One-on-One Interview with Brian Roberts: Protein Therapeutics Manager at EpiVax
We recently sat down with our very own Protein Therapeutics Manager, Brian Roberts, to discuss his ongoing work with PANDA. In this exclusive interview, he shares what his job entails and the drive behind it. He also gives us an insight into his new project: the What If Machine (WhIM for short). Much like the What If Machine from the well-known American cartoon Futurama, the purpose of WhIM is to analyze the outcomes of external possibilities. Read on to find out more!
Tell us a bit about yourself.
I have had a fascination with how our body fights disease since I was a child, and after taking my first Immunology course as an undergraduate, I knew that Immunology was the field I wanted to pursue. I earned my PhD in Cell and Molecular Biology from the University of Vermont (UVM), where I studied sex differences in viral-induced autoimmunity focusing on the role of Toll-like Receptors 2 and 4 in disease susceptibility. After leaving UVM, I briefly worked as a Post-doc at the University of Connecticut Health Center before coming to EpiVax in 2015 as a Post-doc. In January of 2018, I was promoted to the role of Protein Therapeutics Manager.
What’s your role at EpiVax?
My role is two-fold. A large part of the Protein Therapeutics group is our new PANDA (Peptide Abbreviated New Drug Application) program. While our tools were initially designed with the intent of developing safer and more effective vaccine targets, peptide drug manufacturers came to us looking to see if their products were immunogenic and if so, can we deimmunize them leading to the creation of our ISPRI tool kit and the PreDeFT analysis. This in silico analysis is followed up by a series of lab based in vitro assays to confirm the results of the in silico predictions. Once we have predicted sequences, we test for the ability of those peptides to bind a panel of soluble HLA Class-II supertype alleles. Our HLA-binding assay is followed up by a naïve T-cells assay (in vitro immunogenicity protocol, IVIP) to determine if the drug candidate is capable of initiating an immune response.
When manufacturing a generic drug, the Food and Drug Administration (FDA) now requires an abbreviated new drug application (ANDA) which is to show that (1) the generic drug functions as well as the reference listed drug (RLD), and (2) that the generic drug and any associated impurities that arise from the manufacturing process is no more immunogenic than the RLD. Criteria 2 led to the development of our PANDA program. After completion of the in silico and in vitro analysis, we provide our clients with an FDA ready report that can be submitted to the FDA as a part of their ANDA filing.
Additionally, the protein therapeutics group is tasked with developing deimmunized products that we can take to market. This involves a similar process where we can ultimately deimmunize immunogenic peptide therapeutics by making sequence modifications, or by incorporating EpiVax’s Tregitope technology.
What do you think is really exciting about your new PANDA project?
In the next 4 years, roughly 80 drugs are coming off patent, and those companies looking to make generics will need to submit ANDA applications to the FDA. From a business perspective, this is a great opportunity for us and a provider of immunogenicity screening. The interest that we have already seen in this program proves that EpiVax is considered a leading expert in this field and the business that we generate will only help us strengthen and expand our offerings while showing the industry just how powerful our tools are.
We are currently working on the What If Machine. This idea evolved from a discussion among Annie De Groot (CEO, CSO), Bill Martin (CIO, COO), and the FDA. By using WhIM, we can build a matrix that helps us predict the effects common impurities such as truncations, deletions, and duplications, have on immunogenicity. It should be interesting to see what we find!
What If Machine from Futurama