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.

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.

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.

Frank Rotella

  • Director of Operations, New Jersey
  • Bioanalytical Services

Mr. Frank M. Rotella has 20 years of experience in the “large molecule” immunology-based pharmaceutical industry, the majority of his career being in the ligand binding arena. As Director of Operations of the New Jersey bioanalytical lab facility, Mr. Rotella is responsible for providing support for the full development, validation, and use of immunoassays (ELISA, ECL, Gyros, Quanterix, and cell-based) for client drug programs. In addition Mr. Rotella oversees laboratory operations for services that include translational sciences, vaccine development, and GMP drug qualifications. Prior to Smithers, he held the position of Manager of Bioanalysis for Syneos Health. In this role, Mr. Rotella led a team of scientists in the development, validation, and bioanalysis of assays for pre-clinical and clinical studies. Additionally, he cultivated strong partnerships with clients and presented innovative analytical techniques at numerous international conferences. Prior to Syneos Health, Mr. Rotella worked at Bristol-Myers Squibb as a Sample Operations Lead, managing immune-oncology trials, and leading meetings with the clinical teams for drugs such as Opdivo (Nivolumab). Mr. Rotella also held the position of Scientist at Janssen R&D in the Biologics Clinical Pharmacology Department. In this capacity, he validated and performed immunoassays to support programs for key molecules including Stelara (Ustekinumab), Simponi (Golimumab), and Tremfya (Guselkumab). Mr. Rotella is a certified Project Manager as well as Lean Six Sigma Black Belt. He holds a B.S. degree in Biology and Chemistry from The College of New Jersey and is currently completing his Executive M.B.A. from Villanova University.

Angela Ambakhutwala

  • Group Team Lead/Project Manager
  • Bioanalytical Services

Dr. Angela Ambakhutwala is an Immunologist with over 20 years of experience in T cell Biology, functional assays and cellular biology and expertise in the development of ELISA-based methods for detection of immune responses for infectious disease and cancer (ELISA, ELISPOT, Luminex, Flow cytometry). She has significant experience in assay development, project management, and data analysis and has led both R&D and clinical sample analysis teams. In her role as group team lead/project manager, Dr. Ambakhutwala is responsible for the scientific and technical management of method validations and ensuring regulatory oversight of client’s studies. Prior to Smithers Avanza, she held the position of Senior Group Leader at PPD Laboratories in Richmond, VA. Dr. Ambakhutwala holds an undergraduate degree in Biology (B.A., 1993) from Carthage College in Kenosha, WI, and a Ph.D. in Molecular Microbiology and Immunology (1999) from the University of Missouri-Columbia. Dr. Ambakhutwala has authored and co-authored 16 publications and presented over 15 meeting presentation abstracts/posters.

Nick Doperalski

  • Group Lead/Project Manager
  • Bioanalytical Services

Mr. Doperalski has over 16 years of biological science research experience, including 7 years developing and validating analytical immunoassays in a GLP environment on various platforms (ELISA, ECL, RIA, Fluorescence, and Gyrolab™). He earned a B.S. degree in Biology (2001) from the University of Wisconsin-Stevens Point, and an M.S. focused in toxicology (2009) from the University of Florida. Mr. Doperalski performed neuroscience research at the University of Wisconsin-Madison and University of Florida where he employed numerous techniques including electrophysiology, plethysmography, immunochemistry, and histochemistry, as well as molecular biology techniques including quantitative-PCR and isolation/purification/quantification of RNA. During his research in the area of toxicology, Mr. Doperalski studied gene and protein expression, including the first cloning of three genes involved in steroid synthesis in an aquatic model species. He also utilized small molecule purification techniques, GC-MS, and histochemistry. Mr. Doperalski has co-authored 15 publications as well as numerous professional conference abstracts. Prior to joining Smithers Avanza, he was a Research Scientist at PPD Laboratories in Richmond, VA.

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.

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.

Robert L. Moore

  • Director, Business Development
  • Bioanalytical Services

Robert L. Moore, Ph.D. has over 13 years of biomedical research, small and large molecule bioanalytical project management and sales experience, resulting in peer-reviewed publications, academic and industry awards. Receiving his doctorate in Immunology/Microbiology from the Boston University dual-degree program in 2010, Robert now provides bioanalytical support for large-molecule pre- and clinical GLP/GMP drug development, manufacturing and commercialization. Prior to joining Smithers Avanza, Robert’s scientific experience includes his time as a research technician at the Dana-Farber Cancer Institute (Boston, MA) where he performed oligodendroglioma research, a post-doctoral fellowship at Boston University studying the role of Sirtuins in hormone refractory breast cancer, as Sales Director for Molecular MS Diagnostics (Cranston, RI) providing small-molecule analytical services and as a Business Development Account Executive at Bioagilytix Labs (Durham, NC) where he provided large-molecule bioanalytical services.

Susan Weymouth

  • Business Development Support Associate
  • Bioanalytical Services

Ms. Susan Weymouth is the Support Associate for Business Development. She has more than 15 years of experience in providing detail-oriented cost proposals for Immunogenicity, Pharmacokinetic and Biomarker assays on various platforms in support of clinical and non-clinical studies. She has considerable experience working with client-specific proposal templates and maintaining client relationships. Prior to Smithers Avanza, Ms. Weymouth held the position of Client Services Associate at Covance, a subsidiary of LabCorp, and was responsible for generating cost proposals for large and small molecule studies. She previously held the position of Senior Client Manager for ten years at Tandem Labs, Inc., a LabCorp Company, where she was responsible for assessing client requirements, generating cost proposals, hosting client visits and responding to RFI and RFP requests.