Why the Pandemic is Rewriting the Biopharma Rule Book

Pharmaceutical Executive, Pharmaceutical Executive-08-01-2021, Volume 41, Issue 8

Changes necessitated by COVID will drive unprecedented transformation of industry.

From one of the most terrible crises humanity has faced in a generation, has emerged an incredible spirit of collaboration and remarkable achievements like nothing I’ve seen before in my many years in this industry. As we try to predict how our world might change going forward, it’s clear that demand is growing for more vaccines, faster development, and easier access for patients—all of which means we need increased capacity, which has been the biggest challenge we’ve faced during the pandemic. Not only do we need to crack this capacity challenge, we need to understand how the rise of mRNA will drive a seismic shift toward genomic medicines more broadly because this will define the biopharma industry here on in.

As companies look to invest in and use mRNA and genomics for their therapies, they turn to science and technology companies to help them navigate the complex challenges of these new modalities. Our experience of the COVID-19 vaccine race has awoken a need for speed in the industry. Biopharma and life sciences leaders ask how we can supercharge everything from downstream processing to pharmacological characterization. Our operating company, Pall Corporation, designed the manufacturing process for the Oxford/AstraZeneca COVID-19 vaccine in a record-breaking eight weeks—something that would previously have taken years—by deploying standardized processes and state-of-the-art single-use technologies. Innovation like this shows what remarkable breakthroughs are possible when the partnership between biopharma and life sciences strengthens.

Business model needs to change

As biopharma looks increasingly to science and technology companies to help them find innovative ways to efficiently develop and biomanufacture genomic medicines at scale and increase speed to market, a second center of gravity is emerging in the industry. Deep science and technology expertise is now needed to complement the traditional—and still essential—focus on pathobiology/clinical development. As a result of this new environment, biopharma needs to tear up the rule book and write a new one—about becoming more efficient, more productive, and more agile, and ultimately better able to make high-quality drugs more accessible to more people.

Innovation and digital transformation will be absolutely vital. We’ve now seen how big data analytics and machine learning/AI can help us understand the spread of disease, map variants, and model enzymes. This technology is being deployed across all parts of the industry, from early drug discovery to large-scale manufacturing. Biopharma cannot transform alone, as we’ve seen in the work of our operating companies with their industry customers. For example, one of Danaher’s operating companies, IDBS, has developed the world’s first biopharma life cycle management system, called IDBS Polar. It’s a new cloud-based data management platform that enables biopharma companies to curate the highly contextualized data needed to support insight, analytics, and machine learning.

There will be greater demand for technologies like this going forward, and greater collaboration between biopharma and science and technology companies to solve the increasingly complex scientific challenges that arise. The ties that have been strengthened during the pandemic will get much closer moving forward, to the benefit of all parties.

Industry’s future

People have asked me if I think the biopharma and life sciences industries will merge in the near future. If by life sciences, we mean science and technology—the equipment, technological innovation, and know-how fundamental to everything from scaling up the manufacture of a COVID-19 vaccine, to using machine learning to analyze research data, or performing in-line testing of new drugs in the manufacturing suite—then, I’d say that while these industries will probably not become indistinguishable, the degrees of separation are becoming smaller every day. It’s an evolution I welcome and believe will greatly benefit all partners involved, especially the patients that both industries ultimately serve.

Jose-Carlos Gutiérrez-Ramos, PhD, Chief Science Officer, Danaher