CCS Staff Expertise

Our scientists and regulatory professionals have broad experience in the pharmaceutical and life sciences disciplines. PhD- and masters-level scientists provide expertise in biology, chemistry, biochemistry, pharmacology, toxicology, anatomy, and pathology. As well, our staff includes health professionals such as registered nurses and nutritionists. Our regulatory and quality control professionals have experience with both large- and small-scale clinical trial monitoring and data safety. Our staff also includes IT/data management programmers, statisticians, information search specialists, desktop publishing experts, conference and meeting planners, and editors.

CCS Associates Executive Team

CAROLINE C. SIGMAN, PHD, PRESIDENT, CEO: Biochemist with training in medicinal and organic chemistry, pharmacology, and toxicology. Extensive experience in strategic planning for drug development and management of drug development efforts. More than 25 years experience in designing and developing individualized systems for efficient retrieval, organization, and analysis of scientific information. Specialized knowledge of chemical carcinogenesis, cancer chemoprevention, structure-activity relationships, literature search, critical evaluation of health effects data on chemicals, and research and development strategies for chemical and pharmaceutical products. Preparation and editing of scientific manuscripts for publication, data summaries for regulatory filings, and preclinical and clinical development plans.

DONYA BAGHERI, MA, DABT, SENIOR DIRECTOR, RESEARCH AND DEVELOPMENT: Board-certified toxicologist with extensive experience in design and development of specialized scientific and regulatory databases, with emphasis on critical assessment, organization, and presentation of preclinical and clinical data. Expertise in scientific report writing and detailed evaluation and analysis, including structure-activity relationships of toxicological, cancer chemoprevention, and skin sensitization data. Experienced in cancer chemoprevention drug development, including clinical trial management, monitoring, and regulatory compliance.

LINDA A. DOODY, PHD, DABT, SENIOR DIRECTOR, CLINICAL RESEARCH AND REGULATORY AFFAIRS: Board-certified toxicologist experienced in drug development, including critical evaluation of pharmacology, toxicity and efficacy data, regulatory strategy planning, management and preparation of IND and NDA submissions, and development of intermediate biomarkers of carcinogenesis as surrogate endpoints for cancer. Skilled in preparation of written reports and manuscripts, management and editing of specialized journal supplements. Broad background in management and performance of mammalian and microbial genotoxicity testing (GLP), chronic rodent toxicity and dietary studies, xenobiotic metabolism and biochemical toxicity assays, assay development, and primary cell culture.

KATHRYN Z. GUYTON, PHD, DABT, DIRECTOR, SCIENTIFIC AFFAIRS:
Board-certified toxicologist with expertise in scientific report writing, and in preparation of INDs, NDAs, and Annual Reports. Broad knowledge of toxicology and carcinogenesis, including molecular mechanisms of carcinogenesis and chemoprevention. Skilled in critical evaluation and analysis of pharmacology, toxicity, mechanisms of action, and efficacy data on cancer chemopreventive agents. Extensive study of antioxidants and free radicals, including signal transduction and gene regulation by oxidative stress, mechanisms of resistance to oxidant injury, and the role of free radicals in toxicology, carcinogenesis and aging.

DAN MILGRAM, DIRECTOR, IT/DATA MANAGEMENT:
Oracle Clinical applications analyst with broad background in clinical information systems, product implementation, and validation. Knowledgeable in clinical data collection and analysis methods. Proficient in clinical trial design and implementation. Skilled in use of Oracle Clinical 3.0 and 3.1.1, Presidio 3.3, Clintrial 3.3, Clintrace 2.5, Clintrace 2.6.1, Windows NT, Win9x, Unix, Mac OS, Oracle 7.x, Sybase, SQL, PL/SQL.

MEENA NAVIDI, PHD, DIRECTOR, PRECLINICAL RESEARCH PROJECTS:
Biochemist/nutritionist skilled in preparation of INDs and Annual reports for IND-sponsored agents. Special expertise in designing animal experiments for basic and preclinical research. Broad background in reviewing protocols, concepts, and informed consents. Responsible for cancer chemoprevention drug discovery and development program. Skilled in creation of testing prioritization methodologies based on health effects and other properties of drugs and chemicals and product development status tracking. Knowledgeable in preparation of summaries of clinical and preclinical testing. Experienced in presentation of results in oral and written reports and specialized database formats.

Kopelovich, L., Fay, J.R., Glazer, R.I. and Crowell, J.A. Peroxisome proliferator-activator modulators as potential chemopreventive agents. Mol. Therapeut. 1: 357-363, 2002.

O'Shaughnessy, J.A., Kelloff, G.J., Gordon, G.B., Dannenberg, A.J., Hong, W.K., Fabian, C.J., Sigman, C.C., Bertagnolli, M.M., Stratton, S.P., Lam, S., Nelson, W.G., Meyskens, F.L., Alberts, D.S., Follen, M., Rustgi, A.K., Papadimitrakopoulou, V., Scardino, P.T., Gazdar, A.F., Wattenberg, L.W., Sporn, M.B., Sakr, W.A., Lippman, S.M. and Von Hoff, D.D. Treatment and prevention of intraepithelial neoplasia: An important target for accelerated new agent development: Recommendations of the American Association for Cancer Research Task Force on the Treatment and Prevention of Intraepithelial Neoplasia. Clin. Cancer Res. 8: 314-345, 2002.

Sigman, C.C., Holmes, C.A., Liu, Y.-J., Doeltz, M.K., Navidi, M., Thompson, S., Eisenhauer, K., Kelly, E., Le, D., Smith, L., Sevin, J., King, M., Tran, D., Singer, D.S., Fung, V.A. and Zaika, E.L. Survey of Compounds Which Have Been Tested for Carcinogenic Activity: 1999-2000 Volume. U.S. Department of Health and Human Services, National Institutes of Health, National Cancer Institute, NIH Publications No. 98-149. 2 vols. Washington, DC: U.S. Government Printing Office (In Press).

Kelloff, G.J., Higley, H.R., Brawer, M.S., Lucia, M.S., Sigman, C.C., and Crawford, E.D. Chemoprevention strategies in prostate: An overview. Rev. Urol. 4: 69-77, 2002.

Guyton, K.Z., Kensler, T.W. and Posner, G.H. Cancer chemoprevention using natural vitamin D and synthetic analogs. Annu. Rev. Pharmacol. Toxicol. 42: 421-442, 2001.

Kelloff, G.J., Lieberman, R., Steele, V.E., Boone, C.W., Lubet, R.A., Kopelovich, L., Malone, W.A., Crowell, J.A., Higley, H.R. and Sigman, C.C. Agents, biomarkers, and cohorts for chemopreventive agent development in prostate cancer. Urology 57 (Suppl. 1): 46-51, 2001.

Kelloff, G.J., Sigman, C.C., Hawk, E.T., Johnson, K.M., Crowell, J.A. and Guyton, K.Z. Surrogate end-point biomarkers in chemopreventive drug development. IARC Sci Publ. 154: 13-26, 2001.

Crowell, J.A., and Holmes, C.J. Agent Identification and Preclinical Testing. In Cancer Chemoprevention. Edited by Raymond, C. Bergan. Boston, Kluwer Academic Publishing. 2001.

Hansen, L.A., Sigman, C.C., Andreola, F., Ross, S.A., Kelloff, G.J. and De Luca, L.M. Retinoids in chemoprevention and differentiation therapy. Carcinogenesis 21: 1271-1279, 2000.

Kelloff, G.J., Sigman, C.C., Johnson, K.M., Boone, C.W., Greenwald, P., Crowell, J.A., Hawk, E.T. and Doody, L.A. Perspectives on surrogate endpoints in the development of drugs that reduce the risk of cancer. Cancer Epidemiol. Biomarkers Prev. 9: 127-134, 2000.

Steele, V.E., Kelloff, G.J., Balentine, D., Boone, C.W., Mehta, R., Bagheri, D., Sigman, C.C., Zhu, S., and Sharma, S. Comparative chemopreventive mechanisms of green tea, black tea, and selected polyphenol extracts measured by in vitro bioassays. Carcinogenesis 21: 63-68, 2000.

Steele, V.E., Holmes, C.A., Hawk, E.T., Kopelovich, L., Lubet, R.A., Crowell, J.A., Sigman, C.C. and Kelloff, G.J. Lipoxygenase inhibitors as potential cancer chemopreventives. Cancer Epidemiol. Biomarkers. Prev. 8: 467–483, 1999.

Benezra, C., Sigman, C.C., Bagheri, D., Fraginals, R., and Maibach, H.I. Molecular Aspects of Allergic Contact Dermatitis. In: R.J.G. Rycroft and J.G. Richard (eds.) Textbook of Contact Dermatitis. New York: Springer-Verlag Publishers, 1992, Chapt. 4, pp. 105–119.

Sigman, C.C., Thompson, K.L. and Helmes, C.T. QSAR, PROPHET, and environmental toxicology. II. Structure-activity classification of chemicals as carcinogens. In: Golberg, L. (ed.) Structure-Activity Correlation as a Predictive Tool in Toxicology. Washington, D.C.: Hemisphere Publishing Corporation, 1983, pp. 198–205.