I stumbled across this article that has a nice illustration depicting the process of developing a new vaccine. The figure above shows us the steps in vaccine development from the creation of the vaccine candidate through preclinical and clinical studies to regulatory approval and lifecycle management. As you can see, the “road blocks” are challenges along this process. The first few blocks, also known as “the valley of death” illustrates the numerous obstacles that come about during the transition from laboratory to clinical-trial-enabling activities. There are many complexities in this process such as manufacturing process, formulation and qualitative/quantitative research.
There are also many resources that are needed when conducting clinical trials for vaccines such as a robust infrastructure, state of the art labs for processing clinical samples, as well as highly trained personnel. “The national regulatory authorities and ethics committee members who approve the studies to move forward must understand the approach to vaccine design and manufacturing, the implications of preclinical study results and immunologic assay performance, and intended outcomes to appropriately assess benefit versus risk for their populations” (Heaton). Early engagement with local community leaders is essential to address potential concerns about study conduct and avoid myths and rumors that may circulate once the study has started. This concept goes back to our class where we spoke of empathy when understanding a problem. They need to be asking the right who, what, when, why, how questions in order to get the right insight. It is important for those in a higher position to be properly informed so that there is no miscommunication and everyone is on the same page regarding any skepticisms. The conductors of the trials also need to be empathetic to the participants depending on the severity or sensitivity of the disease at play.
Adding to point of asking the right questions, The Five Why’s article from class explains a 7 step process to troubleshooting and problem solving. This can also be used in conjunction with LEAN and root cause analysis. An example of when to use this tool when creating a new vaccine would be during any of the roadblocks depicted above. You must first assemble a team and define the problem. Then, ask the first ‘Why’. “Why is this problem occurring?” Then, for each answer you have, ask more questions that branch out from there. An example of how to map this out can be found in the article. When you can no longer as anymore questions, that is when a process change or counter measure should become apparent. One this is determined, you must speak with your group about how to prevent this from recurring and lastly, monitor your counter-measures. Do they make the problem better or worse?
As testing in each phase goes on, a number of challenges are also presented. Funding being one of the biggest and most important when developing a vaccine. “Government and philanthropic organizations are supplementing private sector funding and are the sole funders for development in many cases but cannot bear the funding burden alone. Development funding from all stakeholders is needed.” Some other challenges that arise are getting a target population who are all healthy individuals. There are also many safety measures in place during vaccine trials – many of which could go off the rails if not monitored closely. Large clinical trials can have up to several thousand subjects and need to obtain a license beforehand in order to establish the safety profile and inform the benefit-risk assessment for using the vaccine widely. Safety must also continue to be monitored post-licensure in case any uncommon adverse reactions become present. “Each of these challenges is amplified even further for pivotal, confirmatory phase 3 trials, which are larger still.” I imagine that an affinity diagram can be created for each phase to break down each problem and gain insight into the root cause. Mapping out your process and having an illustration like the one above is critical to any project in order to clearly illustrate the pain points in the process as well as the flow. This will be helpful when looking for a precedent for new projects (in this case creating vaccines), but also looking for new ways to innovate the existing process.
Heaton, Penny M. “Challenges of Developing Novel Vaccines with Particular Global Health Importance.” Frontiers in Immunology, Frontiers Media S.A., 14 Oct. 2020, www.ncbi.nlm.nih.gov/pmc/articles/PMC7591467/.
Pojasek, R. (2000). ‘Asking “Why?” Five Times,’ Environmental Quality Management, Volume 10, Issue 1, 79–84. Available here. [Accessed March 6, 2017.], https://www.mindtools.com/pages/article/newTMC_5W.htm/.