Our medicines have a profound impact on lives, because everything we do focuses on that goal

Working together, we solve problems and achieve goals

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Kyowa Kirin North America is a fully integrated specialty pharmaceutical company, where people work together to understand clinical needs and opportunities for innovation that can result in real advances for patients. Since 2018, the North American organization has received approval from the US Food and Drug Administration (FDA) to market 3 first-in-class medicines – achievements we share with the scientific, medical, and advocacy communities who contributed greatly to the success of these programs.

Our values drive our achievements

At Kyowa Kirin, our Core Values drive us to do everything we can to answer the needs of patients, their families, and medical professionals. We act consistently with these Core Values in mind – Commitment to Life, Innovation, Integrity, and Teamwork/Wa.

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Commitment to Life

We strive to contribute to the health and well-being of communities by pursuing advances in life sciences and technologies.

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Integrity

We aim to do the right things by being sincere, honest, and ethically consistent in all our business practices and interactions.

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Innovation

We transform lives with passion and excitement — challenging the status quo in all that we do.

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Teamwork/Wa*

We believe in one for all, and all for one by going beyond boundaries and collaborating with our stakeholders.

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*Wa = The Japanese principle of seeking the harmony of the team over personal interests.

Teamwork is at the heart
of our business, and our success

Within our walls and across our industry, collaboration is the way Kyowa Kirin North America does business. Our history of innovation is built on forming and fostering collaborations that accelerate the delivery of new science to patients and heighten the impact of every person involved.

Some collaborations start small and grow to deliver extraordinary results. This has been true throughout Kyowa Kirin’s history. The Kyowa Kirin-Amgen joint venture, which lasted from 1984 until 2017, resulted in the development, worldwide commercialization, and manufacturing of epoetin alfa (marketed as Epogen® in the US, Espo® in Japan), filgrastim (Neupogen® in the US, Gran® in Japan), pegfilgrastim (Neulasta® in the US, G-Lasta® in Japan), and darbepoetin alfa (Aranesp® in the US, NESP® in Japan). Today, Kyowa Kirin continues to enjoy strong, enduring relationships with the La Jolla Institute for Immunology Research and a variety of other business partners focused on advancing discoveries for patients. We also continue to work across our business to find new ideas in need of acceleration.

When you join our team, you become part of an organization that believes in an integrated and collaborative approach to solving problems and achieving goals. We welcome people who share our spirit of innovation and enthusiasm for helping patients to join us.

Kyowa Kirin North America Leadership

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Steve Schaefer
President, North America
Mr. Steve Schaefer joined Kyowa Kirin in April 2023, bringing more than 25 years of experience in the pharmaceutical industry across multiple therapeutic areas, including Neuroscience, Cardiovascular, Endocrine and Gastroenterology. In his most recent role as Senior Vice President, Neuroscience Business Unit and Head of US Commercial Operations, Mr. Schaefer was responsible for a commercial portfolio of specialty medicines delivering multi-billion dollar annual revenues as well as commercial data and advanced analytics, forecasting, sales and marketing operations, and corporate training and leadership development. Prior to Takeda, Mr. Schaefer held several leadership roles at Eli Lilly and Company, including work in marketing, sales, product commercialization and running the US Specialty Business Unit. Mr. Schaefer began his career in the United States Marines Corps, where he attained the rank of Captain. A decorated veteran, he is passionate about veterans affairs. He holds a B.A. in economics from University of Illinois at Champaign, and an M.B.A. from LaSalle University, Philadelphia.
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Steve Schaefer
President, North America
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Ana Bastiani-Posner
Executive Vice President, Chief Financial Officer
Ms. Ana Bastiani-Posner joined Kyowa Kirin in June 2020 as EVP, chief financial officer for Kyowa Kirin North America. Prior to Kyowa Kirin, Ms. Bastiani-Posner held the position of SVP, finance and administration at the New York Genome Center as a member of its executive team. In the last 20 years, Ms. Bastiani-Posner held positions of increasing responsibility in the pharmaceutical industry at Schering-Plough, Novartis and Allergan across multiple functions including R&D, G&A, commercial finance, and corporate financial planning & analysis. She developed deal models, led Merger and acquisition activities, business integration and synergy efforts through several pharmaceutical deals including the proposed mega-merger of Pfizer-Allergan. She is originally from Brazil where she began her finance career in the banking industry in 1985. She holds a bachelor's degree from the Pontifícia Universidade Católica do Rio Grande do Sul and a master of international management from Thunderbird American Graduate School of International Management.
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Ana Bastiani-Posner
Executive Vice President, Chief Financial Officer
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Tara D’Orsi, JD
Executive Vice President, Chief Compliance Officer and General Counsel
Ms. Tara D’Orsi joined Kyowa Kirin in September 2017 and was appointed EVP, chief compliance officer and general counsel in 2019. Prior to joining Kyowa Kirin, Ms. D’Orsi was a member of the Life Sciences group at Lowenstein Sandler LLP, where she advised biotech and pharmaceutical companies on legal and compliance matters throughout a medicine's lifecycle, from development through commercialization. Throughout her career, Ms. D’Orsi has played a leadership role in providing legal and compliance advice designed to minimize risk and achieve her clients’ business objectives. She previously served as the General Counsel of Robert Wood Johnson University Hospital Rahway and spent 6 years as Senior Counsel of Reliant Pharmaceuticals, before it was acquired by GlaxoSmithKline in 2007. She began her career with a judicial clerkship in the New Jersey State Superior Court before taking positions in the Life Sciences and Healthcare groups at Gibbons PC and K&L Gates LLP.
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Tara D’Orsi, JD
Executive Vice President, Chief Compliance Officer and General Counsel
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Mitch Katz
Senior Vice President, Global Clinical Operations

Dr. Mitchell Katz is an accomplished leader with over 25 years of experience in the pharmaceutical and biotechnology sectors in the areas of preclinical and clinical research, pharmaceutical operations, and regulatory affairs. In his current role as the Senior Vice President of Global Clinical Operations for Kyowa Kirin, Inc. Dr. Katz plays a vital role in shaping the strategic and operating framework of Kyowa Kirin’s broad global clinical development program within the Global Development Organization. Dr. Katz is leading the efforts to ensure operational excellence and continuously improve process and performance across clinical operations activities. He is a global leader, with responsibility for supervising clinical operations staff in North America, Europe, and Japan.

Dr. Katz's extensive and esteemed career spans across various start-up biotechnology companies, including Acorda Therapeutics, InterMune, Connetics, and NABI. He has served as Vice President, Development Operations, at Ferring Pharmaceuticals, Inc., and as the Head of Clinical Research and Drug Safety Operations at Purdue Pharma L.P. Additionally, Dr. Katz held management positions at Eisai, Ortho Biotech, and Schering-Plough, contributing to seven (7) successful New Drug Application (NDA) submissions.

Dr. Katz holds a B.A. in Biology, a Ph.D. in Microbiology, and served as a postdoctoral research fellow at Downstate Medical Center in NY. His commitment to advancing pharmaceutical and biotechnological innovation is evident through his comprehensive background and leadership in the industry.

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Mitch Katz
Senior Vice President, Global Clinical Operations
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Eslie Dennis, MD, MBChB, FCP(SA)
SVP, Chief Medical Officer Kyowa Kirin North America
Dr. Eslie Dennis joined Kyowa Kirin in May 2021 as SVP, Chief Medical Officer for Kyowa Kirin North America. Prior to joining this organization, she was Vice President and Head Global Medical Affairs at Ventana/Roche Tissue Diagnostics. She is a physician with 10 years experience in clinical practice (internal medicine and hematology/oncology) and research, and over 20 years international biopharma experience holding positions of increasing responsibility in pharmaceutical and diagnostic organizations at MSD, Novartis and Roche, including leadership of public-private consortia at the Critical Path Institute. Throughout her career, Dr. Dennis has championed innovative science and solutions to address unmet needs for patients and society, particularly addressing healthcare disparities. Dr. Dennis received her MBChB from the Godfrey Huggins School of Medicine in Harare, Zimbabwe, and was the recipient of the Winston Churchill, Margaret Low, and Prankard-Jones Scholarships, as well as the Guy Elliot Bursary.  She is a Fellow of the College of Physicians of South Africa and received her internal medicine and hematology/oncology training at Groote Schuur Hospital in Cape Town, South Africa.
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Eslie Dennis, MD, MBChB, FCP(SA)
SVP, Chief Medical Officer Kyowa Kirin North America
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Gunnar Kaufmann, PhD
Chief Scientific Officer

Dr. Kaufmann oversees KKNA’s team of researchers based in La Jolla, CA, as well as the Open Innovation Department, which seeks external partnerships to accelerate drug discovery and the application of new biotechnologies.

Dr. Kaufmann is an immunologist and chemical biologist experienced in discovery and preclinical development of small molecule and biotherapeutic drug product candidates, including monoclonal antibodies, bispecific antibodies, antibody drug conjugates, cellular therapies, and vaccines.

He has expertise in multiple therapeutic areas, including immunology and oncology, as well as in preclinical research strategies. He has, throughout his career, taken projects from inception through non-clinical R&D into clinical trials. In addition to being an active member of several industry associations, Dr. Kaufmann also serves as an Adjunct Assistant Professor at The Scripps Research Institute in the Departments of Chemistry and Immunology and Microbial Science.

Dr. Kaufmann received his PhD in Biology from The Scripps Research Institute, his Master of Science in Human Biology from the University of Greifswald, Germany, and his Bachelor of Science in Human Biology from The Philipp University, Germany.

Dr. Kaufmann is an active member of the German Society for Immunology, the American Association of Immunologists, the Society for Immunotherapy of Cancer, and the American Society for Clinical Oncology. He has authored more than 50 peer-reviewed publications.

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Gunnar Kaufmann, PhD
Chief Scientific Officer
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Casilda Barnes, PharmD
Vice President, Head of Regulatory Affairs
Dr. Casilda Barnes is VP of Regulatory Affairs at Kyowa Kirin, North America. Dr. Barnes has more than 25 years of global experience in Regulatory Affairs which includes Pre and post approval regulatory strategy, advertising and promotion regulatory compliance which was gained at leading pharmaceutical companies including Pfizer, Celgene, and Schering Plough. She has led biologic and small-molecule NDA/BLA filings in Oncology, Rare Disease, Neurology, Immunology and Inflammatory Disease areas, at all product lifecycle phases through commercialization. Most notably, Dr. Barnes has provided strategic regulatory leadership to successfully bring market applications from filing through approval and post launch, resulting in treatments to include psoriatic arthritis, migraine headaches , and chemotherapy induced nausea and vomiting. Dr. Barnes holds a Bachelor of Science degree in Pharmacy from Howard University and a Doctor of Pharmacy degree from the Albany College of Pharmacy. She recently received her Drug Information Association Regulatory Affairs Certificate (RAC).
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Casilda Barnes, PharmD
Vice President, Head of Regulatory Affairs
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Paul Testa, MS, MBA
Executive Vice President, Supply Chain and Operations
Mr. Paul Testa joined Kyowa Kirin in 2019 as EVP for supply chain and operations. Previously, he held senior executive positions in global supply chain and operations at Shire (acquired by Takeda) and Johnson & Johnson — most recently leading 500+ professionals in 25+ countries, leading a supply chain strategic transformation, and helping Shire to grow its revenue from $3 billion to ~$15 billion. He earned a bachelor of science degree from Rensselaer Polytechnic Institute, a master of science degree from Washington University, and a master of business administration degree from Boston University.
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Paul Testa, MS, MBA
Executive Vice President, Supply Chain and Operations
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Britt Byers, MA
Senior Vice President, Human Resources North America
Britt Byers joined Kyowa Kirin in January 2021 and was appointed SVP, Head of Human Resources for North America. Over a 25 year career, Britt has held senior roles spanning the pharmaceutical industry, with Sanofi and Novartis, as well as in the financial services sector, with Bank of America. Her experience includes a wide range of HR roles with deep expertise as a Strategic Business Partner to Commercial teams, R&D and global functions as well as Shared Service leadership with oversight for HR Operations, Call Center management, Occupational Health, Meeting & Events Management, Multimedia Studio and Travel and Expense. Mrs. Byers also serves as a board member for a private nonprofit agency, JBWS, that provides safety, support and solutions for abuse and aims at the prevention of domestic violence. Britt earned a Bachelor of Arts degree in Psychology at Susquehanna University and a Master of Arts in Organizational Psychology at Kean University.
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Britt Byers, MA
Senior Vice President, Human Resources North America
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Nancy Maher
Senior Vice President, Chief Information Officer

Ms. Maher has an extensive record of accomplishment as a global IT leader in the pharmaceutical, medical device, and consumer goods industries, including managing large-scale, technology-enabled business transformation programs.

Ms. Maher previously served as VP, Divisional Information Officer for Global Commercial, Medical Affairs, Corporate Functions, and Global Digital Technologies for Gilead Sciences. In this role, she managed business relationship management, IT strategy, platform solutions and cross-divisional capabilities. Prior to Gilead, Ms. Maher held senior IT and digital strategy roles at Teva, Allergan, Merck, and Schering-Plough.

She holds a BS in Marketing from the University of Maryland.

Ms. Maher serves in an advisory capacity on several industry and technology-related boards.

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Nancy Maher
Senior Vice President, Chief Information Officer
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Rieko Waxman, MS
Executive Vice President, Corporate Planning
Rieko Waxman leads Corporate Planning for Kyowa Kirin North America. She joined Kyowa Kirin Co., Ltd. more than 20 years ago, spending more than 15 years working as a CMC research scientist, with expertise in molecular biology, biotechnology, oncology, and Bioassay Development. In 2018, she became Manager of Corporate Strategy and Planning and four years later was promoted to Executive Vice President of Kyowa Kirin North America. She holds a Master’s Degree in Biology from Nagoya University, Japan.
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Rieko Waxman, MS
Executive Vice President, Corporate Planning
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Joseph Zarkoski
Vice President, North America Quality Assurance

Mr. Zarkoski brings 30 years of industry experience in quality, manufacturing, and supply chain roles, developing processes and leading teams at both site and global levels. Over the course of his career, Joseph has also held leadership roles at Wyeth, Merck & Co., Johnson & Johnson, Pfizer, and Shire.

He earned a Bachelor of Science degree in biology from Villanova University.

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Joseph Zarkoski
Vice President, North America Quality Assurance
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Doug Grant
General Manager, Canada
Doug Grant joined Kyowa Kirin in January 2021 and was appointed the General Manager for Kyowa Kirin Canada.  Additional, he holds the position of Interim Head, NA Commercial Operations for Kyowa Kirin.  Over a 35 year career, Doug has held senior roles spanning the NA pharmaceutical industry, with Bayer, BMS, Pfizer and Marion Merrell Dow.  His experience includes managing product launches and in-market brands within Rare Diseases, Specialty Markets and General Medicine; such as Oncology, Ophthalmology, Cardiovascular, Pulmonary Hypertension and Hematology.  His functional leadership spans Business Unit Leadership, Marketing and Sales Management, Market Access, Pricing, Health Economics and Corporate & Public Affairs.  Mr. Grant received his BSc from York University in Toronto and has served on several industry boards.
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Doug Grant
General Manager, Canada
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Nilay Gami, RPh, MPH
VP, Global Head of PV Operations & NA Regional Head of PV
Mr. Nilay Gami joined Kyowa Kirin in April 2020 and is responsible for the North American PV organization as well as leading PV operations globally. Prior to joining Kyowa Kirin, Nilay obtained extensive patient safety and leadership experience from global safety organizations at Pfizer and Johnson & Johnson. Nilay is a registered pharmacist, obtaining his pharmacy degree from Rutgers University and an MPH in Health Policy & Management from New York Medical College.
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Nilay Gami, RPh, MPH
VP, Global Head of PV Operations & NA Regional Head of PV
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Lauren Walrath, MBA
Vice President, Public Affairs
Lauren Walrath is Vice President, Public Affairs for Kyowa Kirin North America (KKNA). Ms. Walrath's career began 20+ years ago in advertising agencies, launching new products and digital services for Fortune 200 companies, including P&G, Kodak, American Express and TD Ameritrade. Lauren worked for Bristol-Myers Squibb from 2006 to 2014, leading communications and change management for the Global Development & Medical Affairs and Worldwide Commercial organizations, and then growing patient advocacy in support of BMS' Immuno-Oncology franchise. Lauren's passion for biopharma corporate communications led her to senior roles with Atlantis Healthcare and Aquestive Therapeutics before joining Kyowa Kirin in 2019. At KKNA, Lauren manages public relations, social media, employee communications, and advocacy engagements across disease areas. She holds an MBA from Columbia University, a BA with honors Pennsylvania State University, and sits on the boards of several community organizations.
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Lauren Walrath, MBA
Vice President, Public Affairs
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Ernesto Aycardi
Chief Development Officer

Dr. Aycardi brings more than 20 years of experience in the pharmaceutical industry and clinical development.

He previously served as Xenon Pharmaceuticals’ Chief Medical Officer. Dr. Aycardi also has held key roles in clinical development, biostatistics, data management, translational medicine and medical research with Teva Pharmaceuticals, EMD Serono, Biogen Idec and Merck & Co.

Dr. Aycardi’s has worked in multiple therapeutic areas throughout his career, but has concentrated heavily in Neurology and conditions of the Central Nervous System.

He received his medical degree in his home country of Colombia, and was a practicing neurologist there prior to joining the pharmaceutical industry.

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Ernesto Aycardi
Chief Development Officer
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Chris Valosky
Vice President, North America, CNS Franchise Head

Mr. Valosky brings more than 24 years of industry experience, including Marketing and Sales leadership roles within Endocrinology, Cardiovascular, Obesity, Neuroscience, Oncology, and Digital Therapeutic fields. He worked for six years in marketing at Eli Lilly, 15 years at Takeda in various roles of increasing responsibility growing brands and sales, and most recently served as Vice President of Sales & Marketing at Pear Therapeutics, where he successfully launched the first FDA-authorized prescription digital therapeutics.

Mr. Valosky earned his Master in Business Administration from Indiana University and his Bachelor of Science in Business Administration from The Ohio State University.

In his spare time, Mr. Valosky serves as a mentor for the Healthcare Businesswomen’s Association, and volunteers with the Knights of Columbus and Canine Companions for Independence.

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Chris Valosky
Vice President, North America, CNS Franchise Head
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Patrick Adams
Vice President, North America, Market Access & Pricing

Mr. Adams is a pricing strategy expert who is future focused with the ability to gather and transform insights into strategy and an established record of driving profitability across multiple therapeutic areas. Previously working for Payer Sciences, Sanofi, and Novo Nordisk, he brings global market access experience in launching products within North America, Europe, and Japan. Expertise in enterprise strategy development, with focus on profit growth through pricing and market access strategies.

He earned his Master of Business Administration from Fox School of Business at Temple University and his Bachelor of Business Administration from Miami University.

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Patrick Adams
Vice President, North America, Market Access & Pricing
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Greg Palko
Vice President, North America, Oncology Franchise Head

Mr. Palko is a strategic pharmaceutical industry commercial executive with significant leadership demonstrated in US and Global Marketing, US Sales, Franchise and Portfolio Strategy, New Product Planning and Business Development, and Advertising Agency Client Management. Currently, Greg is VP, Oncology Franchise Head for the North America Region.

He brings nearly 25 years of oncology experience across both solid and hematologic cancers (eg prostate, lung, ovarian, breast, CRC, CML, CLL, AML, multiple myeloma, and lymphoma) and launching several successful oncology products. He previously served as Commercial Head of Oncology at Imbrium Therapeutics, Head of US Oncology Sales at Sun Pharma, and Global Franchise Head for Hematology at Novartis.

Mr. Palko earned a Pharmacy degree from Rutgers University and a Masters of Business Administration from Fairleigh Dickinson University. He has served as adjunct professor for Fairleigh Dickenson University’s Pharmacy School and has led multiple pharmacy and business student preceptorships during his pharmaceutical career.

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Greg Palko
Vice President, North America, Oncology Franchise Head
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Richard Wilson
Vice President, North America, Rare Disease Franchise Head

Mr. Wilson brings more than 25 years of diversified experience in Sales, Global/US Marketing, Alliance Management, Business Development & Licensing, and General Management.

He previously served as Vice President and Head US Endocrine Franchise at Takeda, where he had full P&L responsibility for the US Endocrine Franchise and general management for all cross-functional activities (Marketing, Sales, Medical, Market Access, Patient Services). He also represented US interests to ensure Global strategic alignment (Global Project Team) and with LCM activities including Business Development & Licensing.

He worked for 3 years at Shire and more than 11 years at Novartis, where after rising through the global ranks, he ultimately served as Executive Director of Global Strategic Alliances and as Business Development and Licensing Executive Director.

He earned his Master of Business Administration from Cornell Johnson Graduate School of Management and his Bachelor of Science in Chemistry from the University of Exeter.

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Richard Wilson
Vice President, North America, Rare Disease Franchise Head
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Jeremy Morrissey
Executive Director, North America, Commercial Operations

Mr. Morrissey brings more than 20 years experience in commercial operations, analytics, and marketing, with expertise in analytical-based approaches to the marketplace and new product launches. He has successfully led cross-functional teams in strategic initiatives focusing on cost reduction and productivity improvement, resulting in millions of dollars in savings and reduced expenses. He has extensive knowledge of pharmaceutical, medical device, and CPG industries.

Mr. Morrissey earned his Master of Business Administration from the Fordham Gabelli School of Business and his Bachelor's Degree in mass communications from the University at Albany, SUNY.

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Jeremy Morrissey
Executive Director, North America, Commercial Operations
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Hidekuni Kaito
Senior Vice President, North America, Head of GPM/NPP Office

Hidekuni Kaito has over 20 years of clinical development, project management, business development, and oncology/hemato-oncology expertise both in Japan and the United States. He previously held roles of increasing responsibility at Fujifilm Kyowa Kirin Biologics and Centus Therapeutics. Hide-san received his Bachelor of Science from Saitama University and his Master of Science from the University of Tokyo.

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Hidekuni Kaito
Senior Vice President, North America, Head of GPM/NPP Office

Global directors and officers

“Advocating for patients touches me personally and professionally. I love providing patients and caregivers the support they need to make the most informed decisions about their care.”

– Liz Butcher, Associate Director
Patient Advocacy and Communications, Rare Disease

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