Post on 03-Jun-2018
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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