An Interview with Savio P. Clemente

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.

With Phase 1 testing now complete and showing positive results, U.S.

Specialty Formulations of Allentown is moving forward with the oral COVID-19 vaccine that it is producing.

Innovation was the theme for the Ben Franklin Technology Partners of Northeastern Pennsylvania’s annual iXchange event.

Attendees gathered virtually for the May 18 event that included the presentation of six innovation awards to early-stage technology companies, established manufacturers and individuals who have helped the organization advance the technology economy of northeastern Pennsylvania.

One of the winners was Peter Molinaro, CEO and chairman of Berks County-based Adhezion Biomedical. He received the Frederick J. Beste III Partnership Award, which is presented to an individual whose “strong vision, dedication, and commitment have helped the Ben Franklin Technology Partners accomplish its goals.”

Angelo Valletta, president and CEO of Ben Franklin Technology Partners of Northeastern Pennsylvania, tied his opening remarks to the theme of the event — “Innovators; Past, Present and Future” — saying innovation is essential to the work of Ben Franklin Technology Partners.

“More and more we’re seeing the importance of innovation to accelerate growth, mitigate the downsides of that growth and address crises and improve the human condition,” Valetta said. “Innovation and technology also create highly paid, family wealth-sustaining jobs.”

He added that over the course of the last two years, Ben Franklin clients have applied technology quickly and effectively to address issues.

“From biotech companies developing vaccines and tests to telemedicine providers facilitating remote medicine to learning platforms allowing instruction at home and so much more,” Valletta said, adding that by creating and retaining good jobs, the clients of Ben Franklin Technology Partners are the foundation of a robust regional economy.

An Allentown company, U.S. Specialty Formulations, is developing a new oral COVID-19 vaccine that promises to expand the number of people vaccinated around the world. The vaccine is undergoing clinical trials now. Grover Silcox reports.

An Allentown biopharmaceutical firm is making progress on an oral vaccine for the COVID-19 virus that could be a game changer in the fight against the disease.

Kyle Flannigan and Garry Morefield of U.S. Specialty formulations said the ease and safety of the vaccine is what’s needed in the next stage in the fight against COVID-19 in the U.S. and around the globe. “It’s of strategic importance and an advantage to the U.S.,” said Morefield.

The week of March 13 is Patient Safety Week, and the safety of vaccine is one of its key advantages, said Flannigan. “What we’ve done is created and shown that an oral platform works. It’s stable at normal and even higher temperatures,” he said. “It doesn’t require a healthcare professional to administer it and it doesn’t require any special kind of shipping,” he said.

It’s the partners’ hope that the ease of the oral vaccine will help get the vaccine to more impoverished countries with less health care infrastructure or even more rural regions of the country where people don’t have easy access to health care.

Once an industrial powerhouse, Pennsylvania’s Lehigh Valley has evolved to become the Northeast’s logistics hub.

Driving east on Pennsylvania’s I-78, bound for the highway’s terminus at lower Manhattan’s Holland Tunnel, you’ll pass miles of vast farmland, spot billboards for God and sheepskin coats, and behold the constant presence of Blue Mountain, an Appalachian ridge. As you advance toward Allentown, trucks soon outnumber cars, and then, as you motor closer to the state’s third-largest city, warehouses dominate a fading landscape of cornfields.

This is the Lehigh Valley, a sprawling region that once nourished colonial America, fueled the nation’s industrial rise, and shaped its urban skylines. Today, thanks in part to its serendipitous location and enterprising local leadership, the Valley has become a global hub for the logistics and warehousing industry.

In an age when algorithms feed consumer demands, the Lehigh Valley has become the East Coast’s supply-chain empire for transporting one-click goods on interstate highways.

Covering 726 square miles of suburbs and rural townships in Lehigh and Northampton Counties—centered on the cities of Allentown, Bethlehem, and Easton—the Valley adjoins metro New York and Philadelphia and stands within one truck shift of 100 million people. As e-commerce expanded over the past decade—and then accelerated dramatically amid the pandemic—the Valley transformed into prime territory for retailers like Amazon and Walmart but also for third-party logistics: the outsourced assembly and storage of companies’ products in warehouses, often called “fulfillment” centers, and their distribution through freight services.

Warehousing growth has played a crucial role in the region’s booming economy, thanks to its close proximity to New York City’s massive base of online shoppers, the limited supply of land in neighboring New Jersey, and a favorable business climate, compared with other parts of the Northeast.

Despite fewer support networks, less access to resources, and an unrelenting global pandemic, many Black-owned businesses have achieved an astonishing feat since 2020. They continue to rise and flourish even in a struggling economy. According to NBC News, American Black business owners increased by a staggering 38 percent from February 2020 to August 2021. Black entrepreneurship is booming across all industries and these enterprising business owners are smashing barriers, celebrating diversity, and representing the next generation of Black-owned businesses.

Kyle Y. Flanigan, Ph.D., Cofounder of US Specialty Formulations, LLC

Dr. Kyle Flanigan, Ph.D., co-founder of US Specialty Formulations, LLC, is one of the very few Black owners of a biotech company. Dr. Flanigan’s specialty is in the development and commercialization of medication bringing oral vaccines to market. He is an innovator in vaccines and immunotherapies, small molecule formulations, botanical pharmaceutical-grade extracts, and contract manufacturing.

Young Paris, Musician, Fashion Icon & NFT Entrepreneur

Young Paris is known for his electrifying, high-energy musical performances. His dynamic tracks even caught the eye of Jay-Z’s ROC Nation, leading to a deal with the label in 2016, where he worked alongside artists such as Wizkid, Tiwa Savage, Olamide, Skales, Jay Park, and Trinidad James. However, Paris is so much more than a talented musician and producer. He’s a Renaissance man, a prolific creator, tastemaker, and entrepreneur, making his mark in music, art, fashion, real estate, and the NFT space.

Chef Derrick McCray, Senior Owner and CEO

Chef Derrick McCray, Senior Owner and CEO of McCray’s Backyard BBQ & Seafood, is a third-generation pitmaster carrying on his family’s tradition of serving up the best barbeque in the world. From addiction, homelessness, and several near-death experiences to serving up his world-famous barbeque to celebrities such as Serena and Venus Williams, Brad Pitt, Earvin “Magic” Johnson, Dan Marino, former President Bill Clinton, and President Joe Biden, McCray knows how to play the long game.

For Kyle Flanigan of Bethlehem, one of few African Americans in a pharmaceutical business leadership position, getting into the field wasn’t a challenge; it was what came afterward. “The challenge for Black people in this industry is recognition and promotion,” said Flanigan, 51, co-founder and chief executive officer of US Specialty Formulations, which makes medications and vaccines.

The numerous systemic and institutional challenges for Blacks have been well documented by others,” said Flanigan, who declined to discuss anything negative he may have experienced. His focus is instead on making USSF the first company to get an oral COVID vaccine approved for public use. That history-making accomplishment could add Flanigan to the list of people whose contributions are celebrated during Black History Month.

However, Flanigan’s demeanor doesn’t indicate someone who’d let it go to his head. He admits his simple love for his line of work outweighs any desire for glory. “Creating an oral vaccine [for any illness] is an extraordinarily difficult process,” Flanigan said. “People have been trying for a very long time.

Before it can be approved by the Food and Drug Administration for public use, a vaccine must go through pre-clinical-trial lab testing and then three clinical trial phases, where it’s tested on progressively larger numbers of people.

Brief Summary:

To evaluate the safety of 2 dose vaccination schedule of orally administered CoV2-OGEN1 In healthy subjects

Detailed Description:

The study will be conducted at 1 site in NZ. Patients who sign an Informed Consent and meet all eligibility criteria will be administered oral doses of 50mcg, 100mcg and 200mcg CoV2-OGEN1 on Day 1 and Day 15 during Cohort 1-3 respectively.

Follow up visit in all the 3 cohorts will be performed at 1 week, 2 weeks, 3 weeks, 4 weeks, 6 weeks, 3 months, 6 months, and 12 months. One sentinel subject will be dosed at the start of each cohort and will be monitored for 24 hours post administration before the remainder of the cohort can be recruited. Each cohort will include one sentinel subject.

Follow up visit in all the 3 cohorts will be performed at 1 week, 2 weeks, 3 weeks, 4 weeks, 6 weeks, 3 months, 6 months, and 12 months. One sentinel subject will be dosed at the start of each cohort and will be monitored for 24 hours post administration before the remainder of the cohort can be recruited. Each cohort will include one sentinel subject.