CSS Associates

STRATEGIC PLANNING FOR DRUG, BIOLOGIC, AND DEVICE DEVELOPMENT

CCS Associates has a strong record of providing consulting services on strategies for drug development. Among the tools we develop and use are databases of critically evaluated data on the subject under study, with capabilities for searching and analysis on parameters of interest. Our experience includes:

Nonclinical and clinical drug development planning and timelines. We have authored more than 50 clinical development plans for cancer prevention and treatment agents (drug and biologics) alone. Our database contains more than 30,000 entries on potential cancer chemopreventive activity agents.
Technology assessment such as evaluating nonclinical efficacy and toxicity testing models and potential applications of medical devices.
Structure-activity and mechanism of action evaluation of drug activity and safety.
Regulatory strategies for drugs such as those derived from natural products, molecularly targeted cancer preventives and therapies, substances that move across indications (e.g., from antiinflammatory to cancer preventive), and functional imaging biomarkers for use as efficacy endpoints.
Assessment of biomarkers for use in all phases of drug development. For example, currently we are providing scientific support to the FDA, NCI, CMS Oncology Biomarkers Qualification Initiative (http://otir.cancer.gov/programs/partnerships_fda.asp) and The Biomarkers Consortium, a public-private partnership among the pharmaceutical industry, NCI, FDA, CMS and advocates convened by the Foundation for NIH (http://www.biomarkersconsortium.org/).