I feel fortunate that I've been able to work on the basic science end of our fight against HIV, that I've been able to work in the lab and in the pilot plant and on the factory floor, making drugs for HIV, and that I've been able to help design low-cost supply chains.”
In January 1994, with much of the East Coast buried in snow, Merck scientists in Pennsylvania confronted the elements to continue their work in the lab. The Washington Post later described them as “brave or stupid,” but the researchers were motivated by something big: the potential for a breakthrough discovery in the fight against HIV.
Six years earlier, Merck had been the first to prove that inhibiting the HIV protease enzyme could prevent the virus from replicating. That discovery, however, was only the beginning. Shortly thereafter, the researchers and scientists endured a number of discouraging setbacks, including the failure of a promising compound and the death of one of our lead researchers in the Lockerbie bombing of Pan Am flight 103.
But our colleagues would not be deterred in their search.
Michael (Mike) Thien, Ph.D., who currently heads up Global Science, Technology and Commercialization for Merck Manufacturing Division, was one of those scientists.
“It was a big challenge. The product itself was probably the most complex chemical entity that we had ever made,” Mike remembers. “But we felt every day the real pressure of the fact that there were no good therapies for HIV at the time. And so that added a great sense of urgency to the work that we were doing. No one said that they couldn't do this or that. No one said they couldn't stay after and work longer.”
All told, Merck invested more than $700 million ($1.3 billion in today’s dollars) in the project, which included a massive clinical trial involving some 4,800 patients in 11 countries. Our commitment was finally rewarded in 1996, when the Food and Drug Administration (FDA) approved our treatment for HIV in just 42 days, the fastest approval in FDA history.
But before this breakthrough, Mike only encountered what he described as “failures” in his work. “Over the course of a two and a half year period, I went from working on eight things that failed to one thing that worked. But that one thing that worked? Well, that was a watershed moment in my life.”
It’s something he encourages other scientists and researchers to remember. “There aren’t a lot of businesses where when something enters clinical trials, it only has a nine percent chance of making it all the way through to the marketplace,” he says. “When you’re doing development work in our business, you are going in with the philosophy that, yes, you’re going to get to work on a lot of great things. But you’ll be really, really lucky if one of them is going to the marketplace to make a difference.”
As he enters his 27th year at the company, Mike currently runs the scientific and technology area in manufacturing at Merck. “I get to do three things: From a manufacturing perspective, my area works on the last bits of development for processes and products and packaging for new products – we get them ready to be manufactured. The second thing is getting these very complex technical processes ready for the manufacturing floor. They have challenges from time to time. So I oversee the technical teams to identify why we might be having an issue and how to fix it. The last thing I’m responsible for are all of our capital assets-- all of the buildings and factories we build.”
He’s still as busy as ever, but Mike only sees the bright side of all of the work. “There are some things you can do working for a company like Merck that you would never be able to do in academia, where I would never be able to develop a new operating model or come up with a new manufacturing process. I would never be able to say that my work contributed to help the lives of hundreds of thousands of people. Those are the things you don’t get to say as an academician,” he notes.
“But at a company like Merck, you get to say them with pride.”