Case Study on Six Sigma (2014 ExL Conference-Philly)

8/12/2019 Case Study on Six Sigma (2014 ExL Conference-Philly)

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George Betts, MBA, CPMHead of Medical Affairs Operations

IPSEN

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Views and comments provided from this presentation

are solely of the presenter and do not in anyway

represent the views and/or comments of Ipsen.

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! As the Clinical Development stage is the most expensive phase of bringing a newdrug to market, nearly every pharmaceutical company over the past decade has

placed much emphasis on finding new ways to increase productivity and process

improving.

! This case study begins with an overview of the companys pressing need toidentify areas to drive productivity and reduce costs in the Clinical Development

organization.

! Utilizing the DMAIC principle of Six Sigma (Define, Measure, Analyze, Improve,and Control), the case study walks through the steps highlighting the challenges

and achievements along the way.

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! Rising coststo develop new drugs

! Challenges in meeting enrollment goalsinclinical trials

! Lost future revenues for delaysin clinicaldevelopment

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! A cross-functional team was assembled toevaluate ways to accelerate timelines inclinical development trials

! Careful consideration was taken to includethe right key stakeholders on the core team

! Frequent communication throughout thedevelopment of the initiative was essential

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Define

Measure

Analyzemprove

Control

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! The D (Define) in the DMAIC process focuses onselectinghigh-impact areas to focus on

! Very important to have the team collectively definetheproblem

! What may be perceived as the easiest step, can be achallenge

! A key deliverable in the Define phaseis a team charter

Define

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Problem Statement:

Delays in clinical trial execution result in delays to bring

promising new medicines to patients in need, increasedcosts to bringing new drugs to market which translate to

higher prescription prices.

Scope:

US Clinical Development and US Clinical Operations.This initiative will focus on the critical path activities of

clinical trial operations examining every step fromprotocol development to FPFV

Areas of Focus:

Protocol Development Site identification Contracting cycle-time Delays in trial launch (FPFV)Approach:

Utilize Six Sigma principles: DMAIC Define, Measure,Analyze, Improve, Control

Conduct further interviews with key stakeholders tofurther define needs and validate proposed solutions

Core Team Members: Name - Name Name - Name Name - Name Name - Name Name - Name

Key Metrics to Measure Success:

+15% improvement in protocol development cycle-time +15% improvement in SSU cycle-time

-15% reduction in number of non-enrolling centersTimelines:

Conduct kick-off mtg and define and align teamon objectives

Analyze off-site feedback and Identify potentialwork streams

For further review with the CDMA Leadership team Produce recommendations and share with CDMA

Leadership

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! The M (Measure) in the DMAIC is aboutdocumenting the current process, validating how it

is measured, and assessing baseline performance.

! We utilized tools in this phase which include trendcharts, fishbone diagram, critical path methodprocess flowcharts, and stick diagrams,

! Its critical to measure the right things and toestablish acceptable baselines

! By creating a critical path process chart, the team can focusin on what steps are important that if delayed, will extend theentire project.

! Establish baselines such as:! Step A!to!Step B should take at most weeksto complete

Measure

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! The A (Analyze) in the DMAIC is when the teamisolates the top causes behind the metric being

investigated.

!It can be the most time-consuming phase.

! Can lead right into identifying the possible solutions(Improve stage) and often can be done together

! We utilized the fishbone diagram tool Was mostvaluable

Analyze

Problem

Causes

Causes

Fishbone Diagram

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! A.K.A. Cause and Effectdiagram

! Very useful in opening updialogue among cross-

functional team members

! Was most effective toidentify where the root

problems were

Problem

Causes

Causes

Fishbone Diagram

Analyze

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Getting studysites up and

running during

start-up takes

too long (avg =19 weeks)

Contracts take too long tonegotiate

Fishbone Diagram

Purchase new externalFMV tool (PICAS)

Create new Contract Manager RoleCRAs and Study Mgrs. too busyduring SSU with other priorities

No organized internal orexternal benchmarks used

for assessing FMV

Study Managers/CRAs notexperienced to negotiate

contract language

Initial legal reviewtakes >3weeks avg.

Legal staff underreasourced

80% of sites demandmore compensation

than offered

CRAs notempowered to

negotiate

Develop pre-approved back-up language.

Free us Study Mgrs/CRAs bycentralizing the SSU activities.

Establish master agreements with repeat centers

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ProtocolDevelopment,

Site Selection

and SSU can

be improved

Fishbone Diagram

Studies often have a high % ofnon-enrolling sites

Country feasibilityassessments not

done consistently

Too often the protocolschange significantly after

sites are selected

Wrong sites areselected

Redesign CountryFeasibility Process

Change Site Selection SOP tohave process start AFTER

final protocol is produced

Site selection donetoo early (prior to

final protocol)

Lack of training andawareness on

importance of countryfeasibility assessments

Contracts take too long tonegotiate

Purchase new external

FMV tool (PICAS)

Create new Contract Manager RoleCRAs and Study Mgrs. too busyduring SSU with other priorities

No organized internal orexternal benchmarks used

for assessing FMV

Study Managers/CRAs notexperienced to negotiate

contract language

Initial legal reviewtakes >3weeks avg.

Legal staff underreasourced

80% of sites demandmore compensation

than offered

CRAs notempowered to

negotiate

Develop pre-approved back-up language.

Free us Study Mgrs/CRAs bycentralizing the SSU activities.

Establish master agreements with repeat centers

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! The I (Improve) in the DMAIC is when the teamfocuses on fully understanding the top causes

identified in the Analyze phase,

! with the intent of either controlling or eliminating those causesto achieve improved performance.

! The overall theme for the Improve phase is processredesign

! Can often be done at the time the team is in theAnalyze phase

Improve

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! The C (Control) in the DMAIC is how the organizationsets up controls and monitors the effects of the

changes made in the Improve phase to guarantee

lasting results.

! Often there are process settings, setup procedures, etc.,that require employees to follow specific requirements

in daily operations! these items are typically documented in a control plan.! In cases like this the Six Sigma team should do everything possible to

error-proof the process, and should then add the appropriate checks and

balances to the quality system for the long run

! Develop a scorecard that includes the key metrics theteam defined and have regular reviews with respective

leadership

Control

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! Encourage a Six Sigma Mind-Set within yourorganizations

! Eliminate the thinking that, its always been done this way.! Company leaders are continually looking to streamline operations and

improve processes

! When starting a process improvement effort, ensure you getbuy-in (sponsorship) from all relevant stakeholders within

your organization

! Throughout the process, provide continual updates tosponsors

! Carefully define your problem statement and projectcharter in the beginning with input from the team

involved.

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Case Study on Six Sigma (2014 ExL Conference-Philly)

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