Our experienced staff will work closely with your team to understand the requirements of your development program and will ensure that the right team is put into place to accomplish the tasks at hand. From the start of project discussions, ClinSmart will draw upon the expertise of industry opinion leaders and will form expert panels with the necessary therapeutic experience to provide consultation and input into the design of the study.

Anup Dam, M.S. - President and CEO

As founder of Stat-Trade, Inc. (parent company of ClinSmart) Mr. Dam utilized his more than 15 years of biomedical and related industry experience to develop and grow the company. His pharmaceutical experience began in 1986 with G.D. Searle (Pharmacia) and subsequently with Abbott Laboratories and Wallace Laboratories. His biomedical industry experience included senior level positions as Lead Analyst in the successful approval of the first new drug in the 1990’s for epilepsy and the first non-steroidal nasal spray for allergies ever approved by the FDA. In addition, he has actively contributed to more than seven NDAs in such therapeutic areas as CNS, cardiology, infectious disease and allergy/immunology.

Mr. Dam received an M.S. in Statistics from the University of Illinois and also from Dhaka University in Bangladesh.

Donald P. Cox, Ph.D., M.B.A. - Vice President, Regulatory Affairs & Product Development

Dr. Cox joined ClinSmart in 2004. He has over 36 years experience in biotechnology research, regulatory affairs, quality assurance and marketing with companies such as Janssen Pharmaceuticals and Flemington Pharmaceutical Corporation. During that time, he managed the regulatory, customer service and marketing support for over 50 products serving the immunology/biochemistry research markets. He has worked closely with the FDA for many years in putting together IND/NDA submissions and gaining timely approval of a number of both pharmaceutical and medical device products in a variety of therapeutic areas.

Dr. Cox received his Ph.D. and M.S. from the University of Wisconsin and his M.B.A. from Temple University.

Raymond E. Tobey, M.D. - Chief Medical Officer

Dr. Tobey joined ClinSmart in 2002 and has been involved with pharmaceutical research and development since 1982. During that time he worked for Merck Research where he headed the Phase I-III clinical team for respiratory diseases and worked closely with Astra Pharmaceutical in Sweden and Keisei Pharmaceutical in Japan. His clinical development background includes therapeutic areas such as allergy, asthma, anti-infective, AIDS vaccine, immunology blood products and dermatology. He served as Vice President of R&D for Dermik Laboratories, a division of Central Research, Rhone-Poulenc Rorer. Dr. Tobey also served as President of the American Academy of Pharmaceutical Physicians in 1998.

Dr. Tobey received his B.A. from Brown University and an M.D. from Tufts University School of Medicine.

Arthur G. Itkin, Ph.D. - Senior Director, Biostatistics

Dr. Itkin joined ClinSmart in 1996. He has more than 30-years of statistics and clinical trial experience within the pharmaceutical industry with companies such as Wallace Laboratories, ICI Pharmaceuticals, E.R. Squibb and Sons, and Merck. He has provided and directed the statistical support for more than 50 NDAs in such therapeutic areas as cardiology, infectious diseases, CNS, dermatology, allergy/immunology and oncology. In addition to his pharmaceutical experience, Dr. Itkin has extensive teaching experience at the University of Delaware, The College of New jersey, Villanova University and Johns Hopkins University.

Dr. Itkin received an M.S. in Mathematics from the University of New York, an M.S. in Statistics from Rutgers University, and a Ph.D. in Biostatistics from Johns Hopkins University.

John E. Higson, M.B.A. - Director, Business Development

Mr. Higson joined ClinSmart in 2008 and has more than 30 years experience in the pharmaceutical business. Before joining ClinSmart, Mr. Higson was the Director of Portfolio and Project Management for MedPointe Pharmaceuticals in Somerset, NJ (now Meda). His responsibilities included the oversight of all new product development projects and life cycle management activities. His experience extends into all areas of pharmaceutical development and commercialization including non-clinical, clinical, CMC and commercial launches. Prior to MedPointe, Mr. Higson was the Director of Planning and Project Management for Wallace Laboratories. During his tenure at Wallace, Mr. Higson was the project leader for several successful NDAs and INDs. Prior to Wallace, Mr. Higson worked for SmithKline Corporation (now GSK) for more than 20 years in project management, clinical pathology and cardiovascular pharmacology.

Mr. Higson received his B.S. from St. Joseph’s University and his M.B.A from Widener University.

Meena Dam, B.A. - Director, Project Management

Ms. Dam joined ClinSmart in 2007. She has 20 years of experience in the pharmaceutical industry with companies such as Bristol-Myers Squibb, Pfizer and Bio-Imaging. Her responsibilities have included global project management and Phase II and III clinical data management. She has interacted with both U.S and international clients in completing a variety of complex projects that that have led to successful regulatory submissions.

Ms. Dam received her B.A. in Economics from the University of Illinois at Chicago.