K. Gregory Moore Ph.D. Phone: (434)202-3019 Email: kgmoore1@gmail.com Cell: (434)996-4357 Mail: P.O. Box 203 Batesville VA 22924 Creative biotechnology entrepreneur with a strong multi-disciplinary approach and 22 years of professional research and management experience. Prominent areas of my skill set include business development, project management, strategic marketing, and lab management. Professional Work Experience President Vigilance Biotechnology LLC, Batesville VA 8/2012-Present Founded a new biotechnology company, Vigilance Biotechnology LLC (www.vigbio.com); primary responsibility has been to provide the vision and lead the growth and business development of the company. Created the business plan, developed the corporate, financial, and information technologies structures, built the added-value service product portfolio, and now implementing an effective marketing strategy. Developed a services portfolio providing biotechnology business services and medicinal healthcare consultant services to clients. Vigilance provides pharmacovigilance services, business plan assessments, evaluations of technologies and acquisitions, technical writing, and expert testimony services. The novel Personal Medicinal Consultant Service provides clients with custom healthcare information about the drugs, OTC products, and dietary supplements that they are using; helping to identify the source(s) of any side-effects reported by the client and any potentially harmful interactions in their therapeutic regimen. Technical Director Bio-Cat Inc., Troy VA 2/2011-6/2012 Primary responsibility was to oversee the science and technology programs at Bio-Cat and its two subsidiaries, Enzitech LLC and Crossroads Pharmaceuticals LLC. Bio-Cat provides custom enzyme blends, probiotics, and testing services to the cGMP dietary supplement, nutraceutical, baking, food, feed, and cleaning markets. Set up the R&D project decision process and supervised the R&D Applications Lab Group involved in custom blend product development, formulations, competitor product characterizations, and patent data support. Supervised the QC Lab Manager and the team of QC Biochemists and Microbiologists that performed enzyme activity assays, FTIR identity assays, heavy metal and allergen detection assays, and microbiology assays under ISO 9001:2008 and ISO 17025:2005 standards. Supervised the Quality Assurance and Regulatory Affairs department representing Bio-Cat at government/industry policy meetings, and communicating the company's position on FDA guidance to trade associations, FDA officials, Lobbyists, and Standards organizations. Developed and grew the enzyme activity & microbial testing businesses of Enzitech LLC. Successfully developed and prosecuted 2 new patents (US 8,268,305 and US 8,071,089) working directing with company patent lawyers and USPTO Examiners. Negotiated with CROs for services. Director, Market Development Director, Product Line Strategy American Type Culture Collection (ATCC), Manassas VA 5/2010-11/2010 5/2009-5/2010 As ATCC Director of Market Development, primary responsibility was to develop a new custom BioServices business for ATCC leveraging its core competencies. Served as direct point-of-contact for custom requests; 1 developing specialized project teams, costing projects and negotiating quotes with customers, and working closely with Lab Managers to complete projects under ISO 9001:2008, GLP, and ISO 17025:2005. Managed 35-40 active projects at a time. Grew the new BioServices business to >$500K closed custom orders in 6 months and developed a custom order pipeline (>$1M) for BioServices such as viral production and titration, bacterial characterization and identification, STR genetic testing, large scale production (microbes, cell lines, and recombinant proteins), and custom DNA & RNA purification services. Responsible for the product management and marketing of the Microbiology business at ATCC (17,000 products) in the areas of virology, bacteriology, mycology, protistology, and vaccine-related products and assay kits. Developed plan highlighting BSL-2 and BSL-3 capabilities. As ATCC Director of Product Line Strategy, primary responsibility was managing the Molecular Genomics (5.5 million products) and Cell Biology (4,000 products) businesses at the ATCC providing strategic vision for new product development, and developing global business and marketing plans for new products and kits. Director, Technology and Alliance 5/2006-10/2008 Fellow, Technology and Alliance Millipore Corporate Technology Office, Millipore Corporation, Billerica MA Primary responsibility was customer-driven business development of Millipore life sciences products and services in the drug discovery and research reagents markets. Built external alliances and negotiated for strategic new technology licenses that could be incorporated into Millipore’s drug discovery products and services in 3-5 years. Evaluated novel cell-based and in-vitro nanotechnology assays, small molecule label-free microarray assays, and pre-clinical toxicology assays for potential licensing. Developed a 5-year technology roadmap for the Millipore Drug Discovery business. Served on 2 due diligence teams looking at potential acquisitions of technology companies, evaluating patents and assets, and developing financial projections. Director, Scientific Sourcing and New Technologies Director, Business Development, Drug Discovery Serologicals Corporation, Atlanta GA 9/2004-5/2006 (acquired by Millipore in 5/2006) Primary responsibilities were business development working directing with Sales Managers to drive sales, and product management and marketing of Serologicals’ life sciences products and services. Managed enzymes, antibodies, assay kits, GPCRs, cDNA, and SiRNA product lines. Responsible for selecting, positioning, and marketing Serologicals’ drug discovery products and small molecule enzyme contract testing services (e.g., for kinases: KinaseProfiler). Team achieved average yearly revenue increases of 27% growing the business to $32M. Served on 5 due diligence teams evaluating technology companies for potential acquisition. Director of Business Development, Drug Discovery Upstate Group Inc., Charlottesville VA 8/2002-9/2004 (acquired by Serologicals in 9/2004) Primary responsibilities were business development involving external company collaborations and supervision of a customer-driven R&D laboratory (Customer Solutions Laboratory). Responsible for selecting, positioning, and marketing Upstate’s drug discovery products and small molecule kinase inhibitor contract testing services (KinaseProfiler). Team achieved average yearly revenue increases of 35% growing the business to $21M. 2 Regularly gave company presentations to industrial customers, investment bankers and at scientific conferences. Traveled (25%) nationally & internationally to grow customer accounts. Set up a new Customer Solutions Lab business that performed multiplex cytokine testing services (Luminex assay technology) and evaluated new technologies for licensing/acquisition. Supervised a Ph.D. Lab Manager and 2 technicians in the Customer Solutions Laboratory. Wrote NIH and SBIR grant applications leveraging Upstate’s global core competencies; testified in court and gave sworn depositions in a case involving potential patent infringement. Drug Discovery Product Manager Business Development Manager Upstate Biotechnology, Inc., Lake Placid, NY 5/99-8/2002 Responsible for selecting, positioning, and marketing new products for the drug discovery market (i.e., kinases, phosphatases, antibodies, GCPRs, assay kits and contract services). As team leader, achieved average yearly revenue increases of 115% and grew business to $11M. Gained extensive experience in technology licensing and gave presentations nationally and internationally about Upstate’s products and technologies to pharmaceutical customers and investment bankers. 2 business development plans written by me were approved and implemented: (1) “Business Plan for the Establishment of a High Throughput Screening Product Unit” (11/98). The Scottish business unit focused on producing recombinant enzymes and the testing of chemical libraries for inhibitory activities against the enzymes (KinaseProfiler). (2) “Business Plan for the Establishment of a Luminex Detection Technology Product Unit” (4/2000). My team developed products based on the Luminex fluorescent bead immunoassay technology. As Beadlyte® Team Leader, new business grew to $4M. R&D Laboratory Manager Cell Biology Group Leader Upstate Biotechnology, Inc., Lake Placid, NY 6/93-5/99 Set up and supervised a QC laboratory and the first R&D laboratory at Upstate that developed 521 new bioreagent products and assay kits in 6 years through either internal development or polishing of licensed material. Products developed and tested included kinases, phosphatases, proteases, cellular digestive enzymes, antibodies, kinase assay and ELISA kits. Set up and supervised a recombinant protein core facility (bacterial, mammalian cell exp). Directly supervised 11 people at a time (B.Sc., M.Sc., and Ph.D. levels) in R&D lab and Technical Service. Managed 30-40 projects at a time. Yale Research Affiliate in Pharmacology (consultant position) Associate Research Scientist in Pharmacology (Yale research faculty) Post-Doctoral Research Associate in Pharmacology Department of Pharmacology and Developmental Therapeutics Program Yale University School of Medicine, New Haven CT 6/93-8/97 10/91-6/93 6/89-10/91 Studied the biochemical and molecular mechanisms of neoplastic keratinocyte differentiation and apoptosis with Dr. Alan C. Sartorelli, Head of the Yale Comprehensive Cancer Center. A major focus of this research was the effect of the annexins and transglutaminase on differentiation and EGF receptor signaling. Developed cell-based immunoassays to evaluate chemical library candidates (retinoic acid, vitamin D analogs) as possible therapeutic agents for the treatment of squamous carcinoma. 3 Ph.D. in Toxicological Sciences 1990 (Immunotoxicology program) 8/84-6/89 Division of Toxicological Sciences, Department of Environmental Health Sciences The Johns Hopkins University Medical Institutions, School of Public Health, Baltimore MD Studied cellular/molecular mechanisms associated with skin hypersensitivity (immediate, late phase, and delayed-type immune responses) and chronic inflammation with Dr. Arthur M. Dannenberg, Jr. Developed in vitro assays to study skin toxicity based on organ culture. Evaluated agents for toxicity, hypersensitivity, and inflammation using in vivo animal models. Studied skin carcinogenesis in mice in vivo with Drs. Tom Kensler and Michael Trush. Immunology Research Technician III The Johns Hopkins Hospital Pediatric Oncology Center The Johns Hopkins University School of Medicine, Baltimore MD 6/80-6/84 B.S. in Microbiology 1978 University of Maryland, College Park MD 8/74-8/78 2012 Patent “Methods and compositions to reduce serum levels of triacylglycerides in human beings using a fungal lipase”. Christopher Schuler, Edward Schuler, Christopher Penet, Gregory Moore, Kelly Gregory. US 8,268,305. Some Key Publications of Mine Moore, K.G., Speckmann, W, and Herzig, R. The Use of siRNA to Validate Immunofluorescence Studies. Methods in Molecular Biology 356: 245-251, 2006. Huang, X., Li, Y., Tanaka, K., Moore K.G., and Hayashi, J. Cloning and Characterization of Lnk, a Signal Transduction Protein that Links T-Cell Receptor Activation Signal to Phospholipase C, Grb2 and Phosphatidylinositol 3-Kinase. Proc. Natl. Acad. Sci. USA 92: 11618-11622, 1995. Moore, K.G., and Dannenberg, A.M. Jr. Immediate and Delayed (Late Phase) Dermal Contact Sensitivity Reactions in Guinea Pigs: Passive Transfer by IgG1 Antibodies, Initiation by Mast Cells Degranulation, and Suppression by Soybean Proteinase Inhibitor. Int. Arch. Allergy Immunol. 101:72-81, 1993. Moore, K.G., and Sartorelli, A.C. Annexin I and Involucrin are Cross-Linked by Particulate Transglutaminase into the Cornified Cell Envelope of Squamous Cell Carcinoma Y1. Exp. Cell Res. 200:186-195, 1992. Moore, K.G., and Dannenberg, A.M. Jr. Antigen-Specific IgG1-Mediated Epidermal Cell Injury: A Component of Contact Hypersensitivity Reactions in Guinea Pigs, Measurable In Vitro in Full-Thickness Skin Explants. J. Invest. Dermatol. 98:929-935, 1992. Kensler, T.W., Egner, P.A., Moore, K.G, Taffe, B.G., Twerdok, L.E., and Trush, M.A. Role of Inflammatory Cells in the Metabolic Activation of Polycyclic Aromatic Hydrocarbons in Mouse Skin. Toxicol. Appl. Pharmacol. 90(2):337-346, 1987 4