Upload
irene-miller
View
215
Download
0
Tags:
Embed Size (px)
Citation preview
Medicines Differentiation AnalyticsIncreasing 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 AnalyticsIncreasing Pipeline Returns
2
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
crea
sin
g G
ov’
t R
egu
lati
on
© Medicines Differentiation Analytics LLC 2011 – all rights reserved - PATENT PENDING
Medicines Differentiation AnalyticsIncreasing 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 AnalyticsIncreasing Pipeline Returns
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
© Medicines Differentiation Analytics LLC 2011 – all rights reserved - PATENT PENDING
Medicines Differentiation AnalyticsIncreasing Pipeline Returns
5
MDA Overall Methodology
Unmet Needs:PatientsPrescribersCaregiversPayersApprovers
Customer Value Statements
(CVS)
Customer Value Statements
(CVS)Standard Parameters:
EfficacySafety
TolerabilityConvenience
Cost
Healthcare Differentiation
Instrument (HDI)
Healthcare Differentiation
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)
Real/Win/Worth Analysis (RWW)
Access/Reimbursement
Strategy
Access/Reimbursement
Strategy
Predicting Behavior:Based on prior actions
© Medicines Differentiation Analytics LLC 2011 – all rights reserved - PATENT PENDING
Medicines Differentiation AnalyticsIncreasing Pipeline Returns
6
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
Customer Value Statements
(CVS)
Customer Value Statements
(CVS)
Healthcare Differentiation
Instrument (HDI)
Healthcare Differentiation
Instrument (HDI)
Differentiated Label StrategyDifferentiated Label Strategy
Access/Reimbursement
Strategy
Access/Reimbursement
Strategy
Real/Win/Worth Analysis (RWW)
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 AnalyticsIncreasing 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 AnalyticsIncreasing 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
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.
© Medicines Differentiation Analytics LLC 2011 – all rights reserved - PATENT PENDING
Medicines Differentiation AnalyticsIncreasing 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 AnalyticsIncreasing Pipeline Returns
Now go to Demo
10
© Medicines Differentiation Analytics LLC 2011 – all rights reserved - PATENT PENDING
Medicines Differentiation AnalyticsIncreasing Pipeline Returns
Add RWW slide - TBD
11
© Medicines Differentiation Analytics LLC 2011 – all rights reserved - PATENT PENDING
Medicines Differentiation AnalyticsIncreasing Pipeline Returns
‘‘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
© Medicines Differentiation Analytics LLC 2011 – all rights reserved - PATENT PENDING
Medicines Differentiation AnalyticsIncreasing Pipeline Returns
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
© Medicines Differentiation Analytics LLC 2011 – all rights reserved - PATENT PENDING
Medicines Differentiation AnalyticsIncreasing 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 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…..
© Medicines Differentiation Analytics LLC 2011 – all rights reserved - PATENT PENDING
Medicines Differentiation AnalyticsIncreasing Pipeline ReturnsFor More Information Contact: