317. Inside Breast Cancer Drug Development with Celcuity CEO Brian Sullivan

Love the podcast? Send us a text! When we hear that a new breast cancer treatment has received FDA approval, we often see the headline, but rarely the years of research, difficult decisions, and clinical trials that made that milestone possible. So what actually happens behind the scenes? In this episode of Breast Cancer Conversations , Laura Carfang, EdD, Founder and CEO of SurvivingBreastCancer.org, welcomes Brian Sullivan, CEO and Co-Founder of Celcuity, for an inside look at the science and development process behind new breast cancer treatments. Brian shares how his career as an entrepreneur led him into biotechnology, why Celcuity became interested in the PI3K/AKT/mTOR (PAM) pathway, and how studying the signals that regulate cancer cell growth helped inform the company's research. Laura brings the patient perspective to the conversation, asking the questions many people have when they hear about a new medication or clinical trial: What exactly is a cancer pathway? How do researchers decide whether a drug is worth studying? What is the difference between a Phase 1 and Phase 3 trial? And how can patients understand the potential benefits and risks of participating in clinical research? The discussion also explores the development of REVTORPYK (gedatolisib), which received FDA approval on July 14, 2026, for use in combination with fulvestrant, with or without palbociclib, for a specific population of adults with HR-positive, HER2-negative locally advanced or metastatic breast cancer without a PIK3CA mutation, following progression on or after endocrine therapy in the metastatic setting. Beyond the scientific milestones, this conversation highlights the people behind clinical research working to answer important questions about breast cancer treatment. In This Episode, You'll Learn How an idea becomes a potential cancer treatment — and why drug development can take years What the PI3K/AKT/mTOR (PAM) pathway is and why researchers study it in breast cancer How targeted therapies differ from traditional chemotherapy What happens during clinical trials and how researchers evaluate new treatments What randomization, blinding, informed consent, and progression-free survival mean Why clinical trial participation is an important part of advancing cancer research How researchers and the FDA evaluate clinical evidence before approving a new treatment About Our Guest Brian Sullivan is the CEO and Co-Founder of Celcuity, a biopharmaceutical company focused on developing targeted therapies. In this conversation, Brian shares his entrepreneurial background, Celcuity's approach to cancer research, and the clinical development journey that led to an FDA-approved breast cancer treatment. Resources Mentioned SurvivingBreastCancer.org: https://www.survivingbreastcancer.org SBC Programs and Events: https://www.survivingbreastcancer.org/events Clinical trial information: https://clinicaltrials.gov REVTORPYK prescribing and patient information: https://www.revtorpyk.com FDA adverse event reporting: https://www.fda.gov/medwatch Important Medical Information This podcast is intended for educational purposes and does not constitute medical advice. Treatment decisions should be made with a qualified healthcare professional based on each person's diagnosis, treatment history, medical needs, and preferences. REVTORPYK is approved for a specific patient population and ca