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LIFECYCLE MANAGEMENT
         Maximizing product and portfolio value throughout the commercial lifecycle



                                                                                                                 PRE-LAUNCH

                                                                                                   When preparing to commercialize
                                                                                                   a product, there are many
                                                                                                   opportunities to maximize gains
                                                                                                   and establish processes and
PROFIT




                                                                                                   systems that enable you to
                                                                                                   optimize value at later stages.

            PRE-LAUNCH                                                         LATE STAGE
                                       GROWTH
                                        STAGE                                                                    GROWTH STAGE


                                                 TIME                                              During the patented period, critical
                                                                                                   to maximizing your investment is
                                                                                                   understanding future opportunities
                                                                                                   and threats to growth. We carry out
                                                                                                   assessments to help you understand
  LIFECYCLE MANAGEMENT PLAN
                                                                                                   how the environment has changed
                                                                                                   since post Phase III planning. We
 Establishing the Process
                                                                                                   also assess the impacts for future
 We develop a structured approach for LCM at each stage of the process whilst managing
                                                                                                   LCM planning, specifically assessing
 stakeholders.
                                                                                                   follow-on indications, reformulations
 Brainstorming Options                                                                             and fixed dose combinations.
 To ensure a comprehensive assessment is undertaken, we work with you to develop
 and supply a full option appraisal. To ideate, select and prioritize activities, we facilitate
 brainstorming sessions with key stakeholders. We shape and inform the dialogue to inspire
 a robust option analysis.                                                                                       LATE STAGE
 Prioritising to Your Needs
 We identify clear organizational priorities which are integrated into the overall decision        At loss of exclusivity, it is vital to
 making process. This is developed into a roadmap for immediate and long-term returns on           engage the most profitable tactics
 investment.                                                                                       for competing with generics or
                                                                                                   biosimilars. We provide a prioritized
 Building Business Cases                                                                           list of tactics which are framed
 In order to build a clear understanding of where the LCM option fits into the overall portfolio   around the geographical and
 strategy, we support you in building robust business cases aligned to your brand and              environmental context (i.e. level of
 business strategy.                                                                                stakeholder influence post loss of
                                                                                                   expiry, generic substitution, pricing
                                                                                                   and reimbursement). These are
                                                                                                   forecasted using relevant data and
                                                                                                   analogues analysis, whilst assessing
                                                                                                   the implications for your brand.




Our consultants operate globally; our head offices are located in:
UK 	     119 Farringdon Road, London EC1R 3DA | +44 (0)20 7675 7000
US 	     52 Vanderbilt Avenue, 7th Floor, New York, NY 10017 | +1 (212) 686 7400                         info@datamonitorconsulting.com
Japan 	 7th Kotakudo GINZA Building, 5-14-5, Ginza, Chuo, Tokyo 104-0061 | +81 (0)3 5148 7910            www.datamonitorconsulting.com
RESULTS IN PRACTICE: HOW WE’VE HELPED OTHERS


 OUR EXPERTISE

Datamonitor Consulting has vast expertise in LCM. We are thought leaders in this field and have been teaching and ideating for our clients’ brands
for over 10 years. Our specific expertise focuses on:

• Identifying and engaging key internal and external stakeholders

• Synthesizing shared and disparate product and business perspectives

• Driving cross-functional decision making

We prioritize and validate key LCM options through client consensus building, up-to-date market and medical data combined with
Datamonitor insight.




 LAUNCH PHASE LCM                                                            PATENT EXPIRY PLANNING

                    The Issue                                                                    The Issue
                    The Brand team for a late Phase III brand                                    A mid-cap European Pharma company was
                    needed to build a lifecycle management plan to                               facing the reality of patent expiry of a key
                    support mid-term expansion of a key immunology                               revenue driving brand within two years, and
                    franchise, culminating in the development of a                               needed to build country-level management plans
                    business case for management approval.                                       to maximize brand potential through the launch
                                                                                                 of generic competitors.



                    Our Approach                                                                 Our Approach
                    We designed a systematic process for initial idea                            Over a period of six months, we evaluated the
                    generation, including:                                                       stakeholder and market landscape for patent
                                                                                                 expiry across 15 markets, developing likely
                    • Internal and external input                                                erosion models for the brand that considered
                                                                                                 both market and therapeutic factors. Building
                    • Prioritization of opportunities in an active 	
                                                                                                 from this process, we developed a portfolio
                    	 workshop setting
                                                                                                 of tactical options that were viable in different
                    • Validation of priorities with internal teams and 	                         market environments, which we explored and
                    	 key opinion leaders.                                                       initiated for action planning in a series of pan-
                                                                                                 market workshops.
                    Working in close partnership with the client
                    team, we supported the development of a set
                    of validated business cases to enable effective
                    decision making.




                    The Result                                                                   The Result
                    From an initial list of over 100 potential                                   Our client was able to segment and cluster
                    opportunities, 10 prioritized LCM opportunities                              markets based on the likely impact of generic
                    were identified for the target brand on the basis                            erosion and appropriate tactical response. This
                    of commercial opportunity and feasibility to                                 enabled more effective global support to each
                    execute. Through further validation, a final                                 affiliate. Meanwhile, affiliates were able to learn
                    business case with three priority and two backup                             from the experience and expertise of other
                    opportunities was developed, challenged by                                   market peers, enabling a more effective and
                    management, and subsequently approved.                                       refined execution of tactics.




Our consultants operate globally; our head offices are located in:
UK 	     119 Farringdon Road, London EC1R 3DA | +44 (0)20 7675 7000
US 	     52 Vanderbilt Avenue, 7th Floor, New York, NY 10017 | +1 (212) 686 7400                                info@datamonitorconsulting.com
Japan 	 7th Kotakudo GINZA Building, 5-14-5, Ginza, Chuo, Tokyo 104-0061 | +81 (0)3 5148 7910                   www.datamonitorconsulting.com

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Datamonitor Consulting: Lifecycle Management in the Pharmaceutical and Biotechnology Industry

  • 1. LIFECYCLE MANAGEMENT Maximizing product and portfolio value throughout the commercial lifecycle PRE-LAUNCH When preparing to commercialize a product, there are many opportunities to maximize gains and establish processes and PROFIT systems that enable you to optimize value at later stages. PRE-LAUNCH LATE STAGE GROWTH STAGE GROWTH STAGE TIME During the patented period, critical to maximizing your investment is understanding future opportunities and threats to growth. We carry out assessments to help you understand LIFECYCLE MANAGEMENT PLAN how the environment has changed since post Phase III planning. We Establishing the Process also assess the impacts for future We develop a structured approach for LCM at each stage of the process whilst managing LCM planning, specifically assessing stakeholders. follow-on indications, reformulations Brainstorming Options and fixed dose combinations. To ensure a comprehensive assessment is undertaken, we work with you to develop and supply a full option appraisal. To ideate, select and prioritize activities, we facilitate brainstorming sessions with key stakeholders. We shape and inform the dialogue to inspire a robust option analysis. LATE STAGE Prioritising to Your Needs We identify clear organizational priorities which are integrated into the overall decision At loss of exclusivity, it is vital to making process. This is developed into a roadmap for immediate and long-term returns on engage the most profitable tactics investment. for competing with generics or biosimilars. We provide a prioritized Building Business Cases list of tactics which are framed In order to build a clear understanding of where the LCM option fits into the overall portfolio around the geographical and strategy, we support you in building robust business cases aligned to your brand and environmental context (i.e. level of business strategy. stakeholder influence post loss of expiry, generic substitution, pricing and reimbursement). These are forecasted using relevant data and analogues analysis, whilst assessing the implications for your brand. Our consultants operate globally; our head offices are located in: UK 119 Farringdon Road, London EC1R 3DA | +44 (0)20 7675 7000 US 52 Vanderbilt Avenue, 7th Floor, New York, NY 10017 | +1 (212) 686 7400 info@datamonitorconsulting.com Japan 7th Kotakudo GINZA Building, 5-14-5, Ginza, Chuo, Tokyo 104-0061 | +81 (0)3 5148 7910 www.datamonitorconsulting.com
  • 2. RESULTS IN PRACTICE: HOW WE’VE HELPED OTHERS OUR EXPERTISE Datamonitor Consulting has vast expertise in LCM. We are thought leaders in this field and have been teaching and ideating for our clients’ brands for over 10 years. Our specific expertise focuses on: • Identifying and engaging key internal and external stakeholders • Synthesizing shared and disparate product and business perspectives • Driving cross-functional decision making We prioritize and validate key LCM options through client consensus building, up-to-date market and medical data combined with Datamonitor insight. LAUNCH PHASE LCM PATENT EXPIRY PLANNING The Issue The Issue The Brand team for a late Phase III brand A mid-cap European Pharma company was needed to build a lifecycle management plan to facing the reality of patent expiry of a key support mid-term expansion of a key immunology revenue driving brand within two years, and franchise, culminating in the development of a needed to build country-level management plans business case for management approval. to maximize brand potential through the launch of generic competitors. Our Approach Our Approach We designed a systematic process for initial idea Over a period of six months, we evaluated the generation, including: stakeholder and market landscape for patent expiry across 15 markets, developing likely • Internal and external input erosion models for the brand that considered both market and therapeutic factors. Building • Prioritization of opportunities in an active from this process, we developed a portfolio workshop setting of tactical options that were viable in different • Validation of priorities with internal teams and market environments, which we explored and key opinion leaders. initiated for action planning in a series of pan- market workshops. Working in close partnership with the client team, we supported the development of a set of validated business cases to enable effective decision making. The Result The Result From an initial list of over 100 potential Our client was able to segment and cluster opportunities, 10 prioritized LCM opportunities markets based on the likely impact of generic were identified for the target brand on the basis erosion and appropriate tactical response. This of commercial opportunity and feasibility to enabled more effective global support to each execute. Through further validation, a final affiliate. Meanwhile, affiliates were able to learn business case with three priority and two backup from the experience and expertise of other opportunities was developed, challenged by market peers, enabling a more effective and management, and subsequently approved. refined execution of tactics. Our consultants operate globally; our head offices are located in: UK 119 Farringdon Road, London EC1R 3DA | +44 (0)20 7675 7000 US 52 Vanderbilt Avenue, 7th Floor, New York, NY 10017 | +1 (212) 686 7400 info@datamonitorconsulting.com Japan 7th Kotakudo GINZA Building, 5-14-5, Ginza, Chuo, Tokyo 104-0061 | +81 (0)3 5148 7910 www.datamonitorconsulting.com