Bioanalytical Services Advisory Board

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.

Dan Sikkema

  • Advisory Board
  • Bioanalytical Services

Dr. Dan Sikkema is Vice President, Accelerator and Pharma services for Quanterix Corporation. Dr. Sikkema brings 25 years’ experience in the biopharmaceutical, vaccine and cell/gene therapy fields supporting oncology, neurosciences, respiratory, immunology and infectious disease. He has held positions of increasing responsibility at Bristol-Myers Squibb, Wyeth, Merck, Sanofi Pasteur, Frontage Laboratories and GlaxoSmithKline. In his career, he has contributed to the licensure of Prev(e)nar, Meningitec, Gardasil, RotaTeq, ProQuad, Zostavax, and Dengue vaccines, also Ofatumumab, Raxibacumab, Benlysta, Albiglutide, Mepolizumab, Denosumab, and other biopharmaceuticals, as well as Strimvelis (the world’s first ex vivo cell/gene therapy product). He has also worked with the World Health Organization, National Institute for Biological Standards and Controls (NIBSC), US Centers for Disease Control, FDA and EMA in roles as an invited expert and as an advisor. Dr. Sikkema holds a BS in Medical Technology from Northern Michigan University, and a PhD in Microbiology and Public Health from Michigan State University, College of Medicine. He was a Post-Doctoral Fellow in Infectious Diseases at SUNY at Buffalo, School of Medicine and a Research Assistant Professor in Infectious Disease at SUNY at Buffalo. Dr. Sikkema is a Registered Medical Technologist with the American Society for Clinical Pathologists. He has Chaired Division V (Clinical and Diagnostic Immunology) for American Society for Microbiology and was Coordinator for an Innovative Medicine Initiative project ABIRISK, the largest funded project to study Immunogenicity of Biotherapeutics. He has authored 30 peer-reviewed publications and has delivered more than 75 public presentations globally at scientific symposia.

Marian Kelley

  • Advisory Board
  • Bioanalytical Services

Ms. Marian Kelley received her B.A. in biology in 1970 from Gwynedd Mercy College and her M.A. in biology in 1974 from West Chester State University. Ms. Kelley worked at J&J PRD and Centocor, J&J’s Biotech facility for over 12 years before forming MKelley Consulting LLC. Marian Kelley led the protein bioanalytical group at PRD conducting GLP bioanalysis in house and outsourcing to CROs to develop protein drugs. A major accomplishment was her work on the erythropoietin (EPO) project. To address the EPO immunogenicity issues she developed and validated LBAs methods to screen, and confirm positives, and characterized their anti-EPO neutralizing activity using cell-based assays. She helped set up compliant CLIA labs in France, Germany and Australia and monitored the labs to ensure compliance and consistency. She transferred to Centocor as the Director of Compliance and helped the Clinical Pharmacology Department incorporate the latest thinking in GLPs into their preclinical and clinical bioanalysis programs to support PK and immunogenicity testing as well as “fit for purpose” assay validations to support biomarker studies. Ms. Kelley was founding secretary of the Ligand Binding Assay Bioanalytical Focus Group (LBABFG) in the Biotech section of AAPS. She remains an active member of the Focus Group and co-chaired the Workshop on Assay Reproducibility for Incurred Samples held in Crystal City in February, 2008. She was the corresponding author of the DeSilva Paper: Recommendations for the Bioanalytical Method Validation of Ligand-binding Assays to Support Pharmacokinetic Assessments of Macromolecules; Pharm Res, 2003, Vol 20, No 11, pp. 1885-1900. Her most recent publications are on the topic of Bioanalytical Approaches to Quantify ‘Free and Total” Biotherapeutic Monoclonal Antibodies and Quality Assessment of Biotherapeutic Monoclonal Antibodies.

Andrew Eisen

  • Advisory Board
  • Bioanalytical Services

Dr. Andrew Eisen received his A.B. in physics from Princeton in 1976 and his MD/PhD (biophysics) in 1982 from the University of Pennsylvania. Presently, Dr. Eisen is serving as a consultant to biotechs and pharmas on the utilization and implementation of translational medicine and biomarkers. He is a physician-scientist working in the field of Translational Medicine within biotech & pharma. His clinical training was completed at Children’s Hospital of Philadelphia (Pediatrics) and NIDDK (Clinical and Molecular Genetics). He began his academic career in 1989 at The Albert Einstein College of Medicine (NY) as an Asst. Professor of Pediatrics & Molecular Genetics. There, his laboratory was engaged in basic research on homologous recombination and applications to gene therapy. This work lead Dr. Eisen to become scientific co-founder of ArborVita Associates, a biotech engaged in the development and commercialization of the direct genome modification / gene targeting method he developed. Dr. Eisen then joined the genomics-based CuraGen Corp. (CT) in 1999 to start and lead the drug target discovery program in Metabolic Diseases in a partnership with Bayer. Subsequently he moved to Daiichi-Sakyo Pharma (NJ) in 2005 to bring pharmacogenomics and translational expertise to early drug development. In 2008 he was recruited to Eisai Pharma (NJ) to develop and lead Translational Medicine / Biomarker efforts across multiple therapeutic areas. In 2011 he started Translational Medicine Strategies consulting.

Yale H. Caplan

  • Advisory Board
  • Bioanalytical Services

Dr. Yale H. Caplan received his Bachelor’s degree in Pharmacy (1963) and Ph.D. degree in Medicinal Chemistry (1968) from the University of Maryland at Baltimore (School of Pharmacy). He is a Board Certified forensic toxicologist (American Board of Forensic Toxicology). He was Chief Toxicologist for the Office of the Chief Medical Examiner (State of Maryland) and Scientific Director of the State of Maryland’s Alcohol Testing Program (1974-1991). He was Director of Toxicology and Forensic Toxicology for Quest Diagnostics, (formally Maryland Medical Laboratory) in Baltimore (1977-1999). Dr. Caplan is currently Laboratory Director for the State of Maryland, Division of Parole and Probation, Adjunct Professor in the Department of Pharmaceutical Sciences of the University of Maryland School of Pharmacy, a scientific consultant to Aegis Sciences Corporation and a member of the State of Maryland Forensic Laboratory Advisory Committee. Dr. Caplan’s professional activities and awards include: President of the American Board of Forensic Toxicology (1988-2008) and recipient of the Board’s Distinguished Service Award (2008); President of the American Academy of Forensic Sciences (1987-1988), and recipient of the Academy’s Rolla N. Harger Award (1989) (forensic toxicology) and Distinguished Fellow Award (1996); President of the Society of Forensic Toxicologists (1981); Chairman (1991-1993) of the National Safety Council’s Committee on Alcohol and Other Drugs and recipient of the Council’s Robert F. Borkenstein Award (2000); Chairman of the Maryland Section of the American Chemical Society (1973) and recipient of the 1994 Maryland Chemist Award. He is Associate Editor of the Journal of Analytical Toxicology and serves as an advisor to attorneys and government agencies regarding alcohol and drug testing issues.

Thomas A. Kubic

  • Advisory Board
  • Bioanalytical Services

Dr. Thomas A. Kubic holds a Ph.D. with a concentration in Forensic Science from C.U.N.Y., a Masters Degree in Chemistry from Long Island University and a Law degree from St. John’s University. He has been admitted to the New York State Bar. He has been awarded the Paul L. Kirk award (1997) for contributions to criminalistics and forensic science by the Criminalistics Section of the American Academy of Forensic Sciences and the Arthur Neiderhoffer Scholarship for significant contributions to the field of Criminal Justice by the Graduate School City University of New York. He retired from a municipal crime laboratory where he spent over 20 years as a forensic microscopist, is a member of the FBI sponsored SWGMAT committee on forensic glass analysis, is a technical expert with NIST’s laboratory accreditation program (NVLAP), and has been the laboratory director of a N.Y. State accredited environmental laboratory. Dr. Kubic, is currently an Associate Professor of forensic chemical instrumentation, electron microscopy, advanced trace evidence analysis and scientific expert testimony at John Jay College of Criminal Justice, C.U.N.Y. He enjoys dual appointments to the Doctorial Faculties in both Forensic Science and Chemistry at the Graduate Center of C.U.N.Y. He is currently the Program Director for the Doctoral Program in Forensic Science at C.U.N.Y. He is the Director of the New York State Not-for-Profit Educational Corporation, TAKA Instructional Agency where he has developed and taught classes in Scanning Electron Microscopy, X-ray Spectroscopy, Asbestos Analysis by light and electron microscopy, X-Ray Diffraction, Forensic Glass Analysis, Gun Shot Residue Analysis by SEM and EDS, and Quality Data for Forensic Chemists. He has been an instructor in a number of microscopy and industrial hygiene courses at the continuing education program of EOSHI a division of UMDNJ, Rutgers University. Dr. Kubic’s research interests are in the application of light and electron microscopy with digital image techniques, to the analysis of particulates and microscopic forensic evidence. He mentors graduate students in forensic science and criminalistic’s research at John Jay College. He maintains a successful consulting company dealing with the identification and characterization of particulate materials by light and electron microscopy especially when of forensic import. Dr. Kubic has qualified as an expert and testified to his opinions in both Federal and State Courts in criminal and civil actions. He is the author of over 20 scientific and technical articles as well as a number of textbook chapters, and has made over 80 presentations at technical conferences. He is the co-author of an atlas on the application of light microscopy for criminalists, chemists, and conservators and a laboratory manual for beginning forensic science students. He is a Fellow of the American Academy of Forensic Sciences and holds Fellow status as a certified criminalist. He is a member of the New York Microscopical Society, The Microscopy Society of America, The Microbeam Analysis Society, and The American Chemical Society as well as other professional organizations.