We 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.
Can you talk to us about manufacturing? How’d you figure it all out? We’d love to hear the story.
Dr. Flanigan and Dr. Morefield wanted to start a small manufacturing facility that would produce clinical materials for a Group A strep vaccine, as well as new and innovative products for the market at large. After several conversations and putting together various business models, they learned the USSF model would prove successful because there was not a lot of capacity globally for small-batch manufacturing.
They established a business model and reviewed it with former colleagues and began raising money through Pennsylvania incubator organizations. Funds raised did not meet the goal, but their existing skill base allowed the co-founders to move forward.
Dr. Flanigan and Dr. Morefield built by hand USSF’s first clean room suite. In 2014, they released USSF’s first clinical batch and by 2015, they released their first product into the market for customers.
By 2016, it was obvious customers wanted more capacity, which allowed expansion outside the clean room suite. They investigated fundraising efforts to acquire a larger facility. In 2019, even though USSF’s fundraising efforts fell short, with a true entrepreneurial spirit, Kyle and Gary persevered and purchased a much larger facility for its operations.
As COVID took hold in 2020, USSF pivoted one of its joint development projects into the oral COVID vaccine and again, fundraising efforts began.
USSF was able to fund its Human Clinical Trial Phase 1 using its own resources.
As USSF is in the process of securing funding for Phase 2 and Phase 3, this oral booster is a reality nationally, as well as internationally. With increased funding, USSF will be able to develop 10 million doses in 18 months – enough doses to cover, for example, the population of New Zealand of five million – with the current two dose regimen .
USSF is looking for additional funding – from private investors and governments – to continue its successful work and spearhead a kinder vaccination method for the United States and abroad.
Contact Info:
- Website: https://ussfgmp.com/
- Linkedin: https://www.linkedin.com/company/us-specialty-formulations-llc/
- Other: Dr. Flanigan’s LinkedIn, https://www.linkedin.com/in/kyleyflanigan/
Image Credits
US Specialty Formulations LLC