Paul Denny-Gouldson

Contract research, development, and manufacturing organizations (CRO/CDMOs) are well established in the drug development lifecycle and are often used for dedicated activities along the drug discovery and preclinical development process. Each of these main areas (discovery and development) of the drug development process breaks into specific areas. These areas can include target identification, target validation, lead identification, early pharmacology, high throughput screening (HTS), adsorption, distribution, metabolism, and excretion (ADME), drug metabolism and pharmacokinetics (DMPK), bioanalysis, formulations, safety/toxicity, process development, and scale up, etc. Domain specialist CROs have emerged in this space as well as larger “platform” CROs who offer full “end-to-end” service.

	The shift to large molecule/biologics as drug candidates has been occurring for the past 10–15 years (1)-the trend often attributed to the success of Herceptin, Genentech’s blockbuster treatment for certain types of breast cancer. Many pharma and biotech companies have looked to mimic this success, as evidenced by the increase in new drug applications for biologic-based drugs, year-on-year for 10 years. As companies rapidly change their focus, they may lack the laboratory space, instrumentation, and often, the scientific domain knowledge to support biologics research without a huge resource investment.

Bio/Pharma Laboratory Best Practices 2018 

	Paul Denny-Gouldson is vice president of Strategic Solutions at IDBS.

Best Practices for Today's Bio/Pharma Laboratory 2018

	When referring to this article, please cite it as P. Denny-Gouldson, "Barriers and Solutions to Effective External Collaboration in Biopharma," 

Pharmaceutical Technology Bio/Pharma Laboratory Best Practices 

Articles

As biopharma companies rapidly change their focus, they may lack the laboratory space, instrumentation, and the scientific knowledge to support biologics research.

Barriers and Solutions to Effective External Collaboration in Biopharma

In the face of spiralling R&D costs, currently estimated at $800 million to produce a new drug, the discovery industry is constantly searching for ways to keep expenditure low, increase productivity and meet ever-stricter guidelines imposed by regulatory bodies. 

One valuable strategy for drug discovery is to examine how maximum value can be extracted from a life science organization's primary asset — knowledge. Exploiting and manipulating this knowledge effectively is crucial in the competitive environment of creating new drugs, yet many organizations still rely on the traditional medium of paper-based lab notebooks to record and store their valuable experimental research. 

The inherent disadvantages of storing experimental information in this way include difficulty in: 					

Sharing data (there is probably only one notebook where the data is stored).

Accessing data (locating the exact page containing the required data is time-consuming).

Making changes (if, for example, experimental conditions change during the course of the experiment).

Extracting information to create reports.

Querying the data to find the exact information you need in the context of the experiment.

Proving compliance to a process or regulatory set of guidelines.

While paper-based lab notebooks may have served the industry well in the past, there is a growing demand to bring the industry into the 21st century and adopt a more efficient method of recording, accessing and searching experimental data and corporate knowledge.  

Electronic laboratory notebooks (ELNs) are electronic record-keeping tools that provide an IT solution to the problems presented by storing vital research information on paper. All of the knowledge associated with an experiment is stored securely in a central location, where it can be searched and accessed with comparative ease. 

Locating and extracting the exact data that a researcher or manager wants, when they want it, simplifies report creation and improves communication across an organization. This ensures decisions are based on accurate and up-to-date data. 

In particular, the new generation ELNs solve the following issues facing drug discovery organizations: 					

Intellectual property (IP) protection — life sciences organizations invest considerable time and money on protecting IP because of the limitations of paper lab book systems. 

Compliance/QA/QC — meeting stricter industry compliancy regulations using paper lab notebooks leads to time-consuming and inefficient paper chases while tracking and authenticating amendments.

Research efficiency — the significant amount of time that scientists spend on writing and administering reports from paper-based experimental results could be used more efficiently to conduct research.

Corporate knowledge and IP are the fundamental building blocks of any scientific organization, but if a company can't easily access its own data, and so is unaware of the information it possesses, protecting IP can seem an impossible task. 

Paper-based information poses many problems when proving, for example, 'first to invent' in a patent case or legal proceedings. Information is not necessarily chronological or legible. The context of associated experimental information, such as graphs, data spreadsheets or results printouts attached to a page, can easily be mislaid.  

An electronic version of a company's lab books allows efficient knowledge mining because of the ability to search for, locate and extract information easily. An ELN can significantly reduce the time and cost of searching for previous data and knowledge. Improved IP collection, storage, protection and measurement fulfil essential scientific legal requirements. The risk of lost IP when personnel leave the organization is reduced, making adherence to legal compliance issues easier to prove. 

Paper notebooks lack an audit trail to verify what was entered when and by whom, and time and effort is wasted checking for signatures, date stamping and sign-offs that authenticate data entry and track amendments. With no easily visible history of the experiment and no in-built security to control access to the experimental data, an organization faces challenges when trying to enforce good manufacturing practice 

(GMP) and good laboratory practice (GLP), and to adhere to regulatory guidelines such as 21 CFR part 11. 

 The best ELNs can generate audit trail information, so that each addition and change of content is tracked, time-stamped and authorized in a manner that is fully compliant with 21 CFR part 11, demonstrating a clear advantage compared with recording experimental data using paper lab notebooks. 

An ELN can typically provide improved traceability and a stronger enforcement of policy and procedure by providing control over the data entry process to enforce GMP and GLP. 

Privileges associated with user roles and groups can control access to system functions and visibility of data, while electronic time-stamping and author sign-off provides an audit trail of all access to and changes to the data.  

Researchers need a tool that supports research and discovery by removing some of the administrative and practical headaches that plague science today (Figure 1). 

 Figure 1 An ELN securely stores and manages data, allowing scientists to concentrate on research.			

It is currently estimated that a researcher spends anything from 5–25% of available research time formatting, cutting and pasting, and transcribing data into paper notebooks, depending on the level of regulation in a laboratory. Writing a report, for example, often involves copying from a paper lab book into a spreadsheet or reporting application, duplicating the task of data entry. The chronological nature of a lab book does not lend itself to quick and efficient searching — experiments can be split over different pages or even books.  

Studies show that an average scientist will save 20% of their time through use of a new generation ELN. At one day a week for each scientist, the estimated time saved for a typical laboratory team of 40 researchers equates to 160 days a month, or 384 weeks a year, of human resource that can be used to increase efficiency and productivity elsewhere.  

Significantly faster retrieval of data from past experiments using a good ELN can free up an organization's resources to extend its research and discovery beyond the limits imposed by the administrative overheads and duplicate activities inherent in paper-based notebooks.  

Previously, ELNs have catered for individual chemistry applications and did not provide a working environment that was easy to use across multiple scientific disciplines. For an ELN solution to be successful and meet the range of scientific needs, it needs to be able to cater for very process-driven input from departments such as analytical chemistry as well as less process-driven groups such as exploratory biology. 

An IT solution should provide a working environment that is agreeable and pleasing to the researcher, without forcing the scientist to learn and adopt a totally new way of working.  

An ELN with an open standards data format — that can store and search information of any data type — would be flexible enough to meet the needs of scientists across the scope of disciplines, from molecular biology to analytical chemistry, and pharmacology to genomics and proteomics, whether in academic research laboratories or a highly regulated GLP environment (Figure 2). An ELN with such an information infrastructure would accommodate easy integration with other systems and the scalability to add new functions as 'extensions' for individual scientific areas as and when needed. 

Figure 2 A successful ELN solution accommodates multiple scientific disciplines.			

One way an 'open standard' architecture can be achieved is by storing record data as finite objects rather than in standard document formats. 

Recording data using component objects can: 					

Enhance searching — getting straight to the data.

Make reporting easier— rather than copying and pasting into reports, objects can be used instead, which retain a link to the original information, making maintenance of information within a report easier to manage.

Business process management and business decision support.

The use of objects means that individual packets of data can be electronically signed and also used elsewhere in the organization through the use of business process management (BPM) and business decision support (BDS) tools — a feature that is becoming more and more appropriate in an enterprise ELN solution. 

The industry requires a software tool that emulates a traditional paper lab book by collecting all relevant information concerning experiments, but also provides a safe repository for all experimental data. The need is NOT for a word processing package, a spreadsheet package, a chemical structure editor or statistical package, which already exist and provide useful but specific functions. The data generated by researchers is often scattered around a computer hard drive and other corporate databases and laboratory information management systems (LIMS).  

The perfect ELN system captures all the information that a scientist generates and stores it in a manner that allows easy but controlled access, focused searching, data mining and reporting — functions that a paper lab book cannot provide. It also permits additional experimental information to be added as it becomes available whilst a tamper-proof tracking system maintains an audit trail of all the changes made. 

In the face of spiralling R&D costs, currently estimated at $800 million to produce a new drug, the discovery industry is constantly searching for ways to keep expenditure low, increase productivity and meet ever-stricter guidelines imposed by regulatory bodies.