Envisioning a Transformed Clinical Trials Enterprise for 2030

Workshop

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The evolution of health care is expanding the possibilities for integration of clinical research into the continuum of clinical care; new approaches are enabling the collection of data in real-world settings; and new modalities, such as digital health technologies and artificial intelligence applications, are being leveraged to overcome challenges and advance clinical research. At the same time, the clinical research enterprise is strained by rising costs, varying global regulatory and economic landscapes, increasing complexity of clinical trials, barriers to recruitment and retention of research participants, and a clinical research workforce that is under tremendous demands.

Looking ahead to 2030, the Forum on Drug Discovery, Development, and Translation of the National Academies of Sciences, Engineering, and Medicine convened a public workshop for stakeholders from across the drug research and development life cycle to reflect on the lessons learned over the past 10 years and consider opportunities for the future. The workshop was designed to consider goals and priority action items that could advance the vision of a 2030 clinical trials enterprise that is more efficient, effective, person-centered, inclusive, and integrated into the health care delivery system so that outcomes and experiences for all stakeholders are improved. This Proceedings of a Workshop summarizes the presentations and discussions that took place during the four-part virtual public workshop held on January 26, February 9, March 24, and May 11, 2021.

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138 pages · 6 x 9 · paperback
ISBN Paperback: 0-309-26928-8
ISBN Ebook: 0-309-26929-6
DOI: https://doi.org/10.17226/26349

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National Academies of Sciences, Engineering, and Medicine. 2022. Envisioning a Transformed Clinical Trials Enterprise for 2030: Proceedings of a Workshop. Washington, DC: The National Academies Press.

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Steven K. Galson

Steven K. Galson, M.D., M.P.H., senior vice president, Research and Development, joined Amgen in 2010 as vice president, Global Regulatory Affairs and in 2014 became senior vice president managing global regulatory and safety. In January 2021 he stepped down from this position to focus on leading the company’s COVID response activities. Galson is also on the Executive Committee of the Clinical Trial Transformation Initiative and a Trustee of the Keck Graduate Institute. Prior to Amgen, Galson was senior vice president for Civilian Health Operations and chief health scientist at Science Applications International Corporation. Galson spent more than 20 years in government service, including two years as acting Surgeon General of the United States. Previously, he served as director of the Food and Drug Administration's (FDA) Center for Drug Evaluation and Research (CDER), where he provided leadership for the center's broad national and international programs in pharmaceutical regulation. Galson began his Public Health Service (PHS) career as an epidemiological investigator at the Centers for Disease Control and Prevention (CDC) after completing a residency in internal medicine at the Hospitals of the Medical College of Pennsylvania. He also held senior-level positions at the Environmental Protection Agency (EPA); the Department of Energy, where he was chief medical officer; and the Department of Health and Human Services. Prior to his arrival at the FDA, Galson was director of the EPA's Office of Science Coordination and Policy, Office of Prevention, Pesticides and Toxic Substances. He holds a B.S. from Stony Brook University, an M.D. from Mt. Sinai School of Medicine, and an M.P.H. from the Harvard School of Public Health.

Esther Krofah

Esther Krofah is the executive director of FasterCures, a center of the Milken Institute. She has deep experience in the government, nonprofit, and for-profit sectors, where she has led efforts to bring together diverse stakeholder groups to solve critical issues and achieve shared goals that improve the lives of patients. Most recently, Krofah was the director of public policy leading GlaxoSmithKline's engagement with the U.S. Department of Health and Human Services (HHS) and relevant Executive Branch agencies on broad health-care policy issues, including leadership in improving vaccinations and care for people living with HIV. Prior to GSK, Krofah served as the deputy director of HHS' Office of Health Reform, where she led the development of policy positions for significant regulator priorities, including the health insurance marketplaces. Prior to HHS, Krofah served as a program director at the National Governors Association (NGA) health-care division, working directly with governors' health policy advisors, state Medicaid directors, and state health commissioners on health insurance, health workforce, and Medicaid coverage issues. Before joining the NGA, Krofah worked in consulting at Deloitte Consulting LLP, where she worked with public sector and commercial clients, including assisting states in developing state-based exchanges. Krofah received a B.A. from Duke University and a Masters of Public Policy from the Harvard University John F. Kennedy School of Government.

Amy P. Abernethy

Dr. Amy Abernethy is an oncologist and internationally recognized clinical data expert and clinical researcher. As the Principal Deputy Commissioner of Food and Drugs, Dr. Abernethy helps oversee FDA's day-to-day functioning and directs special and high-priority cross-cutting initiatives that impact the regulation of drugs, medical devices, tobacco and food. As acting Chief Information Officer, she oversees FDA's data and technical vision, and its execution. She has held multiple executive roles at Flatiron Health and was professor of medicine at Duke University School of Medicine, where she ran the Center for Learning Health Care and the Duke Cancer Care Research Program. Dr. Abernethy received her M.D. at Duke University, where she did her internal medicine residency, served as chief resident, and completed her hematology/oncology fellowship. She received her Ph.D. from Flinders University, her B.A. from the University of Pennsylvania and is boarded in palliative medicine.

Anita L. Allen

Dr. Anita L. Allen is an internationally renowned expert on privacy law and ethics, and is recognized for contributions to legal philosophy, women’s rights, and diversity in higher education. In July 2013, Allen was appointed Penn’s Vice Provost for Faculty, and in 2015, Chair of the Penn Provost’s Advisory Council on Arts, Culture and the Humanities. From 2010 to 2017, she served on President Obama’s Presidential Commission for the Study of Bioethical Issues. She was presented the Lifetime Achievement Award of the Electronic Privacy Information Center in 2015 and elected to the National Academy of Medicine in 2016. In 2017 Allen was elected Vice-President/President Elect of the Eastern Division of the American Philosophical Association. In 2015 Allen was on the summer faculty of the School of Criticism and Theory at Cornell. A two-year term as an Associate of the Johns Hopkins Humanities Center concludes in 2018. Her books include Unpopular Privacy: What Must We Hide (Oxford, 2011); Privacy Law and Society (Thomson/West, 2017); The New Ethics: A Guided Tour of the 21st Century Moral Landscape (Miramax/Hyperion, 2004); and Why Privacy Isn’t Everything: Feminist Reflections on Personal Accountability (Rowman and Littlefield, 2003).

Christopher P. Austin

Dr. Christopher P. Austin is Director of the National Center for Advancing Translational Sciences (NCATS) at the U.S. National Institutes of Health. NCATS’ mission is to catalyze the generation of innovative methods and technologies that will enhance the development, testing, and implementation of diagnostics and therapeutics across a wide range of human diseases and conditions. Before becoming NCATS Director in September 2012, he was director of the NCATS Division of Preclinical Innovation, which focuses on translating basic science discoveries into new treatments, particularly for rare and neglected diseases, and developing new technologies and paradigms to improve the efficiency of therapeutic and diagnostic development. In this role, he founded and directed numerous initiatives including the NIH Chemical Genomics Center (NCGC), the Therapeutics for Rare and Neglected Diseases (TRND) program, and the Toxicology in the 21st Century (Tox21) program. Before joining NIH in 2002, Dr. Austin directed research programs genomics-based target discovery, pharmacogenomics, and neuropsychiatric drug development at Merck, with a particular focus on schizophrenia. Dr. Austin received his A.B. in biology from Princeton and M.D. from Harvard Medical School. He completed clinical training in internal medicine and neurology at the Massachusetts General Hospital, and a fellowship in genetics at Harvard.

Howard A. Burris, III

Dr. Howard A. Burris, III serves as president and chief medical officer of Sarah Cannon, as well as the executive director, drug development for the research institute. He is an associate of Tennessee Oncology, PLLC, where he practices medical oncology. Dr. Burris' clinical research career has focused on the development of new cancer agents with an emphasis on first in human therapies, having led the trials of many novel antibodies, small molecules, and chemotherapies now FDA approved, including ado-trastuzumab emtansine, everolimus, and gemcitabine. In 1997, he established in Nashville the first community based early phase drug development program, which grew into the Sarah Cannon Research Institute. He has authored over 400 publications and 700 abstracts. Sarah Cannon has now dosed over 350 first in human anticancer therapies and enrolls more than 3000 patients per year into clinical trials. Dr Burris will serve as the elected president of ASCO in 2019-2020. He also currently serves on the Board of ASCO’s Conquer Cancer Foundation. Additionally in 2014, Dr. Burris was selected by his peers as a Giant of Cancer Care for his achievements in drug development. Dr. Burris completed his undergraduate education at the United States Military Academy at West Point, his medical degree at the University of South Alabama, and his internal medicine residency and oncology fellowship at Brooke Army Medical Center in San Antonio. While in Texas, he also served as the Director of Clinical Research at The Institute for Drug Development of the Cancer Therapy and Research Center and The University of Texas Health Science Center. He attained the rank of lieutenant colonel in the US Army, and among his decorations, he was awarded a Meritorious Service Medal with oak leaf cluster for his service in Operation Joint Endeavor.

Luther T. Clark

Dr. Luther T. Clark is Deputy Chief Patient Officer and Global Director, Scientific Medical and Patient Perspective (SMPP) in the Office of the Chief Patient Officer (OCPO) at Merck. In this role, he is responsible for (1) gathering internal and external scientific and medical information to assist with decision-making at the highest levels; (2) collaborating across Merck to increase the voice of patients, directly and indirectly in decision-making; (3) collaborating with key internal and external stakeholders in development of a systematized approach for collecting and incorporating patient insights across the patient journey and product lifecycle; and (4) representing Merck externally, expanding bi-directional exchange with key patient and professional leaders and organizations. Dr Clark leads Merck’s Patient Insights Team, is co-leader of the team that champions Health Care Equities (including promotion of health literacy and research diversity) and chairs the Patient Engagement, Health Literacy & Clinical Trials Diversity Investigator Initiated Studies Research Committee. Prior to joining Merck, Dr Clark was Chief of the Division of Cardiovascular Medicine at the State University of New York Downstate Medical Center (SUNY Downstate) and founding Director of the National Institutes of Health (NIH) funded Brooklyn Health Disparities Research Center. Dr Clark earned his Bachelor of Arts degree from Harvard College and his Medical degree from Harvard Medical School. He is a Fellow of the American College of Cardiology (FACC) and the American College of Physicians (FACP), and a past member of the Board of Directors of the Founders Affiliate of the American Heart Association. He is a nationally and internationally recognized leader in cardiovascular education, clinical investigation, cardiovascular disease prevention, and health equity. He has authored more than 100 publications and edited and was principal contributor to the textbook Cardiovascular Disease and Diabetes (McGraw-Hill). Dr Clark has received numerous awards and honors, including the Harvard University Alumni Lifetime Achievement Award for Excellence in Medicine. He is the current President of the Health Science Center at Brooklyn Foundation (HSCB Foundation), SUNY Downstate Medical Center.

Giselle Corbie-Smith

Dr. Giselle Corbie-Smith is nationally recognized for her scholarly work on the inclusion of disparity populations in research, and has over a decade of experience in using community engagement to conduct innovative, translational health equity research. Her empirical work, using both qualitative and quantitative methodologies, has focused on the methodological, ethical, and practical issues of research to address racial disparities in health. A Kenan Distinguished Professor in the Departments of Social Medicine and Medicine at the UNC School of Medicine in Chapel Hill, NC, Dr. Corbie-Smith has served as the Principal Investigator of several community-based participatory research projects focused on disease risk reduction among rural racial and ethnic minorities. These projects have include funding through the National Heart Lung and Blood Institute, the Robert Wood Johnson Foundation, the National Center for Minority Health and Health Disparities, the National Institute of Nursing Research, Greenwall Foundation, and the National Human Genome Research Institute. Dr. Corbie-Smith is accomplished in drawing communities, faculty, and health care providers into working partnerships in clinical and translational research. This engagement ultimately transforms the way that academic investigators and community members interact while boosting public trust in research. She has also shown a deep commitment to working in North Carolina by bringing research to communities, involving community members as partners in research, and improving health of minority populations and underserved areas. In 2013, she established and became Director of the UNC Center for Health Equity Research (CHER) to bring together collaborative multidisciplinary teams of scholars, trainees, and community members to improve North Carolina communities’ health through shared commitment to innovation, collaboration, and health equity. Dr. Corbie-Smith is currently the Co-PI for RWJF’s Advancing Change Leadership Clinical Scholars Program, which provides intensive learning, collaboration, networking, and leadership development to seasoned clinicians to create a community of practitioners promoting health equity across the country. She recently served as the President of the Society of General Internal Medicine (SGIM). In 2018, she was elected to the National Academy of Medicine.

M. Khair ElZarrad

Dr. M. Khair ElZarrad is the Deputy Director of the Office of Medical Policy (OMP) at FDA’s Center for Drug Evaluation and Research (CDER), where he leads the development, coordination, and implementation of medical policy programs and strategic initiatives. Dr. ElZarrad currently leads multiple projects focused on exploring the potential utility of real-world evidence, innovative clinical trial designs, and the integration of technological advances in pharmaceutical development. Dr. ElZarrad is the rapporteur for the International Council for Harmonisation’s ongoing work to revise the international Good Clinical Practice Guideline (ICH-E6(R2)). Prior to joining the FDA, he served as Acting Director of the Clinical and Healthcare Research Policy Division with the Office of Science Policy at the National Institutes of Health (NIH). At NIH, he worked on policies related to human subject protections; the design, conduct, and oversight of clinical research; and enhancing quality assurance programs at pharmaceutical development and production facilities. He earned a doctoral degree in medical sciences with a focus on cancer metastases from the University of South Alabama, as well as a master’s degree in public health from the Johns Hopkins Bloomberg School of Public Health.

Jennifer Goldsack

Jennifer Goldsack is the Executive Director at the Digital Medicine Society (DiME), a new professional organization promoting the adoption of digital technologies for health. Previously, Ms Goldsack spent several years at the Clinical Trials Transformation Initiative (CTTI) where she led development and implementation several projects within CTTI’s Mobile Program and was the operational co-lead on the first randomized clinical trial using FDA’s Sentinel System. Ms Goldsack spent five years working in research at the Hospital of the University of Pennsylvania, first in Outcomes Research in the Department of Surgery and later in the Department of Medicine. More recently, Ms Goldsack helped launch the Value Institute, a pragmatic research and innovation center embedded in a large academic medical center in Delaware. Ms Goldsack earned her master’s degree in chemistry from the University of Oxford, England, her masters in the history and sociology of medicine from the University of Pennsylvania, and her MBA from the George Washington University. Additionally, she is a certified Lean Six Sigma Green Belt and a Certified Professional in Healthcare Quality. Ms Goldsack is a retired athlete, formerly a Pan American Games Champion, Olympian and World Championship silver medalist.

Richard A. Moscicki

Dr. Richard A. Moscicki is the executive vice president of science and regulatory advocacy and the chief medical officer at the Pharmaceutical Research and Manufacturers of America (PhRMA). Dr. Moscicki came to PhRMA in 2017 after serving as the deputy center director for science operations for the U.S. Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) since 2013. While at FDA, Dr. Moscicki brought executive direction of Center operations and leadership in overseeing the development, implementation, and direction of CDER’s programs. Previous positions include serving as chief medical officer at Genzyme Corporation from 1992 to 2011 where he was responsible for worldwide global regulatory and pharmacovigilance matters, as well as all aspects of clinical research and medical affairs for the company. He served and a senior vice president and head of clinical development at Sanofi-Genzyme from 2011-2013. Dr. Moscicki received his medical degree from Northwestern University Medical School. He is board certified in internal medicine, diagnostic and laboratory immunology, and allergy and immunology. He completed his residency in Internal Medicine, followed by a fellowship at Massachusetts General Hospital (MGH) in clinical immunology and immunopathology. He remained on staff at MGH and on the faculty of Harvard Medical School from 1979 until 2013.

Amy Patterson

Dr. Amy Patterson is the Chief Science Advisor and Director of Scientific Research Programs, Policy, and Strategic Initiatives in the Immediate Office of the Director (IOD) of the National Heart, Lung, and Blood Institute (NHLBI), part of the National Institutes of Health (NIH). In this role, she provides leadership and strategic coordination of trans-NHLBI efforts and manages a broad portfolio of issues germane to the conduct of clinical research, research oversight, policy development, major new scientific initiatives, and relationships with organizations within and external to the Institute.
Prior to joining the NHLBI in 2015, Dr. Patterson served as the NIH Associate Director for Science Policy and as the NIH Associate Director for Biosecurity and Biosafety Policy. Her responsibilities encompassed areas such as human subjects protections; the organization and oversight of clinical trials; scientific, social, and ethical considerations in genetics research and human gene transfer trials; and safety and security implications of emerging new technologies.
Prior to coming to the NIH Office of the Director, she served as the Deputy Director of the Division of Cellular and Gene Therapies and Medical Officer in the Division of Clinical Trial Design and Analysis at the FDA Center for Biologics Evaluation and Research. Dr. Patterson received her B.A. (Cum Laude) in biology from Harvard University and her M.D. (Alpha Omega Alpha) from Albert Einstein College of Medicine. She conducted her internship and residency in internal medicine at New York Hospital and Memorial Sloan Kettering and completed her post-doctoral clinical research fellowships in adult and pediatric endocrinology and metabolism at the NIH.

Joseph Scheeren

Dr. Joseph Scheeren started his pharmaceutical industry career in 1982 with Servier in Paris, responsible for Regulatory Affairs Northern and Eastern Europe, and Clinical Development in Munich from 1986 - 1987. In 1991, he was appointed Head of Worldwide Regulatory Affairs at Serono, Geneva. In 1992, he took over responsibility of the Global Regulatory Affairs department of Roussel UCLAF in Paris. In 1996, he moved to New Jersey to head the Global Marketed Product Regulatory Affairs Department of Hoechst Marion Roussel. After the merger with Rhone Poulenc Rorer in 2000, he was nominated to a similar position. Dr. Scheeren joined Bayer Pharmaceuticals as Senior Vice President, Head of Global Regulatory Affairs (GRA), in 2004, responsible for development in the US and in 2009 became Site Head US in Montville, NJ. In 2012, he assumed in addition to his responsibilities as Head of GRA, the position of Head of Global Development Asia in Beijing and in 2015, was appointed Head of GRA Pharma and Consumer Care of Bayer Healthcare, Basel. In January 2018, he was appointed Senior Advisor R&D, Bayer AG in Berlin and left Bayer AG at the end of 2018. Since January 2019, he is Adjunct Professor at Peking University for Regulatory Sciences in the Department of Clinical Research. He became President & CEO of Critical Path Institute in April of 2019, headquartered in Tucson, Arizona. Dr. Scheeren holds many memberships and designations, serving on Advisory Boards at the Center for Innovation in Regulatory Science, the Regulatory Affairs track at Yale University, and the Center of Regulatory Excellence in Singapore. He is also a foreign member of the Academie Nationale de Pharmacie, France, and a lecturer at Yale University. Dr. Scheeren studied pharmacy at the University of Leiden.

Anantha Shekhar

Dr. Anantha Shekhar is a nationally recognized researcher at University of Pittsburgh School of Medicine. Dr. Shekhar was named executive associate dean for research affairs in August 2015, overseeing all research-related activities at the Indiana University School of Medicine. He is one of six executive associate deans who make up the school’s executive leadership team with Dean Jay L. Hess, MD, PhD. Dr. Shekhar is the founding director of the Indiana Clinical and Translational Sciences Institute (Indiana CTSI), a statewide institute within Indiana University School of Medicine, supported by a CTSA grant from the US National Institutes of Health and established in 2008 as a joint partnership of Indiana University, Purdue University, the University of Notre Dame and numerous life sciences businesses and community organizations. The Institute’s mission is to assist in the rapid translation of new discoveries into novel treatments. In addition to his roles with the Indiana CTSI and IU School of Medicine, Dr. Shekhar is the Associate Vice President for University Affairs, Indiana University; Executive Vice President of Academic Affairs for Clinical Research, IU Health; August M. Watanabe Professor of Medical Research, Professor of Psychiatry, Neurobiology and Pharmacology & Toxicology at IU School of Medicine.

Pamela Tenaerts

Dr. Pamela Tenaerts is Executive Director of the Clinical Trials Transformation Initiative (CTTI).
Dr. Tenaerts works closely with the CTTI Executive Committee to develop and implement strategies to accomplish CTTI’s mission. She provides senior level oversight of the day-to- day operations of CTTI and orchestrates efforts to effectively engage all interested stakeholders to improve the conduct of clinical trials. She is a member of PCORI's CTAP expert post-award subcommittee and MIT’s Collaborative Initiatives Clinical Trials Process Expert Advisory Board, a Member of the Advisory Council North America, DIA. With more than 20 years’ experience in the conduct of clinical trials across a number of sectors, she practiced medicine in both the emergency department and private practice setting for several years before embarking on a career in research. Most recently Dr. Tenaerts oversaw European operations for CoAxia, a medical device company focused on cerebral ischemia. She received her MD from Catholic University of Leuven, Belgium, and a MBA from the University of South Florida. She speaks five languages and has obtained Six Sigma Green Belt certification.

Chris Yoo

Dr. Chris Yoo has over 25 years of experience in advancing cutting-edge biomedical information technology. He is the founder and CEO of Systems Imagination, Inc., which offers advanced cognitive computing technology to translate big data into valuable insights. At IBM, he was instrumental as Head of Strategy and Planning for IBM’s Information Based Medicine business, a new unit that pioneered the infusion of high performance computing and research into the nascent fields of personalized medicine and molecular therapeutics based on genomics. Throughout his career, he has also held leadership positions at Cisco, Oracle, and Applied Biosystems. As a serial entrepreneur, Dr. Yoo has created value in new companies that accelerate the adoption of smarter, technology-based systems such as cognitive computing, big data analytics, and knowledge engineering. He has founded and successfully engineered the exit of startups including MedTrust Online, the world’s first and largest online community of cancer doctors treating difficult cases with molecular medicine knowledge. He has also founded Golden Gateway Partners, a trans-Pacific technology consulting company, TransMed Partners, the first boutique consultancy for translational medicine, and LabBook, the first electronic laboratory notebook for HCLS researchers. In addition to his leadership roles at Systems Oncology and Systems Imagination, Dr. Yoo is also a Faculty Associate in the College of Health Solutions at Arizona State University. Dr. Yoo received his PhD in Cell and Molecular Biology from Yale University, and completed his postdoctoral fellowship at UC Berkeley.

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Envisioning a Transformed Clinical Trials Enterprise for 2030 - A Workshop

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