Pandora’s Pharma Box is Wide Open| Now it’s time to demystify Drug Development and usher in the next generation of leaders

A new Breed of Stakeholders

Most of us are outsiders to the multi-tiered and complex process known as Drug Therapy development and in our lifetime, we rarely see the full picture. Recently, the glimpse we have had into the industry is just enough to get us into trouble and create havoc among the newly “engaged” and perhaps poorly informed resulting in a series of unimaginable societal outcomes such as the politicizing of science. The public display of frustration over vaccine development, availability, and mandates has likely added to the negative perception of the industry (a/l/a “Big Pharma). Rather than second guessing something we know so little about, we should be celebrating the fact that the industry is actually able to finally implement some new processes and systems to make things happen more quickly.

Digging deeper, one can see positive developments that far outweigh what’s lurking on the surface. It’s exciting and heartwarming to realize that behind the scenes there are committed people who are working hard and highly motivated to make a positive impact. Recently, I have had the privilege of hearing stories from dozens of industry insiders on what motivates them to do their important work and how things are changing. Behind the scenes are committed science and technology professionals who are working hard and highly motivated to make a positive impact. There are droves of young people heading into Life Sciences to “make a difference” and this can only be good for our country’s future.

A Complex Industry

For years, the labyrinthine process of drug therapy development has taken place behind guarded walls of large pharmaceutical companies. Most average consumers would not even know what questions to ask when it came to the timeframes necessary to run a drug through all of its testing, clinical trials, and approvals. Yet, the FDA process is fairly straightforward, perhaps oversimplified. Statistically it’s good to note that few research projects (see below) materialize into final products

Developing a new drug takes between 10-to-15 years and $2.6 billion, as estimated by the Tufts Center for the Study of Drug Development, to get from conception to store shelves. The process involves thousands of steps and input from scientists working in a range of areas, including chemistry, biology, pharmacology, and medicine. The three main stages progress from the discovery of a new candidate to investigations showing if and how that would take effect to, finally, the development of a suitable production method. It’s a painstaking process with a lot of failure along the way. In fact, some 86 percent of all drugs fail in clinical trials, according to a recent MIT study. Scientists then have to go back to the drawing board.

Similarly, it can be argued that startups often go by the wayside in the Venture world – one source saying that 75% of those actually funded, fail! In the drug therapy world, our attention span gets tested and often takes long enough to find a cure that we lose interest over time. Then, along comes the Pandemic where time was clearly of the essence and everyone was jumping in to the fray. Forgive the pun, but this event took the mask off this mysterious process and has exposed the sector to a discussion about which most of us are painfully unqualified to undertake. As an outside observer who has been following it from the point of view of the technology sector, the last decade of technology startups has aimed to disrupt areas that had big room for improvement – simplifying the clinical trial documentation, for example. Companies like OpenClinica, DrugDev, or bigger players like Veeva which is creating efficiencies through the Cloud and industry bench marking tools that are destined to raise the bar further than we thought possible.

Pre-Covid, the public discussion seemed to enjoy beating up on Pharma companies because all we really see is high prices, inaccessibility, and paperwork. But now it seems we have a huge population of newly minted consumer experts who have taken their frustration to a new level; questioning the scientists; the procedures; and the timeframes that have been long and cumbersome. For example, the untrained consumer can easily jump to the conclusion that the vaccine was not tested enough through operation “Warp Speed” because based on what we have experienced it SHOULD have taken longer in the world where this WAS the accepted norm.

A Call for Education and Collaboration

What seems to be missing in this public array of confusion is a cogent “pharma development” education discussion for the masses that is endorsed and supported by the Life Sciences industry and academia as one cohesive discussion. It’s quite likely, for example, that the use of technology to close the gap on very antiquated processes might just have been catapulted into everyday application but many of these companies are operating in their own silos and time frames.

Some relatively basic changes were long overdue and, in the works, but were accelerated when the Pandemic forced people to keep physical distances in check. Applications that have recently come forward include capturing clinical trial data on mobile devices and reaching people more efficiently via video conferencing have already had a huge impact. These are just the tip of the iceberg as there are also more players than ever in this sandbox pushing innovation in much more complex parts of this heavily regulated industry. The Boston Business Journal recently reported that Life Sciences companies in Massachusetts collectively raised more than $13B in funding in 2021 and many have gone public and are counted in the top 25 IPO’s.

Ushering in Next Generation of Life Science Leaders

In my recent advisory work in the sector, I have had the pleasure of speaking to many dedicated life sciences professionals. Their stories are powerful. Their commitment to a better future for the industry – impressive. The Pandemic has galvanized them. This is an important positive outcome of the last few years. But it’s easy to see how this positive could be turned into a negative if the industry can’t take the reins on the public discussion. To turn it around, the conversation has to be expanded to create a level playing field for novices to better understand the types of changes that have been made and the impact this has had.

There’s a huge opportunity for all parts of this sector to come together to bridge the learning gap. As consumers and observers, let’s step back and take a breather and use this as an opportunity to learn about this industry. As for the industry, serious consideration should be given to an industry-wide “call to action” to take up this educational imperative. The combination of underlying drivers – confused stakeholders, a complex industry, a gap in education, and new leadership creates a momentous and unique stage for collaboration.