• Louis Allesandrine

    VP Oncology Marketing

    Louis Allesandrine

    VP Oncology Marketing

    "At Otsuka, we drive innovation and creativity by following the company philosophy; Taking the Road Less Traveled. It helps us address unmet needs of patients, their caregivers, and healthcare professionals, keeping us focused on doing our part to provide better health worldwide."

    As Vice President of Oncology Marketing and Sales at Otsuka America Pharmaceutical, Inc. (OAPI) I am responsible for leading the strategic development and execution of our U.S.-based commercial oncology business. This includes the co-promotion of SPRYCEL® (dasatinib) with BMS and our clinical stage collaborations with Astex Pharmaceuticals, a member of The Otsuka Group. Our goal is to develop and bring novel cancer therapeutics to market; meeting the needs of patients, their care givers and healthcare professionals. I joined OAPI in 2017 after 25 years of commercial experience in the pharmaceutical industry. Prior to joining OAPI, I served 6 years as Vice President, Oncology Marketing at Boehringer Ingelheim. Earlier in my career I held a series of leadership positions in sales and marketing focused in the areas of oncology and urology specialty care. I received an M.B.A. degree from Quinnipiac University.
  • John Bardi
    John A. Bardi

    M.S.
    VP, Government Affairs, Advocacy and Digital Medicines Business Development

    John Bardi

    John A. Bardi

    M.S.
    VP, Government Affairs, Advocacy and Digital Medicines Business Development

    “Otsuka’s mission is centered on making the world a better place through improved health. This mission extends beyond developing products and solutions, and includes our commitment to giving back to the community and supporting causes and organizations that help people in need.”

    As Vice President of Government Affairs, Advocacy and Digital Medicines Business Development at Otsuka America Pharmaceutical, Inc. (OAPI), I oversee the strategic development and execution of Otsuka’s government affairs federal and state advocacy and policy work in support of our short and longer term business goals. Additionally, I am leading Otsuka’s external business development efforts in support of our emerging Digital Medicines platform and serve as Board Chair for the Otsuka Political Action Committee. Before joining Otsuka, I worked as Vice President, U.S. Managed Markets supporting access for a diversified portfolio of small and large molecule company assets. My career journey at BMS started as an original member of the ABILIFY® (aripiprazole) Marketing team as Senior Director, Payer Marketing. Prior to joining BMS, I worked for GlaxoSmithKline as Vice President, Long Term Care Channel Accounts, and Director of National Accounts, Institutional Sales. Prior to joining the pharmaceutical industry, I served as Vice President, Clinical and Professional Services, at The Children’s Hospital of Philadelphia and as Assistant Administrator for Clinical Services at the George Washington University Medical Center in Washington, DC I received a B.A. degree from West Chester University of Pennsylvania and a Master of Health Services Administration degree from The George Washington University.
  • Kevin Donovan
    Kevin B. Donovan

    M.S.
    Sr. VP, Otsuka-People, Business Services & Communications.

    Kevin Donovan

    Kevin B. Donovan

    M.S.
    Sr. VP, Otsuka-People, Business Services & Communications.

    “Otsuka-people dare to dream and we take the road less traveled to influence the future.”

    As the Senior Vice President of Otsuka-People, Business Services & Communications at Otsuka America Pharmaceutical, Inc., (OAPI) I have responsibility for overseeing all human resources functions for the U.S. business. Before joining Otsuka in 2009, I was Director, Human Resources, U.S. Field Sales, at AstraZeneca, supporting a sales force of approximately 6,000 people. At AstraZeneca, I also held positions of Director, Global Human Resources Strategy, in London and Director, Human Resources, U.S. Operations. Earlier, I spent eight years at Bristol-Myers Squibb (BMS) and DuPont Pharmaceuticals Co., which was acquired by BMS. I have a B.S. degree from the University of Delaware and a Master’s degree in Organization Dynamics from the University of Pennsylvania.
  • Shabnam Kazmi
    Shabnam Kazmi

    M.B.A.
    VP, Patient Access and Adherence

    Shabnam Kazmi

    Shabnam Kazmi

    M.B.A.
    VP, Patient Access and Adherence

    "We pride ourselves on supporting patients, their families and their caregivers on their treatment journey. We understand that patients and their families are facing many challenges beyond the illness itself, and we do our best to support their access to their prescribed treatments. We are committed to that goal every single day."

    I am Vice President, Patient Access and Adherence at Otsuka America Pharmaceutical, Inc. I currently oversee Otsuka’s ASSURETM program, which provides patient assistance such as reimbursement and access services, free product and nurse navigators. Previously I was the commercial lead for a corporate initiative to take on full operating responsibility for ABILIFY® (aripiprazole) from BMS in 75 countries around the world, expanding our corporate footprint and moving the company towards a more globally-coordinated business model.  I first joined OAPI in 2009 to establish the organization’s Oncology business including the launch of the co-promotion with BMS of SPRYCEL® (dasatinib) and Ixempra (ixabepilone) and the establishment of a dedicated oncology sales force. Prior to joining Otsuka, I held roles of increasing responsibility at Sanofi and BMS focused mainly on product launch, new product planning & licensing and business development, mostly in the oncology area. I serve on the boards of three non-profit associations in support of oncology patients and community philanthropic activities. I received an A.B. degree in Biochemistry and Economics at Smith College in Northampton, MA and an M.B.A. degree from Harvard Business School in Cambridge, MA.
  • Rob Laverty
    Rob Laverty

    M.B.A.
    VP, Market Access

    Rob Laverty

    Rob Laverty

    M.B.A.
    VP, Market Access

    "At other companies you have a job and you’re sort of in a box. You may not get to go outside of the box. At Otsuka, we have a role, but we aren’t confined to it. Every day we get to go outside of our role. Here, we can do and think differently. We have the freedom to go beyond our roles to contribute, to innovate and produce outcomes that impact our overall mission. That’s what makes Otsuka unique."

    As Vice President of Market Access at Otsuka America Pharmaceutical, Inc. (OAPI) I lead the strategic approach and execution of our business-to-business relationships with all of our payors, trade customers and emerging access channels. This includes pricing and contracting, early product development, strategy and market access marketing. I am also a member of the Brand Development & Commercialization and Pharmaceutical Operating Committees, US Leadership Team (USLT) and also of the Joint Executive Team (JET). I was previously Senior Director of Market Access and continue to be responsible for payer and trade strategy and interactions, pricing strategy, contracting, market access operations, and development of early market access strategy. Before joining Otsuka in 2012, I spent 18 years at Bristol-Myers Squibb, where most recently I was the Executive Director of Global Market Access. My team built worldwide market access strategies and developed value propositions for the Neuroscience, Cardiovascular, and Metabolic pipelines. I received a B.S. degree in Management Science from Kean University and an M.B.A. in Finance from Fairleigh Dickinson University – Madison Campus in New Jersey.
  • Jennifer McGee, Esq.

    J.D.
    Chief Compliance Officer, VP Ethics & Compliance

    Jennifer McGee, Esq.

    J.D.
    Chief Compliance Officer, VP Ethics & Compliance

    As Senior Director and Chief Compliance Officer, I am responsible for ensuring that Otsuka America Pharmaceutical, Inc. and Otsuka Pharmaceutical Development & Commercialization, Inc. maintain a robust and effective ethics and compliance program.  I joined Otsuka in January 2011, as Senior Compliance Counsel, and assumed the responsibilities of Chief Compliance Officer in May 2015.  Prior to joining Otsuka, I worked as a litigator at a multinational law firm, focusing on defending pharmaceutical and medical device manufacturers in government investigations and lawsuits.  I also served in the United States Army for more than 13 years, trying more than 70 felony criminal trials, and remain in the United States Army Reserves.  I earned a B.A. degree from St. Lawrence University and a Juris Doctor degree from University of Maryland School of Law.
  • Innes Meldrum

    VP, CNS Marketing

    Innes Meldrum

    VP, CNS Marketing

    "My motivation for working at Otsuka is that most companies talk about innovation but at Otsuka it's part of the DNA. One of my favorite quotes is that "the definition of insanity is doing the same thing and expecting different results" by Albert Einstein. I believe strongly that the essence of marketing is effectively differentiating vs the competition and to do this requires adopting new approaches that challenge conventional thinking and by implication the status quo. Otsuka provides an environment that actively encourages this."

    As Vice President of the CNS & Cardio-Renal Marketing organization at Otsuka America Pharmaceutical, Inc. (OAPI) I am responsible for leading our Marketing teams to create, execute, and innovative differentiated marketing strategies and tactics. I also have responsibility for commercialization of our CNS & Cardio-Renal pipelines. I have more than 20 years of experience in executive strategic, marketing, sales and business operations in both the pharmaceutical and technology industries. I joined Otsuka in 2017. Prior to joining Otsuka, I spent 3 years at Orexo, as Head of US Sales and Marketing, focused on the Opioid Addiction market. Before this I worked in a variety of Global and US roles with Novartis and most recently was Head of Sales and Marketing of the U.S. Neuro-Psych business. Prior to this I spent 10 years working in the tech. industry with Nortel Networks, HP and Agilent Technologies focussed on developing solutions for the Wireless Telecomms industry. I earned a B.Eng. in Electrical and Electronic Engineering from Strathclyde University in Glasgow, Scotland.
  • Mary Michael


    VP Congress Stakeholder Management & Patient Advocacy

    Mary Michael


    VP Congress Stakeholder Management & Patient Advocacy

    “Otsuka embraces innovative thinking. It is not our slogan, but our calling to create patient-centered solutions for some of the toughest diseases in CNS, oncology, and more. We don’t shy away from problems. We embrace them to find solutions.”

    As Vice President of Patient Advocacy and Stakeholder Management at Otsuka America Pharmaceutical, Inc. (OAPI), I have the unique opportunity to work with trailblazing leaders both inside and outside the clinic walls to create innovative patient-centered solutions. It is my responsibility to understand how the world is changing across multiple disease categories, and I pull together the thoughts, ideas, and research from a global array of key opinion leaders, patient advocates, technologists, caregivers, and more to incubate novel business solutions. I am able to bring innovation to Otsuka by engaging with stakeholders from the world’s most prestigious medical centers to local advocacy chapters. Before coming to Otsuka, I spent nine years with Wyeth Pharmaceuticals in Opinion Leader and Advocacy Relations, where I developed and executed our Global Opinion Leader business strategies across the Specialty products portfolio. Prior to Wyeth, I was at Bristol-Myers Squibb for 13 years, in a variety of positions. At Otsuka, I have spearheaded the launch of the Global Council on Alzheimer’s Disease (GCAD), a collection of preeminent experts who influence the Alzheimer’s space, including science, medicine, technology, policy, advocacy, and caregiving. Through GCAD, I have jumpstarted technological innovation, framed a patient navigation model for Alzheimer’s, and helped improve communications between families and healthcare providers. I am a graduate of Virginia Tech as well as Singularity University.
  • Elaine O'Hara
    Elaine O'Hara

    M.B.A.
    Sr VP, Sales & Marketing

    Elaine O'Hara

    Elaine O'Hara

    M.B.A.
    Sr VP, Sales & Marketing

    "One of my favorite quotes that drives me and helps describe the Otsuka employee experience is from Zig Ziglar 'The greatest of all mistakes is to do nothing because you think you can do a little.' Opportunities at Otsuka are limitless and within everyone’s reach if you have the drive and ambition to seek them."

    As Senior Vice President of the U.S. Sales & Marketing organization at Otsuka America Pharmaceutical, Inc. (OAPI) I am responsible for working with our U.S.-based teams to create and execute the sales and marketing strategies across our brands. I also have responsibility for early commercial development including life-cycle management strategy across our therapeutic area portfolios. I have more than 20 years of experience in executive strategic, marketing, and business operations in the pharmaceutical industry. I joined Otsuka in 2012 as strategic lead for the renal-cardiovascular commercial business. Prior to joining Otsuka, I spent 14 years at Wyeth/Pfizer. My last position at Pfizer was Anti-infective Portfolio Commercial Lead in the U.S. Specialty Care business. Earlier at Wyeth, I held a series of leadership positions in the vaccine, anti-infective, and transplant and oncology franchises. Before joining Wyeth, I worked in product management at Astra Merck, Inc. I was also a Senior Consultant at Andersen Consulting (Accenture). I earned a B.A. degree in Music and French from National University of Ireland and an M.B.A. degree with a concentration in Marketing from the Haub School of Business, Saint Joseph’s University.
  • Edward Stelmakh
    Edward Stelmakh

    CPA, CMA
    VP, CFO

    Edward Stelmakh

    Edward Stelmakh

    CPA, CMA
    VP, CFO

    "My primary motivation for working at Otsuka is to help define and execute on our corporate strategic goals as we deal with continuously changing landscape of internal and external challenges and opportunities. I have a real passion for driving positive change and working in an environment where one can make significant impact across a broad spectrum of areas. I truly believe that the only constant in life is change and Otsuka’s success as an organization is hinged upon its willingness and ability to embrace changes occurring in the pharmaceutical industry landscape."

    As Vice President and CFO at Otsuka America Pharmaceutical, Inc. (OAPI) I am responsible for all of the Finance functions supporting the U.S. business, as well as Otsuka Pharmaceutical Development & Commercialization, Inc.(OPDC). Prior to joining Otsuka in 2015, I spent six years as Vice President, Finance, Clinical Development and Commercialization Services at Covance (a division of LabCorp), supporting a global division with approximately 5,000 employees worldwide. Prior to Covance, I held a variety of positions with growing responsibilities within Organon (acquired by Schering Plough), Sanofi-Aventis and Johnson & Johnson. My experience includes a broad spectrum of financial roles, including international assignments in the Netherlands and Russia. I received a B.S. in Finance from Towson University, and an M.B.A. from University of Baltimore. I am also a Certified Public Accountant (New Jersey) and a Certified Management Accountant.
  • Steven Weis
    Steven J. Weisel, Esq.

    J.D.
    VP & General Counsel

    Steven Weis

    Steven J. Weisel, Esq.

    J.D.
    VP & General Counsel

    "Otsuka is committed to conducting business with integrity at all times. We strive to be creative and innovative without ever losing sight of the laws and regulations that govern our industry and the trust that doctors, patients, and their families have placed in us."

    As Vice President and General Counsel at Otsuka Pharmaceutical Development & Commercialization, Inc., (OPDC) I lead the Legal Affairs department, which provides legal counsel and support to OPDC and its sister company Otsuka America Pharmaceutical, Inc. (OAPI). Earlier at Otsuka, I held various leadership positions in Legal Affairs and Human Resources, such as Senior Director & Corporate Counsel, Senior Corporate Attorney, and Senior Human Resources Business Partner. I joined Otsuka in 2001 after a career in business that included overseeing human resources functions at a major commercial printing company and two technology companies. I earned a B.A. degree and a Juris Doctor degree from The George Washington University.
  • Andrew Wright
    Andrew Wright


    VP, Digital Medicines

    Andrew Wright

    Andrew Wright


    VP, Digital Medicines

    “Our journey with digital medicine was inspired by the late President of Otsuka, Dr. Taro Iwamoto. He drove the value of innovation. He challenged us to think differently about solving unmet healthcare needs through alliances and technology. We are working to fulfill this vision by going beyond the pill.”

    As Vice President of Digital Medicines, at Otsuka America Pharmaceutical, Inc. (OAPI) I am responsible for leading the commercialization of wearable computing and digital products. Our goal is to enable improved patient medication adherence and better-informed physician decision-making to tailor treatment to the patient’s needs. I have more than 25 years of U.S. and Global experience in commercial leadership roles in the pharmaceutical industry. Earlier, I worked at Novartis as Head, HCP Digital/Multi-Channel Marketing, Global Commercialization, and was responsible for identifying and developing digital and multi-channel solutions that enhanced customer engagement. Prior to that, as Executive Director, Insights & Innovation, I led and developed a team responsible for customer/brand insights and innovation across the U.S. pharmaceutical business. I also held senior marketing and sales roles for in-line and launch brands at Novartis, producing consistently strong results. At Pharmacia, I led the launch of a major product in 11 markets across Europe. My Bachelor of Science degree is in Business Administration from Crewe and Alsager College.
  • William Carson
    William H. Carson

    A.B., M.D.
    President & CEO, OPDC

    William Carson

    William H. Carson

    A.B., M.D.
    President & CEO, OPDC

    “Otsuka’s relentless pursuit of innovative solutions that address unmet patient needs while leveraging cutting edge technology enables us to deliver on our mission – developing new products for better health worldwide. The challenges in mental health and oncology are extensive and complex, but Otsuka-people are determined and committed to developing solutions. We have a robust and diverse pipeline that prepares us to meet the needs of today, and shape the world of tomorrow.”

    I am the President & CEO of Otsuka Pharmaceutical Development & Commercialization, Inc. (OPDC). My responsibilities include leading the team that develops new products and brings them to market, as well as creating strategic plans for the company’s product portfolio to ensure development programs meet quality and safety standards required by medical and regulatory agencies. Since my appointment in 2010, I have led the development efforts of compounds in neuroscience, cardio-renal, and oncology, and was instrumental in the development and registration of ABILIFY MAINTENA® (aripiprazole) for extended-release injectable suspension. I also helped guide the development and registration of SAMSCA® (tolvaptan), marking the first time Otsuka successfully developed and commercialized a product entirely on its own in the U.S. I joined Otsuka in 2002 as a board-certified psychiatrist and served as OPDC’s Senior Vice President, Global Clinical Development, overseeing the development of Otsuka-discovered compounds. During my career at Otsuka—and earlier at Bristol-Myers Squibb (BMS)—I was one of the key drivers in the development and commercialization of ABILIFY® (aripiprazole), which Otsuka marketed in collaboration with BMS. I received an A.B. degree in history and science from Harvard University and an M.D. degree from Case Western Reserve University.
  • Frank S. Czerwiec
    Frank S. Czerwiec

    M.D., PhD
    VP, Global Clinical Development

    Frank S. Czerwiec

    Frank S. Czerwiec

    M.D., PhD
    VP, Global Clinical Development

    "Otsuka’s culture is globally humane, hearkening back to Louis Pasteur who said, ‘One does not ask of one who suffers: What is your country? What is your Religion? One merely says: You suffer, that is enough for me.’ Through a prepared mind and the good fortune of being able to work with dedicated people sharing such vision, we have the privilege of helping patients without hope. Being able to grow with such a company and with its people has always been reward enough."

    As Vice President, Global Clinical Development, I work collaboratively toward development of our Clinical Development team’s leadership in developing important new drugs, devices and other tools for the betterment of human health. As the Brand Team Co-Chair for tolvaptan, for its indications of hyponatremia and autosomal dominant polycystic kidney disease (ADPKD), I have represented Otsuka before patient-advocacy groups, the Critical-Path’s PKD Outcomes Consortium and ADPKD Summit, ASN’s Kidney Health Initiative, IQ Consortium’s Drug Induced Liver Injury group, reimbursement agencies, and as a member of several of PhRMA’s working groups. I have worked in the Otsuka Clinical Development group since 1998 contributing to the FDA Cardio-Renal Advisory Committee’s approval decision for PLETAL® (cilostazol) in peripheral vascular disease. As the Project Leader for tolvaptan, our team secured global approvals for hyponatremia SAMSCA® (tolvaptan). For ADPKD, I helped develop and lead Otsuka’s first truly global pivotal trial conducted in, and supporting approval for, all 3 ICH regions (PMDA, EMA, FDA). This has thus far led to ADPKD approvals for tolvaptan in Japan (as SAMSCA), Europe and Canada (as JINARC® (tolvaptan)). I earned a B.A. in Chemistry from the University of South Florida. At the University of Miami Miller School of Medicine I earned both an M.D. and a Ph.D. (biochemistry and molecular biology) and completed my Residency in Internal Medicine through ABIM’s 4-year Clinical Researcher Track. I continued my post-doctoral research at the NIH as part of my fellowship in Adult Endocrinology and Metabolism at the NICHD & NIDDK.  I then focused on late-stage clinical research at Merck US Human Health before joining Otsuka.
  • Al D’Alonzo
    Al D’Alonzo

    Ph.D.
    VP, Promotional Compliance

    Al D’Alonzo

    Al D’Alonzo

    Ph.D.
    VP, Promotional Compliance

    “At Otsuka there is a commitment to the patients, their families and the healthcare professionals that treat them. Otsuka takes integrity seriously and the responsibility to provide accurate information for the safe and effective use of our products. Otsuka is a company dedicated to its employees, ensuring them the ability to learn and grow together in their role and to innovate in a free-thinking environment for optimal success.”

    As Vice President, Promotional Compliance, I am responsible for regulatory review and approval of promotional materials for all marketed Otsuka products in the United States. I have more than 30 years of experience in the pharmaceutical industry across areas of Drug Discovery, Medical Affairs, and Regulatory Affairs. Following a post-doctoral fellowship at the University of California Los Angeles, my career in the pharmaceutical industry began at Proctor & Gamble Pharmaceuticals, and then to Bristol-Myers Squibb (BMS). At BMS I was a Principal Scientist in Drug Discovery, evaluating the efficacy and safety of newly developed cardiovascular compounds.  I joined the Medical Affairs department at BMS where I led Medical Strategy in the cardiovascular area, and later joined Promotion Compliance within Regulatory Affairs. Since joining Otsuka in 2009, I, along with my team, helped the commercial launch of SAMSCA® (tolvaptan), ABILIFY MAINTENA® (aripiprazole) and REXULTI® (brexipiprazole). I received a B.A. in Biology & Chemistry from La Salle University, a M.S. in physiology from Seton Hall University, and a Ph.D. in pharmacology from the University of Medicine & Dentistry of New Jersey.
  • Debbie Daniel
    Debbie Daniel

    M.B.A.
    VP, Corporate Projects

    Debbie Daniel

    Debbie Daniel

    M.B.A.
    VP, Corporate Projects

    "Throughout my tenure at the organization, I’ve been inspired by Otsuka’s environment of dynamic challenges and opportunities. The organization is constantly evolving and changing and you just never know what you will be challenged to work on next."

    As Vice President of Corporate Projects for Otsuka Pharmaceutical Development & Commercialization, Inc. (OPDC) I manage the company’s Operating Committee, leading initiatives such as Global Pharmacovigilance Reform and Oncology Alliance Management, as well as expanding the scope of corporate projects. Since joining Otsuka in August 1997 as a Program Manager for ABILIFY® (aripiprazole), I have also been responsible for the project management of development and commercialization activities for various products as well as the managerial oversight of the quality management, project management and corporate management departments. Prior to joining Otsuka, I held roles in Clinical Development and Central Contracts and Grants at the R.W. Johnson Pharmaceutical Research Institute. My career in health care began as a medical technologist at Duke University Medical Center. I am certified in Medical Technology through the American Society of Clinical Pathologists and am a member of the Drug Information Association. I received a B.S. degree in Medical Technology from the University of North Carolina at Chapel Hill and an M.B.A. from Penn State University with an emphasis in Marketing.
  • Timothy Goggin
    Timothy Goggin

    Ph.D.
    VP, Clinical Pharmacology

    Timothy Goggin

    Timothy Goggin

    Ph.D.
    VP, Clinical Pharmacology

    "We take great pride in our organization because Otsuka goes boldly where others fear to tread."

    As Vice President of Clinical Pharmacology & Pharmacometrics at Otsuka Pharmaceutical Development & Commercialization, Inc. (OPDC), I plan, conduct and analyze pre-clinical and Phase I - Phase III clinical studies. I have more than 26 years of experience in drug discovery and development and have worked in diverse therapeutic domains, including oncology, cardiovascular, metabolic, central nervous system, respiratory, infectious, and inflammatory disease areas. Immediately prior to joining Otsuka, I served as Clinical Pharmacology Site Head for Novartis in Basel, Switzerland, leading the Clinical Pharmacology Function in the Oncology Business Unit and serving as Line Manager and Scientific Mentor to clinical pharmacologists working on projects at all stages of clinical development. I previously held several positions at Roche both from 1987 – 2000 in Basel, Switzerland, and from 2003 – 2010 in Switzerland and the U.S. Those positions included Global Head of Biomathematics, Clinical Pharmacology Expert, and Site Matrix Leader. I received a B.Sc. (Hons) from University College Cork and a Ph.D. in Analytical Chemistry from University College Cork and Cork University Hospital, where I was a Research Fellow in the Clinical Investigation Unit.
  • David Goldberger
    David Goldberger

    MLS
    VP, Regulatory Affairs

    David Goldberger

    David Goldberger

    MLS
    VP, Regulatory Affairs

    “At Otsuka we are all in it together, our strength is how we collaborate across functions and groups to make sure we deliver with high quality and on time to Health Authorities, and patients”

    As Vice President of Regulatory Affairs, I am responsible for overseeing the CNS, Oncology, Digital and Ophthalmology therapeutic areas, CMC Regulatory Affairs, Labeling and Medical Writing. I have 35 years of pharmaceutical industry and clinical/homecare pharmacy practice experience, with 21 of those years spent at Johnson & Johnson (J&J). I began my industry career at J&J in the Clinical Supplies Dept. and moved into Regulatory Affairs, ultimately becoming Senior Director. I have worked on Early Development, Late Development and Marketed products in multiple therapeutic areas including CNS, Anti-Infectives, Cardiovascular, Oncology, Women’s Health, Endocrine and Metabolism. In addition, I have headed the Regulatory Information, In-licensing Scientific Due Diligence, Labeling Operations and Regulatory Affairs Business Support groups. I was also the Global Head of the Early Development Regulatory Affairs group. I hold a B.S. and Master’s degree in Pharmacy from Rutgers University and am Regulatory Affairs Certified from the Regulatory Affairs Professional Society.
  • Nick Kurahashi

    M.S.
    VP, Global CNS Business

    Nick Kurahashi

    M.S.
    VP, Global CNS Business

    I am Vice President of the Global CNS Business for Otsuka Pharmaceutical Development & Commercialization, Inc. (OPDC). I am responsible for Alliance Management with companies with which we have formed alliances, as well as development of global clinical and commercialization strategy for CNS and digital innovation products. My career at Otsuka began in 1988, as a researcher and organic chemist for psychiatry disorders in the CNS group in Japan and has steadily progressed to the clinical and commercial side, as well as taking on global roles. In 1996, I became the Product Development Coordinator responsible for the development and coordination of the global clinical and commercialization plan for the anti-platelet agent. Starting in 2000, I was the International Manager of ABILIFY® (aripiprazole), Otsuka America Pharmaceutical, Inc. I managed the coordination between the US, EU, Japan and Asia, as well as Alliance Management. By 2003, I became the ABILIFY Product Marketing Manager leading the brand in Japan, until beginning my current role in 2010. I had the unique opportunity and honor of contributing to the research and development as well as commercialization of ABILIFY. During my tenure at Otsuka global mobility has afforded us an opportunity to exchange knowledge with our peers as we bring different perspectives and problem-solving abilities to the conversation based on our professional backgrounds.  Today, I am really passionate about the future of Otsuka and how our company can leverage technology and digital innovation to advance healthcare and help make the world a healthier place for all.  Prior to joining Otsuka, I received my Master of Science for Pharmacy from Gifu Pharmaceutical University. 
  • Robert McQuade
    Robert McQuade

    Ph.D.
    Executive VP & Chief Strategic Officer

    smaller image of bob mcquade

    Robert McQuade

    Ph.D.
    Executive VP & Chief Strategic Officer

    Otsuka is not right for everyone. It is a dynamic environment for those who wish to be challenged and engaged every day. We are focused on bringing important new drugs and innovations to patients, especially for those with serious mental illness. This has been my personal goal throughout my career and through Otsuka I believe that I have in fact made a difference in the lives of these patients.

    As Executive Vice President & Chief Strategic Officer at Otsuka Pharmaceutical Development & Commercialization, Inc., (OPDC) I am responsible for coordinating the development strategy for our compounds across their life cycle.   I have more than 30 years of experience in the discovery, development, and marketing of drugs for the treatment of mental illness. My career started as a post-doctoral fellow in central nervous system (CNS) research at Schering-Plough Pharmaceuticals and gradually advanced to Associate Director of CNS Pharmacology.  In this role, I supervised the biochemical pharmacology group in their efforts to discover new drugs for mental illness, including schizophrenia and Alzheimer’s disease. I next joined the Global Medical Affairs team at Bristol-Myers Squibb (BMS). While at BMS, I was responsible for various products, including psychiatric treatments for generalized anxiety disorder and major depressive disorder.  More importantly, I was part of the team that helped form the alliance between BMS and Otsuka for the development and commercialization of aripiprazole. It was only natural that I ultimately joined Otsuka in 2004 to oversee global medical affairs for ABILIFY® (aripiprazole).  My roles have grown over the years and now I am responsible for the global development strategy for Otsuka’s compounds in the CNS, cardio-renal and oncology therapeutic areas. In addition, I am involved in many of Otsuka’s external collaborations and business development initiatives. I received a B.S. degree from Davidson College and a Ph.D. from the University of North Carolina-Chapel Hill.
  • Hirotaka Noma
    Hirotaka Noma

    M.B.A.
    VP, Finance

    Hirotaka Noma

    Hirotaka Noma

    M.B.A.
    VP, Finance

    "My prime motivation for working at Otsuka is to help make the company better. At Otsuka, I can actually help make an impact to the company with my own actions."

    As Vice President of Finance at Otsuka Pharmaceutical Development & Commercialization Inc. (OPDC) I am responsible for leading all financial functions for the company. I joined Otsuka in 1993 as a staff accountant and transitioned in 2000 to Guangdong Otsuka Pharmaceutical Co., Ltd., as Vice President. After brief stints as Otsuka Foods Co., Ltd., Finance Officer and Shanghai Otsuka Foods Co., Ltd., Chairman and CEO, I became Otsuka Pharmaceutical Co., Ltd., Senior Director, Finance. In 2013, I was appointed OPC Senior Director, Department of Strategic Think and Business Execution for Global Pharmaceutical Business. I received a bachelor’s degree from Keio University in Tokyo and an M.B.A. from Business Breakthrough University.
  • Margaretta Nyilas
    Margaretta Nyilas

    M.D.
    SVP, Clinical Management & Business Operations

    Margaretta Nyilas

    Margaretta Nyilas

    M.D.
    SVP, Clinical Management & Business Operations

    “At Otsuka, we are reimagining the clinical trial process from start to finish. Through the use of technologies and innovative methodology, our goal is to increase the speed and quality of clinical trials in order to get new medicines to patients faster.”

    I am Senior Vice President of Clinical Management & Business Operations at Otsuka Pharmaceutical Development & Commercialization, Inc. (OPDC). I have 18 years of diverse pharmaceutical industry experience with a successful track record of execution of global clinical programs from regulatory launch through life cycle management. During my 10-year tenure at Otsuka, and during previous tenures at Purdue Pharma and Bristol-Myers Squibb, I consistently demonstrated strong leadership in leading multiple functions and complex development portfolios of novel CNS and analgesic compounds and in the fields of oncology, anti-infective, and cardio-renal therapeutic areas. I have pioneered clinical research innovations, digital health platforms, and e-trials. My versatile cross-cultural understanding has helped me to develop great flexibility, working within a diverse organization. I led the APEX (Aripiprazole Pediatric Efficacy Program) trials and worked closely with Otsuka America Pharmaceutical, Inc. (OAPI) and OPDC colleagues to oversee the life cycle development of ABILIFY® (aripiprazole). I received an M.D. from Semmelweis Medical School in Budapest, Hungary, and subsequently a post-doctoral degree in Clinical Pharmacology in 2002.
  • Deborah Proffit
    Deborah Profit

    Ph.D.
    Leader, Otsuka Information Technology

    Deborah Proffit

    Deborah Profit

    Ph.D.
    Leader, Otsuka Information Technology

    “The knowledge sharing facilitated through our collaborations with some of the most prestigious institutions of higher learning in the country has been unprecedented. These collaborations have challenged us to think differently and evaluate how we can improve our own processes and introduce new methodologies in order to achieve the best possible outcomes.”

    As the Leader of Otsuka Information Technology (OIT) at Otsuka Pharmaceutical Development & Commercialization, Inc. (OPDC) I am responsible for both the R&D and Commercial arms of the Otsuka IT organization. Since 2001, I have driven strategy and solutions by collaborating with functional departments, key stakeholders and external parties to increase Otsuka’s probability of clinical, regulatory and technical success. I am responsible for facilitating creative technical solutions across clinical development and commercial teams, coordinating engagements with external innovation companies/consultancies, and actively leading cross-functional pilots, prototypes and enterprise wide IT solutions. In addition, I have a key role in transitioning various pilots and prototypes to full-scale projects to leverage solutions that complement the business portfolio to include digital medicine, digital health and big data platforms. Prior to joining Otsuka Information Technology, key roles within the organization included Director, Corporate Projects for over five years and Associate Director of Clinical Operations for nine years. Before 2001, I spent over seven years as Director, Project Management at a top tier global clinical research organization (CRO). I have undergraduate degrees in nursing and psychology, a Master of Science in Regulatory Affairs - Drugs, Biologics and Medical Device, and a Doctorate in Leadership Studies with a concentration in Innovation and Creativity.
  • Mirza Rahman
    Mirza Rahman

    M.D., M.P.H., FAAFP, FACPM.
    VP, Clinical Safety & Pharmacovigilance, and Global Head of Pharmacovigilance

    Mirza Rahman

    Mirza Rahman

    M.D., M.P.H., FAAFP, FACPM.
    VP, Clinical Safety & Pharmacovigilance, and Global Head of Pharmacovigilance

    "At Otsuka, we recognize that drug safety is everyone’s business, not just the responsibility of the people working in Global Pharmacovigilance (GPV) and even as we seek to create new products for better health worldwide, all of us at Otsuka are focused on creating a world-class drug-safety organization, where patient safety is our highest priority."

    I am Vice President, Clinical Safety & Pharmacovigilance, and the Global Head of Pharmacovigilance at Otsuka Pharmaceutical Development & Commercialization (OPDC), Inc. Shortly after joining Otsuka in 2013, I led the Otsuka Global Pharmacovigilance Reform Initiative, and currently lead all of Otsuka's pharmacovigilance operations globally. Additionally, I have been responsible for Global Medical Affairs activities at OPDC. I joined Otsuka from Merck Research Laboratories, where I was an Executive Director in the Clinical Risk Management/Global Safety department. There, I led a team that performed global pharmacovigilance and risk management activities for more than 425 Merck products. Prior to this, I was a Worldwide Vice President, Health Economics & Reimbursement at Ortho-Clinical Diagnostics, Johnson & Johnson. I earned an M.P.H. from Columbia University, an M.D. degree from the Stony Brook School of Medicine, and a B.S. degree from the Sophie Davis School of Biomedical Education at City College of the City University of New York. I am a Fellow of both the American Academy of Family Physicians (AAFP) and the American College of Preventive Medicine (ACPM), which in 2014 bestowed upon me their highest honor, the ACPM Distinguished Service Award.
  • Shashank Rohatagi
    Shashank Rohatagi

    Ph.D., M.B.A.
    Leader, Otsuka Data Sciences

    Shashank Rohatagi

    Shashank Rohatagi

    Ph.D., M.B.A.
    Leader, Otsuka Data Sciences

    “What’s exciting about Otsuka is that we’re already leveraging big data and analytics to provide unique products and solutions. From digitizing our processes in clinical areas to risk-based monitoring to connecting all of our data through data mapping – we are doing the eTrials of the future, today.”

    As the Head of Otsuka Data Sciences I lead the Biometrics, Data Management, Clinical Programming, Innovative Solutions and Smart and Secure Team. During my tenure at Otsuka, I have also led teams with expertise in comparative genomics, rare disease modeling, predictive analytics, software development, machine learning, pharmaceutical science, statistical genomics, and pharmacometrics. I have over 20 years of experience in the pharmaceutical Industry including as a leader in key scientific areas and strategic initiatives at the front line of science and technology at several pharmaceutical companies in the United States and India, such as Somerset Pharmaceuticals, Aventis, Daiichi Sankyo, Piramal Life Sciences, and Otsuka. 

    My diverse experience in drug development includes preclinical, Phase I/II/III and also life cycle management, and I have supported more than 10 NDAs and several INDs across various therapeutic areas including CNS, oncology, cardiovascular, anti-infectives, asthma/allergy and medical devices. I have a Ph.D. in Pharmacokinetics and an M.B.A. in Management and Information Systems and currently hold adjunct faculty positions at the University of Florida and at University of Tennessee.
  • Raymond Sanchez
    Raymond Sanchez

    A.B., M.D.
    Sr. VP, Global Clinical Development, CNS

    Raymond Sanchez

    Raymond Sanchez

    A.B., M.D.
    Sr. VP, Global Clinical Development, CNS

    "At Otsuka, we are committed to drug discovery and the development of novel therapies to address unmet needs. My peers and I have dedicated our careers to bringing new treatment options to patients and practitioners. We are driven by the opportunities to explore new therapeutic mechanisms, develop novel clinical trial designs, as well as leverage technology to confront the ongoing challenges in pharmaceutical development and advance medical research tailored to the development and availability of the best therapies to treat illnesses. "

    As Senior Vice President of Global Clinical Development, at Otsuka Pharmaceutical Development & Commercialization, Inc. (OPDC), I have responsibility for overseeing all development activities across the therapeutic areas. I joined Otsuka in 2007 to lead the ABILIFY® (aripiprazole) life cycle management programs. I also led the ABILIFY MAINTENA® (aripiprazole) program that received FDA approval in February 2013, as well as a subsequent approval for acute schizophrenia. Since then, I have served as co-lead for the clinical development and submission of the NDA for REXULTI® (brexpiprazole) that received FDA approval in July 2015.  In addition, I have managed the clinical development efforts for the treatment of Tourette’s syndrome with ABILIFY®, and have worked closely with OPDC and other Otsuka colleagues to achieve significant advances in the life cycle development of ABILIFY® (aripiprazole) and other CNS programs. Prior to joining Otsuka, I worked at Bristol-Myers Squibb (BMS) as Group Director, Neuroscience Medical, based in Wallingford, Connecticut, and then in Paris, France, where I was the ABILIFY® (aripiprazole) Medical Lead for Europe. I received an A.B. degree from the Weinberg College of Arts and Sciences at Northwestern University and an M.D. from the Feinberg School of Medicine at Northwestern University and trained in psychiatry at the Yale School of Medicine.
  • Nina Spiller
    Nina Spiller

    Pharm.D.
    VP, Clinical Management

    Nina Spiller

    Nina Spiller

    Pharm.D.
    VP, Clinical Management

    "At Otsuka we are encouraged to embrace ambiguity in order to realize what is truly possible"

    As Vice President of Clinical Management at Otsuka Pharmaceutical Development & Commercialization, Inc. (OPDC), I am responsible for fostering efficiency, innovation, applied learning and global standardization within Clinical Management and Clinical and IT Outsourcing. Since joining Otsuka in 2009, I have had multiple opportunities including reshaping the Clinical Management function, innovating the clinical trial process, and leading the efforts to transition the global ABILIFY® (aripiprazole) business, contributing to efforts to transform several business functions in the process. Prior to joining Otsuka, I held various roles within Clinical Management at the contract research organization (CRO) SCIREX Corporation (now Premier Research), and also served as Associate Director, Central Clinical Operations for Bristol-Myers Squibb I earned my B.S. in Pharmacy from Northeastern University and a Pharm.D. from the University of Maryland, Baltimore.
  • John Bardi
    John Sokol

    M.S.
    VP, Technical Operations

    John Bardi

    John Sokol

    M.S.
    VP, Technical Operations

    “There are limitless opportunities at Otsuka to learn and to grow. It’s the Jissho culture. We push people to try new things and learn new areas of responsibilities, and then reward them when they succeed. I experienced this first-hand.”

    As Vice President of Technical Operations at Otsuka Pharmaceutical Development & Commercialization Inc. (OPDC), I am responsible for pharmaceutical and medical device product development, global clinical supplies, and product supply for the US and international markets.   I joined Otsuka in 2011 as the Director of Packaging and Device Technology and helped launch the company's first combination product,  ABILIFY MAINTENA® (aripiprazole). Prior to joining Otsuka, I spent 16 years at Bristol-Myers Squibb, most recently as Associate Director, Package Development. My team delivered high-quality, cost-effective packaging solutions for oncology, cardiovascular, metabolic, and virology products globally.  I previously had similar responsibilities at Warner-Lambert and Block Drug Company. I earned a B.S. in Packaging Engineering from Rutgers University and an M.S. in Engineering Management from the New Jersey Institute of Technology. 
  • Henrietta Ukwu
    Henrietta Ukwu

    M.D., FACP., FRAPS.
    Sr. VP, Global Regulatory Affairs

    Henrietta Ukwu

    Henrietta Ukwu

    M.D., FACP., FRAPS.
    Sr. VP, Global Regulatory Affairs

    "At Otsuka, there are no boundaries to aspirations, achievements and appetite for innovation to drive health care solutions and make a difference to humanity."

    As Senior Vice President of Global Regulatory Affairs at Otsuka Pharmaceutical Development & Commercialization, Inc., (OPDC) I have responsibility for leading the global regulatory team, overseeing successful execution of regulatory activities and professional development of the team. My 23 years of professional global regulatory experience includes contributing to over 20 original new drug and biologics products development and approvals; enriching the regulatory profession through publications, including authoring the Global Regulatory Systems textbook and teaching and mentoring many successful regulatory professional protégés. My early regulatory career was spent at Merck, where I held increasingly senior regulatory leadership positions. At Wyeth Pharmaceuticals, I oversaw all therapeutic areas across all regions including responsibility for WHO and developing world countries. I joined Otsuka in 2013 from Pharmaceutical Product Development, LLC, having served as Senior Vice President, Head, Global Regulatory Affairs. I am a Fellow of the American College of Physicians (FACP) and Fellow of the Regulatory Affairs Professionals Society (FRAPS) and have received many awards for contributions to medicine and the pharmaceutical industry. My medical and surgical degrees are from the University of Jos School of Medicine in Nigeria, and I completed a postgraduate Internal Medicine residency at Baptist Hospital, University of Tennessee. My fellowship in Infectious Diseases was completed at the Vanderbilt University Medical Center in Nashville, Tennessee.
  • Steven Weis
    Steven J. Weisel, Esq.

    J.D.
    VP & General Counsel

    Steven Weis

    Steven J. Weisel, Esq.

    J.D.
    VP & General Counsel

    "Otsuka is committed to conducting business with integrity at all times. We strive to be creative and innovative without ever losing sight of the laws and regulations that govern our industry and the trust that doctors, patients, and their families have placed in us."

    As Vice President and General Counsel at Otsuka Pharmaceutical Development & Commercialization, Inc., (OPDC) I lead the Legal Affairs department, which provides legal counsel and support to OPDC and its sister company Otsuka America Pharmaceutical, Inc. (OAPI). Earlier at Otsuka, I held various leadership positions in Legal Affairs and Human Resources, such as Senior Director & Corporate Counsel, Senior Corporate Attorney, and Senior Human Resources Business Partner. I joined Otsuka in 2001 after a career in business that included overseeing human resources functions at a major commercial printing company and two technology companies. I earned a B.A. degree and a Juris Doctor degree from The George Washington University.

NEUROSCIENCE

Otsuka has been committed for more than 3 decades to developing novel drugs for neurological conditions such as schizophrenia.