medicines differentiation analytics increasing pipeline returns medicines differentiation analytics...

Medicines Differentiation AnalyticsIncreasing Pipeline Returns

Medicines Differentiation Analytics Methodology

Review with …….

Date, 2011

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© Medicines Differentiation Analytics LLC 2011 – all rights reserved - PATENT PENDING


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Ever increasing challenges of the Path to Market …

Challenges Facing the Pharmaceutical Industry

Fu

nd

ing

Red

uced

Vast Scientific Data Growing

Increasing Power of Customer Base Need for more effective,

yet standard & simple, Differentiation Analysis

Greater Return On Investment DecisionsIn

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"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



Reflects True Differentiation

Is Customer Driven

Monetizes Value across PortfoliosProviding 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 needThe likelihood your asset will win in the market against other alternativesThe 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: ApprovedPaid 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



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MDA Overall Methodology

Unmet Needs:PatientsPrescribersCaregiversPayersApprovers

Customer Value Statements

(CVS)


(CVS)Standard Parameters:

EfficacySafety

TolerabilityConvenience

Cost

Healthcare Differentiation

Instrument (HDI)


Instrument (HDI)

Begin with the End in Mind:

Differentiated Label Sections,

Competitors Claims,Ideal &

Fallback Claims

Differentiated Label StrategyDifferentiated Label Strategy

Investment Decisions that

result in:

SignificantlyImproved

ROI

Probability this Asset will be:Taken, Prescribed, Approved and Paid For over all other alternatives.

Real/Win/Worth Analysis (RWW)


Access/Reimbursement

Strategy


Strategy

Predicting Behavior:Based on prior actions



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HealthCare Differentiation Instrument

Unmet Needs:PatientsPrescribersCaregiversPayersApprovers

Standard Parameters:Efficacy

SafetyTolerability

ConvenienceCost

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:

SignificantlyImproved

ROI


(CVS)


(CVS)


Instrument (HDI)


Instrument (HDI)

Differentiated Label StrategyDifferentiated Label Strategy


Strategy


Strategy



Predicting Behavior:Based on prior actions

Todays Focus



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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



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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

11For Internal Use Only

Example: Program XYZ Planned/Desired Range

Observed performance

Key Criteria

Cat

eg

ory

1C

ate

go

ry 2

scale scale

scale scale

scale scale

scale scale

Parameter A

Parameter B

Parameter C

Parameter D

Compound and Indication: TextPatient population: TextComments: Text Leading Pipeline Programs

Leading In-Line Products

DifferentiationScore

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.



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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



Now go to Demo

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Add RWW slide - TBD

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‘‘Turbo Tax’ for Medicine Development!Turbo Tax’ for Medicine Development!‘‘Turbo Tax’ for Medicine Development!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



The Vision…..

Results: a kiosk for any asset to measure it’s differentiation against all current & future 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.competitor’s based on common set of Customer Needs & Parameters by Disease Area.

Results: a kiosk for any asset to measure it’s differentiation against all current & future 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.competitor’s based on common set of Customer Needs & Parameters by Disease Area.

Most Bio/Pharma With 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 ToolsStandard 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 TeamObjective Differentiation Scores by Parameter and Overall – to determine the likelihood it will be approved, paid for, prescribed and taken

ProductivityManual 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



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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 Links the ScienceScience of Medicines Research to the Unmet of Medicines Research to the Unmet CustomerCustomer Needs Resulting in a Greater Needs Resulting in a Greater ROIROI from your Research Investments ! from your Research Investments !

Benefits to XXX…..


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