What has R&D learned from COVID-19

A linear approach to developing and commercializing drugs has led to the long timelines and high costs that we see today for taking a product to market. Asset strategy based purely on regulatory approval considerations rather than a blend of regulatory, market access and commercialization insight at every stage of the development process contributes to the high number of clinical and commercial failures that we in the industry today. In short if we decided to invent the process of clinical development and commercialization today we would do it very differently and in a far more adaptive, agile manner. Parallel processing regulatory, clinical, real world evidence and commercialization activities in an integrated manner can significantly reduce timelines for taking products to patients and manage the inherent risk in this process far more effectively. A much closer dialogue between regulators, payers, patients, prescribers and drug developers is required.

 In 2020 we have seen a glimpse of the art of the possible in vaccine development albeit as a result of a significant external force. Why must extreme necessity have to be the mother of all invention though? It’s true that a Coronavirus scientifically represents an easier target than other pathogens and very quickly a Chinese team uploaded the genetic sequence to a public site so that scientists could literally take existing vaccine programs and swap in the COVID-10 specific ‘cassette’. There are however other behaviors at play here that hopefully will be learnings for other ‘high unmet need’ disease programs and that have as extreme an impact on families and society as COVID but perhaps don’t attract the daily media attention.

Regulators, having learned from the Ebola crisis, took a far more proactive approach to communicating with companies about required efficacy thresholds; the tap for funding was quickly opened wide and capital flowed in to these programs versus the usual measured milestone based investment decision making approach. Now, what about cancer, neuroscience and microbial infectious diseases, societal and economic impact is enormous here too and in the short term is going to get much larger as a result of COVID. So academic and private drug discovery organizations need to sit down with regulators, payers, healthcare professionals, governments, charities and funding organizations now, define the priorities and ask ‘What is it going to take to address this’?. Let’s not move on so quickly that we forget the lessons learned here. It’s not just the process of drug development that needs looking at, it’s the way society funds research into areas of unmet need, its public / private funding models and its academic/private research collaborations that provide the engine and it’s an integrated product development model that provides the fuel..