By Kathleen Doheny

The COVID-19 vaccines were a remarkable medical accomplishment, credited with preventing more than 3 million deaths and 18 million hospitalizations in the U.S. alone in 2 years, but scientists and public health officials say future versions will have to work even better.

Current vaccines are best at preventing serious illness, hospitalizations, and death. Improved vaccines would need to up the ante and make infection and transmission far less likely.

Researchers from around the globe are also working on ways to make the vaccines easier – think pill, liquid, nasal spray, or patch – while making them less vulnerable to variants, with fewer side effects.

All of this could perhaps help many people overcome their resistance to getting vaccinated, which is plainly evident from the numbers: Worldwide about 72% of people have received at least one dose of a COVID vaccine. The number of Americans with one dose is higher at more than 81%, but just 16.3% have agreed to get a booster, according to the CDC.

The current crop of vaccines, notably mRNA, may not be enough. Anthony Fauci, MD, the former head of the National Institute of Allergy and Infectious Diseases, and former chief medical adviser to the president, recently told WebMD, “We certainly want next-generation vaccines” that are broader and more adaptable, cover multiple variants, and offer “a greater degree of duration.”

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There are several great ideas, dreamt and thought up by people every day. An idea alone however is not sufficient to change the world. A person’s ability to execute upon the idea is key.

In the United States today, black doctors are vastly underrepresented. Only 5% of physicians nationwide are black. Why is it so important to have better representation? What steps can be taken to fix this discrepancy? In this interview series, we are talking to successful black men and women in medicine about their career, their accomplishments, and how others may follow their path. As a part of this series, I had the distinct pleasure of interviewing Kyle Flanigan, Ph.D.

With more than 25 years of experience, Dr. Kyle Flanigan, Co-founder and CEO of US Specialty Formulations LLC (USSF), is an expert in all pharmaceutical and medical performance materials development stages. One of the few Black Ph.D.’s to launch 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 more. Can you tell us a bit about your childhood “backstory”?

Iwas born in St Louis, Missouri and grew up with both parents deep in the science field. All aspects of the chemistry industry surrounded my three siblings and me. With my father’s expertise, we moved every few years as required by his career demands. As a result, my three siblings and I were highly motivated to achieve academic success. I had a solid foundation and a healthy upbringing and grew up with structure, fun and awareness of the sensitivities of culture, race and religion. My mother actively ensured we were provided with opportunities and not prejudiced against the color of our skin.

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

Can you tell us a story about what brought you to this specific career path? When in the world of semiconductor discipline, could easily be applied in biotechnology — designing and running a pharmaceutical company.

I saw the connection and overlap between the semiconductor industry and the opportunities in biotech. The joy of science is that the principles and thought processes can be applied to different disciplines. With a deep interest in this connection, I built my knowledge in designing and building a pharmaceutical and development company.

US Specialty Formulations is working to create an oral, thermo-stable COVID vaccine

Kyle Flanigan, Ph.D., always enjoyed tinkering and exploring new technologies. His first love was the U.S. space program and technologies that could benefit exploration. Later in life, he became an explorer of new paths, the development of shelf-stable, oral vaccines for multiple viral threats.

A graduate of Howard University with a degree in chemistry, Flanigan dreamed of working in the space program. He spent time in the astronaut candidate program before pivoting to develop computer chips for Intel Corp. From there, his career took him to Honeywell and then to Malinckrodt. There, he got a glimpse of the pharmaceutical world and his career trajectory changed.

It changed even further during a conversation with longtime friend and business partner Garry Morefield. The two men discussed the need for faster and easier vaccine delivery. Morefield, founder of Bethlehem, Penn.-based VaxForm LLC, had been working on a strep throat vaccine. The two men believed the development timeline could be accelerated if they did it on their own. That conversation sparked the formation of Allentown-based US Specialty Formulations.

Flanigan and Morefield launched USSF in 2013. The mission was to produce clinical materials that could support drug development for clients, as well as for the strep program.

When COVID-19 spread across the globe, Flanigan and his colleagues, like many companies, quickly pivoted the strep vaccine program to tackle the new viral threat. The situation was dire and there was a need for new therapeutics and vaccines to be developed. Flanigan, who now serves as chief executive officer of USSF, said the vaccine technology developed by USSF was ideal for respiratory infections. What’s more, USSF’s approach was aimed at manufacturing an oral vaccine.

What if you could drink your COVID-19 vaccine instead of rolling up your sleeve? No needle — just a “swish and swallow,” and your new immunity is down the hatch.

You might be able to within the next couple of years, as researchers expand their focus onto mucosal vaccines, which include nasal or inhaled vaccines as well as “swish and swallow” oral vaccines such as QYNDR, which completed its phase 1 clinical trial and is currently waiting on more funding to conduct the more detailed, advanced trials that could actually bring the vaccine to market.

The QYNDR vaccine is pronounced “kinder,” because it’s a softer way to deliver a vaccine, says Kyle Flanigan, founder of QYNDR’s maker, US Specialty Formulations. Promising clinical trial results from New Zealand offer hope that QYNDR will be a viable option for protection against the string of COVID-19 variants circulating. The findings have not been peer-reviewed yet.

But to advance it to the additional clinical trials needed to take it to review and market, they need funding from investors. This week, Flanigan was in San Francisco at the JP Morgan Healthcare Conference trying to get that funding.

From a small biotech start-up firm in Allentown, Pennsylvania, two scientists are leading their team to bring an oral COVID-19 vaccine to market – one that will be easier to use, longer lasting and with fewer side effects.

Kyle Flanigan and Garry Morefield co-founded US Specialty Formulations LLC (USSF) through discussions while watching their daughters compete in gymnastics. This came with just $100,000 and the ambition to grow their site into a thriving biotech and pharmaceutical facility. Today, the 41,000-square-foot manufacturing facility spans more than two acres and has become a hub of experts creating diverse solutions, applications and approaches to help clients overcome hurdles in drug discovery and development.

US Specialty Formulations is a minority-controlled business and certified Current Good Manufacturing Practice (cGMP) manufacturer of sterile injectable, topical and specialty pharmaceuticals. It manufactures its own branded prescription products and provides clinical materials for investigational new drug applications, specialty formulations, adjuvants and fermentation and purification services requested by various biotech companies.

The US Specialty Formulations team applies agile high-performance teams system to facilitate collaboration and problem solving – ensuring clients’ products go to market efficiently and seamlessly. From initial stages of development to commercial manufacture, they leverage their methods, analytics, scale-up technologies and technology transfer to guide small compound and vaccine development.

With a portfolio that includes a range of vaccine candidates, small molecule formulations and botanical pharmaceutical grade extracts, Flanigan and Morefield are bringing their mucosal COVID-19 vaccine to market. They pivoted their formula from an oral DTaP (diphtheria), a childhood vaccine most of the population received, initially targeted for human clinical trials in early 2020.

How has US Specialty Formulations been able to adapt the DTaP vaccine for COVID?

In the early pre-clinical development work, we looked at extending the shelf life of existing vaccines using this oral technology. For those experiments, we used an expired DTap vaccine. The experiments showed that after applying our technology to the expired DTap vaccine, it generated immune responses on par with a ‘fresh’ vaccine vs. a poor immune response from the unmodified and expired stock DTap vaccine. The current oral platform benefited from these early experiments and the learnings incorporated into the COVID vaccine.

We (Canvasrebel) recently connected with Kyle Flanigan, Ph.D. and have shared our conversation below.

Hi Kyle, thanks for joining us today. Covid has brought about so many changes – has your business model changed?

US Specialty Formulations LLC (USSF) was founded to provide clinical materials to the vaccine and new drug development sponsors. With COVID, USSF found itself in the lead position as a clinical trial sponsor versus a contractor. USSF’s business model went from a pharmaceutical manufacturer to a hybrid pharmaceutical development and manufacturing company.

Kyle, love having you share your insights with us. Before we ask you more questions, maybe you can take a moment to introduce yourself to our readers who might have missed our earlier conversations?

USSF was founded on the basis of process and formulation development and high-tech business management. The organization offers our customers value-deep knowledge of the best way to manufacture never-been-done formulations and the flexibility to work with small companies who know what they want the end result to be but don’t know how to get there. USSF offers multiple high-quality interactions with multiple touchpoints and intimate team contact.

The results are high-quality products where USSF is well integrated with the customer’s integration team.

We’d love to hear about you met your business partner.

Dr. Kyle Flanigan and Dr. Garry Morefield met and co-founded US Specialty Formulations LLC through several discussions while watching their daughters compete in gymnastics. With just $100,000, they had the ambition to grow their site into a successful biotech and pharmaceutical facility.

Today, the 41,000-sq.-ft. manufacturing facility spans over two acres and is becoming a well-regarded clinical materials provider for sponsors seeking a responsive and dynamic manufacturing partner. With a successful conclusion of the Human Phase 1 Clinical Trial, USSF can offer an exciting oral vaccine delivery platform for future vaccine candidates.

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As part of my series about “developments in the travel industry over the next five years”, I had the pleasure of interviewing Dr. Kyle Flanigan.With more than 20 years of experience, Dr. Kyle Flanigan is an expert in development of performance materials.

With more than 20 years of experience, Dr. Kyle Flanigan is an expert in development of performance materials. He is leading a team to bring an oral COVID-19 vaccine to market — one that will be easier to use, longer lasting and with less side effects.

Thank you so much for joining us! Can you tell us a story about what brought you to this specific career path?

US Specialty Formulations LLC (USSF) was founded to provide clinical materials to the vaccine and new drug development sponsors. With COVID, USSF found itself in the lead position as a clinical trial sponsor versus a contractor.

I love to build things, I always have, mentally and physically. This career, as a CEO of a start-up for a manufacturing and vaccine development company, fits so well as it encompasses many forms of building. Building teams, building a vaccine, building a business and building an infrastructure.

Dr. Kyle Flanigan, Ph.D., discusses the benefits of an oral COVID-19 vaccine.

Doctors are still trying to perfect the COVID-19 vaccines. Dr. Kyle Flanigan, Ph.D., co-founder and CEO of USSF, discussed his work with Dr. Garry Morefield, Ph.D., on an oral vaccine against the virus.

Flanigan: We believe our oral platform is the future of vaccines. It is evident that an oral vaccine does not require needles, thus the additional benefits include ease of use, non-invasive delivery method, and the manufacturing is significantly less risky. The US Specialty Formulations LLC (USSF) COV2-OGEN1 oral vaccine is stable to very high temperatures and does not need the same cold-chain logistics and storage requirements as other vaccines that are currently on the market.

A significant feature is that it is stable up to 140° Fahrenheit for more than three months. Further, an oral vaccine does not require a health care practitioner to administer. For a country looking to vaccinate its population, it is an ideal option as more people are likely to take it.

Our vaccine shows a significant IgA response in both serum and mucosal systems which is considered key for preventing respiratory infection. It is an oral vaccine that meets people’s lifestyles.