PHARMACEUTICAL LABS LAB FOCUS


When it comes to electronically transcribing paper laboratory notebooks onto a central database for project reporting, regulatory reasons or for the protection of intellectual property (IP), deciphering illegible notes will cause data inaccuracies. Savvy organisations have adopted electronic laboratory notebooks (ELNs) and data management infrastructures to safeguard against data corruption and reduce the margin of human error. ELNs can be used to track and ‘check’ data entries to individual scientists, producing accurate time-stamped records of work. ELNs can also streamline the drug discovery process in pharmaceutical laboratories by integrating with existing data management systems.


CREDIBILTY


AND ACCURACY The second common pain point experienced by scientists is the integrity and validity of data produced. Although this is important for data that is produced internally, even more scrutiny should be applied when working with external partners, such as contract research, development and manufacturing organisations (CROs/CDOs/CMOs/ CxOs). Collaboration between pharmaceutical organisations is not a new phenomenon, but the industry has seen a steady increase in collaboration and outsourcing since the turn of the century, and this shows no sign of slowing down. The Royal Society released a report, ‘Knowledge, networks and nations: Global scientific collaboration in the 21st century’, stating that “less than 26% of papers are the product of one institution alone, and over a third have multiple nationalities sharing authorship.”


Working with CROs and foreign nationalities can present challenges in scientific discovery, most notably when communicating responsibilities and defining ownership of intellectual property (IP). Organisations


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collaborating with CROs on a global scale can add another layer of protection to their data by using advanced informatics such as ELNs and data centric collaboration tools – these can be used to define and track tasks, the progress of work packages, responsibilities for data signoff and track authorship of IP.


IP is a pharmaceutical organisation’s most valuable asset as it forms the building blocks for patents – so sharing sensitive IP with a CxO is a constant concern. Since 2013, the US has operated under a first-to-file-patent system, making the ownership of IP and timings in the drug discovery process extremely important. Gibbons Legal IP specialists have said that, in the event of a false claim, a detailed time-stamped electronic notebook can help determine who plagiarised the invention from the true inventor, stating that laboratory notebooks “remain important for the purposes of determining or correcting inventorship.”


FOLLOWING


THE RULES Another apprehension in the pharmaceutical industry is ensuring CxOs are complying with regulation standards, as many CxOs operate in different countries from their sponsoring organisation. There have been incidents, like this example at the Semler Research Centre in Bangalore, where regulation compliance has not been upheld and data integrity has been compromised. Such incidents can be prevented by utilising data management systems and informatics tools.


There is a long history of scientists using informatics tools in pharmaceutical to assist with data management and there are also software applications to assist with this process. Using informatics tools, sponsor organisations can create rules aligning with industry regulations to ensure CxOs are always compliant when handling and creating data. Electronically recording and


sharing data protects the reputation and work of both the sponsoring and contracted organisations.


STARTING FROM SCRATCH The last pain point routinely emphasised by scientists is the need to regularly start research processes from scratch every time, rather than using a standard operating procedure (SOP) template. The time spent creating, testing and validating procedures, which are likely to exist already, could be used far more effectively.


Using a comprehensive data management software system that has both the appropriate capabilities to complement scientific research and development, and ensures previous experiments are searchable, undoubtedly helps maximise efficiency. The World Health Organization’s (WHO) Good Laboratory Practice Handbook outlines the benefits of storing SOPs on a centralised system as this helps with “formatting, numbering, issuing, modifying and withdrawal of SOPs.” The WHO handbook also states electronically storing SOPs helps “avoid duplication of effort, inconsistency between SOPs, delays, lack of traceability and incomplete distribution.”


Pharmaceutical organisations have been identifying the pain points that hinder research and development for many years. The scientific informatics industry has been responding to this with the creation of scientifically tailored software and solutions that help reduce their pain which in turn fuel innovation, improve efficiency and allow decisions to be made quicker.


Paul Denny-Gouldson heads the overall strategic planning for the various market verticals and scientific domains at IDBS. He obtained his Ph.D. in Computational Biology from Essex University in 1996, and has authored more than 25 scientific papers and book chapters.


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