 Milestone: Selection of Candidates |
|
Action / Deliverable |
Supporting Services |
| First API Synthesis |
Route selection support, identify future routes for evaluation, IP assessment
of synthetic route(s). |
| Preliminary COG Assessment |
Preparation of initial COG assessment to understand project economics. |
 Milestone: Lead Candidate Selection |
|
Action / Deliverable |
Supporting Services |
| Toxicology Studies |
Provide support for development and execution of toxicology studies. Select drug product form for toxicology and phase 1 clinical, establishing API requirements, managing preparation of API & DP for toxicology and clinical trial. |
 Milestone: Phase 1 Study Preparation |
|
Action / Deliverable |
Supporting Services |
| Select CMO, set up Manufacturing Contracts |
Identification of suppliers. Managing and evaluating RFPs. QA audits and recommendations for vendor selection. |
| Develop Clinical Formulation |
Provide advice on formulation options and manage development activities. Manage evaluation of API particle size & solid state characterization/salt form evaluation. |
| Make GMP API for Product Development |
Manage CMO activities. |
 Milestone: IND Preparation and Filing |
|
Action / Deliverable |
Supporting Services |
| Pre-IND/IND Meeting with FDA |
Provide regulatory and scientific support for CMC aspects of Pre-IND meeting. |
| Prepare & File IND/IMPD |
CMC input and preparation of IND/IMPD filings. |
 Milestone: Phase 1 Trial & Result Assessment |
|
Action / Deliverable |
Supporting Services |
| Initiate Phase 1 Trial |
Manage clinical trial material supply. |
| Phase 1 Study Clinical Assessment |
Provide technical and financial assessment of any clinical outcomes impacting drug product formulation requirements. |
 Milestone: Phase 2 Trial Design |
|
Action / Deliverable |
Supporting Services |
| Phase 2 IND/IMPD Amendment Submission |
CMC input and preparation of IND/IMPD amendments. |
| Manufacture API and Drug Product for Phase 2 Clinical Supplies |
Manage supply chain for clinical trial material, manage CMO activities. |
 Milestone: Phase 2 Trial – Establish Proof of Concept |
|
Action / Deliverable |
Supporting Services |
| Initiation of Phase 2 Clinical Studies |
Manage CMO activities and clinical trial material supply. Support initiation of Phase 2 API/DP stability studies. |
| COG Assessment |
Prepare Detailed COG Assessment. |
| Develop Commercial and Alternate Future Routes for API. |
Review existing routes and suggest novel routes. Execute laboratory scale synthesis and evaluate routes based on experimental results. |
 Milestone: Synthetic Route Selected/Identify Commercial DP Formulation |
|
Action / Deliverable |
Supporting Services |
| Develop DP commercial prototypes & DP Scale Up |
Based on solid state characteristics for dosing and market requirements, evaluate need to develop alternate formulation for Phase 3 and commercial supply. |
| API Synthetic Route Selected |
Management of method development activities. Lock API particle size distribution & solid state/salt form. |
| Evaluate Potential Alternative Suppliers |
API and DP Supplier identification, evaluation and recommendations. cGMP audits and remediation. |
| Formulate Preliminary Commercialization/Launch Plan |
Provide support to align clinical, marketing and sales requirements to create preliminary manufacturing and supply chain plan. |
 Milestone: Scale-up of API Route |
|
Action / Deliverable |
Supporting Services |
| Run API Scale-up Batches |
API process development and technology transfer planning and support. Update OEL for intermediates & API. REACH assessment. |
| Select Commercial API and DP Launch Sites |
Identification of vendors. Managing and evaluating RFPs. QA audits and recommendations for vendor selection. Preparation of manufacturing strategy & launch plan refinement. |
 Milestone: Decision to Proceed with Phase 3/Full Development |
|
Action / Deliverable |
Supporting Services |
| Finalize Registrational Strategy for API & DP Batches |
Development of CMC regulatory strategy for NDA/MAA Filings. Defining Starting Material, Intermediate, API, Drug Product Matrix for Stability Studies. |
| Update Packaging Standards |
Packaging design & development services. |
| Update COG Assessment |
Updated COG based on additional API/DP information. |
 Milestone: API & Drug Product Process Lock |
|
Action / Deliverable |
Supporting Services |
| API & DP Process Lock |
Support Process Development, COG Impact Review & Final Recommendation to lock processes. |
| Form Launch Team |
Support selection of resources required for Launch Team and update Launch Plan. |
| Preliminary DP Specifications and Process Robustness/Scale-up |
Drug product analytical specification recommendations, robustness study design, technology transfer and scale-up support. |
| DP Life Cycle Opportunities |
Evaluation of IP and/or advanced formulation technology. |
 Milestone: End of Phase 2 Meeting |
|
Action / Deliverable |
Supporting Services |
| End of Phase 2 Meeting with FDA |
CMC Regulatory support for preparation and execution of end of Phase 2 meeting. |
| Start of API Registrational Batch Stability Studies |
Develop stability protocol. Provide recommendations for manufacturing registrational strategy. |
| Early Manufacturing Assessment |
Strategic evaluation of API and DP process technology for long term commercial manufacture |
 Milestone: Phase 3 Trial/DP Stability Study Initiation |
|
Action / Deliverable |
Supporting Services |
| Drug Product Registrational Batches Complete |
Updated COG based on registrational batches. |
| API/DP Technology Transfer to Commercial Sites (if app.) |
Manage critical process parameter assessment and failure mode analysis in the laboratory. Technology transfer report preparation & review. Update commercial manufacturing plan. Preparation of validation protocols. |
| Start of Drug Product Registrational Stability Studies |
Develop stability protocol. |
 Milestone: 12 Months to NDA Filing |
|
Action / Deliverable |
Supporting Services |
| Propose Registrational Specifications for DP |
Preparation and review of DP specifications. Preparation of formulation development reports. |
| API Validation Complete |
Review of API validation & report preparation. Updated COG based on commercial site/validated process. |
 Milestone: 6 Months to NDA/MAA Filing |
|
Action / Deliverable |
Supporting Services |
| DP Process Demonstration Batches Completed |
Process Demonstration Protocol preparation and review. Updated COG. |
| API from Commercial Facility on Stability |
Stability Study Design. |
| DP Validation Plan |
Prepare Plan and Validation Protocols. |
| Supply Chain Assessment |
Supply Chain Review. Review of Vendor DMF’s and Audits Planning for Supply Chain Expansion and identification of future vendors. |
 Milestone: 4 Months to NDA Filing |
|
Action / Deliverable |
Supporting Services |
| 12 Month Registrational Stability Report |
Review Stability report / preparation of CMC Stability section. |
| CMC Section of NDA/MAA complete |
CMC Section Preparation and Review. |
| Finalize DP Validation Protocols |
Validation Protocol review. |
| Begin DP Validation |
Validation Protocol review. |
| First Complete Launch Plan |
Prepare and budget resources for launch. |
 Milestone: File NDA/MAA |
|
Action / Deliverable |
Supporting Services |
| Complete DP Validation |
Review Protocols and prepare Validation reports. |
| Secure Registration Samples for Rest of World Registration |
ROW Regulatory Support/MAA Preparation. Plan and Manage Analytical Technology Transfers to EU release site(s). |
| Respond to Regulatory Agencies |
CMC Regulatory Support for FDA and EMEA Deficiency Letter(s). |
| Finalization of Launch Plans |
Project Management and Execution. |
 Milestone: Anticipated Approval – 3 Months to Launch |
|
Action / Deliverable |
Supporting Services |
| Satisfactory PAI Development and Manufacturing Sites |
PAI Preparation/Mock Audits. |
| At Risk Manufacture of Launch Supplies (if applicable) |
Manage Supply Chain Activities. Project Management and Execution. |
| Respond to Regulatory Agencies |
CMC Regulatory Support for Tier 1 and 2 Country Deficiency Letter(s). |
| Launch Plan Execution |
Schedule production and logistics, contingency planning. Manage Analytical technology transfers to ROW release sites. |
 Milestone: NDA/MAA Approval – Product Launch |
|
Action / Deliverable |
Supporting Services |
| Product Packaged for Launch |
Manage Supply Chain activities. |
| Product Delivered into Supply Chain |
Supply Chain Support/Project Management. Contingency execution. |
 Milestone: Post Launch Activities |
|
Action / Deliverable |
Supporting Services |
| ROW Filings and Launches |
CMC Regulatory support for Tier 1 – 4 country launches. |
| Life Cycle Development |
Management and execution of new IP or enabling technology. |
| Supply Chain Expansion |
Execution of Supply Chain expansion. Vendor Audits, technology transfer preparation and execution. |
The development path represents a hypothetical timeline and elements may differ based on project specifics.
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