Caroline C. Sigman, PhD, President, CEO: Dr. Sigman is a biochemist with extensive experience in medicinal and organic chemistry, pharmacology, and toxicology, as well as strategic planning for drug development and management of drug development efforts. She has been in the forefront of designing and developing individualized systems for efficient retrieval, organization, and analysis of scientific information for more than 25 years. Her specialized knowledge includes mechanisms of carcinogenesis, cancer chemoprevention and treatment, structure-activity relationships, literature search, critical evaluation of health effects data on chemicals, and research and development strategies for pharmaceutical, biologic and diagnostic products. Recently, she has been instrumental in the design and implementation of clinical studies to validate and qualify cancer biomarkers under a public-private partnership including NCI, FDA, CMS, advocates, and industry. She is well-known for her many publications in the field of cancer drug development.
Executive Team
 |
||
![[space]](images/space.gif){kind=small} |
||
Donya Bagheri, MA, DABT®, Executive Director, Research and Development: Ms. Bagheri is a board-certified toxicologist with extensive experience in managing investigational clinical programs, including overseeing monitoring and regulatory compliance. She has extensive experience in design and development of specialized relational databases, with emphasis on critical assessment, organization, and presentation of preclinical and clinical data. She is skilled in scientific report writing and detailed evaluation and analysis, including structure-activity relationships of toxicological, oncology, and skin sensitization data. |
 |
|
|
||
 |
Linda A. Doody, PhD, DABT®, Executive Director, Clinical Research and Regulatory Affairs: Dr. Doody is a board-certified toxicologist with expertise in pharmaceutical product development, including critical evaluation of pharmacology, toxicology, and efficacy data; regulatory strategy planning; management and preparation of regulatory submissions [IND and NDA (including eCTD format), CTA, IDE, DMF]; and clinical safety assessment. Her broad background in management and performance of mammalian and microbial genotoxicity testing, chronic rodent toxicity and dietary studies, xenobiotic metabolism and biochemical toxicity assays, assay development, and primary cell culture are a particular asset. She has special expertise in development of botanical products as drugs, as well as intermediate biomarkers of carcinogenesis as surrogate endpoints in drug development. She is currently involved in development of an AE/SAE reporting system (caAERS) for NCI’s Cancer Biomedical Informatics Grid (caBIG®), and providing regulatory expertise to accelerate co-development of biomarkers and breast cancer treatments in a study sponsored by The Biomarkers Consortium. Dr. Doody is knowledgeable in preparing written reports and manuscripts as well as managing and editing specialized journal supplements.
|
|
|
||
Howard R. Higley, PhD, DABT®, Director, Scientific Affairs: Dr. Higley is an anatomist/toxicologist with extensive experience in drug development in biologics, pharmaceuticals, and medical devices. He has special expertise in histopathology, molecular biology, large and small animal surgery, tissue culture, and statistical analysis. Dr. Higley also has a broad background in project management and the requirements for successful medical product registration. He has performed scientific and regulatory reviews, prepared IND filings, and served as investigator liaison in support of NCI, DCP studies examining chemoprevention agents for breast, ovary, skin, lung, prostate, cervical, head and neck, and hematopoietic cancers. In collaboration with NCI, Cancer Imaging Program, and The FNIH Biomarkers Consortium, he has worked on projects examining surrogate endpoint strategies to accelerate regulatory approval of new cancer drugs. He is Project Manager on an NICHD contract that provides systematic literature summaries and assessments of drug information for the Best Pharmaceuticals for Children Act program. |
 |
|
|
||
 |
Meena Navidi, PhD, Director, Preclinical Research Projects: Dr. Navidi, a biochemist/nutritionist with special expertise in designing animal experiments for basic and nonclinical research, is responsible for our cancer chemoprevention drug discovery and development program. Her extensive skills include creating testing prioritization methodologies based on health effects and other properties of drugs and chemicals, as well as product development status tracking. She is knowledgeable in preparation of clinical and preclinical testing summaries, and has lengthy experience in presenting results in oral and written reports and specialized database formats.
|
|
|
||
Dan Milgram, Director, IT and Data Management: As Director of IT/Data Management, Mr. Milgram has over 17 years in the biopharmaceutical industry as both a study coordinator and, more extensively, as an expert on clinical information systems. He has a broad background in designing, developing, validating, implementing, and maintaining sponsor-located and remote data capture systems in single-site as well as large, multicenter trials. He is knowledgeable in clinical and safety data collection as well as data analysis methods. Mr. Milgram is skilled in the use of Oracle RDBMS and Oracle’s vertical applications as well as a variety of other proprietary and open source technologies. Examples of such technologies are: J2EE, MySQL, SQLServer, UNIX, Windows, MAC,HL-7 RIM, UMLS, SNOMED, MedDRA, WHODRUG. |
 |
|
|
||
 |
Susan A. Thompson, Director, Administration and Human Resources, is an experienced manager skilled in coordinating administrative staff. Ms. Thompson is knowledgeable in technical and scientific writing and editing, use of databases, chemical structure software, and graphic presentation software. She has extensive experience organizing and producing scientific conferences and serves as an effective liaison for quality service relations between company projects and clients, vendors, consultants, and subcontractors. Her in-depth knowledge of human resources and employment practices accompanies a broad background in grievance resolution.
|
|