The life sciences industry’s recent success in developing COVID-19 vaccines in record time offers a glimpse into how the industry can accelerate its positive impacts on improving sustaining human life – including its role in meeting increasingly demanding sustainability goals.
On average, it takes 10 to 12 years to bring a new drug to market. The COVID-19 vaccines were developed and made available within just a year. After only 18 months, more than 5 billion doses were administered. How? A common global mission among researchers, regulators and manufacturers set a new milestone for collaboration and technological innovation.
“Accelerated innovation cycles are going to become the new normal in life sciences,” said Daniel Matlis, president of life sciences industry analyst firm Axendia. “This new paradigm is a synchronous process where all stakeholders have full visibility of the drug development cycle and can collaborate and share insights and feedback at every stage. Regulatory reviews can also be accelerated through what the FDA calls the review of the future. This approach will help all organizations to understand the potential of a drug early on and accelerate time to market for safe and effective candidates.”
The industry’s ability to pull together for the sake of humanity has given rise to renewed optimism for how it can do its part to tackle other global challenges, including climate change.
“Investors are increasingly evaluating life sciences companies based on criteria beyond margin and top-line growth, including how their solutions contribute to sustainable development goals linked to the health of individuals, societies and the environment,” Pamela Spence, global health sciences and wellness industry leader at professional services firm EY (formerly Ernst & Young), wrote in a recent LinkedIn article.
As a result, despite all the good they do, life sciences businesses also must demonstrate that they are up to the challenge of meeting carbon emissions targets, along with other sustainability goals.
“The focus on sustainability is not just about the environment anymore,” Matlis said. “We’re hearing a rallying cry for the industry to transform and operate at the convergence of sustaining human life, the environment and business. Regulatory agencies are actively encouraging innovation. This is the time for modernization and digital transformation; we need to see life sciences companies take advantage of emerging technologies such as artificial intelligence, modeling and simulation, machine learning and virtual reality to transform the way they discover and bring new drugs to market.”
SUSTAIN THE ENVIRONMENT
International non-profit organization Health Care Without Harm estimates that – if the life sciences industry were a country – it would be the fifth-largest greenhouse gas emitter on the planet. With this year’s COP26 UN climate change conference opening on October 31, life sciences companies know they must significantly reduce their carbon footprint, especially in the manufacturing stage.
“Since 2015, we have reduced our carbon emissions from operations by almost a third and our water consumption by almost one fifth.”Pascal Soriot
UK-based biopharmaceutical company AstraZeneca is doing precisely that through its “Ambition Zero Carbon” strategy, which uses renewable energy for both power and heat. The goal: to achieve zero carbon emissions from AstraZeneca’s global operations by 2025 and ensure its entire value chain is carbon negative by 2030.
“Since 2015, we have reduced our carbon emissions from operations by almost a third and our water consumption by almost one fifth,” AstraZeneca CEO Pascal Soriot said at the beginning of 2020.
In Singapore, meanwhile, biotechnology company Amgen opened a next-generation biomanufacturing facility designed to make its manufacturing process leaner, greener, faster, more productive and less expensive. The plant has a flexible, modular design that allows the company to easily scale up production and quickly switch between different types of equipment so that it can make different products – a critical ability for disease outbreaks, for example.
The new factory reflects a growing trend among life sciences manufacturers to move from batch to continuous manufacturing – an approach widely adopted in other industries. Unlike batch manufacturing, which involves many stops and starts as a product moves from stage to stage in production, pharmaceuticals made using continuous manufacturing are produced in a never-ending stream.
The US Food and Drug Administration (FDA) credits this switch with allowing pharmaceutical manufacturers to respond more nimbly to market changes without having to scale up their equipment and increase their footprint. Eliminating repeated stops and starts also reduces waste product and lowers the likelihood of drug shortages. Global consulting firm PwC estimates that continuous manufacturing could reduce the industry’s carbon footprint by as much as 80%.
“Embracing continuous manufacturing will send a signal to the general population that pharma companies are using the best of new technologies, not only to improve efficiency but to ensure they are on track to play their part in meeting carbon reduction targets,” the PwC authors observed in their report, “Towards a Net Zero future in pharma – the role of continuous manufacturing.”
“The flexibility of continuous manufacturing production future-proofs facilities, equipping them to produce multiple current medicines as well as upcoming innovative therapies, reducing the risk exposure to investments.”
Digital transformation with virtual twins of manufacturing plants and processes enables the switch. Having a virtual replica of real-world pharmaceutical processes, products and plants from end to end manufacturing and beyond, ensuring that life sciences manufacturers can produce what they expect from the start of manufacturing.
IMPROVING HUMAN LIFE
COVID-19 has demonstrated more clearly than ever that health – and innovation – transcends borders. If the industry continues to collaborate globally, decisions will be made faster and regulators will be able to see critical data upfront to fast-track approval processes – and, ultimately, improve and save more human lives.
Business innovation platforms that coordinate the activities of all stakeholders via the cloud are an obvious way to achieve synchronous collaboration. These platforms also support virtual twin experiences, scientifically accurate 3D simulations viewed in the context of their environment. By allowing researchers to quickly try, reject or prove different approaches, these computer simulations help scientists accelerate development and testing virtually, without risk to humans, and can be used to identify the most effective treatments for individual patients.
Korean health and dental manufacturer Meta Biomed is applying virtual twin experiences to better understand how biocompatible materials react and respond in the human body. Eventually, the simulations will help surgeons choose the most appropriate sutures and materials for each patient ahead of medical procedures, helping to relieve pain, ensure fast healing and deliver the best surgical outcomes.
“Meta Biomed will increasingly focus on personalized healthcare,” the company’s vice president, Yeon Chun Yoo, said. “In order to achieve this, data and simulation are very important. Our customers can get a glimpse of the predictions and results before and after surgical procedures so they can expect high-quality services based on accurate data. We expect that digital data and customer experiences will help us increase our innovation capabilities.”
SUSTAIN THE BUSINESS
Corporate Knights, which annually ranks the world’s most sustainable corporations, found that the top 100 earn 41% of their revenues from products or services aligned with the United Nations’ 17 Sustainable Development Goals (SDGs). In contrast, companies listed on the MSCI ACWI stock index, which tracks the performance of more than 3,000 stocks in developing and emerging markets, earn just 8% of their revenues from SDG-aligned activities.
Virtualization could help bring more of the industry’s profits into alignment with the SDG by modeling, testing and refining ideas, products and processes in the computer, where experimentation is quick and affordable, before committing expensive and limited physical resources.
“When you’re running a study in silico, you can run thousands of tests in the time it would take you to do a single physical trial,” Matlis said. “In early-stage R&D, virtual twins can be used to quickly identify promising molecules and compounds. Eventually, we’ll be able to leverage in silico trials, minimizing the need for in vivo studies” in live patients.
A study carried out by researchers at Massachusetts Institute of Technology (MIT) found that only 14% of new drugs make it all the way to market, with huge implications for the overall cost of drug development. More virtual testing could substantially increase this success rate.
Projects like the European Commission-backed SimCardioTest, an international consortium of 10 partners designing new predictive tools for cardiovascular diseases – aim to demonstrate how computer modeling and simulation can reduce development costs and shorten time-to-market for new drugs and medical devices.
“The long and expensive development, as well as the registration processes for new drugs and medical devices, are becoming unsustainable,” one of the project’s partners said. “Modeling and simulation can reduce these costs up to 50%.”
LESSONS FROM THE PANDEMIC
The months of the COVID-19 pandemic have sharpened the life sciences industry’s focus on strengthening health systems and adopting the latest technologies to transform the way drugs are brought to market, Matlis said.
“From a business standpoint, there are a lot of opportunities to become more cost-effective and resilient across the entire value network through sustainability initiatives – from raw material to patient,” Matlis said. “Sometimes, it takes a life-changing event to change behavior. We are encouraged to see that the technologies developed and lessons learned from the pandemic are being applied now and in the future. Because this isn’t the only disruption or threat we’ll encounter. Perhaps the next disruptor will be an extreme weather event or geopolitical unrest. Businesses will need to model for that to build resilience into their value network and minimize impact.”
Changing the industry’s approach to its business – and the attitudes of its regulators – may be one positive impact of the pandemic.
“Many organizations have literally been frozen in time, over-engineering their facilities to last 12-15 years, from the moment their drug application was approved until it came off patent,” Matlis said. “It’s resulted in inefficiencies across the value chain and lack of modernization. The vast majority of sites are still running things the way they used to, but we must change to always be leaning forward.”
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