With all the options available for scaling up the biotech pipeline, choosing what to do and how to do it can easily result in decision fatigue. Being able to narrow down options according to efficiency is thus key. And there is no better way to do this than to look at how different biotech companies fared during times of crisis, the ultimate test for efficiency across the pipeline.

When considering crises, perhaps the most significant one for the biotech industry in modern times has been COVID-19. Bringing the world to a near standstill at its first peak, it exposed critical gaps and weaknesses across the pipeline. Especially as the world becomes ever more integrated, the COVID-19 crisis provides valuable lessons on the fundamental problems and solutions of ensuring efficient scalability across the biotech space to thrive in both times of both plenty and scarcity.

 

Troubleshooting in R&D

 

Fundamental to the whole biotech pipeline is R&D, an area in which COVID-19 exposed key areas of vulnerability. Global lockdowns caused supply chain disruptions that made it harder to procure necessary materials and equipment for both pre-existing and novel protocols. The pandemic also exposed key issues of overreliance on hands-on staff. As safety restrictions and quarantines forced the bulk of lab work to either shift online or be put on pause, R&D labs worldwide were left functioning at under 50% capacity with a 75% drop in general productivity. [1]

Central to solving each of these problems is being proactive, building strong relationships with trusted partners and creating a plan of action that outlines key considerations and milestones ahead of time. And the key to this plan of action is optimizing equipment and workflows as early as possible:

  •  Increased lab automation and integrated accessories that require fewer hands reduce staffing hours and ensure development can continue on a largely remote basis, both saving money in the long run and increasing efficiency, whether in a crisis or not.
  • High-throughput technologies that can be automated, such as multi-well plate formats (processing more samples in shorter periods of time) and multiplexing at scale (getting more data from limited samples and running multiple samples simultaneously), increase precision and reduce development timelines.
  • More efficient workflows that use modular components and sequential steps mean that companies do not need to start from scratch when scaling capacity up or down or adapting to new pharmaceutical pressures.
  • By conducting drug substance work and drug product work simultaneously, developers can avoid redundant activities and delays when it comes in manufacturing.
  • Use of Good Manufacturing Practice (GMP) or clinical grade reagents in closed or cleanroom environments earlier in the R&D process may facilitate the transfer of Standard Operating Procedures (SOPs) to preclinical and clinical manufacturing.

 

Problems and solutions for scaling up clinical trials

 

COVID-19 also exposed key vulnerabilities in clinical trials- for both those already running and those ramping up. By April 6th, 2020, for example, just weeks after the beginning of global lockdowns, over 2,850 trials  around the world, responsible for approximately 900,000 patients, as well as 4 million planned enrollees , were delayed or put on hold. This happened due to fast-changing legislation, closures of clinical trial facilities, and disrupted supply chains that created challenges in procuring clinical supplies.

The problems exposed in the clinical trial sphere extend from those experienced in R&D. To avoid unnecessary delays, companies need legal oversight and strong relationships with various stakeholders to ensure complete availability of the entire clinical pipeline  in advance, from access to facilities and patient cohorts to material supply chains and expertise. Moreover, ensuring that Active Pharmaceutical Ingredients (APIs) can be produced under cGMP conditions for Phase I, II, and III clinical trials ahead of time is crucial in order to avoid time-consuming hurdles later on.

 

Optimizing the commercial production pipeline

 

The early months of COVID-19 exposed major weaknesses in commercial production pipelines. The shipment of raw materials and equipment was severely disrupted. This was only made worse by staff being unable to attend work due to quarantines and rapidly changing legislation that made it difficult to keep up with legal guidelines. As such, planning ahead with strong relationships with suppliers is crucial to ensuring access to the whole material and equipment supply chain in any circumstance. Automated production workflows are also key for both ensuring productivity during times of crises and cutting costs in the long term. Meanwhile, access to the most up-to-date commercial use rights, assurance of best input materials, and proven QA standards to achieve regulatory compliance are vital in order to avoid cumbersome legal headaches and delays when fast access to the market is a priority.

 

Solutions for every step of the biotech pipeline

 

How a company invests in these different solutions depends very much on which will enhance its productivity most. For some, it may make sense to invest in expertise and equipment that help get more out of samples and process data faster during R&D. For others, it may make sense to outsource certain processes to a trusted partner. Not only could this option slash costs, but it could also grant access to international labs with the latest equipment and expertise, and reduce friction in transferring protocols from research to development and beyond. Partnering with existing players who can offer up-to-date legal oversight could also accelerate time-to-market.

To conclude, lessons from global crises such as COVID-19 are key to understanding fundamental problems in the biotech pipeline and narrowing down solutions for scaling up. Whether it’s investing in efficiency-driven equipment early on to increase precision and cut costs or creating strong partnerships to secure logistics and legal oversight, these lessons are invaluable for making decisions on how to scale up for future healthcare needs, during a crisis or not.

 

Learn more about how Thermo Fisher Scientific can help you scale with innovative solutions and outsourcing services and how we have been able to leverage our scale and resources to help the world move forward in response to COVID-19.
 

See the stories of the people at Thermo Fisher Scientific Sample Prep business and Bioscience Division who led an unprecedented and inspiring response across the globe to the COVID-19 crisis.

Resources

Style Sheet for Global Design System