Thermo this week introduced Darwin, the latest in its line of purpose-built laboratory information management systems (LIMS).

The Darwin LIMS is aimed at managing the data required to bring a drug from the pre-clinical trials stage through clinical trials and manufacturing.

The data collected in this wide range of operations is subject to a slew of regulatory requirements. Thermo’s approach in the LIMS market has been to focus on what it calls commercial off-the-shelf (COTS) LIMS, which are LIMS built for specific applications of a particular industry. To that end, Darwin includes out-of-the-box features to support data collected for drug-related R&D, development, quality assurance and quality control, and many manufacturing functions.

“We have targeted LIMS,” says Dave Champagne, vice president and general manager of Thermo’s informatics business. “They are application-specific, purpose-built LIMS that are easier to deploy, install, and validate in a regulated environment.”

While there are certainly other LIMS designed for the life sciences, much of the LIMS market is taking a more generic approach. For example, the LIMS market in 2004 was $335 million, and industry analysts estimate the market will grow to about $500 million by 2009. The industries driving this growth are pharmaceutical, chemical, and petrochemical.

To meet the wide range of needs across these multiple industries and across varied applications within these industries, many vendors offer generic LIMS that tout great flexibility in that they can be tailored for any application. The downside to this approach is that such LIMS often need a great amount of customization.

Thermo contends that taking a general purpose LIMS and customizing it to meet pharmaceutical industry regulatory requirements is not trivial, requires constant re-validation when anything is changed, and adds to the cost to any LIMS deployment project. “With generic systems you have large overhead to get a LIMS compliant,” says Richard Wagner, senior product manager at Thermo.

Since the Darwin LIMS is designed to cover the pre-clinical, clinical, and manufacturing stages, it includes many features aimed at ensuring that the data meets the regulatory requirements of the FDA and other international agencies.

The package has the common functions found in virtually all LIMS, including a test results database and sample registration and management capabilities. But the software also includes the ICH (International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use) templates for stability studies.

In addition, Darwin comes with about 15 pre-configured libraries, including those for formulation types, sample types, indications, dosage forms, package types, and controlled substance schedules. The software also has special wizards that let managers define the business logic and the sequence of steps required to perform dissolution testing and tests for content uniformity, and to conduct assays.

Addressing Multiple Needs
While providing the safeguards (e.g., electronic signature support, audit trails, etc.) to ensure that clinical trial and manufacturing data meets regulatory compliance, Darwin also gives life science companies a way to manage pre-clinical R&D data, which might not have the same requirements.

“R&D requires a high degree of flexibility with minimal compliance overhead, while [clinical and manufacturing operations] require rigid compliance control,” says Wagner. He notes that because of these opposing requirements, companies often use different LIMS for each group.

To give R&D more flexibility, Darwin flags the acquired data as being from R&D efforts and, as such, the user knows it does not necessarily meet the requirements that clinical or production data would. If other departments want to use that data, it would then be subject to all of the regulatory requirements (e.g., changes would be documented and audit trails would be generated when the data was accessed).

The Darwin LIMS was announced in late December, and this week’s press conference was Thermo’s official introduction of the product. The product is available now.

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