Operational Analysis

National Gene Vector Biorepository

Aaron Boeke, Kevin Largent, Kyle McClurg, Sean SeacatNot present: Patrick Doumas and Peter Tichenor

Faculty Advisor: Prof. Mohan V. Tatikonda (tatikonda@iupui.edu)

February 22, 2012

Agenda

• Background• Investigation• Problem Definition• Project Overview • Questions

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.o Archiving Serviceso Insertion Site Analysiso Pharmacology and Toxicology Resourceso Reagent Repository 

• Housed within the Department of Medical and Molecular Genetics in the IUSM.o Made possible by a grant from the National

Center for Research Resources (NCRR)

Objective

• NGVB requested assistance from a Kelley MBA team to:o (1) analyze workflow; o (2) make suggestions for improved internal

and external communications; and o (3) develop a system to manage inputs and

outputs.

Defining the Problem• Discussed concerns with NGVB manager

o Weekly meetings• Toured the NGVB Facilities

o Certification Labo Freezer and Deep-Freeze Storage Sites

• Met with staff to better understand gene therapy research environmento Troy Hawkins - Molecular Diagnostics

Supervisoro Lisa Duffy - Certification Lab Supervisor

Defining the Problem We also reviewed:

o Standard operating procedureso Initial customer informationo Product/service catalogo Stepped through the customer’s order entry

process using the NGVB websiteo Worked to understand each step an order

goes through in the process

Initial Findings• Current process documentation can be enhanced

o General o Customer problems

• Lack of standardizationo Labeling and storage of productso Use of electronic database across product

lines• Uncertainty regarding the quality of the

customer's experience• Uncertainty of demand across product lines

o Difficulty in determining batch sizes, stock levels, and reorder points

Process Analysis• Process Flow Diagrams

o 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 Customero Decreased turn-around time

Customer Analysis

• Database analysiso Variety, volume, and frequency of orders

• Qualitative interviews with local customerso Analyze experiences of customers from a

variety of perspectives new vs. repeat customers local vs. international frequent vs. infrequent 

Intended Deliverables • Detailed process characterization and capacity

analysis o Bottleneck identificationo Flow time analysis

• Analysis of current customer set and historical order patternso Demand forecastingo Production schedulingo Improved customer order fulfillment time

• Optimization of storage capacity

IU Vector Production Facility

  • Background

o Provides gene therapy production and testing services with a focus on lentiviral gene transfer

• Project- In Project Scope Phaseo Provide detailed understanding of overhead

cost in order to appropriately price serviceso Working in compliance with FDA and

NIH regulations and guidelines

Questions?

 Thank you