RIP Sinead. She was Fearless.

She was irreverent. She risked her career to speak out about sexual abuse. She sang with real, raw, emotion. She showed up, and she stood up. She embodied Fearless, Sinead is gone, but we are keeping Fearless in our hearts.

 

Following New Leaders: EpiVax 2.0

Speaking of Fearless, how are you at ‘stepping back’? It’s not so easy sometimes!  I turned 66 in 2022, and I am starting to step back from my leadership roles, as promised. While we search for the next CSO/CEO for EpiVax, I have stepped down from running Clinica Esperanza / Hope Clinic (I was Executive Director/Medical Director), and GAIA Vaccine Foundation (I was interim ED).

I’ve thrown down the challenge, and here are the results: Meet Tiffani Crippin, new ED of GAIA VF, and Morgan Leonard, new ED of CEHC! They are outstanding Next Gen leaders! I am beyond proud of their work. Now my big challenge is to keep my mouth shut. All this to say…. it can be done! 

And then on to the next challenge – stepping back being CSO at EpiVax, and then, from the CEO job before I am 70! I have a plan A (in case you were wondering), but of course we need to have a plan B. Write me here if you are interested in “Improving human (and animal) health, everywhere” with a team of Fearless Scientists. After the transition, I am looking forward to spending more time writing, thinking, presenting, discussing, networking, and mentoring. I will be supporting Next Gen Fearless Scientists at EpiVax as they stretch their wings! 

 

Need a Guideline for Peptide ANDAs? Our PANDA Paper is Out!

Check out the latest Epi-paper in Drug Discovery Today! It details the ultimate stepwise approach to immunogenicity risk assessment of generic peptide drugs, complete with case studies. Thank you FDA OGD for your support of this initial review of our ‘orthogonal’ approach!
 

 

The Tides are Churning

Eli Lilly is one of the most valuable pharma companies in the world, thanks to their obesity drug portfolio. With a value of $438.0 billion, Lilly is currently bigger than JNJ! (hence reducing the price on insulin is easy, right?) thanks to new data from a study of retatrutide in overweight patients. Retatrutide is a triple agonist (GIP/GLP-1 + glucagon receptor) while the others only activate GLP-1 or GLP-1/GIP.  Retratrutide is also not very human-like, and has one of our favorite immunogenic features, an EpiBar: 

While the trial showed an impressive mean weight reduction of 24.2% over 48 weeks, no information was reported with respect to immunogenicity. We have a few questions … about this unnatural peptide …  wouldn’t you want to evaluate potential for immunogenicity, given the promiscuous and non-human (low JanusMatrix score) of the peptide cluster illustrated above?  We’ll be watching for immunogenicity in Phase III. Check back to see what we find!

 

EpiVax Birthday Cake Alert!

Fall 2023 Travel Schedule in EpiVax August Newsletter

We’ll be bringing our 25th birthday celebrations into the fall, and across the globe!
Find our complete Fall 2023 travel schedule here.  Interested in meeting up at any of those events? Shoot me a message!