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For Internal Use Only 1
Breakout Materials
MDI
LAD
RWW
For Internal Use Only 2
LAD Breakout Objectives
Provide introduction to Label as Driver as a process for ensuring our Planned Label is competitive and drives the Integrated Medicine Plan
Value of LAD
Process & tool to create a Planned Label
How Planned Label will evolve from DP to DP
Begin to apply LAD to your asset
Determine critical success factors of the Label Sections for your asset
Begin to establish Planned & Fall Back Labels
Discuss next steps for your asset
For Internal Use Only 3
Label as Driver: beginning with the goal in mind….
Figure out what you want your label to say
Figure out what you need to do to be able to say it
Discuss your ideas w/FDA as you go along (if appropriate)
Use “label as a driver” process (LAD) to guide and prioritize
asset team activities
For Internal Use Only 4
The expected outcome of the Label as Driver process
The Label Claim* is driven from our Unmet Need (patient, payer, provider, approver or care-giver) and linked to the Value Proposition
There is clarity to the exact wording we strive for Label Claim and how that compares to competitor claims
The Label Claim is the most competitive for COMPANY – able to address multiple needs (pricing/access, detailed aids, formulary, etc).
There is clarity to how the Label Claim will be achieved thru our Integrated Medicine Plans (clinical, regulatory, commercial, access)
* See LAD Glossary for definition* See LAD Glossary for definition
For Internal Use Only 5
LAD Glossary Terms we will use:
Process Elements: Label as Driver Process: the set of activities which assist in identifying and
achieving the Planned Label for COMPANY. LAD Grid: Tying the unmet need, to the actual Label Claims, to the plan/roadmap
to achieve Product Profile and Planned Label. An on-going contract that captures the activities associated with specific Development activities and the Regulatory likelihood of success.
Label Claim: the exact wording/statement proposed in the final label that assists COMPANY in getting regulatory approval, pricing/access, and promotions, etc. The label claim can come from various label sections not just indications.
Planned Label Claim: the most competitive Label Claim we strive for. It must be realistic and have a high probability of success.
Fall Back Label Claims: alternative Label Claims if the Planned Label is not achievable.
Use of Product Profile versus TPP Product Profile: used to capture the key attributes of a product to be successful.
Typically created by Commercial Development to communicate key commercial attributes required. One can not promote from a Product Profile, as they are not written as label claims – particularly in early development.
Target Product Profile (TPP): discussion document used with FDA. Contains label claim statements that are promotable.
Terms we will not use: Target Label Learn Grid
For Internal Use Only 6
Label As Driver Process
1. Define the Opportunity(what)
3. Receive Endorsements
A Well Differentiated, Value-Added Label, and a Sustainable Product
Deliver on important unmet medical need
2. Develop Roadmap
(how)
For Internal Use Only 7
Label As Driver Process: 3 Major Activities in the overall Process
1.Define the Opportunity
(what)
3. Receive Endorsement
2. Develop Roadmap
(how)
LAD is an ongoing process to be done at each DP and as market or asset data changesLAD is an ongoing process to be done at each DP and as market or asset data changes
Articulate unmet customer need
Identify which label sections are critical success factors
Conduct competitive labeling assessment
Create MDI
Establish “planned” & “fall-back” position options
Develop & market test label claims
Present summary to Governance (BU/PRC) for endorsement with the target label as the core of the presentation
(Note: Allow for flexibility depending on BU/Governance)
Determine how to achieve the Label Claims (statements)
Data sources and endpoints
Trials/Study Designs Regulatory assessment
Identify why we can/can’t achieve desired product positioning
Use the LAD Grid as a contract to achieve the Label Claims
For Internal Use Only 88
“As a PATIENT, I need...”
“As a PAYER, I can only reimburse if…... "
“As a PROVIDER, I see current methods lacking in this area…..it is a great unmet need that I would prescribe if available….
Speak from the perspective of a patient, payer, and provider.. Try to limit inputs to 2-3 key points per customer.
This is not asset specific at this time, just what the unmet need is.
PROVIDERS
PAYERS
PATIENTS
Summary of Unmet Customer Need
“As a REGULATOR, there is a need for a safer or more effective solution in this area…REGULATORS
“As a CAREGIVER, there is a need to be able to administer more simply…..CAREGIVER
8
1.Define the Opportunity
(what)
3. Receive Endorsement
2. Develop Roadmap:
Integrated program(how)
For Internal Use Only 99
Promotional Claims/ Differentiation
• Which claims differentiate from competitors
• Which claims are key to acceptance as SOC
Revenue drivers
• Development program to encompass all target patient populations in revenue forecasts
• Critical issues for revenues e.g. duration of treatment
Market Access • Label must align with value proposition and value drivers
Fit with Clinical Practice
• Dosage, administration convenience
• No onerous requirement e.g. special monitoring
• Use with likely concomitant therapies
Additional Factors
• Requirement for diagnostic or biomarker
Red Flags • Acceptable limits for AEs, contra-indications
Label Sections *1: Indications and Usage2: Dosage and Administration3: Dosage Forms and Strengths 4: Contraindications 5: Warnings and Precautions6: Adverse Reactions 7: Drug Interactions 8: Use in Specific Populations9: (Drug Abuse and Dependence)10: (Over-dosage)11: (Description)12: (Clinical Pharmacology)13: (Non-clinical Toxicology) 14: (Clinical Section)15: (References)16: (How Supplied/Storage and Handling)
Identify Critical Success Factors
1.Define the Opportunity
(what)
3. Receive Endorsement
2. Develop Roadmap:
Integrated program(how)
* Note: this should be done on global basis, based on asset & market needs* Note: this should be done on global basis, based on asset & market needs
For Internal Use Only 10
COMPANY Competitor 1 Competitor 2 Competitor 3Critical Label Section X
– Specific claims – Specific claims –Specific claims –Specifi claims
Critical Label Section Y
– Specific claims – Specific claims – Specific claims – Specific claims
Critical Label Section Z
– Specific claims – Specific claims – Specific claims - Specific claims
Competitive Assessment
From the LAD process, highlight the competitor claims on only the critical
label sectionsProvide the conclusion or outcome
of this competitive assessment.
Conclusion……………………
1.Define the Opportunity
(what)
3. Receive Endorsement
2. Develop Roadmap:
Integrated program(how)
For Internal Use Only 1111
LAD Worksheet
Dose
(size, type – tablet, LFC,
etc., number)
Regimen
(qd, bid, feed effect, time of
day, etc)
Route of Administration
(oral, patch, inhaled,
injected, etc.)
Packaging / Device options
Storage
Conditions (for biologics /
sterile pharms only)
PRESENTATION
Medical/ClinicalInput
Regulatory Input
Clinical and Regulatory to comment on Marketing’s inputs:
• Can what is being asked for be achieved through a clinical program?
• What is the relevant regulatory commentary regarding key requirements, precedents?
• What are risks we need to consider?
• If significant risk exists, are there mitigation options to consider?
“Must Have” Attributes
“Nice to Have”Attributes
Commercial Development & Access to populate “critical needs” and “other needs” columns as pre-work to the
LAD team kick-off:
• “Must Have” are items that must be achieved or the product is in jeopardy. These attributes represent the absolute minimum hurdles for commercial success
• “Nice to Have” should be thought of as upside options, or marketing/OR's wishes. We will value these and decide whether to pursue them later in the process. Note: These may be of extremely high value so should not be thought of as
1.Define the Opportunity
(what)
3. Receive Endorsement
2. Develop Roadmap:
Integrated program(how)
For Internal Use Only 12
Medicine A is indicated for the treatment of patients with [x]
Planned Claim: (best label claim)
Fall-back (1): (2nd best label claim)
Fall-back (2): (3rd best label claim)
Fall-back (3): (worse case label claim)
Establish Planned & Fall-backs Critical Claims
Outline in exact label claim wording your desired label and various fall back positions.
This is an opportunity to discuss the benefits of the best label claim, along with the
challenges/risks to achieve it.This can be similar to or based on a BOP (Best, Optimistic, Pessimistic profile) - but
put into language as we want the label claim to be written.
1.Define the Opportunity
(what)
3. Receive Endorsement
2. Develop Roadmap:
Integrated program(how)
For Internal Use Only 13
Label as Driver for PRODUCT “X”
Executive summary
Key differentiated /value claims to be outlined here
Product Vision
Projected positioning of the product to be entered here.
Label Section that provides differentiation eg. Indications, etc
Product Profile Claim / Labeling Statement Plan to Achieve
(Data Source and Endpoints)
Regulatory Assessment / Competitive Benchmarking
Ex: Treatment of specific diseases
n Specific language for indicationn Endpoints to be studiedn Population to be studied
n Study design (e.g. placebo/active controlled, X number of subjects, duration)
n PRO plansn Measurementsn Desired outcome compared to
SOCn Benefit/Risk Assessment
n Regulatory acceptability of Indication
n Regulatory adequacy of clinical database to support claims
n Regulatory assessment of comparators, dose, population, endpoints, SAPs and Benefit/Risk
n Consistent with guidelines?n Precedents, standards
(SBAs/EPARs/labels)n Agency acceptance of PROs /
tool validationn Discussions required
Ex: Prevention different aspect of disease
n Specific language for indicationn Endpoints to be studiedn Population to be studied
n Study design (e.g. placebo/active controlled, X number of subjects, duration)
n Different toolsn Benefit/Risk Assessment
Label As Driver (LAD) Grid – Label As Driver (LAD) Grid –
Describe the unmet need & value
proposition
Describe the unmet need & value
proposition
Describe how to achieve the claims
Describe how to achieve the claims
1.Define the Opportunity
(what)
3. Receive Endorsement
2. Develop Roadmap:
Integrated program(how)
Include the exact wording in the
planned claims
Include the exact wording in the
planned claims
Provide robust Regulatory
assessment & Probability of Success
Provide robust Regulatory
assessment & Probability of Success
For Internal Use Only 14
LAD Grid Example
PRA-027 Uterine Fibroids’ LAD Grid Development Strategy
TPP Claim / Labeling Statement Data Sources and EndpointsRegulatory Assessment /
Competitive Benchmarking
Value Proposition: For women who want relief from symptomatic fibroids, PRA-027 offers reduction of symptoms, and is a uterine-sparing treatment that reduces or delays the need for fertility-limiting invasive procedures. Unlike other PRMs, GnRH analogs, or procedures, PRA-027 therapy does not cause treatment-limiting endometrial changes, intolerable hypoestrogenic side effects, or expose women to the risks and costs of invasive procedures.
Positioning Statement: For women who want relief from symptomatic fibroids, PRA is the first nonsteroidal, oral therapy that unlike PRMs, GnRHs, or surgery, offers long-term resolution of anemia and symptoms, and reduces or delays the need for fertility-limiting procedures.
Target Audience: Women with symptomatic uterine fibroids, seeking long-term, effective, well-tolerated, uterine-sparing therapy.
Unmet Need: There is no long-term drug therapy available for treatment of bleeding or symptoms associated with uterine fibroids.
Key differentiation for PRA-027 vs. Lupron (GnRH Agonists): PRA-027 will have a simpler oral dosing regimen vs. provider administered injection. PRA-027 will not cause intolerable hypoestrogenic side effects, including osteopenia. PRA-027 will be safe to use for long-term suppression of symptoms.Meaningful point(s) of differentiation vs. surgery and potential PRMs, not yet on market No or fewer treatment-limiting endometrial changes PRA-027 does not diminish future fertility or expose women to the risks and costs of procedures Improved bleeding control [basis for belief? Bob M] More rapid onset of activity [basis for belief? Bob M] Fewer hypoestrogenic side effectsDisclaimer: Positioning Statements are forward-looking marketing tools that do not necessarily reflect the approved
promotional message for the product.
14
1.Define the Opportunity
(what)
3. Receive Endorsement
2. Develop Roadmap:
Integrated program(how)
For Internal Use Only 15
Label Claims – Life Cycle
If successful, the key claims (promotions, TV commercials, print ads, etc.) we will deliver are:
█ - High POS █ - Medium POS █ - Low POS
AtLaunch
0-2YearsPost
Launch
LongTerm
1.Define the Opportunity
(what)
3. Receive Endorsement
2. Develop Roadmap:
Integrated program(how)