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• Cognizant 20-20 Insights




Shaping a Three-Layered Intended
Strategy to Realize Benefits for Life
Sciences R&D Site Closures
To ensure minimal disruption and impact to regular business operations,
leadership teams must ensure that closure and transition to a new site is
smooth; this requires effective change management, as well as efficient
knowledge retention and management.

      Executive Summary                                      new site is smooth; this requires effective change
                                                             management, as well as efficient knowledge
      The global life sciences industry is undergoing a
                                                             retention and management.
      wave of mergers and acquisitions, organizational
      transformations and restructurings. R&D site           To attain this, life sciences organizations should
      closures are a consequence of radical changes to       embrace the three-layer intended strategy, pre-
      the traditional life sciences research and devel-      sented in this paper, to execute a site closure
      opment business model. Since 2009 there have           program that results in substantial business
      been nearly 18 R&D site closures in the U.S. and       benefits that exceed expectations. The three layers
      14 in the EU region, based on public disclosures.      pivot around strategic considerations, tactical con-
                                                             siderations and operational considerations.
      To remain competitive, life sciences organizations
      are focusing on core research/therapeutic areas
                                                             Industry Trends Influencing
      and consolidating their R&D locations (closing
                                                             R&D Strategic Changes
      some sites and relocating others to lower-cost
      destinations) and selectively outsourcing activities   As revenue growth slows, the R&D strategies of
      to external service providers to gain efficiency and   life sciences players are morphing. These changes
      reduce costs. The decision to close an R&D site is     are in response to:
      a major, sensitive issue for life sciences organiza-
                                                             •	 Patent cliff: With patents on many blockbuster
      tions. Once decided upon, the closure must be            drugs due to expire, an estimated $290 billion
      delicately managed and executed because it can           in sales are at risk between 2012 and 2018.1
      have a significant long-term impact on the orga-         There are also persistent fears of government-
      nization. To ensure minimal disruption and impact        backed healthcare reforms aimed at reducing
      to regular business operations, leadership teams         exclusivity periods enjoyed by drug makers in
      must ensure that the closure and transition to a         different geographies.




      cognizant 20-20 insights | december 2012
•	 Post-merger   integration activities or con-        Key R&D Site Closures Since 2009
  solidation: R&D consolidation is an important
  aspect of post-merger integration, as it helps           Year                      Companies
  bolster productivity and reduce costs. For
                                                           2009            Pfizer, Merck, Eli Lilly
  example, in 2009 Pfizer consolidated R&D
  operations and closed six R&D sites in the UK            2010            GlaxoSmithKline, AstraZeneca,
  and U.S. following its acquisition of Wyeth.                             Pfizer, Takeda, Abbott Labs,
                                                                           Sanofi-Aventis, Bayer, Roche,
•	 Shift toward selective outsourcing: Due to                              Novartis
  margin pressures driven by higher development
                                                            2011           Pfizer, Novartis
  costs, increasing regulatory compliance costs,
  reduced R&D budgets, government-enforced                 2012            Sanofi, AstraZeneca, Roche
  price cuts and intellectual-property-related         Figure 1
  taxation laws, life sciences organizations have
  gradually embraced cost-reduction strategies
  such as selective outsourcing of R&D activities      laborative approach, with selective outsourcing
  to academic institutions (early stage research)      and “open innovation,” are gradually phasing out
  and contract research organizations (CROs).          oversized facilities, which is creating greater job
                                                       insecurity across the industry.
•	 Pipeline deficiencies: In the past, life sciences
  organizations relied on a robust pipeline of new     Typical site closure activities run the gamut, from
  products that opened up new revenue streams          exiting the site completely, to reducing its existing
  to offset revenue lost from patent expiration        footprint by exiting partially, or by consolidating
  of existing products in the market. However,         operations across multiple sites. Regardless of
  a sharp decline in successful innovation due         the approach taken, the primary goal is to help
  to increasingly complex disease targets and          the organizations reduce costs, consolidate R&D
  numerous late-stage new product failures has         efforts, focus on core therapeutic areas, create
  had an adverse impact on returns from R&D            a leaner organization and redirect resources to
  expenditures.                                        areas of greater focus or ROI. Figure 2 illustrates
                                                       the key parameters of the rationale for R&D site
•	 Location  optimization: The top-10 global
                                                       closures.
  pharmaceuticals companies occupy at least
  430 million square feet of office, manufactur-
  ing and specialist research space around the
  world, of which approximately 75% is owned
  — one of the highest ownership ratios of any
                                                       Indicative Business Case for
  corporate sector.2 To address the issue of           R&D Site Closures
  high fixed costs, the pharmaceuticals sector
  is beginning to gravitate toward all-purpose
  campuses containing manufacturing, R&D,
  sales, marketing and administration functions.
                                                                                   Reduce
                                                                                    costs
Site Closure Decisions and
Possible Impact
Life sciences organizations face increasing cost             Redirect
                                                           resources to                               Consolidate
pressures due to drying pipelines and declining              areas of                                 R&D efforts
                                                           greater focus
productivity in R&D operations, forcing them
to rethink their core focus areas in an effort to
improve efficiency and lower operating costs. This
has also resulted in the cessation of operations
in “not so important” therapeutic areas. In 2009
alone, major pharmaceuticals players announced                     Focus on core                 Lean
                                                                    therapeutic               organization
site closures and layoffs of more than 40,000                          areas

staffers the world over.3 Figure 1 reveals some
of the site closures/site consolidation announce-
ments. New-age R&D organizations, those that
are increasingly adopting a more open and col-         Figure 2




                        cognizant 20-20 insights       2
Our Three-Stage Strategy for R&D Site Closures




                Layer One: Strategic Considerations
                                                                 Shaping Three-Layered
                Layer Two: Tactical Considerations
                                                                 Intended Strategy for
                                                                 Effective and Efficient
                Layer Three: Operational Considerations          R&D Site Closures




Figure 3


Three-Layered Strategy for Successful                            align with the organization’s green initia-
Site Closures                                                    tives (site redevelopment and sale).
A wide range of internal and external attributes          •	 Build a climate for change and continuous-
of life sciences organizations were carefully                 ly assess the effectiveness of the change
considered in our adaptable and flexible strategic            management plan.
approach for developing a three-layered strategy
for successful R&D site closures (see Figure 3).
                                                              >> Develop a climate for change in the organi-
                                                                 zation to improve the readiness of the orga-
                                                                 nization for change.
Layer One: Strategic Considerations
The key strategic considerations must first be                >> Identify the impact of change and conduct a
identified to provide an overall objective and                   change readiness assessment. The assess-
direction on the organizational initiative required              ment must consider who will be impacted
to realize the expected business benefits from                   by the change, what the impact is and how
site closures. Some of these strategic consider-                 to maximize readiness for the change.
ations for R&D site closures could include:                   >> Ensure the change is managed in the most
                                                                 effective manner and an assessment of
•	 Define a clear site exit strategy or site                     the change management plan is done at
  transition strategy and align it with primary                  regular intervals to ensure methodologies
  business objectives of the site closure.                       implemented to manage change are effec-
   >> After the organizational announcement of                   tive, focused and improving continuously
      a site closure, there is an immediate need                 throughout the change period.
      to define and develop the site exit strategy,
      site transition strategy, identify the impact-
                                                          •	 Develop    effective communication with
                                                              consistent and targeted messaging from the
      ed business areas and the key stakeholders              leadership team.
      involved in it.
                                                              >> The site exit decision brings job losses and
   >> Ensure that primary business objectives of                 some turbulence in daily operational ac-
      the site closure initiative are aligned with               tivities. It is highly recommended that ac-
      the organizational objectives and expecta-                 curate, consistent and targeted message
      tions from site closure.                                   content is created for organization-wide
   >> Work with municipal planning authorities to                communication.
      help find socially responsible solutions to
      help employees impacted by the site exit as
                                                              >> Ongoing communications and stakehold-
                                                                 er management activity must encourage
      well as the impact on the region as a whole.               movement along the change curve.
   >> Define site remediation and cleanup goals               >> Prepare and execute a communication plan
      to reduce environmental impact and to                      and training plan.


                       cognizant 20-20 insights           3
•	 Define benefits of site closure strategy and                 sure that all team members are working in
  identify measures to track the realization of                 an integrated manner.
  benefits. It is essential to track and quantify
  the benefits of the site closure activities.
                                                             >> Project oversight and coordination: Sys-
                                                                tems integrators provide an assurance
  Methods for quantifying benefits could include
                                                                role that ensures preparedness for smooth
  measuring the savings from reduced opera-
                                                                functioning of program activities; they also
  tional costs and return on investment metrics,
                                                                maintain oversight and coordination of pro-
  such as direct contribution to the company’s
                                                                gram-level activities.
  market position and revenues generated, etc.
                                                             >> Conflict   management and resolution:
Layer Two: Tactical Considerations                              This is extremely critical in multi-vendor
Key tactical considerations must then be identified             scenarios where there could be differences
to establish a logical approach to successfully                 in approach. Any delay in issue resolution
executing R&D site closures. These tactical imper-              can place a program at risk. A standard ap-
atives could include the following steps:                       proach for conflict resolution must be cre-
                                                                ated and agreed upon with all the vendors/
•	 Develop a dedicated “systems integrator”                     suppliers. Teamwork and collaboration must
  team to manage the multi-vendor ecosystem.                    be the guiding principle in the formulation
                                                                of this approach. In collaborative ways of
   >> Supplier    integration and management:
                                                                working, systems integrator teams involve
       The systems integrator is a crucial function
       in site closures programs because of the                 suppliers in the conflict management pro-
       complex engagement structure that results                cess, identify the underlying issues and, in
       from multi-vendor environments. Systems                  theory, arrive at a solution acceptable to all.
       integrators act as a glue to bind all suppli-         >> Audit management and support: Systems
       ers by defining and enforcing unified oper-              integrators maintain key audit artifacts and
       ating principles and ways of working. They               provide a support program during IT com-
       form an umbrella over all the suppliers to               pliance audits. This team will also work with
       manage and oversee their activities and en-              vendors to collect evidence and material in




   Quick Take
Managing Site Closure for a Leading Global Pharma Player

Client Situation                                         •	 A   structured approach for multiple supplier
                                                             management and integration, project oversight
•	 A  leading pharmaceuticals organization
                                                             and coordination, conflict management,
  identified efficiency improvement as one of the
                                                             audit management and communications
  primary areas of focus in its R&D strategy. Site
                                                             management. This structured approach helped
  closure and consolidation was identified as an
                                                             in avoiding delays, reduced ambiguity in
  important means of achieving this objective.
                                                             cross-supplier communications and provided
•	 As part of this initiative, the IT function defined       a seamless transition of activities across
  a roadmap for R&D consolidation that covered               suppliers with improved IT compliance.
  operations across all global R&D sites. We were
  engaged by IT leadership to act as a strategic         •	 Management       of end-to-end site closure
                                                             activities, including applications migration,
  partner in planning and executing site closure
                                                             decommissioning and clean-up activities on
  activities across multiple R&D sites.
                                                             the application estate, reporting, etc.
Benefits Delivered                                       •	 Effective   relationship management with all
We worked with the client’s program leadership               suppliers, resulting in improved quality and
team and provided a strategic direction to the site          timely delivery.
closure activities. As such, we provided:


                        cognizant 20-20 insights         4
support of their compliance with the audit               problems during migrations and potentially
     findings.                                                impact other dependent applications.

  >> Identify cross-supplier dependencies and              >> Define   a structure to record the data
     facilitate communications: System inte-                  collected to ensure ease in data mining
     grators facilitate communications on cross-              activities: The template for data collec-
     supplier dependencies, key announcements                 tion must be reviewed and agreed upon
     and program decisions. This helps to reduce              by all the stakeholders of the site closure
     ambiguity in communication and retains a                 program. The data collection effort should
     single communications channel and a ”one                 not create a mountain of information that
     communications approach.”                                generates no valuable insights and results
                                                              in tremendous data mining efforts. At the
•	 Develop a robust governance structure:                     same time, data gathering must be compre-
   >> Create a clearly defined responsible,                   hensive enough to ensure all information is
     accountable, consulted and informed                      available for decision-making; there should
     (RACI) matrix: Ensuring clarity on roles                 not be a need to repeat the exercise at fu-
     and responsibilities is an absolute business             ture points in the program.
     essential to avoid duplication of efforts and
     reduce ambiguity in ownership of activi-              >> Identify  applications interdependencies:
     ties. In a site closure program, there could             Early identification of dependencies will
     be multiple suppliers who might have some                help in creating groups of dependent ap-
     overlaps and dependencies on each other.                 plications that can then be migrated en
     Defining and agreeing to a RACI approach                 masse. Doing this will reduce the possible
     with all the suppliers during the initial                disruptions in service for these applications
     phase of the program will reduce conflicts               as well as other dependent applications.
     and the risks during the execute phase.               >> Application   rationalization: The purpose
                                                              of this is to identify quick win opportuni-
  >> Management      reporting through a joint
                                                              ties for decommissioning and thus reduce
     program management office (PMO): A
                                                              migration efforts by eliminating/decommis-
     joint PMO handling reporting will reduce
                                                              sioning applications that are not required
     the requirements of status/progress re-
                                                              by users in other sites or users from this
     porting of multiple suppliers. The quality of
                                                              site moving to other sites.
     reports will improve by having “one version
     of truth” produced by a joint PMO with in-        •	 Business continuity — managing disruption
     formation provided by all suppliers.                  to business-as-usual (BAU) activities: The
                                                           site closure program disrupts BAU, impacting
Layer Three: Operational Considerations                    the availability of applications to end users.
•	 Information discovery: This phase is essential          Site closure programs must identify and factor
  for a clear understanding of application avail-          in the specific requirements of critical or
  ability, criticality and architectural interdepen-       complex applications in the scope of migration.
  dencies to diligently scope migration waves              Program leaders should plan a customized
  and create a data inventory of the entire                approach for such applications to minimize
  application estate. It is important to validate          application downtime. Communicating realistic
  this data inventory using multiple manual and            downtime for the applications in advance will
  automated approaches. It would be dangerous              help in managing business expectations and
  to assume that applications currently in use             aid in planning ways to minimize the disruption.
  represent the entire set to be migrated. Ensure
  one version of the truth is worked upon by all       •	 Define   “unified processes” for application
                                                           migration and decommissioning across
  parties and maintained on an ongoing basis
                                                           regions: Standard processes that minimize the
  >> One applications data inventory to ensure             deviations across regions will result in better
     accuracy and completeness of the infor-               audit results and will reduce efforts to manage
     mation stored: One of the most important              multiple processes across regions.
     considerations for application migration and
     decommissioning is the completeness and           •	 Data    loss prevention: Due to the level of
                                                           complexity and the quantum of work involving
     accuracy of the data inventory for each ap-
                                                           large volumes of data in application migrations
     plication. Incomplete data sets could cause
                                                           and decommissioning, there is a big risk of



                       cognizant 20-20 insights        5
data loss associated with it. It must be ensured      •	 Knowledge retention and management: This
     that the application owner places appropriate             can be accomplished by ensuring that informa-
     measures for data backup to reduce the prob-              tion and data from applications being decom-
     ability of data loss resulting from migration             missioned are archived. Knowledge retention
     initiatives. For instance, there could be many            will ensure the availability of legacy informa-
     regulated applications that have mandates                 tion in the event key staffers leave the orga-
     from health/legal authorities for data retention          nization or as a result of regulatory audits or
     and storage.                                              legal inquiries. The retention and management
                                                               of knowledge stored in the applications decom-
•	 IT    compliance, GxP — which includes good
                                                               missioned will also improve the reusability of
     laboratory practice (GLP), good manufactur-
                                                               the information and save efforts to reinvent the
     ing practice (GMP) and good clinical practice
                                                               wheel. This data can also be used to generate
     (GCP) — SOX and legal hold requirements: A
                                                               valuable insights to reinforce management
     regulatory impact analysis must be performed
                                                               decision-making.
     on the application landscape impacted by the
     site closure program. Appropriate actions must
                                                           The Way Forward
     be identified for each application to ensure
     regulatory compliance, as per the following:          Life sciences organizations face overwhelming
                                                           challenges to bring down costs. R&D site closures
     >> Data retention requirements from health            are among the key R&D levers companies can apply
        authorities: Regulatory authorities have           to an overall cost-reduction strategy. Although
        clear mandates for data retention with suf-        this is a complex activity fraught with operational
        ficient details provided to life sciences or-      sensitivities, the three-layered approach outlined
        ganizations on the data types required and         above provides most of the necessary inputs for
        timelines. Life sciences organizations must        shaping the strategy to achieve most if not all of
        comply with these requirements; noncom-            a life sciences organization’s business objectives.
        pliance could result in penalties or more          (See the accompanying sidebar on page 4 for a
        serious consequences for the organization.         brief illustration of how this methodology can be
     >> Legal   hold on system, information and            applied.)
        data: It is critically important to identify the
        systems and information/data subjected to          The potential savings from the site closures must
        legal hold before migration and decommis-          be directed to core focus areas leading to higher
        sioning of applications.                           return on investment. The absolute savings
                                                           can be maximized if the site closures program
     >> Requirements on the system’s downtime              is managed in an operationally effective and
        for some critical applications (financial          efficient manner.
        systems, adverse event reporting system,
        etc.).


Footnotes
1	
     “World Preview 2018-Embracing the Patent Cliff,” www.evaluatepharma.com.
2	
     “The Pharmaceutical Sector: Real estate implications of industry wide change,” Nov. 2009,
     http://www.cbre.eu.
3	
     Chemical and Engineering News; company Web sites; Fierce Pharma.


About the Authors
Dinesh Singh is a Consulting Manager with Cognizant Business Consulting’s Life Sciences Practice. He is
a seasoned advisor with nine-plus years of experience in business strategy, large transformation initia-
tives and complex program management consulting in the life sciences industry. He has worked with
leading pharmaceuticals clients to help them address key business problems and align their strategies.
He can be reached at Dinesh.Singh@cognizant.com.

Rohan Desai is a Consultant with Cognizant Business Consulting. He has worked as a solution consultant
for various life sciences solution development activities, projects and pursuits. He can be reached at
Rohan.Desai@cognizant.com.


                          cognizant 20-20 insights         6
About Cognizant
Cognizant (NASDAQ: CTSH) is a leading provider of information technology, consulting, and business process out-
sourcing services, dedicated to helping the world’s leading companies build stronger businesses. Headquartered in
Teaneck, New Jersey (U.S.), Cognizant combines a passion for client satisfaction, technology innovation, deep industry
and business process expertise, and a global, collaborative workforce that embodies the future of work. With over 50
delivery centers worldwide and approximately 150,400 employees as of September 30, 2012, Cognizant is a member of
the NASDAQ-100, the S&P 500, the Forbes Global 2000, and the Fortune 500 and is ranked among the top performing
and fastest growing companies in the world. Visit us online at www.cognizant.com or follow us on Twitter: Cognizant.


                                         World Headquarters                  European Headquarters                 India Operations Headquarters
                                         500 Frank W. Burr Blvd.             1 Kingdom Street                      #5/535, Old Mahabalipuram Road
                                         Teaneck, NJ 07666 USA               Paddington Central                    Okkiyam Pettai, Thoraipakkam
                                         Phone: +1 201 801 0233              London W2 6BD                         Chennai, 600 096 India
                                         Fax: +1 201 801 0243                Phone: +44 (0) 20 7297 7600           Phone: +91 (0) 44 4209 6000
                                         Toll Free: +1 888 937 3277          Fax: +44 (0) 20 7121 0102             Fax: +91 (0) 44 4209 6060
                                         Email: inquiry@cognizant.com        Email: infouk@cognizant.com           Email: inquiryindia@cognizant.com


©
­­ Copyright 2012, Cognizant. All rights reserved. No part of this document may be reproduced, stored in a retrieval system, transmitted in any form or by any
means, electronic, mechanical, photocopying, recording, or otherwise, without the express written permission from Cognizant. The information contained herein is
subject to change without notice. All other trademarks mentioned herein are the property of their respective owners.

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Shaping a Three-Layered Intended Strategy to Realize Benefits for Life Sciences R&D Site Closures

  • 1. • Cognizant 20-20 Insights Shaping a Three-Layered Intended Strategy to Realize Benefits for Life Sciences R&D Site Closures To ensure minimal disruption and impact to regular business operations, leadership teams must ensure that closure and transition to a new site is smooth; this requires effective change management, as well as efficient knowledge retention and management. Executive Summary new site is smooth; this requires effective change management, as well as efficient knowledge The global life sciences industry is undergoing a retention and management. wave of mergers and acquisitions, organizational transformations and restructurings. R&D site To attain this, life sciences organizations should closures are a consequence of radical changes to embrace the three-layer intended strategy, pre- the traditional life sciences research and devel- sented in this paper, to execute a site closure opment business model. Since 2009 there have program that results in substantial business been nearly 18 R&D site closures in the U.S. and benefits that exceed expectations. The three layers 14 in the EU region, based on public disclosures. pivot around strategic considerations, tactical con- siderations and operational considerations. To remain competitive, life sciences organizations are focusing on core research/therapeutic areas Industry Trends Influencing and consolidating their R&D locations (closing R&D Strategic Changes some sites and relocating others to lower-cost destinations) and selectively outsourcing activities As revenue growth slows, the R&D strategies of to external service providers to gain efficiency and life sciences players are morphing. These changes reduce costs. The decision to close an R&D site is are in response to: a major, sensitive issue for life sciences organiza- • Patent cliff: With patents on many blockbuster tions. Once decided upon, the closure must be drugs due to expire, an estimated $290 billion delicately managed and executed because it can in sales are at risk between 2012 and 2018.1 have a significant long-term impact on the orga- There are also persistent fears of government- nization. To ensure minimal disruption and impact backed healthcare reforms aimed at reducing to regular business operations, leadership teams exclusivity periods enjoyed by drug makers in must ensure that the closure and transition to a different geographies. cognizant 20-20 insights | december 2012
  • 2. • Post-merger integration activities or con- Key R&D Site Closures Since 2009 solidation: R&D consolidation is an important aspect of post-merger integration, as it helps Year Companies bolster productivity and reduce costs. For 2009 Pfizer, Merck, Eli Lilly example, in 2009 Pfizer consolidated R&D operations and closed six R&D sites in the UK 2010 GlaxoSmithKline, AstraZeneca, and U.S. following its acquisition of Wyeth. Pfizer, Takeda, Abbott Labs, Sanofi-Aventis, Bayer, Roche, • Shift toward selective outsourcing: Due to Novartis margin pressures driven by higher development 2011 Pfizer, Novartis costs, increasing regulatory compliance costs, reduced R&D budgets, government-enforced 2012 Sanofi, AstraZeneca, Roche price cuts and intellectual-property-related Figure 1 taxation laws, life sciences organizations have gradually embraced cost-reduction strategies such as selective outsourcing of R&D activities laborative approach, with selective outsourcing to academic institutions (early stage research) and “open innovation,” are gradually phasing out and contract research organizations (CROs). oversized facilities, which is creating greater job insecurity across the industry. • Pipeline deficiencies: In the past, life sciences organizations relied on a robust pipeline of new Typical site closure activities run the gamut, from products that opened up new revenue streams exiting the site completely, to reducing its existing to offset revenue lost from patent expiration footprint by exiting partially, or by consolidating of existing products in the market. However, operations across multiple sites. Regardless of a sharp decline in successful innovation due the approach taken, the primary goal is to help to increasingly complex disease targets and the organizations reduce costs, consolidate R&D numerous late-stage new product failures has efforts, focus on core therapeutic areas, create had an adverse impact on returns from R&D a leaner organization and redirect resources to expenditures. areas of greater focus or ROI. Figure 2 illustrates the key parameters of the rationale for R&D site • Location optimization: The top-10 global closures. pharmaceuticals companies occupy at least 430 million square feet of office, manufactur- ing and specialist research space around the world, of which approximately 75% is owned — one of the highest ownership ratios of any Indicative Business Case for corporate sector.2 To address the issue of R&D Site Closures high fixed costs, the pharmaceuticals sector is beginning to gravitate toward all-purpose campuses containing manufacturing, R&D, sales, marketing and administration functions. Reduce costs Site Closure Decisions and Possible Impact Life sciences organizations face increasing cost Redirect resources to Consolidate pressures due to drying pipelines and declining areas of R&D efforts greater focus productivity in R&D operations, forcing them to rethink their core focus areas in an effort to improve efficiency and lower operating costs. This has also resulted in the cessation of operations in “not so important” therapeutic areas. In 2009 alone, major pharmaceuticals players announced Focus on core Lean therapeutic organization site closures and layoffs of more than 40,000 areas staffers the world over.3 Figure 1 reveals some of the site closures/site consolidation announce- ments. New-age R&D organizations, those that are increasingly adopting a more open and col- Figure 2 cognizant 20-20 insights 2
  • 3. Our Three-Stage Strategy for R&D Site Closures Layer One: Strategic Considerations Shaping Three-Layered Layer Two: Tactical Considerations Intended Strategy for Effective and Efficient Layer Three: Operational Considerations R&D Site Closures Figure 3 Three-Layered Strategy for Successful align with the organization’s green initia- Site Closures tives (site redevelopment and sale). A wide range of internal and external attributes • Build a climate for change and continuous- of life sciences organizations were carefully ly assess the effectiveness of the change considered in our adaptable and flexible strategic management plan. approach for developing a three-layered strategy for successful R&D site closures (see Figure 3). >> Develop a climate for change in the organi- zation to improve the readiness of the orga- nization for change. Layer One: Strategic Considerations The key strategic considerations must first be >> Identify the impact of change and conduct a identified to provide an overall objective and change readiness assessment. The assess- direction on the organizational initiative required ment must consider who will be impacted to realize the expected business benefits from by the change, what the impact is and how site closures. Some of these strategic consider- to maximize readiness for the change. ations for R&D site closures could include: >> Ensure the change is managed in the most effective manner and an assessment of • Define a clear site exit strategy or site the change management plan is done at transition strategy and align it with primary regular intervals to ensure methodologies business objectives of the site closure. implemented to manage change are effec- >> After the organizational announcement of tive, focused and improving continuously a site closure, there is an immediate need throughout the change period. to define and develop the site exit strategy, site transition strategy, identify the impact- • Develop effective communication with consistent and targeted messaging from the ed business areas and the key stakeholders leadership team. involved in it. >> The site exit decision brings job losses and >> Ensure that primary business objectives of some turbulence in daily operational ac- the site closure initiative are aligned with tivities. It is highly recommended that ac- the organizational objectives and expecta- curate, consistent and targeted message tions from site closure. content is created for organization-wide >> Work with municipal planning authorities to communication. help find socially responsible solutions to help employees impacted by the site exit as >> Ongoing communications and stakehold- er management activity must encourage well as the impact on the region as a whole. movement along the change curve. >> Define site remediation and cleanup goals >> Prepare and execute a communication plan to reduce environmental impact and to and training plan. cognizant 20-20 insights 3
  • 4. • Define benefits of site closure strategy and sure that all team members are working in identify measures to track the realization of an integrated manner. benefits. It is essential to track and quantify the benefits of the site closure activities. >> Project oversight and coordination: Sys- tems integrators provide an assurance Methods for quantifying benefits could include role that ensures preparedness for smooth measuring the savings from reduced opera- functioning of program activities; they also tional costs and return on investment metrics, maintain oversight and coordination of pro- such as direct contribution to the company’s gram-level activities. market position and revenues generated, etc. >> Conflict management and resolution: Layer Two: Tactical Considerations This is extremely critical in multi-vendor Key tactical considerations must then be identified scenarios where there could be differences to establish a logical approach to successfully in approach. Any delay in issue resolution executing R&D site closures. These tactical imper- can place a program at risk. A standard ap- atives could include the following steps: proach for conflict resolution must be cre- ated and agreed upon with all the vendors/ • Develop a dedicated “systems integrator” suppliers. Teamwork and collaboration must team to manage the multi-vendor ecosystem. be the guiding principle in the formulation of this approach. In collaborative ways of >> Supplier integration and management: working, systems integrator teams involve The systems integrator is a crucial function in site closures programs because of the suppliers in the conflict management pro- complex engagement structure that results cess, identify the underlying issues and, in from multi-vendor environments. Systems theory, arrive at a solution acceptable to all. integrators act as a glue to bind all suppli- >> Audit management and support: Systems ers by defining and enforcing unified oper- integrators maintain key audit artifacts and ating principles and ways of working. They provide a support program during IT com- form an umbrella over all the suppliers to pliance audits. This team will also work with manage and oversee their activities and en- vendors to collect evidence and material in Quick Take Managing Site Closure for a Leading Global Pharma Player Client Situation • A structured approach for multiple supplier management and integration, project oversight • A leading pharmaceuticals organization and coordination, conflict management, identified efficiency improvement as one of the audit management and communications primary areas of focus in its R&D strategy. Site management. This structured approach helped closure and consolidation was identified as an in avoiding delays, reduced ambiguity in important means of achieving this objective. cross-supplier communications and provided • As part of this initiative, the IT function defined a seamless transition of activities across a roadmap for R&D consolidation that covered suppliers with improved IT compliance. operations across all global R&D sites. We were engaged by IT leadership to act as a strategic • Management of end-to-end site closure activities, including applications migration, partner in planning and executing site closure decommissioning and clean-up activities on activities across multiple R&D sites. the application estate, reporting, etc. Benefits Delivered • Effective relationship management with all We worked with the client’s program leadership suppliers, resulting in improved quality and team and provided a strategic direction to the site timely delivery. closure activities. As such, we provided: cognizant 20-20 insights 4
  • 5. support of their compliance with the audit problems during migrations and potentially findings. impact other dependent applications. >> Identify cross-supplier dependencies and >> Define a structure to record the data facilitate communications: System inte- collected to ensure ease in data mining grators facilitate communications on cross- activities: The template for data collec- supplier dependencies, key announcements tion must be reviewed and agreed upon and program decisions. This helps to reduce by all the stakeholders of the site closure ambiguity in communication and retains a program. The data collection effort should single communications channel and a ”one not create a mountain of information that communications approach.” generates no valuable insights and results in tremendous data mining efforts. At the • Develop a robust governance structure: same time, data gathering must be compre- >> Create a clearly defined responsible, hensive enough to ensure all information is accountable, consulted and informed available for decision-making; there should (RACI) matrix: Ensuring clarity on roles not be a need to repeat the exercise at fu- and responsibilities is an absolute business ture points in the program. essential to avoid duplication of efforts and reduce ambiguity in ownership of activi- >> Identify applications interdependencies: ties. In a site closure program, there could Early identification of dependencies will be multiple suppliers who might have some help in creating groups of dependent ap- overlaps and dependencies on each other. plications that can then be migrated en Defining and agreeing to a RACI approach masse. Doing this will reduce the possible with all the suppliers during the initial disruptions in service for these applications phase of the program will reduce conflicts as well as other dependent applications. and the risks during the execute phase. >> Application rationalization: The purpose of this is to identify quick win opportuni- >> Management reporting through a joint ties for decommissioning and thus reduce program management office (PMO): A migration efforts by eliminating/decommis- joint PMO handling reporting will reduce sioning applications that are not required the requirements of status/progress re- by users in other sites or users from this porting of multiple suppliers. The quality of site moving to other sites. reports will improve by having “one version of truth” produced by a joint PMO with in- • Business continuity — managing disruption formation provided by all suppliers. to business-as-usual (BAU) activities: The site closure program disrupts BAU, impacting Layer Three: Operational Considerations the availability of applications to end users. • Information discovery: This phase is essential Site closure programs must identify and factor for a clear understanding of application avail- in the specific requirements of critical or ability, criticality and architectural interdepen- complex applications in the scope of migration. dencies to diligently scope migration waves Program leaders should plan a customized and create a data inventory of the entire approach for such applications to minimize application estate. It is important to validate application downtime. Communicating realistic this data inventory using multiple manual and downtime for the applications in advance will automated approaches. It would be dangerous help in managing business expectations and to assume that applications currently in use aid in planning ways to minimize the disruption. represent the entire set to be migrated. Ensure one version of the truth is worked upon by all • Define “unified processes” for application migration and decommissioning across parties and maintained on an ongoing basis regions: Standard processes that minimize the >> One applications data inventory to ensure deviations across regions will result in better accuracy and completeness of the infor- audit results and will reduce efforts to manage mation stored: One of the most important multiple processes across regions. considerations for application migration and decommissioning is the completeness and • Data loss prevention: Due to the level of complexity and the quantum of work involving accuracy of the data inventory for each ap- large volumes of data in application migrations plication. Incomplete data sets could cause and decommissioning, there is a big risk of cognizant 20-20 insights 5
  • 6. data loss associated with it. It must be ensured • Knowledge retention and management: This that the application owner places appropriate can be accomplished by ensuring that informa- measures for data backup to reduce the prob- tion and data from applications being decom- ability of data loss resulting from migration missioned are archived. Knowledge retention initiatives. For instance, there could be many will ensure the availability of legacy informa- regulated applications that have mandates tion in the event key staffers leave the orga- from health/legal authorities for data retention nization or as a result of regulatory audits or and storage. legal inquiries. The retention and management of knowledge stored in the applications decom- • IT compliance, GxP — which includes good missioned will also improve the reusability of laboratory practice (GLP), good manufactur- the information and save efforts to reinvent the ing practice (GMP) and good clinical practice wheel. This data can also be used to generate (GCP) — SOX and legal hold requirements: A valuable insights to reinforce management regulatory impact analysis must be performed decision-making. on the application landscape impacted by the site closure program. Appropriate actions must The Way Forward be identified for each application to ensure regulatory compliance, as per the following: Life sciences organizations face overwhelming challenges to bring down costs. R&D site closures >> Data retention requirements from health are among the key R&D levers companies can apply authorities: Regulatory authorities have to an overall cost-reduction strategy. Although clear mandates for data retention with suf- this is a complex activity fraught with operational ficient details provided to life sciences or- sensitivities, the three-layered approach outlined ganizations on the data types required and above provides most of the necessary inputs for timelines. Life sciences organizations must shaping the strategy to achieve most if not all of comply with these requirements; noncom- a life sciences organization’s business objectives. pliance could result in penalties or more (See the accompanying sidebar on page 4 for a serious consequences for the organization. brief illustration of how this methodology can be >> Legal hold on system, information and applied.) data: It is critically important to identify the systems and information/data subjected to The potential savings from the site closures must legal hold before migration and decommis- be directed to core focus areas leading to higher sioning of applications. return on investment. The absolute savings can be maximized if the site closures program >> Requirements on the system’s downtime is managed in an operationally effective and for some critical applications (financial efficient manner. systems, adverse event reporting system, etc.). Footnotes 1 “World Preview 2018-Embracing the Patent Cliff,” www.evaluatepharma.com. 2 “The Pharmaceutical Sector: Real estate implications of industry wide change,” Nov. 2009, http://www.cbre.eu. 3 Chemical and Engineering News; company Web sites; Fierce Pharma. About the Authors Dinesh Singh is a Consulting Manager with Cognizant Business Consulting’s Life Sciences Practice. He is a seasoned advisor with nine-plus years of experience in business strategy, large transformation initia- tives and complex program management consulting in the life sciences industry. He has worked with leading pharmaceuticals clients to help them address key business problems and align their strategies. He can be reached at Dinesh.Singh@cognizant.com. Rohan Desai is a Consultant with Cognizant Business Consulting. He has worked as a solution consultant for various life sciences solution development activities, projects and pursuits. He can be reached at Rohan.Desai@cognizant.com. cognizant 20-20 insights 6
  • 7. About Cognizant Cognizant (NASDAQ: CTSH) is a leading provider of information technology, consulting, and business process out- sourcing services, dedicated to helping the world’s leading companies build stronger businesses. Headquartered in Teaneck, New Jersey (U.S.), Cognizant combines a passion for client satisfaction, technology innovation, deep industry and business process expertise, and a global, collaborative workforce that embodies the future of work. With over 50 delivery centers worldwide and approximately 150,400 employees as of September 30, 2012, Cognizant is a member of the NASDAQ-100, the S&P 500, the Forbes Global 2000, and the Fortune 500 and is ranked among the top performing and fastest growing companies in the world. Visit us online at www.cognizant.com or follow us on Twitter: Cognizant. World Headquarters European Headquarters India Operations Headquarters 500 Frank W. Burr Blvd. 1 Kingdom Street #5/535, Old Mahabalipuram Road Teaneck, NJ 07666 USA Paddington Central Okkiyam Pettai, Thoraipakkam Phone: +1 201 801 0233 London W2 6BD Chennai, 600 096 India Fax: +1 201 801 0243 Phone: +44 (0) 20 7297 7600 Phone: +91 (0) 44 4209 6000 Toll Free: +1 888 937 3277 Fax: +44 (0) 20 7121 0102 Fax: +91 (0) 44 4209 6060 Email: inquiry@cognizant.com Email: infouk@cognizant.com Email: inquiryindia@cognizant.com © ­­ Copyright 2012, Cognizant. All rights reserved. No part of this document may be reproduced, stored in a retrieval system, transmitted in any form or by any means, electronic, mechanical, photocopying, recording, or otherwise, without the express written permission from Cognizant. The information contained herein is subject to change without notice. All other trademarks mentioned herein are the property of their respective owners.