Designed Experiments for Life Sciences

In this one-of-a-kind workshop, learn how to apply DOE to life science problems. We welcome scientists, engineers, and technical professionals working in the pharmaceutical, biomedical technology and biomedical device fields, as well as organizations and institutions that devote the majority of their efforts to research, development, technology transfer, or commercialization of these fields. Throughout this course you will explore cases that come directly from this industry!

During a fast-paced two days explore the use of fractional factorial designs for the screening and characterization of products or processes. Also see how to achieve top performance via response surface designs, mixture designs, and multiple response optimization.  Practice applying all of these DOE tools while working through cases involving time-release coating, medical device design, assay optimization, synthetic mediums, and much more.

This class is only available as a private on-site workshop.

Designed Experiments for Life Sciences

Details

Designed Experiments for Life Sciences (DELS), 2 days, (1.6 CEU, In-House Only)

Customized DOE applications for the life science industry (developed due to popular demand!)

Optimize your Product or Process

In this one-of-a-kind workshop, learn how to apply DOE to life science problems. We welcome scientists, engineers, and technical professionals working in the pharmaceutical, biomedical technology and biomedical device fields, as well as organizations and institutions that devote the majority of their efforts to research, development, technology transfer, or commercialization of these fields. Throughout this course you will explore cases that come directly from this industry!

During a fast-paced two days explore the use of fractional factorial designs for the screening and characterization of products or processes. Also see how to achieve top performance via response surface designs, mixture designs, and multiple response optimization.  Practice applying all of these DOE tools while working through cases involving time-release coating, medical device design, assay optimization, synthetic mediums, and much more.

Stat-Ease's highly experienced DOE experts will provide you with individualized guidance and support after class to help you get started on your next project—at no extra cost!

The DELS workshop provides a broad survey of the three major types of DOE designs—factorials, response surfaces, and mixtures. After completing the course you may want to further your education by attending one of Stat-Ease's core courses (EDME, RSM, MIX).

Two optional fun and easy-to-read texts, DOE Simplified and RSM Simplified, authored by Mark Anderson and Pat Whitcomb, provide supplemental background reading for all DOE topics covered.

Simulations Provide Practice

Use Design-Expert® software to practice designing and analyzing experiments throughout the workshop. The software provides easy-to-use graphical tools to find key variables and view results. You will be given a path to all simulation and data files used in class, which are posted to a special Internet site where you can also link to a free fully-functional, but time-limited, copy of Design-Expert software for use after class.

"Nice mix of computer time and lecture with good real-life examples." 
—Applied mathematician and quality scientist for a medical-diagnostics manufacturer

Course Outline

 

Day 1

Section 1—Introduction to Factorial Design

 
  • Brief description of factorial design
    • The factorial design planning process
  • Basics of factorial design (microwave popcorn)
    • Multiple response optimization
 

Section 2—Enhancements for Full Factorials

 
  • Replicated full factorial (mouse cell assay)
    • Explanation of power
  • 28 full factorial (assay contaminants)
    • Blocking

Lunch

Section 3—Fractional Factorials

 
  • Fractional factorials
    • 28-2 fractional factorial (assay contaminants)
    • Setup and aliases
  • Minimum-run resolution V (MR5) designs (stent delivery)
    • Response transformation
Day 2 General Factorials
 
  • Immunofluorescent assay optimization
 

Section 4—Introduction to Response Surface Design

 
  • Factorial with center points (bench reaction)
  • Introducing Response Surface Methods “RSM”
  • Augmenting to central composite design “CCD”
  • “Good” response surface designs
  • Sizing for precision
 

Section 5—Response Surface Methodology

 
  • Instructor-led exercise (fluid bed coating)
    • Building the design
    • Details of analysis
    • Optimization
    • Quality by Design “QbD”
 Lunch Section 6—Constrained Response Surface
 
  • Constrained design space
    • Optimal design
    • Stent spray coating
   Section 7—Introduction to Mixture Design
 
  • Quality by Design
  • Illustrative example (tableting process)
  Section 8—Introduction to Mixture Design
 
  • What makes a mixture?
  • Mixture (Scheffé) polynomials
  • Simplex lattice designs (synthetic medium)
  • Constrained mixture (antiseptic)
  Summary
 
  • Next steps

Prerequisites

Math skills, knowledge of basic statistics, and exposure to simple comparative experiments (e.g. two-sample t-test) are recommended. If you aren't ready for the Designed Experiments for Life Sciences workshop, take the online PreDOE course first (a $95 value you get for free! It takes 3-6 hours to complete. You can work at your own pace). You can assess your abilities by first taking the free self-assessment questionnaire—which is available as a pre-test within the PreDOE course—at www.statease.net.

Before attending class, please go through the One-Factor Tutorial, and then look at the One-Factor Self-Study presentation. You will find links to both below.

  1. One-Factor Tutorial
  2. One-Factor Self-Study

For more information, contact the Workshop Coordinator by e-mail or by calling 1.612.746.2038.

Additional Information

PDHs 16
Additional Information No