Our Research & Development Leadership Team
As Global Head of R&D at the Janssen Pharmaceutical Companies of Johnson & Johnson, Mathai’s mission is to focus the energy of the best research and development teams in the world at the intersection of profound unmet medical need and actionable breakthroughs in science and technology to make medicines of unequivocal benefit for humanity. The team works across a wide range of therapeutic areas and biological pathways. Janssen’s approach to medicines is patient-focused, agnostic to both source of the idea and the treatment modality. The team is invested deeply in data sciences in every aspect of R&D. Janssen R&D has fueled the growth of Janssen to be the largest pharmaceutical company in the United States, and the fourth largest in the world.
Prior to joining Janssen in June 2017, Mathai was Senior Vice President at Merck Research Laboratories, responsible for research in the areas of Cardiovascular, Metabolic and Renal Diseases, Oncology/Immuno-Oncology and Immunology. Jointly with his team, he initiated numerous new programs and progressed eight into early clinical development. Prior to Merck, Mathai led R&D at Theravance, a company he co-founded in the San Francisco Bay Area in 1997 based on his work at Harvard University. His talented team of 200 scientists nominated 31 development candidates in 17 years, created five approved products and created a pipeline containing many additional late development-stage compounds. In 2014, he and the Theravance Leadership Team separated Theravance into two publicly traded companies: Innoviva (INVA) and Theravance Biopharma (TBPH).
Mathai has more than 150 peer-reviewed publications and patents and serves on various boards and advisory committees. He received his M.D. from Harvard Medical School/Massachusetts Institute of Technology (HST program) and his Ph.D. in Chemistry from Harvard University's Department of Chemistry, working with George Whitesides. He received his BSc in Chemistry and Biochemistry from Dalhousie University in Halifax, Nova Scotia.
Neil Davie is Global Therapeutic Area Head, Pulmonary Hypertension, leading the therapeutic area’s strategy and portfolio execution, including clinical development, He has extensive experience as a drug developer leading projects across multiple therapeutic areas, particularly in specialty/rare diseases with high unmet medical need. He has held leadership roles with increased responsibility allied with strategic pharmaceutical drug development across early and late programs in the area of pulmonary, neurology, immunology and hematology.
Prior to joining Janssen in October 2019, Neil worked at UCB Pharma as Development Lead with responsibility and accountability for their innovative subcutaneous anti-FcRn monoclonal antibody platform, rozanolixizumab. Prior to this, he spent five years at Bayer as Vice President of Clinical Development responsible for the development of riociguat (Adempas) in chronic thromboembolic pulmonary hypertension (CTEPH) and pulmonary arterial hypertension (PAH); he successfully represented Bayer at the FDA Advisory Committee, leading to the approval of Adempas in both indications. Before joining Bayer, he was Senior Medical Director in the Pulmonary Vascular Development Group at Pfizer, working on Revatio (sildenafil citrate) for PAH and additional rare diseases. Previously he was at Encysive Pharmaceuticals, where he was Director of Scientific Affairs for the launch of Thelin (sitaxentan sodium) for PAH in Europe, Australia and Canada.
Neil obtained his BSc. in Human Biology from the University of Leeds and his Ph.D. in Pulmonary Pharmacology from Imperial College London. He completed a post-doctoral fellowship at the University of Colorado Health Sciences Center (Stenmark Lab), in the field of pulmonary hypertension. He was appointed Assistant Professor of Pediatric Cardiology at the Children’s Hospital in Denver, working in the pulmonary hypertension lab of Dunbar Ivy. Previously, he held the post of Visiting Professor of Cellular & Respiratory Medicine at the University of Newcastle, working with Professor Paul Corris.
Ruxandra Draghia-Akli, M.D., Ph.D., is Global Head, Johnson & Johnson Global Public Health R&D. In this role, Ruxandra and her team advance Global Public Health into the next era of innovation by leveraging critical discovery, development and regulatory capabilities across Janssen R&D. She provides alignment with the overall end-to-end strategy of Johnson & Johnson Global Public Health, collaborating with the Infectious Disease & Vaccines Therapeutic Area and other Janssen R&D Therapeutic Areas that have assets with potential application in global public health settings. She also collaborates with the J&J Innovation Centers and external partners to build important networks and identify new opportunities.
Ruxandra’ expertise includes more than two decades of impactful work within industry, government and academia. She served as Vice President for Public Health and Scientific Affairs with Merck & Co., contributing to Merck’s global vaccines pipeline and maintaining key partnerships with international organizations and the scientific community. Prior to her role at Merck, she worked with the European Commission, first as Director-Health, Directorate-General for Research and later as Deputy Director General, Directorate-General Research, overseeing programmatic, legislative, and research and innovation policy issues, and contributing to the Commission’s Health Programme, a strategy for improving public health, preventing illness and eliminating dangers to physical and mental health.
Prior to joining the Commission, Ruxandra spent nearly 20 years as a medical doctor and a researcher in Romania, France and the US. She holds a Ph.D. in human genetics from the Romanian Academy of Medical Sciences, University Carol Davila in Bucharest, where she also obtained her M.D. She participated in a fellowship program in the Genetics and Metabolic Pathology Department at René Descartes University in Paris, France, and completed her post-doctoral training in molecular biology at Baylor College of Medicine in the United States. Ruxandra has authored and co-authored more than 100 peered-reviewed papers and book chapters and holds more than 100 patents and patent applications in the areas of gene therapy, vector design, electroporation and other physical methods of delivery of macromolecules, novel vaccines and endocrinology. She is also the inventor of the first gene therapy product ever for use in farm animals. Ruxandra participated in the development and success of several global and European consortia and served on scientific boards, such as the international rare disease research consortium, or the Innovative Medicines Initiative.
As Global Leader for Pharmaceutical R&D Communications, Paul leads development and execution of comprehensive communication strategies to enhance the reputation and support the research & development and innovation priorities of Janssen and Johnson & Johnson.
Prior to joining the company, Paul served as vice president, R&D network relationships and strategic communications at Takeda, where he led the global R&D communications team and served as communications counselor to the chief medical and scientific officers. He served on the core team that identified industry drivers of innovation, including modality diversification, external innovation and data sciences, then mapped and implemented Takeda’s pivotal R&D transformation.
Before joining Takeda, Paul served as Managing Director for Chandler Chicco Agency based in New York City. During his 12 years at Chandler Chicco, he and his team provided extensive support for several Janssen medicines in the areas of oncology and cardiovascular & metabolism.
Najat Khan, Ph.D., is the Chief Data Science Officer and the Global Head (Vice President) of Strategy & Operations for Janssen Research & Development. In this role, Najat shapes the R&D strategic vision and operationalizes across multiple high priority areas to ensure Janssen R&D continues to deliver on transformational medicines for patients. These include building new capabilities such as creating a best-in-class R&D data science organization by selecting the highest priority questions to pursue, systematically deploying Data Science capabilities, while being a key catalyst in forming strategic external partnerships to accelerate on-going efforts.
Najat also collaborates with the various Janssen R&D therapeutic and functional heads, as well as Commercial and Business Development leaders on a wide variety of cross-functional strategic, portfolio related, and operational priorities while ensuring the respective insights are incorporated effectively within the broader Janssen community.
Prior to her current role, Najat was the Head of R&D Strategic Initiatives. In a brief period, she was able to develop and execute a comprehensive program comprising of more than 25 of Janssen’s R&D strategic initiatives, and was instrumental in launching our data science efforts, defining our R&D strategy for pursuing opportunities in new diseases area, enhancing early stage external innovation, etc.
Najat has more than 10 years of global healthcare experience in pharmaceutical, biotechnology, business and academia. Prior to joining Janssen, she was a Principal at The Boston Consulting Group (BCG) where she has led and executed multiple strategic initiatives across research, commercial, business and clinical development, mergers and acquisitions and operations. Within R&D, areas of focus included portfolio governance and decision-making, R&D operating model optimization (including both clinical development and operations), external innovation and Digital Health. While at BCG, Najat also led the implementation of the Women’s Mentorship program and recruitment and retention efforts as recruiting director and career development advisor.
Najat received her B.A. in Chemistry with a minor in Economics from Colgate University and her Ph.D. in Organic Chemistry from the University of Pennsylvania with publications in high-impact journals such as Nature, Proceeding of the National Academy of Sciences, etc. She was also a fellow at the Penn Center for Innovation and led multiple licensee / partnership arrangements between UPenn and leading pharmaceutical and large cap biotech companies.
As Global Head of Data Strategy, Sean helps drive data science strategy and execution in partnership with data science and regulatory teams across Janssen Research & Development. Sean is a physician-data scientist and board-certified oncologist with an entrepreneurial spirit and experience combining translational and clinical research with data science and health technology to address areas of unmet need in therapeutic development and care delivery.
Sean joined the company from the U.S. Food and Drug Administration (FDA) Oncology Center of Excellence, where he led the Center’s bioinformatics initiatives, supporting an integrated approach in the clinical evaluation of drugs, biologics and devices for the treatment of cancer. His work at the Center focused on innovations in clinical trial design, digital health, real-world evidence and advanced analytics, including artificial intelligence and machine learning. He was also the founding director of Information Exchange and Data Transformation, the FDA’s first data science and technology incubator for de-risking solutions through internal research and development and strategic partnerships.
Prior to his tenure in federal government, Sean was the cofounder of Hello Health, where he developed an innovative integrated telemedicine, point-of-care data visualization, and advanced analytical platform for optimizing patient care and clinical research. The company’s core technology offerings were first operationalized in a multidisciplinary network of clinics called SKMD that he founded and for which he served as the Chief Medical Officer.
Sean’s background includes positions as an adjunct clinical investigator at the National Cancer Institute and a research affiliate the Massachusetts Institute of Technology, focusing on financial engineering and on the application of artificial intelligence and machine learning in biomedical research and clinical development.
Sean received his M.D. from the University of Maryland School of Medicine, and his Master of Public Health from The George Washington University.
Michael Krams, M.D., is Global Head, Quantitative Sciences, Janssen R&D, leading a global team of statisticians, modelers and clinical pharmacologists, who apply quantitative intelligence and model-based drug development across all therapeutic areas. The team brings quantitative approaches to drug development to enable the best possible decision, at the earliest timepoint, in the most efficient manner, and deliver innovative medicines to patients.
Mike is a neurologist with expertise in functional brain imaging gained from his work at the Institute of Neurology in London. He trained in neurology and internal medicine at the universities of Essen and Munich and is a graduate of the University of Munich medical school.
Before joining Janssen, Mike served as Vice President, Adaptive Trials and Applied Program Strategies for Wyeth Research. At Pfizer he worked in clinical development, designing and implementing an adaptive dose-ranging study with real-time estimation of the dose response and real-time adaptive treatment allocation and stopping rules.
Mike co-authored more than 50 papers for peer-reviewed publications, many of which have explored issues related to adaptive designs in drug development. As former co-chair of the Pharmaceutical Research and Manufacturers of America (PhRMA) working group on adaptive designs, he contributed to making adaptive designs a more widely used methodology. Mike is an advocate of fostering broader cooperation across academia, government and industry research and development to improve the probability of success in drug development.
As Global Oncology Therapeutic Area Head for the Janssen Pharmaceutical Companies of Johnson & Johnson, Peter F. Lebowitz, M.D., Ph.D. is responsible for the discovery, development and life cycle advancement of the company’s robust oncology pipeline and portfolio. He leads a global team of scientists that bring together expertise in small molecules, advanced biologics, cell therapies, vaccine platforms, translational research, diagnostics, and immuno-oncology. Under Peter’s leadership, Janssen Oncology has achieved many noteworthy milestones, including major product approvals for several first-in-class therapies; multiple U.S. Food and Drug Administration Breakthrough Therapy Designations; and tremendous, rapid growth within the group’s early development portfolio.
With a strategy focused on driving towards transformational therapies, Peter also successfully established an external innovation strategy to advance science and novel therapeutics in core disease areas, including hematologic malignancies, prostate cancer, immuno-oncology, and lung cancer. The combination of these efforts has led to more than 80 strategic oncology partnerships across the life sciences ecosystem and continues to distinguish Janssen as an industry leader and global oncology innovator.
Prior to his appointment as Global Oncology Therapeutic Area Head, Peter served as the Hematologic Malignancies Disease Area Leader within Janssen Research & Development. In this role, he had responsibility for creating and executing the scientific strategy to advance internal and externally sourced discovery and development programs. Together with his team, Peter is recognized for building an industry-leading hematologic malignancies portfolio that has been foundational for scientific innovation and has progressed important therapeutics that have transformed patient care.
Before joining Janssen R&D, Peter held Vice President positions in Discovery and Early/Late-stage Clinical Development for another pharmaceutical company where he successfully filed 10 Investigational New Drug Applications and played a significant role in the global registration of three oncology medicines. During his tenure, he also directly led major programs from preclinical discovery through pivotal Phase 3 registration trials.
Prior to transitioning to the pharmaceutical industry, Peter served as Assistant Professor of Medicine, Division of Hematology/Oncology at the Lombardi Comprehensive Cancer Center at Georgetown University Medical Center. There he established an independently funded translational and clinical research program and led numerous clinical research programs as a principal investigator. He also had the privilege of caring for many oncology patients during this time. Peter graduated magna cum laude from Harvard University, holds a master’s degree in Health Care Policy from Oxford University, and earned his medical degree and doctorate from the University of Pennsylvania School of Medicine. He completed clinical training in Internal Medicine at Duke University Medicinal Center and his Hematology/Oncology fellowship at the National Cancer Institute, National Institutes of Health. He is board-certified in Internal Medicine and Medical Oncology.
David M. Lee, M.D., Ph.D., is Global Immunology Therapeutic Area Head for the Janssen Pharmaceutical Companies of Johnson & Johnson where he leads a team focused on end-to-end pipeline and a portfolio of treatments for immune-mediated disease. Under his leadership, Immunology researchers are working to build on the success of our current portfolio, which includes STELARA® (ustekinumab) and REMICADE® (infliximab), two of Johnson & Johnson’s largest products.
Prior to joining Johnson & Johnson in September 2018, David was based in Basel, Switzerland, where he served as Global Head, Immunology, Inflammation and Infectious Disease Discovery and Translation Area for Roche, and prior to that, as Global Head of Autoimmunity, Dermatology, and Transplant Translational Medicine at the Novartis Institutes for BioMedical Research. In each of these roles, he led on the strategic approaches that fed those companies’ pipelines, prioritized assets, and accelerated their development. His ability to develop external collaborations and to lead and develop his teams was central to his success in each organization.
Before transitioning to the pharmaceutical industry, David was a faculty member at Brigham and Women’s Hospital/Harvard Medical School. While there, his research laboratory focused on disease mechanisms in Rheumatology and he also practiced Rheumatology. As a precursor to his career in industry, while at Harvard, he also participated in co-founding multiple start-ups. Ultimately, one – a biotech – was acquired by a major pharmaceutical company.
He is an active author and speaker, having completed more than 80 peer-reviewed publications and book chapters, and more than 100 lectures/seminars.
David earned his undergraduate degree at Stanford University, where he discovered his fascination with the intricacies of the immune system. He subsequently earned his M.D. and Ph.D. in Microbiology/Immunology from the Duke University School of Medicine. His passion for developing new medicines is rooted in his experiences treating patients as a practicing rheumatologist.
As Head of Asia Pacific R&D, Zili oversees all R&D activities within Asia Pacific, leading over 1,400 science professionals dedicated to delivering transformational healthcare innovation across the region.
Zili joined Janssen in June 2019 from the U.S. Food and Drug Administration (FDA) where he served as Associate Director for Global Affairs at the Office of Generic Drugs. There he contributed significantly to the expansion of International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) to the field of generic drugs, playing a critical role in China’s National Medical Products Administration’s membership in ICH in 2017.
Before rejoining the FDA in 2015, Zili had over 10 years of leadership and program management experience in pharmaceutical R&D at both Merck and the Bill and Melinda Gates Foundations, where he built high-performance and science-driven organizations and drove substantial increases in R&D productivity. At Merck, he served in positions of increasing responsibility in clinical development and regulatory affairs at global, regional and local levels. His roles included Medical Director of MSD China, Head of China and Asia Pacific Regulatory Policy, and Executive Director and Head of Emerging Markets Regulatory Strategy. At the Bill & Melinda Gates Foundation, Zili served as Deputy Director and Head of China R&D.
Zili first joined the FDA in 2000 as a medical reviewer for drug safety. Later he was promoted to medical team leader for overseeing IND and NDA reviews in defined therapeutic areas. In addition, Zili participated in FDA guidance development for the industry and presented at the FDA’s advisory committee meeting on behalf of the agency. Zili was a recipient of numerous FDA awards, including 2003 FDA Scientific Achievement Award and 2014 FDA Distinguished Alumni Award.
Zili is a graduate of Peking Union Medical College and completed his residency training at Johns Hopkins in 2000. In addition to his medical degree, Zili also holds two master’s degrees in public health.
James F. List, M.D., Ph.D. is the Global Therapeutic Area Head of Cardiovascular & Metabolism (CVM), leading a global team focused on creating new solutions for improving cardiovascular and diabetes care and disease interception. Jim has end-to-end research and development responsibility for the Janssen CVM portfolio, including drug discovery, clinical development, and external innovation. Jim joined Janssen in 2014.
Prior to joining Janssen, James served with Bristol-Myers Squibb as Vice President, Diabetes Development with responsibility for the diabetes joint venture alliance with AstraZeneca.
Earlier in his career, James was a faculty member of the Harvard Medical School in Cambridge, Massachusetts with clinical responsibilities in General Endocrinology and Thyroid. He graduated from Stanford University in Stanford, California and completed his M.D. and Ph.D. from the University of Minnesota in Minneapolis, Minnesota. He completed his medical training at Brigham and Women’s Hospital, Boston Children’s Hospital and the Massachusetts General Hospital, and is board certified in Internal Medicine, Pediatrics and Endocrinology.
Bill Martin, Ph.D., is Global Therapeutic Head for Neuroscience at Janssen Research & Development, LLC, one of the Johnson & Johnson pharmaceutical companies. Prior to joining Janssen R&D, Bill was President and Chief Executive Officer of Blackthorn Therapeutics, and previously served as the company’s Chief Scientific Officer and Head of R&D. He co-founded Blackthorn, which integrates computational and clinical neuroscience and applies a precision medicine approach to creating novel therapeutics for central nervous system (CNS) disorders.
Before Blackthorn, Bill held multiple leadership positions at Theravance Biopharma, including leading the company’s research portfolio planning initiative and serving as a member of the strategic partnership team and project team leader for an advanced clinical stage CNS program. He began his career at Merck, where he contributed to the strategic direction of the company’s Neuroscience franchise.
Bill is a member of the Board of Directors for Brown University’s Carney Institute for Brain Science and has held leadership positions in the Society for Neuroscience, the American Physiology Society and the International Brain Research Organization. He has published extensively on neuroscience and brain disorders, with more than 75 publications in scientific journals.
Bill received a bachelor’s in Psychology from Swarthmore College and a doctorate in Experimental Psychology from Brown University. He conducted postdoctoral research at the Keck Center for Integrative Neuroscience at the University of California, San Francisco.
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.
Peter Ronco is responsible for leading the Global Development organization in delivering the portfolio on time, within budget, and with robust quality while continuously improving to optimize efficiency and the patient and investigator experience in our studies. The Global Development organization harnesses the functional and geographic expertise to bring insights into the shaping of our development programs to enable the correct development decision at the earliest timepoint in the most efficient manner.
The Global Development organization has a globally distributed workforce of more than 6,000 internal and external employees who are responsible for the operational execution of all Phase I – IV studies (including Medical Affairs programs) across all therapeutic areas and all geographic regions. They are accountable for identifying and implementing innovative clinical trial approaches and technologies that meet the current and future needs of the portfolio while also shaping our environment to build for the future. Global Development is comprised of eight key functions: Global Clinical Operations, Portfolio Delivery Operations, Medical Affairs Operations, Quantitative Sciences, Integrated Data Analytics & Reporting, Project Management Office, Enabling Business Information Solutions and Business Operations.
Prior to joining Janssen in 2017, Peter was Senior Vice President of Global Clinical Operations at Bristol Myers-Squibb (BMS) where he had spent 14 years holding positions of increasing leadership in Medical Affairs, Regulatory Operations and R&D Operations. He also serves on the TransCelerate Biopharmaceutical Board of Directors. Prior to joining BMS, Peter was a consultant with Accenture, focusing on post-merger integration of R&D organizations. He is a graduate of Nottingham University in the UK.
Sanjaya Singh, Ph.D., is Global Head, Janssen BioTherapeutics within Janssen Research & Development. Sanjaya is responsible for leading an organization focused on biotherapeutic research, discovery, clinical pharmacology and strategic external collaboration. In this role, Sanjaya drives the strategy and overall vision to expand and apply the capabilities of Janssen Research & Development to the discovery and development of protein, peptide and cell-based therapeutics.
Sanjaya is an accomplished scientific and business leader with more than 25 years of industry and academic experience. Prior to joining Johnson & Johnson, Sanjaya spent nine years at Boehringer Ingelheim, most recently serving as Vice President, Biotherapeutics Discovery. During his tenure, Sanjaya led a global team responsible for building a competitive and productive pre-clinical and clinical biotherapeutics pipeline. He has successfully led the identification of therapeutic targets in the field of immunomodulation and has developed biologic molecules in the fields of immunology, oncology, ophthalmology, cardio-metabolic and infectious disease.
In the realm of academia, Sanjaya held a faculty position in the Department of Molecular Biology at the Institute of Life Sciences in India. An author of numerous peer-reviewed articles, Sanjaya also is co-author on more than 25 patents.
Sanjaya earned a Ph.D. in Molecular Biology from Banaras Hindu University, Varanasi, Uttar Pradesh, India. He served as a Postdoctoral Fellow in the Department of Molecular Oncology at the University of Texas MD Anderson Cancer Center, Houston, Texas, and as a Research Associate in the Department of Biochemistry and Molecular Biology, also at MD Anderson Cancer Center in Texas.
Richard Tillyer, Ph.D, is Global Head, Discovery, Product Development & Supply, Janssen Research and Development. In this role, he leads an integrated discovery, process development and clinical supply organization that comprises all modalities including small molecules, traditional and non-traditional single molecule biologics, and larger, more complex multicomponent biologics including RNA, viruses and cells.
Rich joined Janssen in 2018 from Merck & Co (MSD outside the United States), where he acquired extensive experience in all stages of drug discovery and product development across numerous therapeutic areas and modalities. During his 25-year tenure, he led large and varying aspects of Merck Research Labs, including Process Chemistry, Toxicology, Drug Metabolism and Pharmacokinetics, Formulation, Biologics and Vaccines Process Development, High Throughput Screening, Discovery Biology, Medicinal Chemistry, Computational Chemistry and various platform groups. Under his leadership, Rich’s teams contributed to the discovery and development of most major products introduced by Merck over the last two decades and significantly advanced the company’s current pipeline. He led or actively contributed to major strategic initiatives including large and small-scale mergers and R&D integrations (most notably, the integration of Schering-Plough announced in 2009).
Rich obtained his Ph.D. in Chemistry from the University of British Columbia, Canada, and a post-doctoral research fellowship in Chemistry from the University of Cambridge, UK. He has published more than 70 scientific articles and publications and he holds several patents.
As head of the Global Regulatory Affairs (GRA) within Janssen Pharma, Karin Van Baelen leads an organization of approximately 900 highly qualified colleagues who foster relationships with Health Authorities around the world and deliver innovative healthcare solutions to patients. Under her leadership, the GRA organization influences and interprets global regulatory requirements and enables our company to meet those guidelines. In addition, GRA oversees the development of regulatory strategy for products from all therapeutic areas, as well as the delivery of high-quality, on-time regulatory submissions and approvals. GRA also engages in policy development at national and international levels in the regulatory, biotechnology and clinical development arenas
Previously, Karin served as Vice President of Regional Regulatory Affairs and Global Regulatory Operations, leading activities in Europe, Middle East, Africa, Russia (EMEA), Asia Pacific and Latin America and overseeing the Labeling & Submissions Management organization. From 2008 to 2013, she led the EMEA Regional Regulatory Affairs team in all regulatory aspects for all therapeutic areas and all operating company regulatory organizations in the region. Karin also served as Vice President of Global Regulatory Affairs for Tibotec BVBA where she created and led its global regulatory team and contributed to the development and approvals of several products in the Janssen Infectious Diseases & Vaccines portfolio. She also worked with GRA at the Janssen Research Foundation and was responsible for the worldwide registrations of several key products, including medications for severe mood disorders and pain. Karin joined Johnson & Johnson in 1993 from Upjohn Benelux where she submitted numerous Marketing Authorization Applications and obtained approvals in Europe and emerging markets.
Karin has a strong record of developing successful leaders and served as the EMEA Diversity & Inclusion regional champion.
Karin obtained her Doctor of Pharmacy (Pharm.D.) degree at the University of Antwerp, Belgium in 1988. Karin serves with the European Federation of Pharmaceutical Industries and Associations’ (EFPIA) Scientific Regulatory & Manufacturing Policy Committee (SRMPC) and with the Pharmaceutical Research and Manufacturers of America’s Regulatory Affairs Coordination Committee (RACC).
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 the 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 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, focusing on vaccines. Since 2011 he has been overseeing R&D at Janssen Vaccines & Prevention B.V. 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 of 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.