‘Perseverance paid off’ says former Cynapsus CEO

1. In your business experience, perseverance plays a large role. Could you elaborate on its role and share an example?

AG: At Cynapsus, from the very beginning, there were naysayers who did not believe that a thin film strip of apomorphine for Parkinson’s “off” episodes was going to succeed. The naysayers (including key opinion leaders or KOLs as well as investors and bank analysts) also said that our patents were not going to be granted (they were), that the chemical solution was not going to work (it did), that there was an infinitesimally small market that was not going to expand (to greater than a billion per annum), and so on.

My mantra and my passion, which I shared with my core team, was that our IP [intellectual property] would prevail and that our solution would be meaningful for Parkinson’s patients and their caregivers, so our market would expand.

And yet, along the way, we encountered events and confronted realities that required change to go forward. I’ll give you two specific examples. First, in our preliminary models for testing on rabbits, we had a formulation that showed over 90% absorption, which was very good. When we started trials on human beings, we had a different outcome. So, we had to go back to find a better balance and change some ingredients.

A second setback required us to dig in even deeper. In the US, a new product may win FDA [Food and Drug Administration] approval if it’s therapeutically equivalent to a reference product (one that has already been granted FDA approval) despite being materially different. This approval pathway – also known as Section 505(b)(2) – required that our product delivered the same C-Max [peak] and AUC [area under the curve] as the reference product (in our case, subcutaneous injections of apomorphine). In our first human trial, we did not achieve that. Honestly, we thought we were sunk. But on closer examination of the clinical data, we realized we had some added benefits. Our CMO [chief medical officer] knew FDA law very well and he homed in on a little-known interpretation of equivalence – clinical equivalence – that was acceptable to the FDA. That specialist knowledge saved the project.

Perseverance definitely paid off for us, but it wasn’t easy. Getting it right involved intuition and instincts, as well as careful analyses of possible scenarios over time. When someone quotes “The Gambler” by Kenny Rogers and says you have to “know when to fold them,” I believe that goes against the notion of having a long-term goal.

2. Hearing about your close call with the FDA’s equivalence requirements reminds me of something I heard you say before: “Surround yourself with the best people in their fields – people who are smarter than you.” So, how do you know if they’re smarter than you? And smarter than you in what? We all have our strengths and weaknesses.

AG: That’s a great question. For my management team, I want to hire people with extensive experience, including successes and failures – because failures teach us where not to go and what not to do. I ask: Do their experiences demonstrate their functional expertise and management acumen? Do the people they worked with identify them as real experts (and not just shooting from the hip)? Have they resolved difficult problems? Do they have good analytical skills for testing out various scenarios? Can they accept others’ challenges to get to a better decision or solution? In a high-growth setting, can they focus on delivery and persevere to get there?

I also ask: How much risk do they take on? Too many risk-takers on one team (given that I am one myself) is not good. In the end, I ask myself how a person might add to the group’s success. That’s determined by their experience, intelligence, and perseverance as well as their reactive and proactive capabilities.

To give you an example. I was looking to hire an expert in thin-film manufacturing, someone scientifically adept enough to solve problems on the go and work well in a small team. I also wanted this person to have a sense of humor and be self-assured, driven, and passionate about what we were doing. By asking around, I found someone: a global leader in thin-film manufacturing living in Switzerland with 50 product launches already under his belt. It took me a year to convince him to join us.

3. Convincing people seems to be an important part of your job. I know you’ve said storytelling is critical for success. How did you learn to tell a good story?

AG: From reading a lot and hearing others do it well — or not so well. My days working as an investment banker brought home the need to deliver a message succinctly and effectively. In life sciences, you must be able to tell a brief but coherent story about your company in investor presentations, large and small. Who are you? Why is what you have important? Why is it better than the others out there? How will you succeed? I have heard many of my peers go too deep into the science. To tell a good story in business, I think you need a big-picture view of the strategy and a willingness to mine personal experiences that are real and relatable.

4. What role has ethics played in your leadership journey and can you give us some examples of the ethical dilemmas you have had to manage?

AG: My most challenging ethical dilemma centered on the projected pricing of our product. At the start of Phase 3 studies [for FDA approval] in 2015, Cynapsus had to invest in some very expensive consultants to help us get data on patients, caregivers, and neurologists (specifically specialists in movement disorders) regarding how they’d either use, manage, or prescribe the drug candidate. These consultants also studied our commercial plan and consumers’ willingness to pay.