| Business Description |
| The company is a contract research organization that provides a broad range of clinical research and drug development services to the pharmaceutical and biotechnology industries. The company augments the research and development
activities of pharmaceutical and biotechnology companies by offering high quality, value added clinical research services and proprietary information technology designed to reduce drug development time and expense. The Company's services include Phase II to Phase IV clinical trial design and management, clinical data management, biostatistical analysis, medical writing and regulatory consultation and representation. The company believes that it is one of a
small number of CROs capable of providing a broad range of services within multiple therapeutic areas, including cardiovascular, central nervous system, gastrointestinal, immunology, oncology, respiratory, skeletal disease and
inflammation. Since its inception, the company has served more than 40 clients, including 12 of the world's 20 largest pharmaceutical companies. In 1996, Kendle participated in 62 studies at approximately 4,100 sites involving approximately 20,000 patients. |
| Competition |
| The Company primarily competes against in-house research departments of pharmaceutical and biotechnology companies, universities and teaching hospitals and other full-service CROs, a number of which possess substantially greater capital, technical and other resources than the Company. CROs generally compete on the basis of previous experience, medical and scientific expertise in
specific therapeutic areas, the quality of contract research, the ability to organize and manage large-scale trials on a global basis, medical database management capabilities, the ability to provide statistical and regulatory services, the ability to recruit investigators, the ability to integrate information technology with systems to improve the efficiency of contract research, an international presence with strategically located facilities, financial viability and price. The Company's failure to compete effectively in
any one or more of these areas could have a material adverse effect on the Company. The CRO industry is highly fragmented, with several hundred CROs ranging from small, limited-service providers to full-service, global drug development corporations. However, the CRO industry is consolidating. This consolidation trend has been caused, in part, by the decision of pharmaceutical and biotechnology company clients to contract with fewer CROs, streamlining the outsourcing process by entering into preferred provider relationships with a few CROs or awarding a smaller number of large contracts to qualified CROs. This trend is likely to increase competition among the larger CROs for both clients
and acquisition candidates and may lead to price and other forms of competition that could have a material adverse effect on the Company. |
| Officer Name | Title | Age |
| Candace Kendle Bryan, Pharm.D. | Chairman of the Board and Chief Executive Officer | 50 |
| Mandyam K. Srirama, Ph.D. | Director, Biostatistics | 63 |
| Jere M. Hardy | Director, Clinical Data Management | 52 |
| William K. Sietsema, Ph.D. | Director, Clinical Research | 41 |
| Peter F. Djuric, Pharm.D. | Director, Clinical Research | 48 |
| Michael F. Bayer | Director, Clinical Services | 49 |
| Stephen G. Scheurer | Director, Human Resources | 48 |
| Gary M. Wedig | Director, Information Technology | 47 |
| Lois B. Rosenberger, Ph.D. | Director, Regulatory Affairs | 46 |
| Ann Hagen, M.D. | Director, Safety Surveillance | 39 |
| Philip E. Beekman | Member, Board of Directors | 65 |
| Charles A. Sanders, M.D. | Member, Board of Directors | 65 |
| Christopher C. Bergen | President, Chief Operating Officer, Secretary and Member, Board of Directors | 47 |
| Timothy M. Mooney | Vice President -- Finance, Chief Financial Officer, Treasurer and Member, Board of Directors | 49 |