Jim Mongiardo: Boundary Hunter
Jim Mongiardo has had a fascinating career to date. He has run a string of medical and biotech companies over the past 25 years. He is a quick study. More important – and the reason he has succeeded so often – he quickly learns the business boundaries for each company he has managed and how to push those boundaries as far as he reasonably can. It takes smarts to learn operational, investment and regulatory boundaries. It takes courage to understand when you have reached your limits.
Immediately following his graduation from Harvard Law School, Mongiardo started out as a litigator in the New Jersey state court system but soon grew restless. He wanted to try his hand at business. Finding a job at Schering-Plough (merging with Merck & Company in 2009) he entered a management training program and soon to become head of marketing for Schering’s Over the Counter and Prescription Drug business.
It was when Mongiardo became responsible the prescription medication Intron-A, originally developed by biotech giant Biogen, that he really learned the types of skills it took to run a high-science big business. Intron-A is used for a wide range of diseases, eventually brought in revenue of more than $4 billion per year.
That’s when Mongiardo became hooked. He wanted to run his own cutting-edge biotech. That’s also when he began to learn how to push the business boundaries, yet still finding ways to achieve success.
Boundary #1: Raise the money. After that, know the science and know your limits.
Jim was somewhat surprised at how much he had to know and control when running a biotech, or medical device startup. Not only was this former history major supposed to hunt for money around the world pitching his company’s new product to global investors, but also he had manage the science as well.
“I was the business guy who had to run the business, all of the business. I quickly understood that I was also responsible for the science – even though I had a chief scientist on board. So if something goes wrong with the science, I was the person held responsible.” Mongiardo recalled.
At some point in all science-based enterprises, the science may overtake the need for its chief business manager. Mongiardo learned that lesson as well.
For one of his medical startups, he raised enough funds to develop and mature a company producing a specialized medical test kit but then realized the firm needed better science to improve the product. The company had all the money they would need to achieve success. What it needed now was a bench scientist to direct the rest of the testing and development. He knew his limits, his boundaries and left the firm. When the firm reached its new targets it was able to sell its technology. It had reached its goal and Jim had fueled its success.
Boundary #2: Learn how far to push and when to retreat from the government.
Working with regulatory agencies, such as the FDA, presents another boundary challenge.
Pharmaceutical companies want to push claims as far as they reasonably can – yet receive FDA approval. Sometimes this means pushing hard on the limits, while having a backup plan to support the argument when the FDA disagrees with your position.
Mongiardo recalled attending a conference at a time when he was responsible for introducing a new steroid inhaler. “There was a speaker from FDA whose responsibility was to enforce advertising regulations,” he recalls, “This was the official who would go back to you if he didn’t like your advertising. So he was there describing all sorts of products where he found companies at fault, making claims they could not support. Then he comes to my advertising campaign and said to this audience that our inhaler was in the gray area but he would let it go. I was proud.”
Another time he introduced a new cold product that claimed three mechanisms of action (MOA) that made the product effective and better than anything else on the market. One of the MOAs was supported by a test trial with a group of monkeys. This claim was not made in the initial advertising reviewed by the FDA but in the follow-up campaign, a change that an FDA official found to be entirely unacceptable. As a result, the official sent an angry letter to Mongiardo’s company.
“We pushed back on the official, telling him that this was a backup advertising campaign which was supported by the monkey trial,” says Mongiardo.
“We compromised with the FDA. The resolution allowed us to continue with the ad campaign with only our adding an asterisk leading to a footnote. That footnote stated the third mechanism of action was based on a monkey study.”
“We got to run entire campaign by just modifying the claim with a footnote. The lesson for me is ‘Know the Agency’ and its rules. Just because the FDA said you shouldn’t do this or that, doesn’t mean you can’t push back.”
Talking to this somewhat soft-speaking CEO belies his tenacious character. Beyond the excitement that science-based businesses brings to Jim Mongiardo, he has also learned that running a science business is more than just pushing the boundaries of science. It also requires a CEO that knows how to juggle the science while at the same time pushing the boundaries of business.