What is the single most difficult aspect of launching your own company or bringing your product to market?

Issue: October 10, 2016

Click here to read the Cover Story , "Ophthalmologist-entrepreneurs need a thick skin and plenty of patience to succeed."

Balance is crucial

For any new company looking to bring a unique product to market, it is crucial that a balance is struck between each of the relevant constituencies across each stage of the process. This is particularly difficult in the field of ophthalmology when dealing with patients having either no vision or very poor visual acuity (such as hand motion). Indeed, it is not uncommon that the two most important constituencies — the regulatory agencies and the payers — would have divergent or misaligned focal points. Gaining the satisfaction of both is the most difficult aspect that we have to anticipate here, because what might be very meaningful for a patient’s quality of life might not translate into a measurable and statistical difference in EDTRS letters from baseline.

Approval from the various regulatory agencies is the priority, as that must come first before marketing of the product can begin. In ophthalmology, the clinical outcome these agencies most often seek is around visual acuity, and it provides a quantitative measurement by which these agencies may determine effectiveness of the product in question. But once a product has the approval of the regulators, an entrepreneur’s attention is immediately turned to market access activities on the ground, and you have to start looking at the reimbursement strategy. In this case, visual acuity measurements, though important, are not the question — what payers want to know is, “Does your product improve the patient’s quality of life?” That may not translate into visual acuity as one might think and we could have really good results in patients that relate to an improved quality of life but still have mixed results on visual acuity.

The fact that there is no straightforward solution is what makes the balance extremely difficult for us, as for each single disease we need to understand it early on (in fact the intimate design of the clinical trials has to reflect it), and very early on prepare such alignment that will provide us market approval and market access.

Bernard Gilly, PhD, is the co-founder and CEO of GenSight Biologics and chairman of the board of directors. He is also the non-executive chairman of Pixium Vision.

Balancing passion and objectivity

In the past 25 years, I have been involved in three biotech startups including, most recently, Allegro Ophthalmics. In my experience, the single most challenging aspect about starting a company or developing a new product is communicating your convictions in a way that motivates others to share your passion. After all, you are putting your reputation, your time and your money on the line — and convincing others to do the same can be a tall order.

Innovators always run the risk that passionate belief in a new idea could cloud one’s judgment of risks or obscure pitfalls on the development path, so it is important to seek out other perspectives and objective evidence. At Allegro, we did this by “torture testing” our new drug candidate, Luminate. There is a saying among entrepreneurs: “If you are going to fail, fail fast.” We moved quickly to test our drug candidate at the cellular level, on animals, and in a small proof-of-concept human study, so that we could realistically assess the potential for moving forward with development.

Balance is critical. I believe in what I have. I believe this idea and this product will be valuable to doctors and patients alike. At the same time, you must listen very carefully to your advisors to avoid mistakes. Achieving this balance between passionate belief and objective science allows you to stay focused and to keep moving the needle — and the product — forward.

Vicken Karageozian, MD, is the president, chief medical officer and co-founder of Allegro Ophthalmics.