Building Biotech Champions: Cultivating Breakthroughs In A Dynamic Field
By Shankar Musunuri, PhD, MBA, Chairman, CEO, and Co-Founder of Ocugen
Leading a biotech company in this dynamic industry requires a strong, agile team and a championship mindset. Applying the same strategies that led my Philadelphia Eagles to the Superbowl, just as a solid defense wins championships, it sets us up for biotech success by ensuring scientific rigor, regulatory resilience, and long-term value creation in the face of a field that, by definition, is constantly changing. And as coach, you need to keep an eye out for the best plays, or creative solutions to operate efficiently so the team can maximize resources when the going gets tough.
Building A Championship Team
Ocugen’s work focuses on advancing game-changing gene therapies targeting major blindness diseases. For the next few seasons, we face a challenging schedule to meet our goal of three BLAs in three years: OCU400 for retinitis pigmentosa (RP) in 2026; OCU410ST for Stargardt disease in 2027; and OCU410 for geographic atrophy (GA) in 2028. But as a leader in ophthalmology gene therapies, we are up for the challenge!
Our novel modifier gene therapy approach uses nuclear hormone receptors or “master genes” to reset the entire cell network and restore health in the retina rather than targeting a single gene mutation. Because of this differentiated mechanism of action our gene-agnostic therapeutic candidates target the entire disease and have the potential to address unmet medical needs for large patient populations for inherited retinal diseases like RP and Stargardt disease as well as multifactorial diseases like geographic atrophy — late-stage dry age-related macular degeneration, with the potential to stop or even reverse disease progression.
In founding the company, it was critical to assemble a team of all-stars who, beyond having extensive experience in their fields, would work well together and be willing to check their egos at the door as we got back to basics; getting scrappy, rolling up our sleeves, and demonstrating a keen openness to learning as we navigate the evolving field in front of us. This required recruiting team members that, beyond understanding the complexities of the industry, can switch up plays and think creatively about how we can potentially bring innovative therapies to market and help improve the lives of patients. To make a real difference in biotech, we need disruptors who know when to test the status quo and push scientific boundaries. We’re driving science toward the end zone, with the goal of delivering real impact for the patients who are counting on us to deliver big wins.
Unparalleled Innovation Is The Best Offense
To enable breakthroughs and address the world’s most pressing health challenges, it’s on us as leaders to promote an environment that fosters sustainable innovation. Ocugen’s modifier gene therapy platform presents a paradigm shift in treating major blindness diseases, with a one-time therapy for life. And retinal diseases are just the beginning. We are also looking to expand into neurological diseases like Alzheimer’s, Parkinson’s, and autism. We believe we’re part of a team standing at the edge of a technological breakthrough; one that has the power to change the way the world understands and treats disease. To get here, we knew there wouldn’t be a well-worn path for us to follow. Instead, we’ve focused on aggressively pursuing our biggest R&D goals and setting the highest possible bar for ourselves as we seek to break new ground, allowing the science to light our way to the Big Game.
Leaning On A Robust Clinical Development Strategy As Defense
With market headwinds and regulatory complexity inherent to the field, we must always play defense by staying on top of evolving agency guidelines, making data-driven decisions, and keeping the end goal of improving patient lives in our line of sight. Approaching regulatory relationships with the same kind of collaborative, open spirit found on the field can help drive us toward regulatory touchdowns; milestones that can shape clinical programs and ultimately improve the lives of millions of patients.
We envision a future where next-generation gene therapies are accessible to people across the globe. Developing a robust clinical development strategy that prioritizes regulatory compliance and operational efficiencies is therefore the best defense as we work to get our therapies to the end zone.
All Eyes On Game Day
At Ocugen, we’re dedicated to bringing game-changing gene therapies to market and are working even harder to provide access to patients globally. This is why we’re putting our best players on the field and strategically coordinating offense and defense with an innovative game plan. With a united team and sharp tactics, we can turn the tide and drive all the way to the end zone, delivering breakthrough gene therapies to patients facing vision loss.
About The Author:
Dr. Shankar Musunuri, Ph.D., MBA, is Chairman, CEO, and Co-Founder of Ocugen, a publicly traded biotechnology company dedicated to bringing game-changing gene and cell therapies and vaccines to market. Musunuri is a seasoned biotech veteran with over 30 years of experience advancing and commercializing a diverse portfolio of products. Prior to co-founding Ocugen in 2013, he held leadership roles at numerous companies ranging from large multinational biotechnology companies such as Wyeth and Pfizer to start-up biotech companies.