Iteration and Collaboration: Two drivers accelerating the biotech revolution

Scientists first genetically engineered bacteria to resist antibiotics during an experiment in the early 1970s [1]. That breakthrough moment is widely considered as the birth of modern biotechnology.

Now, 50 years later, the global biotech market has grown to be valued at roughly $750 billion and have thousands of novel therapies in the pipeline [2][3]. That’s not an average evolution. We’re rather in the midst of a biotech revolution.

I see that revolution around us every day. It’s happening in our local health clinics, where we went to get the COVID-19 shots that leverage mRNA technology. It’s happening in top hospitals around the world, where patients can receive cutting-edge cancer therapies utilizing their own T-cells, modified to fight the cancer within their body. And it’s happening at our Merck Life Science sites and the sites of our customers and partners, where teams of scientists and engineers are rolling up their sleeves to chase the next breakthrough.

As I head into the World Economic Forum, I’m thinking about how we can accelerate this revolution – and the future of medicine – together. How many more diseases can we cure or prevent? How quickly and how effectively? How many more lives can we impact and improve?

A clear driver behind the new era of medicine

There’s one area with especially high potential to answer these questions: novel modalities. mRNA, cell and gene therapies, high-potency active pharmaceutical ingredients (HP-APIs), viral vectors – they’re all at the heart of these scientific advancements that are treating, curing and preventing life-threatening diseases.

It will take cooperation in the right areas to realize the full potential of novel modalities. Two areas of overlapping expertise can pave the way here:

1)?Building products from a base model – not from scratch

Vaccine development during the pandemic brought us a quick, clear line of sight into the requirements to bring an mRNA therapy to market. Now, that model is established – and mRNA’s potential to combat health challenges beyond COVID-19 is one big step closer to being unlocked. It’s also given us a good example of how to quickly turn possibility into reality for other modalities.

Expertise in established products for “traditional” modalities drives the development and commercialization of “novel” therapies. It’s an area where we have strong firsthand insight at Merck. We have a long history of developing and delivering products and services to make, purify, formulate and test antibodies and other traditional modalities. Using our existing portfolio, leveraging our expertise and delivering new innovation, we’re now setting the standard for processing of novel modalities. That includes developing data, products and manufacturing templates that give customers a stronger starting point than developing what they need from scratch. Take the COVID-19 mRNA vaccines as an example, where we leveraged two decades of experience to provide the lipid nanoparticles that enable successful delivery of the mRNA therapy into your cells.

Across the industry, the universal aim is to ensure flexibility, scalability, quality and speed for novel modalities. That starts by taking what we know from existing therapeutic development and finding innovative ways to apply that to novels.

2)?Connecting processes – and partnerships – to create efficiencies

The other key is to find points of connection and collaboration – in both a technical sense and when working with customers and partners.

From the technical perspective, requirements for new products will accelerate more efficient processes. Intensification, including digitalization and yield improvements, are key to further novel modalities. The future is a more connected, automated and digitized drug manufacturing process – powered by innovations like Artificial Intelligence.

Manufacturing suppliers are partnering with pharma companies to develop these more efficient processes and products. Together, the focus will be driving productivity, higher reliability and shortened early phase timelines. Which is a big part of why, at Merck Group , we’ve integrated our innovation approach into how we work and cooperate – starting within our walls and extending well beyond to customers and partners. For example, our Process Solutions products are used by our CDMO and Testing Services teams. That’s an obvious synergy, but our CTDMO team is then able to act as the “voice of customer,” helping us anticipate the innovation needs of external customers and better collaborate on the cutting edge.

Making “novel” the new “norm”

If novel modalities are the driving force in this biotech revolution, then we must focus efforts on advancing their development to drive a real impact on life and health. By leveraging existing knowledge and innovative approaches to collaboration, we can accelerate the scientific breakthroughs shaping the future of the industry – and of medicine.

50 years after the rise of modern biotech, we are on the path to make “novel” the “norm” for the patients who need these therapies most. Where will we be 50 years from now? I hope with fully developed cures, treatments and preventative drugs that are just getting started today.

[1] Cohen SN, Chang AC, Boyer HW, Helling RB. Construction of biologically functional bacterial plasmids in vitro. Proc Natl Acad Sci U S A. 1973 Nov;70(11):3240-4. doi: 10.1073/pnas.70.11.3240. PMID: 4594039; PMCID: PMC427208

[2] The Future of Emerging Biopharma and Biotech. almacgroup.com. Published 2021.

[3] Innovation in the Biopharmaceutical Pipeline. phrma.org. Published 2021.