October is Rocking! Off to Amsterdam and Stockholm
EpiVax Sets the Standards for the Generic Drug Industry
Ok . . . that’s an over-the-top headline! But read the press release! It reflects our excitement about our new contract with FDA and, the statement is actually correct! We just landed a two-year, $2 million contract from the FDA’s Office of Generic Drugs (OGD) to develop control peptides that will be used to standardize the immunogenicity risk assessment of peptide impurities for generic drug products. These standardized controls will demonstrate consistency across assay formats for ANDA applications enabling FDA regulators to evaluate the sensitivity and specificity of assays that use different methodologies.
Ok, that’s pretty awesome. Right?
This new project builds on several previous FDA contracts that expanded the use of computational immunology methods such the EpiMatrix, JanusMatrix, and WhIM algorithms, which can categorize drug impurities based on immunogenicity risk. In vitro validation using naive T cell assays is a key component of this exploration. We’re publishing the methods as quickly as we can (follow us on Linked in and watch this space) while working with FDA experts to expedite the regulatory assessment of generic peptide drugs and make them more accessible to consumers.
Where’s the AI in that? Well, Bill and Guilhem have been tinkering with the tools and we’ll be ready to show off some of the great AI-HI (Human Intelligence) improvements – to PANDA clients and ISPRI users in November. We are already applying AI-updated tools to our in-house projects, of course!
Yes, we’re excited, and we’re also grateful for this opportunity. Read more about EpiVax’s PANDA® Approach to immunogenicity risk assessment of generic peptide drugs in our initial publications, here and here.
Don’t Miss our 10th B’day Party in Amsterdam
The 10th annual Amsterdam Immunogenicity and Tolerance Seminar (AIT) will take place on November 8th. We’ve got an amazing lineup of speakers, including Charlotte Fribert from Toleranzia, Sophie Tourdot from Pfizer, Femke Broere from Utrecht University, Peter Aaby from The Bandim Health Project, Mihai Netea from Radboud University, and Mariatheresa Coppola from HypoVax.
Honestly, this is going to be a great conversation between some true visionaries in the vaccine and tolerance space. NOT TO MISS!.
There’s so much more to it than just talks! We’ll have scientific posters on display, opportunities for networking with the academic and industry leaders in attendance, a cocktail reception, and more. Tell your friends and have them register so we can save a seat (and lunch) for them. Want to present a poster during the seminar? Just submit a brief abstract here!
Japan and Seoul, so great to see you! (And thank you!)
We just returned from Tokyo and Seoul where we got to catch up with our old friends (Hiro! Yoshi! Takuya! Joon! Toshi! And so many more) and meet new colleagues, eat lots of good food, and share exciting research in three separate seminars!
First was the fan favorite Westin Immunogenicity Seminar* which was packed with lively discussions as usual (our16th year!). The very next day, with our co-organizers, we held the first ever AI / Computational Vaccinology Symposium!** The overarching theme was how computational methods are reshaping vaccine and biologics development. Stay tuned for next year – and submit suggestions to me! Then, on to Seoul, Korea! where EpiVax and key collaborators presented a computational vaccinology workshop during ISV’s Annual Congress. A special thanks to Manon Cox (NextWaveBio), Yoshi Takahashi (NIID Japan), and Chaok Seok (Seoul National University & Galux, Inc.) for filling in for me! and for sharing their research during this event.
* See pictures here for the 16th Westin Immunogenicity Seminar
** See pictures here for the 1st Westin Computational Vaccinology Seminar
