Understanding Challenges Towards Effective Life Cycle Management (LCM) Pharmaceutical Product Lifecycle Management Confere...
Agenda <ul><li>Overview of current pharmaceutical environment </li></ul><ul><li>Key Challenges in the LCM landscape </li><...
Overview of the Current Environment Overall it’s the perception of value which is undergoing a change in the industry
The Source of the Problem Note: Net innovation in a given year represents peak life cycle sales for each drug launched tha...
The New Business Model The role of information has changed considerably from a peripheral point to a more integrated level...
The Starting Point <ul><li>Accept that a major change is happening in the pharmaceutical market space AND </li></ul><ul><l...
Key Challenges in the LCM Landscape <ul><li>Integration of core strategy </li></ul><ul><ul><li>Should  the strategy be cen...
Benefits of Integration <ul><li>Development of Better Insights </li></ul><ul><ul><li>In this new information-rich age, int...
How Does Integration Help You Make Better Decision in LCM? Multiple Secondary,  Tertiary and Proprietary  Sources Cross-co...
Case Studies and Examples <ul><li>One-size-fits-all strategy v/s customised approaches </li></ul><ul><li>Win-win propositi...
Launch Sequencing Case Studies –  Evolution Over Time 2000 2005 2010 <ul><li>Companies are taking an increasing global vie...
Launch Sequencing Case Studies –  Primary Vs Secondary Care Markets  <ul><li>Based on our sample of case studies, primary-...
Industry-Payer Partnership  Landscape Matrix <ul><li>The  time and financial commitment required to build industry-payer  ...
Payer Partnerships Implications <ul><li>In the United States, industry has been able to develop “downstream” partnerships ...
Selection of LCM Tactics <ul><li>New indications </li></ul><ul><li>New formulations </li></ul><ul><li>Paediatric market ex...
Conclusion and Recommendations <ul><li>LCM must be a priority in today’s rapidly changing environment  </li></ul><ul><li>B...
<ul><li>Visit the IHS Healthcare & Pharma Blog </li></ul><ul><li>Get weekly insights on the events  </li></ul><ul><li>and ...
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Pharmaceutical Lifecycle Management Challenges - Slides from Pharmaceutical Product Lifecycle Management Conference, London, 26th January 2012

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Slides from Praful Mehta's presentation at Pharmaceutical Product Lifecycle Management Conference,
London, 26th January 2012

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Pharmaceutical Lifecycle Management Challenges - Slides from Pharmaceutical Product Lifecycle Management Conference, London, 26th January 2012

  1. 1. Understanding Challenges Towards Effective Life Cycle Management (LCM) Pharmaceutical Product Lifecycle Management Conference London, 26 th January 2012 Praful Mehta, Senior Analyst, IHS
  2. 2. Agenda <ul><li>Overview of current pharmaceutical environment </li></ul><ul><li>Key Challenges in the LCM landscape </li></ul><ul><li>Case studies and examples </li></ul><ul><li>Conclusion and Recommendations </li></ul><ul><li>Q&A </li></ul>
  3. 3. Overview of the Current Environment Overall it’s the perception of value which is undergoing a change in the industry
  4. 4. The Source of the Problem Note: Net innovation in a given year represents peak life cycle sales for each drug launched that year, less prior year sales for each drug expiring that year. Source: Goldman Sachs Research, FactSet, company data BOOM PERIOD LOST DECADE OF INNOVATION WILL PHARMA TAKE THE RED PILL OR BLUE PILL? Factor Xa’s Alzheimer's HDL Hepatitis C Vaccines Oncology Obesity Diabetes R&D Spend Poor capital allocation
  5. 5. The New Business Model The role of information has changed considerably from a peripheral point to a more integrated level The Biggest Challenge In a traditional blockbuster dependent model, information flows from one decision making entity to the next in peripheries but not within entities In a payer centric model, information flows between entities is much more rapid and ensures development of more effective solutions Payers and Specialists are the key decision makers Information Information Insight will play a deeper role in ensuring sustainability
  6. 6. The Starting Point <ul><li>Accept that a major change is happening in the pharmaceutical market space AND </li></ul><ul><li>Understand what is changing so as to adapt accordingly </li></ul><ul><li>Charles Darwin </li></ul><ul><ul><li>“ It is not the strongest of the species that survives, nor the most intelligent, but the one most responsive to change”  </li></ul></ul>‘ One of the most critical steps in developing a cohesive LCM strategy for any product portfolio is to dissect the strategy in various dimensions and target each dimension with the right tactic so as to maximise strategic effectiveness’ – A Thought Leader’s Viewpoint
  7. 7. Key Challenges in the LCM Landscape <ul><li>Integration of core strategy </li></ul><ul><ul><li>Should the strategy be centralised or project based? </li></ul></ul><ul><ul><li>When should LCM strategy be implemented - at an early stage of the asset or at later stage? </li></ul></ul><ul><ul><li>What are the implications of an integrated approach? </li></ul></ul><ul><li>The importance of understanding the changing environment </li></ul><ul><ul><li>What are the key developments which can affect the LCM outlook significantly? </li></ul></ul><ul><ul><li>How can companies synthesise insights from today’s information overload? </li></ul></ul><ul><li>The need to accommodate tactical changes to current LCM strategic landscape? </li></ul><ul><ul><li>What tactical measures can be implemented to reinforce the overall strategy without antagonizing stakeholders? </li></ul></ul><ul><ul><li>Who should be held accountable for implementing those changes and measuring its performance? </li></ul></ul><ul><li>Optimizing engagement channels and marketing approaches </li></ul><ul><ul><li>What tools are most beneficial in achieving maximum ROI? </li></ul></ul><ul><ul><li>What are the success factors of channel optimisation? </li></ul></ul>
  8. 8. Benefits of Integration <ul><li>Development of Better Insights </li></ul><ul><ul><li>In this new information-rich age, integration starts with re-aligning your information sources so as to draw meaningful insights </li></ul></ul><ul><li>Increase in Market Share </li></ul><ul><ul><li>A completely integrated strategy can help companies find new markets for existing products and increase the overall market presence </li></ul></ul><ul><li>Improved Patient Compliance </li></ul><ul><ul><li>From a clinical perspective, the use of an integrated life-cycle management (LCM) strategy can also offer improved safety/efficacy profiles or improved dosing regimens, thereby enhancing patient compliance </li></ul></ul><ul><li>Increase in Overall Value </li></ul><ul><ul><li>The perception of value is one the biggest challenges in these economic times and an integrated approach can help deliver the value at an optimal cost. This could be achieved by demonstrating that the new medication significantly improves the lives of patients, either through increased compliance, reduction of side effects or improved therapeutic outcomes. </li></ul></ul><ul><li>Timely Intervention </li></ul><ul><ul><li>An integrated approach ensures that insights are utilised to draw meaningful conclusion thereby ensuring the right time to pull different strategic levers </li></ul></ul>
  9. 9. How Does Integration Help You Make Better Decision in LCM? Multiple Secondary, Tertiary and Proprietary Sources Cross-country analysis of pricing, cost and sales data Analysis of treatment and dosing regimen Insights Dimensions of Data Collation * IHS Therapy Area Focused Services Help Clients Develop Meaningful Insights by Collating Information and Analysis in One Platform Analysis of trial endpoints, outcome parameters and cross country trial data Analysis of reimbursement, regulatory and policy environment Analysis of alliances, patents and financial data Drug / Disease Overview Clinical Trial Information Treatment Paradigm Pricing, Cost and Sales Information Regulatory and Reimbursement Information In 2011, almost two-thirds of LCM initiatives were shelved due to poor insights
  10. 10. Case Studies and Examples <ul><li>One-size-fits-all strategy v/s customised approaches </li></ul><ul><li>Win-win proposition - Analysis of issues and subsequent communication with stakeholders can help introduce tactical changes in the overall strategy </li></ul><ul><li>Event analysis like launch sequencing, payer partnerships, therapy compliance and adherence rates, and therapeutic licensing trends can help design a successful product portfolio strategy </li></ul><ul><li>Examples of analyses which can help companies choose a right LCM course for their product portfolio: </li></ul><ul><ul><li>Analysis of Launch Sequencing </li></ul></ul><ul><ul><li>Analysis of Payer-Partnerships in the Industry </li></ul></ul>
  11. 11. Launch Sequencing Case Studies – Evolution Over Time 2000 2005 2010 <ul><li>Companies are taking an increasing global view of drug launches as illustrated by the shorter time it took in 2010 (see X axis) to roll out medicines across geographies. </li></ul><ul><li>The lag between first and second launch has narrowed over the last five years. </li></ul><ul><li>Strategies have evolved over the last five years but not so much between 2000 and 2005. </li></ul>Efient/Effient Onglyza Victoza Prolia Revlimid Baraclude Tarceva Xolair Actos Zyprexa Herceptin Lantus
  12. 12. Launch Sequencing Case Studies – Primary Vs Secondary Care Markets <ul><li>Based on our sample of case studies, primary-care medicines seem to be rolled out across more geographies than secondary-care medicines, which even in 2010 seem to remain targeted to mature, top-tier markets at least at first. </li></ul>Onglyza Victoza Votrient Prolia Primary Care Secondary Care
  13. 13. Industry-Payer Partnership Landscape Matrix <ul><li>The time and financial commitment required to build industry-payer partnerships mean that these tend to be best suited to Big Pharma </li></ul><ul><li>Smaller industry players needing a rapid return on investment will struggle to find the resources to engage in such longer-term activities </li></ul><ul><li>For smaller players, however, with specialty or niche products requiring service redesign or physician and patient training, partnering with payers may be a necessity rather than a choice in their market-access efforts </li></ul>Company Size Asset Nature Large Medium Small Niche/Specialty Invest to bolster market access, manage international price level and build relationships Manage Selectively to promote market access and build relationships Manage Selectively according to Need Chronic Diseases Manage selectively based on resources and overall portfolio Non-niche/specialty Non-chronic diseases Invest to build relationships N/A
  14. 14. Payer Partnerships Implications <ul><li>In the United States, industry has been able to develop “downstream” partnerships that are product or portfolio specific. In France and the United Kingdom, however, partnering tends to be done more broadly (e.g.,around general service design or education), and may have only indirect benefits for market access In these cases the motive is focused on cases, building relationships and securing potential follow-on opportunities for collaboration that may have more direct benefit </li></ul><ul><li>Risk sharing is likely to continue to play a prominent role in a number of European markets for some time. Both industry and public payers are keen to see these schemes evolve towards fairer risk-management tools. In this context, mutual trust and transparency will be key to success, although both stakeholders will need to consider whether transparency needs to extend to the commercial side of the agreement </li></ul><ul><li>Transparency involves setting objectives, expectations, metrics, timelines, and responsibilities up front and in collaboration. In the eye of payers, it is also important to have the right parameters in place so that a partnership can readily be reproduced by other organisations within a healthcare system. Indeed, payers feel that one indication of a successful partnership is if it can be highlighted as an example of best practice </li></ul><ul><li>A successful partnership is often defined by payers as one that met its objectives. With such a basic definition of success, the difficulty lies in setting relevant, specific, measurable, achievable, realistic, time-bound objectives for these partnerships </li></ul>
  15. 15. Selection of LCM Tactics <ul><li>New indications </li></ul><ul><li>New formulations </li></ul><ul><li>Paediatric market exclusivity </li></ul><ul><li>Disease management programs </li></ul><ul><li>Strategic pricing changes </li></ul><ul><li>Authorized generics </li></ul><ul><li>Combination products </li></ul><ul><li>Next-generation products </li></ul><ul><li>New dosing regimens </li></ul><ul><li>Patent litigation </li></ul><ul><li>Rx-to-OTC switches </li></ul>External Forces Internal Forces Potential return on investment, Market Research Insights, Competitor’s Strategy, Execution Cost and Time and Time from Patent Expiration Understanding of threats and opportunities, Level of resources and funding, Level of Integration within the company and Ability to implement initiatives
  16. 16. Conclusion and Recommendations <ul><li>LCM must be a priority in today’s rapidly changing environment </li></ul><ul><li>Better insights about the operating environment will govern sustainability </li></ul><ul><li>Integration is the key to a successful LCM strategy </li></ul><ul><li>A clear definition of various performance matrices and expected ROIs will help develop a cohesive strategy </li></ul><ul><li>The choice of the strategy will depend on complete analysis of internal and external environment </li></ul><ul><li>A new successful engagement model must take a proactive approach towards meeting stakeholder expectations </li></ul>
  17. 17. <ul><li>Visit the IHS Healthcare & Pharma Blog </li></ul><ul><li>Get weekly insights on the events </li></ul><ul><li>and trends shaping the industry: </li></ul><ul><li>www.ihs.com/healthcareblog </li></ul>

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