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Formulating new solutions for poorly water-soluble drugs - even your most challenging drug candidates. 

 

Who we are

Tyndall Formulation Services, LLC is a contract research organization (CRO) that specializes in developing drug delivery technologies and applications for poorly water-soluble drugs, with an emphasis in oncology.  

Our company founder Kevin Sill, Ph.D., is an expert in drug delivery technologies. He’s taken an idea from concept to clinical use, with deep experience in research, clinical development, executive leadership and the support of drug delivery solutions. 

 
 

What we do

Our core service is the development of novel polymer excipients and drug delivery technologies. We’re a trusted partner that can help with everything from preclinical development, drug delivery, manufacturing and intellectual property.

Why choose Tyndall?

Hundreds of new polymer biomaterials are prepared by researchers each year. Yet, only a handful of these new materials are ever administered to patients. The truth is, the development of new polymer excipients has been extraordinarily limited in the past.  

 

Tyndall has developed a series of novel polymer excipients capable of encapsulating a wide array of hydrophobic therapeutic molecules with proven success. We have demonstrated that our novel polymer excipients can be safely administered at doses over ten times greater than anticipated doses.

Benefits of our water-soluble polymer excipients:

  • Non-immunogenic and biodegradable

  • Superior performance with drug loading efficiencies >90%

  • Straightforward, scalable manufacturing/formulation processes

  • Can cause fewer side effects 

  • GMP manufacturing scheduled to begin in early 2020

  • GLP toxicology studies scheduled to begin in early 2020

  • Adheres to FDA standards, with the first-in-man use anticipated in 2020

Tyndall also plans to submit Drug Master Files for each excipient with FDA in 2021 to support the wide use of our novel polymer excipients by our current and future clients.  

 

Meet our team

Kevin Sill, Ph.D., founder and president of Tyndall Formulation Services, has nearly 20 years of experience in research, clinical development, and leadership roles in the biotechnology industry, with proven success in the development of cancer drugs.

 

At Tyndall Formulation Services, he is responsible for the strategic development of formulation products and leading projects for the company’s current pharmaceutical partner’s asset development.

Dr. Sill has managed hundreds of intellectual property dockets, co-invented 27 issued US patents and 61 international patents, and co-authored 23 articles in peer-reviewed publications. He was also named “Young Innovator of the Year” by R&D Magazine.

 

In 2004, Dr. Sill co-founded Intezyne Technologies, a privately held corporation focused on developing breakthrough cancer therapies. He became Chief Science Officer, leading the development of the company’s nanoparticle delivery technology from conception to clinical trial. In 2011, he became a registered US patent agent to strengthen Intezyne’s intellectual property program.

 

Dr. Sill became Intezyne’s Chief Executive Officer in 2015 where he secured $10 million in Series A institutional funding, acquired a biotechnology company, and implemented a corporate restructure to shift the company’s focus to clinical development. He also negotiated corporate contracts for manufacturing, clinical trial, research and material transfer agreements. 

 

Bradford Sullivan, Ph.D., vice president of Tyndall Formulation Services, has extensive experience in the pharmaceutical industry, with roles from preliminary research and development to manufacturing and regulatory support for clinical trials.

Dr. Sullivan guides Tyndall’s formulation services business and grows its pharmaceutical asset portfolio. He also directs the synthesis, characterization, and application of new polymer excipients while managing the cGMP manufacturing at partner contract research organizations.

Prior to Tyndall, Dr. Sullivan worked at Intezyne Technologies for six years. Starting as a Senior Chemist in 2013, he soon became Chemistry Manager, focusing on the synthesis of the company’s drug delivery co-polymers and handled large-scale production of the excipients for transfer to cGMP manufacturing partners. Dr. Sullivan was later promoted into the role of Director of Chemistry, Manufacturing and Controls where he led the successful cGMP manufacturing of Intezyne’s ruthenium-based oncology drug and provided U.S. and foreign regulatory support for the company’s two clinical assets. Dr. Sullivan is a registered U.S. patent agent who strategized, drafted, and prosecuted the company’s patent applications. 

Contact Tyndall