SciReg’s Professionals

SciReg’s consultants provide the highest level of technical expertise combined with professional integrity. Relying upon extensive experience gained while working within product testing laboratories, government, and academia, and for pharmaceutical, pesticide, animal health, and chemical companies, SciReg provides its clients with practical, cost-effective, proactive, and goal-oriented consulting services.

 

Mr. James S. Damico

Mr. Damico is president and founder of SciReg, Inc. He has extensive experience and expertise in regulatory affairs, quality assurance, and scientific investigations pertaining to the regulation of agricultural and non-agricultural pesticides, and human/veterinary health products.

Mr. Damico is involved in all phases of SciReg’s consulting services including expert witness testimony, product approval activities, and development and presentation of training programs in GLPs, veterinary GCPs, and regulatory compliance. He is also responsible for designing, monitoring, and quality assuring various clinical and non-clinical studies to support product approvals including analytical chemistry, residue chemistry, efficacy, environmental fate, ecotoxicity, worker exposure, target animal safety, mammalian toxicity, and mutagenicity studies. Further, Mr. Damico is intimately involved in development of alternative strategies to satisfy product approval requirements in the absence of complete data sets.

Before establishing SciReg, Mr. Damico was Manager of Regulatory Affairs at SRA International, Inc., a consulting firm where he implemented and oversaw the company’s product registration, approval, and testing processes. Mr. Damico began his career at Hazleton Laboratories, Inc. (now Covance Laboratories, Inc.), a leading contract toxicology, chemistry, and environmental testing firm. At Hazleton, he conducted acute, subchronic, chronic, teratogenicity, and reproduction toxicology studies and then served as a quality assurance supervisor managing the GLP audit activities of a team of auditors reviewing data generated to support FDA, EPA, and international product approvals.

Mr. Damico earned his bachelor’s of science degree in biology at Virginia Polytechnic Institute and State University. He is an active member of the Society of Quality Assurance (SQA), the National Capital Area Regional Society of Quality Assurance (NCARSQA), the Regulatory Affairs Professionals Society (RAPS), and is a Registered Quality Assurance Professional in Good Laboratory Practices. Mr. Damico has served on SQA's Regional Chapter Presidents Committee and as President, Vice President, Past President, Program Committee Chair, and Nominating Committee Chair for NCARSQA.

 

Dr. David H. Dawe

Dr. Dawe has excelled in the agricultural crop protection industry for over 30 years. He has extensive experience in product research and development, from discovery, evaluation, identification, and registration of new products to market development and technical sales support for currently-approved products. Dr. Dawe is involved in all aspects of SciReg's product development and registration activities and is able to offer expert advice to our clients on a wide range of issues including pesticide product research and development, patent approaches, sales and marketing technical support, market analysis, product labeling and distribution, new product registrations and strategies, and defense and maintenance of existing product registrations.

Prior to joining SciReg, Dr. Dawe managed his own consulting business focused on Federal and State registration of crop protection products, market development, and technical sales support for various pesticide products. In addition, he has served as the Director of Biological Research and Development at BASF Corporation, Manager of Herbicide, Plant Regulator, and Fungicide Research at FMC Corporation, and Group Leader for Fungicide Discovery at American Cyanamid Company. Dr. Dawe was Director of ABC Laboratories' California facility and served as Product Development/Technical Services Manager at United Agri Products (UAP West), a leading pesticide distribution company.

Dr. Dawe earned his Ph.D. in Plant Pathology and masters in Nematology from Iowa State University and his bachelor's degree in Biology from Mankato State College. He is a member of the California Association of Pest Control Advisors (CAPCA), was a member of the Public Relations Committee of that organization, and is a past associate member of the National Association of Independent Crop Consultants.

 

Mr. Frederick T. Smith

Mr. Smith has numerous years of experience in pesticide and chemical testing, quality assurance, and regulatory affairs. Mr. Smith provides a full range of regulatory services to clients requiring product approval/registration support.

Prior to joining SciReg, Mr. Smith was a senior consultant for ChemReg International, and a regulatory scientist for SRA International. Throughout his consulting career, Mr. Smith has worked with small start-up companies, mid-sized companies, and large, multi-nationals to obtain and maintain pesticide registrations for agricultural, antimicrobial, biochemical, and microbial products. Mr. Smith works extensively with novel, cutting-edge antimicrobial technologies and unique, new active ingredients.

Mr. Smith has developed client-specific registration strategies to expedite regulatory processes, placed and monitored hundreds of studies in a variety of scientific disciplines to support product registrations, conducted scientific and regulatory audits of reports and data, and served as an expert witness in data compensation arbitrations. He has also worked at Hazleton Laboratories, Inc. (now Covance Laboratories, Inc.) as a quality assurance auditor where he reviewed acute, subchronic, chronic, teratogenicity, reproduction, and mutagenicity data generated to support FDA and EPA product approvals. At Tegeris Laboratories, he served as a study coordinator conducting acute, subchronic, and chronic rodent and canine toxicology studies.

Mr. Smith earned his bachelor’s of science degree in biology at the University of Maryland. He is an active member of the Society of Quality Assurance, the National Capital Area Regional Society of Quality Assurance, and is a Registered Quality Assurance Professional in Good Laboratory Practices.

 

Ms. Felicia L. Sellers

Ms. Sellers provides a full range of consulting services to our EPA-, FDA-, and internationally-regulated clients. She has experience in regulatory compliance, quality assurance, and the conduct of studies required to support product approvals. She has vast exposure to, and knowledge in, most facets of antimicrobial efficacy testing. In addition, Ms. Sellers has experience with the application of the Good Laboratory Practice (GLP) regulations and Good Clinical Practices (GCP) to regulatory studies. She also coordinates most of SciReg’s quality assurance activities, including the review of studies for compliance with U.S. and international regulations and guidelines.

Prior to joining SciReg, Ms. Sellers served as a technologist, study coordinator, group leader, and study director with a leading contract efficacy testing laboratory. Her responsibilities as study director and group leader involved the management of research and development projects, as well as overall responsibility for the technical conduct of efficacy studies, including the interpretation, analysis, documentation, and reporting of study results. Ms. Sellers was also involved in the supervision and training of technical staff, generation and implementation of study protocols and Standard Operating Procedures (SOPs), and compliance activities associated with FDA and EPA regulations.

Ms. Sellers earned her bachelor's of science degree in biology from James Madison University and is currently working on her master's degree in biomedical science, with a concentration in regulatory compliance, at Hood College. She is an affiliate member of the Society of Quality Assurance and an active member of the National Capital Area Regional Society of Quality Assurance.