Mission: Our Commitment
Shionogi is committed to developing even better medicines and delivering them to patients in need. By constantly improving our technologies and services, we have worked to enhance the positive impact of our products on patient ...
FDA Accepts Shionogi’s Supplemental New Drug Application with Priority Review for FETROJA® (cefiderocol) for the Treatment of Hospital-Acquired Bacterial Pneumonia and Ventilator-Associated Bacterial Pneumonia
OSAKA, Japan & FLORHAM PARK, N.J.–(BUSINESS WIRE)– In response to the novel coronavirus (SARS-CoV-2), Shionogi & Co., Ltd. (hereafter “Shionogi”), a pharmaceutical company with a major focus on infectious diseases, has joined the ranks of pharmaceutical companies across the globe and is working with public institutions, academia and partner companies in the following efforts to fight against COVID-19.
Shionogi Inc. is the U.S. subsidiary of Shionogi & Co., Ltd., a 140-year-old global pharmaceutical company with headquarters in Osaka, Japan. In the U.S., Shionogi Inc. leverages our science-based heritage to develop and commercialize pharmaceutical products to treat unmet medical needs in our core areas of infectious diseases and pain, as well as other areas of high medical need, including chronic liver disease.
More than 23,000 men, women and children in the U.S. die every year from antibiotic-resistant infections1 while over 4,000 Americans perish from influenza.2 In addition, over 100 million suffer from chronic pain3 and 3.9 million adults in the U.S. are diagnosed with liver disease.4 Shionogi’s mission is to supply the best possible medicines to protect the health and well-being of the patients we serve.
With over 50 years of anti-infective research experience, Shionogi has helped to revolutionize the development of antibacterial and antiviral treatments. As bacteria, pathogens and other viruses adapt to resist existing treatments—causing millions of untreatable infections around the world—Shionogi is pursuing the development of novel treatments to combat this evolving threat.
Shionogi, both itself and through innovative alliances, is also pursuing the development of new treatments in other areas of high medical need, including inflammatory pain, neuropathic pain, Alzheimer’s disease and ADHD.
At Shionogi Inc., we’re intensely focused on developing and commercializing the scientific breakthroughs emerging from our research laboratories in Japan as well as discoveries of our strategic alliance partners. We couple our innovative discovery base with capabilities to advance drug candidates rapidly from lab to clinic to patient, forming, where appropriate, bold new partnerships to accelerate and amplify the availability of these new medications to patients around the world.
In 1878, Gisaburo Shiono, Sr. founded the company that became Shionogi & Co., Ltd. Still located on the original site in Osaka, Japan, today’s Shionogi retains its entrepreneurial spirit while having the resources of a fully integrated pharmaceutical company serving patients worldwide.
Our research scientists have discovered therapeutics including naldemedine, rosuvastatin and dolutegravir, and are currently working on many more potential future products.
In 2008, Shionogi acquired Sciele Pharma, Inc., a specialty pharmaceutical company based in Atlanta, Georgia, and in 2011, merged it with Shionogi’s small existing development organization in New Jersey. The resulting company became Shionogi Inc., which has the mandate to bring Shionogi innovation to U.S. patients. In 2017, Shionogi Inc. gained approval of Symproic®, the first medicine both discovered and globally developed by Shionogi.
Shionogi Inc. now has a development organization capable of conducting multiple simultaneous late-stage clinical programs and submitting new drug application (NDA) filings worldwide, and we are now establishing the commercial capabilities to effectively bring these medicines to the appropriate patients.
The Shionogi Inc. leadership team has decades of combined pharmaceutical and industry experience in developing and commercializing therapeutics.
Since 2011, when Shionogi Inc. was established in the U.S., our leadership team has focused on bringing the benefits of Shionogi’s small molecule drug innovations to U.S. patients through our own efforts and through multiple inventive collaborations. During this period, Shionogi Inc. gained our first two New Chemical Entity (NCE) approvals while reshaping our business around our science-based heritage and core areas of infectious diseases and pain.
Dr. Akira Kato joined Shionogi in 1990. In his nearly 30-year tenure with the company, Dr. Kato has led the organization in multiple capacities, including roles as corporate officer and vice president of business development, completing a wide range of transactions with global pharmaceutical and biotechnology companies that included licensing agreements, equity investments and academic collaborations. Prior to his years in business development, Dr. Kato was head of the Pain and Neurology Department for Shionogi’s Discovery Research Laboratories. This leadership role was the culmination of a 20-year scientific career in the central nervous system field where he was responsible for the non-clinical and clinical developments of CNS candidates and significant work in the CNS field through several research collaborations with global pharmaceutical and biotechnology companies. Dr. Kato had been honored as a visiting scientist, Center for Learning and Memory at MIT and has authored or co-authored over 40 peer-reviewed scientific publications. He earned both his master’s degree and Ph.D. in pharmacology from Meijo University in Japan.
Tadashi Hara joined Shionogi Inc. in July 2010 as Executive Vice President and Chief Financial Officer. Mr. Hara originally joined Shionogi & Co., Ltd. based in Japan in 1995 and since that time has held a variety of positions with growing responsibilities in commercial, financial planning and analysis, accounting, taxes, treasury, internal controls, business development support and other corporate functions at the Shionogi group companies on a global basis. Mr. Hara began his career with Shionogi as a sales representative in Japan, then moved to the U.S. in 2006 to serve as Director of Accounting and Finance at Shionogi USA Inc. where he was responsible for a broad spectrum of financial functions and various administrative roles. During his time with Shionogi USA Inc., he also played a key global role to liaise between Japan and the U.S., supporting R&D and business functions. Mr. Hara also served as director of the board and held senior leadership roles for other Shionogi group entities.
Mr. Hara received a Bachelor’s Degree in Psychology from Waseda University in Japan. He is a Certified Public Accountant.
Joseph Spagnardi joined Shionogi Inc. in June 2013 and is currently Executive Vice President overseeing Legal and Compliance. In this role, Mr. Spagnardi serves as the General Counsel, Chief Compliance Officer and Corporate Secretary of the company, and is responsible for all legal and compliance matters. Mr. Spagnardi has extensive legal experience in both private practice and senior corporate legal roles, most of which has been in the pharmaceutical industry. In his previous position, he served as the Senior Vice President, General Counsel and Secretary of Inspire Pharmaceuticals, Inc., a publicly traded pharmaceutical company, acquired by Merck & Co., Inc. Prior to that, Mr. Spagnardi held senior legal positions at GlaxoSmithKline, where he served as Assistant General Counsel – R&D Operations, and Glaxo Wellcome, where he served as a Senior Counsel focusing on transactional matters. Mr. Spagnardi started his legal career at the law firm of Winthrop, Stimson, Putnam & Roberts, now Pillsbury Winthrop Shaw Pittman, in New York, specializing in corporate transactions.
Mr. Spagnardi holds a J.D. with Honors from the University of North Carolina School of Law and a B.S. in Business Administration (Finance) from the University of Delaware. He has been admitted to the Bar in the State of New York since 1990.
Nathan McCutcheon, Executive Vice President and Chief Commercial Officer
Nathan McCutcheon joined Shionogi Inc. in December 2019 as Executive Vice President overseeing all commercial aspects of the U.S. business. In this role, Mr. McCutcheon serves as Chief Commercial Officer and is responsible for all sales, marketing, managed care, commercial operations and new product planning. Mr. McCutcheon has an extensive background in all aspects of commercialization in large, mid-sized and start-up pharmaceutical companies across multiple therapeutic areas. In his previous positions he has served as general manager of multiple business units, led product launches and has held roles in both global and in-line commercialization. He has worked on and led billion dollar brands in the U.S. including Cymbalta, Botox Therapeutic and Acthar. Mr. McCutcheon has also held leadership roles at Mallinckrodt, Allergan and Eli Lilly among others.
At Shionogi Inc. our people are the center of our organization. Their diverse backgrounds, cultures, experience, and areas of expertise provide perspectives that are essential to our mission of improving the quality of life for patients and their families. At Shionogi we embrace and develop this diversity, allowing employees to drive an ongoing collaborative and innovative work environment, which is critical to our organization’s culture and success.
Our values represent a balance of who we are and how we operate. They are the foundation of our culture and ensure a spirit of innovation, inclusion, and dedication to achieving extraordinary results.
Collaboration is central to who we are and how we work. We combine the spirit and nimbleness of an entrepreneurial culture with the resources of a global company.
Our fast-paced, results-driven culture is based on rapidly delivering therapeutics to patients with serious unmet medical needs. This hands-on, can-do environment provides the opportunity to advance your career while continually learning new skills that contribute to your team’s success.
Our people are the foundation of our culture at Shionogi Inc. If you’re seeking the opportunity for career advancement, the excitement of a dynamic workplace and the gratification of delivering therapies to patients in need, Shionogi Inc. is the right place to be.
I worked at Shionogi Inc. full-time (More than 5 years)
Ability to lead teams
Lattitude for decision making
Difficult due to time differences between US and Japan.
I applied online and was later contacted for a phone screen. After a phone screen with the person who would have been my direct supervisor, I was invited to schedule an in-person, half-day interview consisting of 3 rounds with team members.
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