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Infectious Diseases & Vaccines: Leadership

Infectious Diseases & Vaccines: Leaders

 

Infectious Diseases & Vaccines

Infectious Diseases & Vaccines

The structure of HIV
The structure of HIV

JAMES MERSON, Ph.D.

GLOBAL HEAD
INFECTIOUS DISEASES

James Merson, Ph.D., is the Global Therapeutic Area Head for Infectious Diseases at Janssen Research & Development, L.L.C. He is a member of the Senior R&D Leadership Team, leading the global Infectious Disease therapeutics team as they continue to create and advance transformational medicines to help treat, prevent and cure patients with respiratory infections, HIV and hepatitis B.

James holds more than 30 years of R&D experience in antivirals, vaccines and immuno-oncology. Previously at Pfizer, Inc., he held a succession of leadership positions, including Chief Scientific Officer of the Vaccine Immunotherapeutics Research Unit, co-leader of Infectious Diseases and Head of their Antiviral Therapeutic Area.

James is committed to exploring new avenues of research in the fight against infectious diseases. Under his leadership, Janssen continues to deliver on its robust infectious disease therapeutic pipeline, while also applying cutting-edge science and technologies to help accelerate discovery and development.

In addition to James’s antiviral expertise where he pioneered the development of a series antiviral molecules for the treatment of HIV and hepatitis C, his research has focused on novel avenues of science. These include the exploration of gene therapy to treat HIV, prophylactic vaccines to prevent various infectious diseases, therapeutic vaccines to treat chronic diseases such as asthma, smoking and dyslipidemia, as well as combining immunomodulators with vaccines and oncolytic viruses to treat various types of cancers. He has authored and co-authored more than 45 scientific publications and posters.

James is a member of the New York Academy of Sciences, the British Society of Immunology and International Society of Vaccines.

He holds a Ph.D. in microbiology and immunology from Baylor College of Medicine, Houston, Texas and a Bachelor of Arts in biology from Bellarmine College, Louisville, Kentucky.

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James Merson, Ph.D.

Global Head
Infectious Diseases

PENNY HEATON, M.D.

GLOBAL THERAPEUTIC AREA HEAD
VACCINES
JANSSEN RESEARCH & DEVELOPMENT, LLC

Penny Heaton, M.D., is the Global Therapeutic Area Head for Vaccines at Janssen Research & Development, L.L.C. In this role, she leads a global team focused on developing transformational vaccines to prevent some of the most devastating infectious diseases the world faces today.

Penny holds two decades of vaccine research and development experience. She recently served as the Chief Executive Officer for the Bill & Melinda Gates Medical Research Institute (Gates MRI), where she led the development of investigational products from pre-clinical through late-stage development against multiple diseases including HIV, TB, malaria, pneumonia, enteric diseases, and polio. She has also led vaccine clinical research and development for companies including Novartis, Merck and Novavax.  Notably, during her time at Meck, Penny co-developed a rotavirus vaccine which has been licensed in more than 100 countries and universally recommended by the World Health Organization for infants worldwide.   

Penny began her career at the U.S. Centers for Disease Control and Prevention conducting diarrheal disease surveillance and investigating outbreaks of foodborne and diarrheal diseases, influencing her life-long passion for vaccine development.

A graduate of the University of Louisville School of Medicine in Kentucky, Penny is board-certified in Pediatrics and Pediatric Infectious Diseases. She is a member of the Pediatric Infectious Diseases Society and a fellow of the American Academy of Pediatrics.

Penny Heaton, M.D.

Global Therapeutic Area Head
Vaccines
Janssen Research & Development, LLC

SAMUELE BUTERA

GLOBAL COMMERCIAL STRATEGY LEADER

Samuele Butera is the Global Commercial Strategy Leader for Infectious Diseases and Vaccines. He leads Janssen’s efforts to build and maximize the value of the infectious diseases portfolio and pipeline in areas of high unmet need such as HIV, hepatitis B, respiratory syncytial virus (RSV), influenza, and extraintestinal pathogenic E. coli (ExPEC).

With a proven track record in delivering global healthcare innovation and business leadership, Samuele’s goal is to bring transformational solutions to patients, healthcare providers and healthcare systems around the world.

Prior to joining the Johnson & Johnson Family of Companies, Samuele spent 13 years at Novartis, where he was most recently the Global Cell & Gene Therapies Business Leader in Oncology. In this role, he was responsible for leading and overseeing all of Novartis’ activities to ensure the successful global launch of cell and gene therapies, which included the first CAR-T therapy for children and young adults with B-cell acute lymphoblastic leukemia. He also oversaw the market preparations for the launch of the first U.S. biosimilar while leading Sandoz Biopharmaceuticals, North America.

Samuele was formerly a consultant at McKinsey & Company, where he advised clients on corporate strategy, mergers and acquisitions, alliances, operational effectiveness, and organizational redesign. He has also worked in financial markets with Goldman Sachs, and on international economic development initiatives with the United Nations.

Samuele earned a Bachelor of Science in International Economics from Bocconi University in Milan, Italy, and a Master of Public Policy from Harvard University in Boston, Massachusetts.

Samuele Butera

Global Commercial Strategy Leader

JOHAN VAN HOOF, M.D.

MANAGING DIRECTOR
JANSSEN VACCINES AND PREVENTION B.V.

Johan Van Hoof, M.D. received his medical degree (cum laude) from the University of Antwerp, Belgium, in the Department of Anatomy and Embryology at Rijksuniversitair Centrum Antwerpen, Belgium. He studied business management at Krauthammer International School and the International Executive Programme INSEAD, Fontainebleau, France.

Johan joined the Johnson & Johnson Family of Companies in April 2005 as Vice President, Data Management and Early Clinical Development. Following roles as Chief Operating Officer (COO) of Johnson & Johnson Pharmaceutical Research, LLC, and Head of the Global Development Organization, he was appointed Global Therapeutic Area Head for Infectious Diseases & Vaccines in 2010. Since 2011 he has been overseeing research & development at Janssen Vaccines as Managing Director.

Before joining the Johnson & Johnson Family of Companies, Johan acquired more than 20 years of experience in the vaccine industry, having worked with Pasteur Mérieux Connaught, Chiron Vaccines and GlaxoSmithKline (GSK) Biologicals. During this period, he held leadership roles with increasing responsibilities, including Head New Product Development at GSK Biologicals. Johan was actively involved in the development and licensing of a new generation of childhood and adult vaccines in disease areas such as pertussis (pediatric combined vaccines), meningitis, rotaviral diarrhea, hepatitis, flu and HPV.

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Johan Van Hoof, M.D.

Managing Director
Janssen Vaccines and Prevention B.V.

JAN POOLMAN, PH.D.

HEAD, BACTERIAL VACCINES DISCOVERY AND EARLY DEVELOPMENT
DAS LEADER, BACTERIAL VACCINES

In his role, Jan Poolman, Ph.D., oversees the development of new vaccines against prevalent bacteria that are resistant to antibiotics.

Previously, from 1986-1996, Jan was Head of Vaccines R&D at the National Institute for Public Health and the Environment in the Netherlands. In 1997 he was appointed Head & Vice President, Bacterial Vaccines R&D at GSK Biologicals in Belgium. During his tenure until 2011, he contributed to the licensure of several products, including pertussis combinations, meningococcal and pneumococcal vaccines.

Jan obtained a Master of Science in Chemistry in 1975 and a Ph.D. in Meningococcal Surface Structure in 1981 from the University of Amsterdam. In 1982 he was awarded an NIH post-doctoral fellowship research position at the University of Washington in Seattle, USA. In 1983, Jan returned to the University of Amsterdam as Assistant-Professor Bacteriology.

Jan has published more than 200 articles in peer-reviewed journals and is a member of the Editorial Board for the Expert Review of articles for the journal Vaccines.

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Jan Poolman, Ph.D.

Head
Bacterial Vaccines Discovery and Early Development, DAS Leader
Bacterial Vaccines

LISA CALDWELL

GLOBAL COVID-19
COMMERCIAL LEADER

Lisa Caldwell is responsible for working with teams across Johnson & Johnson on the potential launch of our investigational COVID-19 vaccine candidate, if proven to be effective with a good safety profile. Before taking this role, Lisa led the Janssen Global Commercial Strategy for Bacterial Vaccines, partnering closely with the full cross-functional team working in this space.

Prior to joining the Johnson & Johnson Family of Companies, Lisa was the Global Marketing Director for a shingles vaccine at GSK. In this capacity, she and her team helped shape the launch, go-to-market strategy, stakeholder education and communications for North America and Europe, while planning for expansion in China and Japan. Prior to this role, Lisa led the U.S. Vaccines Consumer Strategy team at GSK. She played a key role in embedding a new capability in the business unit, while delivering strong business results for the adult and adolescent portfolio.

Before joining GSK, Lisa spent 15 years at Merck in roles of increasing responsibility across several primary care and specialty brands at various stages of the product life cycle.

Lisa graduated from Howard University with a Bachelor of Science in Microbiology and received a Master of Business Administration from Pennsylvania State University.

Lisa Caldwell

Global COVID-19 Commercial Leader

HANNEKE SCHUITEMAKER, PH.D.

Vice President, Head, Viral Vaccine Discovery & Translational Medicine
DAS Leader, Viral Vaccines

Hanneke Schuitemaker, Ph.D., is the Head of Viral Vaccine Discovery and Translational Medicine and Disease Area Stronghold Leader for Viral Vaccines at Janssen Vaccines & Prevention B.V. In this role, she oversees Janssen’s viral vaccine programs including investigational vaccine candidates for HIV, respiratory syncytial virus (RSV), Ebola, Zika, COVID-2019 and HPV. In addition, she is a Professor of Virology at the Amsterdam University Medical Center, holding this function since 2004.

Previously, Hanneke worked for more than 20 years on HIV-1 pathogenesis, first at Sanquin (1989-2007), the blood supply foundation in the Netherlands, where  she was the chair of the department of Clinical Viro-Immunology (1998-2007), and then at the Amsterdam University Medical Center (2008-2010), where she was the chair of the Department of Experimental Immunology and a member of the Research Council. From mid-2003 to mid-2004, she worked as a visiting scientist at The Scripps Research Institute in La Jolla, California.

Hanneke is a medical biologist by training, receiving her Ph.D. in Medicine in 1992 from the University of Amsterdam She has successfully trained more than 30 Ph.D. students and co-authored close to 300 peer-reviewed scientific articles.
 

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Hanneke Schuitemaker, Ph.D.

Vice President, Head
Viral Vaccine Discovery &
Translational Medicine
DAS Leader

HEATHER L DAVIS, PH.D.

Vice President, R&D
DAS Leader, Hepatitis

As Disease Area Stronghold R&D Leader for Hepatitis, Heather Davis, Ph.D., leads the Hepatitis team to advance their goal of transforming disease management and outcomes for patients who are chronically infected with the hepatitis B virus (HBV). Heather is deeply committed to developing innovative treatment options that will help to alleviate the burden of HBV in populations around the world.

Prior to joining the Johnson & Johnson Family of Companies, Heather was Head of R&D Portfolio and Program Management for Seqirus, a company developing influenza vaccines. Previously, she worked for Pfizer as Executive Director in Vaccine R&D and Site Head, with responsibility for all Canadian R&D activities including animal pharmacology studies, clinical assay development and conduction, as well as Program Lead for two global therapeutic vaccine programs that she led from early discovery through Phase 1 testing.

Heather was also a scientific co-founder of Coley Pharmaceutical Group, a biotechnology company developing CpG oligonucleotides (TLR9 agonists) as vaccine adjuvants and immune modulators in infectious disease and oncology. While at Coley, she led R&D efforts in both hepatitis B (vaccines) and hepatitis C (immune therapy). Before this, Heather worked in academia, first at McGill University Faculty of Medicine (Montreal), and then at the University of Ottawa – during this time, she was a pioneer in the field of DNA vaccines, developing the first DNA vaccine for HBV.

Heather received her Ph.D. from the University of Western Ontario and did post-doctoral and sabbatical work at the University of British Columbia (Vancouver) and the Pasteur Institute (Paris). Over her career, Heather has authored 116 peer-reviewed manuscripts and is the inventor on 13 patent families.

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Heather L Davis, Ph.D.

Vice President, R&D
DAS Leader, Hepatitis

JASON CHIEN, M.D., M.S.

Vice President
DAS Leader
Respiratory Infections

Jason Chien, M.D., M.S. is Vice President, Disease Area Stronghold Leader for Respiratory Infections at Janssen. As a distinguished scientist, Jason has a deep commitment to reducing the burden of respiratory viral infections, especially in populations at the highest risk for morbidity and mortality.

Prior to joining the Johnson & Johnson Family of Companies, Jason was the Global Respiratory Lead at Gilead Sciences, leading the development priorities and commercial strategy for addressing respiratory and infection-related unmet needs in adults and children. He and his team advanced multiple antiviral, anti-inflammatory, and anti-fibrotic programs through early and late stage development.

Jason has also served as Associate Professor of Pulmonary and Critical Care Medicine at the University of Washington and Associate Member of the Fred Hutchinson Cancer Research Center.

Jason obtained his undergraduate degree from the University of Michigan, his medical degree from UMDNJ-New Jersey Medical School, and his Master’s degree in Genetic Epidemiology from the University of Washington. His post-graduate training includes an Internal Medicine Residency and Infectious Diseases Fellowship at Case Western Reserve University, and a Pulmonary and Critical Care Medicine Fellowship at the University of Washington.

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Jason Chien, M.D., M.S.

Vice President
DAS Leader
Respiratory Infections

JUSTINE DONNELLY

DAS COMMERCIAL LEADER
RESPIRATORY INFECTIONS

As Disease Area Stronghold (DAS) Leader, Justine Donnelly is responsible for leading the Janssen Global Commercial Strategy for Respiratory, partnering closely with the full cross-functional team.

Justine has 25 years’ commercial experience, including 20 years at Johnson and Johnson. She first started at Cordis in the Medical Devices sector and moved into the Pharmaceutical sector in 2004. Since then she has held various global and US positions, working across disease areas including cardiovascular, metabolics, men’s health, anti-infectives, and dermatology. She launched medical devices and treatments in the US and has led large teams selling therapeutics in infectious disease, pain management, cardiovascular, diabetes, and psoriasis.

She has been leading the Respiratory Infections DAS as the Commercial Lead within GCSO since 2017. She has a Master of Business Administration from Kellogg School of Management at Northwestern University, a Master of Engineering Management, and a Bachelor of Science in Business Administration.

 

Justine Donnelly

DAS Commercial Leader
Respiratory Infections

MACAYA DOUOGUIH, M.D., M.P.H.

HEAD
CLINICAL DEVELOPMENT AND MEDICAL AFFAIRS
VACCINES

Macaya Douoguih, M.D., M.P.H., is Head of Clinical Development and Medical Affairs, Vaccines at Janssen. Macaya heads a team of physicians and scientists that lead the clinical development of the viral and bacterial vaccine programs, working closely with the R&D organization towards the goal of licensing three novel best-in-class vaccines by 2025.

Prior to this role, Macaya was the Clinical Franchise Leader for Emerging Diseases, overseeing the clinical development of Janssen’s vaccines portfolio against pathogens of global significance and for bio preparedness, such as Ebola/Filoviruses, Zika, and Polio.

Macaya joined Janssen Vaccines in 2010 as Medical Leader for several vaccine/large molecule programs in Infectious Diseases & Vaccines and was instrumental in leading the accelerated monovalent clinical program for Janssen’s Ebola vaccine during the 2014/2015 outbreak, which initiated 10 concurrent clinical studies.

Before joining the Johnson & Johnson Family of Companies, Macaya led the clinical development of Crucell’s adenovirus-based TB vaccine candidate at Aeras. Earlier she held several positions focused on infectious diseases clinical research and public health.

Macaya has a medical degree from the University of Wisconsin-Madison Medical School and a Master of Public Health from Johns Hopkins Bloomberg School of Public Health.

 

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Macaya Douoguih, M.D., M.P.H.

Head
Clinical Development and Medical Affairs
Vaccines

ISABEL NAJERA, PH.D.

VICE PRESIDENT
GLOBAL HEAD OF RESEARCH
INFECTIOUS DISEASES AND VACCINES

Isabel Najera, Ph.D. joined Janssen in September 2020 as the Global Head of Research for Infectious Diseases and Vaccines. In this role, through her scientific expertise and leadership, she develops an industry-leading discovery research portfolio to tackle infections caused by viruses including HIV, hepatitis B, respiratory syncytial virus, influenza, and human rhinovirus, as well as bacteria, using a variety of therapeutic modalities.

Isabel has more than 20 years of experience in infectious disease research and development. Prior to joining Janssen, she served as Chief Scientific Officer at Virion Biotherapeutics Ltd (2018-2020), a VC-backed biotechnology company. Prior to that, she worked at Roche for 19 years in the area of drug discovery and development for infectious diseases. During that time she held several leadership positions and contributed to and led pivotal research in support of five marketed compounds.

Isabel holds a Bachelor of Science in Chemistry, Biochemistry and a Master of Science in Biotechnology. She completed her Ph.D. at the Universidad Complutense de Madrid, Spain, has authored more than 70 peer-reviewed publications, and holds 18 patents.

Isabel Najera, Ph.D.

Vice President
Global Head of Research
Infectious Diseases and Vaccines

BRIAN WOODFALL, M.D.

GLOBAL HEAD
DEVELOPMENT
INFECTIOUS DISEASES

Brian Woodfall, M.D., is Global Head of Development, Infectious Diseases where he oversees the development of key therapeutics for Janssen.

Brian joined the Johnson & Johnson Family of Companies in 2003, at Tibotec, a company specializing in the discovery and development of innovative HIV/AIDS drugs and superior anti-infectives for diseases of high unmet medical need. As head of the Medical Department at Tibotec, he had responsibilities across global development in the areas of HIV, hepatitis C and tuberculosis. From 2011 to 2013, Brian held the role of Vice President for Medical Affairs for Janssen covering the EMEA region (Europe, Middle East and Africa).

Brian completed his medical degree at the University of Saskatchewan, Canada, followed by post-graduate training at the University of British Columbia. For 15 years, he had a private practice with a focus on HIV. During this time, he was involved in clinical care, teaching, research and community-based volunteer organizations. As a co-founder of Spectrum Health Care Ltd. in Vancouver, B.C., he was instrumental in the conception, funding, implementation and day-to-day management of an integrated multi-disciplinary clinic dealing with HIV.

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Brian Woodfall, M.D.

Head
Development
Infectious Diseases

DIRK REDLICH, PH.D.

HEAD
VACCINES PROCESS AND ANALYTICAL DEVELOPMENT

Dirk Redlich, Ph.D., is Head of Vaccines Process and Analytical Development at Janssen. Dirk’s team operates three pilot plants and vaccines launch facilities in Leiden, the Netherlands, and Bern, Switzerland. The scope of responsibility includes the process and analytical development of vaccines and clinical trial material manufacturing.

Dirk joined the Janssen Research Foundation, a Johnson & Johnson company, to lead the analytical method development in 2001. Dirk contributed to numerous early and late drug development programs in areas such as oncology and infectious disease. Accepting roles with increasing responsibilities, Dirk led activities in various areas of pharmaceutical drug development, ranging from analytical and formulation development, to program management, process excellence, and served as strategy and operations leader. Dirk has worked in Europe, Asia and the US.

As of June 2011, Dirk became part of the integration team after the acquisition of Crucell, the Vaccine company acquired by J&J in February 2011. Dirk became head of program management and strategy and operations, moving into his current role in 2014.

Dirk has authored more than 20 peer reviewed articles and book chapters. He is an active speaker at scientific conferences in the area of vaccine development and manufacturing.

Dirk received his Ph.D. in Chemistry from the Technical University of Munich and was a research fellow at the Technical University of Weihenstephan, Freising, Germany. Dirk is also an alumnus of the Harvard Business School, where he completed an advanced management program.

Dirk Redlich, Ph.D.

Head
Vaccines Process and Analytical Development

CHRISTIAN RODSETH

Commercial DAS Leader
Hepatitis

Christian Rodseth is responsible for leading the Janssen Global Commercial Strategy for Hepatitis, partnering closely with the full cross-functional team.

Christian joined the Johnson & Johnson Family of Companies in 2006 as medical sales representative in South Africa and held several roles of increasing responsibility within sales, marketing and market access. In his last role as Sales & Marketing Director, South Africa & Sub-Saharan Africa, he successfully launched a treatment for prostate cancer and two treatments for autoimmune diseases.

Most recently, he held the position of General Manager, Janssen Romania where he oversaw the successful launches of seven products spanning oncology, autoimmune conditions, neuroscience and infectious diseases. In addition to internal business success, Christian played an active role in shaping the external debate through his role as President of the National Innovative Pharmaceutical Association.

Christian is an alumnus of the Talent Acceleration Program, Action Learning Program and Accelerate Executive Leadership programs. He holds an honors degree in Occupational Therapy and a degree in International Business Administration with distinction from the Wits and Warwick Business Schools.

Christian Rodseth

Commercial DAS Leader
Hepatitis

JEFFREY STODDARD, M.D.

VICE PRESIDENT
MEDICAL AFFAIRS

As Vice President, Medical Affairs, Jeffrey Stoddard, M.D., is responsible for leading Janssen’s medical affairs efforts for the entirety of the Infectious Diseases & Vaccines portfolio, partnering closely with the Commercial and R&D leaders, and the full cross-functional team.

Jeff joined the Johnson & Johnson Family of Companies from GSK Vaccines where he was US Medical Affairs Lead, Zoster, and was instrumental in all aspects of the medical, commercial and late stage development launch workstreams related to the company’s shingles vaccine from 2017 through 2019. His expertise ranges across vaccines (viral and bacterial, pediatric and adult), biologics, and small molecules. He has advised national governments regarding vaccine policy and has worked extensively in the R&D stages within the biopharmaceutical industry, as well as commercial strategy from pre-launch planning to launch execution.

Prior to GSK, Jeff worked at Novavax, where his work focused on older adult and maternal respiratory syncytial virus (RSV) vaccine development. He also worked in academic and policy research roles and served as Vice President and Global Head of Medical Affairs at Novartis Vaccines. He has authored more than 70 peer-reviewed journal articles, and four chapters in medical textbooks.

Jeff is a graduate of the University of Wisconsin Medical School, completed a residency at the Johns Hopkins Hospital in Baltimore, and completed a postdoctoral fellowship at the University of California-San Francisco. He is a board-certified pediatrician with advanced postdoctoral training in health policy.

Jeffrey Stoddard, M.D.

Vice President
Medical Affairs