Kunihiko Ito, MBA

President / CEO

Kunihiko Ito joined ONO PHARMA USA, INC. as the President / CEO in April 2020. As an Officer of ONO PHARMACEUTICAL CO., LTD. and the President and Chief Executive Officer of ONO PHARMA USA, INC., Kunihiko is responsible for leading the US organization in planning, directing, and executing all business objectives to drive corporate growth.

Kunihiko has over 25 years of extensive experience within ONO including sales, licensing, business development, corporate development, new launches, the start-up of the South Korea & Taiwan subsidiaries and as Head of Overseas Strategy and Head of International Business in Headquarters. He also has held over 15 years of overseas assignments including in the UK, Taiwan and in South Korea as Branch Manager and President / CEO.

Kunihiko holds an M.B.A. from the Graduate School of Management, GLOBIS University, and two Certificates from Duke University (Fuqua) Business School Executive Education (Drug Development, Reimbursement & Regulation) and Columbia Business School Executive Education Finance Program (M&A).

Mitsunobu Tanimoto

Executive Vice President, US Head of Clinical Development

Mitsunobu Tanimoto joined ONO PHARMA USA, INC. as the Executive Vice President, US Head of Clinical Development in January 2023. As US Head of Clinical Development, Mitsunobu is responsible for leading the US Clinical Development organization in planning, directing, and executing all clinical development activities.

Mitsunobu has over 20 years of extensive experience within ONO PHARMACEUTICAL group. He has wide-ranging clinical development experiences, including non-oncology and oncology. Mitsunobu worked in the Clinical Development Planning organization at ONO PHARMACEUTICAL CO., LTD. in Japan prior to being transferred to OPUS. He also has held over 2 years of overseas assignments in the UK to conduct clinical studies in the UK and EU countries prior to joining OPUS.

Mitsunobu holds a Bachelor of Science Degree in Life Sciences, University of Hyogo School of Science.

David Trexler

Chief Commercial Officer

David Trexler joined ONO PHARMA USA, INC. as the Chief Commercial Officer (CCO) in September, 2021. As a member of the executive leadership team, David is responsible for leading the Commercial organization in planning, directing, and executing all commercial objectives to drive corporate growth.

David brings more than 30 years of pharmaceutical and biotechnology experience. Most recently he served as President and Member of the Board of Directors of MorphoSys US Inc., a business of MorphoSys AG, Planegg/Munich, Germany, where he was responsible for establishing Morphosys’ commercial capabilities in preparation for the commercialization and launch of the company’s first product in the U.S. Prior to joining Morhphosys, David held a variety of progressive leadership roles at EMD Serono, including serving as the Senior Vice President, US Oncology Commercial, where he built the first commercial oncology footprint for the company in the US. He also previously held leadership roles at Eisai Inc., Mylan Bertek Pharmaceuticals and Sanofi-Aventis Pharmaceuticals.

David holds an Executive M.B.A., from Fairleigh Dickinson University, in Madison, NJ and a Bachelor of Science Degree in Biology from Lenoir-Rhyne College, in Hickory, NC.

Daniel Moynihan

General Counsel

Daniel Moynihan joined ONO PHARMA USA, INC. as General Counsel in June, 2022. As a member of the executive leadership team, Dan is responsible for developing solutions to legal and regulatory challenges by working closely as a strategic advisor and business partner to the President / CEO and senior team to ensure OPUS’s business practices, policies, and programs comply with all legal requirements.

Dan has extensive legal and compliance experience at U.S. and global life sciences companies. In his previous positions, Dan has built legal and compliance teams and has established or revamped compliance programs to meet the evolving expectations of regulators. Before joining OPUS, Dan held a range of senior Legal and Compliance roles at Spero Therapeutics, Oncopeptides, Akcea Therapeutics, MilliporeSigma, and EMD Serono. Dan previously was division counsel at EMD Serono, supporting the company’s oncology, endocrinology and fertility franchises. Prior to EMD Serono, Dan practiced law in-house and in private practice in the U.S. and the U.K.

Dan holds a J.D. from the Columbus School of Law at the Catholic University of America and a B.A. in Economics from the College of the Holy Cross and has been practicing law for more than 25 years.

Donna Supko, Ph.D.

Vice President, Regulatory Affairs

Dr. Donna Supko joined ONO PHARMA USA, INC. in June, 2020, as the Vice President, Regulatory Affairs where she is responsible for regulatory activities supporting the development and commercialization of the US product portfolio. Her oversight includes strategy for successful regulatory applications across CMC, nonclinical, clinical development and regulatory operations throughout the product lifecycle.

Donna has over 30 years’ experience in drug development and regulatory affairs encompassing drug, biologic, device and combination products across multiple therapeutic areas. Her regulatory experience spans a number of small biotech companies as well as larger companies including EMD Serono, where she had global responsibility for the development portfolio, Sanofi-Genzyme where she led global Oncology Regulatory Affairs, Eisai Pharmaceuticals and Stryker Biotech. Throughout her career Donna has been responsible for 11 successful marketing authorization applications, including 5 in the oncology therapeutic area.

Donna earned her Ph.D. in Pharmacology from Ohio State University College of Pharmacy, and completed her postdoctoral fellowship at Johns Hopkins University School of Medicine, Department of Neurology, Kennedy Krieger Institute. She also holds a M.S. in Pharmaceutics and Pharmaceutical Chemistry from Ohio State University, and a B.S. in Pharmacy from Philadelphia College of Pharmacy.

U. Shivraj Sohur,
M.D., Ph.D.

Vice President, Medical – Neurology

Dr. Shivraj Sohur joined ONO PHARMA USA, INC. in June, 2021, serving as the Vice President, Neurology Clinical Development. He leads neurology clinical development activities in the US and globally, while providing medical and strategy input on OPUS’ various clinical development projects.

With a two-decade career focused on the treatment of neuropsychiatric disorders, Shiv has held a variety of leadership positions, most recently with Alexion Pharmaceuticals, where he was a clinical lead in a Guillain Barré Syndrome III Study in Japan, culminating in Sakigake fast-track and Orphan Drug designations. Prior to joining Alexion, Shiv worked for Alkermes and Pfizer, where he served in a variety of roles, each leading to significant accomplishments in neuroscience programs.

Shiv earned his M.D. and Ph.D. from Vanderbilt University in Nashville, TN, and holds a B.S. in Biology and Chemistry, from Angelo State University, in San Angelo, Texas. In addition to his academic credentials, Shiv is on faculty at Harvard Medical School and continues to be a part-time faculty in Neurology with sub-specialization in Movement Disorders, practicing at Massachusetts General Hospital in Boston, MA.

Thomas Lechner,
MSc. Ph.D.

Vice President, Medical Affairs

Dr. Thomas Lechner joined ONO PHARMA USA, INC. in April 2022, assuming the role of Vice President, Medical Affairs, where he is responsible for establishing the company’s core medical strategy in the US.

Thomas brings over 20 years of Medical Affairs experience in the US and Europe, and joins OPUS most recently from Morphosys, where he was responsible for providing leadership and medical strategy for the US Medical Affairs organization. In his prior experience, Thomas held a variety of progressively responsible roles with both Boehringer-Ingleheim in Germany and Pfizer in the US.

Thomas has a Master of Science degree in Microbiology from the University of Innsbruck, Austria and a Doctoral degree (Dr. rer. nat) in Molecular Genetics from the University of Innsbruck, Austria. Prior to moving to industry, he conducted his postdoctoral research in Epigenetics as a fellow at a Howard Hughes Medical Institute at Penn State University in the USA.

Archana Sondhi

Vice President, Sales & Marketing

Archana Sondhi joined ONO PHARMA USA, INC. in May 2022, as the Vice President of Sales and Marketing. She is responsible for building the sales and marketing capabilities in preparation for commercialization and launch activities at OPUS in the US.

Archana is an accomplished healthcare leader with a track record of 20+ years of global and US experience across all phases of the pharmaceutical lifecycle. She joined OPUS from AstraZeneca, where she was the Head of Marketing, Hematology in the US and was responsible for brand strategy, and life cycle management across the Hematology portfolio including a blockbuster drug. Archana’s prior experience includes progressive brand leadership, and commercial roles with Sanofi Genzyme and Bristol-Myers Squibb in Oncology. Archana began her career as a Scientist working on formulation and toxicology studies, gained experience in various commercialization roles, and eventually found her true calling in Sales and Marketing.

Archana earned her M.S. in Chemistry and Biochemistry from Texas Tech in Lubbock, TX, and her Bachelor of Technology in Chemical Engineering from the Indian Institute of Technology in Bombay, India.

Raymond Frost

Vice President, Market Access

Raymond Frost joined ONO PHARMA USA, INC. in August 2022 as the Vice President of Market Access. As a member of the commercial leadership team, Ray is responsible for building OPUS Market Access function.

Ray has held numerous leadership roles in commercial and pre-commercial organizations. Most recently serving as Vice President, US & Global Market Access at Zealand Pharma. While at Zealand, Ray was responsible for overseeing, patient support, national accounts, trade & distribution, payer marketing and pricing strategy. Prior to his role at Zealand Ray served in commercial leadership roles at Melinta Therapeutics, The Medicines Company, Bayer HealthCare, Eisai and MGI PHARMA, Inc.

Ray holds a B.A. in Political Science from Hofstra University.

Charles Schmidheiser

Vice President, Business Operations

Charles Schmidheiser joined ONO PHARMA USA, INC. in March 2022 as the Vice President of Business Operations. As a member of the commercial leadership team, Chuck is responsible for building OPUS commercial operations capabilities.

Chuck brings more than 20 years of biotechnology and pharmaceutical industry experience to OPUS. In his prior experience, Chuck has held a number of leadership roles in sales, marketing and commercial operations in commercial and pre-commercial organizations, most recently serving as Vice President, Commercial Insights and Operations at Dicerna Pharmaceuticals, now a wholly-owned subsidiary of Novo Nordisk. Prior to Dicerna, he worked for Takeda Pharmaceuticals and Shire Pharmaceuticals as Senior Director of US Sales Operations, where he led the commercial data management and commercial operations processes for the US Sales organization.

Chuck holds a B.S., Mathematics from Moravian College and served in the US Navy after graduating.

Maria Wallace

Vice President, Quality Assurance

Maria Wallace joined ONO PHARMA USA, INC. in September, 2021 as the Vice President of Quality Assurance, where she is responsible for providing strategic direction, leadership and management in all aspects of Quality Assurance for the company in the US.

Maria’s extensive experience includes progressive leadership roles at Taiho Oncology, most recently serving as Vice President of Quality Assurance. Her prior experience includes a variety of QA leadership roles at Sankyo Pharma and Genetics Institute.

Maria holds an M.S. degree in Quality Assurance and Regulatory Affairs from Temple University and is a Registered Nurse in New York State.

Sarala Gudiwada,
MBBS, MPH

Vice President, Drug Safety and Pharmacovigilance

Dr. Sarala Gudiwada joined ONO PHARMA USA, INC. in March, 2021 as the Vice President of Drug Safety and Pharmacovigilance, where she is responsible for leading safety assessments and risk management of various programs in the US and globally.

Sarala brings over 15 years of experience in building and leading teams responsible for signal detection and risk management across clinical and marketed products in various therapeutic areas. She joined OPUS from Asahi Kasai Pharma America, where she provided Pharmacovigilance leadership to both the US and Japan across the Oncology, Infectious Disease and Pain therapeutic areas. Her prior experience includes progressive drug safety and pharmacovigilance roles at Vertex Pharmaceuticals, Nektar Therapeutics and Bio Marin Pharmaceuticals.

Sarala earned her MBBS at Siddhartha Medical College in India, and her MPH from the University of Massachusetts in Amherst, MA. She is certified by the Education Commission for Foreign Medical Graduates, making her eligible for US Board Certification.

Howard Fingert,
M.D., FACP

Vice President, Medical - Oncology

Dr. Howard Fingert joined ONO PHARMA USA, INC. in September, 2022, assuming the role of Vice President, Medical Oncology. In this role, Howard will guide early- and late-phase clinical research.

Howard brings to OPUS more than 25 years of experience conducting clinical trials in North America, Europe, Japan and other regions. Prior to joining OPUS, Howard led clinical and regulatory functions from Phase 1 through commercialization at leading biopharmaceutical companies including Takeda, Pfizer, and EMD Serono. His industry work includes extensive roles in public-private partnerships with the US FDA, US National Cancer Institute, and multi-regional organizations.

Howard earned his MD from Harvard Medical School and is, board certified in medical oncology and hematology. His publications represent original research in clinical and regulatory sciences, and he has held a diverse range of teaching roles related to clinical R&D and regulatory sciences at Massachusetts General Hospital, Dana Farber Cancer Institute, and the MIT Sloan School of Management.