Patients and Patience
Bringing a new drug or medical device to market takes time and patience. It takes perseverance working through the many steps in the commercialization process, and seeing the weeks pass by, when you believe you have something that could be saving patients’ lives.
I’ve been working on biotech startups for almost 20 years, have founded a few companies and have reviewed hundreds for funding. Every entrepreneur and company founder is passionate about their technology and makes a case why it is such an important contribution to medicine. Sometimes a technology does not look so strong to an outside reviewer. Other time I see companies where I say to myself “wow, if that really works it is going to be a game changer”.
As I got to know Dr. Martin Mangino (Marty) and conducted due diligence on PEG-20k I became a true believer in the potential for it to have a huge impact on patient lives. Sure, you can say that every company co-founder becomes a believer regardless of how outsiders see the technology. But I would respond that I’ve been doing this a long time, have become a bit cynical and was not easy to convince. More importantly the animal data, from multiple experiments, indicated very high efficacy (I’m not making any medical claims here). Furthermore, I interviewed a significant number of highly credible and experienced doctors, some who were very familiar with Marty’s work and others who were not, and they were equally impressed with the potential.
So now we are slugging our way through the early stages of a biotech startup. Working on securing non-dilutive funding for clinical trials, working through the early stages of the FDA process, and trying to build up awareness of a medical strategy that could have a major positive impact on patient survival but absolutely represents a medical paradigm shift. We are making steady progress, but it all takes time.
And when you think about the patients, taking time is frustrating. I think to myself, “every week of delay, waiting for the next agency meeting or paperwork approval, is ultimately another week before PEG-20k is in the market saving lives”. That is another week of patients who don’t get the benefit we believe PEG-20k will bring.
But at the end of the day that is the biotech startup story. The processes and procedures are in place to ensure safety and integrity of new life science products and we are fully committed to supporting them. Each new day we must put the frustration aside and do our best to move the technology forward. And I am confident and optimistic that the day will come when we can pause and rest a little when PEG-20k is an approved biotech solution saving patients lives.