Choosing to grow their biotechnology sectors can offer developing countries vast opportunities, helping them to grow economically, providing new jobs, and supporting sustainable development, public health, and environmental protection.
In recent times, significant growth has been achieved by the developing world in biotechnology fields, mainly tied to food production, healthcare, and other dimensions of human well-being. This is thanks to the fact that biotechnology can actually provide developing countries with an opportunity to adopt technologies that can be tailored to their own environmental and societal needs.
But, alongside the opportunities come many challenges, all of which need to be overcome by these countries before a successful biotech sector can be implemented.
“In order for developing countries to have a thriving biotech industry they need
education (awareness), the right health and safety products, and the regulatory watch dogs inspecting and enforcing the laws. I call this the triangle of success. A country can have the regulatory pressure and lots of money to spend, but without education and awareness, a biotech sector will not take off,” commented Ramin Najafi, chief executive officer (CEO) and founder of Emery Pharma, founder of NovaBay Pharmaceuticals, and founder of CP Lab Safety.
Government commitment to biotechnology in developing countries
Without structured public support, growing a successful biotech sector can be extremely difficult, with local talent and small biotech companies in developing countries instead looking elsewhere – to the developed world – to gain capital in order to advance their projects.
Therefore, governments need to be interested in easing the costs of investments for biotech startups and creating a robust innovation policy that can enable a successful biotech ecosystem in their domestic market.
Ways in which they can do this include financing cutting-edge R&D through partnerships with biotech startups, supporting the creation of specialized biotech incubator labs, and facilitating clinical trials and regulatory modernization.
Cem Zorlular, CEO of Er-Kim Pharmaceuticals, provided Turkey as a good example of how developing countries can go about building their biotech sector with government support and innovation, after the country has put a high emphasis on tiered growth of the local biotech and pharma industry.
The first step for the government here was to replace imported generics with locally manufactured products, before expanding into local biosimilars and having a local biotech environment.
“…They have built a centralized innovation driver similar to other countries, which we call TÜBİTAK, which basically has, not only research centers, but also has grants that they give to universities. These grants are determined more from what is the right level of innovation we should strive for, as opposed to basic level research,” explained Zorlular.
“So, we’ve seen these grants turned into very specific outcomes a bit faster than if they were open-handed grants, so we were able to start manufacturing locally biosimilars and now that has expanded into building a locally grown PD-1 (for example)…so the government has been able to incubate a very good ecosystem in a world where these technologies have been a bit too advanced for developing countries.”
Following the correct procedures
Cutting corners may seem tempting for developing countries when building their biotech sector, so that they can get ahead faster, but there are many reasons why this isn’t a good idea, and why the correct procedures should be followed at all times, particularly with regard to lab safety.
As a recent investigation into the Chinese biotech sector by the Washington Post suggested, not adhering to safety measures when conducting research with dangerous, highly infectious pathogens could carry the danger of starting another pandemic. The report shows that, despite China pouring billions of dollars into lab construction and genetic engineering in an effort to become a ‘science superpower’, safety practices have failed to keep up.
The potentially grievous consequences of not following best practices is exactly why any developing countries looking to grow their biotech sector need to be extremely cautious and thorough.
“Regarding chemical or pharmaceutical research where many different hazardous chemicals may be utilized, a thoughtful plan must be in place to manage employees, and environmental safety, otherwise there is a danger that those activities could harm employees and the environment. In regards to biological research, a careful risk analysis must be conducted prior to any activity. Those risk analyses should include the potential of biologics, contaminating employees and the environment, and how to prevent that from happening in the first place,” said Najafi.
Although the correct procedures should be followed, it can be challenging for developing countries to implement all the necessary safety measures when conducting trials.
“This is due to several challenges. Experience is a crucial factor for success, but other considerations include: resource limitations, collaboration, communication, and knowledge transfer with international partners and research institutions, logistics, and limited or poor capacity of regulations to meet international standards. Additionally, financial constraints, lack of trained personnel, cultural and ethical issues, and limited access to the latest information can also pose challenges,” explained Jessie Wang Ph.D, senior director, cancer pharm and cell support/general manager of Crown Bioscience, Taicang, China.
However, she added that, with support from the international community in the form of funding, technology transfer, and training programs, it is possible for these countries to overcome the challenges mentioned and ensure that trials are safe and effective. Plus, collaboration with international organizations and regulatory bodies can help to ensure trials are conducted in accordance with international standards and ethical guidelines.
Furthermore, Wang pointed out that data reliability is also important, and that following the correct procedures and safety measures to standardize protocols ensures that the data collected is accurate, reliable and reproducible, so it can be used as a reference in human trials.
If everything is done correctly, biotechnology in developing countries can bring great opportunities, from economic growth, job creation, and an overall better healthcare system.
Economic growth is particularly important for any developing country, and one such way this can be achieved is through attracting study sponsors to the country with a credible and trustworthy biotech sector, along with low costs.
Sergey Jakimov, co-founder and managing partner of LongeVC, suggested Ukraine was a great example of having a healthcare and biotech sector that was able to attract study sponsors to the country and bring in a lot of money, prior to the Russia-Ukraine war.
“…The specialist workforce was there, the infrastructure and the clinical facilities were there, but the cost was seven to eight times lower – the cost per patient was seven to eight times lower – and if you look at the statistics, the amount of clinical trials that big pharma was conducting in Ukraine prior to the war was staggering, and these were major clinical trials, mind you; these were oncology, these were neurodegenerative, these were cardiovascular diseases,” said Jakimov.
Now, he said the same strategy is being repeated in Latin America, in countries such as Brazil and Argentina, with numerous clinical trials taking place there.
It goes to show that, if developing countries can overcome the challenges they face when attempting to grow their biotech sector, they could certainly end up reaping the benefits that biotechnology has to offer.