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Hundreds of biotech companies spring to life each year in pursuit of the same basic goal: to make it big.

Some succeed. Genzyme began in 1981 as a startup with a handful of employees in an old clothing warehouse on the edge of what was then known as the “Combat Zone” — Boston’s red light district. Others do well, though maybe not on the Genzyme scale. Many more startups fail.

One exceedingly tricky step is designing and executing the programs needed to move a product through clinical evaluation and clinical trials. As a consultant who advises young biotech companies on regulatory and clinical strategies, I’ve seen companies execute this flawlessly and others fail miserably. Here are five of the costliest missteps that startups make.


Misidentifying key audiences

It’s essential to recognize that the Food and Drug Administration and other regulatory bodies are your customers right now — not investors, physicians, your board, or even patients. Focus on the relevant audience(s) in each stage of the process. Understand that as the work progresses, your targets may change.

Suffering from myopia

Don’t believe that the physicians and researchers on your board (whether it’s a board of directors, a scientific advisory board, or a medical advisory board) are the only people whose opinions matter. Yes, they are experts, but they aren’t always close enough to think through the details. Seek out and listen to diverse opinions from people with related and meaningful experiences, not just those with lofty titles.


Falling in love with your dreams

A classic mistake is mistrusting or not believing that data from early-development and preclinical studies is relevant to designing clinical trials. Forging ahead while disregarding safety issues that emerged from an early development program can be a disastrous oversight. Take a lesson from the Hippocratic oath and do no harm. Ignoring safety issues sets a fragile foundation that can potentially hurt people and ultimately sink a venture.

Not acknowledging that others may know better

It’s easy for a company founder or early-development team to think they know what needs to be done. But realistic and perceptive advice offered by senior operational people — whether they are consultants or employees — can be essential. Seek feedback from anyone in the know and remain open to varied opinions, even if they don’t necessarily agree with yours.

Ignoring potential hurdles

Designing and executing a clinical development plan is difficult work that can demand day-to-day effort. But it’s also important to look ahead and anticipate the risks inherent in early clinical development. Have a crisis management and communications plan at the ready just in case things don’t go as planned.

The takeaway from these slip-ups is that people running startup ventures must be willing to be open, expect the unexpected, and think beyond their own experiences. Biotech passion projects can save and improve lives, and may even turn into big businesses. While a startup in this industry can have exciting potential, the hard work invested in it will bear fruit only if its product succeeds in clinical evaluation and clinical trials. Keep yourself on track, learn to swallow your pride, and your startup might just make it big.

Laurie Halloran is founder, president, and CEO of Halloran Consulting.