Lorin Grieve, GameMaster, Instructor and Ravi Patel, PharmD, Innovation Advisor | both School of Pharmacy, University of Pittsburgh Learning from Iteration of a Serious Game for Drug Development Drug Discovery and Development is complicated process. The work and the money invested in the process is easy to miss when delivered via traditional didactic means. This prompted the creation of RxPedition, is a serious game designed to teach pharmacy students about the process of bringing a drug candidate to market through company formations, clinical trial simulation, organic controversy management, and a mock Food and Drug Administration board. Come learn how, through multiple iterations of this serious game, to address student games of “academic chicken,” incorporating 21st Century Skills (creativity, communication, collaboration, critical thinking), and challenges with assessment methods for serious games. Presented by the Serious Play Conference seriousplayconf.com at Orlando, University of Central Florida, UCF, July 24-26, 2019

1. RxPedition
Serious Game for Drug Development
And Learning From Iteration

3. Objectives
● Broadly explain the process of drug development
● Understand the complications in teaching the process of
drug development through traditional didactic means
● Understand the process of iterative gameful instructional
design in the making of RxPedition

4. Introduction
● Rev. Lady Dr. Lorin Grieve
● Instructor, Instructional Designer
● University of Pittsburgh School of Pharmacy
● Specialties:
○ Gameful Instructional Design
○ Simulation
○ LGBTQ Health

5. Drug Development
● Process of taking a compound through clinical trials to be
approved for human use
○ Average of 10 years from start to finish
○ Average cost of $2.6 Billion (1.4 direct: 1.2 time)
○ Average success rate: 13.8%
■ Vaccines: 33.4%
■ Autoimmune: 15.1%
■ Oncology: 3.4%

6. Drug Development
● Pre-clinical
○ In silico models
○ Animal models
○ Identify lead compounds

7. Drug Development
● Phase 1
○ First-in-human
■ Very low dose, frequent blood draws
■ Establish pharmacokinetic (PK) elements
○ Stepwise Dose Escalation
■ Slowly increase the dose
■ Establish safe dose and side effects

8. Drug Development
● Phase 2
○ Hundreds of people with target disease
○ Extended dosing schemes
○ Establish long term PK and side effects
○ Acts as “proof of concept”

9. Drug Development
● Phase 3
○ Thousands of people with target disease
○ Much more extended dosing, up to several years
○ Confirm Phase 2 data + rare side effects
○ Prove non-inferiority or superiority

10. Drug Development
● Approval/Post Approval
○ FDA approval
○ Post-market evaluations
■ Super rare side effects
■ Population differences
■ Alternative indications

11. Yikes!

12. RxPedition
● 15 week, live-action role-playing, educational experience
○ 115-120 students
○ 20 groups of 5 or 6
○ Meets twice a week for 4 hours each time
● Student groups act as mock biotech startup companies

13. RxPedition
● Students play C-suite executives
○ CEO, CSO, CFO, etc
○ Sign contracts for their roles
○ Grades incentivized per roles
● Groups must manage resources as a team to succeed
○ Money, Time, Quality, Public Image

14. RxPedition
● Lectures very limited
○ No more than one hour a week
● Inquiry-based experimental exploration
○ Direction to go
○ Resources
○ Task to perform
○ Time to do it

15. RxPedition
● Preclinical
○ Animal trials simulated
○ Results given to the companies
○ Lead compounds are auctioned off

16. RxPedition
● Phase 1 Trials
○ Research real phase 1 trials
○ Use animal data to write protocol
○ Protocol is simulated
○ Data returned and evaluated
○ Companies present to potential investors

17. RxPedition
● Sidebar - Technological Backbone
○ SimCYP, Centura
■ Simulates drug trials “in silico”
■ Used in the industry
■ Provides PK information, but no efficacy or side effects
○ Custom Models
■ Nonlinear prediction modeling
■ Extrapolated from literature
■ Takes SimCYP output and estimates efficacy and side effects

18. RxPedition
● Phase 2 Trials
○ Offers made and finalized with Investors
○ Research and design phase 2 trials
○ Trials simulated
○ Data returned to groups
○ Results presented to Investor and CEOs

19. RxPedition
● Phase 3 Trials
○ Offers made and finalized with Investors
○ Research and design phase 3 trials
○ Trials simulated
○ Data returned to groups
○ Results presented to Investor and CEOs

20. RxPedition
● FDA Approval
○ Presentation to faculty in role as FDA
○ Approval either given or denied
○ Ten year profits simulated for approved companies
○ Final meeting debrief and celebration of successes

21. Iteration

22. RxPedition - Iterations
● First Cohort
○ Roles given, not reinforced
○ Role-based Jigsaw sessions
○ Grading Pass/Fail - Yay!
○ PD info only sample totals for side effects
○ Formulas used were black box
○ First year students

23. RxPedition - Iterations
● Second Cohort
○ Roles given, reinforced
○ Grading Pass/Fail - Boo!
○ PD info only sample totals for side effects
○ Formulas used were black box
○ Rules were hard to follow
○ Second year students

24. RxPedition - Iterations
● Third Cohort
○ Roles given, reinforced, incentivized
○ Grading Based on Roles
○ Side effects given for individuals
○ Formulas derived from literature
○ Rules transparent
○ Second year students

25. RxPedition - Iterations
● Future
○ Curriculum Committee - Pedagogy vs Andragogy
■ Lectures, Quizzes, Exam
■ Level the roles and experience
■ Make even more transparent
■ Remove a credit hour

26. Did it Work?

27. RxPedition - Results
● 21st Century Skills
○ Critical Thinking
○ Creativity
○ Collaboration
○ Communication
○ Resiliency

28. RxPedition - Results
● Student Surveys
○ Every year students rate themselves more confident in
all skill areas following experience
○ Retrospective surveys show that confidence increase
still
○ HERE
● Student testimonials

29. RxPedition - Results
● Stories

30. RxPedition - Future
● Curriculum Committee
○ Pedagogy vs Andragogy
● More options
● Refined models

31. loringrieve@pitt.edu