Bioanalytical Services Team

Ira S. DuBey

  • Executive Vice President
  • Chairman of the Advisory Board
  • Bioanalytical Services

Dr. Ira S. DuBey has over 25 years of senior executive experience managing and building science-based businesses. He is Executive Vice President, Bioanalytical Services and Chairman of the Advisory Board for Smithers Avanza. In this capacity, he is responsible for the management of the Bioanalytical Services business and continued growth strategy of Smithers Avanza, and in ensuring that there is alignment between scientific expertise, operational excellence and business expansion into appropriate sectors. Prior to Smithers Avanza, Dr. DuBey held the position of Vice President and General Manager of Biotechnology Services for Tandem Labs, Inc. a LabCorp Company. Dr. DuBey conceived and built the business at Tandem Labs that supported the development of large molecule drugs (biologics) and therapeutic vaccines. Prior to Tandem Labs, he held the position of Director of Immunochemistry Services for Covance Laboratories, Inc. In this capacity he was responsible for providing laboratory services that supported NIH work as well as the development of large molecule drugs, such as protein drugs and MAB drugs. The facility was both a GLP laboratory and CLIA certified and supported both pre-clinical and clinical development. Dr. DuBey holds an M.S. degree in Toxicology from the University of Maryland Graduate School, an M.B.A. from the Johns Hopkins University and a Ph.D. from the Graduate Center of CUNY.

Nadia Kulagina

  • Director of Science
  • Bioanalytical Services

Dr. Kulagina has 15 years of experience in assay development for large molecules, toxins and pathogens on various platforms (ELISA, ECL, RIA, Cell-based, Fluorescence, Luminex and microelectrode arrays). In her role as Director of Science, Dr. Kulagina is responsible for scientific oversight, project management and maintains close and regular liaison with clients. Dr. Kulagina also manages a team of scientists and project managers that support large molecule assay development, validation and sample analysis for biotherapeutics research, focusing on monoclonal antibody therapeutics. Prior to Smithers Avanza, she served as Senior Lead Principal Investigator at Covance Labs. Dr. Kulagina holds a Master of Science from Moscow State University, Russia, and a PhD in Chemistry from University of Pittsburgh, Pittsburgh, PA. Dr. Kulagina has authored and co-authored multiple presentation abstracts, and 22 publications, including one patent.

Brian Hoffpauir

  • Director of Operations, Maryland
  • Bioanalytical Services

Dr. Hoffpauir is a certified Project Manager with nearly 10 years of experience developing and validating analytical immunoassays on multiple platforms (ELISA, ECL, Gyrolab™) and has served as principal investigator for bioanalytical studies supporting GLP and non-GLP studies of large-molecule biotherapeutics. In his role as Director of Operations at Smithers, he is responsible for the daily operation of the laboratory, evaluating and implementing new technologies, and providing technical guidance and resources to ensure operational teams can meet client demands. Dr. Hoffpauir received his B.S. degree and PhD from Louisiana State University. He is a member of the American Association of Pharmaceutical Scientists and the Project Management Institute, and has authored numerous publications.

Adriana Lopez

  • Associate Director
  • Bioanalytical Services

Ms. Lopez has 11 years of experience in bioanalytical analysis including assay development, troubleshooting and validation, GLP regulations, timeline management for clinical studies and technology transfer to and from CROs. Ms. Lopez's background includes five years of supervisory and project management experience, providing technical and regulatory oversight of client’s studies. Previously, she worked at Tandem Labs, A LabCorp Company, where her primary responsibility was to oversee the development and validation of clinical and biomarker assays, and the analysis of clinical and nonclinical samples for all therapeutic programs in a GLP laboratory. In addition, she was responsible for training personnel (QC/QA, PMs and analyst) on how to use the Watson LIMS system. Prior to joining Tandem Labs, Ms. Lopez was employed at Amylin Pharmaceuticals, where she designed, optimized, validated and performed custom and commercially available ELISAs on various platforms (Luminex, M5, and MSD). In addition, she was responsible for interfacing with contract laboratory facilities to ensure smooth lab-to-lab transfer of laboratory methods. In this role she was responsible for the training of CRO personnel. Once the method was transferred successfully, she had oversight of the scientific progress towards program goals. Ms. Lopez obtained a Bachelor of Science degree from California State University of Long Beach, CA.

Maria Ourmanova

  • Manager of Bioassay
  • Bioanalytical Services

Ms. Ourmanova is responsible for the development and validation of cell based assays including neutralizing antibody assays (NAB), toxin neutralization assays (TNA) as well as other immune based methodologies. She has over 10 years experience working in GLP immunoassay laboratories. Ms. Ourmanova has extensive experience with different types of Neutralization assays such as Competitive Ligand Binding and Functional assays following regulatory guidelines. She has more than 30 years hands-on experience with cell-based Proof of Concept, Potency and Nab assays (cell proliferation, cytokine release, apoptosis, inhibition of Interferon virus protection, chemotaxis). She has also developed and validated various Immunogenicity, Pharmacokinetic and Biomarker assays on both ELISA and MSD platforms. Prior to coming to Smithers Avanza she worked at Human Genome Sciences were she was involved not only in assay development and validation for numerous drug candidates (one of which went to market), but also provided sample analysis in support of Pre-Clinical and Clinical Trials. Her initial experience at Cell Culture Collection of Research Institute of Molecular Biology (Russia) also included NHL Cell banks validation for the vaccine preparation. She holds a MSc from Novosibirsk State University, Novosibirsk, Russia.

Stephen Ullrich

  • Senior Project Manager 
  • Bioanalytical Services

Dr. Ullrich has over 20 years of biotechnology R&D and managerial experience with a successful record for developing and validating various GLP bioanalytical assays on various platforms (ELISA, ECL, Cell-based, Fluorescence and Gyrolab™). He has extensive experience in protein purification and characterization and including the use of the biosensor instruments (BIAcore and Forte Bio) for protein characterization, and purifying and preparing delivering protein reagents and conjugates used in the R&D, QC and Clinical Assay departments. While working at Human Genome Sciences, Dr. Ullrich was involved in development of 2 FDA approved drugs. As Senior Project Manager at Smithers Avanza, Dr. Ullrich is responsible for the scientific and technical administration of method development, validation and sample analysis studies. Prior to joining Smithers Avanza, he held the position of Principal Investigator at Covance Labs, Chantilly, VA. Dr. Ullrich obtained his PhD in Biochemistry from Albany Medical College and held Staff Fellow and Expert positions at the NIH. He has authored and co-authored over 50 publications, including one patent, as well as numerous meeting abstracts. He has been an invited speaker at several industry conferences.

Janine Denis Cook

  • CLIA Director
  • Bioanalytical Services

Dr. Cook is a clinical chemist who is board-certified as a Diplomate of the American Board of Clinical Chemistry. Dr. Cook received her doctorate in chemistry from the University of Iowa. She completed a postdoctoral fellowship in biochemistry at The Johns Hopkins University as well as one in clinical chemistry at the University of Maryland Baltimore. Dr. Cook has 14 years of experience in clinical laboratory medicine, including at a university clinical laboratory (University of Maryland Medical Center), a reference laboratory (Quest Diagnostics), and a hospital laboratory (Mercy Medical Center). She served as an Assistant Professor for seven years at the School of Medicine, University of Maryland, Baltimore, where she taught undergraduate and graduate courses in medical technology and biomedical research and conducted funded research on biomarkers for fetal alcohol spectrum disorders. For eight years, Dr. Cook worked within the Department of Health and Human Services to provide scientific, technical, and regulatory guidance on federal drug testing. In addition, She has served as the CLIA director for two Clinical Research Organizations and has consulted in both the private and public sectors.