By Rob Wright, Chief Editor, Life Science Leader
Follow Me On Twitter @RfwrightLSL
“Hope is a good thing, maybe the best of things, and no good thing ever dies.” Andy Dufresne, in letter to “Red,” The Shawshank Redemption (1994).
If you work (or worked) in the biopharmaceutical industry, you have an important job ahead of you. Because no matter what position you held in this industry, you know as well as I, that the probability is nearly zero of developing a safe, effective, and durable vaccine for COVID-19 that is ready to be distributed to 300 million Americans before the end of this year. Afterall, the fastest vaccine every developed was for mumps back in the 1960s, and that took Merck a little over four years. More recently, and with much better technology, Merck developed a vaccine for Ebola in just five years. Yes, it is true that the U.S. government has taken unprecedented actions to remove regulatory roadblocks and even implemented Operation Warp Speed to accelerate development, manufacturing, and distribution of a safe and effective COVID-19 vaccine toward a goal of being ready by January 2021. But the reality is, we are attempting to do that which typically takes 7 to 10 years in less than one year.
If the biopharma industry fails to deliver on the politically established end-of-year timeline for a COVID-19 vaccine, who do you think the American people are going to blame? In recent years, our industry has been used by both political parties as a convenient scapegoat for everything that is wrong with healthcare. This blame game becomes even more evident during a presidential election cycle.
So, your job that I mentioned in the first sentence, is to begin preparing the American people for the reality that lies ahead. We need to educate them that we will most likely be dealing with COVID-19 for years to come. If we don’t take it upon ourselves to communicate the reality of our situation, proactively and urgently, there is the possibility of irreparable damage being done — to the biopharmaceutical industry’s image and reputation, along with that of the psyche of the American people. To do so, though, we must communicate in a language they understand.
Developing A Communication Strategy To Educate Your Friends, Family And Neighbors
We all know our industry has a language of its own. So, when we are talking to family, friends, and neighbors about the challenges of bringing a COVID-19 vaccine to market, if we use terms like SOP, fill finish, cold chain, and scalability, its likely our message will be met with a blank stare and confusion. Take the idea of scale-up for example. How do we help people understand the difference between making 500 test vaccine vials in a lab for a clinical trial, versus scaling up to manufacture, label, package, and control-temperature ship hundreds of millions of vaccines across the United States? Perhaps you could start with an analogy. For example, let’s say grandma makes a mean lasagna for 10 people. She says it normally takes about 30 minutes to make. “Does that include the time it took to go pick out all the ingredients at the store?” you might ask. Well, of course not, but you need to point this out because, in the case of mass manufacturing a vaccine, the “ingredients” also don’t magically show up at the factory. You also need to point out that the delicious taste of Grandma’s lasagna took years of perfecting the recipe.
Now, transition to explaining the concept of scaling up. You explain that grandma’s lasagna is so good, that you bet millions of Americans would buy it if they could purchase it in the frozen food section of their grocery store. Then get them thinking about everything involved in taking the knowledge grandma has for making this one tray of lasagna and being able to mass produce millions of trays of lasagna. You’d need to be able to purchase all the ingredients in very large quantities (i.e., the train load). You’d need a place to safely store those ingredients from pests. You’d need a place to assemble all the lasagnas, and you would need the various machines and people to do that. You’d need to develop a written procedure for how to exactly assemble the lasagnas, and then train all of those responsible on which steps to complete and in what order so all of the lasagnas are made to the same consistency. You’d have to prove you were able to consistently produce a safe product to the satisfaction of food regulatory authorities. You’d need to procure millions of trays to put the lasagnas in, and all of those would have a plastic safety seal that would go over top. You’d need boxes to put the sealed lasagna tray in, and those boxes would need to be labeled with branding, ingredients, and instructions for how to cook. You’d need shipping boxes (i.e., 12 lasagna boxes to a case), packaging machines, palletizing machines, shrink wrap, and a loading dock. As each lasagna would need to be flash frozen, you’d need a machine that does that, too. And, as the item is to be shipped frozen, you’d need a trucking company with freezer trucks capable of delivering the product all over the U.S., and equipment that monitored the temperature of those trucks. Now, perhaps you could partner with a company that already has everything in place needed to do this, but you’d still need to find a slot for when they could fit your lasagna manufacturing project into their schedule.
This analogy may seem silly. But if you think about it, so too does the establishment of timelines for completing a COVID-19 vaccine that aren’t built on the decades of scientific knowledge and wisdom by those who have been there and done that. We’ve seen what has happened to our industry’s reputation with the public when we haven’t taken ownership for managing the message (i.e., dead last of 25 industries). Finally, here’s another reality worth getting across to family, friends, and neighbors. The only reason the U.S.A has the majority of the world’s COVID-19 therapeutics in development, is because the industry was very healthy to begin with, and had the financial and technological wherewithal to begin their development — at significant financial risk! And while there are currently more than 155 vaccines against the coronavirus in development around the world (22 in human trials), given the track record for how many failures (i.e., 9,999) it takes to get just one therapeutic across the finish line, we can hope for a miracle, but should help the American public to remain grounded in reality. If we don’t, many Americans will be sorely disappointed when the summer of 2021 doesn’t look much different than what we are all currently experiencing. Rest assured, though, it will be biopharma that will shoulder the bulk of the blame.