He later said, “You’ve got to know your provider well, and it’s better if you know your provider from a previous life.” Theuer described Tracon as more of a classic virtual biotech that licenses drug candidates from academic laboratories. “The real strength of our team is in clinical and regulatory development,” he said.
—Maintaining tight controls over intellectual property also is important, said CEO Steve Kaldor of Ambrx, a six-year-old biotech creating a new class of longer-lasting protein drugs through partnerships with pharmaceutical companies. Because Ambrx is “creating new compositions of matter for every drug we develop,” Kaldor says the company keeps the research internal and retains key aspects of drug development internally.
—On outsourcing production tasks known as CMC, or chemistry, manufacturing and controls, Kaldor said, “We look to relationships where there is scalability. Once we build trust, then we can back off a little. But to state the obvious here, some of these companies are really close to going belly up, so it’s important to do your due diligence.”
—Keep in mind that many contract research organizations “over promise and under deliver,” said Dobak. “When they have a lot of contracts to manage, it’s hard to ensure that they’re going to maintain a laser focus on your project.”
—When asked if it’s important to oursource with local providers, Dobak said, “I think it’s so important to be able to sit down with someone and see what they’re doing, and important to be able to do that locally.”
—Hiring internally can be tricky with a small staff, said Tracon’s Theuer. “It only makes sense to hire someone when that person is cost effective,” Theuer said. “You have to make sure that person doesn’t break the highly functional nature of a small team.”
—When asked what’s important in choosing a contract manufacturer, Theuer said, “Their track record of success, and the ability to support a small company is the single most important factor.”
