Scientific and Technical Risk Assessment: Killer Experiments

Step 1: Comprehensive Risk Identification

• Literature and Market Analysis: Regularly review scientific literature and monitor relevant announcement channels to identify potential technical challenges and market needs. Whilst doing the early risk scoping, you can skip ahead to Step 4 and set up a combination of PubMed and google alerts to monitor the relevant scientific and technical landscapes that is critical to maintain a comprehensive risk landscape understanding.
• Stake Holder Consultations: Engage with industry experts for insights on applicability and potential challenges of your technology, in light of the scientific and market risks. As an early-stage researcher, you can often benefit from enquiring with scientific experts both within and outside your immediate network, to integrate their feedback into your scientific and technical strategy.
• Technology Readiness Assessment: Critically evaluate the level of proof of concept you have received to date, and your technology’s ‘readiness level’ indicating how much further you need to develop it to reach different funding stages. As well as the scientific and technological development, scalability within technical and scientific constraints should also be considered.

Step 2: Designing and Conducting Pivotal Experiments

• Defining 'Killer Experiments': These are designed to rigorously test the core hypotheses of your technology. Failure in these experiments could mean a significant pivot or halt in your project. Identifying the outcomes of these as early as possible, with as limited capital as possible is optimal, and crucially sought by early investors.
• Focused Objectives and Robust Design: Ensure each experiment is designed with clear objectives and robust methodology to yield conclusive results.
• Resource Prioritization: It is crucial to allocate resources strategically for these high-stake experiments. Non-dilutive funding (which does not take equity e.g. grants) and early dilutive funding (taking a % of the company in return for capital) is predominantly spent on ‘killer experiments’, to begin to de-risk the scientific and technical risks.

Step 3: Analysing Outcomes and Mitigating Risks

• Objective Data Analysis: Analyse experimental data objectively, recalling that disproving hypothesis you hold is incredibly valuable, allowing you to save time and resources going down the wrong path.
• Adaptive Strategy: Be prepared to actively pivot your development strategy based on experimental outcomes.
• Risk Prioritization and Mitigation Planning: Post-experiment, reassess and prioritize risks, and develop a roadmap for addressing them, including contingency plans for critical risks.

Step 4: Continuous Monitoring and Documentation

• Regular Risk Review: Continuously reassess risks as your project progresses and new information emerges, creating a plan to stay on top of newly released, potentially relevant literature. This can include setting up a combination of PubMed and google alerts to monitor the relevant scientific and technical landscapes that is critical to maintain a comprehensive risk landscape understanding.
• Documentation: Maintain detailed records of risk assessments, experiment designs, outcomes, and mitigation strategies. Structuring your records in an orderly fashion is crucial, and can form part of your ‘date room’
• Flexibility and Learning: Adapt your strategy as needed and view each experiment as a learning opportunity.

Effective management of scientific and technical risks, through the execution of well-planned killer/pivotal experiments, is essential for the success of a biotech venture. This approach not only tests the feasibility of your technology but also prepares you to adapt and evolve in response to new findings and challenges.