Gayle Freudinger
Gayle Freudinger is a seasoned regulatory and business development leader with more than 35 years of experience across the biotechnology, pharmaceutical services, and research services industries. She currently serves as Director of Business Development at ProPharma, where she specializes in regulatory consulting for emerging biotech and medical device companies. A former RAPS member and active participant in industry organizations such as the Drug Information Association (DIA), Gayle is known for her ability to bridge scientific innovation with regulatory strategy, helping clients navigate complex FDA and global regulatory pathways.
Throughout her career, Gayle has built deep expertise spanning regulatory strategy, real-world evidence, analytics, market access, and consultative selling. Her professional journey includes senior leadership roles at organizations such as Cardinal Health, ICON, Covance, IMS Health, and IQVIA, where she supported drug and device development across all phases—from early research through post-approval. She has worked extensively with INDs, NDAs, BLAs, 510(k)s, PMAs, and FDA meetings, and has contributed to innovative industry initiatives, including the development of one of the first prescription discount card programs to accurately attribute prescriptions to physicians.
Gayle brings a strategic, relationship-driven approach to her work, emphasizing early regulatory planning to reduce risk and prevent costly development delays. Drawing on her foundation in marketing from Arizona State University and decades of hands-on industry experience, she combines regulatory foresight, data-driven insights, and collaborative leadership to support successful product development and commercialization. Based in Southern California, Gayle is also passionate about environmental causes, particularly ocean conservation, and values global perspectives gained through international travel and engagement.
• Drug Information Association (DIA) Member
• Arizona State University - B.S.
• DIA (Drug Information Association)
• RAPS (Regulatory Affairs Professionals Society)
What’s the best career advice you’ve ever received?
The best career advice I ever received was to constantly ask: "So what?"
Whether you’re building a presentation, pitching a client, or catching up with a friend, understanding your audience’s "why" is essential. In sales, this means pivoting from listing features to highlighting benefits. In a meeting with your manager, it means moving past the problem to explain its impact and your proposed solution.
Next time you’re preparing to speak, run your ideas through the "So what?" filter. If you can’t answer it, your audience won't be able to either.
What advice would you give to young women entering your industry?
I encourage young women to dream big and never place limits on their potential. It’s important to avoid comparing your journey to others, as every path is unique. Embrace challenges as opportunities for growth and learning, and remain adaptable as the industry continues to evolve.
What are the biggest challenges or opportunities in your field right now?
In 2026, the biotech and pharma landscape is shifting from "pure science" to a high-stakes game of navigating new laws, organizational shifts, and advanced technologies. Some of the biggest regulatory challenges for the industry right now include:
1. Drug Price Negotiations
The Inflation Reduction Act (IRA) is the biggest shift in decades. For the first time, the U.S. government is directly negotiating prices for the most expensive drugs.
* The Challenge: As of 2026, the first round of negotiated price cuts is taking effect. This lowers profit margins, forcing companies to rethink which new drugs are worth the massive cost of development.
2. A "New" FDA: Personnel and Policy Shifts
The FDA has recently undergone significant structural changes, including a push to reduce the agency's headcount.
* The Challenge: With roughly 15-25% fewer staff members than in previous years, companies are facing longer review timelines and "regulatory uncertainty." While new leadership is pushing for faster approvals for priority drugs, the loss of experienced career reviewers has made the standard path more unpredictable.
3. Accelerated Pathways and "Plausible Mechanism"
To counter the delays caused by staffing cuts, the FDA has introduced more flexible ways to get drugs to market, especially for rare diseases.
* The Challenge: A new "Plausible Mechanism" pathway allows some personalized therapies to be approved without traditional, massive clinical trials. While this sounds like a win, it places a huge burden on companies to prove their drug works using "Real-World Evidence" and advanced statistics rather than just raw trial numbers.
4. The AI "Black Box"
Companies are using AI to design new molecules and run clinical trials faster. However, regulators are still figuring out how to "police" an algorithm.
* The Challenge: Regulators now demand traceability. If an AI designs a drug or selects patients for a trial, the company must prove how the AI made those decisions. There is a high bar for preventing "algorithmic bias" or errors that a human might have missed.
What values are most important to you in your work and personal life?
Locations
ProPharma
San Diego, CA 92054