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ALENKA TOMAZIC, Ph.D. Home: Celovška 106 1000 Ljubljana Slovenia Phone: 386-1-505-2385 Fax: 386-1-514-3285 E-mail: [email protected] _________________________________________________ QUALIFICATIONS SUMMARY Twenty eight years of varied theoretical and applied research experience in the fields of classical synthetic and combinatorial organic chemistry, radiosynthesis, medicinal and agricultural chemistry. Extensively published in peer reviewed journals. Author of patents. Outstanding record of success in creative analysis and strategic problem solving based on interdisciplinary background. Ten years experience of strategic management of the R&D portfolio. Multilingual. PROFESSIONAL EXPERIENCE ANTEXBIOLOGICS, Gaithersburg, MD, USA Director, Department of Organic Chemistry 2000-2002 I was responsible for leading the company Small Molecule Drug Discovery Program which was specifically targeted at the identification and early stage evaluation (preclinical and Phase I) of novel anti-infectives. Reporting to the VP(R&D), this senior level position was responsible for planning, managing organizing and directing all regulatory Chemistry, Manufacturing and Controls (CMC) portion of drug development. Key responsibilities included directing the anti-infective discovery research program, taking a creative approach in selecting new leads and guiding products through development process from research bench to Clinical Trial Phase I in collaboration with computational chemists, microbiologists, animal modelers, pharmacologists and physicians. Responsibilities also included identifying and implementing formulation technologies that enhance biopharmacuetic performance of NCEs. Supervised seven Synthetic/ Medicinal Chemists (six Ph.Ds, one MS), four analytical chemists (two Ph.Ds, two MSs), two MS spectrometrists and two NMR spectrometrists. Supervised chemoinformatic activities. Supervised a Combinatorial Chemistry Group. Supervised IP activities. Structured the company outsourcing R&D and manufacturing projects. (negotiating CDAs and developing successful contracts). Coordinated consultant activities. Head, Department of Organic Chemistry 1999 - 2000 Directed a research program focused on new antibiotics with broad spectrum activities and as organism specific antibacterial agents. Pathogens that have high incidence rate and have increasing antibiotic resistance to currently available antibiotics were of primary interest. Responsible for directing medicinal and analytical chemistry, chemistry development, lead development, and intellectual property projects. Responsibilities also included evaluations of outside technologies and management of corporate collaborations pertaining to chemistry projects. Group Leader, Chemistry 1997 - 1999 Lead generation and optimization through the design, synthesis, and screening of small molecules combinatorial libraries in highly collaborative, multidisciplinary team-based approach to discovery of anti-infective NCEs. Lead optimization employing structure-based design Methods for assessing and improving the quality of screening libraries The preparation of biased compound libraries tailored for specific therapeutic targets The marriage of empirical and computational methods for drug discovery of novel antibiotics. ISOGEN L.L.C., Naperville, IL, USA 1996-1997 Principal Scientists, R&D Responsible for 4 major programs of structure/activity-based design of small, bioactive compounds for a major player in the food additive industry. Experienced in small molecule synthesis (10 mg to 1 kg) of novel fine chemicals based upon isoprenoid technology (25-hydroxy vitamin D3, zeaxantin and –carotene derivatives). Developed a route to key intermediates in a major program, leading to a marketed product Surveyed process research, process development and scale-up operation Organized cGMP-compliant production THE BIONETICS CORPORATION, Jefferson, AR, USA 1993-1996 Lead Chemist/Project Manager, On-Site Synthesis Contract National Center for Toxicological Research, a division of Food and Drug Administration (FDA). The design, optimization, and execution of custom synthetic and fermentative routes for the production of unlabeled, stable isotope (2H, 13C) and radio-isotope (3H, 14C) labeled compounds in support of research protocols conducted under The National Toxicology Program. Set up and operation of four laboratories for synthetic production of specifically labeled compounds. Set up and operation of a laboratory for fermentative production of specifically labeled compounds. Performed a range of analytical tests for raw materials, intermediates and finished products. Day to day operation, troubleshooting and maintenance of three HPLC systems, three NMR systems (500, 400, 300 MHz), GC, GC/MS, FT-IR, and UV-Vis systems. Authorized User of radioisotopes Initiate, plan and direct all activities of assigned staff providing technical support of chemical synthesis necessary to delivery of assigned compounds on a schedule negotiated with the government. Identify and project all resources (manpower, materials, subcontracting) necessary to manage the technical and financial obligations of the contract within available financial limits. Proposal and technical report preparation; project budgeting MEDICAL UNIVERSITY OF SOUTH CAROLINA, Charleston, SC, USA 1989-1993 Assistant Professor, Department of Pharmaceutical Sciences Designed, synthesized and applied quinazoline chemistry to the development of new antineoplastic antifolates. Investigated the inhibition of enzymes involved in de novo formation of dihydrofolic acid, DHFR and other enzymes which utilize tetrahydrofolate cofactors. UNIVERSITY OF LJUBLJANA, Ljubljana, SLOVENIA 1987-1988 Docent, Department of Agriculture Provided technical and scientific support required to perform routine and special analyses in the field of environmental protection. MEDICAL UNIVERSITY OF SOUTH CAROLINA, Charleston, SC, USA 1985-1987 Postdoctoral Associate, Department of Pharmaceutical Sciences Structure/activity-based design and syntheses of selected analogues of folic acid and aminopterin targeted for colon adenocarcinoma, systemic mycotic infections, leprosy and opportunistic microbial infections. Initiated preparation of affinity resins for the purification of tetrahydrofolate dependant enzymes Development of fluorescent and photoaffinity analogues of novel tetrahydrofolates as potential probes for proteins involved in the uptake of folates into mammalian cells. THE WEIZMANN INSTITUTE OF SCIENCE, Rehovot, ISRAEL 1983-1984 Visiting Senior Scientist, Department of Organic Chemistry Designed and developed a total synthesis of the racemic form of sex pheromone of the citrus mealybug (+/-)-citrilolacetate and (+/-) junionone. CORNELL UNIVERSITY, Ithaca, NY, USA 1982-1983 Postdoctoral Associate, Department of Organic Chemistry Developed a synthetic route for the substituted indolocarbazole system found in the natural antibiotic, staurosporine, produced by Streptomyces staurosporeus. THE WEIZMANN INSTITUTE OF SCIENCE, Rehovot, ISRAEL 1980 –1982 Postdoctoral fellow, Department of Organic Chemistry Designed and synthesized various cyclopropane carboxylates used as intermediates for preparation of substituted dienoates and dienedioates. INSTITUTE JOŽEF ŠTEFAN, Ljubljana, SLOVENIA 1974-1976 Research Associate, Department of Organic/Analytical Chemistry Responsibilities included developing, validating and transferring methods for the assay and impurity measurements of drug substances and related materials. Broadened skills in MS, GC, MS/GC, HPLC, IR and UV. EDUCATION UNIVERSITY OF LJUBLJANA, Ljubljana, SLOVENIA Ph.D. in Organic Chemistry Thesis: ˝ Some Transformations of Azines with Hydroxylamine˝ Thesis Director: Prof. Miha Tišler 1978-1980 UNIVERSITY OF LJUBLJANA, Ljubljana, SLOVENIA M.S. in Organic Chemistry Thesis: ˝ Some Transformations of Azines with Hydroxylamine˝ Thesis Director: Prof. Miha Tišler 1976-1978 UNIVERSITY OF LJUBLJANA, Ljubljana, SLOVENIA B.S. in Chemistry Thesis: ˝ Degradation of the Metallic Chelates in Mass Spectrometer˝ Thesis Director: Prof. Jože Marcel 1969-1974 ANCILLARY EDUCATION Advances in Structure –Guided Drug Discovery (In Silico Techniques & SAR Approaches). La Jolla, CA, November 2002 Integrating ADME/Tox and High Throughput Synthesis Strategies and Analysis for Drug Discovery: Shortening the Time to Lead Discovery and its Advancement to the Clinic. Short Course, ACS National Meeting, Orlando FL, April 2002 Effective Supervision of Scientists and the Technical Staff. Short Course, ACS National Meeting, Orlando FL, April 2002 Leadership Principles for R&D Managers and Scientists. Short Course, ACS National Meeting, Orlando FL, April 2002 Organic Chemistry of Drug Design and Drug Action. Short Course, ACS National Meeting, Orlando FL, April 2002 Modern Organic Chemistry: Modern methods and Strategies. Short Course, ACS National Meeting, Orlando FL, April 2002 Experimental Design for Productivity and Quality in R& D. Short Course, ACS National Meeting, Orlando FL, April 2002 Strategic Management of the R&D Portfolio. Short Course, Drug Discovery Technology 2000, August 2000, Boston, MA Practical LC/MS and CE / MS. Short Course, Drug Discovery Technology 2000, August 2000, Boston, MA Combinatorial Chemistry: Solid and Solution Phase Synthesis. Drug Discovery Case Histories, Drug Discovery Technology 2000, August 2000, Boston, MA Drug Discovery Using Molecular Biology Techniques to Find Drug Targets. Drug Discovery Case Histories, Drug Discovery Technology 2000, August 2000, Boston, MA The Role of Toxicology in Drug Discovery. Drug Discovery Case Histories, Drug Discovery Technology 2000, August 2000, Boston, MA New Technologies for High Speed Dispensing, Synthesis, and Storage of Compounds for HTS. Technology Workshop, Drug Discovery Technology 2000, August 2000, Boston, MA Partnering in Drug Discovery. November 2000, La Jolla, CA Frontiers In Organic Chemistry. ACS Lecture/Lab Course, Dr. Barry M. Trost, Course Director, June 1999, Palo Alto, CA Chemical engineering and Process Fundamentals for Chemists. ACS Short Courses, November 1996, Summerset, NJ Supervisory Training Course. Wackenhut Training Institute, October 1994, Hampton, VA Management of Research and Development Organizations. University of Kansas, Division of Continuing Education, November 1992, Overland Park, KS Methods, Interpretation, and Strategies for Problem Solving NMR Workshop. Varian Associates, September 1985, Zurich, Switzerland TEACHING EXPERIENCE Six year teaching experience including: Essentials of Organic Chemistry, Organic Chemistry Review, Advanced Organic Chemistry, Special Topics in Organic Synthesis, Experimental Organic Chemistry. HONORS AND AWARDS Mina -James-Heinemann International Scholarship in 1980/1981 (Competitive Award, Bonn Germany) Schmidt Grant in 1983/1984, Co-investigator, (Israeli Academy of Sciences and Art) Award of Pharmaceutical Company Krka (Slovenia) for M.S. Degree Thesis. Undergraduate and graduate scholarship from the Research Council of Slovenia. PROFESSIONAL AFILLIATIONS American Chemical Society (ACS) Division of Organic Chemistry Division of Medicinal Chemistry Division of Analytical Chemistry Division of Chemical Education Computers in Chemistry Division Division of Chemical Information Industrial and Engineering Chemistry Division International Isotope Society