Kazem Kazempour, PhD

President & CEO 

Dr. Kazempour, President & CEO, co-founded Amarex Clinical Research in 1998, a full-service contract research organization providing services to the pharmaceutical, biotech, and device communities. Dr. Kazempour serves on the George Washington University Regulatory Affairs Advisory Board, teaching at George Washington  University Medical Center and Montgomery College. 

Dr. Kazempour started his career as a mathematical statistician working at Genetics Institute in 1975 and published his first article on genetics in 1979. His experience in the industry and FDA has allowed him to understand biometrics, quality assurance and quality control from both a sponsor's perspective, as the provider of the data and from a regulatory perspective, as the reviewer of the data. Dr. Kazempour has worked in many therapeutic areas including vaccines, anti-infectives, anti-virals, AIDS, and cardiovascular, as well as medical devices, as his expertise and knowledge has been a key contributor in the approval of these drugs and devices. Additionally, Dr. Kazempour has established, presented, and participated in many Data Safety Monitoring Boards (DSMB). 

During his more than 30 years of experience in biomedical research, Dr. Kazempour has conducted research activities with the National Institutes of Health (NIH), pharmaceutical industry and various universities. While at the Food and Drug Administration (FDA) as a statistical reviewer, he received several awards for innovative problem solving and teamwork along with contributions to the drug approval process. During his tenure at the FDA, Dr. Kazempour also worked as a Senior Staff Fellow and as a Mathematical Statistician responsible for supervising and conducting independent statistical analyses of clinical trials and reviewing statistical sections of submitted protocols and statistical analyses. 

Dr. Kazempour has been active in the biomedical research community throughout his career as an organizer, a panel discussion member, and presenter at national and international meetings. He has made presentations to the FDA, and FDA advisory committees on more than 30 different drugs. Dr. Kazempour has authored numerous published articles, book chapters, and technical reports.  

Dr. Kazempour has served as Global Biometrics Senior Director for an international pharmaceutical company. While in this position, he was responsible for the global standardization of biostatistical, scientific programming, and data management procedures. He also implemented International Council of Harmonisation (ICH) guidelines and validated the programs for all biometrics offices. Additionally, he prepared and presented the biometrical aspects of study designs of Investigational New Drug Applications (IND), New Drug Application (NDA) and Pre-Market Approval (PMA) to regulatory agencies in the US and Europe.

Dr. Kazempour received his Ph.D in Statistics from Colorado State University, Fort Collins.

Kush Dhody, MD, MS

Vice President, Clinical Operations 

Dr. Kush Dhody, Vice President of Clinical Operations for Amarex Clinical Research, is responsible for providing the strategic direction for the implementation and execution of clinical trials, and for overseeing the operational delivery of the clinical study programs. Dr. Dhody works extensively in the areas of oncology, infectious diseases, and wound healing.

Dr. Dhody is a seasoned clinical research professional with academic, clinical, and pharmaceutical research experience spanning more than 15 years. His experience ranges from serving as an investigator, to managing Phase I - IV studies for drugs, devices and biologics, within a CRO environment for mid to large sized pharmaceutical and biotechnology companies. Dr. Dhody has held several leadership positions in clinical operations and in drug development while executing clinical development programs from IND through NDA. Serving as Clinical Program Director for several NCE development projects, he has a highly successful track record of managing diverse cross-functional teams from data management, biometrics, regulatory affairs, clinical compliance, pharmacovigilance, and as liaison for investigators and clinical site staff in order to achieve overall project delivery. Dr. Dhody has written/developed 20+ protocols and prepared several individual and integrated study reports and co-lead teams in preparation of ISEs and ISSs.

Dr. Dhody earned his Doctor of Medicine (MD equivalent) degree from the University of Pune in India, and his Master of Science in Clinical Research from Cranfield University in the UK. He has an ACRP certification as a Clinical Research Professional.

Peter Frantz, MS, MBA

Sr. Vice President, Business Operations 

Peter Frantz, Vice President of Business Operations for Amarex Clinical Research, is responsible for all business operations, including: business development, corporate accounting, financial planning, business planning and contracting.

Peter has over 10 years of experience in research and pharmaceutical product development, including: project management of domestic and international trials, day-to-day management of lead drug candidates, strategic planning for new medical products, and investor relations. Peter joined Amarex Clinical Research in 2007 and previously worked in a variety of senior level positions with small biopharmaceutical organizations to large government consulting firms. 

Peter earned his Master's degree in Biochemistry and Molecular Biology with a Specialization in Biotechnology, and in Business Administration from Georgetown University.

Hana Mekonnen, MA

Vice President, Biometrics 

Hana Mekonnen, Vice President of Biometrics for Amarex Clinical Research, is responsible for the development of Statistical Analysis Plans, creating programs in SAS to analyze data, providing statistical opinions of analyzed data, and working with sponsors to develop protocols, study reports and data analysis that is presented to the FDA. Hana has worked on multiple Integrated Summaries  of Safety (ISS) and Integrated Summaries of Efficacy (ISE) reports that have been submitted to FDA for drug approvals, and she has been present at a number of FDA meetings to defend the analyses presented. 

Prior to joining Amarex Clinical Research in 2008, Hana previously has worked as a statistician for a large pharmaceutical company, and has taught statistics at the university level. Hana earned her Master's degree in Statistics from Columbia University.

Herman Wong

Vice President, Information Technology

Herman Wong, Vice President of Information Technology for Amarex Clinical Research, has more than 18 years of experience in the clinical research industry. Upon joining Amarex in 2000, Herman was tasked with developing a data entry system for paper-based clinical trials. This system was effectively used by Amarex on more than 50 trials for over a decade. Then, as the biotech industry moved from paper-based instruments to electronic data capture, Herman has led Amarex in implementing an advanced web-based data collection system, which has been used in 25+ clinical trials. At the same time, Herman has also contributed to advancements in the technology and life sciences sectors. He is an experienced auditor who has inspected numerous electronic data capture (EDC) organizations, including the National Institutes of Health, and helped them improve their processes.

Herman earned his Bachelor's from University of Maryland.

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