Arnold & Porter Kaye Scholer LLP

Hi, my name's Robby Margolis.

I'm the Director of Wellbeing at Arnold & Porter and a member of the New York City Bar Association's Mental Health and Wellbeing Committee.

And I'm excited to be here today with my friend and co-collaborator, Jordana Confino.

Hello, I am Jordana Confino.

[upbeat music] Hello, and welcome back to Better BioPharma, the official podcast of BioProcess Online.

I'm your host, Tyler Minichillo, and in this episode, I'm joined by Ava Temkin and Elizabeth Trentacost from Arnold & Porter, where Ava is a partner and Elizabeth is a senior associate.

Today we're gonna be talking about some 2026 regulatory updates, and specifically the US Department of Health and Human Services' Operation Trailblazer initiative and what it means for sponsor companies.

Ava and Elizabeth, thank you so much for joining me today on this episode of Better BioPharma.

I'm excited for our conversation.

I've been looking forward to it, and, uh, for a little bit of background, Ava and I met each other at BIO this year.

Uh, we attended some regulatory sessions, and I'm, I'm keen to hear your, your takeaways from those, Ava, but first I was hoping, uh, one or both of you could give our audience a bit of background about Arnold & Porter and kinda the work that you guys do as consultants there.

So A&P is an international law firm.

Yes, he's in Trump appointee, but he had a long career.

Arnold Porter, reputable law firm, the Department of Justice and on the Hill.

You know, very smart person.

He's the person who restored Jim Acosta's credentials.

Thank you.

And just so the court knows, the Exhibit 4, the letter from Arnold and Porter, is the claim... that we filed against the DLA relating to the $7.9 million.

And we'll discuss that later, but I just wanted to identify that for now, Your Honor.

And we do have a stipulation with the DOJ on exhibits.

There's a number of disputes that we have with the government about how that contract was performed against, and I think as the government alluded to in their motion or their objection, they have some counterclaims against us.

But ultimately, we filed a $86 million claim against the DLA shortly before we filed Chapter 11 to preserve our rights under that contract.

Can you just turn to the back of the exhibit book? It's the loose letter from Arnold and Porter.

Is this the claim that you're referring to?

So I was an early comer to compliance.

From Big Law, I was a partner at Arnold and Porter for about 10 years.

Then I decided to go to the Kleptocracy Initiative and continue on with anti-corruption work.

It was mainly foreign officials who had either stolen money from their countries or received bribes.

And when we did, we tended to do what I did, which was start my own consulting.

Tools are very different then.

And I do have my own tools now, but I started out doing compliance consulting similar to what you were doing at Arnold and Porter.

Yeah.

I'll give you a short bio on each of them.

Larry Killeen, is currently a senior counsel at Arnold and Porter.

He represents clients on administrative, regulatory, and enforcement matters involving federal agencies such as EPA, USDA,

FDA, and CPSC.

Larry has broad experience advising clients on U.S. and international regulatory programs that govern commercial and consumer use chemicals, pesticides, and antimicrobials.

as well as the products of biotechnology and nanoscale materials.

Prior to joining Arnold and Porter, Larry served as manager in various risk management positions at EPA, including managing the Toscanew Chemicals Program and programs overseeing microbials and pesticides.

Next to Larry is Dr. Maria Doa.

So I was an early comer to compliance.

From Big Law, I was a partner at Arnold & Porter for about 10 years.

Then I decided to go to the Kleptocracy Initiative and continue on with anti-corruption work.

It was mainly anti-corruption.