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Integrated Development

Integrated Development. Pharmaceutical Advisors LLC July 2005. Integrated Development Strategies. Required Between: Discovery & Development Organizations Within Development Organization Between Development Organization and Commercial Organization With RSOs/Suppliers

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Integrated Development

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  1. Integrated Development Pharmaceutical Advisors LLC July 2005

  2. Integrated Development Strategies • Required Between: • Discovery & Development Organizations • Within Development Organization • Between Development Organization and Commercial Organization • With RSOs/Suppliers • Acceleration/Compression Requires Timeline: • Forward from nomination and….. • Backwards from projected NDA filing date and approval/launch target

  3. Start No Later Than… • Candidate Nomination • Transition from Discovery to Development • Candidate Nomination Guidelines • Agreed Criteria Which Need to be Met to Nominate new Drug Candidate • Drives Discovery Strategies from Lead Identification/Optimization to Candidate Nomination • Ensures candidate selection process is driven by agreed targets/goals across portfolio of candidates

  4. Must Be Forward Looking and… • Candidate Nomination • Candidate Nomination Document • Summary of Data/Rational for Progression of Candidate to Development • What are Positive Features of Candidate? • What are Issues/Flaws • For Management Review and Approval • Approval Formally Triggers activities to Progress Candidate to Phase I • integrated planning required to ensure efficient transition • need to define process for managing this transition

  5. Work Back From Commercial Goals • Candidate Nomination Document (CND) Template • Table of Contents • Biological Profile • Market Positioning/Rationale • Competitive Situation • Pharmacokinetics/Pharmacodynamic Summary/Issues (ADME) • Safety Information/Issues • Drug Substance Technology/Issues • Physical Pharmacy/Dosage Form Issues • Bulk Supply Status/Issues • Intellectual Property Status/Issues

  6. Considering a Target Product Profile

  7. Considering a Target Product Profile

  8. Link to Development Planning • Early Development Plan (EDP) • Developed After Approval of CND • Integrated Plan for all Key Activities Leading to IND • To be updated as required by significant changes in strategies/issues • Provides overview of ongoing development activities, issues, timing • Requires Matrix Team to Manage

  9. Early Development Plan • Early Development Plan Template • Table of Contents • Clinical Plan/Strategy • Drug Safety Evaluation Plan • ADME Evaluation/Plan • DS/DP Strategy/Issues • IP Overview/Strategy/Issues • Other

  10. Early Development Plan Clinical Plan/Strategy Drug Safety Evaluation Plan ADME Evaluation/Plan DS/DP Strategy/Issues IP Overview / Strategy/ Issues Financial Integrated Development Executive Summary Marketing Strategy Regulatory Strategy Pre-Clinical Strategy Clinical Strategy Chemical Development Manufacturing Supply Chain Financial Making the Transition

  11. Integrated Plan Contents I Executive Summary • Key Objectives (can include a draft package insert) • Major Milestones & Decision Points • Risk Management Strategy • Financial Overview (project P&L, costs, resources, outsource requirements, etc) Marketing Strategy • Key Indications • Global Market Forecast (regions, revenues, longevity, etc) • Product/Brand Image (size, color, dose, formulation, packaging, etc) • Trademark & Patent issues • Competitive Environment Regulatory Strategy • Country/Regional issues (NDA, MAA, JNDA, PAI timelines, acceleration) • Regulatory Environment (pertinent guidelines, regional differences, etc) • Safety & Efficacy Targets Pre-Clinical Development Strategy • PK studies required (protocol descriptions, pivotal vs. non-pivotal) • Toxicology/Pathology (protocol descriptions, pivotal vs. non-pivotal) • Clinical Development Strategy • Studies required (protocol descriptions, pivotal vs. non-pivotal) Illustrative Example

  12. Integrated Plan Contents II Clinical Development Strategy • Studies required (protocol descriptions, pivotal vs. non-pivotal) Chemical Manufacturing & Control (CMC) Development • Primary API batches • Route & filing strategy • Salt selection strategy • Stability batches • Technology transfer & scale-up • Manufacturing • Dosage form manufacturing site requirements • Delivery systems requirements • Storage & transport requirements • Analytical method development • Process & technology transfer requirements Supply Chain • Volumes (typically units and kgs per year) • Sourcing • Distribution Financial • Capital required • P&L, ROI etc Illustrative Example

  13. Why All This Planning So Early? • Formalizes product development across the business • Provides a common, consistent planning framework across diverse business segments/therapeutic areas • Ensures alignment with business objectives/high-level strategies • Provides management with a high-level overview of a complex project • Provides multi-disciplinary project teams with a clear intent and roadmap • Holds key decision data for review, approval, “go/no go” etc • Provides a basis for monitoring/managing the progress of the project • Achieves consistency across projects • Guides planning at lower levels of detail The Integrated Development Strategy is the guide to developing a drug candidateand the business case for continued project funding.

  14. Common Question • Why all this planning? Our strategy is to license out in Phase II… • Ok if future milestone payments from partner are not needed! • What if partner relationship changes?! • Often more is done than needed because of lack of understanding about phase-appropriate development and quality! • When is GMP material needed? • When do you start collecting NDA documentation?

  15. The Development Strategy Process There are usually three levels of strategy and planning documents maintained throughout the lifetime of the product development effort Integrated Development Strategy (IDS) Prepared by:Project Team Approved by: Senior Management Updated/Reviewed: Quarterly Accountable: Project Team Leader Integrated Development Plan Prepared by:Project Team Approved by: Senior Management Updated/Reviewed: Monthly Accountable: Project Team Leader Pre-Clinical Development Plan Prepared by:Sub-Team Leaders Approved by: Project Team Leader Updated/Reviewed: Weekly Accountable: Sub-Team Leaders Clinical Development Plan Regulatory Development Plan Marketing Development Plan

  16. Timeline Compression • Presents Significant Challenges to Technology Development • Requires earlier investment of resources • API can activities lead the way when compressing clinical timelines • Invest in time critical activities early • Technology • Materials • Better integration of activities with partners essential • Internal • External • Integration of Activities Dictate that During Phase II: • Critical technology must be: • Developed • Demonstrated at scale • Used to support preparation of: • Phase III clinical supplies • ICH stability supplies

  17. Commercial Technology Phase III API/DP Supplies API/DP Technology Phase II API/DP Supplies Timeline Compression Impact CMC Investments then Precede Clinical Phase Preclinical I II III Review API/DP Enabling Technology Phase I API/DP Supplies

  18. Nomination PhI PhII PhIII NDA/MAA Approval API/DP Enabling Technology & Supply Manufacturer API/DP Technology/Supplies RM API DP PhIII Supplies DP Technology API Technology Launch Planning RM API DP RM API DP DP Stability PAIn Planning ICH DP Stability Planning RM API DP ICH Stability Phase II Becomes The Battleground Launch Illustrative Example Raw Materials API Activities DP Activities Enabling

  19. The Phase II Battleground • Often under-considered by both out-licensing and commercially integrated firms • Resource limitations • Poor integration • Emphasis on clinical • Integration of drug development activities • Balancing risk of investments against speed • Risk of CMC investments • versus unknown clinical outcomes • Speed • Delayed CMC investments put CMC activities on critical path to filing • Huge potential impact on time, cost and clinical flexibility that directly impacts value For Out licensing and Integrated companies alike

  20. Nomination PhI PhII PhIII NDA/MAA Launch The Phase II Battleground API Form CHANGE Potentially Impacts Filing Date Commercial Technology Window DP API Clinical Efficacy Determination

  21. Nomination PhI PhII PhIII NDA/MAA Launch The Phase II Battleground API Form CHANGE Potentially Impacts Filing Date Commercial Technology Window DP API Clinical Efficacy Determination

  22. Are You Ready Now? Will You Be Ready?

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