Meet An ABC Expert... Biotech Development JOHN C. ANDERS, Ph.D. Director, Biotech Development Services Dr. Anders brings more than 30 years of drug development experience using the latest technologies required for analysis of biopharmaceutical products. Having worked in the CRO CGMP environment for more than 18 years, he has assisted scores of biopharmaceutical clients with their large molecule products. In addition to his experience with classical biopharmaceuticals, Dr. Anders was instrumental in developing a new class of molecular genomic expression medical diagnostics to meet regulatory requirements; these diagnostics will be critical to the industry's drive to realize the potential of personalized medicine. Key Qualifications: 30 years' experience and academic training in molecular biology and protein chemistry techniques 20 years' experience in development and analytical testing of large molecule drugs—including proteins, peptides, antibodies and oligonucleotides—under GLP and CGMP requirements 10 years' experience in development of small molecule drugs for both preclinical ADME applications as well as CMC applications Experience assisting with numerous IND to NDA regulatory submissions for new drug entities Extensive experience in all common electrophoretic and chromatographic methods for macromolecular analysis Expertise in numerous MS techniques in the analysis of macromolecules ranging from LC/ES/MS/MS to LC/ES/TOF/MS techniques 14 years of prior experience building and leading a state-of-the-art CGMP biopharmaceutical analytical CRO lab Successfully submitted an Investigational Device (IDE) submission to include a clinical validation protocol to the FDA for a lung cancer risk assessment test for current and former smokers over the age of 50. The clinical validation is scheduled to begin Jan 2010. Meet our other Biotech Development Experts: John C. Anders, Ph.D. Robert Marlow Brian G. Talbot Rowel B. Tobias, Ph.D. Roger D. Summers