MD
President & CEO
With 20 years of global pharmaceutical experience, Dr. Klepper provides expertise in medical consulting, benefit-risk assessments, risk management and training. In addition, he oversees all medical writing, coding, and pharmacovigilance services for ISS, Inc. Prior to founding ISS, Inc., Dr. Klepper was senior director of corporate safety and medical services for the Knoll Pharmaceutical Company (formerly Boots Pharmaceutical). He has also held global clinical development responsibilities with Abbott Laboratories. Of particular importance to him are data quality issues and the impact those issues have on the ability of the medical reviewer to provide relevant product benefit-risk assessments. He also has a keen interest in the evaluation and application of new technological tools pertaining to enhancing activities related to ongoing risk assessment. A native of New York, Dr. Klepper received his M.D. from Loyola University's Stritch School of Medicine in Maywood, Illinois, and he has received his board certification in Internal Medicine and Emergency Medicine.

Dr. Cecile M. ‘Skippy’ Berner, DVM
Senior Director
Dr. Berner has 15 years' experience in the global development of cardiovascular, antiobesity, antidepressant, immunomodulatory, and genitourinary pharmaceutical agents. Prior to joining ISS, Inc., she held several clinical research and managerial positions with Boots Pharmaceuticals, Inc., La Jolla Pharmaceutical Company, and PPD Pharmaco. She has directed and participated in nonclinical and Phase 1-3 clinical development programs, as well as in the production of clinical protocols, clinical study reports, INDs, and major nonclinical and clinical summaries for regulatory submissions worldwide. Dr. Berner received her D.V.M. from Louisiana State University School of Veterinary Medicine in 1984, and her B.S. from Nicholls State University in 1974.

Dr. Carmela A. Skillman, RPh, PhD
Senior Director
Dr. Skillman has 17 years’ experience in clinical research in the development of cardiovascular, neurological, antidiabetic, and systemic antifungal agents. She has also worked on projects related to biologicals, proton-pump inhibitors, oral contraceptives, antiretrovirals, and antidepressants. Prior to joining ISS, Inc., she held several clinical research and managerial positions with American (DuPont) Critical Care, Boots (Knoll) Pharmaceuticals, Inc. and Fujisawa USA, Inc. She has directed and participated in Phase 1-4 clinical development programs, including global development, and has a wide array of medical writing experience in the production of clinical and regulatory documents and preparation of manuscripts for publication. Dr. Skillman received her MS and PhD in Pharmacology/Toxicology from Purdue University, completed a postdoctoral fellowship at the University of Cincinnati, and received her BS in Pharmacy from Rutgers University.

Nancy A. Havrilla, MS, RN
Director, Medical Product Safety
Ms. Havrilla has over 10 years of experience in clinical development in the following therapeutic areas: oncology, HIV, sepsis, cardiac, pulmonary, anti-inflammatory and transplant.  Her clinical development experience includes working as a site coordinator, CRA, program manager and developing a drug safety unit. She has directed and participated in Phase 1-3 clinical development programs, including developing protocols, investigator brochures, clinical study reports, annual reports, and INDs. In addition, she has developed drug safety SOPs, developed safety standards/guidelines and assisted with the validation of drug safety databases. As associate director of drug safety for Abgenix, Inc., Ms. Havrilla was responsible for developing the drug safety group, including validation of a safety database, along with development and implementation of safety standards across all projects. She has co-authored abstracts, journal articles and MedDRA® presentations. Ms. Havrilla received her RN from Muhlenberg Hospital School of Nursing, her BSN from St. Xavier College, and her MS from Rush University. She also has over 10 years of experience as a registered nurse.

Diana McFarron, BSN, RN
Manager, Drug Safety
Ms. McFarron is responsible for logging, tracking, entering, evaluating and reporting of serious adverse events (SAEs) to clients and regulatory authorities. A native of Kentucky, Ms. McFarron previously was the clinical trials coordinator for the Duke Clinical Research Institute and quality assurance manager for Quintiles, Inc. She has also worked for several other contract research organizations as project manager and senior clinical research associate. Ms. McFarron received her bachelor’s degree in nursing from Kentucky Weslyan College.