As the former director of the Center for Biologics Evaluation and Research at the FDA, Peter Marks, MD, PhD, discusses new drug and biologic developments that also gave him insight into what is coming in the future. […]
Halia Therapeutics CEO David Bearss, PhD, Mark Ott, MD, dean of the BYU School of Medicine, and Bob Carter, MD, PhD, CEO of University of Utah Health, discussed how the healthcare system will deal with the upcoming “silver tsunami.” […]
Michelle Holyoak and Jacey Skinner discussed several topics affecting the life sciences industry, including FTC policy around non-compete agreements, regulating pharmacy benefit managers, regulation of mergers and acquisitions, and other policies affecting the industry. […]
Dr. Michelle Tarver, Director of the Center for Devices and Radiological Health at the U.S. Food and Drug Administration, joined the 2025 Mayer Brown Utah Life Sciences Summit via live video feed and host a town hall meeting. Dr. Tarver provided opening remarks then entertains questions from the audience. This presentation was recorded on November […]
Carter Dredge, PhD, Bus.D, executive director, Intermountain Health Institute and a Cambridge Fellow gave an insightful presentation about how AI is transforming healthcare by driving novel innovation in care delivery models that reduces costs, expands access and personalizes treament – making the impossible, possible. This presentation was given on November 12, 2025 at the 2025 […]
Utah’s fast-growing life sciences industry creates opportunities for careers in multiple fields, including regulatory affairs, quality, and compliance. RCQ professionals play a crucial role in ensuring the safety, efficacy, and quality of medical devices, diagnostics, and pharmaceutical products. The session focused on regulatory and quality career pathways as shared by local leaders in the discipline […]
Quality systems are essentially an organization’s business system. There are three core QMS systems that must be working well and interrelated within an organization to continuously improve, prevent bureaucracy, and reduce costs. This interactive session examines how these three core systems work together. […]
Utah’s academic centers are playing an important role in developing regulatory affairs professionals who can facilitate the processes and requirements involved in bringing highly regulated products, such as medical devices, diagnostics, and drugs to market. The session discussed regulatory affairs programs offered by the University of Utah and Weber State University. […]
The session focused on the challenges in quality and regulatory efforts around cybersecurity and human factors in GxP Training and Onboarding. Challenges can stem from the potential for hackers to exploit vulnerabilities in connected devices, impacting patient safety. Human factors considerations in training and instruction are easily overlooked and yet are critical to proper product […]
This presentation provided a comprehensive overview of the FDA’s medical device presubmission process, a critical step for manufacturers seeking to efficiently bring safe and effective devices to market. This session examined the strategic advantages of utilizing the presubmission program (Q-Sub), outlining key components and benefits. […]