Biopharma Leadership Through Troubled Waters
By Louis Garguilo, Chief Editor, Outsourced Pharma
Leadership and career opportunities show up in all kinds of places and circumstances. We learned how to take advantage of these in our recent article, Leadership Lessons From Oil Patches To Biopharma Plants.
But in the business of drug development and manufacturing, setbacks can strike quickly, and with blunt force. David Enloe, President and CEO at Ajinomoto Althea, Inc., knows this all too well. Here he describes how devoted – I’m tempted to write “devout” – leadership in the midst of significant difficulties can provide a saving grace.
Should I Stay Or Should I Go
Background: At the turn of the 21st century, a rare, Houston-based biotech, while busy pursuing the development of its own drugs and IP, discovers it has a sought-after talent for viral vector manufacturing, a new and growing field. It decides to pursue contract manufacturing. Enloe, then COO of Introgen Therapeutics, receives board authorization to break off part of the company to form the CMO.
Opening: The calendar flips to 2008, known throughout biopharma (and most of the world) as the year the economy dropped, and virtually stopped. Add to the timing an FDA that suddenly informs Introgen it must undertake another phase three clinical trial, because the standard of care for the disease target changed during their first attempt.
The protagonist: “We’re dead out of money.” The company files for bankruptcy, the principals step away, and Enloe becomes CEO. “I was the first hire, and now I’m tasked with winding this down until I’m the last man standing.”
Enloe wrestles with inner thoughts: “I don’t know if I should stay and have this tattooed onto my personal history.” But he recalls other challenges – and risks – he’s taken on during his career. He decides that “the task is worthy, and the experience will be irreplaceable and valuable somewhere in the future.”
A New Word For Life
Bankruptcy is filed, but there’s a twist: Introgen has a few remaining customers pursuing new drugs, such as the University of Oxford and a malaria vaccine. Enloe travels to Austin, Texas, and stands before the presiding bankruptcy judge. He pleads – and somehow convinces – the magistrate not to order the disbandment of the 11 remaining employees, but instead allow them to continue operations. The equipment, as required by law, will be sold off. Enloe returns to Houston and his remaining employees … and starts looking for more customers.
“Talk about a hard sell,” Enloe comments. “Drumming up new work while selling off assets in bankruptcy is not a business model I wish on my worst enemies.” Yet he’s determined to go on. After some time, he convinces two friends who are active investors in the Houston business community to join him in securing potential funding to buy the equipment back. They locate the entire operation in a small building that was once part of the now defunct Introgen.
In June of 2009, Enloe founds and becomes president and CEO of Vivante GMP Solutions, Inc., a biologics contract manufacturing company. “Vivante is a splinter word around life –being vital, vibrant,” he tells us. “I named it not only because of the new medicines we work on for patients, but also for keeping our organization, and the careers of as many dedicated employees as possible, alive."
I Know You By Name Alone
Enloe stays center stage:
“My specific goal to my two investors is to sell Vivante to Lonza within five years. It doesn't matter I’ve never met anybody who worked at Lonza. I know they have a strong reputation. It’s evident we need strong legs under us to grow our business to critical mass. We have to demonstrate we’ll be around as long as or longer than our clients. They take on enough risk just by nature of the biopharma business. I know that the CMO experience has to be almost boring – at least predictable. They call, it gets made and shipped to them. Of course it’s way harder than that, but it doesn’t need to feel harder to the clients. For me, Lonza is the name that needs to be on our wall.”
In the meantime, the new company struggles. That new life force – specifically the lifeline of funding – is not coming through. Enloe recalls everyone using the one printer that had ink left in the cartridge, not replacing light bulbs, and just making payroll. He remembers sitting in a Mexican restaurant one hot Friday afternoon with a margarita, and lining up three forks: “One represents the funding coming through; the second Lonza coming in; the third, it all coming to an end.”
Then Enloe manages to get a meeting with a Lonza representative. He starts by introducing the subject of some sort of collaboration for viral work.
“What do you want to do with your company long-term?” the guy from Lonza suddenly asks.
“In a few years, I want to sell it to you,” says Enloe without hesitation.
“Well, how about right now?” asks Lonza.
It turns out Lonza is exploring options in the growing viral medicine space. “We outlined the deal in a few minutes,” says Enloe, but Vivante had to hang on during the next eight months it took to get the contracts in order and signed.
“Our original 11 members are now 15,” says Enloe. “My number one condition to Lonza is they can’t let go of even one of my people. That’s my decision. No consolidations, no cost-threshold rationalizations, nothing.
“These employees have been through Introgen, bankruptcy, the sparsest of times at Vivante. I’m most proud that of those 15 original people, I was the first to leave, and I didn’t do so until the time was right for our people, our customers, and for Lonza – three and a half years later.”
Into The Sunset
We end as Enloe rides into the Houston sunset for a new daybreak on San Diego Bay. He becomes the CEO of Althea, a CMO that some nine months prior had been acquired by the Japanese conglomerate, Ajinomoto. More challenges and opportunities lie ahead for leadership; more careers to help along the way.
“When I first told my Introgen gang I was leaving, they said, ‘What on earth are you thinking?’ But I told them it was their turn to move up in their careers, and become the leaders they are capable of becoming,” says Enloe.
He still visits Vivante – now Lonza Houston – a company as he had originally envisioned, vibrant and doing well. His core team is all there. “I tell them what a great job they’re still doing,” says Enloe. “I can’t tell you how proud I am of those guys.”
He again sums up his lessons in leadership and career: “Include people in what you are doing, take calculated risks, learn about yourself, and be damn stubborn.”
Maybe not quite in that order. But surely a recipe that will work for many would-be and practicing leaders.
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David Enloe, President & CEO of Althea Ajinomoto, has been a panelist and participating member of Outsourced Pharma Conferences since our inception. Readers can meet him and other industry executives at Outsourced Pharma San Diego, August 23-24.