Release
2025/12/02
FLORHAM PARK, NJ, December 2, 2025 – Shionogi Inc., a United States subsidiary of Shionogi & Co., Ltd. (Head Office: Osaka, Japan; Chief Executive Officer: Isao Teshirogi, Ph.D.) announced the appointment of Ann Howell, Pharm.D., MS as Senior Vice President, Global Head of Regulatory Affairs.
Dr. Howell brings expertise leading regulatory strategy for both emerging and established biopharmaceutical companies to SHIONOGI Group Companies (hereinafter “SHIONOGI”), where she was previously employed from 2015–2020. She returns at a critical point of growth for the organization, after serving as a key member of development leadership at Forma Therapeutics, Inc. and OnKure Inc. While at Forma Therapeutics, she led the successful integration of the development functions into Novo Nordisk following acquisition.
Throughout her career, Dr. Howell has led regulatory organizations through first-cycle approvals for five new drug applications including Fetroja® (cefiderocol) and Xofluza® (baloxavir marboxil), directed successful FDA advisory committee meetings, and guided teams through high-stakes regulatory challenges involving novel endpoints, complex labeling negotiations, and innovative approval pathways.
“Dr. Howell’s regulatory expertise is unparalleled across the industry, and she brings significant knowledge across multiple disease states to SHIONOGI during a transformative time as we continue to expand our infectious disease portfolio and advance our rare disease programs globally,” said Takeki Uehara, Ph.D., Corporate Officer, Senior Vice President, Global Head of Development, Drug Development and Regulatory Science Division. “In addition, I am confident that Dr. Howell will excel at driving strategic collaboration across regions and functional areas while keeping the needs of patients and families top of mind.”
In her new role, Dr. Howell will lead SHIONOGI’s global regulatory strategy across all development stages, oversee worldwide regulatory submissions and interactions, and partner closely with leadership to accelerate efficient, high-quality development of SHIONOGI’s pipeline.
“I am excited to return to SHIONOGI, where I will be working alongside colleagues I greatly respect and contributing to programs I am proud to support,” said Dr. Howell. “Unconventional problem-solving, adaptive thinking, and fresh perspectives are central to how I lead, and I believe these strengths align closely with SHIONOGI’s goals for efficient, effective development of transformative medicines. I look forward to reconnecting with former colleagues, meeting new ones, and making an immediate positive impact.”
Dr. Howell received her Doctor of Pharmacy degree with Honors and a Master of Science in Pharmaceutical Sciences from the University of Oklahoma. She completed her Post-Doctoral Pharmaceutical Industry Fellowship at Rutgers University and Schering-Plough Research Institute.
About Shionogi Inc.
Shionogi Inc. is a U.S. subsidiary of Shionogi & Co., Ltd., a global pharmaceutical company committed to developing innovative medicines that address unmet medical needs for people worldwide. Over the past six decades, we have discovered several novel antibiotics and medications for HIV and influenza. Today, our infectious disease pipeline includes antibiotics, oral antivirals for COVID-19 and RSV and antifungals. We are also advancing clinical programs in rare disease for Fragile X syndrome, Jordan’s syndrome and Pompe disease, and we are focused on other areas with unmet medical needs, including oncology. Learn more at shionogi.com.
About Shionogi & Co., Ltd.
Shionogi & Co., Ltd. is a 146-year-old global, research-driven pharmaceutical company headquartered in Osaka, Japan, that is dedicated to bringing benefits to patients based on its corporate philosophy of “supplying the best possible medicine to protect the health and wellbeing of the patients we serve.” The company currently markets products in several therapeutic areas including anti-infectives, pain, CNS disorders, cardiovascular diseases and gastroenterology. Shionogi’s research and development currently target two therapeutic areas: infectious diseases and pain/CNS disorders. For more information on Shionogi & Co., Ltd., please visit https://www.shionogi.com/global/en.html.
Forward-Looking Statements
This announcement contains forward-looking statements. These statements are based on expectations in light of the information currently available, assumptions that are subject to risks and uncertainties which could cause actual results to differ materially from these statements. Risks and uncertainties include general domestic and international economic conditions such as general industry and market conditions, and changes of interest rate and currency exchange rate. These risks and uncertainties particularly apply with respect to product-related forward-looking statements. Product risks and uncertainties include, but are not limited to, completion and discontinuation of clinical trials; obtaining regulatory approvals; claims and concerns about product safety and efficacy; technological advances; adverse outcome of important litigation; domestic and foreign healthcare reforms and changes of laws and regulations. Also for existing products, there are manufacturing and marketing risks, which include, but are not limited to, inability to build production capacity to meet demand, lack of availability of raw materials and entry of competitive products. The company disclaims any intention or obligation to update or revise any forward-looking statements whether as a result of new information, future events or otherwise.
For Further Information, Contact:
SHIONOGI Website Inquiry Form: https://www.shionogi.com/global/en/contact.html
U.S. Media: ShionogiCommunications@shionogi.com