December 4-8, 2017 at Atlantic City, New Jersey
The 73rd Deming Conference on Applied Statistics
Sponsored by Metropolitan Section, ASQ and Biopharmaceutical Section, ASA

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12/8/2016 - 12/9/2016 (Thursday and Friday)

Short Course 2: Bioequivalence, Biosimilars, & Statistics in Clinical Pharmacology

Dr. Scott Patterson, Pfizer Inc
Dr. Byron Jones, Novartis Pharma AG
Ms. Johanna Mielke, PhD Candidate, Novartis Pharma AG.

Moderator: Alfred Balch
This course will cover the application and basic elements of the theory of statistical methods in clinical pharmacology. The course will first concentrate upon the techniques used in the assessment of bioequivalence - the study of a drug formulation to confirm its equivalence to another.

The second day will cover newer approaches, scaled average bioequivalence and the developing field of biosimilars, and will touch upon the use of statistics in clinical pharmacology studies of safety and lot consistency studies in Vaccines. The emphasis will be on study design, analysis, and interpretation of data using real-data examples from the authors' experiences.

The course will provide attendees with: (1) a wide range of real examples with datasets, SAS® and R code (from the website accompanying the textbook), (2) applications of statistics in clinical pharmacology drug development with an emphasis upon regulatory applications, and (3) a detailed consideration of the statistical analysis and design of bioequivalence, biosimilarity, and clinical pharmacology studies.

Day 1 of the course will cover:

  • 8:30-10: Biopharmaceutical Development and Clinical Pharmacology (Scott)
  • 10:20-11:50: History and Regulation of Bioequivalence (Scott)
  • 1:10-2:40: Testing for Average Bioequivalence (Byron)
  • 3-4:30: Sample size re-estimation in Average Bioequivalence studies (Byron)

The addition of the section on biosimilarity represents significant new material since the first (and second) approvals of biosimilar products. Biosimilars are biologics that are highly similar to an approved reference product which are shown not to differ meaningfully in safety and efficacy from the approved product.

Day 2 of the course will cover:

  • 8:30-10: Scaled Average Bioequivalence (Scott)
  • 10:20-11:50: Biosimilarity (Johanna)
  • 1:10-2:40: Lot Consistency Studies in Vaccines (Scott)
  • 3-4:30: Clinical Pharmacology Safety Studies (Byron)

Scott Patterson, Ph.D., PStat® is currently the Senior Director of Vaccines Clinical Biostatistics and Quantitative Modelling at Pfizer. He is an expert on the design and statistical analysis of clinical and clinical pharmacology trials and has over 20 years of statistical consulting and collaborative experience. Scott and Byron Jones co-authored the textbook Bioequivalence and Statistics in Clinical Pharmacology, now in its second edition.

Byron Jones, Ph.D., PStat® is a Senior Biometrical Fellow and Executive Director at Novartis Pharma AG. He is an expert in the design and statistical analysis of cross-over trials and co-authored the classic text on this topic (now in its third edition), in addition to his book on Statistical Inference and the textbook used in this course. He is a Fellow of the American Statistical Association and has over 30 years of statistical consulting and collaborative experience.

Johanna Mielke, MSc., received her Master’s Degree in Statistics from the TU Dortmund University in 2015. She is working as a Doctoral Candidate at Novartis Pharma AG. The research for her PhD thesis focuses on optimal designs and analysis methods for the development and approval of biosimilars.

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