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1. Establish Contractual Framework

INPUTS:

  • Strategic Goals

  • Technical Requirements 

  • Regulatory Expectations

  • Cost Analysis

  • Risk Assessment

  • Non-Disclosure Agreement (NDA)

PROCESS:

  1. Define Evaluation Criteria

  2. Prepare RFI and RFP

  3. Draft Technical Agreement

  4. Draft Supply Agreement

OUTPUTS:

  • Request for Information

  • Request for Proposal

  • Decision Evaluation Worksheet

  • Technical Agreement Template

  • Supply Agreement Template

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2. Evaluate CDMO Capabilities and Fit

INPUTS:

  • Request for Information

  • Request for Proposal

  • Decision Evaluation Worksheet

  • Technical Agreement Template

  • Supply Agreement Template 

PROCESS:​

  1. Perform CDMO Research

  2. Issue RFI

  3. Issue RFP

  4. Site Audits and Due Diligence

  5. Compare and Score Options

  6. Collaborative Discussions

OUTPUTS:

  • CDMO Capability Report

  • Selection Recommendation

  • Risk Mitigation Plan

  • Decision-Making Framework​​​​

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3. Decision Analysis and Contract Negotiation

INPUTS:

  • CDMO Capability Report

  • Selection Recommendation  

  • Risk Mitigation Plan

  • Decision-Making Framework

  • Automated Contract Risk Evaluation Tool

PROCESS:

  1. Internal Review and Approval

  2. Contract Negotiation

  3. Contract Execution

  4. Distribute executed contracts to all relevant internal and external stakeholders

OUTPUTS:

  1. Executed Contract

  2. Closeout Letter to All Potential CDMOs

 

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1. Establish Contractual Framework

INPUTS:

  • Strategic Goals: Objectives, timelines, and scope for outsourcing efforts.

  • Technical Requirements: Product specifications, process + scalability needs, technical benchmarks.

  • Regulatory Expectations:  Requirements specific to intended markets and regulatory authorities.

  • Cost Analysis: Detailed budget constraints, cost estimates, and financial viability assessments.

  • Risk Assessment: Evaluation of potential risks such as quality failures, delivery delays, scalability challenges, intellectual property (IP) concerns.

  • Non-Disclosure Agreement (NDA): Pre-negotiated NDAs to protect sensitive information shared during the evaluation process.

PROCESS:

  1. Define Evaluation Criteria.  Develop a robust scoring framework to assess CDMO candidates.

  2. Prepare RFI and RFP.  Draft RFI/RFP documents outlining clear evaluation criteria, project scope, timelines, desired outcomes to gather info from potential CDMOs.

  3. Draft Technical Agreement.  Create draft agreement specifying quality expectations, technical deliverables, compliance requirements, and risk management strategies.

  4. Draft Supply Agreement.  Develop supply agreement encompassing pricing, delivery timelines, production volumes, intellectual property rights, and penalties for NC.

OUTPUTS:

  • Request for Information.  Document sent to gather preliminary information from CDMOs.

  • Request for Proposal. Comprehensive document soliciting detailed proposals based on defined requirements and evaluation criteria.

  • Decision Evaluation Worksheet.  A scoring tool to compare + rank CDMO candidates systematically.

  • Technical Agreement Template.  A structured document template ready for negotiation with selected CDMOs.

  • Supply Agreement Template.  A finalized template detailing key terms and conditions for supply partnerships.

2. Evaluate CDMO Capabilities and Fit

INPUTS:

  • Request for Information.  Document sent to gather preliminary information from CDMOs.

  • Request for Proposal. Comprehensive document soliciting detailed proposals based on defined requirements and evaluation criteria.

  • Decision Evaluation Worksheet.  A scoring tool to compare + rank CDMO candidates systematically.

  • Technical Agreement Template.  A structured document template ready for negotiation with selected CDMOs.

  • Supply Agreement Template.  A finalized template detailing key terms and conditions for supply partnerships.

PROCESS:​

  1. Perform CDMO Research: Collect and analyze information on potential CDMOs, including capability statements and client feedback.

  2. Issue RFI.  Circulate RFI to prospective CDMOs to assess initial suitability.  Down select potential candidates based on their responses + alignment with strategic needs.

  3. Issue RFP.  Send the RFP to the shortlisted CDMOs for detailed submissions.  Further down select candidates based on proposals.

  4. Site Audits and Due Diligence.  Conduct site visits to evaluate facilities, assess quality systems, validate certifications, confirm proposal accuracy.

  5. Compare and Score Options.  Use the Decision Evaluation Worksheet to rank potential CDMOs based on weighted criteria.

  6. Collaborative Discussions.  Engage with shortlisted CDMOs in discussions to evaluate cultural alignment, communication capabilities, and shared expectations.

OUTPUTS:

  • CDMO Capability Report.  Comprehensive analysis of each candidate, outlining strengths, weaknesses, and alignment with strategic goals.

  • Selection Recommendation.  Ranked list of preferred CDMOs with justification based on evaluation outcomes.

  • Risk Mitigation Plan. Document identifying potential risks with selected CDMOs and proposed strategies for managing them.

  • Decision-Making Framework.  A structured approach to proceed with contract negotiations, ensuring alignment with objectives.

3. Decision Analysis + Contract Negotiation

INPUTS:

  • CDMO Capability Report.  Comprehensive analysis of each candidate, outlining strengths, weaknesses, and alignment with strategic goals.

  • Selection Recommendation.  Ranked list of preferred CDMOs with justification based on evaluation outcomes.

  • Risk Mitigation Plan. Document identifying potential risks with selected CDMOs and proposed strategies for managing them.

  • Decision-Making Framework.  A structured approach to proceed with contract negotiations, ensuring alignment with objectives.

PROCESS:

  1. Internal Review and Approval.  Present the down selection outcomes, including the CDMO Capability Report, recommendations, and risk mitigation strategies, to key stakeholders for review and formal approval.

  2. Contract Negotiation.  Engage in discussions with the selected CDMO to finalize terms, including pricing, timelines, deliverables, IP protection, quality, and penalties for non-compliance.  Address and resolve any outstanding issues while ensuring alignment with the organization’s strategic goals.

  3. Contract Execution.  Finalize and sign the agreements, including the Technical Agreement and Supply Agreement, to establish a clear framework for collaboration.

  4. Distribute executed contracts to all relevant internal and external stakeholders.

OUTPUTS:

  1. Executed Contract.  Fully signed and formalized agreements, including both the Technical Agreement and Supply Agreement, ready for implementation and partnership execution.

  2. Closeout Letter to All Potential CDMOs.  Formal communication sent to all participating CDMOs to thank them for their time and effort while informing them of the selection decision, ensuring professionalism and maintaining positive relationships for future opportunities.

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