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    Life sciences leads the way: Balancing standards and speed in a global health crisis

    By Julie Miglin, underwriter - Life Sciences

    Historically vaccines have played an important role in the public health innovations, by reducing mortality rates and helping to control the spread of disease. They work by exposing our bodies to a sample of a virus or part of its genetic code, allowing our immune systems to recognize and fight viral infection just as it would happen when we are exposed to the actual disease.

    While it sounds relatively straightforward, the recent development of COVID-19 vaccines, within a year of the virus’ emergence, is a huge accomplishment for the life sciences industry. To reach this point, those involved will have navigated a myriad of potential pitfalls and risks, made more acute by the pressure to expedite the process to help end the pandemic.

    In the longer term, what has been achieved over the past year under an intense spotlight, could also transform the life sciences industry. The shortened timeframe is likely to increase consumer and investor expectations alike. Being among the first to market with a successful vaccine brings huge financial and reputational gain to pharmaceutical companies. Pressure to expedite the process raises the stakes and increases pressure on those involved in drug and vaccine development to get it right the first time.

    The concept of vaccination is not new; in the late 18th century Edward Jenner discovered that inoculating a person with small doses of cowpox provided immunity against the much more lethal smallpox virus. However, despite what we have learned about behavior of viruses and immunology in the last 200 years, there is no guarantee that any project will produce an effective vaccine.

    Getting a vaccine to market and ensuring it is safe and effective only comes through extensive research and clinical trials, and thorough regulatory review. The process on average takes 10 to 12 years1 and the risk of failure is high. According to research by The Massachusetts Institute of Technology, in the last 20 years only 39.6% of vaccine projects have resulted in a drug being approved to go to market. Today only 26 diseases are preventable through vaccination according to the World Health Organization, and many deadly infectious diseases remain for which we have no effective vaccines or treatments.

    There are many challenges to overcome at different stages in the clinical research and trial process, which have to be navigated within strict regulatory controls.

    Testing the safety and efficacy of a vaccine only comes as the result of extensive research; a process that can easily take two years.

    Before moving to human trials, the sponsor must prove that their candidate meets the US Food and Drug Administrations’ (FDA) basic criteria of safety and efficacy. Failure to prove that the candidate vaccine meets these criteria could mean starting the process over with a back-up candidate costing time and money, potentially losing first-to-market advantage.

    To put things in perspective, the mumps vaccine, previously considered as the fastest to be developed, took four years, while the COVID-19 vaccine took less than 12 months. Several factors contributed to this incredible speed, including knowledge and lessons learned from dealing with MERS and SARS as well as the use of mRNA technology (instead of using a traditionally weakened version of the live virus), which has been studied by scientists for decades, and used in cancer research to target specific cancer cells.

    The rollout of some COVID-19 vaccines in record time driven by the collective efforts of the global life sciences community, health leaders and governments also required public reassurance to alleviate those concerns around reducing the research phase and how to mitigate the potential impact of this on human trials.

    After all, information learned during research forms the basis for human testing. While human trials inherently carry risk, this can be mitigated through proper trial design and ensuring that rigorous protocols are embedded for the duration of the trials, including learned and confirmed cycles to address any variance from anticipated results. Upholding these standards reduces the potential for human error that can lead to bodily injury and claims against those running the trial.

    Risk mitigation

    All vaccines that go through clinical trials, must prove safety and effectiveness. Particularly for the COVID-19 vaccines, the FDA has put in place rigorous standards for sponsors and manufacturers to adhere to. Once these standards are met accordingly, the FDA will determine if the vaccine is approved for Emergency Use Authorized – a temporary authorization under public emergency situations such as a pandemic. The monitoring and adverse events reporting of the vaccines continues beyond the approval. This system allows issues to be identified and addressed earlier on.

    For the life sciences sector, the rapid delivery of vaccines for this global pandemic may create new consumer and corporate expectations for the delivery of vaccines in the future. The industry will have to balance how to manage expectations with how it will operate when ‘normality’ resumes both in terms of what is reasonably possible to deliver safely and compliantly and in terms of the regulatory framework.

    Robust risk management measures and having specialist insurance in place in case claims arise is important, as is having experienced brokers and underwriters who understand the pace of change within the industry. Failure to stay up to date with the rapid changes within the life sciences sector presents not only a risk to trials’ success but potentially to those taking part.

    Claims could arise from bodily injury to trial subjects as a result of failure to properly monitor the trial. Similarly, claims could arise if the sponsor failed to adequately warn the participants about the risks, as providing clear information is critical to participants’ decision over whether to volunteer in a research study. Problems in the running of the trial resulting in lengthy delays could bring suits against contract research organizations (CRO) from sponsor corporations where it causes them a financial loss.

    Even the best-designed trial carries risk. Organizations that understand the risks and factor risk mitigation into the design of the trials are more likely to succeed. In a high stakes sector working with insurance partners that have the experience to understand the complexity of the sector will help the continuous growth of this complex and fast-moving sector.

    For more information please visit the Beazley website at www.beazley.com

    https://www.cdc.gov/coronavirus/2019-ncov/vaccines/different-vaccines/mrna.html

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