Always be a student — sharpen your blade or skill set. A dull chef blade does not work effectively or efficiently. In fact, it can be more dangerous to the job than a sharpened blade. Take time out of work with friends and family for yourself as it has the effect of sharpening your professional blade.
I had the pleasure to interview Mike Daley the Founder and CEO of OrthogenRx. Mr. Daley has a 25+ year career in the biopharmaceutical/device industries. He is the former Medical Director for Hyalgan (first hyaluronic acid approved in the US) and is widely known for his expertise in the HA market.
Thank you so much for joining us! Our readers would love to “get to know you” a bit better. Can you tell us a bit about your ‘backstory’?
Absolutely and thank you for having me. I’ve had a rewarding and challenging career for over thirty years in the biopharmaceutical and medical device industry, both small emerging to fortune 500 companies. I eventually formed OrthogenRx, late-stage development and commercialization company focused in the orthopedics and sports medicine fields based upon my prior experience within the biopharma industry. My vision was to optimize healthcare access by delivering quality healthcare products at an affordable price, balanced with the needs of the healthcare system and accessibility to our patients.
In doing so I developed a strategy to execute on what I considered an efficient and novel regulatory approval process, coupled with best of class commercial strategies that reduce drug development cost and optimize commercial operational efficiencies. Our first product, GenVisc® 850 (sodium hyaluronate), was approved for the treatment of osteoarthritis knee pain in patients that had failed conservative therapy in just eighteen months for a cost of just under $2MM in equity investment. As a matter of perspective, the industry standard for approval of this type of medical device submission is six to eight years at a cost ranging from $70MM to $100MM.
Can you share with us the most interesting story from your career? Can you tell us what lessons or ‘take aways’ you learned from that?
Creativity, perseverance, and excellence in execution will always win over the status quo and playing it safe with unlimited resources. At a later stage in my career, I fell victim to a downsizing (my third experience in my career). I started consulting and was very successful at it but felt less than gratified providing advice, strategy, and direction, and then having to step away. I also thought it would be challenging at my age to find another corporate position that would suitably challenge my skill sets and be rewarding. So while in my 60’s I decided to jump all in and leveraged my experience by starting my own company. I took my savings I had accumulated from consulting and jumped all in. Talk about skin in the game! I had no alternative but to be successful once I decided to make the leap because when you’re in your 60’s there’s not going to be another swing at the bat. With my oldest daughter recently graduating from George Washington University and announcing she was getting married at the Willard Hotel in D.C., my youngest daughter just starting Boston University, and no salary my initial success was only turning my 401k into a 101k!
I’ve always loved the quote attributed to Socrates that “True knowledge exists in knowing that you know nothing.” Even after a long career with much experience gained one must approach every challenge and obstacle as a new one with new lessons to be learned. Being a tinker of many trades but master of none only becomes a strength when you understand the key areas and expertise (e.g.team members) you need to build a company. This, in fact, what being successful scientists do all the time, build and the efficient team then design critical experiments or tasks to complete, just applied differently. I find it very rewarding.
One of my strengths is creative solutions and I strive to push myself in the area constantly. When confronted with an obstacle (I particularly get motivated when someone says, “That’s never been done before.” I visualize a wall and ideate on ways to go over, under or through it. We actually have T-Shirts at OrthogenRx that says…”Most Companies spend their time defining their Operational Box. We at OrthogenRx say, “What’s a box?” I’ve been successfully doing this throughout my career and it has reinforced my own belief that concepts, and ideas applied successfully to solving problems, not just creating solutions, can be universally applied to any startup.
Leaders must be willing to keep a laser focus but be willing to listen and re-evaluate or pivot only when necessary. I once termed the phrase ‘Pivot with Purpose’. But the true success of this strategy can only be realized if one understands that building the right team is essential. The sum is much more effective than any one individual, and every team member is essential to progression. It’s like the block-chain of human capital — interdependent. I am proud to have achieved great success financially with OrthogenRx and that success in large part is due to the sum created by my team. That’s the 90% the other 10% is my unwavering dedication in delivering in the trust afforded me by investors and team. Well, maybe 2% of that is that I can be a real pain in the ass!
Something we are also proud of is OrthogenRx’s second product, TriVisc®, was the first and is still the only product approved in over 20 years under a unique regulatory pathway that was established under FDA Modernization Act (FDAMA) in 1997. We have obtained two Class III medical device product approvals in just 2 years and this is an accomplishment that can stand up against anyone.
What do you think makes your company stand out? Can you share a story?
That’s easy… Teamwork! I believe everyone should hold themselves to the highest standards of excellence and try to lead by example. Recently, we were at risk of not being able to deliver the product at the rate it was selling. Many team members had to influence, refine a strategy and work beyond their defined roles to ensure our manufacturer and entire supply chain stepped up the pace to align the product demand. None of this could have been anticipated and without the creativity and dedication of the team, we never could have successfully met the challenge.
Another measure of success for a company is the ability to maintain a laser focus but listen to changes in the science or market that arise. Entrepreneurs can spend so much time on a business plan they are sometimes blinded to criticisms or new data. I think this is best summarized by one of my favorite quotes from John Steinbeck, Sea of Cortez.
“There is one great difficulty with a good hypothesis. When it is completed and rounded, the corners smooth and the content cohesive and coherent, it is likely to become a thing in itself, a work of art. It is then like a finished sonnet or a painting completed. One hates to disturb it. Even if subsequent information should shoot a hole in it, one hates to tear it down because it was once beautiful and whole.”
A problem with a well thought through hypothesis or even business plan — call it your own ‘beauty’ or even child — is that while you have to appreciate what you created, you need to equally appreciate and understand its flaws, and be open to correct them. We have a highly dedicated and motivated team that strives for constant progression and in the process challenges the status quo while embracing and celebrating the beauty of past successes. Every team member is empowered to insert their skills and creative influence to achieve the best results. If an outsider observed some of our meetings they might be appalled at what seems to be heated discussions and conflict, but out of that conflict rises creative solutions that never cease to amaze me, and we tend to be all on board with a go-forward strategy.
None of us can achieve success without some help along the way. Is there a particular person who you are grateful towards who helped get you to where you are? Can you share a story?
I was fortunate by chance to meet my partner David Toledo Velasquez Ph.D. early in the development of OrthogenRx. Many people are amazed that the second employee was someone with expertise in manufacturing, formulations and quality systems and not a CSO, CMO or CFO. But I knew that someone with his expertise was absolutely essential to fostering interaction with any partner to make sure they were compliant with FDA requirements. David’s outstanding knowledge, dedication, and perseverance are second to none in the industry and he absolutely complimented my skill sets. As a measure of his accomplishments, we have undergone four FDA audits with no major findings. As employee number two it has been our unique combination that has made us successful when few thought we could succeed. He’s a quality member, a valued scientist, and a dear friend.
Ok thank you for all that. Now let’s shift to the main focus of this interview. We would like to explore and flesh out the trait of resilience. How would you define resilience? What do you believe are the characteristics or traits of resilient people?
After my fifth knee replacement surgery — for the record we only have two knees (bilateral replacement and 3 revisions) — I concluded it was time to launch OrthogenRx or become an Orthopedic Surgeon (laughing). Over the past years, there has been blood, sweat and tears shed, to say the least, but lessons have been learned and my team has experienced minimal senior executive turnover. Early in our development we collectively agreed to go to half-salary to preserve cash. These are people with families, mortgages, and bills to pay and that level of commitment was humbling to me. But I recognized this early on and appreciated that if my team was willing to persevere and make sacrifices they should also share in the upside. This is why when I created the equity pool for my company at square one I allocated 32.5% of it to employee incentives. From what I understand that’s pretty unusual as it comes all out of my share and not across all shareholders.
Persistence, dedication, and innovation empowers resilience and makes success a reality. You simply can’t lose when the vision is clear, and the team and chemistry are right. There are always going to market disruption, scientific discoveries, and hiccups along the way but having a team that is synergistic and able to thrive when there is uncertainty can make or break you.
When do you think of resilience, which person comes to mind? Can you explain why you chose that person?
John Teeling, Chairman of the Teeling® Distillery, Dublin, Ireland. His great-great-grandfather in 1782 started a distillery in Dublin. Like most small distillers it went out of business in the early twentieth century. John received his MBA from Wharton and a Ph.D. in Industrial Development Policy from Harvard.
In 1987, John purchased a distillery in Cooley Co. Louth which had previously produced industrial alcohol from potatoes and he converted it to a whiskey distillery, reopening it in 1989 as Cooley® Distillery. The distillery was the first new distillery to launch in Ireland following the consolidations and closures of the 20th century. It took 11 hard years to turn a profit. And in 2011 he sold his distillery to Jim Beam® (now Suntory®) but during the sale negotiated the retention of 16,000 casks of aged whiskey. That was visionary and risky because the renaissance of the Irish whiskey popularity was just beginning. Using these stocks, John Teeling’s son, Jack, was able to launch Teeling Whiskey in 2012 and was later joined by his brother Stephen. John Teeling has been quoted as saying “I love what I do, And what I do is sell mystery, not history.”
In 2015, the Teelings established a new whiskey distillery (just 4 blocks from their family’s original distillery), the first new Irish whiskey distillery in Dublin in 100 years. The 24-year-old single malt, blended from some of the retained 16,000 barrels in 2011, won World Whiskies Awards Best Single Malt of 2019. The perseverance, vision, and leadership of John Teeling is something to be admired. I got to meet him recently at an event sponsored by the Irish American Business Chamber & Network of Philadelphia. He’s truly amazing and visionary.
Has there ever been a time that someone told you something was impossible, but you did it anyway? Can you share the story with us?
I started my company at the age of sixty-two and was told that since the FDA had not approved a product using my proposed pathway in twenty years that it was impossible. I was told this by senior partners and 5 of the leading FDA law firms in Washington, DC when I was first fine-tuning my Business Plan and potentially looking to engage a regulatory law firm. This was back in 2013 and the average hourly billable rate ranged from $800 — $2500. They were all unanimous, “There’s no way you’ll get an FDA approval using this strategy.:
But during my recent career at Sanofi, as a Medical Director, I was given the assignment of supporting the first injectable hyaluronic acid (HA) approved in the U.S. to treat osteoarthritis knee pain, called Hyalgan®, and became aware of the global dynamics of the market and how these products are approved through regulatory bodies. Through this process, I learned about the respective regulatory barrier, reimbursement models, and distribution channels. With the significantly lower regulatory barrier to entry in the European Union, there were over sixty marketed hyaluronic acids (HA) products compared to five in the U.S. There was an inverse correlation with a price to the patient or physician, even for the same HA product, and a country regulatory barrier to market entry. The high regulatory barrier is in the U.S. and there was less competition which translated to HA products approved outside the U.S. were often priced three to four times lower than their U.S. brand. I saw an opportunity to license outside-U.S. products identical to those approved in the U.S. and take advantage of what I believed was a novel regulatory pathway to obtain approval (similar to the generic drug pathway) — but no one had ever done this before. This would enable me to more effectively compete in the market with much lower operating margins or research and development costs. This would also allow me to pass on some of these efficiencies and perhaps save the healthcare system money, and at the same time create greater access/affordability to patients. Fast forward 2 years, and I and my team obtained regulatory approval for our first product, GenVisc 850, in about twenty months for less than $2MM versus industry standard of 6–8 years and $100MM The impossible became possible and real, and our second product, TriVisc, beat these metrics by 60%!
Did you have a time in your life where you had one of your greatest setbacks, but you bounced back from it stronger than ever? Can you share that story with us?
I was in a Ph.D. program and the scientific project I had elected to take on was ‘provocative’ and not the accepted scientific dogma. After four years and three publications, my advisor left the university and I was told that the research was not acceptable for a Ph.D. and find a new advisor. That thesis was based upon the principle that not all tumor cells were identical and that they changed (differentiate) like normal cells and that the immune system could be focused to regulate the growth of tumors. Nowadays it’s called cancer immunotherapy. I went on to complete my Ph.D. at another institution with 4 more publications and went on to do a post-doctoral fellowship at M.I.T. with two years on the faculty. Now I’ve started my own company and achieved another level of success. I am blessed.
The setback while devastating at the time, was a small amount of time for the knowledge and confidence gained. Believe in yourself and that perseverance translated to my experience as an entrepreneur.
Did you have any experiences growing up that have contributed to building your resiliency? Can you share a story? Very early I learned the value of working hard and perseverance.
Shoveling snow for fifty cents an hour and washing cars for a dollar twenty-five an hour — since I already told you I’m in my 60’s that means this was in the late ’50s. I also learned that I wasn’t always the smartest, but there were very few that worked harder and that made me different. And in working those jobs I met people in business who had to do the hard work to support their families. The job was important to them as was pride in a job well done.
In terms of advanced degrees, where you earn yours does not matter. As Janet Jackson said, “What have you done for me lately?” It is what you do with your knowledge that matters. Some people lean on where they earned their degree, their pedigree, for much of their entire lives while others never mention a word about it and use their experience and internal grit as a foundation for their future. I’ve also used this to identify team members with skill sets and drive and not always those that have exactly the prior experience to do what I need them to do when hired. This is because I know that focus will be constantly changing and for me, their internal grit is where their value lies.
I align with the latter. Work hard, earn your successes, listen and embrace your failures learning from them quickly.
Resilience is like a muscle that can be strengthened. In your opinion, what are the five steps that someone can take to become more resilient?
- Listen to others more than you speak to them. These days we all need to listen a lot more, especially me!
- Fail often. It is fine to fail if you pick yourself right up, learn from the failure and move forward stronger than before. Remember all the tough lessons and apply them to the next phase. Rarely do you learn much from your successes?
- Results, Not Excuses. Embrace this RNE philosophy — underpins resilience in our business, as we all are accountable for the goals at hand. Sometimes this means taking responsibility for things you have no control over but need to drive to a successful completion anyway.
- Always be a student — sharpen your blade or skill set. A dull chef blade does not work effectively or efficiently. In fact, it can be more dangerous to the job than a sharpened blade. Take time out of work with friends and family for yourself as it has the effect of sharpening your professional blade.
- Never lose confidence in yourself. Don’t let any situation or person make you doubt your integrity and abilities. But also remember to be constantly monitoring, listening and reassessing your plan to be focused but flexible.
- Be a mentor and seek a mentor — I know you asked for five, but I have to give this extra one. Learn from others. Teach others. Give back to the communities that have given you so much. For me ‘seeking’ is directly related to networking, I can’t emphasize the value of this tool in being an entrepreneur.3)
.You are a person of great influence. If you could inspire a movement that would bring the most amount of good to the most amount of people, what would that be?
I am driven by helping others assess their passions and plot their journey to achieve their dreams. For those just starting their journeys, the key is to keep your options open and try not to close any doors early on. Someone who majors in art in college most certainly can find their path to a rewarding career in the arts or even pivot to attend medical school. Breaking down the social norms and mores about career paths would be a noble effort. We hire people based on ability and integrity rather than what perfect box a recruiter sees them in based on a two-page summary of their lives.
If at the end of my career everyone in my company could take my job and be successful based on how I’ve helped them grow as people and professionals…. well…that would be a crowning achievement for me. Hopefully a few will be able to retire on some Caribbean island!
We are blessed that some very prominent leaders read this column. Is there a person in the world, or in the US with whom you would love to have a private breakfast or lunch with, and why? He or she might just see this, especially if we tag them 🙂
I would love to have breakfast with George Fox, the founder of Quakerism, although I don’t think he’ll be reading this column or then again maybe so. In a time of unrest and upheaval he went against the norm he was disruptive and not only created but successfully grew an inclusive religion and a movement focused on silence and self-reflection, community and personal actions, simplicity and equality. I would enjoy the opportunity to speak with him about that process and the many hostile challenges he faced as those lessons learned would be applicable to business today. I would also thank him for his influence on me to strive to listen, not remove my hat to anyone and not curse. These are all works in progress for me.