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1 Integrated Development Pharmaceutical Advisors LLC July 2005.

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Presentation on theme: "1 Integrated Development Pharmaceutical Advisors LLC July 2005."— Presentation transcript:

1 1 Integrated Development Pharmaceutical Advisors LLC July 2005

2 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 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 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 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 6 Approved Indicated Products Unapproved Products Target Product Profile Parameter Long Acting Anti-XXXXX Long Acting XX Agonist XXX Inhibitor MinimumDesired Class Example XXXXX XXXX EFFICACY ΔFEV1 (vs baseline) XXX-XXX ml (28-31%) XXXml (20%) XXX ml (500 mcg dose) XXX ml (X%) >XX% Quality of Life Indicators # Improvement XXX Development of Tolerance no no (?)XXX Disease Modification ## no ?XXX #Post dose exercise challenge ##Reduction in the rate of XXXXXX Considering a Target Product Profile

7 7 Approved Indicated Products Unapproved Products Target Product Profile Parameter Long Acting Anti-XXX Long Acting XX Agonist XX Inhibitor MinimumDesired SAFETY Safe to Use in Combinationyes ?XXX Anti-XXXX Xyes--XXX- XXX Stimulation XX-yes-XXXXXX- GI Disturbances (nausea, vomiting) -- ? (at elevated doses) XXX Special Populations XX?XXX PHARMACOKINETICS DosingXX mcg ODXXmcg BIDXXX mcg ODXX DeliveryXXXXXXXXPOXX OTHER Annual Cost of Rx (Direct)$XXX $X Reduction in Indirect Costs Considering a Target Product Profile

8 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 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 10 Making the Transition 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

11 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)

12 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

13 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 candidate and the business case for continued project funding.

14 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 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) Integrated Development Strategy (IDS) Integrated Development Plan Prepared by:Project Team Approved by: Senior Management Updated/Reviewed: Quarterly Accountable: Project Team Leader Prepared by:Project Team Approved by: Senior Management Updated/Reviewed: Monthly Accountable: Project Team Leader Pre-Clinical Development Plan Clinical Development Plan Regulatory Development Plan Marketing Development Plan Prepared by:Sub-Team Leaders Approved by: Project Team Leader Updated/Reviewed: Weekly Accountable: Sub-Team Leaders

16 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 17 Timeline Compression Impact CMC Investments then Precede Clinical Phase PreclinicalIIIIIIReview API/DP Enabling Technology Phase I API/DP Supplies API/DP Technology Phase II API/DP Supplies Commercial Technology Phase III API/DP Supplies

18 NominationPhIPhIIPhIIINDA/MAAApproval Launch API/DP Enabling Technology & Supply Manufacturer API/DP Technology/Supplies RMAPIDP PhIII Supplies RMAPIDP Launch Planning RMDPDP StabilityAPI PAIn Planning RMAPIDPICH Stability ICH DP Stability Planning DP Technology API Technology Raw MaterialsAPI ActivitiesDP ActivitiesEnabling Phase II Becomes The Battleground

19 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 The Phase II Battleground NominationPhIPhIIPhIIINDA/MAALaunch API Form DP API Commercial Technology Window CHANGE Potentially Impacts Filing Date Clinical Efficacy Determination

21 The Phase II Battleground NominationPhIPhIIPhIIINDA/MAALaunch API Form DP API Commercial Technology Window CHANGE Potentially Impacts Filing Date Clinical Efficacy Determination

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


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