DEBORAH CHAMP, DVM, MPVM, Dipl. ACVPM
D.A.C. Consulting

SUMMARY OF QUALIFICATIONS

Dr. Champ is a licensed veterinarian with advanced training and certification in epidemiology and biostatistics. She has over 16 years of experience in regulatory submission of statistical reporting for attaining numerous U.S.D.A. licensures of new veterinary biologics and product license support requirements for already licensed products with Fort Dodge Animal Health and Boehringer-Ingelheim Vetmedica. During the product development phase for a new veterinary biologic, it is important to develop appropriate efficacy test, safety test and potency test protocols. Execution of a well-planned and executed study protocol will streamline the approval process for a new veterinary product. Implementation of the study design and statistical analysis plan can be enhanced utilizing the expertise of Dr. Champ.

Her study design expertise includes:

• Vaccine Efficacy

  • Challenge Studies

  • Serological Equivalence

• Vaccine Safety

  • Laboratory Safety

  • Field Safety

• Potency Test Validation

  • Assay Validation

  • Direct Measurement

• Product Stability

• Diagnostic Test Validation

• Research Studies

  • Challenge Model Development

  • Dose Finding Studies

  • Proof of Concept Studies

Dr. Champ is available during all aspects of the statistical oversight process for both research and pivotal studies from protocol development, data collection, data formatting, data analysis, final report writing and regulatory submission. Statistical expertise is instrumental in developing effective study designs that can support a successful submission. Dr. Champ can provide value during the protocol development stage when considering the design elements and determining the appropriate design for the specific study proposal is critical. These design considerations include housing allocation, blinding, randomization, sample size requirements and appropriate replication. Dr. Champ will collaborate with researchers to develop effective study designs and statistical analysis plans to enhance successful completion of the study. She will complete the data analyses according to the established study protocol and provide the appropriate data interpretation in a complete statistical report using graphics and tables to illustrate the important characteristics of the data.

Frequent design types:

• Split-Plot Designs

• Repeated Measures

• Completely Randomized Designs

• Randomized Blocked Designs

• Nested Designs

• Observational Designs

• Test Method Transfer

Common Statistical Methods utilized:

• Bioequivalence /Non Inferiority

• Mitigated Fraction

• Prevented Fraction

• Analysis of Variance and Covariance

• Mixed Models

• Nonlinear Models

• Nonparametric Analysis

• Categorical Data Analysis

• Logistic Regression

• Dose Response Methods

• Linear and non-Linear regression

• Sensitivity/Specificity

• Predictive Values

• ROC curves

• Survival Analysis

Dr. Champ can ensure the data submission adheres to USDA recommendations for data formatting and provide the statistical programming and output files required for regulatory submission. She also will be available to interact with USDA-Center for Veterinary Biologics on statistical issues that may arise during the process of submissions of protocols and reports.