Editor’s Note: The FDA just approved Allergan’s Durysta (bimatoprost implant) 10 mcg for lowering intraocular pressure in patients with open-angle glaucoma or ocular hypertension on March 5, 2020.
Imagine the scenario: Out on a Saturday morning bike ride, lost in thought, you think about a new way to analyze optical nerve damage. The idea has real market potential — you’ve seen too many glaucoma patients to think otherwise. What do you do next?
Most will do nothing. However, a panel of physician-researchers, pharmaceutical industry leaders, and an FDA department head gathered at the recent Glaucoma 360 New Horizons Forum to discuss how to move a product from idea to therapy. The high-level overview included practical regulatory advice and hard-won tips from the trenches.
John Berdahl, MD, surgeon-researcher at Vance Thompson Vision, mapped the crucial first stage for DWIs (Doctors with Ideas): getting the idea into tangible form. He provided the following tips:
1. Make sure your idea is a good idea. A good idea satisfies two primary criteria:
2. Make sure you have the motivation. “If you wake up with the idea in your head every morning, you probably have enough motivation,” he said.
3. Conduct proof of concept research. Test the idea to prove it can (or cannot) be developed. “Here, you need to be honest — with yourself, with your investors, and with the science,” Dr. Berdahl said. “You’re trying to put a bullet in the idea, so if you’re wrong, you don’t spend any more time on it.”
4. Rely on mentors. Dr. Berdahl acknowledges the late Doug Johnson, MD; Tom Samuelson, MD; and Richard Lindstrom, MD, as mentors. Mentors “push researchers forward and point out strengths and weaknesses,” he noted. His mentors asked practical questions about depressurizing the environment around the eye, which forms the basis for Equinox’s research.
5. Protect the idea. Obtain the necessary patents and other intellectual property rights. Dr. Berdahl suggests obtaining intellectual property rights before founding a company. That way, the patent holder can assign rights to the company, which gives the company the right to use the patented products.
6. Read. Specifically, read business books, he said. Learn how to start and run a business, how to secure venture capital funding, and how to execute a business plan.
7. Fail fast and cheap. If the idea fails, better to know after spending a little than a lot. Dr. Berdahl said he built his first prototype using goggles bought on Amazon. “Think about how to get to the answer of ‘is this go or no go’ at every milestone,” said Dr. Berdahl.
Retinal surgeon and entrepreneur Eugene De Juan Jr. added that when you fail, pick up and start again. Repeat as necessary until you have a success. Once you secure investors, don’t fail. “Small companies can’t afford to fail early,” he said. “And investors can’t afford to fail late.”
8. Pathways are critical. Start a dialogue with regulatory agencies and payers early. Wiley Chambers, MD, deputy director of the division of Transplant & Ophthalmology Products for FDA’s Center for Drug Evaluation & Research, explained, the FDA will tell companies what the agency needs to approve a company’s submissions; however, but don’t be afraid to ask why.
9. Assemble a strong team. Build a team dedicated to your idea. Physician-scientists take risks when they hire researchers, but those researchers are taking a risk on you as well. “Deliver on the trust your team puts in you,” Dr. Berdahl said.
Aerie Pharmaceuticals’ Thomas Mitro shared some of his advice that applies to business and to life. “This is a highly competitive field filled with highly competitive people,” he said. “But everyone is also going to be in this industry for a long time, so treat everyone with respect. You never know what might happen.”