Medicines Differentiation Analytics Increasing Pipeline Returns Medicines Differentiation Analytics Methodology Review with ……. Date, 2011 Add any Logo

© Medicines Differentiation Analytics LLC 2011 – all rights reserved - PATENT PENDING Medicines Differentiation Analytics Increasing Pipeline Returns 2 Ever increasing challenges of the Path to Market … Challenges Facing the Pharmaceutical Industry Funding Reduced Vast Scientific Data Growing Increasing Power of Customer Base Need for more effective, yet standard & simple, Differentiation Analysis Greater Return On Investment Decisions Increasing Gov’t Regulation

© Medicines Differentiation Analytics LLC 2011 – all rights reserved - PATENT PENDING Medicines Differentiation Analytics Increasing Pipeline Returns 3 "Our industry is taking too long, we're spending too much, and we're producing far too little. Ironically, the crisis in our innovation model comes at a time when we have vastly more scientific knowledge and data than ever before. But unless we change the way we do research, we won't translate this knowledge into advance." Eli Lilly CEO John Lechleiter, February 2011 “Just as biomedical research has evolved in the past decades, regulatory science — the science and tools we use to assess and evaluate product safety, efficacy, potency, quality and performance — must also evolve.” Dr. Margaret Hamburg, Commissioner of the FDA, stated at the RAPS 2009 Conference, Recent Quotes

© Medicines Differentiation Analytics LLC 2011 – all rights reserved - PATENT PENDING Medicines Differentiation Analytics Increasing Pipeline Returns 4 Reflects True Differentiation Is Customer Driven Monetizes Value across Portfolios Providing the likelihood your medicine will bring the highest Return on Investment (ROI) over other alternatives in your portfolio.  How real the opportunity is - that your medicine directly addresses a significant unmet need  The likelihood your asset will win in the market against other alternatives  The financial worth of the life cycle investment Intent of Medicines Differentiation Analytics Methodology Describing how your medicine will be uniquely differentiated in the market so that it has the highest probability to be:  Approved  Paid For  Prescribed  Taken over all other alternatives Demonstrating how strongly your medicine addresses real unmet needs in the market for:  Patients  Prescribers  Approvers  Payers  Caregivers The Resulting Outcomes: Greater ROI of portfolio decisions, including Differentiation Scores Streamlined process with standard parameters and competitive data by disease area

© Medicines Differentiation Analytics LLC 2011 – all rights reserved - PATENT PENDING Medicines Differentiation Analytics Increasing Pipeline Returns 5 MDA Overall Methodology Unmet Needs: Patients Prescribers Caregivers Payers Approvers Customer Value Statements (CVS) Standard Parameters: Efficacy Safety Tolerability Convenience Cost Healthcare Differentiation Instrument (HDI) Begin with the End in Mind : Differentiated Label Sections, Competitors Claims, Ideal & Fallback Claims Differentiated Label Strategy Investment Decisions that result in: Significantly Improved ROI Probability this Asset will be : Taken, Prescribed, Approved and Paid For over all other alternatives. Real/Win/Worth Analysis (RWW) Access/Reimbur sement Strategy Predicting Behavior: Based on prior actions

© Medicines Differentiation Analytics LLC 2011 – all rights reserved - PATENT PENDING Medicines Differentiation Analytics Increasing Pipeline Returns 6 HealthCare Differentiation Instrument Unmet Needs: Patients Prescribers Caregivers Payers Approvers Standard Parameters: Efficacy Safety Tolerability Convenience Cost Begin with the End in Mind : Differentiated Label Sections, Competitors Claims, Ideal & Fallback Claims Probability this Asset will be : Taken, Prescribed, Approved and Paid For over all other alternatives. Investment Decisions that result in: Significantly Improved ROI Customer Value Statements (CVS) Healthcare Differentiation Instrument (HDI) Differentiated Label Strategy Access/Reimbur sement Strategy Real/Win/Worth Analysis (RWW) Predicting Behavior: Based on prior actions Todays Focus

© Medicines Differentiation Analytics LLC 2011 – all rights reserved - PATENT PENDING Medicines Differentiation Analytics Increasing Pipeline Returns 7 What is a HealthCare Differentiation Instrument (HDI)? The HealthCare Differentiation Instrument (HDI) provides a simple graphical presentation that depicts:  Key characteristics of a medicine that will drive the value in the market place  How the new medicine is expected to compare to the current available treatments and the emerging competition, both positively and negatively Benefits of HDI:  HDI will encourage debate and inquiry into the medicines characteristics  It creates alignment within the team and ensures development of a strategy driven by valuable differentiation  Creates transparency and facilitates discussion of when and how endpoints can be assessed, and outstanding risks to get Governance endorsement  Creates a strong foundation for decision making as data become available  Becomes a platform for repeatable and standard set of analysis within disease area

© Medicines Differentiation Analytics LLC 2011 – all rights reserved - PATENT PENDING Medicines Differentiation Analytics Increasing Pipeline Returns 8 HealthCare Differentiation Instrument Instructions Expected results: ▪ Illustrated value differentiation ▪ Alignment on key value drivers ▪ Robust discussion and decision making Purpose: ▪ Drive robust decision making ▪ Highlight and communicate what differentiates asset in the market place – why patients will want to take it, physicians will prescribe it, and payors will pay for it. Purpose: ▪ Drive robust decision making ▪ Highlight and communicate what differentiates asset in the market place – why patients will want to take it, physicians will prescribe it, and payors will pay for it. How to draft a HDI: Categories are set by Disease Area, and typically include Efficacy, Safety, Convenience, Cost & Tolerability A A 11 For Internal Use Only Example: Program XYZ Planned/Desired Range Observed performance Key Criteria Category 1 Category 2 scale Parameter A Parameter B Parameter C Parameter D Compound and Indication: Text Patient population: Text Comments: Text Leading Pipeline Programs Leading In-Line Products Differentiation Score E E Differentiation Scores are system generated by Parameter B B Parameters & corresponding scales are set by Disease Area; teams can add parameters as needed. C C Competing data in-line and pipe-line are automatically drafted below each line. Teams can update if new data exists. D D Teams add or update their medicines potential or existing data above the line; both target and observed data.

© Medicines Differentiation Analytics LLC 2011 – all rights reserved - PATENT PENDING Medicines Differentiation Analytics Increasing Pipeline Returns 9 HDI application starts with a list of compound attributes Potential differentiation criteria Efficacy Safety Convenience Cost to stakeholder Single patient Patient populations Symptomatic Disease alteration Rise in % of responders per indication Adverse events Product specific Tolerability Population specific (e.g., pediatric, pregnancy) Drug interactions Dosage size Dosing regimen Formulation (e.g. oral, QD) Storage Cost advantage over standard of care Cost advantage over cost of not treating condition Broader indications

© Medicines Differentiation Analytics LLC 2011 – all rights reserved - PATENT PENDING Medicines Differentiation Analytics Increasing Pipeline Returns Now go to Demo 10

© Medicines Differentiation Analytics LLC 2011 – all rights reserved - PATENT PENDING Medicines Differentiation Analytics Increasing Pipeline Returns Add RWW slide - TBD 11

© Medicines Differentiation Analytics LLC 2011 – all rights reserved - PATENT PENDING Medicines Differentiation Analytics Increasing Pipeline Returns ‘Turbo Tax’ for Medicine Development! MedifVu – Brings the MDA Methodology to Life Business Intelligence  Automatically pre-populates data  Recommends parameters  Calculates scores  Predicts outcomes  Provides insight into competitive intelligence Structured Process  Five step process  Standard executive reporting  Error checking  Customer needs linked to label claims Insight Across Portfolio  Analytics comparing across entire portfolio against differentiation and other scores Central Data Base  Global access  Historical trends  Benchmarking  Competitor data by Disease Area

© Medicines Differentiation Analytics LLC 2011 – all rights reserved - PATENT PENDING Medicines Differentiation Analytics Increasing Pipeline Returns The Vision….. Results: a kiosk for any asset to measure it’s differentiation against all current & future competitor’s based on common set of Customer Needs & Parameters by Disease Area. Most Bio/PharmaWith MDA Tie to Unmet Need Limited or no connection, varies by Asset Team, if available it mainly focuses on patient Tie to Customer Value Statements (CVS) required and scored on all Customer Needs (patient, payer, prescriber, caregiver, approver) Decision Making Process Inconsistent Methods and Tools Standard Process & Executive Reports, consistent from pre-POC to Launch Measurements Highly variable within Disease Areas typically focused on science Standard set of Parameters within Disease Area to evaluate assets in all areas (science, commercial & cost) Market Differentiation Evaluation Subjective, varies by Asset Team Objective Differentiation Scores by Parameter and Overall – to determine the likelihood it will be approved, paid for, prescribed and taken Productivity Manual Processes, significant workload for team and reliance on contractors to do market evaluations Automated process, data continually undated from changes in the market, global access for teams Investments Investments given to assets based on ROI that often lack strong tie to customer need or high market differentiation and ultimately fail in market Investment decisions across the portfolio based on ROI’s developed from Differentiation and CVS scores within Disease Areas

© Medicines Differentiation Analytics LLC 2011 – all rights reserved - PATENT PENDING Medicines Differentiation Analytics Increasing Pipeline Returns 14  Customer Driven - Forces the linkage of Customer Need to Measurable Parameter; ultimately to Differentiated Claim  Measurable Insights - New Measurements to objectively evaluate multiple compounds (differentiation, CVS, RWW scores)  Streamlined Process - Automatically populates parameters and competitive data by disease area  Greater ROI - Forces science and commercial views to come together at a very early stage – before big investments are made  Predicting Outcomes – likelihood to be paid, taken, prescribed and approved. Links the Science of Medicines Research to the Unmet Customer Needs Resulting in a Greater ROI from your Research Investments ! Benefits to XXX…..

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