Wendi Carroll, PharmD, has built a career defined by scientific rigor, strategic insight and commitment to improving outcomes for patients living with rare diseases. As the founder and president of Carroll & Morrisette Consulting LLC, she provides critical guidance to small and mid-sized biopharmaceutical companies, helping them navigate the complex processes of product development, regulatory approval and post-market safety monitoring. Dr. Carroll’s work bridges the gap between scientific innovation and patient care, with a special focus on supporting early-stage companies as they move promising therapies toward global availability. Her expertise extends to navigating regulatory submissions with agencies such as the Food and Drug Administration in the United States, the European Medicines Agency in Europe, and the Pharmaceuticals and Medical Devices Agency in Japan.
Dr. Carroll’s professional journey is rooted in a strong academic background. She earned a Doctor of Pharmacy degree from the University of the Pacific and completed a residency at Southern Arizona VA Health Care. This early training instilled a patient-centered approach that continues to inform her decisions as a consultant and leader. Her experiences in clinical settings, combined with her exposure to global research operations, gave her a comprehensive understanding of the pharmaceutical industry and the importance of aligning clinical, regulatory and commercial priorities. Over time, she expanded her focus to include precision medicine and the unique challenges of treating rare and ultra-rare conditions.
Prior to launching her consulting firm, Dr. Carroll played a pivotal role at BioMarin Pharmaceutical Inc. As executive director of the Global Medical Affairs Evidence Generation Center of Excellence, she restructured and expanded the medical affairs study management function, transforming it into a cohesive global operation. She oversaw the design and execution of post-approval evidence strategies, enabling a stronger understanding of therapeutic value across diverse healthcare systems. Before this, she led the Global Medical Affairs Study Management team as senior director, where she focused on aligning scientific data with regulatory expectations and real-world needs.
Dr. Carroll also served in a range of roles at Amgen over two decades, where she contributed to clinical development and risk management operations. These years provided her with the opportunity to refine her leadership style, mentor junior professionals and engage directly with regulatory bodies. Her tenure as a consultant and adjunct professor at Keck Graduate Institute further reinforced her belief in the importance of education and collaboration in advancing healthcare innovation.
Throughout her career, Dr. Carroll has remained committed to supporting others, especially women in science and early-career professionals. She is an active member of civic and professional organizations and serves as board secretary for the Palo Alto Chapter of the Association of Women in Science. She also volunteers for advisory boards and educational outreach efforts, particularly those focused on rare disease awareness and opportunities for children in underserved communities.
Apart from her professional commitments, Dr. Carroll enjoys spending time in her garden, baking, exploring new destinations and reading across genres. Her personal interests reflect the same curiosity and joy in discovery that have defined her professional path. She is focused on growing her consulting practice with an emphasis on precision medicine, while mentoring the next generation of leaders and advocating for continued investment in research for rare pediatric diseases. Through each of these efforts, she continues to shape a legacy rooted in science, service and compassion.