TS12A: STATISTICAL THINKING FOR THE PRECLINICAL RESEARCHER

TUESDAY, JUNE 18 - WEDNESDAY, JUNE 19

INSTRUCTOR:

Perceval Sondag, Senior Manager, Statistics, PharmaLex

A number of recent publications have highlighted the challenges of reproducibility in science, including opportunities for increasing the effectiveness of preclinical development studies by leveraging statistical concepts and practices. In this training seminar, participants will learn a variety of statistical analysis methods relevant to preclinical development, emphasizing the use of statistical thinking and understanding variability to explore and make inferences from data. The benefits of statistically designed experiments will be clear, and several critical study design elements will be described, including: power and sample size, some useful study designs, randomization, standardizing measurements, maximizing the information from an experiment, and sound techniques for analysis. The complexities and solutions for small data sets will also be discussed. Participants will learn from a combination of lecture, case studies, and practicing the application of concepts with realistic examples.

TOPICS TO BE DISCUSSED:

• How can statistical thinking improve decisions and accelerate research?
• Minimize experiments and understand relationships with Design of Experiments
• Use samples to make inferences
• Understand the contribution of measurement error and other sources of variability
• How can statistical thinking help you to avoid mistakes with data
• Confounding and correlation: understand the dangers
• Use exploratory analyses to detect non-randomness and other warning signs
• Interpret statistical results appropriately to draw valid conclusions (especially with small sample sizes)

WHO SHOULD ATTEND:

Directors, Managers, Researchers, and Scientists from Pharma, Biotechs, Academia, Government and Healthcare Organizations working in Pre-Clinical Research, Translational Research, and Statistical Programming.

INSTRUCTOR BIOGRAPHY:

Perceval Sondag, Senior Manager, Statistics, PharmaLex

Perceval Sondag holds a bachelor’s degree in physical therapy and a master’s degree in biostatistics, both obtained from the Catholic University of Louvain-la-Neuve in Belgium. He then began his career by implementing statistical thinking in the newly created Operational Excellence department of the Brussels Saint-Luc University Hospital.

He joined Arlenda in 2013 as a Statistician consultant and moved to the US based team in 2015. He specializes in Bayesian modelling and statistics applied to bioassays and process manufacturing. In addition to his job at Arlenda, providing statistical support for small and big pharmaceutical companies across the globe, he currently works on a PhD thesis about Similarity Testing for Bioassays. He is a member of the USP Expert Panel for Bioassays and has authored or co-authored multiple publications, including a book chapter on assay validation.

DAY 1:

8:00 am - 4:00 pm Seminar Sessions

12:00 - 12:30 pm Lunch Provided

4:20 - 5:20 pm Plenary Keynote Session

5:20 - 6:35 pm Welcome Reception

6:35 - 7:30 pm Breakout Discussion Groups

DAY 2:

8:00 am - 12:00 pm Seminar Sessions

12:50 - 2:20 pm Plenary Keynote Session

Exhibit Hall Refreshment Breaks also provided.

Stay on to attend Wednesday, June 19 - Thursday, June 20

TS12B: Practical Introduction to PKPD Modeling in Drug Discovery and Development: Better, Faster, Cheaper

Recommended Short Course

SC1: Introduction of GPCR-Based Drug Discovery
SC2: Optimizing Drug Metabolism, Drug Clearance and Drug-Drug Interactions
SC7: Fit-for-Purpose Biomarker Assay Development and Validation

Training Seminar Information

Each CHI Training Seminar offers 1.5 days of instruction with start and stop times for each day shown above and on the Event-at-a-Glance published in the onsite Program & Event Guide. Training Seminars will include morning and afternoon refreshment breaks, as applicable, and lunch will be provided to all registered attendees on the full day of the class.

Each person registered specifically for the Training Seminar will be provided with a hard copy handbook for the seminar in which they are registered. A limited number of additional handbooks will be available for other delegates who wish to attend the seminar, but after these have been distributed, no additional books will be available.

Though CHI encourages track hopping between conference programs, we ask that Training Seminars not be disturbed once they have begun. In the interest of maintaining the highest quality learning environment for Training Seminar attendees, and because seminars are conducted differently than conference programming, we ask that attendees commit to attending the entire program, and not engage in track hopping, as to not disturb the hands-on style instruction being offered to the other participants.