1. National Gene Vector Biorepository Aaron Boeke, Kevin Largent, Kyle McClurg, Sean Seacat Not present: Patrick Doumas and Peter Tichenor Faculty Advisor: Prof. Mohan V. Tatikonda (tatikonda@iupui.edu) February 22, 2012 Operational Analysis

2. Agenda Background Investigation Problem Definition Project Overview  Questions

3. Background Mission of the National Gene Vector Biorepository (NGVB) is to provide gene therapy investigators with a variety of services that can enhance their research. Archiving Services Insertion Site Analysis Pharmacology and Toxicology Resources Reagent Repository  Housed within the Department of Medical and Molecular Genetics in the IUSM. Made possible by a grant from the National Center for Research Resources (NCRR)

4. Objective NGVB requested assistance from a Kelley MBA team to: (1) analyze workflow;  (2) make suggestions for improved internal and external communications; and  (3) develop a system to manage inputs and outputs.

5. Defining the Problem Discussed concerns with NGVB manager Weekly meetings Toured the NGVB Facilities Certification Lab Freezer and Deep-Freeze Storage Sites Met with staff to better understand gene therapy research environment Troy Hawkins - Molecular Diagnostics Supervisor Lisa Duffy - Certification Lab Supervisor

6. Defining the Problem We also reviewed: Standard operating procedures Initial customer information Product/service catalog Stepped through the customer’s order entry process using the NGVB website Worked to understand each step an order goes through in the process

7. Initial Findings Current process documentation can be enhanced General Customer problems Lack of standardization Labeling and storage of products Use of electronic database across product lines Uncertainty regarding the quality of the customer's experience Uncertainty of demand across product lines Difficulty in determining batch sizes, stock levels, and reorder points

8. Process Analysis Process Flow Diagrams Current state mapped to gain primary understanding of the NGVB processes Observe processes to understand the physical flow of materials, people, and information Determine constraints and sources of variation Increase Service Level to the Customer Decreased turn-around time

10. Customer Analysis Database analysis Variety, volume, and frequency of orders Qualitative interviews with local customers Analyze experiences of customers from a variety of perspectives new vs. repeat customers local vs. international frequent vs. infrequent 

11. Intended Deliverables Detailed process characterization and capacity analysis Bottleneck identification Flow time analysis Analysis of current customer set and historical order patterns Demand forecasting Production scheduling Improved customer order fulfillment time Optimization of storage capacity

12. IU Vector Production Facility Background Provides gene therapy production and testing services with a focus on lentiviral gene transfer Project- In Project Scope Phase Provide detailed understanding of overhead cost in order to appropriately price services Working in compliance with FDA and NIH regulations and guidelines

13. Questions? Thank you