Category Archives: Biotechnology

BAYER, GINKGO BIOWORKS FORM JV “JOYN BIO”

Wax Selection – Leaders in Pharma, Biotech & MedTech Recruitment

Today, Bayer and Ginkgo Bioworks announced the official name of its joint venture, Joyn Bio.

Bayer and Ginkgo founded Joyn Bio in September 2017 and have since established research operations in Boston, Massachusetts and opened additional facilities in West Sacramento, California. Joyn Bio was founded with the goal of bringing advanced techniques in synthetic biology to agriculture to support the industry’s sustainability efforts, starting with reducing the environmental impact of nitrogen fertilizer.

The plant microbiome living in roots and soil is vital to global farming practices, as it provides nutrients to plants, protects them from pests, and aids them in difficult environmental conditions. Joyn Bio’s first effort in this arena is focused on improving microbes’ ability to provide cereal crops their nitrogen requirements, offering major benefits for sustainable agriculture by reducing the need for additional chemical fertilizers.

“Nitrogen fertilizer is a key component in modern agriculture, but is costly, damaging to the environment and challenging to dose precisely. We are committed to bringing innovations to the agriculture industry that give growers a smarter and more sustainable way to grow our food,” said Johan Kers, Head of Nitrogen Fixation, Joyn Bio. “I’m thrilled to be Joyn Bio’s first employee and help the team in creating a solution that benefits growers and our environment.”

While nitrogen fixation is Joyn Bio’s first focus area, the company is exploring other disruptive applications of synthetic biology in the agriculture industry. The name Joyn Bio references the partnering of the two parent companies, as well as the natural symbiosis between plants and microbes, which is the foundation of the company’s mission.

In addition to the initial USD $100 million Series A investment by Bayer, Ginkgo, and Viking Global Investors LP, Ginkgo is providing access to its organism design technology, laboratory, and office spaces, as well as outfitting a new facility specifically for Joyn Bio. Bayer is providing exclusive access to its own archive of microbial strains and the necessary development intelligence for the application of microbes onto seeds in agriculture.

“We are excited to engage the broader life science community through Joyn Bio. As we establish the company’s scientific programs, this partnership will provide us with state-of-the-art infrastructure and access to the vibrant biotech innovations of the Boston area and agriculture expertise within the Crop Science division of Bayer and their global network of ag customers,” said Dr. Mike Miille, CEO of Joyn Bio. “Advancing our mission even further, we’re looking forward to bringing together the brightest minds in synthetic biology and AgTech as we grow the company.”

The Joyn Bio team is currently characterizing Bayer’s extensive library of more than 100,000 proprietary microbial strains using the high-throughput advanced analytics of Ginkgo’s foundries. The unprecedented scale of biological data generated using the sophisticated foundry tools is enabling Joyn Bio to identify the strains and characteristics necessary to further develop nitrogen fixing bacteria for sustainable agriculture.

Joyn Bio is the 5th investment of Leaps by Bayer, a unit of Bayer investing in the solutions to some of today’s biggest problems. Previous Leaps investments include Casebia (CRISPR/Cas technology) and BlueRock (induced pluripotent stem cell technology).

Joyn Bio has recently entered into an agreement for approximately 20,000 square feet of laboratory and office space within Ginkgo’s Boston Seaport facility hosting up to 30 employees and forming the company headquarters. Additional research efforts are performed at the West Sacramento facility, a global Bayer R&D site for microbial-based solutions in agriculture with 160,000 square feet, over 200 researchers, a state-of-the-art pilot plant, and greenhouses. Joyn Bio’s West Sacramento presence will initially be located in the recently opened, “CoLaborator,” which is Bayer’s newest biotech startup lab space dedicated to housing and fostering innovative ventures to transform modern agriculture.

To date, Joyn Bio has 10 employees split across the two sites and is actively recruiting for scientific positions related to synthetic biology, plant-microbe interactions, and soil ecosystems. Joyn Bio will have its own scientific leadership and management team enabling the company to run as an independent and sustainable organization. For more information, visit www.joynbio.com.

About Joyn Bio
Joyn Bio is a joint venture founded by Bayer and Ginkgo Bioworks developing probiotics for plants to provide growers with next generation solutions to their biggest challenges. Joyn Bio’s first area of focus will be on engineering microbes that provide cereal crops with their nitrogen needs to reduce agriculture’s reliance on nitrogen fertilizer and its environmental impact. Joyn Bio brings together microbiologists, synthetic biologists, plant scientists, and ecologists at its headquarters in Boston, Massachusetts and its plant research facility in West Sacramento, California.

For more information, visit www.joynbio.com.

SOURCE: www.agrimarketing.com

 

How Cuba Became a Biopharma Juggernaut

Wax Selection – Leaders in Pharma, Biotech & MedTech Recruitment

We hear little about the Cuban biopharmaceutical industry, but it merits attention.

The sophisticated system, which the small island nation developed despite limited resources and access to international markets, holds about 1,200 international patents and sells medicine and equipment to more than 50 countries. The industry is entirely publicly funded and managed, and is a key component of one of the most efficient public health care systems in the world. Its goal is to develop drugs of strategic importance to the health care of all people.

igh-tech industrial development isn’t the first thing that comes to mind for many when thinking of Cuba. The island nation more commonly invokes visions of a stunning place frozen in time: Crumbling colonial buildings sit alongside beautiful beaches, while 1950s American cars line city streets awash in the sun’s afternoon glow. Here, life is embedded in a state-controlled and mostly inefficient economy that’s virtually detached from global technology networks.

But there’s something missing in this outsiders’ view of the country, as it can’t account for the enormous successes of Cuba’s biopharmaceutical[1] industry and health care systems. In light of ongoing debates in the U.S. and other nations about the role of government in ensuring people have the health care coverage they need, Cuba’s experience could prove instructive.

There is growing evidence of the Cuban biopharma industry’s success. Local production covers more than 60% of finished pharmaceutical products used in the country, and the industry’s trade balance has remained consistently positive for most of the period 1995-2015. Cuba’s biopharma sector has been able to finance many programs carried out within the nation’s public health system, and it is the main reason behind the affordability of the medical products supplied by the system. In terms of the biotechnology sector specifically, while Cuba’s government does not publish extensive statistics on the matter, industry officials report that the Cuban biotech sector managed to maintain positive, if modest, cash flows at a time when overall cash flows of the industry worldwide had been mostly negative for decades.[2]

While not popularly understood outside the country, Cuba’s biopharma achievements have been recognized by the international scientific community. In 2005, the Laboratory of Synthetic Antigens, a small lab that belongs to the faculty of chemistry of the University of Havana, won the World Intellectual Property Organization (WIPO) Gold Medal Award for developing the world’s first synthetic vaccine (Quimi-Hib) against haemophilus influenza type b (or Hib). More recently, the CIMAvax-EGF vaccine for lung cancer became the first Cuban biopharmaceutical product to earn the U.S. drug regulator’s permission to carry out clinical trials on American soil. The product was developed by the Center for Molecular Immunology, which specializes in antibodies, cancer medicines, and other areas.

Had Cuba been forced to acquire most of its needed medical products at current international prices—rather than develop them on its own—it would not have been able to achieve its  remarkable health advances at a relatively low cost. No matter how well intentioned the government might have been with respect to public health, it would not have been able to subsidize an entire country’s essential medicines. Cuba has, of course, followed a different model, prioritizing domestic innovation and production.

It’s true that high levels of innovation make the Cuban biopharma industry an exception within the country’s overall industrial sector, which lags behind in many areas. However, it has not been an exception in terms of the environment in which it has grown. The architecture of Cuba’s health care system, and the nation’s public investment in free education, research, and innovation, have all been critical factors in the biopharmaceutical industry’s success story, making it a testament to the complexities of economic development, as well as of the role of history and institutions in shaping structural change.

Meeting the Needs of Universal Public Healthcare

Essential to the success of Cuba’s biopharmaceutical industry is the country’s public health care system, which was designed to meet the medical needs of the entire population. The organizing principle of the biopharma industry—as a result both of economic necessity and of Cuba’s publicly stated values—has been producing affordable medicines. It is supported by Cuba’s medical philosophy, which prioritizes prevention—the only viable path for a poor country to provide universal healthcare affordably. The public health care system demands that the industry produce low-cost, high-quality products, and supports it in doing so. As a result, Cuba has become a successful exporter of medical products, particularly biopharmaceuticals.

It all began with an emergency. Before the 1959 revolution, the Caribbean island had been home to a number of highly-trained, well-respected physicians. But nearly half of them left for the United States following a disagreement with the revolutionary authorities over institutional changes they were implementing. The government’s new measures included a unified regulatory framework for all levels of the system—which prior to the revolution had been painfully fragmented—along with a 15% price reduction for home-grown medical products and a 20% cut for imports. The changes provoked foreign companies that dominated the Cuban market, which until that moment had been free to set prices for their products without government regulation, as well as the laboratories, retailers and medical personnel linked to them. The clash led to many closures and other actions, creating a supply crisis that resulted in the nationalization of the industry in 1960.

Those events happened within the context of an already widespread public rejection of profit-seeking medical practices, which encouraged the government to intervene in private clinics and hospitals and to change the country’s philosophy of medical education. At that time, medical guilds were among the most powerful associations in the country, and also were among the most wary of the transformations that were taking place, for both political and financial reasons. From 1959 to 1967, a country with six million inhabitants lost 3,000 of its 6,300 physicians (not including new graduates in those years) and found itself with just 22 professors of medicine and a single medical school. They were sorely needed just as the new government-initiated reforms—designed to increase the availability of health services to underserved areas—were taking effect.

Their exodus prompted state investment in medical education—including the creation of a comprehensive primary care system—while priorities in training doctors shifted to focus on preventative medicine. The guilds disbanded in 1966 as a government-based nationwide union was created, and those in favour of deepening the changes were now free to carry out the project. Medical graduates had already been encouraged to serve in rural medical facilities and not engage in private practice. However, even when the government strongly discouraged, and eventually prohibited, opening new private clinics, a number of practices that already existed and complied with the new measures were allowed to continue. Until the public health system absorbed the last non-public clinics in 1970, the Cuban healthcare system, as it did before the revolution, consisted of three types of healthcare services: public provision, mutual clinics and private provision.

During the first half of 20th century, large public hospitals emerged in the country and provided free services, but they were limited to major cities and were chronically underfunded prior to 1959. Mutual clinics were created by mutual societies of Spanish origin and functioned within cooperative framework. In return for a monthly fee, members of these societies received high-quality medical services of high quality. At the same time in the first half of the 20###sup/sup### century, a significant network of private clinics flourished. They also provided high-quality services, but mostly worked on the profit principle, excluding the millions of people who could not afford to pay. The creation of rural services and other reforms were part of the government’s efforts to provide truly universal access to health services, and to encourage a new ethos of cooperation and solidarity within the medical profession.

Some testimonies of those involved as students at that time show that, even if the government deployed a good deal of ideological exhortation and public relations to attract new graduates for rural medical services, these graduates could choose where they wanted to work. Some decided to go to private clinics or to better-remunerated posts, but most decided to serve in remote rural places out of ideological or civic concerns.

These developments need to be seen within the context of the time and the atmosphere of ideological confrontation that served as inspiration for many young people. Many of them decided to put aside better pay and more comfortable working conditions in favour of serving higher ideals. Government efforts could also be interpreted as a huge behavioural intervention aimed at replacing external motivations for practicing medicine related to prestige and salary for more internal motivations related to personal fulfilment from serving a higher purpose.

The system these graduates were joining, and that Cuba was building, involved an open atmosphere of knowledge-sharing and cooperation. In the context of a centralized, nationwide system, the Cuban health care sector is able to save both time and money. To be sure, “centralized” means that methods and services are standardized and centrally designed. However, medical care and education, even if public, was conceived as a decentralized network of community clinics and hospitals equipped to tailor services to the local population’s needs.

In addition, the focus on primary care ensures the system can collect and synthesize community-based information about the population’s health and disease patterns. This data collection is part of a bigger project: Cuba’s comprehensive, integrated national medical record system determines where greatest health risks to society lie, allowing the government to more efficiently allocate resources. This structure can also substantially reduce drug development because it speeds up informed-consent enrollment in clinical trials—the backbone of drug and treatment development. The government intentionally designed the system in this way to further organizational learning and social efficiency.

The Role of Free Education and Early Investment in Science

Another important part of the Cuban biopharma success story is the broader crusade the government has carried out in favour of more education and scientific research. The resulting investments allowed the country to absorb and translate knowledge into innovative, world-class products.

While the Cuban biotech industry started developing in earnest in the early 1980s, its foundation dates back far earlier. Most Cuban biotechnology research centres emerged from already-existing research groups and labs. But with the exception of maintaining key personnel, most new institutions had to be built from scratch after the revolution, with the support of the Cuban state’s intense investment in scientific research since the 1960s.

One of the most important transformations experienced by Cuban academic medicine during the 1960s was the integration of scientific research into the government’s public healthcare strategy. The period prior to the revolution saw the development important medical scientific institutions. But they had developed because of the individual perseverance of their founders rather than consubstantial elements of public healthcare strategy. Some key examples include the Institute of Cancer, created in 1929, and the Institute for Tropical Medicine, created in 1937. Most research institutions, however, disintegrated in 1959 because their founders had political differences with the government; most of them left the country. A very small, select, group of experts stayed. They, together with younger, inexperienced professors sympathetic to the new government, as well as a significant number of foreign experts invited to teach, helped rebuild the scientific landscape in Cuba. They sophisticated it to an extent unknown in country’s history.

The main organization, born in 1965, is the Centro Nacional de Investigaciones Cientificas (CNIC). Many industry leaders in Cuba received their first scientific training at CNIC, originally a non-profit staffed by a small group of recently-minted physicians. These doctors had answered the government’s call to dedicate themselves to biomedical research. CNIC also employed chemists and engineers of different specialties. As remuneration was far from attractive and the training very demanding, only those really interested in science, and with the talent to afford the task, applied to be graduate students or researchers at CNIC. That first year only 13 students were selected to take the training. There is a testimony of one scientist who, prior to entering the training, turned down a salary of 600 Cuban pesos as assistant professor in favour of a residency in microbiology, where the salary was only 200 pesos. For him, it was about devotion to science.

The main goal of CNIC in its first years was to increase young medical graduates’ knowledge of the sciences and mathematics, and to initiate them into research tasks. It was a postgraduate school designed to produce high-level scientists. To that end, CNIC organized a series of courses and practices taught by Cuban and foreign professors. After taking these courses, several young researchers won graduate scholarships to study in Western and Eastern European countries, which exposed them to the leading research in their fields. Institutions such as the Pasteur Institute, Harvard University, Heidelberg University and Zurich University, to name just a few, hosted Cuban researchers during or after their formative years in CNIC. The fact that the beginnings of the Cuban biotech industry were developing at the same time as the beginnings of genetic engineering worldwide helped put Cuban institutions at the leading edge of the technological frontier.

As it developed, this multi-disciplinary institution became a hub for chemical and biological experimental research and an incubator for Cuba’s other scientific institutions. For example, as early as 1978, researchers at CNIC´s Microorganism Genetic Department knew about the possibility of recombination and were already working on the genetics of microorganisms and molecular biology. In simple terms, recombination involves constructing brand new genetic material (DNA molecules) by mixing (or combining) genetic material from different organisms. In 1986, U.S.-based biotechnology company Chiron developed the technology to obtain a genetically engineered (or DNA recombinant) hepatitis B vaccine; that same year, the Cuban recombinant vaccine was developed using a cheaper method.

A small but impactful neurophysiology unit created within CNIC in 1966 became Cuba’s Neurosciences Centre in 1990. It’s worth noting that the pioneer of the field in Cuba—and founder and current director general of the Cuban Neuroscience Centre—co-authored of a foundational paper with a renowned American neuroscientist. The Centre made Cuba the world’s first public health system to systematically use the quantitative electroencephalogram (qEEG)—a test that analyses the brain’s electrical activity to identify defects or problems.

Since the 1990s, CNIC adopted the form and function of a typical company by focusing on developing products and integrating a trading arm into its structure. But its origin as a focal point of the industry reflected the culture of cooperation that distinguishes the Cuban biopharma industry. Even if the core biotech firms within the industry function under what Cuban officials call a “closed cycle” system (a fluid form of vertical integration), formal or informal co-development are the signature of the industry. The complete realization of CNIC’s most innovative products has often been the result of some sort collaboration between at least two companies. This risk-sharing model has also become a very effective way of providing access to international markets, often in the form of carefully conceived partnerships, technology transfers, licensing and co-marketing agreements.

Cuba’s Enduring Scientific Success

Given this early investment, Cuba’s biopharma industry has evolved rapidly over the past four decades. Tracing its development over that period reveals the resourcefulness and commitment of the Cuban government and the island’s scientists. It also reveals the industry’s breakthrough scientific success.

The Scientific Pole, also known as West Havana Biocluster, was officially created in 1992. Its origins date from 1980 when oncologist Richard Lee Clark, who had served as president of the first cancer hospital in the U.S., travelled with a North American delegation to the island. There he met several Cuban government officials, with whom he discussed his groundbreaking research on interferon, considered a “wonder drug” in the battle to cure cancer. Shortly thereafter, Clark hosted two Cuban scientists at his hospital in Houston, Texas, sharing his research and expertise.

At the direction of Clark, Cuban researchers travelled the following year to the Helsinki-based laboratories of Dr. Kari Cantell, who first isolated interferon from human cells in the 1970s. Six Cuban scientists spent a week working with Cantell and his colleagues learning how to reproduce interferon in large quantities. Upon their return home, they set up a special laboratory in a small house in Havana to try to reproduce the Finnish results and produce interferon in Cuba. By the end of that year, 1981, they had succeeded. Eventually, the product proved not to be a wonder drug against cancer, but instead beneficial against dengue fever—an outbreak of which severely affected Cuba in the 1980s.

In the years that followed, the government policies helped implement a number of additional small pilot projects run by new interdisciplinary working groups, such as the Biologic Front in 1981 and the Center for Biological Research in 1982. When the United Nations Industrial Development Organization (UNIDO) decided to create an institution of excellence for the transfer of biotechnology to developing countries, Cuba applied for the vacancy but lost out to India. Determined to move forward, the Cuban Government then decided to create its own organization with its own resources.

By 1986, Cuba inaugurated CIGB (Centro de Ingeniería Genética y Biotecnología), now one of the country’s most outstanding biotechnology companies. Other important institutions followed. Among the most representative is the Immunoassay Center, created in 1987 to producing and commercializing diagnostic systems. The Finlay Institute opened officially in 1991, and the Center for Molecular Immunology in 1994. Many of these institutions have helped Cuba sell millions of dollars’ worth of biopharmaceutical products.

Greater integration with the rest of the world’s markets could increase the country’s already positive pharmaceutical trade balance from $86 million in 2015 to $119 million by 2020, according to estimates from Business Monitor International (BMI) Research. These are, of course, modest results compared with the performances of leading nations. However, they become impressive when you consider the point of departure and the fact that the biotechnology industry worldwide has historically found it very hard to achieve positive cash flow.

Looking at specific drug succeses, Cuba has produced a number of innovative drugs and vaccines as a result of advances in its biotech sector. Alongside the lung cancer and Hib vaccines mentioned earlier in this article, it has also produced policosanol (PPG), a pharmaceutical derived from sugarcane that reduces morbidity and mortality from atherosclerotic cardiovascular disease. CNIC developed the product, which won a World Intellectual Property Organization (WIPO) gold medal in 1996. Another gold medal winner was Heberprot-P, a novel biomedicine developed by the Centre for Genetic Engineering and Biotechnology (CIGB) for treating foot problems in diabetics. It won the WIPO Award for Best Young Inventor and a WIPO gold medal at the International Inventions Fair in 2011.

Often, these drug innovations from Cuba fail to get the recognition they deserve. Cuba’s VA-MENGOC-BC®, for example, was the first world’s commercially available vaccine against serogroup B meningococcus. The product, developed by the vaccine-focused Finlay Institute, was awarded WIPO’s gold medal in 1989. At the time, it attracted attention from the pharmaceutical giant SmithKline Beecham (now part of GalaxoSmithKline)—but not from the media. Many years later, Swiss drug maker Novartis was mistakenly credited with developing the first vaccine of its kind to fight Meningitis B. Cuba had the drug 24 years earlier[3].

The Upsides and Downsides of Government Involvement

There’s no doubt that Cuban biopharma is an exception within the country; Cuba’s overall economy lags behind in both regional and world rankings. Chronic underperformance and lack of dynamism have been recognisable features for decades. Most sectors in Cuba have a long way to go in terms of international competitiveness, particularly after the economic crisis sparked by the collapse of the Soviet Union, Cuba’s main trade partner during the Cold War. After 1991, and more visibly since 2008, the government introduced several reforms aimed at boosting the economy. But deep inadequacies remain unresolved.

Studies of these structural problems dominate the literature on contemporary Cuba and permeate the current conversation on the subject. Most of them, regardless of ideological persuasion, largely look at on the macroeconomic consequences of, and possible solutions for, these shortcomings. And yet, whether coming from a sympathetic or a downright hostile perspective, most commentators admit that Cuba has created an impressive medical workforce that has produced results.

But if international audiences are more or less familiar with the fact that Cuba has managed to achieve successful health outcomes in many basic indicators—relative to averages for similar populations—it is far less understood that a major factor producing these achievements is a sophisticated industry that sells medicine and equipment to countries around the world.

An exception was a 2009 editorial published by the magazine Nature, which said Cuba had “develop[ed] the world’s most established biotechnology industry, which has grown rapidly even though it eschewed the venture-capital funding model that rich countries consider a prerequisite.”

It’s true: Cuban biotech is a 100% government investment. It’s a sector whose development has avoided the financialized model that has shaped the industry worldwide. And yet, well beyond Cuba, a government as acting as investor in high-tech industries is no new thing. Particularly in the biopharmaceutical industry, government investment has played a critical role in most every country. Consider the U.S. government’s National Institutes of Health (NIH) support of the creation of American biotech, or the programs of the German Federal Ministry of Education and Research, among many other examples. There is actually nothing unusual about the Cuban government’s investment and its strong involvement in biotechnology.

The singularity may come with the fact that Cuba is not only a developing country hindered by a robust economic embargo, but also a communist-socialist country with (until very recently) a fully state-controlled economy, of which the 100% state-owned Cuban biotech sector is part. The business of producing medical products was largely underdeveloped in Cuba before the revolutionary government got involved: foreign subsidiaries controlled 50% of the market, importers accounted for a further 20%, and local generic production was accountable for the remaining 30%. In the 1960s, the government acquired private local producers, and foreign producers reduced imports and closed their plants. In the 1970s, in order to minimize the impact of the U.S. embargo, the government began its first investments in pharmaceutical production plants. Initially, drug purchases from both Western and Eastern Europe complemented these efforts. Then came the biotech.

One does not need to admire the Cuban political system to recognize the success of what observers deemed Cuba’s “billion dollar biotech gamble”: a reference to the seemingly unrealistic decision to invest $1 billion in the 1980s and the 1990s to develop the sector. It’s a “gamble” that has turned out to be the most successful Cuban R&D programs, and one that can serve as a model for other nations.

The lion’s share of today’s Cuban biotech industry is concentrated in BioCubaFarma, a state holding created in 2012 with the government’s economic reforms[4]. It is a vast holding that comprises 33 companies that host more than 21,600 workers—hundreds of them highly-skilled professionals deeply integrated within several research-production activities. One of its explicit goals is to double the exports of the Cuban biopharmaceutical industry to reach more than $1 billion per year within five years. That would have totalled $5.076 billion—a huge difference compared to the previous five years, which saw total exports of $2.779 billion. Whether the industry has achieved this goal is hard to say given the lack of data, so a reasonable assessment of BioCubaFarma’s performance will need to wait.

There are factors that would have helped Cuba achieve this goal, and others that could have hindered it. One aspect that would have helped is the re-establishment of diplomatic relations with the U.S., which relieved many potential buyers and investors from some of the pressures associated with the economic sanctions. On the other hand, the industry needs to do more to incentivize its workers. While in the past, even in the middle of the crisis of the 1990s, qualified personnel were willing to work hard despite lesser financial gains, that doesn’t seem to be so much the case now.

An excessive focus on financial rewards has not helped incentivize workers; in fact, it has proven one of the downsides of the new economic measures introduced since 2008. Important wage increases have taken place since 2014 especially in the health sector, benefiting more than 440,000 healthcare workers, who in most cases saw their salaries grow by more than 100%.

These wage increases do not appear to be having their intended effect of retaining a motivated workforce and boosting productivity; in fact, they appear to be negatively impacting the motivational balance of the biotech workforce. They may have over-stimulated the financial awareness of some employees to the point of irritation, and to the detriment of internal motivation. The industry has seen 40% of its workforce quit over the last two years. Not all of those leaving are scientists, but it is still an alarming number.

Even with all the challenges, in 2014 and 2016 $1.293 billion and $1.940 billion has been saved, respectively, by import substitution. Still, the government needs to better understand behaviour in innovative organizations, and which measures will encourage or discourage employee motivation—a key element in the good functioning of those organizations. If the success of the Cuban biotech actually depended on the high remuneration of their employees, this industry would simply not exist as it does today.

Defying Simplistic Analysis

There is no way one can digest Cuba’s biotech story while relying on conventional narratives on economics and economic development. Adhering to traditional frameworks, and failing to engage in an accurate institutional analysis, would make it impossible to understand how a cash-driven, high-tech industry successfully developed in a poor, developing country.

Because the island is in many ways a singular place, observers inevitably find themselves referring to its many particularities as explanations for the sector’s success. Almost all traditional studies contain important reflections related to institutional questions and other issues specific to Cuba. However, most of these discussions tend to underplay the complex relationship among institutions, innovation and economic development. They tend to end on a static, pessimistic note of conclusion. The analysis of, for example, property rights, ownership, competition, regulation, corporate governance, and related issues is coloured by the simplistic and linear, one-size-fits-all tendencies of neoclassical economics.

As cross-country historical evidence suggests, structural change is a highly idiosyncratic process, which usually works in far more complex ways than assumed. Technological conditions in an economy are the result of non-linear interactions among cultural, geographical, historical and socio-political elements, rather than pre-determined assumptions about behaviour. Innovation is, by most accounts, a messy, uncertain process, which often has little to do with the straightforward causalities conventional narratives offer. Too often, liberalization and privatization are presented as inalienable and natural preconditions, and it becomes impossible to engage in analysis outside that framework. If we want to truly understand the formation and evolution of innovative firms and industries, we need to analyse them in their contexts and be open to what may emerge.

And so it happens that what emerges from a nuanced analysis often has a very unfamiliar face for contemporary audiences. When properly examining Cuban industry, for example, we discover powerful stories that challenge the homogenizing nature of most traditional studies of innovation, with their emphasis on property rights and returns to inventors. The Cuban biotech industry undoubtedly represents the most successful case of science and technology policy in that country’s economic history.

It is also a case that illustrates how having a competent and motivated scientific workforce is a determining factor in a country’s ability to upgrade its economic structure. Cuban scientists learned about biotech when few in the world believed in its potential. They grew along with the research, and therefore were in a better position to take the lead in developing unique innovations. It was, and still is, a risky move, but that’s the history of economic development. This finding opens up scope for other sorts of reflections on the Cuban context in particular, and could ultimately help reshape policymakers’ choices regarding future industrial projects.

Of course, the whole issue inscribes itself within the of-the-moment discussion on the legitimacy of the government’s role as science and technology sponsor. The Cuban example in many ways shows us the good sides of public health and the virtues of a well-calibrated government policy. Of course, Cuba’s path does not need to be mandatory for everybody, but it may be valid for many. And learning about it may help us overcome our own biases—as economists and as human beings.

________

[1] In the Cuban context, the term “biotech” is interchangeable with “biopharma,” and this article uses the terms in this way unless otherwise noted.  Biopharmaceuticals are the products you obtain through the biotechnology process; in other words, biotechnology creates biopharmaceutical products.

More specifically, from a definitional standpoint we understand the biopharmaceutical industry in the way most academics and practitioners (including in the U.S.) usually do, i.e., as a subset of a huge industrial sector devoted to the production of medical products, be they chemically (in the case of pharmaceuticals) or biotechnologically (in the case of biopharmaceuticals) produced. In Cuba this industry is mostly identified with the biotechnology because it is this subset the one that has become commercially relevant, which in turn has contributed to push forward the pharmaceutical side of the industry (mostly in form of generics for the domestic market). Again, this piece uses the terms “biotech” and “biopharma” interchangeably to refer to the Cuban biotech; it makes particular sense for the Cuban case and doing so is compatible with mainstream definitions.

[2] This reference to negative cash flow points to the aggregate results of the biotechnology firms, whose historical performance has been on the whole disappointing in terms of profitability and cash flow. This assertion does not include the traditional pharmaceutical companies, but it has implications for the future of many pharmaceutical firms that are more and more dependent on their biotech subsidiaries, or on their alliances with biotech firms—to the point that they can no longer be definitionally separated.

[3] In 2013 Novartis, received approval from the European Union to market its Bexsero against Meningitis B. The U.S. Food and Drug Administration (FDA) granted accelerated approval in January 2015. The international press has erroneously presented this vaccine as the first of its kind that has successfully fought the condition. Even if the new vaccine is said to be designed for different strains, it is not the first commercially available version—nor, as often repeated by the press, was it the first to be successfully employed in a nationwide meningitis B programme for children. Cuba’s VA-MENGOC-BC®, which also has the potential to fight several strains, has been used in Cuba and other countries for more than two decades with impressive results.

[4] The entity derived from the merger of all institutions of the Scientific Pole in western Havana, the biotechnological side of the industry, and all companies within the Quimefa Group, which represented the traditional Cuban pharmaceutical industry. Quimefa was a state holding created in 2001 devoted to producing small molecules (chemically-based drugs), mostly generics, to substitute for imports.

[1] In the Cuban context, the term “biotech” is interchangeable with “biopharma,” and this article uses the terms in this way unless otherwise noted.  Biopharmaceuticals are the products you obtain through the biotechnology process; in other words, biotechnology creates biopharmaceutical products.

More specifically, from a definitional standpoint we understand the biopharmaceutical industry in the way most academics and practitioners (including in the U.S.) usually do, i.e., as a subset of a huge industrial sector devoted to the production of medical products, be they chemically (in the case of pharmaceuticals) or biotechnologically (in the case of biopharmaceuticals) produced. In Cuba this industry is mostly identified with the biotechnology because it is this subset the one that has become commercially relevant, which in turn has contributed to push forward the pharmaceutical side of the industry (mostly in form of generics for the domestic market). Again, this piece uses the terms “biotech” and “biopharma” interchangeably to refer to the Cuban biotech; it makes particular sense for the Cuban case and doing so is compatible with mainstream definitions.

[2] This reference to negative cash flow points to the aggregate results of the biotechnology firms, whose historical performance has been on the whole disappointing in terms of profitability and cash flow. This assertion does not include the traditional pharmaceutical companies, but it has implications for the future of many pharmaceutical firms that are more and more dependent on their biotech subsidiaries, or on their alliances with biotech firms—to the point that they can no longer be definitionally separated.

[3] In 2013 Novartis, received approval from the European Union to market its Bexsero against Meningitis B. The U.S. Food and Drug Administration (FDA) granted accelerated approval in January 2015. The international press has erroneously presented this vaccine as the first of its kind that has successfully fought the condition. Even if the new vaccine is said to be designed for different strains, it is not the first commercially available version—nor, as often repeated by the press, was it the first to be successfully employed in a nationwide meningitis B programme for children. Cuba’s VA-MENGOC-BC®, which also has the potential to fight several strains, has been used in Cuba and other countries for more than two decades with impressive results.

[4] The entity derived from the merger of all institutions of the Scientific Pole in western Havana, the biotechnological side of the industry, and all companies within the Quimefa Group, which represented the traditional Cuban pharmaceutical industry. Quimefa was a state holding created in 2001 devoted to producing small molecules (chemically-based drugs), mostly generics, to substitute for imports.

SOURCE: www.nakedcapitalism.com/2018/03

Slow-release injectable gel boosts toxicity of cancer-fighting immunotherapy drugs

Wax Selection – Leaders in Pharma, Biotech & MedTech Recruitment

An immunotherapy drug embedded in a slow-release hydrogel invented at Rice University in collaboration with the University of Texas Health Science Center at Houston (UTHealth) appears to be highly effective at killing cancer cells.

STINGel combines a new class of immunotherapy drugs called stimulator of interferon gene (STING) agonists with an injectable hydrogel that releases the drug in a steady dose to activate the immune system to kill cancer cells. It was developed by the Rice lab of chemist and bioengineer Jeffrey Hartgerink and Rice alum Simon Young, an assistant professor of oral and maxillofacial surgery at UTHealth.

In clinical trials, immunotherapy drugs have demonstrated strong cancer-fighting abilities. Research has also found that the drugs are flushed quickly from the body, and current trials require multiple injections.

The new research, which is detailed in Biomaterials, showed that slow-release peptide gels could continuously deliver immunotherapy drugs to tumor sites for long periods of time.

Hartgerink is a pioneer in the development of self-assembling multidomain peptide (MDP) hydrogels, which mimic the body’s extracellular matrix to encourage the growth of cells and vascular systems for tissue repair. The hydrogel is injected as a liquid, turns semisolid inside the body and slowly degrades over time.

The hydrogel in the new study is also welcoming to cells, but when the invaders are cancer cells, they’re in for trouble. Immunotherapy drugs known as cyclic dinucleotides (CDNs) await them inside the gel.

Hartgerink, a professor of chemistry and bioengineering, said the concentration of CDN in the hydrogel is important.

“The normal approach to CDN delivery is simple injection, but this leads to very rapid diffusion of the drug throughout the body and reduces its concentration at the site of the tumor to very low levels,” he said. “Using the same amount of CDN, the STINGel approach allows the concentration of CDN near the tumor to remain much higher for long periods of time.”

STINGel was studied both in lab cultures and in vivo. For the in vivo portion, six groups of 10 rodents each were treated with CDN alone, control collagens alone or with CDN, MDP alone or STINGel (CDN plus MDP). Only one in 10 CDN or collagen plus CDN animals survived 105 days, but six of 10 animals treated with STINGel survived. These also proved resistant to further implantation of cancer cells, meaning their immune systems were trained to successfully identify and destroy both the existing cancer and future occurrence of that cancer, Hartgerink said.

The lab tested more common hydrogels but found that they were unable to provide the same controlled release and also failed to provide an additional benefit over CDN treatment seen in clinical trials. “The MDP hydrogel provides a unique environment for the release of CDN that other gels just can’t match,” Hartgerink said.

“The CDN we used in this study is currently in clinical trials,” he said. “We think that our STINGel approach has the potential to significantly broaden the scope of this powerful immunotherapy drug to a larger range of resistant cancers.”

SOURCE: www.news-medical.net/news/20180307

Sanofi, Evotec in major infectious disease R&D transfer and license deal

Wax Selection – Leaders in Pharma, Biotech & MedTech Recruitment

Big Pharma Sanofi and German CRO-biotech drug discovery hybrid Evotec are penning a deal that will see Sanofi license out a host of infectious disease assets to the biotech, with 100 staffers also moving into its R&D engine.

Sanofi is paying a one-time, upfront fee of €60 million ($74 million) to Evotec, a small sum, but one backed up with a promise to “provide significant further long-term funding to ensure support and progression of the portfolio,” although exact financial details were not shared.

The deal drills down like this: Sanofi will license most of its infectious disease (ID) research and early-stage portfolio (around 10 assets all-told) and move this unit, with around Sanofi 100 staffers alongside it, into Evotec (although this does not include the French pharma’s vaccine R&D unit).

Evotec, which does its own research and also relies heavily on external collaborations with biopharmas and academic biomedical research, will run this “open innovation platform” near Lyon, France, where Sanofi Pasteur is HQ’d.

Sanofi holds on to certain option rights on the development, manufacturing, and commercialization of anti-infective products and will “continue to be involved in infectious disease through its vaccines research and development and its global health programs,” it says in a statement.

The focus of the Evotec drug discovery will be on “new mode-of-action antimicrobials,” the pair say.

Werner Lanthaler, Ph.D., CEO of Evotec, said: “Since the acquisition of Euprotec (UK) in 2014, Evotec has had a significant strategic interest and demonstrated expertise in infectious diseases research, with an ambition to grow and become the drug discovery and development leader in this space together with its partners.

“We are pleased to be working and expanding our strategic relationship with Sanofi, which has a long history in providing novel anti-infective agents to markets globally. Finding a way to motivate more public funding and academic initiatives for the progress of novel anti-infectives on Evotec’s platform will be a key success factor for this initiative.”

The deal is still being talked over, but should be done in the coming months.

Evotec already has a series of deals with the likes of Eli Lilly, Tesaro, Oxford University, and even has its own spin-out in the form of Topas Therapeutics.

Elias Zerhouni, M.D., president of global R&D for Sanofi, adds: “Research in the field of anti-infectives is an area where building critical mass through partnering is particularly important. This new French-based open innovation center will benefit from the high-quality science ecosystem. Evotec is a trusted partner in drug discovery and has the ambition and capacity to become a real leader in the fight against infectious diseases.”

This also comes as Sanofi continues to retool its R&D, getting back into cancer as well as blood disorders via its $11.6 billion deal for Biogen spin-out Bioverativ.

SOURCE: www.fiercebiotech.com/biotech

Big pharma could turn to viruses to boost cancer immunotherapies

Wax Selection – Leaders in Pharma, Biotech & MedTech Recruitment

Merck & Co’s $394 million acquisition of Viralytics has stoked interest in oncolytic viruses, a class of drugs that have been in the shadow of the checkpoint inhibitors and CAR-T therapies that are helping to set the standard of care in cancer.

But Merck’s deal to acquire Viralytics suggests this could be about to change, according to one of the Australian company’s close competitors, Norway’s Targovax.

Representatives of Targovax interviewed by pharmaphorum said the marketplace is set to get increasingly crowded in the future as pharma tries to use the approach to improve efficacy of checkpoint inhibitors.

There is only one FDA-approved oncolytic virus, Amgen’s Imlygic (talimogene laherparepvec) in 2015, but sales have been disappointing.

But with another 10 oncolytic viruses in clinical development, and another 40 in labs, the hope is that oncolytic viruses could be used to ‘prime’ tumours before treatment with checkpoint inhibitor immunotherapy, which has a response rate as low as 20% in some cancers.

Oncolytic viruses work by injecting genetic material into cancer cells, which modify them and make them visible to the immune system, which moves in to destroy the.

The issue with Imlygic is that it is approved as a monotherapy – and the thinking is that oncolytic viruses are likely to be more effective when used in combination with other drugs, notably immunotherapy drugs such as checkpoint inhibitors.

This is the approach taken by Viralytics, and by Targovax, which is looking to find partners as it progresses its two oncolytic viruses through the clinical trial process.

Now that Viralytics is effectively part of Merck & Co, this leaves Targovax as one of the most advanced independent biotechs working with oncolytic viruses.

Bristol-Myers Squibb has also done a big oncolytic virus deal, acquiring rights late last year to an “armed virus” targeting cancer from the UK biotech, PsiOxus Therapeutics, worth almost $900 million if the project is successful.

Merck deal ‘no suprise’

Targovax’s chief medical officer, Magnus Jaderberg, told pharmaphorum in an interview that the Viralytics deal came as no surprise following strong phase 2 results from its Cavatak, based on the Coxsackievirus, back in 2015.

Jaderberg said: “As soon as they released the data we felt that somebody would go after them and we were right. We were not surprised about the deal and we think it is very positive for us.”

He expects more interest in oncolytic viruses from Roche and Genentech, which so far have not done a big oncolytic virus deal, perhaps to boost their immunotherapy Tecentriq, which has produced some mixed results in trials.

Already partnered with Medimmune on one deal, Targovax is planning a phase 2 trial of its adenovirus-based drug TG01, targeting resected pancreatic cancer in combination with Merck’s Keytruda (pembrolizumab).

This could be extended to a phase 3 trial leading to registration in this disease, where there has been no significant progress for the best part of two decades CHECK.

Targeting RAS mutations, the drug could be used in 30% of all cancers that express this biomarker, suggesting a sales potential well in excess of the $400 million a year the company forecasts if approved in early pancreatic cancer.

Also in the Targovax pipeline is ONCOS-102, an oncolytic virus, which is in phase 1b/2 trials for mesothelioma and could produce an early readout in the coming weeks.

It is also developing ONCOS-102 in partnership with AstraZeneca’s MedImmune unit and the Cancer Research Institute for ovarian and colorectal cancer.

Jaderberg has been busy tapping up his contacts in big pharma having previously worked as chief medical officer for Bristol Myers Squibb in Europe.

He has already been in talks with manufacturers of checkpoint inhibitors to try and get licensing deals in place to fund further development.

Wiklund said: “It is tough as a small biotech to lift a phase 3 programme – it is obvious we are interested in licensing out one or both of our programmes.”

But Targovax’s CFO Erik Digman Wiklund was cagey about the prospects of a big buyout as seen in the case of Viralytics. “It is incredibly unpredictable, it is difficult to make any comment,” he said.

SOURCE: www.pharmaphorum.com/news

Microsoft transforms diagnosis with AI systems

Wax Selection – Leaders in Pharma, Biotech & MedTech Recruitment

The AI system aims to quicken the process of finding illnesses from blood tests.

Diagnosing patients just got a lot easier thanks to a Microsoft partnership with a biotech company that uses AI to check for multiple illnesses.

Taking the next step with technology in the healthcare sector, Microsoft has partnered with biotechnology company Adaptive to create a method for smarter blood tests using AI. The aim of using the technology is to check for hundreds of diseases at one given time, as a universal diagnostic tool.

The use of AI could drastically reduce the amount of time it takes for patients to be diagnosed, by having all types of cases catered for at one point, as well as putting patients through just one trawl of tests instead of multiple. In turn, the technology benefits doctors by saving them the job of carrying out multiple tests, when AI can do it in one swift move.

“We believe deeply in the potential for this partnership with Adaptive and have made a substantial financial investment in the company. We believe deeply in the potential for this partnership with Adaptive and have made a substantial financial investment in the company. With Microsoft’s help, adaptive biotechnologies will attempt to map the genetics of the human immune system or immunome,” Peter Lee, Corporate Vice President, AI and Research at Microsoft said.

Additionally, doctors hope that by checking for more than one disease at once will help with treatments by allowing doctors to look at correlations between different disease states and finding a better cure to target more than one illness.

The system will work by using AI to decode a patient’s immune system, come up with a diagnosis based on past trends and then treat disease with the best medication according to the system.

Adaptive Biotechnologies said to start with the two companies will focus on identifying diseases that are normally diagnosed at a later stage, such as pancreatic and ovarian cancer, and the AI system will help to identify these conditions much more easily and quickly in the future.

“Some conditions, like cancer or autoimmune disorders, can be difficult to diagnose,” said Chad Robbins, co-founder and chief executive officer of Adaptive Biotechnologies. “But this universal map of the immune system will enable earlier and more accurate diagnosis of disease.”

The partnership between the two companies is set to be discussed in further detail at the JP Morgan Healthcare Conference in San Francisco on Wednesday 10th January.

SOURCE: www.cbronline.com/news

National Market Access Lead, Associate Director

Wax Selection – Leaders in Pharma, Biotech & MedTech Recruitment

Are you truly making a difference?

This is the mantra for our client who focuses on developing innovative therapies for people coping with serious diseases the world over.

If you would consider yourself to be an expert on NHS funding and access policies and have a broad background in developing and executing strategic commissioning and access plans at a National level for highly specialised products, then we would like to speak with you.

Our client is a global biotechnology company with over 40 years of heritage working across multiple specialist therapy areas.

Ideally, we are looking for somebody with a background in developing and executing market access strategies for biologic products , and who is capable of working efficiently in a cross-functional matrix environment.

You do not need to have HEOR experience, however, working knowledge of budget impact modelling would be advantageous.

Why apply?

– Highly visible position working a priority area of the business

– Autonomous position reporting into an incredibly seasoned and empowering industry expert

– Collaborative and innovation focussed business environment

– Industry leading salary and benefits package with a big focus on wellness.

Process:

– Initial telephone interview with us on application, if you decide you would like to proceed further, we would submit your details to the hiring manager for review

– The second stage would be a relatively informal first stage interview with the hiring manager to ascertain fit both sides

– If you are still interested, and the hiring manager agrees! There will be an HR interview along with a structured assessment process which will include a variety of stakeholders from the business – it is likely that the process will extend into January 2018. However, our client is keen to close the position down within the next 4-6 weeks.

To discuss this position in detail or for any further information, please contact Wax Selection on 0844 8009021.

Symbiosis Pharmaceutical Services opens US office

Wax Selection – Leaders in Pharma, Biotech & MedTech Recruitment

Symbiosis Pharmaceutical Services, a Scottish contract manufacturing organisation (CMO) has opened an office in North America in response to continued demand from US-based biotechnology companies for its vial filling expertise.

The sterile filling specialist’s commercial site in Cambridge, Boston, MA, supports clients on both the East and West Coast, as well as giving the CMO a base for reaching new customers in this territory. The company is currently on a recruitment drive to strengthen its US commercial team.

Increased demand for both liquid and lyophilised formulations in injectable dosage forms at Symbiosis has been driven mainly by biotech firms looking for an outsourcing partner with small-scale aseptic manufacturing capabilities to support clinical trials.

Colin MacKay, CEO at Symbiosis Pharmaceutical Services, said: “Given Cambridge [Boston] is the epicentre of the global biotech community, it was the ideal location for us to open an office in the US. So far it has been a great success and we foresee that continuing as we continue to reflect the demand from US-based biotechnology firms looking for small-scale aseptic manufacturing resources.”

“Back in 2015, we took the decision to strategically focus on the North American market after we identified a surge in funding for early stage biotech companies, which are exactly the type of drug development company that are best suited to seek our manufacturing scale and specialist capabilities.”

“As expected, our expertise in filling biologic and small molecule products, combined with our ability to offer rapid access to sterile manufacturing slots, has been very well received by pre-clinical and phase I-II biotech and pharma companies, which has helped to fuel our steady growth.”

“Since strengthening our US-focused personnel and developing our relationships with networks like ISPE and MassBio, we have significantly grown our US client base, which is projected to account for around half of our revenues in 2017. Opening the office on the US East Coast has added to the success of the company’s growth strategy.”

For the last 12 months, Symbiosis has grown revenues by 40% and has also continued to recruit steadily, increasing staff by 30% to meet demand for its aseptic fill/finish service.

MacKay said: “At a macro level, demand for biologic and highly potent products is likely being driven by the increased emphasis on the development of treatments for small patient populations in the case of orphan indications, new oncology products requiring containment capabilities and novel tailored personalised medicines.”

“Those kind of products require specific GMP manufacturing skills for the small-scale production of sterile batches for clinical trials, hence the clear uptake in demand for what we do at Symbiosis.”

SOURCE: www.manufacturingchemist.com/news

Eurofins makes £4 million investment in new Scottish facility

Wax Selection – Leaders in Pharma, Biotech & MedTech Recruitment

Eurofins Scientific, a specialist in bioanalytical testing, has opened a new pharmaceutical chemistry and microbiology facility in Livingston, Scotland, following a £4 million investment.

The 5800 m2 facility will become one of the largest dedicated testing sites of its kind in the UK and the biopharmaceutical product testing (BPT) UK business, plans to double employee numbers in the next five years.

The new facility will allow the BPT business to expand its finished product and raw materials testing, and increase capacity to deal with higher volumes.

A greater number of technical specialists will also be available to work on method development and validation.

GMP microbiology contract testing will be a focus, alongside elemental impurity testing, which has benefited from the purchase of new equipment to enhance the capability of inductively coupled plasma mass spectrometry (ICP-MS) testing, enabling the company to meet growing demand for this service.

Eurofins will also invest in more high-performance liquid chromatography equipment, increasing its capacity by 40%.

Alison Clayton, General Manager, said the Livingston site would be one of the largest of all the Eurofins UK sites, which form part of a network of laboratories working together across the UK, Ireland and Europe.

“The large investment in the facility will position the company in the best place to attract new customers thanks to greatly increased capacity and is in line with Eurofins’ intent to attract significant future growth and development opportunities,” she said.

Eurofins BPT UK business will move from its current site in Newbridge, Edinburgh. The Livingston facility will also house new laboratories for Eurofins’ water testing business.

The investment follows Eurofins’ acquisition of Exova’s pharmaceutical, food and water testing business in the UK and Ireland in July 2016, and the subsequent purchase of ILS’s pharmaceutical business in October 2016.

Eurofins BPT UK’s work is critical to drug development compliance testing prior to products being released to market. The company is a crucial part of the supply chain in facilitating the release of products and ultimately benefiting patient health.

The business is part of Eurofins Scientific, an international life sciences company, which provides a unique range of analytical testing services to clients across multiple industries worldwide.

SOURCE: www.manufacturingchemist.com/news

Sterling invests £6m in new milling micronisation and solid form facility

Wax Selection – Leaders in Pharma, Biotech & MedTech Recruitment

Contract development and manufacturing organisation (CDMO) Sterling Pharma Solutions is investing £6 million into a new facility at its UK site to strengthen and expand its milling, micronisation and solid form capabilities.

The 40 acre site in Dudley, North East England, will meet growing demand for pharmaceutical API particle size control technology and expand Sterling’s laboratory capabilities to provide a full solid form offering including polymorph screening, salt selection, particle engineering and crystallisation scale-up.

Four new milling areas will house a range of new technologies, including mechanical milling, spiral jet milling and small lab scale trial mills. Supporting the CDMO’s expertise in handling potent and hazardous materials, the facility will also provide containment to handle OEB 4 classified molecules and offer ISO 8 cleanroom environments.

Kevin Cook, CEO at Sterling Pharma Solutions, said: “From our UK facility, we are building a global active pharmaceutical ingredient (API) services business with customers in the US, UK, Europe and Asia. This latest investment is an important step in bolstering our offering so we can cater for growing market demand, including the need for high potency capabilities to reflect the global drug pipeline.”

“We are proud that we can take products from proof of concept to commercial scale manufacturing all on one site and the new facility will strengthen our current offering by adding additional milling, micronisation and solid form capabilities.”

Established in 1969, Sterling’s site has a strong heritage in API services and a successful track record of compliance with both the MHRA and FDA. The investment forms part of a 15 month strategic development plan totalling almost £12m, which will also see the expansion of the CDMO’s GMP kilo laboratories and pilot plant.

Expected to be operational by mid 2018 the milling, micronisation and solid form facility will create more than 15 jobs in the next 18 months, bringing Sterling’s total workforce to around 400 employees.

Kevin continues: “Our strong growth can be attributed to a number of factors, including the emerging pharma sector in the US and big pharma demand for the complex and hazardous chemistries we provide. We have focussed our strategy on the diversification of our customer and product base, and have recently expanded our presence in the Asian markets including Japan. We will continue to invest to ensure we meet the diverse needs of our customers globally.”

SOURCE: www.manufacturingchemist.com/news/article_page