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1. Establish PMO Governance Structure + Drug Development/Tech Transfer Stage Gate Process

INPUTS:​​

  • Drug Development Regulatory Requirements

  • Technical Transfer Guidance​ (PDA, ISPE, ICH)​​

  • Program Management Body of Knowledge 

  • Cloud based Project Scheduling Software

  • Cloud based document storage (Sharepoint)

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PROCESS:

  1. Create Drug Development Stage Gate Process

  2. Create Tech Transfer Tailorable Process

  3. Create Program Planning Templates:

    • Create the Rolling Wave Project Schedule​

    • Establish the Risk Log​

    • Draft the Communication Plan​

    • Establish the Schedule Change Log​

    • Establish the Key Decision Log​

    • Define Team Roles+ Responsibilities (RACI)​

  4. Establish Program(s) Site Repository​

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OUTPUTS:

  • Comprehensive Program Plan:​

    • Project Schedule​

    • Risk Log​

    • Communication Plan​

    • Change Log ​

    • Key Decision Log​

    • RACI Matrix​

  • Program Plan uploaded to Shared Site​

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Download

 

2. Develop a Comprehensive Program Plan

INPUTS:

  • CDMO Executed Contract​

  • Drug Development Stage Gate Process

  • Technical Transfer Guidance

  • Client + CDMO Governance Structure​

  • Program Planning Templates​​

  • PMO Program Planning Guidance Documents

  • Cloud based Project Scheduling Software

  • Cloud based document storage (Sharepoint)

​

PROCESS:

  1. Create the Rolling Wave Project Schedule​

  2. Establish the Risk Log​

  3. Draft the Communication Plan​

  4. Establish the Schedule Change Log​

  5. Establish the Key Decision Log​

  6. Define Team Roles and Responsibilities (RACI)​

  7. Establish Shared Core Team Site Repository

  8. Establish timing for Periodic Reviews​

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OUTPUTS:

  • Comprehensive Program Plan:​

    • Project Schedule​

    • Risk Log​

    • Communication Plan​

    • Change Log ​

    • Key Decision Log​

    • RACI Matrix​

  • Program Plan uploaded to Shared Site​

​

​

​

​

Download

 

3. Launch the Core Team

INPUTS:

  • Comprehensive Program Plan:​

    • Project Schedule​

    • Risk Log​

    • Communication Plan​

    • Change Log ​

    • Key Decision Log​

    • RACI Matrix​

PROCESS:

  1. Assemble cross-functional core team with representation from both Client and CDMO 

  2. Conduct a formal Program Kickoff Meeting to align on:

    • Program objectives and success criteria

    • Key milestones and deliverables

    • Roles and responsibilities (confirming RACI)

    • Meeting cadence + communication protocols

    • Escalation paths and decision-making structure

  3. Establish shared tools or platforms for collaboration (e.g., dashboards, SharePoint, Smartsheet, Teams)

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OUTPUTS:

  • Fully aligned and mobilized core team

  • Kickoff meeting summary, including action items and next steps

  • Finalized RACI and team directory

  • Agreed-upon meeting cadence and reporting mechanisms

  • Team alignment around program goals, timeline, and performance expectations

​

Download

1. Establish PMO Governance Structure + Drug Development/Tech Transfer Stage Gate Process

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INPUTS:

  • CDMO Executed Contract:  Signed agreement defining the project scope, deliverables, timelines, and roles for both the Client and CDMO.

  • Drug Development Stage Gate Process:  A structured framework to track key decision points and milestones critical to drug development progress.

  • Technical Transfer Guidance:  Detailed documentation to ensure efficient knowledge, process, and data transfer between the Client and CDMO.

  • Client + CDMO Governance Structure:  Organizational framework outlining roles, communication flow, and escalation paths to promote effective collaboration.

  • Program Planning Templates:   Standardized templates designed to streamline the creation of schedules, communication plans, and logs.

  • PMO Program Planning Guidance Documents:  Guiding principles from the Program Management Office for effective planning and oversight.

  • Cloud-Based Project Scheduling Software:  Digital tools enabling real-time task tracking, schedule updates, and team coordination.

  • Cloud-Based Document Storage (SharePoint):  A secure, shared platform for storing, accessing, and managing project-related documentation.

PROCESS:

  1. Create the Rolling Wave Project Schedule developing a progressively detailed schedule to address immediate tasks while planning future phases iteratively.

  2. Establish the Risk Log:  Identify, assess, and document risks, defining mitigation plans and assigning ownership for effective risk management.

  3. Draft the Communication Plan:  Create a structured plan for regular updates, stakeholder communication, and reporting protocols.

  4. Establish the Schedule Change Log:  Maintain a record of approved schedule changes, documenting rationale and potential impacts.

  5. Establish the Key Decision Log:  Log critical decisions, including rationale, responsible parties, and outcomes for traceability.

  6. Define Team Roles and Responsibilities (RACI):  Clarify roles by assigning tasks as Responsible, Accountable, Consulted, Informed ensures accountability + efficiency.

  7. Establish Shared Core Team Site Repository:  Set up a centralized site for storing and sharing program documents, promoting transparency and collaboration.

  8. Establish Timing for Periodic Reviews:  Schedule regular reviews to evaluate progress, address challenges, and refine plans based on new insights.

OUTPUTS:

  1. Comprehensive Program Plan:  A single, cohesive document integrating all aspects of the program plan for reference and execution.

  2. Project Schedule:  A detailed timeline with milestones, dependencies, and deliverables to guide project progress.

  3. Risk Log:  A dynamic document outlining identified risks, mitigation strategies, and monitoring activities.

  4. Communication Plan:  A formal document specifying communication processes, meeting schedules, and stakeholder engagement protocols.

  5. Change Log:  A well-maintained record of schedule modifications, providing clarity and traceability for project changes.

  6. Key Decision Log:  A detailed repository of significant decisions, supporting audits and future strategic planning.

  7. RACI Matrix:  A visual representation of roles and responsibilities to ensure clarity and effective collaboration.

  8. Program Plan Uploaded to Shared Site:  The finalized program plan is securely uploaded to the shared document repository for team-wide access.

2. Develop a Comprehensive Program Plan

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INPUTS

  • CDMO Executed Contract: Formal agreement outlining scope, responsibilities, timelines, and deliverables between the client and CDMO.

  • Drug Development Stage Gate Process: Defined development phases and criteria used to assess readiness and progress at each stage.

  • Technical Transfer Guidance: Documentation that outlines requirements and best practices for successful technology transfer.

  • Client + CDMO Governance Structure: Established oversight framework with clear escalation paths and decision-making authority.

  • Program Planning Templates: Pre-approved tools and formats to ensure consistency and completeness in project planning.

  • PMO Program Planning Guidance Documents: Standardized methodologies and best practices issued by the PMO to guide planning activities.

  • Cloud-based Project Scheduling Software: Digital platform (e.g., Smartsheet, MS Project) used to create and manage dynamic project schedules.

  • Cloud-based Document Storage (SharePoint): Centralized digital repository for real-time access to program documentation and collaboration.

PROCESS

  1. Create the Rolling Wave Project Schedule: Develop a phased project timeline with increasing detail as project milestones approach.

  2. Establish the Risk Log: Identify, assess, and track potential risks that could impact the program with defined mitigation strategies.

  3. Draft the Communication Plan: Define how, when, and to whom project information will be communicated to ensure alignment and transparency.

  4. Establish the Schedule Change Log: Set up a system to document and track approved changes to the project schedule over time.

  5. Establish the Key Decision Log: Capture all major program decisions, including rationale, ownership, and impact.

  6. Define Team Roles and Responsibilities (RACI): Clarify task ownership across stakeholders using the Responsible, Accountable, Consulted, Informed matrix.

  7. Establish Shared Core Team Site Repository: Create a centralized site for storing and accessing all key documents and logs.

  8. Establish Timing for Periodic Reviews: Define cadence and structure for recurring governance or team check-in meetings.

OUTPUTS

  • Comprehensive Program Plan: A complete, aligned project management plan encompassing scope, timeline, risks, and responsibilities.

  • Project Schedule: A structured and time-phased plan showing critical path, milestones, and deliverables.

  • Risk Log: A living document tracking identified risks and associated mitigation strategies.

  • Communication Plan: Approved framework detailing communication channels, frequency, and responsibilities.

  • Change Log: Historical record of approved project schedule modifications.

  • Key Decision Log: A documented history of significant program decisions with context and accountability.

  • RACI Matrix: A finalized map of team roles and responsibilities for each key activity.

  • Program Plan Uploaded to Shared Site: All planning documents are organized and accessible to stakeholders via the shared digital platform

3. Launch the Core Team

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INPUTS

  • Comprehensive Program Plan: A complete, aligned project management plan encompassing scope, timeline, risks, and responsibilities.

  • Project Schedule: A structured and time-phased plan showing critical path, milestones, and deliverables.

  • Risk Log: A living document tracking identified risks and associated mitigation strategies.

  • Communication Plan: Approved framework detailing communication channels, frequency, and responsibilities.

  • Change Log: Historical record of approved project schedule modifications.

  • Key Decision Log: A documented history of significant program decisions with context and accountability.

  • RACI Matrix: A finalized map of team roles and responsibilities for each key activity.

  • Program Plan Uploaded to Shared Site: All planning documents are organized and accessible to stakeholders via the shared digital platform

PROCESS

  1. Assemble cross-functional core team with representation from both Client and CDMO:  Identify and assign key functional representatives from both organizations to ensure holistic program ownership and collaboration.

  2. Conduct a formal Program Kickoff Meeting to align on:  Host a structured kickoff session to set the foundation for successful execution and collaboration.

    • Program objectives and success criteria:  Clearly define what success looks like for the program, aligned to strategic business and technical outcomes.

    • Key milestones and deliverables:  Review the high-level timeline and establish mutual agreement on critical path items and handoffs.

    • Roles and responsibilities (confirming RACI):  Validate team roles using a RACI to clarify ownership and eliminate ambiguity.

    • Meeting cadence + communication protocols:  Set expectations for how and when the team will communicate and meet throughout the program.

    • Escalation paths and decision-making structure:  Establish governance structure and clear escalation procedures to enable timely issue resolution.

  3. Establish shared tools or platforms for collaboration (e.g., dashboards, SharePoint, Smartsheet, Teams):  Align on digital tools and repositories to support transparency, real-time updates, and document control.

OUTPUTS

  • Fully aligned and mobilized core team:  A committed, cross-functional team with clear roles, responsibilities, and readiness to execute.

  • Kickoff meeting summary, including action items + next steps:  A documented record of key decisions, open actions, and initial tasks agreed upon during the kickoff.

  • Finalized RACI and team directory:  A shared reference detailing role assignments and contact information for all core team members.

  • Agreed-upon meeting cadence and reporting mechanisms:  Defined rhythm for team engagement and performance tracking, with tools and formats confirmed.

  • Team alignment around program goals, timeline, and performance expectations:  Shared understanding of project scope, milestones, and success metrics, fostering unified execution.

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