Non-clinical statistics for research and development

Interview with Sam Gardner

In this episode, we talk about non-clinical research and development and how statisticians contribute to these efforts. Join us while we talk about the following important phases of R&D.

Statisticians support more than just clinical trials in R&D. Some non-clinical areas where statisticians contribute to drug development include:

• Discovery
  • High throughout screening of drug candidates
  • Genomics
• Early Phase
  • Safety studies (animals)
  • Animal models for efficacy
  • In-vitro Analytical methods to predict in-vivo performance
• Mid-late phase
  • Determining manufacturing process targets for clinical trial material (process definition)
  • Determining the best formulation for a drug product
  • Developing robust and accurate analytical methods to assess the quality of the drug substance and drug product
  • Assessing the stability of the drug product
  • Determining the full manufacturing process and the control strategy to ensure high quality (process characterization), including
    • Operating Ranges
    • Determining Critical Process Parameters
    • Developing quality specifications for inputs (drug substance, raw materials) and outputs (drug product specifications)

There are other areas that statisticians can contribute in non-clinical R&D…. basically anywhere you need to generate and evaluate data in R&D, you can find an application of statistics.

Sam Gardner

Founder, Owner, and Principal Consultant for Wildstat Consulting, LLC. 

Sam holds a BS in Mathematics and Chemistry from Purdue University, a MS in Mathematics from Creighton University, and a MS in Statistics from the University of Kentucky.

Sam has held numerous roles in his career. Right out of college, he earned a commission as an officer in the United States Air Force. For 12 years, he worked as a military scientific analyst in several roles, including weapon systems modeling and simulation, flight test planning and data analysis, and human factors research and development. He was also a member of the faculty at the Air Force Institute of Technology, where he taught statistics and experimental design to fellow officers in the graduate engineering, science, and logistics programs.  

After his military service, Sam joined Eli Lilly and Company and worked in research and development and manufacturing as a statistician and as a process chemist. He later made a career transition to the SAS Institute, where was a technical expert in the JMP Division, and that role gave him a broad exposure to hundreds of companies that are using statistics to solve business problems. He returned to Eli Lilly in the Advanced Analytics group, focusing on the application of predictive modeling in support of sales and marketing.  He then moved back into research and development at Elanco Animal Health, where he led the Experimental Design and Statistics team with a focus on applying Quality by Design to the development of new pharmaceutical products.  

After three decades of work in government and industry, Sam decided to launch his own business to provide consulting services that utilize his talents in statistical thinking, problem solving, experimental design, and statistics and predictive modeling.   

Sam is a member of the American Statistical Association, and he also serves as a volunteer member of the United States Pharmacopoeia’s Statistics Expert Committee.  

Sam lives in Lafayette, Indiana, USA, with his wife, Susan, and together they have four adult children.