We love to hear from our listeners. Send us a message. On this week&#x27;s episode of the Business of Biotech, Brian Sullivan, CEO at Celcuity, talks about winning the company&#x27;s first FDA approval for Revtorpyk, a kinase inhibitor for breast cancer patients, and why targeting an “untreated disease mechanism” can beat chasing a single mutation. Brian also discusses the process for licensing a shelved Pfizer asset for development, designing Phase 3 trials that challenge assumptions, the benefits of FDA&#x27;s Real-Time Oncology Review, and managing downside risk while advancing new indications, all while building a launch-ready company without losing pipeline momentum. Access this and hundreds of episodes of the Business of Biotech videocast under the Business of Biotech tab at lifescienceleader.com. Subscribe to our monthly Business of Biotech newsletter. Get in touch with guest and topic suggestions: ben.comer@lifescienceleader.com Find Ben Comer on LinkedIn: https://www.linkedin.com/in/bencomer/

Getting To A First Product Approval With Celcuity's Brian Sullivan

Business Of Biotech

Welcome back to Business Of Biotech. I'm your host, Ben Comer, Chief Editor at Life Science Leader, and today I'm speaking with Brian Sullivan, Co-Founder, Chairman, and CEO at Cellcuity, a biotech company that received FDA approval on July 14th for RevTorpic, generic name GetaTalacib, which was indicated in combination with Fulvestrant for HR-positive and HR-2-negative locally advanced or metastatic breast cancer patients.

without a PIC3CA mutation. It's the company's first product approval, but hopefully not the last. RevTorpic is also in active development for other breast cancer types, including use as a first-line therapy, as well as a metastatic castration-resistant prostate cancer candidate.

Brian is a serial entrepreneur. He worked previously as chairman and CEO at SterileMed, a medical device company sold to J&J for $330 million in 2011. And before that, he co-founded and led Recovery Engineering, a filtration company that he took public and sold to Procter & Gamble for $265 million in 1999.

I'm thrilled to have Brian on the show today to talk about RevTorpic's approval and what it means for breast cancer patients, how he identified and licensed GetaTalacib from Pfizer, his engagement with the FDA up through approval, commercialization plans, and how to balance ongoing pipeline development with a new drug launch. Brian, thank you so much for being here. Oh, it's my pleasure. Thanks for having me. I want to start off with a couple of questions on your background.

I just mentioned that you've led and sold two companies, a water filtration company, a medical device company that reprocessed single-use devices prior to self-cuity. What did you learn from those experiences? And what made you want to take a swing at cancer therapeutics? Well, you know, I started my first company out of college, right? And so one of the benefits...

Getting To A First Product Approval With Celcuity's Brian Sullivan

Read the full transcript

The candid version is on a podcast,
not the earnings call.

Getting To A First Product Approval With Celcuity's Brian Sullivan

Read the full transcript

The candid version is on a podcast, not the earnings call.

The candid version is on a podcast,
not the earnings call.