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Leading Change: How Biopharma Can Thrive in A Time of Transformation

By: Kevin Chance, Vice President, Danaher Corporation

Biopharma leaders face a host of new challenges and opportunities. Having been largely limited to small molecules and monoclonal antibodies for decades, the industry can now choose from antibody-drug conjugates, cell and gene therapies, RNA-based therapeutics, bifunctional molecules and a wealth of other emerging modalities with new, distinct requirements. The number of advanced therapy clinical trials jumped by 71% from 2015 to 2020 (1,2).

The need for fundamentally different approaches is being driven by a growing toolbox of R&D technologies, which is empowering the biopharma industry to identify new therapeutic targets and uncover ways to hit once-undruggable receptors. COVID-19 turbocharged the trend by accelerating the validation of mRNA. In the space of one year, mRNA went from an unproven technology to a validated, highly effective vaccine modality, potentially applicable to a range of infectious diseases, cancers and other therapeutic areas. As a result, companies are lining up to enter the space. 

The pace of change and the complexity of these challenges are new to the biopharma industry and are stretching its ability to turn science into reality. After a multi-decade move from small molecules to more complex monoclonal antibodies, the industry is having to adapt to a multitude of still more challenging modalities and supply chains far faster. 

What we achieved in the pandemic, while admittedly under extraordinary circumstances, can provide the blueprint for how the biopharma industry can solve this challenge. Standardization was crucial to vastly accelerating speed to market and we now need to apply this to processes across the industry, day in, day out. We need to embrace Lean principles and Design Thinking in everything we do. In many cases this means doing things differently than before. But if we’re to navigate this period of change and embrace the opportunities that are ahead of us, there is simply no other option.

How Pall and University of Oxford slashed vaccine timelines

When the COVID-19 pandemic hit in early 2020, the University of Oxford recognized the need to rethink established processes as it sought to develop and scale up a vaccine in record time. Facing extraordinary time pressures, the university tasked Pall Corporation, a Danaher operating company, with developing a process suitable for the manufacture of the millions of doses of its viral vector vaccine needed to protect the world. 

The team benefited from work Pall did 18 months before the COVID-19 pandemic began, which laid the foundations for its rapid response to the crisis. Back then, Pall created viral vector process development templates by identifying patterns in earlier projects to inform a standard platform. 

Pall sought to understand the process requirements of customers and map out standard production steps. In doing so, Pall identified focal points for process design and prioritized technical gaps to align its process to customer needs. The initiative resulted in a template with 80% reusable elements. Only 20% of viral vector process development now requires customization.

Using the template freed Pall to focus on the unique aspects of the Oxford vaccine, enabling it to cut the time required for the design of the scale-up process from two years to eight weeks.

The need to embrace continuous improvement

Pall's work to enable vaccine production at scale involved multiple steps, such as establishing optimal purification activities, the specification and building of equipment, and the configuration and supply of consumables. This was managed by a co-located 20-person cross-functional team that was supported by hundreds of additional Pall team members – a huge undertaking in the midst of a pandemic. 

The principles that enabled Pall to effectively deploy this team and accelerate the process development phase with such remarkable success were derived from the Danaher Business System (DBS), which has hardwired continuous improvement into every action taken by its parent company for decades. DBS grew out of Danaher’s 1980s alliance with Japanese leaders in Kaizen, a mindset that supports continuous improvement and embraces change.

For the COVID-19 vaccine project, Pall used the principles of DBS and tools from its DBS toolkit to design the process for scaling up manufacturing. In that situation, as in all others faced by Danaher operating companies, Pall leveraged DBS to solve problems, communicate, measure, and report on its progress. 

Supercharging science and technology innovation

The vaccine project is an extreme example of the sort of time savings that Danaher’s commitment to continuous improvement routinely enables. But this philosophy guides everything that the Danaher operating companies do on a day-to-day basis – including how they work with each other.

SCIEX and Beckman Coulter Life Sciences worked together to develop an ultra-high throughput sample screening system called ECHO® MS, which uses advanced Acoustic Droplet Ejection technology to deliver high quality, reproducible results at up to 3 samples per second – up to 50 times faster than conventional technology that is comparable.

Using the principles of DBS, Beckman Coulter Life Sciences set up a dedicated team, mapped out the detailed process upfront and stayed in constant contact to maintain the schedule. Then, the team applied Lean principles usually reserved for agile software development to the hardware project.

The Lean principles allowed for iterative design that sped up development by eliminating the waste associated with waterfall development. Everyone working on the project was active at all times to move the program forward, resulting in development taking 18 months less than would be possible using traditional means.

Shaping the future of biopharma

The pandemic has shown that new, faster forms of development are possible. Everyone, most importantly patients, now knows it is possible to address unmet needs far faster than in the past. The new challenge is to close the gap between the typical 12-year development timeline and the 12-month turnaround achieved in the pandemic. 

Biopharma companies are now experimenting with ways to rise to that challenge, equipped with models such as adaptive and hybrid clinical trials that they battle-tested in the pandemic. Yet, even with proven, more efficient approaches, no single organization will be able to drive the transformation. As happened in the pandemic, the best outcomes will require drug developers, regulators, science and technology innovators and biopharma companies to collaborate, embrace change and support continuous improvement. 

References
1. 2015 Annual Data Report on gene and cellular therapies. https://alliancerm.org/wp-content/uploads/2018/04/ARM_Annual_Report_2015_Web_Version_FINAL.pdf.

2. ARM Global Regenerative Medicine & Advanced Therapy Sector Report H1 2020. http://alliancerm.org/wp-content/uploads/2020/08/ARM_1H-Report_-FINAL.pdf.

This article was created in collaboration with the sponsoring company and our sales and marketing team. The editorial team does not contribute.