Xeris Appoints Anh Nguyen, MD, MBA as Chief Medical Officer

Xeris Biopharma Holdings, Inc. (Nasdaq: XERS), a growth-oriented biopharmaceutical company committed to improving patient lives by developing and commercializing innovative products across a range of therapies, has announced the appointment of Dr. Anh Nguyen, MD, MBA, as its new Chief Medical Officer (CMO). Dr. Nguyen succeeds Ken Johnson, PharmD, SVP, Global Development and Medical Affairs, who will retire on April 1, 2025. In this role, Dr. Nguyen will oversee the Medical, Regulatory, Preclinical and Clinical Development, and Pharmacovigilance functions, reporting directly to John Shannon, Xeris' CEO.

Dr. Nguyen brings an extensive wealth of clinical and leadership experience to his new position at Xeris. With a background in developing first-in-class therapies, including circular RNA-based oncology treatments, gene-edited xenotransplants, immuno-oncology vaccines, and allogeneic CAR-T therapies, Dr. Nguyen is well-equipped to drive advancements in regulatory strategy, clinical development, medical affairs, and commercial launches. His previous roles at Xeris Pharmaceuticals and Asklepios Biopharmaceutical have provided him with valuable insights into the biopharmaceutical industry, making him an ideal fit for this new position.

During his previous tenure at Xeris, Dr. Nguyen led the program medical lead for Gvoke®’s NDA and MAA approvals, demonstrating his ability to navigate regulatory processes and achieve successful outcomes. He also obtained multiple IND clearances for endocrine and rare disease therapies, showcasing his expertise in clinical development and regulatory affairs. Additionally, Dr. Nguyen contributed to the development of novel endocrine drug co-formulations for diabetes, immunology, and pediatric epilepsy, indicating his ability to innovate and adapt to different therapeutic areas.

At Asklepios Biopharmaceutical (AskBio), Dr. Nguyen directed the IND clearance and early-phase clinical trials of AAV gene therapies for neuromuscular rare disease, highlighting his experience in leading clinical trials and managing regulatory processes. He also shaped clinical and regulatory policies for breakthrough therapies while serving as a medical officer at the NIH, FDA, and CMS, showcasing his understanding of regulatory environments and his ability to influence policy. During his Robert Wood Johnson Foundation Health Policy Fellowship serving on the US Senate HELP Committee, Dr. Nguyen was a key contributor to the landmark "21st Century Cures Act". He also led the establishment of an ambulatory surgical service to expedite pediatric orphan disease and oncology trials, earning the prestigious NIH Director's Award, which demonstrates his leadership skills and commitment to improving patient care.

Dr. Nguyen's appointment comes at a critical time for Xeris, as the company prepares for the Phase 3 development of XP-8121 and continues to grow its commercial portfolio, particularly Recorlev®. His leadership and expertise in clinical development, regulatory affairs, and strategic partnerships will be invaluable in driving the success of Xeris' pipeline and commercial portfolio.

In conclusion, Xeris Biopharma Holdings' appointment of Dr. Anh Nguyen, MD, MBA, as its new Chief Medical Officer is a strategic move that aligns with the company's goals for its product pipeline and commercial portfolio. Dr. Nguyen's extensive experience in clinical development, regulatory affairs, and strategic partnerships, coupled with his leadership skills and commitment to improving patient care, makes him an ideal fit for this new position. As Xeris continues to grow and develop its pipeline, particularly XP-8121 and Recorlev®, Dr. Nguyen's expertise and vision will be crucial in driving the company's success.