Inc.

There have been multiple ramifications of the COVID-19 pandemic for drug development. Some of these have been well-publicized, most notably the delay of clinical trials, which was largely due to the potential exposure of volunteers, patients, and staff to the virus. Additionally, the widespread supply chain interruptions that are discussed frequently in the lay press also affected drugs and other clinical trial supplies.

However, there is an area of drug development affected by the pandemic that has not received much attention. That is the decrease in interaction among people in academia, biotech, and pharma that has traditionally yielded substantial progress in target and drug discovery as well as in advancing compounds through the various stages of development.

There are respective diverse merits to universities, biotechs, and pharma where each may complement the other to enhance the various stages of R&D, from first-in-man studies, through proof of mechanism and proof of concept, and even later stages of development and post-registration trials. The relative academic freedom and small group structures intrinsic to universities and biotech may have advantages for a more streamlined process and quick decision-making, whether that is to further explore a novel mechanism or to terminate a project. Clearly though, once it is decided that a specific target or mechanism is worthy of further experimentation, the collaboration of academia, biotech, and pharma is important to advancing a program expeditiously, with each site utilizing their respective strengths. For example, universities have excellent scientists, but typically turn to medicinal chemists, pharmacologists, and toxicologists working in pharma to further evaluate a compound. Additionally, pharma has more resources to invest in promising targets than most universities and small biotech companies. And if a compound is advanced to clinical trials, the translational medicine and clinical trialists readily available in pharma are experienced in testing these compounds for safety and efficacy. At all stages of drug discovery and development, the comprehensive and continual interactions among academia, biotech, and pharma are critical to ensure medicines are being discovered and developed appropriately to meet unmet medical needs.

 With the first mRNA vaccines being made available during the pandemic inform us that the continued innovation can occur even during a pandemic. It will be interesting to see how new advances in technology, such as the metaverse and artificial intelligence, may mitigate some of these issues 

An example at Daiichi Sankyo Company Ltd (DS), is our long-standing collaboration with Sanford Burnham Prebys in La Jolla, California. We initially entered a comprehensive alliance to develop first-in-class therapeutics for the treatment of cardiovascular-metabolic diseases. This was later extended to include rare diseases and oncology. The collaboration was based on an open-innovation model to bridge the gap between target discovery and pre-clinical drug development. The focus was on studying new mechanisms of disease to identify, validate, and screen novel drug targets to address unmet medical needs worldwide. Sanford Burnham Prebys identified and validated targets in collaboration with Daiichi Sankyo, after which collaborative teams conduct drug screening to identify compounds that modulated the targets using facilities at both sites. Scientists at Daiichi Sankyo have appreciated continued and expanded access to Sanford Burnham Prebys’ deep human biology insights and drug discovery technology, with the goal of advancing lead compounds toward clinical trials. During the pandemic, due to respective quarantines in California and Tokyo, experiments were delayed at both partners’ sites leading to missed timelines on multiple occasions. However, due to the close, collaborative relationship that has developed over many years between our two groups, we were able to support each other. We covered each other’s workloads as each respective lab opened in the different regions, even if it was not a task initially allocated to that group. Additionally, there was also flexibility as to the allocation and utilization of the budget from one fiscal year to the next as some timelines were extended beyond the original plan.

From nearly the beginning of the pandemic, the traditional interaction among academia, biotech, and pharma was disturbed. One of the first major meetings cancelled was a key annual university tech transfer meeting for engaging organizations across multiple disciplines, followed by the Keystone conferences and numerous scientific, clinical, and business meetings. There was a near instantaneous collapse of the usual conferences that were relied on to publicize novel ideas and advance scientific knowledge and drug development. While technology became increasingly sophisticated in allowing meeting participants to interact virtually, this never approached the collegial, informal, intermingling that occurs when you happen to engage the person sitting next to you in a conversation about their work. In addition, at virtual scientific and medical conferences, one can no longer approach someone at their poster or after their talk. These spontaneous personal interactions were all but eliminated.

Other interactions between academia, biotech, and pharma based upon mutual interest in a research or clinical project were either delayed or came to a halt. For example, something as simple as a material transfer agreement, which allows a compound to be transferred from a university or biotech to a pharma that is interested in reproducing data, may not have occurred since either or both labs may have been closed due to pandemic restrictions. These types of interruptions led to delays in starting collaborations and potentially extending the timeline for the entire drug development process.

In conclusion, one of the lessons for drug developers from this pandemic is the vital intersection of academia, biotech, and pharma have in producing medical therapies. Even though the ideal will probably always be in-person meetings, we need to be able to continually think of innovative ways of communicating and working together effectively to ensure that progress to develop safe and efficacious drugs to meet unmet medical needs is not delayed, even when extraneous forces do not allow us to communicate or allocate work as effectively as we would like. With the first mRNA vaccines being made available during the pandemic inform us that the continued innovation can occur even during a pandemic. It will be interesting to see how new advances in technology, such as the metaverse and artificial intelligence, may mitigate some of these issues. However, for the foreseeable future, in-person events and collaborations will continue to be the method of choice for advancing science into new medicines.