Largely opaque and proprietary R&D environments in the life sciences sector need to make way for strategies facilitated by sustainable investment models, open sourcing and multi-lateral partnerships, to deal with a growing threat from infectious/zoonosis diseases
“There are decades where nothing happens, and there are weeks where decades happen.” These words by Russian revolutionary, Vladimir Lenin describe the current scenario to a ‘T’.
Most of us have seen more disruptions over the last few weeks than probably ever before in our lifetime, especially if one is a millennial or younger. Yet, these times are also a watershed in terms of the lessons for mankind. The impact and implications of the coronavirus pandemic will shape new norms and mindsets, approaches and agendas worldwide for a long time to come.
Hopefully, it will also usher a more cohesive approach to the way we practise and publish scientific research. Because it is critical, especially in the life sciences industry to battle a growing threat from diseases of zoonotic origin.
Let’s look at some of the major factors that demand this shift:
Massive socio-economic fallouts of pandemics: Prashant Khadayate, Practice Head of Healthcare at GlobalData shares, “A 2019 joint report from the World Health Organization (WHO) and the World Bank estimated the impact of pandemics to cost to 2.2 per cent – 4.8 per cent of global GDP ($3 trillion), and this was estimated even before COVID-19 pandemic. The report further notes that, in such an event, South Asia’s GDP could potentially fall by two per cent ($53 billion), and sub-Saharan Africa’s GDP by 1.7 per cent ($28 billion).”
He explains the devastating impact of pandemics on the world with two more examples:
- In 2009, the H1N1 influenza pandemic in Mexico also had a profound economic impact. The outbreak directly affected tourism, the service sector, retail trade, transport, entertainment, the agricultural industry (particularly pig farmers), and depressed international investment. The outbreak is estimated to have reduced economic activity by 0.3 per cent to 0.5 per cent of gross domestic product (i.e. between $2.7 and $4.5 billion)
- In 2002/2003, SARS spread to 28 countries, affected around 8500 people worldwide, and claimed 800 lives. The numbers were relatively small compared with the 1.8 million people who die of diarrhoeal diseases each year and most of them are children. However, the economic impact of SARS on the global economy was enormous – an estimated $50–140 billion and thus its impact went well beyond those who were infected with the virus.
“This current COVID-19 outbreak has also shown us that the losses can be substantial, globally causing trillions in short-term damage with likely long-term socio-economic implications,” he adds.
Rohitashwa Prasad, Partner, J Sagar Associates elaborates, “Economies come to a halt, people across social strata lose jobs, and supply chains are disrupted causing shortages even for necessities such as food and medicines. The complex web of integration of the global economy ensures that these fallouts spread worldwide almost as fast as the pandemic itself. COVID-19 is a live example where we are seeing these issues unfolding in varying degrees across the world.”
Shifting focus of pharma companies: Over the past decade, many pharma companies had shifted their focus from infectious diseases to more areas like oncology, cardiac care and other lifestyle diseases. Explaining why, Prasad states, “Treatment for infectious diseases typically lasts for much less time than for chronic diseases – a week or 10 days compared to months or even a lifetime for the latter. Also, since infectious diseases are regarded as a public health issue, with a much greater incidence in poor countries, the likelihood that drugs to treat these will be subject to price controls is higher. Hence the returns that a drug company can expect on R&D expenses for developing drugs to combat infectious diseases is disproportionately lower.”
Secondly, he points out, “Vaccine development to prevent pandemics has not been a priority for Big Pharma because these are not profitable products in their portfolio. Firstly, the research and development, and manufacturing of vaccines are more expensive compared to other drugs. For example, clinical trials for vaccines take more time and are riskier. Secondly, a vaccine by its very nature is required not more than two or three times in the lifetime of a person. Thus, on balance, the cost-benefit and risk-reward profiles are skewed towards the former.”
But, this move has left the world exposed to outbreaks such as the one caused by the novel coronavirus.
Accelerating threat from zoonotic sources: “The world is staring at a looming infectious/zoonotic diseases crises,” points out Prasad. Khadayate also reiterates, “It is difficult to predict which pathogen will spur the next epidemic or pandemic. No one can predict where it will originate and at what level it will impact in terms of infection.”
Prasad cites AMR as an example to explain his point. “Imprudent use of antibiotics in the livestock industry for boosting production rather than for treating diseases, their indiscriminate prescription by doctors, and improper unsupervised use by patients, has resulted in the worldwide growth of antibiotic resistance bacteria. Several common infectious diseases already are untreatable by existing antibiotics. Many very important antibiotic drugs, it is feared, will lose their efficacy in the not-too-distant future. A 2019 U.N. report has warned that drug-resistant bacteria can cause up to 10 million deaths each year by 2050 and damage the global economy,” apprises Prasad.
Reimagining R&D with Open Science
Thus, for multiple reasons, the COVID-19 pandemic has made it imperative to reimagine R&D in the life sciences completely. It is glaringly obvious that the largely opaque and fortified proprietary R&D environments in the pharma and healthcare industries need to make way for more open strategies facilitated by differentiated investment models, data-sharing, a broader collaboration between stakeholders and multi-sectoral partnerships, especially in the area of infectious diseases/zoonotic diseases.
As Khadayate explains, “Research on infectious diseases considered to be global health challenges need to be broadly pursued in partnership with governments and philanthropic organisations through the public-private model.”
And, COVID-19 has highlighted that Open Science facilitated by Open Source, could be the key to solutions for public health challenges. Some leading proponents of these concepts explain how.
Enable faster drug development and discovery: New drug discovery and development is a long-process spanning over a decade and costing over $2 billion approximately. Reportedly, the average rate of failure in R&D is 95 per cent! However, open science strategies, have the potential to usher more efficient ways to research the life sciences sector. They can help fast-track drug and vaccine discovery and development by enabling the global scientific community to explore a wide range of indications and diseases in parallel and share learnings quickly through publications. This, in turn, reduces risks of failure, allows the researchers to focus on the most encouraging indications, optimises the effort, as well as minimises wastage and duplication.
Jaykumar Menon, International Chair and Co-Founder, Open Source Pharma Foundation outlines, “Open source has come to the fore. The standard models are too slow. We cannot wait 12 to 20 years for a drug.
They are duplicative, and chaotic, and produce products, often made with public funding, that may be locked behind country and company walls. We need the whole world looking together at this, at once. Countries and companies are doing things they never would have before. The genome was shared publicly, there are pledges for open IP, people are using open, real-time data, and some promises for affordability and access are being made. Taken together, this is a high watermark for open source.”
Dr Jayasree K Iyer, Executive Director, Access to Medicine Foundation, also outlines, “Many of the compounds, molecules and technologies are in the hands of pharma companies and small biotechs, and need to be pooled together to ensure that we have the best chance of finding and rapidly developing new drugs vaccines and diagnostics. Open science helps to speed up development as innovators can have access to these and underlying data faster.”
Improve pandemic preparedness: The COVID-19 pandemic has exposed significant gaps and challenges in the existing global pandemic preparedness. And, as the world is currently witnessing the havoc that pandemics can wreak on the economic, social, and political fronts, it is needless to point out that building more robust frameworks to prevent, contain and respond to such large-scale outbreaks in future is a priority. This, among other things, will also include creation and implementation of open strategies in the life sciences sector to ensure key goals such as affordability, innovation and health-centred governance.
Dr Iyer details, “To be truly prepared for any pandemic, there must be the availability of a vast array of potential compounds, molecules and technologies that could be active against this virus, so that these can be tested to discover and develop treatments and vaccines.
She elaborates, “Supporting open science, funding basic research with partners, risk-sharing in areas where a commercial market is not available is a role for funders and governments. And strategically helping to facilitate access to drugs, vaccines and diagnostics so that everyone regardless of gender, income or geographic location can have access is something that governments, funders and other stakeholders play a pivotal role in. In many cases we need also the implementation NGOs, who have experience in ensuring access in specific countries, to ensure access when such drugs, vaccines and diagnostics are available.”
Menon explains, “Open source includes the element of the whole world being able to look together at once at a problem. With enough eyes, the saying goes, all bugs are shallow. This is particularly germane when the entire world is battling a bug. In countries like India, with its vast human resources, this offers much promise. Open source also includes the idea of the products being affordable – or even the common property of all humankind to use a phrase from the law of the sea and the Moon Treaty. It also connotes open forms of intellectual property, which enable low-income countries to have access to the research. All of these are particularly relevant to countries like India, and the response to COVID-19.”
Facilitate equitable access to medicines: The importance of equitable access to medicines and healthcare services has been reinforced by COVID-19, underlining that imbalances in healthcare can have a devastating impact.
Recently, a UN General Assembly comprising 193 members embraced the Mexico-drafted resolution for ‘international cooperation to ensure global access to medicines, vaccines and medical equipment to face COVID-19’. India was a co-sponsor of this UN General Assembly resolution that pledged to ensure just, transparent and equitable access to essential medical supplies and any future vaccines developed to fight Covid-19.
However, this will also require more collaboration in the way medicines are developed, manufactured, authorised, and distributed, enabled by Open Source and Open Science.
Dr Iyer expounds, “In life sciences historically, open science has been opened up for poverty-related diseases where there is little to no commercial market and a need for new products. But, COVID-19 will definitely reinforce the value of open science, be it patent and compound pools, open data platforms, open access publications and collaborative development platforms.”
Menon apprises, “Over 90 per cent of diseases have no approved treatment. The primary reason, in brief, is an insufficient return on investment. Neglected diseases afflict poor people, rare diseases afflict small numbers, and antibiotics have short courses of treatment and limited revenue streams.
“There is a massive market failure in the centre of the biomedical enterprise, as Mike Stebbins, formerly of the Obama White House, likes to point out. So, we need governments to step in, philanthropists to catalyse, and a lower-cost-and-more-rapid model, which the open-source paradigm provides. We also need a global open-source hub to further institutionalise this model. The Government of India, the African Union, the US NIH, the WHO and others should join hands to bring this into being; and there is an appetite for doing so. Just like during the Great Depression, there is a window of opportunity now to create an alternate system, one that is more just, more efficient, and that better serves the public,” he emphasises.
Peek into the future
So, is Open Science finally going to get more acceptance and see more large-scale adoption across the globe? Well, that’s what the experts believe.
Dr Iyer states, “I believe with COVID-19, more investment in open science will be available for pandemic preparedness, for this disease and others to come. And several life sciences and pharma companies will participate with their assets. In fact, several governments and organisations are already discussing the set-up of patent pools, and there have been discussions on making available knowhow and recipes needed for components of diagnostic testing for the COVID-19 virus.”
Menon opines, “It (COVID-19) will lead to a deconstruction of the narrative that the standard, proprietary, large-entity driven model is the only way to go, especially in neglected diseases and areas of market failure. At a minimum, we will see a co-existence and détente between open source and closed models, just like in the IT sector. The open model is in the ascendant.”
And, given the huge potential of Open Science to tackle complex scientific and technological challenges, achieve operational efficiencies, and develop new competencies, and fast-track innovation it seems the way to go in the life sciences sector as it looks at rebuilding and fortifying its defence against infectious diseases.