Cuba has five COVID-19 vaccines in clinical trials and is on track to receive emergency use authorization from the country’s regulatory agency to begin mass vaccination with two of those candidates: Abdala and SOBERANA 02. Results from phase 1 and 2 trials of these vaccines, the first developed and produced in Latin America, have been […]

To the Editors:The COVID-19 pandemic has led to collapse of national health systems across the globe, overwhelmed by the imbalance between health care needs and availability of human and material resources. To control and prevent further transmission, Cuba has developed intersectoral strategies in which the biotech industry has been deeply involved.[1,2] One of several products […]

This MEDICC Review roundtable gathers some of Cuba’s top researchers in the fields of vaccines and biotechnology, all of whom work in institutions belonging to BioCubaFarma, the umbrella company of Cuban biotech and pharmaceutical R&D, production, distribution and export. Founded in 2012, the company is comprised of 34 enterprises with 61 lines of production and […]

ABSTRACT
Forty-three years after it was founded, with billions of dollars invested, the global biotech industry is still not positioned as a mature low-risk sector for the international investor community. Despite the clear commercial success of a number of leading companies and overall growth of the industry’s revenues, most biotech companies are not profitable and many fail to overcome the formidable barrier constituted by the high cost of the sector’s research and development. However, over the last four years, visible signs of change have appeared, which could be harbingers of an approaching turning point in this trend.

This article analyzes the historic background of the biotech industry’s business models and corporate structures, as well as

their impact on the industry’s financial framework. It examines recent changes implemented by the sector’s main actors—including young startups, venture capital funds and big pharma companies—to mitigate financial risk associated with development of new biotechnology products.

Finally, it discusses the challenges and opportunities that these tendencies entail for Cuban biotechnology development and proposes adoption of business policies more tolerant of the financial risk inherent in this sector, as a condition for attracting venture capital.

KEYWORDS Biotechnology, fund raising, risk management, entrepreneurship, Cuba

Every year, meningococcal infection by Neisseria meningitidis causes over 500,000 cases and 85,000 deaths in the world, with 20% of survivors suffering sequelae. In Cuba its incidence in 1980 reached 5.9 cases per 100,000 population; about 80% of cases were serogroup B, prompting health authorities to declare meningococcal disease the country’s main public health problem.

Several provinces reported over 120 cases per 100,000 children aged <1 year, overwhelmingly serogroup B. At that time, no vaccines existed with proven efficacy against N. meningitidis serogroup B, nor was there a vaccine candidate that could be successful in the short term. By 1989, researchers in Havana had developed a Cuban meningococcal B and C vaccine, VA-MENGOC-BC, the world’s first against serogroup B meningococcal disease. Its efficacy of 83% was demonstrated in a prospective, randomized, double-blind, placebo-controlled field study. Vaccine production used vesicle or proteoliposome technology for the first time. The same year, the World Intellectual Property Organization awarded its gold medal to the main authors of the VA-MENGOC-BC patent.

The vaccine was used in a mass vaccination campaign and later included in Cuba’s National Immunization Program, with a cumulative impact on incidence of serogroup B meningococcal disease greater than 95% (93%–98%). Mass, systematic vaccination shifted the spectrum of meningococcal strains in healthy asymptomatic carriers and strains circulating among population groups toward nonvirulent phenotypes. The disease ceased to be a public health problem in the country. VA-MENGOC-BC is the most widely applied vaccine against serogroup B meningococcal disease in the world. Over 60 million doses have been administered in Latin America. In several countries where it has been applied, in which strains other than the vaccine-targeted strains circulate, VA–MENGOC–BC has demonstrated effectiveness against all (55%–98% in children aged ≤4 years and 73%–100% in children aged >4 years). The vaccine and its proteoliposome technology have had an impact and continue to have potential, not only for meningococcal disease, but also for development of other vaccines and adjuvants.

KEYWORDS Neisseria meningitidis, meningococcal disease, meningococcal vaccine, biotechnology, pharmaceutical industry, bacterial meningitis, meningococcal meningitis, immunization, vaccination, Cuba

Cuba’s public health outcomes are rooted in political and social phenomena that have favored achievement of health indicators well above expectations for an economy of its size. A less studied causal component of Cuba’s development in health is the creation, from early in the 1960s, of scientific research capacity throughout the health system, including use of science to launch a domestic industry for manufacturing high-tech products. This component should play an even greater role in meeting Cuba’s 21st century health challenges, especially the demographic and epidemiological transitions, increasing prevalence of chronic diseases, rapid emergence of a complex-product biotechnology pharmacopoeia, greater molecular stratification of diseases, rising health costs, and the need to maintain communicable diseases under control in a global context of climate change and more population mobility.

Tackling these challenges will demand greater scientific influence in the health system, application of a scientific approach in all activities and at all levels, and integration with scientific endeavors of other sectors such as agriculture, industry and education.

KEYWORDS Public health, science, health care costs, health workforce, chronic disease, biotechnology, immunology, aging, Cuba

In 1961, the USA severed diplomatic relations with Cuba, and in 1962 an embargo was imposed on trade and financial relations with that country. It was not until five decades later that the USA and Cuba would reestablish relations. This opened the way for the New York State Trade Mission to Cuba in April 2015, during which Cuba’s Molecular Immunology Center and Buffalo, New York’s Roswell Park Cancer Institute signed a formal agreement that would set in motion biotechnology research collaboration to address one of the most important causes of death in both countries. Significant research from Cuba led to this groundbreaking collaboration. The purpose of this paper is to discuss the development of this cooperation, from the Molecular Immunology Center’s initial investigations, through the opening of a phase I clinical trial at Roswell Park Cancer Institute with therapies developed at the Center. This cooperation was responsible for the first clinical trial for CIMAvax-EGF involving advanced-stage non-small cell lung cancer patients in the USA. A license was also approved by the US Department of the Treasury’s Office of Foreign Assets Control authorizing a commercial partnership for development of biotechnology products, combining the cancer research efforts of both institutions. This unusual collaboration between Cuba and the USA—the US economic embargo and travel restrictions not withstanding—opens good prospects for expanded medical research between the two countries. While political and logistical challenges remain, the shared mission and dedication of these Cuban and US scientists points the way towards relationships that can lead to development, testing, approval and use of promising new therapies for cancer patients.

KEYWORDS Biotechnology, clinical trials, cancer vaccines, cancer immunotherapy, non-small cell lung cancer, NSCLC, Cuba, USA

This roundtable began with world-renowned US and Cuban experts in arboviruses (particularly those transmitted by mosquitoes) but was quickly transformed with the participation of globally recognized scientists in other fields. All have contributed and continue to contribute to the often frustrating efforts to advance bilateral health cooperation, for the benefit of the USA, Cuba and the world. Each from their own vantage point argues why such cooperation can release potential to create scientific synergies capable of addressing some of the most perplexing and urgent global health problems.

Intersectoral action in health refers to actions led by the health sector based on coordinated national and local policies, strategically oriented to address priority health issues where actions by other sectors can have a decisive impact on health outcomes. A Cuban example of this approach is the joint efforts by the Ministry of Public Health and the biotechnology industry in development and application of technologies for cervical cancer screening, early detection and treatment. The resulting products have been used by the National Health System since 2010, as part of efforts to reduce cervical cancer mortality. This is an example of intersectoral action intended to identify and contribute to solving problems affecting people’s well-being and quality of life.

KEYWORDS Cancer, intersectoral action, biotechnology, cervical cancer, early diagnosis, colposcopy, health technologies, Cuba

The article presents global data on access to pharmaceuticals and discusses underlying barriers. Two are highly visible: pricing policies and intellectual property rights; two are less recognized: the regulatory environment and scientific and technological capacities. Two ongoing transitions influence and even distort the problem of universal access to medications: the epidemiologic transition to an increasing burden of chronic non-communicable diseases; and the growing role of biotechnology products (especially immunobiologicals) in the pharmacopeia. Examples from Cuba and Brazil are used to explore what can and should be done to address commercial, regulatory, and technological aspects of assuring universal access to medications.

KEYWORDS Biotechnology, biological products, clinical trials, drug costs, economics, pharmaceutical, pharmaceutical preparations, intellectual property, patents, access to health care, world health, Cuba, Brazil