A 12-Step Program for Start-Ups

Featured Blog by Denni O. Day

I recently traveled to meet with the president of a fledgling biotech firm. They have a promising new veterinary product and want to get FDA approval so they can start selling and paying back their investors. My visit was both exciting and frustrating. Seeing their initial clinical results was the exciting part. If these results are confirmed by more extensive testing, the new product has tremendous potential. If they can get it approved before a competitor hits the market with a similar therapy.

The frustrating part was trying to get them to focus on the many important and specific steps they will have to take to get their marketing approval. I did my best to explain the approval process, suggested a few regulatory consultants who could help them with their New Animal Drug Application, and offered to help them write their protocol and prepare for their clinical trial. I even spoke with several of their advisors in an attempt to get everyone headed in the same direction. How much of my advice they take remains to be seen.

By the time I reached the airport for my flight home, my frustration had dissolved into empathy. Fifteen years ago, I too was a hopeful entrepreneur. I too was torn in a hundred different directions by the seemingly endless demands of my customers, suppliers, investors, and employees. I too needed a guiding hand to keep me on the road to success. Many mistakes, a handful of helpful suggestions, and a few timely words of wisdom have enabled me to get where I am today. Even so, I still don’t have all the answers. However, I have learned a few things.

  1. Define your dream. Clearly. Then follow it. Relentlessly. Many businesses fail because they forget why they started. If your goal is to develop and sell a product, then everything not directly related to that is a waste of time. In the veterinary pharmaceutical world, you can develop all sorts of new products, and even produce warehouses full of them. But, until you complete a successful clinical trial and secure FDA approval, you can’t sell any of it.
  2. Embrace set-backs. Unless you’re a quitter. There are many ways to reach your goal. When one door closes, look for an open one. And keep looking until you find it.
  3. Ask “What if?” Start each day with this important question. It forces you to consider new possibilities. It sometimes results in an “aha!” moment. They make the difference.
  4. Hire the best. Only. One top-notch employee or consultant is worth ten mediocre ones. If you think you can’t afford them, ask yourself how many mistakes you can afford. Instead, find the money.
  5. Lead. Don’t manage. Share your vision with everyone on your team. Support them with all your might. Then stay out of their way.
  6. Ask. Don’t tell. We have two ears and one mouth for a reason. Listen. Really. You’ll be amazed by what you hear.
  7. Be end user-centric. Always. It’s not about you. It’s all about them. So never forget the animals that your product is supposed to help.
  8. Do it well. Cut waste not corners. Foster a culture of excellence regarding everything. If it’s worth doing, do it right. The first time. Every time. Otherwise don’t do it at all.
  9. Do it now. Later is for losers. Develop a sense of urgency. You may not be the only one working on your indication. The first to market controls the market. Time really is money. And, besides, the animals are waiting.
  10. Be ethical. Truly. It builds trust all around. It is worth more than any amount of money. It also helps you sleep at night.
  11. Clinical trials are necessary. But they are not easy. You can’t get your product approved without a clinical trial. You can run the trial yourself, but you shouldn’t. It’s sort of like trying to do your own root canal. Why risk the pain?
  12. Every investigator is a good veterinarian. The obverse is not always true. Following a protocol exactly and adhering to Good Clinical Practice guidelines are not easy tasks, but they are essential to the success of any clinical trial. A good investigator understands this. More importantly, they also believe it.

As my plane began its descent toward my home airport, I wondered again whether the president of the biotech start-up and her advisors would follow any of my suggestions. Given the apparent potential of their product to help our ailing four­-legged friends, I sincerely hope so.