Bioanalytical Services Advisory Board

Ira S. DuBey

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

Mr. 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, Mr. DuBey held the position of Vice President and General Manager of Biotechnology Services for Tandem Labs, Inc. a LabCorp Company. Mr. 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, Ira 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. Mr. DuBey holds an M.S. degree in Toxicology from the University of Maryland Graduate School and a M.B.A. from the Johns Hopkins University.

Andrew Eisen

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. Andrew Eisen, MD, PhD 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

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.

Edward Jackson Cone

Edward J. Cone received his B.S. in chemistry from Mobile College in 1967 and his Ph. D. in organic chemistry in 1971 from the University of Alabama. From 1971 to 1972 he held a post-doctoral appointment in the Department of Chemistry, University of Kentucky. His work at the University of Kentucky was in the area of tobacco chemistry. In the summer of 1972, he joined the staff of the Addiction Research Center, National Institute on Drug Abuse. In 1984, the center was moved to Baltimore, MD, where he served as Chief of the Chemistry and Drug Metabolism Section and Acting Branch Chief of Clinical Pharmacology until 1998. From 1977 to 1985 he served as a member of the adjunct faculty in the Division of Pharmaceutics and Pharmaceutical Analysis, School of Pharmacy, University of Kentucky. He has also been appointed as Adjunct Professor of Psychiatry at Johns Hopkins School of Medicine. Dr. Cone serves on the editorial board of the Journal of Analytical Toxicology and is a reviewer for numerous chemical and pharmacology journals. Dr. Cone served as Vice-Chairman of the Institutional Reviews Board for the Intramural Research Program, NIDA, in Baltimore, MD from 1996-98. His research interests are in drug delivery systems, kinetics and disposition of drugs, and in the relationship of drug testing results to drug-induced effects. Dr. Cone’s research on the kinetics and dynamics of drug exposure effects of environmental inhalation of drugs, and the use of alternative biological media for drug detection has been recognized world-wide. Dr. Cone’s research has resulted in the publication of over 250 scientific articles on the detection and analysis of drugs in biological media. Dr. Cone has received a number of awards including the Alan Curry Award in 2006, from The International Association of Forensic Toxicologists. Presently, Dr. Cone is serving as a consultant to private industry and various government agencies on matters relation to the standardization of drug testing methodologies and drug surveillance systems.

Marian Kelley

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. 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 Marian’s 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. Kelley helped set up compliant CLIA labs in France, Germany and Australia and monitored the labs to ensure compliance and consistency. Marian 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. Marian 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. Marian 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.

Thomas A. Kubic

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.

Sidney Pestka

Dr. Pestka is known as the “Father of Interferon” for his seminal work on interferon that gave birth to what is, today, a $6 billion dollar market directed at the therapy of hepatitis, multiple sclerosis, cancer, and other diseases that affect mankind. He was the first to purify interferon, the first to clone mature interferons and the first to develop a commercialized recombinant biotherapeutic—interferon alpha. Many of his achievements have broad application in the biotechnology and pharmaceutical industries. Pestka graduated summa cum laude with a B.A. in chemistry from Princeton University (1957) and received his medical degree from the University of Pennsylvania School of Medicine (1961). After graduating from medical school, he was an intern in medicine and pediatrics. Afterwards, he worked at the National Institutes of Health (NIH) in the laboratory of Dr. Marshall W. Nirenberg, where he was part of the team working on the genetic code, protein synthesis and ribosome function—work that led to Nirenberg’s 1968 Nobel Prize in Physiology or Medicine. In 1966, Pestka moved to the NIH’s National Cancer Institute to concentrate his research on protein synthesis. Three years later, he left the NIH to go to the Roche Institute of Molecular Biology in Nutley, New Jersey, where he focused on defining how antibiotics worked and proteins are synthesized and, later, how to purify interferons. At the Institute, he was the first to purify interferon alpha and beta; to develop reverse phase high-performance liquid chromatography (RP-HPLC) for protein purification; to genetically engineer interferons; and to manufacture interferons for human therapy. It was here that he also discovered anti-messenger RNA (“Antisense-mRNA”), a method to shut off expression of any gene. Today, Dr. Pestka serves as Professor at the Department of Molecular Genetics, Microbiology and Immunology at the Robert Wood Johnson Medical School (RWJMS) of the University of Medicine and Dentistry of New Jersey. At RWJMS he identified the interferon receptors and, in the process, discovered several interleukins and their receptors. Using a novel technology application of FRET (Foerster or Fluorescence Resonance Energy Transfer) that Dr. Pestka developed during a 1976 collaboration, he demonstrated how proteins interact with their receptors in living cells. Dr. Pestka is also Chairman and Chief Scientific Officer of PBL InterferonSource, a biotechnology company focused on providing scientists around the world with interferon-related products, services, information and know-how. Dr. Pestka’s research is currently focused on interferons and cytokines; receptors and signal transduction; immunotherapy of cancer; and prevention, treatment and control of cancers and viral diseases. Dr. Pestka holds 270 U.S. and foreign patents. He has published 430 papers and edited five books related to protein biosynthesis and interferons — several of which are classics and still cited today. Dr. Pestka is a 2001 National Medal of Technology laureate and has received the 2001 Seymour & Vivian Milstein Award for Excellence in Interferon and Cytokine Research; the 2004 Warren Alpert Foundation Scientific Prize from Harvard Medical School; the 2006 Lemelson-MIT Lifetime Achievement Award; the 2009 Molecular Biology Medal from the National Institutes of Health for his role in deciphering the genetic code and the mechanism of protein synthesis; and the 2010 Edward J. Ill Outstanding Medical Research Scientist Award for Basic Biomedical Research. He holds an honorary doctorate in science from Rider University (1987) and has played an important role at the International Society for Interferon and Cytokine Research, where he served as secretary (1989-1993, 1996-2005), vice president (1992-1993) and president (1994-1995).