Good Pill Project Scope Statement

G OOD P ILL P ROJECT S COPE S TATEMENT 6/16/2024

Project Scope Statement Template T ABLE OF C ONTENTS I NTRODUCTION ................................................................................................................................. 3 P ROJECT P URPOSE AND J USTIFICATION ........................................................................................... 3 S COPE D ESCRIPTION ......................................................................................................................... 3 H IGH L EVEL R EQUIREMENTS ........................................................................................................... 3 B OUNDARIES .................................................................................................................................... 3 S TRATEGY ........................................................................................................................................ 4 D ELIVERABLES ................................................................................................................................. 4 A CCEPTANCE C RITERIA .................................................................................................................... 4 C ONSTRAINTS ................................................................................................................................... 4 A SSUMPTIONS ................................................................................................................................... 4 C OST E STIMATE ............................................................................................................................... 4 C OST B ENEFIT A NALYSIS ................................................................................................................. 5 2

Project Scope Statement Template ensuring that project evaluations are uniform and consistent across various research sites The main objective of Good Pill’s initiative will be to boost the pharmaceutical development portfolio's overall worth and efficiency. The business goals of increasing return on investment, lowering attrition rates in R&D, and ensuring that projects align with the organization's strategic goals are all supported by optimizing these processes. S COPE D ESCRIPTION The scope will include crucial improvements that are intended to improve pharmaceutical development portfolio management. Strengthening the evaluation methodology and indicating more thorough and robust evaluation will be a top priority. The corporate review and prioritizing process optimization will guarantee a coordinated and practical selection of projects. The Target Product Profile (TPP) and stage-gate decision processes will be used to seek organized and clarified review phase. This will be critical towards making an improvement upon the pharmaceutical market. A risk analysis will be incorporated to anticipate and resolve any further issues found. The Net Present Value (NPV) technique will be highlighted to estimate the value of projects. Simplified assessments of research projects are supported, as this will foster uniformity in monitoring development to maintain a consistent and effective oversight. Lastly, the scope suggests using scoring techniques to improve the evaluation of research initiatives. H IGH -L EVEL P ROJECT R EQUIREMENTS The high standards needed to improve pharmaceutical R&D portfolio management varies. To ensure a consistent strategy for product development, TPPs specific to R&D projects must be created and standardized. In order to streamline the assessment and advancement of each project, a stage-gate decision process will be applied consistently across all project stages. An additional critical component, risk assessment, is the creation of evaluation benchmarks that can accurately analyze prospective difficulties. A uniform set of criteria is essential to evaluating the research portfolio to maintain consistent assessment standards. There is also a call for the development and seamless integration of a simplified financial ranking system that will use epidemiological insights and market data to forecast project potential success and profitability. This recognizes the dynamic intersection of science and business 4

Project Scope Statement Template P ROJECT B OUNDARIES The limits that have been established for improving pharmaceutical R&D portfolio management are stated to keep things focused and productive. Activities are aimed to assess and improve the current portfolio management procedures. This ensures the activities are tailored to the moment's needs and are covered by the scope. Project managers will then receive training sessions to familiarize themselves with the nuances of new tools and the processes to facilitate it. There will also be a focused effort to implement new evaluation standards and scoring techniques. This will help maintain the consistency and thoroughness of the assessment process. The initiative will not include the introduction of new pharmaceutical development projects. However, it is crucial to understanding what lies outside the set restrictions. The fundamental business structure and overarching corporate strategy will not be changed. As a result, the organization's integrity will be preserved. P ROJECT S TRATEGY In order to review and improve Good Pill Industries’ current processes, a cross-functional team composed of members from R&D, project management, financial analysis, and strategic planning will work cooperatively. Their compass will provide the best practices, industry benchmarks, and data-driven choices possible. P ROJECT D ELIVERABLES Portfolio Management: Refinement of evaluation methodologies. Enhanced prioritization processes Refinement of evaluation methodologies. Enhanced prioritization processes Refinement of evaluation methodologies. Enhanced prioritization processes  Evaluation methodology refinement  Prioritization process enhancements Key Management Tools:  Project Scope Statement  Development and utilization of Target Product Profile (TPP).  Implementation of a stage-gate decision process Risk Management:  Comprehensive risk analysis incorporating both strategic and operational perspectives.  Use of predictive models and benchmarks. 5

Project Scope Statement Template  Regular risk assessments and management strategies. Pharmaceutical Valuation:  Tracking and forecasting drug candidate progress.  Financial projections and evaluations.  Estimation of clinical phase durations  Track and forecast drug candidate progress  Track financial projections and evaluations  Estimate clinical phase durations Evaluation methodology refinement Prioritization process enhancement A CCEPTANCE C RITERIA The strict and varied acceptance standards for improving pharmaceutical R&D portfolio management. Implementing the improved portfolio management processes and ensuring seamless integration into the current operational framework are crucial success indicators. A measurable improvement in the attrition rates of R&D projects, which denotes increased efficiency and effectiveness, will also serve as a concrete success metric. As a result of the improvements made, pharmaceutical development projects are also anticipated to see an increase in their return on investment. Positive feedback from stakeholders closes the feedback loop, validating the effectiveness and suitability of the recently implemented processes P ROJECT C ONSTRAINTS At the moment, there are limitations to the project. Despite that, we intend to improve our pharmaceutical R&D portfolio management. A constrained budget will be set aside expressly for process optimization, limiting the depth of the incoming improvements. The resistance from team members who grew accustomed to the current procedures is a present challenge. This could obstruct a smooth transition to newer methodologies. Potential technological limitations could also make these difficulties more challenging to overcome, prevent a seamless implementation of the improvements Good Pill Industries currently desires. P ROJECT A SSUMPTIONS There are several crucial presumptions form the basis for improving the pharmaceutical R&D portfolio management. Those involved share a common vision for progress, agreeing on process optimization being an essential move to make. The business has the necessary assets and technological foundation to implement the recommended changes with efficiency. The initiative's foundation is resting on the conviction that the ongoing project data is accurate and up-to-date. This ensures that the choices made will be guided by pertinent information. C OST E STIMATES 7

Project Scope Statement Template Expense Estimated Budget Expended to Date Estimate to Complete Variance LC-1 Development Cost $100MM $85MM $15MM $70MM LC-1 Annual Expenses (3 years) $120MM $80MM $40MM $80MM LC-2 Development Cost $300MM $180MM $120MM $180MM LC-2 Annual Expenses (3 years) $195MM $130MM $65MM $130MM LC-3 Development Cost $600MM $420MM $180MM $420MM LC-3 Annual Expenses (3 years) $240MM $160MM $80MM $160MM LC-4 Development Cost $220MM $165MM $55MM $165MM LC-4 Annual Expenses (3 years) $195MM $130MM $65MM $130MM C OST B ENEFIT A NALYSIS The cost/benefit analysis will be both convincing and comprehensive, as it aims to improve pharmaceutical R&D portfolio management. $1-2 million is being set aside for the process optimization. The anticipated advantages are expected to outweigh this cost significantly. An ROI increase will happen due to the completion of successful projects is anticipated. There will also be a decrease in financial losses due to the early identification and termination of low- potential projects. Savings from the adoption of streamlined and effective project management procedures will be promised by the optimization. The business reputation will improve as well fostering confidence within the stakeholders. This will also strengthen the organization's position in the industry. 8