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BUSINESS
U.S. Food and Drug Administration

How 3 CEOs overcame tough business challenges

Jeanne Blake
Special for USA TODAY
Katrine Bosley, CEO of Editas Medicine.

Bold leaders listen carefully, are resourceful and communicate constantly. Three CEOs tell how they overcame a challenge by exercising these qualities.

Katrine Bosley is CEO of Editas Medicine, a young biotech based on a novel way to turn on, turn off and alter genes.

Listen carefully. At my last company, Avila Therapeutics, we were working on a new kind of molecule that most industry people thought was a terrible idea – that there would be safety issues. The head of chemistry at one Big Pharma company told me, "You guys are crazy to be doing that."

We had to figure out how to address our critics' concerns with data. After looking at our new data, that same chemist — to his credit — said, "Hmm, that's interesting. That's different from what I thought."

It was a combination of figuring out what's worth pursuing, listening carefully to people's concerns so we could overcome them, and creating the data to support it. That's what we did.

Today the industry thinks that kind of chemistry's a great idea. Three drugs invented by Avila are in development with patients right now, and one of them is showing very promising results in lung cancer patients.

David Lucchino is CEO of Entrega, a start-up developing a new way to deliver drugs that had previously required injection.

David Lucchino, CEO of Entrega.

Be resourceful. Our company was facing a do-or-die moment with the Food and Drug Administration. We didn't have any slack in terms of funding, hitting our deadlines or maintaining our board's confidence.

Then I learned the director of the FDA division we were going to be dealing with had retired a year earlier. I found his home telephone number in the White Pages (very old-school!) and called him cold.

He had started a consulting firm, but his bar for taking on new clients was very high. I convinced him to become part of our team. He taught us how to communicate with the FDA about our technology.

We won the agency's approval for our first product within a year of our application — an unusually fast pace. It was largely due to the unexpected opportunity I saw to add a crucial player to our team.

Cheryl Blanchard is CEO of Microchips Biotech, a start-up developing an implantable microchip-based drug-delivery system.

Cheryl Blanchard, CEO of Microchips Biotech.

Communicate constantly. In my last job at an orthopedic implant company called Zimmer, I launched a new venture for them. The CEO told me to show him "how we should get this done." But there was no road map. I had to cobble a strategy together from nothing. The key was constant, open communication to all the stakeholders.

Finally we got to the point of launching products, and I had to convince a highly skeptical sales force at a national conference. They were very shrewd, right? But they were hungry for something new. They'd been listening to these dry speeches all day about new products. And I thought, "Oh. No. That wasn't the way to do it." When it was my turn, I got up there and just put my guts into it.

Afterward our sales reps and distributors and sales management people said, "Oh my gosh. This is huge." I knew we were on our way. That business is now a big deal at Zimmer.

At Microchips, I communicate the same way. But employees can tell if somebody's being sincere or if they're acting and putting on a show. I communicate the good, the bad and the ugly.

Jeanne Blake is president of Blake Works, an executive leadership communications consulting firm.

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