Bruce K. Bernard, PhD, Fellow ATS, RAC

EDUCATION:

Purdue Universitv. West Lafavette, Indiana
     Year: 1971
     Degree: Ph.D.
     Major: Pharmacology and Toxicology
     Minor: Biostatistics and Psychology
     Awards: Public Health Service Pre-doctoral fellows (A competitive                            scholarship awarded in neurtoxicology by the
     National Institutes of Health based upon undergraduate research and
           coursework/grades and proposed graduate research; awards are for
           one to four years); Awarded for four years: 1967 — 1971

Universitv of Connecticut. Storrs. Connecticut,
     Year: 1967
     Degree: BA
     Major: Psychology
     Minor: Statistics and Pharmacology
     Awards: Magna cum Laude
     Graduated with Distinction (Based on original research and achievement in            course work)
     National (Academic) Honor Society — Phi Beta Kappa
     National (Academic) Honor Society — Phi Kappa Phi
     National (Psychology) Honor Society — Psi Chi
     National (Pharmacy) Honor Society — Rho Chi

EXPERIENCE:

SRA INTERNATIONAL. INC.. (since 2013 SRA Consultinq, Inc) Cambridqe, MD.  Position: President. Years: 1982 — present

Some consulting appointments of note include:

     National Academy of Sciences. National Research Council
          Position: Senior Staff Toxicologist. Project Director
          Years: 1985 — 1986
          Committee: Committee on Methods for the In Vivo Toxicity Testing
               of Complex Mixtures (USEPA Sponsored)
          Publication: Complex Mixtures: Methods for In Vivo Toxicity Testing,                        1988)

     National Academv of Sciences. National Research Council
          Position: Senior Staff Toxicologist, Staff Officer
          Years: 1986 — 1987
          Committee: Safe Drinking Water Committee (USEPA Sponsored)
                 Publications: Pharmacokinetics in Risk Assessment;                                          Drinking Water and Health, Volume 7 & 8, 1987) . National Academv                  of Sciences.

     National Research Council
          Position: Senior Staff Toxicologist, Project Officer and Liaison with the                     Food and Drug Administration
          Years: 1987 — 1989; Committee: Committee for the Evaluation of                             Additives in the US; Food Supply (USFDA Sponsored) Publication:                     FDAINAS Food Additive Survey — V . Water Qualitv and Health ouncil

     Water Quality and Health Council

          Position: Expert Panel Member
          Years: 1992 — present
          Publication: Assorted, issues of contaminated water and health,
               risk assessment, communication, and balancing of competing risks.

     U.S. Food and Drug Administration
          Position: Consultant
          Years: 1994 — 1997
          Assignment: Worked with the Center Director and his senior staff,
               prepared guidelines (including both scientific and quality assurance                    criteria) for acceptance of petitions for filing and procedures for                          scientific data evaluation by agency reviewers

     U.S. Food and Druq Administration: Animal Health Industry

          Position: Consultant/CoordinatorlLiaison
          Years: 1992 — 1996
          Assignment: Worked with both organizations to develop a mutually
               acceptable set of guidelines for use by FDA in evaluating the results                 of animal studies
          Publication: Good Target Animal Study Practices: Clinical Investigators                  and Monitors (May 1997)

Activities Related to Submission to Federal Agencies
     Positions: Consultant to human and veterinary drug, medical device, food,             beverage, cosmetic and agricultural chemical companies
     Years: 1982 — present

Activities Related to: Preparation/Review of Submission — FDA (CDER,
CBER, CVM, CFSAN. CDRH), EPA (OPP, OPPT)
Products: Applications, position papers, presentations, etc.

Constitute and Administer Panels (Expert. GRAS. Pathology Working Groups. I have empaneled more than 300 panels on food additives, pharmaceutical products, dietary supplements, infant formulas, and consumer products since 1982; all have been accepted by FDA Years: 1982 — present

Some Past Current Clients: Abbott Laboratories, Appleton Papers, Ajinomoto Co.,American Cyanamid, American Home Products, Cadbury-Schepps, Calpis, Cytec Industries, Ft. Dodge Pharmaceuticals. Haarmann & Reimer, OxyChem, PepsiCo., Ross Products 

National Institute of Arthritis. Diabetes. Digestive, and Kidney Diseases (National Institutes of Health)  Position: Research and Regulatory Toxicologist; Years: 1985-1987

National Institute of Neuroloqical and Communicative Disorder and Stroke (National Institutes of Health)
Position: Research and Regulatory Toxicologist
Years: 1985-1989

Activities Related to Quality Assurance (e.a., GLP. GMP. GCP) Positions: Consultant to human and veterinary drug, medical device, food, beverage, cosmetic and agricultural chemical companies and federal agencies.  Years: 1982 — present

Activities: Facilities audits, Study Monitoring, Study design, execution, data collection, raw data and final report evaluation.  Deliverables: Reports of findings, impact of deviations, suggestions for solutions

US Navy. Dept. of Defense (Submarine Naval Base. Groton. CT)
     Position: Senior Toxicologist
     Years: 1986 — 1987
     Committee: Evaluation of Issues Related to Thermal Combustion
          Toxicity on Subsurface Vessels (e.g., initiation, suppression,                               decomposition products, biological effects and escape) Report:                        Classified .

Lederle Pharmaceutical Laboratories. Inc.
     Position: Chairman, Research and Development Advisory Board

Liposome Technology, Inc. 1986-1988
     Position: Chairman, Scientific Advisory Board
     Years: 1987 — 1989 .

Flavor and Extract Manufacturers' Association
     Position: Director, Regulatory and Scientific Affairs
     Years: 1982 — 1985 Publications: Recent Progress in the Consideration of        Flavoring Ingredients under the Food Additives Amendment 13 & 14 .

American Industrial Health Council
     Position: Staff Officer
     Year: 1983 — 1984
     Committee: Chemical Carcinogenesis
     Publication: Criteria for Evidence of Chemical Carcinogenicity (Science)

CAMPBELL UNIVERSITY, School of Pharmacy. Buies Creek, NC                           Position: Adjunct Professor
      Years: 1995 — present
      Discipline: Pharmaceutical Sciences
      Lecture in undergraduate courses on pharmacology, toxicology with                        emphasis on the effects of chemicals on living organisms, and                          biostatistics with emphasis data interpretation

IIT RESEARCH INSTITUTE. Chicaqo, Illinois
     Position: Director, Standard Oil Toxicology Program
     Years: 1979-1 982.                                                                                                 Established and directed a 30,000-square-foot toxicology facility;                            supervised approximately 30 scientists; managed an annual budget of              approximately $6 million; designed/supervised/executed several                        hundred studies for the purpose of evaluating consumer and worker-                exposed products . Supervised construction of a complete toxicology                laboratory including inhalation
      Responsible for the purchase and installation of capital equipment                     Responsible for overall management of program including establishment                and maintenance of the Quality Assurance Program and all interaction              with Federal regulatory agencies . Hired all supervisory and technical                personnel; trained all staff in various phases of study execution in                      accordance with SOPs and GLPs; handling, compounding                                and dispensing of test substances; monitoring environmental factors               (e.g., water food, temperature, humidity); performing necropsy/gross                 observation; collecting specimens for histopathology, clinical chemistry,           and hematology analysis; presenting data; analyzing statistics; and                   report writing . Developed program policies, training manuals and                       assembled 450 — 600 SOPS to comply with Good Laboratory Practices.      Conducted standard safety assessment tests including acute, subchronic,              chronic toxicity and carcinogenicity studies, and specialized                               assessment tests including inhalation, mutagenicity, reproduction,                     teratology, cytogenetic, and developmental studies . Directed protocol               preparation, study execution, data analyses, and report generation;                   completed and released 350 — 370 study reports . Supervised                             development and utilization of an automated and computerized data                   acquisition system

Univ. of Chicago, Dept. Psychiatry, Chicago, Ill.                                                         Position: Adjunct Professor                                                                                   Years: 1977 — 1980                                                                                                  Discipline: Psychiatry . Lectured in graduate courses on the effects of the                interactions of stress and drugs, on behavior; Conducted research on                the effects of drugs and stress on behavior

G.D. Searle & Co.. Skokie, Illinois
     Position: Senior Toxicologist
     General and Neurobehavioral/Developmental Toxicology
     Years: 1977 — 1979.
     Group Leader of Rodent Toxicology
     Responsible for management of general subchronic, chronic toxicity and               specialized muscle irritation studies, single and multi-dose                                 pharmacokinetic evaluations;managed a staff of 12 — 14 scientists .              Designed laboratory facilities for developmental teratology . Directed                       protocol preparation, study execution, data analyses, and                                   report generation

UNIVERSITY OF CONNECTICUT. Storrs. Connecticut
     Position: Associate Professor (Tenured)
     Years: 1976 — 1977
     Position: Assistant Professor
     Years: 1971 — 1976.
     Discipline Pharmacology & Toxicology
          Taught undergraduate pharmacology and toxicology courses and                             laboratories to medical, nursing, and pharmacy students, with                           special emphasis in central nervous system effects . Conducted                       graduate and interdepartmental courses in biostatistics, including                       both parametric and nonparametric applications
          Established and supervised Honors Program for undergraduate                              students and supervised graduate research programs .                                 Performed basic research resulting in 20 published articles, 1                                  monograph, and 10 unpublished communications

Honors and Awards
     Recipient. National Science Foundation, 1974
     Lederle Faculty Award, 1974
     NIH and NSF Research Awards (3) — funded to present personal research
          results at the International Congress of Biological Psychiatry (Buenos               Aires, Argentina, Honolulu, Hawaii, and Barcelona, Spain) and American           College of Neuropsychopharmacology (San Juan, Puerto Rico)

National Institute of Drug Abuse.and National Institute of Arthritis, Metabolism          and Digestive Diseases (National Institutes of Health)
     Position: Consulting Research Toxicologist
     Years: 1972 — 1978.                                                                                                Validated state-of-the-art neurotoxicity testing equipment involving                           computer analysis of video recorded interactive behavioral responses in           animals under the influence of various drugs of abuse (e.g., cocaine,                 LSD, mescaline, PCP).

PROFESSIONAL SOCIETIES:
     Academy of Toxicological Sciences (Fellow)
     American College of Neuropsychopharmacology (Workshop Chairman and
          Presenter)        
     American College of Toxicology (Member, Workshop Chairman, Presenter)
     American Psychological Association (Member)
     American Society of Pharmacology 8 Experimental Therapeutics (Past                   Member and Presenter)     
     Psi Chi (National Honor Society for Psychology) — Member
     Regulatory Affairs Professionals Society (Member and Certified)      
     Society of Toxicology (Member and Presenter)
     Midwest Society of Toxicology (Executive Board Counselor, Membership
          Chairman)
     Mid-Atlantic Society of Toxicology (Program Committee Member)
     Toxicology Forum (Member, Workshop Chairman, Presenter)     
     World Congress of Biological Psychiatry (Workshop Chairman and                         Presenter)

EDITORIAL DUTIES:
     International Journal of Toxicoloqy (Associate Editor, 1997 — present;                       Section Editor, General Toxicology, 1982 — 1997; Reviewer, 1979 -1982)
     Regulatory Toxicologv and Pharmacology (Editorial Board, 1989 — 2004)
     Toxicologv and Industrial Health (Section Ed., Pharmaceutical Toxicology,               retired)
     Flavor and Fragrance Materials (Consulting Editor, retired)
     Neurobehavioral Toxicoloqv & Teratoloqy (Editorial Board, retired)
     Neuroscience Research (Editorial Board, retired)
     Expert Opinion on Druq Metabolism and Toxicoloqy — (Reviewer)
     The Philippine Agricultural Scientist (Reviewer)
     Toxicoloqv Mechanisms and Methods (Reviewer)