risk assessment process, developing risk assessment frameworks, and facilitating risk identification and evaluation. They assist in the development of risk mitigation plans and track risk progress throughout the project.

Research Scientists: Responsible for identifying scientific risks, such as challenges in target identification, assay development, or compound screening, and providing input on risk mitigation strategies.

Regulatory Affairs: Ensures that the risk assessment process includes regulatory risks related to clinical trial approval, regulatory submissions, and compliance with global regulations.

Quality Assurance (QA): Ensures that risk management practices adhere to internal quality standards and regulatory requirements, providing oversight of risk mitigation efforts.

4) Procedure

The following steps outline the detailed procedure for risk assessment in drug discovery projects:

1. Step 1: Risk Identification
   1. Conduct a comprehensive risk identification session with all key stakeholders, including project managers, scientists, regulatory teams, and quality assurance personnel, to identify potential risks associated with the drug discovery project.
   2. Identify risks across different domains, including scientific risks (e.g., target validation, compound efficacy), regulatory risks (e.g., clinical trial approval delays), operational risks (e.g., resource constraints, timelines), and financial risks (e.g., funding limitations, cost overruns).
   3. Document all identified risks, categorizing them into primary risk areas (e.g., scientific, regulatory, operational) and assigning severity levels (e.g., high, medium, low).
2. Step 2: Risk Evaluation
   1. Assess the likelihood and potential impact of each identified risk. This can be done using qualitative methods (e.g., expert judgment, brainstorming sessions) or quantitative methods (e.g., probability analysis, risk scoring).
   2. For each risk, determine the probability of occurrence and the potential severity of its impact on the project. Use a risk matrix or risk scoring system to prioritize risks based on their potential impact on project timelines, budget, and regulatory compliance.
   3. Evaluate the interdependencies between risks and how one risk could exacerbate or trigger others, creating a compound risk situation.
3. Step 3: Risk Mitigation Planning
   1. Develop risk mitigation strategies for the most critical risks identified during the evaluation process. These strategies should aim to either eliminate, reduce, or manage the impact of the risks.
   2. For each risk, propose specific actions to mitigate it, assign responsibility for mitigation, and establish timelines for implementing mitigation measures. For example, if there is a risk of clinical trial delays, a mitigation strategy may involve proactive communication with regulatory bodies to address concerns promptly.
   3. Ensure that risk mitigation strategies are realistic and achievable within the project’s budget and timeline constraints. Consider alternative strategies if the primary mitigation approach is not feasible.
4. Step 4: Risk Monitoring and Tracking
   1. Establish a process for monitoring identified risks and tracking the progress of risk mitigation efforts. This may involve regular project review meetings, risk tracking tools, and documentation systems.
   2. Assign team members to monitor specific risks and ensure that mitigation actions are being implemented according to plan. Track any changes in the risk profile throughout the course of the project.
   3. Periodically update the risk assessment as new risks emerge, and existing risks evolve. Adjust risk mitigation plans as necessary to address any changes in the project’s scope or external factors (e.g., changes in regulatory requirements, new scientific discoveries).
5. Step 5: Communication of Risk Assessment Results
   1. Communicate the risk assessment results to all relevant stakeholders, including project teams, senior management, and external partners. Provide an overview of identified risks, their potential impact, and the mitigation strategies in place.
   2. Ensure that risk assessment results are presented in a clear, concise manner, using visual aids (e.g., risk matrix, charts) to enhance understanding and facilitate decision-making.
   3. Share updates on risk status, highlighting any significant changes, new risks, or adjustments to mitigation strategies, during regular project meetings or review sessions.
6. Step 6: Post-Project Risk Review
   1. At the conclusion of the drug discovery project, conduct a post-project review to assess the effectiveness of the risk management process. Identify lessons learned from the risk assessment and mitigation efforts, and document recommendations for improving future projects.
   2. Evaluate whether the risk mitigation strategies successfully minimized the impact of risks and whether any unforeseen risks emerged during the project that were not adequately addressed.
   3. Integrate the findings from the post-project review into future risk assessment practices to improve the risk management process and ensure that new projects benefit from past experiences.

5) Abbreviations

• FTO: Freedom-to-Operate
• QA: Quality Assurance
• GLP: Good Laboratory Practices
• GCP: Good Clinical Practices
• IP: Intellectual Property

6) Documents

The following documents should be maintained throughout the risk assessment process:

1. Risk Identification and Evaluation Report
2. Risk Mitigation Plan
3. Project Risk Monitoring Logs
4. Risk Assessment Communication Documents
5. Post-Project Risk Review Report

7) Reference

References to regulatory guidelines and scientific literature that support this SOP:

• FDA Guidelines on Risk Management in Drug Development
• ICH Guidelines for Risk Management in Clinical Trials
• ISO 31000:2018 Risk Management Standards

8) SOP Version

Version 1.0