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Breakout Materials

Breakout Materials. MDI LAD RWW. 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

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Breakout Materials

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  1. Breakout Materials • MDI • LAD • RWW

  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 2

  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 3

  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 4

  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 5

  6. Label As Driver Process Deliver on important unmet medical need 2. Develop Roadmap (how) • Define the Opportunity • (what) 3. Receive Endorsements A Well Differentiated, Value-Added Label, and a Sustainable Product 6

  7. Label As Driver Process: 3 Major Activities in the overall Process • Define the Opportunity(what) 2. Develop Roadmap (how) 3. Receive Endorsement • 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 • 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 • 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) LAD is an ongoing process to be done at each DP and as market or asset data changes 7

  8. Summary of Unmet Customer Need P A T I E N T S “As a PATIENT, I need...” 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. P A Y E R S “As a PAYER, I can only reimburse if…... " P R O V I D E R S “As a PROVIDER, I see current methods lacking in this area…..it is a great unmet need that I would prescribe if available…. R E G U L A T O R S “As a REGULATOR, there is a need for a safer or more effective solution in this area… C A R E G I V E R “As a CAREGIVER, there is a need to be able to administer more simply….. • Define the Opportunity(what) 2. Develop Roadmap: Integrated program (how) 3. Receive Endorsement 8 8 8

  9. Identify Critical Success Factors Label Sections * 1: Indications and Usage 2: Dosage and Administration 3: Dosage Forms and Strengths 4: Contraindications 5: Warnings and Precautions 6: Adverse Reactions 7: Drug Interactions 8: Use in Specific Populations 9: (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) • Define the Opportunity(what) 2. Develop Roadmap: Integrated program (how) 3. Receive Endorsement * Note: this should be done on global basis, based on asset & market needs 9 9

  10. Competitive Assessment From the LAD process, highlight the competitor claims on only the critical label sections Provide the conclusion or outcome of this competitive assessment. Conclusion…………………… • Define the Opportunity(what) 2. Develop Roadmap: Integrated program (how) 3. Receive Endorsement 10

  11. LAD Worksheet “Must Have” Attributes “Nice to Have” Attributes Medical/Clinical Input Regulatory Input P R E S E N T A T I O N • 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? • 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 • Define the Opportunity(what) 2. Develop Roadmap: Integrated program (how) 3. Receive Endorsement 11 11

  12. Establish Planned & Fall-backs Critical Claims 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) 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. • Define the Opportunity(what) 2. Develop Roadmap: Integrated program (how) 3. Receive Endorsement 12

  13. Label As Driver (LAD) Grid – Describe the unmet need & value proposition • Define the Opportunity(what) 2. Develop Roadmap: Integrated program (how) 3. Receive Endorsement Include the exact wording in the planned claims Describe how to achieve the claims Provide robust Regulatory assessment & Probability of Success 13

  14. LAD Grid Example • Define the Opportunity(what) 2. Develop Roadmap: Integrated program (how) 3. Receive Endorsement 14 14

  15. Label Claims – Life Cycle • Define the Opportunity(what) 2. Develop Roadmap: Integrated program (how) 3. Receive Endorsement If successful, the key claims (promotions, TV commercials, print ads, etc.) we will deliver are: At Launch 0-2 Years Post Launch Long Term █- High POS █- Medium POS █ - Low POS 15

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