Heroes Of The COVID Crisis: How Kyle Y Flanigan Stepped Up To Make A Difference During The Covid-19 Pandemic

Reflecting on my team and how they went above and beyond during the pandemic, I had a glimpse of what it means to be a hero. The team performed well beyond what anyone in the industry expected, executing a Phase I Human Clinical Trial for COVID-19 while conducting core business pharmaceutical operations. These individuals had families and lives outside of work to contend with, but they risked continued exposure to complete the COVID-19 vaccine program tasks.

With our 16-person, small but mighty team, they are the true heroes.

As part of my series about people who stepped up to make a difference during the COVID19 Pandemic, I had the pleasure of interviewing, Kyle Y. Flanigan, Ph.D.

With nearly 30 years of experience, Dr. Kyle Flanigan, CEO and Co-founder of US Specialty Formulations LLC (USSF), is an expert in all pharmaceutical and medical performance materials development stages. One of the few Black owners of a biotech firm, Dr. Flanigan applies the Agile High-Performance Teams system to facilitate collaboration and problem solving — ensuring each of their and their clients’ products go to market efficiently and seamlessly. With a credentialed portfolio that includes a range of vaccine candidates, small molecule formulations and botanical pharmaceutical-grade extracts, Dr. Flanigan has the expertise and equipment to bring a safe, accessible mucosal COVID-19 vaccine to market.

Thank you so much for doing this with us! Before we dig in, our readers would like to get to know you a bit. Can you tell us a bit about how and where you grew up?

I was born in St Louis, Missouri, and grew up with parents who were deeply involved in science. All aspects of pharmaceuticals and the chemistry industry surrounded my three siblings and me. With my father’s pharmaceutical and regulatory expertise, we moved every few years as required by his corporate demands. As a result of my mother’s drive, my siblings and I were highly motivated to achieve academic success. I had a solid foundation in reading, writing, arithmetic and music. All this led to a healthy upbringing with structure, fun and awareness of the sensitivities of culture, race and religion. My mother actively ensured we were provided with opportunities and would challenge any instances of prejudice against the color of our skin.

My grandparents instilled an entrepreneurial spirit in me — and it was a natural progression for me to follow in their combined footsteps.

Is there a particular book that made a significant impact on you? Can you share a story or explain why it resonated with you so much?

Emotional Intelligence by Daniel Goleman. This book dives into the frontiers of psychology and neuroscience, offering insight into our “two minds” — the rational and the emotional — and how they together shape our destiny.

As a Black man, any form of a strong opinion or assertiveness comes across as overly aggressive. This book gave me a new perspective on sharing my opinion authoritatively and respectfully, thus minimizing the fear and insecurity that being Black generates in others.

It has helped me, as a leader, when talking to employees, setting organizational goals and discussing technology or business matters with potential investors to communicate, frame and create context based on my attunement to their specific emotional state.

Emotional intelligence has allowed me to identify people’s feelings and expand my thinking while removing emotional barriers. I choose words and present ideas to convey my point, meeting my audience with minimal resistance from an emotional reference.

Do you have a favorite “Life Lesson Quote”? Do you have a story about how that was relevant in your life or your work?

My favorite life lesson quote is “keep the ball in their court,” which, for me, means doing what needs to be done. Complete every task to achieve a specific goal and don’t give decision makers an excuse to tell you that you can’t do something. You know what you need to do, just do it.

Ok, thank you for all that. Now let’s move to the main focus of our interview. You are currently leading a social impact organization that has stepped up during the COVID-19 Pandemic. Can you tell us a bit about what you and your organization are trying to address?

As the CEO and Co-founder of US Specialty Formulations LLC (USSF), my team of scientists and I are developing an oral, drinkable vaccine called QYNDR (pronounced kinder) for citizens of the world. Studies indicate mucosal vaccines provide more “bang for the buck” in terms of protection.

This next-generation vaccine addresses the challenges of the current COVID-19 vaccines, among other diseases. After completing Phase I of Clinical Trials, we are another step closer to launching a new, multi-faceted oral vaccine that can be stored easily, administered needle-free and has the ability to fight against a range of respiratory diseases and viruses, such as the flu and RSV.

The Phase I Clinical Trial data showed strong evidence that this oral platform and the COVID-19 vaccine are revolutionary industry disruptors and will become the preferred method of vaccination in the future. As we proceed into Phase II and III, we are confident this vaccine will be a more effective platform than other vaccines in clinical commercialization.

In your opinion, what does it mean to be a hero?

Reflecting on my team and how they went above and beyond during the pandemic, I had a glimpse of what it means to be a hero. The team performed well beyond what anyone in the industry expected, executing a Phase I Human Clinical Trial for COVID-19 while conducting core business pharmaceutical operations. These individuals had families and lives outside of work to contend with, but they risked continued exposure to complete the COVID-19 vaccine program tasks.

With our 16-person, small but mighty team, they are the true heroes.

In your opinion or experience, what are “5 characteristics of a hero? Please share a story or example for each.

Heroes are doers and:

• Take pride in the work output
• Accomplish stated goals and milestones
• Embrace purposeful work
• Have a positive impact on humanity
• Have empathy and compassion

The USSF team, with sheer dedication and focus, accomplished as much in 12 months as teams of thousands in big pharma with significant resources achieved in a similar timeframe.

If heroism is rooted in doing something difficult, scary, or even self-sacrificing, what do you think drives some people — ordinary people — to become heroes?

Ordinary people become heroes when they have the ability to identify something that needs to be done and act on it. They use their resources and take responsibility to accomplish goals that others are too afraid, unwilling or incapable of.

What was the specific catalyst for you or your organization to take heroic action? At what point did you personally decide that heroic action needed to be taken?

In early 2020, our biotech firm was approaching the clinical trial stage of oral DTaP and Group A strep vaccines but was able to pivot the development to modify our QYNDR platform to target COVID-19.

The QYNDR oral platform became the vehicle for the vaccine, developed out of urgency. It has demonstrated in its Phase I Human Clinical Trial capability as a prime or booster to better protect against not only SARS-CoV-2 but a range of respiratory viruses, such as the flu and RSV.

Let’s talk a bit about what is happening in the world today. What specifically frightened or frightens you most about the pandemic?

In 2016, my business partner and I, Dr. Garry Morefield, attended a BARDA conference and presented our views on the necessity for rapid capability and first responder needs to address a pandemic. Using forecasting models, deep industry knowledge and expertise, we proposed that the United States would need a specialized vaccine manufacturing facility and technology platform to address a major outbreak. Our prediction of the need for a facility and vaccine technology platform like QYNDR was accurate, but unfortunately, we could not convince investors at the time. Our current stand is that there will be another pandemic in the future, making preparation essential — fast-forward to USSF’s vaccine solution — the QYNDR oral platform delivery system.

Despite that, what gives you hope for the future? Can you explain?

The approval of a vaccine using QYNDR technology will be distributed in other countries, particularly to better the human condition globally, without the unpleasantness of injectables or individuals being denied access due to logistic challenges inherent in other vaccine delivery methods.

Additionally, certain government agencies are now allocating funds to create rapid response networks of innovators and are beginning to invest in creating the infrastructure needed to handle future outbreaks effectively.

What has inspired you the most about the behavior of people during the pandemic, and what behaviors do you find most disappointing?

During COVID-19, the sheer number of vaccine candidates proposed by development labs was inspiring.

It is disappointing that all the investments and vaccine research funding during the pandemic and even today have focused on mRNA vaccines at the exclusion of other vaccine platforms. Funneling capital more fairly, to include smaller biotech firms, would produce more innovative and sustainable vaccines or a disease prevention ecosystem.

Has this crisis caused you to reassess your view of the world or of society? We would love to hear what you mean.

Unfortunately, the crisis reinforced my view that scientific expertise is undervalued by industry and decision makers.

What permanent societal changes would you like to see come out of this crisis?

Entities and individuals who spread disinformation should be held accountable to the same standards as scientists and providers of healthcare products are held to.

A more equitable vaccine design is approved and readily available across the globe.

If you could tell other young people one thing about why they should consider making a positive impact on our environment or society, like you, what would you tell them?

When the human condition improves, it is not necessarily about giving to other people, but it will most likely affect those around you, those you are in direct contact with — your inner circles.

Little improvements coalesce into much more significant shifts in quality of life.

The butterfly effect rests on the notion that the world is deeply interconnected, such that a tiny occurrence can influence a much larger complex system. The effect is named after an allegory for chaos theory; it evokes the idea that a small butterfly flapping its wings could, hypothetically, cause a typhoon.

You are a person of great influence. If you could start a movement that would bring the most amount of good to the most amount of people, what would that be? You never know what your idea can trigger. :-)

My movement would be building and deploying autonomous units in unserved and inhospitable regions. These units would then deploy drone drops to deliver vaccines and medicine. USSF personnel would have the capability to control these units onsite or remotely.

Is there a person in the world, or in the US, with whom you would like to have a private breakfast or lunch, and why? He or she might just see this, especially if we tag them. :-)

I would like to privately meet with Kenneth C. Frazier, Executive Chairman at Merck. I believe that by speaking with Dr. Frazier, he would understand the revolutionary nature of this vaccine platform and the benefits of bringing a drinkable, oral-based vaccine to market, as they are the future. Dr. Frazier also has had to operate at the pinnacle of the corporate tech hierarchy, and I would be interested if he could share his insights and learnings. Great leaders are cultivated by those who preceded them. I am eager to absorb what he is willing to impart.

USSF’s versatile platform allows us to target an expansive portfolio of diseases. Health experts around the globe are calling for vaccines with the exact properties of the USSF vaccine. USSF has developed the technology and cleared a successful human clinical trial. Now, we need the funding to proceed to the larger clinical trials and ramp up manufacturing capability to meet global demand. Today is an excellent time to invest in USSF, as this is the only vaccine currently in development with the breadth of applications and offerings by any pharma company — a core portfolio platform upon which to base future products.

How can our readers further follow your work online?

https://www.linkedin.com/company/us-specialty-formulations-llc/

https://www.linkedin.com/in/kyleyflanigan/

Thank you so much for joining us. This was very inspirational, and we wish you continued success in your important work.