Friday March 31, 2017 0 comments
Dennis Pierro has been director of BioMARC, a biopharmaceutical manufacturing organization at Colorado State University in Fort Collins, since 2012. BioMARC produces therapeutics, diagnostics and vaccines for human clinical trials and commercialization.
As director, Dr. Pierro oversees a program that includes professionals in biosafety, production, quality assurance, quality control, containment facilities, and contract and project management, among others.
His professional interests include facilitating a national platform for high containment manufacturing of biologics, supporting the development of novel high containment biopharmaceutical products, and investigating technologies to enhance the safety infrastructure of high containment laboratories.
He is also an assistant professor in CSU's Department of Microbiology, Immunology and Pathology as a joint appointment within the university's Office of Vice President for Research. Previously employed at the National Institutes of Health, U.S. Centers for Disease Control and the pharma industry, he has co-authored peer-reviewed publications on novel vaccines and other recombinant DNA research projects.
Q: Tell us about BioMARC; specifically, when and why it was founded.
A: BioMARC is a contract manufacturing service unit that is owned and operated by Colorado State University. It was founded in 2006 as part of a larger consortium award from the NIH in the area of biodefense and emerging infectious diseases. We specialize in the production of biological vaccines, therapeutics and diagnostics for human use. Our unique niche is in High Containment Manufacturing, which we identify as the production of biological organisms that require an enhanced biosafety infrastructure. I best explain our role in the manufacturing field by reminding people of the classic model of creating a vaccine; you would grow a wild-type organisms (bacteria or virus) then kill it to create the good vaccine. We serve in the unique role of being able to handle those wild type organisms leading to the good vaccine.
Q: For which agencies does BioMARC develop vaccines?
A: We respond to agency needs as they are advertised by the U.S. government. At the moment, we have projects with the Department of Defense and also Health and Human Services. We are like most other manufacturers in that we are trying to help move products along as the sponsors, in this case the DoD, have successful candidate products that they want to put into humans.
Q: BioMARC recently received a $3 million grant from the Department of Defense to develop a vaccine to protect soldiers from Venezuelan equine encephalitis virus. How will that be accomplished?
A: We are the specialized manufacturer of this vaccine. I use the term specialized because of the unique type of vaccine system in play. It is called a Viral Replicon Particle (VRP) system that is able to present the vaccine in a more direct way and also generate a strong immune response. However, with the added benefit of the VRP system comes some complexity in how it is made. The vaccine itself needs specialized equipment and highly trained technical teams to be able to produce it to meet the requirements. It is very challenging and I am happy to see that we are able to bring the technology to this point. Once this vaccine is made, we will work with the DoD on the best pathway to having it tested in humans under FDA regulated conditions.We would like to see that occur and hope to partner with the DoD in whatever capacity they deem appropriate.
Q: Is there a civilian benefit that may come from this vaccine development?
A: Our contract support is for the DoD’s end goal, which as I understand it is to protect the warfighter. Unfortunately, the decision to make it more broadly available is not for me to comment on. That does not mean “no.” It simply means that since the DoD owns it, it will be up to them on how to use it.
Q: How does BioMARC and the CSU Infectious Disease Research Center keep secure the viruses it works with in developing these vaccines?
A: Biosecurity and Biosafety are very important components of our operations. As part of the university, we comply with the applicable rules and guides as structured by CSU as well as those by regulatory agencies. We take this very seriously and work daily to provide a safe place for our staff, our colleagues and our community, as well as a safe product for the people who will receive the vaccines.