Xeris Biopharma Holdings, Inc. has announced the appointment of Dr. Anh Nguyen as its first Chief Medical Officer (CMO), marking a significant leadership transition as the company prepares for key clinical developments. Dr. Nguyen will succeed Kenneth Johnson, PharmD, who will retire as Senior Vice President of Global Development and Medical Affairs on April 1, 2025.
Strategic Leadership Transition
In his new role, Dr. Nguyen will be responsible for developing and leading the company's entire product portfolio vision, overseeing Medical, Regulatory, Preclinical and Clinical Development, and Pharmacovigilance functions. He will report directly to CEO John Shannon, who expressed confidence in Dr. Nguyen's ability to drive the company's next phase of growth.
"Anh is an accomplished clinician-scientist and biopharma executive dedicated to driving advancements in regulatory strategy, clinical development, medical affairs, and commercial launches," said John Shannon. The timing of this appointment is particularly strategic as Xeris prepares to initiate Phase 3 development of XP-8121 and continues to expand its commercial portfolio, particularly Recorlev®.
Distinguished Career and Expertise
Dr. Nguyen brings an impressive track record in developing innovative therapies, including:
- Circular RNA-based oncology treatments
- Gene-edited xenotransplants
- Immuno-oncology vaccines
- Allogeneic CAR-T therapies
His recent position as Vice President and Therapeutic Sector Lead at Asklepios Biopharmaceutical (AskBio) involved directing IND clearance and early-phase clinical trials for AAV gene therapies targeting neuromuscular rare diseases. Notably, during his previous tenure at Xeris, Dr. Nguyen successfully led the program resulting in Gvoke®'s NDA and MAA approvals.
Policy and Regulatory Experience
Dr. Nguyen's experience extends beyond clinical development to policy-making. As a medical officer at the NIH, FDA, and CMS, he helped shape clinical and regulatory policies for breakthrough therapies. His contributions to the "21st Century Cures Act" during his Robert Wood Johnson Foundation Health Policy Fellowship demonstrate his understanding of the regulatory landscape.
Smooth Leadership Transition
Kenneth Johnson, who has played a crucial role in Xeris' evolution to a commercial-stage biopharmaceutical company, will assist in the leadership transition. "It has been an honor to be part of an exceptionally talented team," Johnson reflected, expressing confidence in Dr. Nguyen's ability to lead the company forward.
Commercial Portfolio and Pipeline
Xeris currently markets three commercial products:
- Recorlev® for endogenous Cushing's syndrome
- Gvoke® for severe hypoglycemia
- Keveyis® for primary periodic paralysis
The company's pipeline includes XP-8121, a Phase 3-ready, once-weekly subcutaneous injection for hypothyroidism, along with early-stage programs utilizing their proprietary XeriSol® and XeriJect® technology platforms.
Dr. Nguyen expressed enthusiasm about his new role: "I'm excited to help lead the scientific efforts at Xeris, to collaborate and usher a new era of transformative therapies that leverage our innovation and strategic partnerships, to redefine patient care."
