A quick Google search for “checklists for biopharma startups” located “The Entrepreneurs Guide to a Biotech Startup”. This very detailed, 98-page treatise covers multiple aspects that an aspiring entrepreneur should consider: but interestingly, laboratory management software isn’t mentioned anywhere, and the only software discussed is for financial and asset management. I suppose the authors regarded data management as something like the plumbing – very necessary, but the less said the better. (Aside: Yes, the guide is from a few years back, but is still very relevant – and informatics systems were already being used as an integral part of biotech processes.)
Given that the immediate product of research is data, the omission of any discussion of tools, infrastructure and resources to manage this valuable corporate IP in a new company is surprising, not to say disappointing. Data has been variously described[i] as the new oil[ii], the new currency and the new bacon[iii] (!) – so clearly it is important (no matter what your metaphorical preference) – and managing data and information efficiently will enhance decision-making and lead to better science at reduced cost.
Biopharma startups come in several flavors. Three of the most common models are: a brand new company with a greenfield site; an academic spin-out looking to commercialize novel technology or other IP; and a newly founded entity following a big pharma break-up or downsizing. These startups will all share a common set of overarching laboratory management software requirements for efficient and consistent data capture, storage, retrieval, visualization and analysis: but they will each have to address a range of different questions reflecting their genesis and background.
Lab Data Management Software for a Brand New Company
With a greenfield site that has new labs and no legacy systems or data, there is a wonderful opportunity to start with modern, state-of-the-art informatics tools and infrastructure. But where to begin? One integrated system from a single vendor, or a combination of best-of-breed applications? Off-the-shelf or custom? Implemented and operated in-house or in the cloud? How much compute power and storage? Which database schema? Dedicated IT staff to manage the laboratory management software system and infrastructure, or outsourced to a third party? Multiple stakeholders are involved here, and someone will need to wear the CTO/CIO hat to address these concerns.
Lab Data Management Software for an Academic Spin-out
There will presumably be some legacy data to be brought over from academia. Depending on the informatics infrastructure in the university, this may be: 1) well-formatted, machine-readable data ready to be loaded into a new system, 2) it may be lurking in paper lab notebooks and reports or in Excel spreadsheets on thumb-drives or in the cloud, or 3) some combination of the previous two or even another option entirely. Academic staff moving to the new spin-out may have had experience with a variety of laboratory management software and tools, possibly with an emphasis on custom-built or open source systems to reduce costs, and will need to assess whether these will meet the requirements in an industrial setting. In any case, setting up a viable informatics infrastructure and then populating it with immediately usable data will be a crucial early step.
Lab Data Management Software for Ex-Big Pharma
The survivors of the rightsizing may bring IP with them, in the form of potential lead compounds, correctly formatted data and/or technology. They will likely also come with experience using enterprise-level laboratory management software systems such as registration, inventory, ELN, LIMS, SDMS, assay data management and the like. They may also be used to an industrial-strength informatics infrastructure maintained and supported by a dedicated staff of trained IS/IT professionals. This experience will color their expectations of the tools that they will need to be successful and may influence their choice of systems (in-house or commercial) and vendors (single source or combination of best-of-breed). In addition, if they plan to engage in collaborative partnerships, they will need secure mechanisms to share data and materials.
Although the staff in the three models come with differing backgrounds, experiences and expectations, we can see that there are common questions to be addressed by all. In a previous blog, we highlighted five challenges facing biopharma R&D:
- Managing new science
- Dealing with change
- Integrating old and new systems
- Collaboration and externalization
- Harmonization and simplification
One could argue that a start-up wouldn’t need to worry about #5, and #3 shouldn’t be a concern unless legacy systems were brought over, but challenges #1, #2 and #4 will be real and will have to be faced from day 1. The optimum solution is for the start-up to opt for a robust and industry-tested informatics platform that: 1) supports their business practices and science; 2) is quick to set up, make operational and maintain; 3) is flexible and scalable as the business evolves; and 4) offers an affordable total cost of ownership (TCO). This is where Thermo Scientific™ Core LIMS™ software is an obvious candidate.
Core LIMS software enhances productivity, fosters communication and delivers superior scientific outcomes while simplifying informatics systems deployment, maintenance and upgrades. Core LIMS software gives management a holistic view of the R&D process, while empowering researchers with the tools they need to perform their science.
Core LIMS software is built on the Thermo Fisher™ Platform for Science™ software using a single technology stack. This enables clients to rapidly add new capabilities to support activities across the value chain. IT staff and power users can easily define and add new workflows, datatypes and apps to the system via configuration, with no custom code; and with no custom coding, system upgrades are quick and straightforward and TCO is lower than with traditional laboratory management software systems.
Leaders in pharma and biopharma start-up companies are using Core LIMS software to deliver dynamic laboratory management software solutions that let them hit the ground running.