ABSTRACT Virologist Dr María Guadalupe Guzmán is recognized as a global leader in dengue research and heads the Pedro Kourí Tropical Medicine Institute’s work as a WHO/PAHO Collaborating Center for the Study of Dengue and Its Vector. The Institute (IPK) was founded in 1937 and is now Cuba’s national reference center for the diagnosis, treatment, control and prevention of communicable diseases. Dr Guzmán is also president of the Cuban Society of Microbiology and Parasitology and directs IPK’s Scientific Council, which is responsible for setting the Institute’s research priorities. A recent h-index analysis found that Dr Guzmán is among the most widely-published and cited Cuban researchers. As part of the National Intersectoral Commission for COVID-19, IPK was integral to the design of Cuba’s COVID-19 Prevention and Control Plan, approved in February 2020, more than a month before the first cases were confirmed in Cuba. This included the three-tiered biosafety training program for frontline health professionals, designed and launched at IPK, which built on the institution’s experience preparing Cuban doctors who served in West Africa with the Henry Reeve Emergency Medical Contingent during the 2014–2016 Ebola outbreak. As of this writing, the Contingent has served in 39 countries fighting COVID-19. Prior to departure, members were trained in biosafety at IPK. Today, IPK conducts COVID-19 testing and research and provides patient care. The institution is supported by an integrated national network of diagnostic laboratories, hospitals and isolation centers. In addition to research related to the clinical evolution and epidemiology of COVID-19, IPK has several studies under way on its diagnosis, pathogenesis, kinetics, immunity and genetics. In July 2020, Dr Guzmán, along with 7 other Cuban specialists, was appointed to the InterAcademy Partnership’s (IAP) COVID-19 Expert Group, a 60-member, multi-disciplinary group comprised of researchers from around the world. The group is designed to promote knowledge sharing and regional and international collaborations concerning the coronavirus using a multisector approach that takes into account the health, social and environmental factors related to the disease. This MEDICC Review interview took place in early July, a few days before the Cuban IAP appointments were announced.

ABSTRACT On August 13, 2020, Cuba’s national regulatory agency, the Center for Quality Control of Medicines, Equipment and Medical Devices (CECMED), authorized clinical trials for SOBERANA 01—Cuba’s first vaccine candidate and the first from Latin America and the Caribbean. On August 24, parallel Phase I/II double blind, randomized, controlled clinical trials were launched at clinical sites in Havana to evaluate the vaccine’s safety and immunogenicity. Analysis of results and development of different formulations are currently under way and Phase III clinical trials are planned for early 2021. At the time of writing, a second vaccine candidate, SOBERANA 02, was in late-stage development and preparing to begin separate trials this fall. Cuba’s biotech industry, comprised of more than 30 research institutes and manufacturing companies in the state-owned conglomerate BioCubaFarma, has developed and distributed vaccines according to international standards of good clinical and manufacturing practices and protocols for decades. BioCubaFarma supplies over 800 products to Cuba’s national health system—349 of those are on Cuba’s Basic Drug List, the medicines approved for use in the country’s health system. Additionally, BioCubaFarma has 2438 patents registered outside Cuba and its products, including vaccines, medicines and medical equipment, are in 100 simultaneous trials at 200 clinical sites and are registered and sold in more than 50 countries. These factors proved advantageous for making a fast, confident pivot towards COVID-19 vaccine development. Specifically, these antecedents meant all necessary technical capacities and regulatory certifications were already in place. Founded in 1989, CECMED was certified as a WHO Level 4 Regulatory Authority of Reference for vaccine control (the highest certification level conferred) in 2017; also in 1989, a team at Cuba’s Finlay Vaccine Institute led by Dr Concepción Campa, developed VA-MENGOC-BC, the world’s first safe, effective vaccine against serogroup B meningococcus; and in 2000, Cuba’s recombinant hepatitis B vaccine received WHO-PAHO pre-qualification. To date, millions of people in Cuba and elsewhere have been immunized against a variety of diseases with vaccines from the island. Shortly after COVID-19 was declared a pandemic by WHO, this expertise was marshaled to develop a Cuban vaccine against the disease. Researchers from the Finlay Vaccine Institute (IFV), the Molecular Immunology Center (CIM) and the University of Havana’s Chemical and Biomolecular Synthesis Laboratory, with support from other BioCubaFarma enterprises, are leading the project aimed at delivering a safe, effective vaccine in 2021. The SOBERANA team, which is working on two vaccine candidates, SOBERANA 01 and SOBERANA 02 and several formulations thereof, is led by Dr Vicente Vérez-Bencomo, IFV Director, Dr Yury Valdés Balbín, IFV Deputy Director; and Dr Dagmar García Rivera, IFV’s Director of Research, a post she has held since 2014. A vaccine expert with a PhD in pharmaceutical sciences, Dr García Rivera is recognized for her multiple contributions to Cuban science, including development of a pneumococcal conjugate vaccine that is concluding Phase III clinical trials in preparation for introduction into the country’s national health system. She was awarded Cuba’s Annual Health Prize, the national prize of the Cuban Academy of Sciences on three occasions, and in 2019, received the Carlos J Finlay Order of Merit. Dr Garcia Rivera has represented Cuba in meetings of WHO, UNICEF and other multilateral organizations. In late September, with safety and immunogenicity trials for SOBERANA 01 continuing apace, Dr Garcia Rivera paused her feverish work schedule for this exclusive interview with MEDICC Review.

How does a developing island nation, beleaguered by climatic challenges and 60 years of adverse geo-political pressures become a beacon of scientific innovation, medical services and applied research—all on a shoestring budget? What’s more, how does such a country, rooted in a traditional patriarchal paradigm, overcome barriers to create a scientific and medical community where the majority of researchers and professionals are women? These are some of the questions that motivated MEDICC Review to publish this series on Cuba’s women in STEM (science, technology and math). Spanning a variety of themes and disciplines exploring the history of women and science; the role of female protagonists in the development of Cuba’s public health and biopharmaceutical sectors; and results produced by women professionals and their colleagues, these interviews illuminate lessons learned and what strategies might be applicable, adapted and replicable in other contexts. This time, we explore the intersection of gender and race in Cuba, a country with the world’s thirdhighest percentage of female parliamentarians—many of them women of color. To help us better understand this complex topic, we spoke with Dr Lourdes Serrano, who served as Director of the Cuban Anthropology Institute* (under the aegis of the Ministry of Science, Technology and the Environment and the Cuban Academy of Sciences) from 1991 to 2005. During her tenure there, Dr Serrano’s research focused almost exclusively on gender and race, including the impact of structural and policy changes since 1959; the manifestations of discrimination and bias in contemporary Cuba; and the role of women in economic, cultural and political life. A lifelong scholar and teacher, Dr Serrano is currently professor at the University of Havana in the Cuban History and Caribbean Studies Departments, and also a coordinator of the Afro-Descendant Caribbean Women’s program in the University’s Caribbean Studies Department.

The 1980s were a watershed for Cuban research in medicine and health: significant financing and material resources buttressed a strategy to improve population health through enhanced biopharmaceutical innovation and clinical best practices applied to Cuba’s universal public health system. Redirecting research priorities and providing substantial public funding to tackle the top population health problems was a radical idea at the time, especially for a developing country like Cuba. Doing so has become a hallmark of Cuba’s scientific achievements and approach ever since. Among the institutions exemplifying this strategy is the Pedro Kourí Tropical Medicine Institute (IPK). Founded in 1937 with a research mission dedicated to parasitology and transmission of known tropical diseases, it wasn’t until the late Dr Gustavo Kourí Flores was appointed director in 1979 that IPK’s core objectives and facilities were expanded to include a comprehensive teaching component, a state-of-the-art clinical hospital to treat tropical and other communicable diseases, and an international collaboration strategy to facilitate knowledge and technology transfer. Today, IPK is Cuba’s national reference center for diagnosis, treatment, control and prevention of communicable diseases and is a regional leader in applied research into so-called neglected diseases—usually diseases of the poor. With departments of parasitology, bacteriology, virology, pharmacology and more, it’s a magnet for some of the country’s most accomplished scientists—most of them women—and a major contributor to Cuba’s portfolio of scientific products, research and publishing. This interview with virologist Dr María Guadalupe Guzmán, director of IPK’s Reference Center for Research and Diagnosis, is the third in MEDICC Review’s series on outstanding Cuban women in science and medicine. Recognized as a leading expert in dengue research, Dr Guzmán is also director of the WHO/PAHO Collaborating Center for Dengue and its Control and was president of the Arbovirus Diagnosis Laboratory Network of the Americas (RELDA) from 2010 through 2018. Currently, she is president of the Cuban Society of Microbiology and Parasitology, directs IPK’s Scientific Council that sets the Institute’s research priorities, and is a distinguished professor and author. In 2016, she published Dengue (Editorial Ciencias Médicas, Havana), the most comprehensive collection of original Cuban research available on the topic.

Art, education, health and nutrition: encouraging healthy eating at an early age is central to the World Food Programme’s (WFP) goals. To this end, using art as a learning and communications tool, the program sponsors WFP in Action, a drawing contest open to youngsters 5–18 years old. Cuba has participated in the contest nationally since the 1990s, and since 2002 has sent a selection of drawings annually to the international competition at WFP headquarters in Rome. In the 2018 edition of the contest, international judges received 5 drawings from each of 20 participating countries. Applying criteria of esthetic appeal, originality and artistic quality, they awarded 20 prizes. Four of the five drawings from Cuba were among the international prize winners. The WFP reproduces prize-winning images in calendars, t-shirts, and other materials to promote their programs and raise funds towards ending world hunger and child malnutrition. WFP began its collaboration with Cuba in 1963, providing emergency relief after Hurricane Flora devastated the island’s eastern provinces. Today, WFP programs in Cuba aim to boost food and nutritional security among the country’s most vulnerable populations, strengthen the food supply chain with an emphasis on high-protein beans (a Cuban dietary staple) and consolidate community resiliency and responsiveness in disaster risk management. MEDICC Review is pleased to reproduce this year’s four winning drawings by Cuban children—each of whom hails from a different province.

Throughout the 1980s, Cuban researchers at the country’s biotech campus known as the Scientific Pole were making innovative discoveries and began developing unique therapies and vaccines unavailable elsewhere in the world. The pace and level of innovation meant prioritizing the establishment of a dedicated, internationally‐certified institute for clinical trials. These and other accomplishments in science and related sectors, coupled with statistics revealing that 53% of all scientists in Cuba are women, prompted MEDICC Review to publish a series of interviews with outstanding Cuban women in science, technology and medicine. In this, the second installment in the series, we spoke with Dr María Amparo Pascual, a biostatistician, researcher and professor, and the driving force behind the design and establishment of Cuba’s Clinical Trials Coordinating Center (CENCEC). From 1991 to 2014, Dr Pascual served as founding director of CENCEC. During that time the center implemented internationally-recognized good clinical practices (GCP), launched the National Clinical Trials Coordinating Network to support trials overseen by CENCEC, began conferring master’s and doctoral degrees in clinical trials; initiated a quality management system for all trials (receiving ISO 9001 certification in 2008) and created the Cuban Public Registry of Clinical Trials—a bilingual, WHO–accredited Primary Registry, the first in the Americas. In 2013, the BBC recognized Dr Pascual as one of the most infl uential female scientists in Latin America for her achievements, including becoming Cuba’s first biostatistician and her work at CENCEC. In 2014, Dr Pascual stepped down as director of CENCEC but didn’t slow down or leave the center she helped build, literally from the ground up: she currently serves as management consultant and researcher at CENCEC, as well as director of the Research Ethics Evaluation System Project there. She is also a professor in the Center’s clinical trials graduate degree program and of bioethics at the Medical University of Havana. She is finishing her doctoral dissertation on clinical trials in Cuba and the founding and evolution of CENCEC.