USE CASES

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Your challenge

You've hired the best and the brightest and given them resources to tackle the most difficult problems in human disease. Your research teams generated many promising proposals. Now you need to decide which ones to fund through development and commercialization. No one is quite sure who are the final decision-makers. The criteria for greenlighting or pausing projects are not clear. This is creating confusion and uncertainty and exacerbating conflict within the organization.

My solution

• Understand the corporate values, objectives, and strategy; document them formally if they are not already documented
• Create an inventory of programs, projects, and initiatives, both R&D and operational
• Work with executive decision-makers to create a prioritization and decision-making framework that matches company values, objectives, and strategy
• Document the process and create tools for portfolio prioritization and management
• Get feedback on the process and tools from functional leads and executive management to ensure that the process is clear, efficient, and sustainable → iterate as needed
• Use the decision-making process and prioritization criteria to assess existing projects, programs, and initiatives, leading to an organized company portfolio

Your challenge

Multiple projects are feeding  into a larger product launch, including manufacturing, software development and validation, and regulatory filings. The individual project teams are very efficient and doing an excellent job with their deliverables. However, the dependencies between the projects are not well mapped out, causing delays during hand-offs from one team to another. Supply and demand planning is not keeping up with the fast pace of the work. Operations is overwhelmed by the tech transfer requests.

My solution

• Identify the objectives of the program, including the minimum viable product definition
• Establish a regular program review, decision-making process, and process for escalating risks to key stakeholders
• Create a full inventory of projects and deliverables contributing to launch; identify dependencies between  them
• Integrate the timelines of individual projects, corporate initiatives,  operations, and commercial activities → create a single overall program timeline
• Align supply chain and procurement activities with the program timeline to ensure materials are available when needed
• Highlight critical points of integration, with emphasis on highest risks for delays if hand-offs don't happen on time
• Create dashboards tracking integrated program milestones 
• Ensure your staff have tools and training to track program progress and re-evaluate the timeline, resourcing, risk, and minimum viable product definition through launch

Your challenge

Your preclinical study lead is on a very tight deadline to deliver data for a regulatory filing. The study lead is highly competent at designing the studies and managing her team to generate the data. However, she has no time left for project tracking and reporting on progress to management. There is no headcount available for a full time project manager to assist her. 

My solution

• Consult with upper management to understand the minimum reporting needs and identify any concerns about the preclinical data delivery
• Mock up several alternative easy-to-use templates and tools for tracking and reporting; review these tools with the technical lead and upper management
• Train the technical lead and others on her team to use the reporting tools; improve and simplify the tools based on feedback
• Train the technical lead and others on basic project management techniques so they track their projects with minimal effort
• Populate the initial project dashboards together with the trained staff to ensure they have a solid starting point

Your challenge

Your company has been hard at work in R&D mode for a few years. You now have a product candidate that is ready to be developed for the commercial market. Your industry is highly regulated, requiring thorough documentation of your internal processes and development data. You have plenty of documentation, but it is not in a formal consistent format. You have a limited time to create and improve your documentation to be ready for regulatory filings and audits.

My solution

• Interview your subject matter experts to compile a full inventory of existing documentation
• Interview your Regulatory and Quality leads to compile a full inventory of required documentation
• Provide a gap analysis between existing and required documents
• Create or update document templates
• Convert existing documents to the new standard template formats
• Create new documents based on information and content provided by your subject matter experts
• Get feedback from your subject matter experts and decision makers to finalize the documents for approval