In Focus: Justifying your ELN investment

Interview with Björn Kull, PhD, Assay development and Screening
at Actar AB

Going from an old-fashioned paper lab notebook to an electronic system is simply a matter of taking the step. User surveys show that once implemented the gains in using an electronic lab notebook system come rapidly in terms of higher productivity and significant time savings. And the users are unwilling to go back. Björn Kull, Manager of Assay development and Screening at Actar AB, describes how working with an electronic lab notebook has improved and simplified his screening workday.

What kind of research do you do?

– The origin of Actar’s business is that we saw that interesting academic discoveries, that hadn’t yet been patented, didn’t have much success in being further developed. The projects were too immature and it was difficult to get larger biotech’s and pharmaceutical companies interested. Actar started with the idea to develop these findings in collaboration with the academic researchers, through identification and validation of compounds, and to get large pharmaceutical companies interested in developing these into candidate drugs. So, you could say that we are the bridge between academic research and the industry.

Can you describe your working procedure before the implementation of electronic lab notebooks?

– We simply used regular paper lab notebooks where you write down your results and sign it. The problem is that many scientists are a little negligent with this. Often the documentation was insufficient and defective, but for us it is very important to have good documentation before future patent applications. Also, the signing and contra-signing of experiments was very time-consuming. You didn’t do it every day or even every week so there was a large gap from the time an experiment was made until it was signed.

Actar implemented ConturELN in April 2008. In what way has ConturELN changed the way you work and what can you do today that you couldn’t do before?

– We haven’t changed the way we work but life has become much easier. Our experimental protocols and results are more regularly updated and signed. Also, since we collaborate with scientists and institutions scattered both geographically and operationally, it has been difficult for the project managers to get control over the projects and to see what has been done. The information has been there but in a different and much more limited form. That is probably one of the major improvements for us with ConturELN; the visibility and the overview of all experiments in different projects. Everyone can easily look into other peoples’ experiments and see what and how it has been done. Considering that our business plan is to sell our results to be developed into drugs, the possibility to extract information and show it to external customers is also very good. We save much time in comparison to compiling that information by hand. But in the end, research documentation is still the be-all and end-all for us and ConturELN has been a great means of assistance.

Are the scientist’s experiments easier to read because of more standardised templates?

– Yes, definitely. The search function, the possibility to copy protocols and the use of templates are some of the major advantages with ConturELN.

Was the transition from the old paper lab notebook system difficult?

– Not at all. The shift has gone very smoothly, also for those with none or little computer literacy. After a week everyone was up and running.

After the implementation, have you done any evaluations in terms of productivity gains? If so, what have they shown?

– It is difficult to estimate because we can not compare with prior ELN as we are documenting much more now. We haven’t done any evaluations in terms of time savings but it is obvious that we save a lot of time. Everyone feels that it has made life a lot easier. You can use the predefined templates which are now available for everyone, it is easy to get a good overview which saves time for the project manager, and you can quickly extract the information you want. In terms of quality there have been significant improvements. We don’t have to justify our ELN investment before our management; it is an obvious decision for us to have it.

Do you want to go back to using old-fashioned paper lab notebooks?

– No, because ConturELN has made life a lot easier for us. Going back feels distant, very passé, and it feels good that we have taken this step. I’m convinced that electronic lab notebooks will be standard within a few years, at least for the industry. It might take a little longer within the academic world. The reason it hasn’t gone quicker I think is because the hesitation whether electronic records would be legally binding as evidence in patent interference cases, but that isn’t an issue any longer.

About Actar AB

Actar is a drug discovery company based on the Karolinska Institute campus in Stockholm, Sweden. The company is a part of the Karolinska Institute’s innovation system. Actar explores innovative drug targets in multiple therapeutic areas resulting from academic research at top European institutions. Actar also collaborates with the academic researchers to perform drug discovery based on these targets. For more information please visit www.actar.se

In Focus: Understanding the legal issues surrounding electronic laboratory notebook (ELN) records.

Interview with Legal Expert Colin G. Sandercock

In recent years electronic records have been used successfully as evidence in patent interference cases. Despite this, some companies are still hesitant in moving towards a fully electronic system for IP protection. In this interview we talk to one of United States’ leading IP lawyers regarding the legal issues surrounding electronic laboratory notebook (ELN) records.

Colin G. Sandercock is a partner in the Litigation and Dispute Resolution Department of Proskauer Rose LLP, co-chair of our Life Sciences Group, and is co-managing partner of the Washington, D.C. office. He practices in the area of life sciences, including licensing, patent and trademarks, and intellectual property. Colin was named in the 2007 and 2008 editions of The Best Lawyers in America in the field of biotechnology law, and in the 2008 edition of Washington DC Super Lawyers, as one of the top attorneys in the Washington, DC, Metro Area in the field of Intellectual Property law. Since 1984, Colin has counseled clients in life science matters including district court litigation, interferences, licensing and the management of domestic and foreign patent portfolios. His technical experience includes biotechnology, pharmaceutical chemistry, organic and inorganic chemistry, medical devices, and chemical and biochemical engineering.

Can you describe the current situation and the difficulties?

- Although there are still executives and lawyers who are concerned about the admissibility of ELN records in legal proceedings, such concerns are largely unwarranted. Provided that the ELN system contains reasonable safeguards to prevent tampering, and that companies take certain steps to comply with U.S. evidence laws, relevant ELN records will be admissible in court proceedings. Indeed, a growing percentage of records involved in U.S. litigation discovery are electronic records such as e-mails and documents maintained either on separate storage media (e.g., backup media) or in document management systems. Companies are increasingly minimizing their use of paper and as time goes on, the majority of documents involved in litigation will have been generated and kept solely in electronic form.

- To be clear, the admissibility of electronic records has been recognized by major U.S. courts for over 30 years. And in 2006, the U.S. Supreme Court promulgated new rules of the Federal Rules of Civil Procedure, which new rules specify procedures relating to discovery of electronic records. These new rules make clear what has been the practice in courts for decades, namely that electronic records (in human-readable form) are admissible evidence.

- The only "difficulties" are associated with the implementation of safeguards in the ELN system and appropriate policies and procedures so as to prevent unauthorized creation of, and/or tampering with ERs. Provided that reasonable safeguards and policies and procedures are implemented, such difficulties become fairly minimal.

Do you see any risks with electronic records?

- The fundamental issue with ERs is the perception that they can be easily altered and that such alterations will be difficult or impossible to detect. In reality, reputable companies will implement ELN system safeguards, as well as policies and procedures for how they create and archive ERs such that alteration would be extremely difficult if not impossible. Furthermore, it will be the rare case when alterations go undetected because such alterations typically will be inconsistent with the rest of the evidence in the case. Ironically, despite all of the concern about ELN records, most ELN systems will create ERs that are far more credible and reliable than records from the paper-based systems they replace, which systems typically have had relatively few safeguards.

How does one create reliable ERs?

- It cannot be overemphasized that there is no set formula for creating a reliable ER. Any ELN system that contains reasonable safeguards against tampering, and provides sufficient assurance that the ER will be available in human-readable form for an indefinite period (at least 35-40 years) can be acceptable. Importantly, however, reliability typically will be a function not only of the system itself, but also the policies and procedures used to create the ERs, commit them to the system, and then maintain them as an archived record. Hence, the ability of any ELN system to create reliable records must be viewed holistically within the overall context of how ERs are created and archived. The ultimate question of whether an ELN system creates reliable records often can be assessed simply by answering the following questions: If a company wants to falsify a record, can it do so? If so, how many people must collude to falsify the record? Obviously, the more difficult it is to falsify a record and the more people who must be involved in the collusion, the more credible the ER will appear.

What about the use of ERs in court proceedings?

- As mentioned, ERs have long been used in court proceedings. Indeed, it is almost unimaginable that any significant court proceeding would not involve a substantial number of e-mails and other electronically created and stored documents. As with any evidence that comes into a courtroom, the ER must be both authenticated and admissible under a specific rule of evidence. Authentication of an ELN record often will be provided by the author of the record, but companies also must prepare for the possibility that the author will be unavailable. When the author of an ELN record is unavailable, the Federal Rules of Evidence, which govern both the federal courts and USPTO, permit a “custodian” of the record to authenticate the record provided that certain requirements are met. It is imperative for companies to understand the foundation that they must establish in order to permit the custodian to introduce the ELN record as a “business record” under the “business record exception” to hearsay (FRE 803(6)). Provided that companies establish a proper foundation for the ELN record to be a business record within the meaning of FRE 803(6), then the record will be admissible, assuming that it qualifies under one of the rules of evidence. Generally speaking, all relevant evidence is admissible and so if the ELN record is relevant, then it likely will be admitted into evidence.

- Admission into evidence, however, is only part of the story. The other issue is whether the record will be deemed credible and reliable by the court and/or jury. Where the ELN record is entirely consistent with the rest of the evidence, there will likely be no challenge to the credibility of the record. Likewise, there will likely be no challenge to an ER where the ELN system, as well as the policies and procedures governing creation and archiving of ELN records, have reasonable safeguards to prevent unauthorized creation and/or tampering. In those infrequent times when the ER is not consistent with the other evidence, then the ELN system may come under scrutiny, which is why it is smart to have the system reviewed by counsel long before litigation arises.

What must ELNs prove?

- The records created by an ELN must prove exactly the same thing as a paper laboratory notebook record, namely, who created the record, when it was created, and what its content was on the date of creation. Additionally, the ELN system should also be able to prove that the record has not been altered since it was created. Again, this last point is a function of both the ELN system itself and the policies and procedures by which ERs are created and archived.

What about the future?

- ERs are not a future, inevitable development; rather, they are here and fast becoming common place among every large pharmaceutical and biotech company, and also among many smaller pharmaceuticals and biotechs. As the saying goes, “the train has left the station.” This development is due to several factors.

- First, the gain to the enterprise from an ELN in terms of knowledge management can be enormous, especially as compared to the paper laboratory notebook, which rarely facilitates collaboration among researchers in different areas of a company. There are many stories about companies that have reviewed their paper records only to find that they have “recreated the wheel” several times over. Essentially, paper laboratory notebook records can create silos of information known only to specific researchers or groups, whereas ELN systems facilitate building on prior work anywhere in the company and using materials and reagents that already have been created by others.

- Second, the gain in efficiency in terms of recording experiments can be significant in some areas of research such as discovery and process chemistry. Electronically creating or “cloning” experiments can save significant time, especially for researchers who only are making slight changes to prior experiments. An associated benefit is often a more complete, thorough, and legible record of the experiment. The ELN also can facilitate review by superiors for productivity (a potentially sensitive point among researchers), good technique and compliance with good notebook keeping procedures.

- Third, companies simply will have to have state-of-the-art tools such as ELNs to attract top researchers. Such researchers are very proficient with computers and databases and frankly will expect any substantial research organization to have an available ELN system. The corollary to this is that the more companies adopt ELNs, the more that other companies will have to “keep up with the Joneses” in order to stay competitive for top talent. It becomes a very real and self-fulfilling prophesy.

About Proskauer Rose LLP

Proskauer Rose LLP, founded in 1875, is an international law firm providing a wide variety of legal services to clients worldwide from offices across the Unites States and in Europe. The Firm has wide experience in all areas of practice important to businesses, such as intellectual property, litigation, patent and trademarks, and its clients include participants in many industries, including chemicals, entertainment, financial services, health care, hospitality, information technology, insurance, internet, manufacturing, media and communications, pharmaceuticals, real estate investment, sports, and transportation. For more information please visit www.proskauer.com

Learn more about how ConturELN can help you protect your patents

In Focus: Interview with Dr. Andrew Mott
The need for high quality in research documentation

Contur’s Quality Manager and Business Analyst Dr. Andrew Mott explains how Contur works with these challenging requirements.

Why is high quality documentation so important within R&D intensive organizations?

– Documentation is critical for research organizations whatever the discipline. Scientists need to rely on their colleagues’ data and results as the basis for conclusions and further experiments – good quality data is a must. During the development process, regulatory requirements necessitate working to quality standards, for example GxP. We are discussing two aspects here, the quality of the documentation and the quality of the software used to record that information. ConturELN is designed to help scientists record their work in a superior way compared to paper lab notebooks.

Having held previous positions as a scientist yourself, what’s it like working in an entrepreneurial company such as Contur?

– The main difference is that I am much closer to the customer, both direct customer contact and that I see the impact of what I work on being implemented in Contur’s products. In my previous positions, the time from lab bench to product was measured in years. Because of Contur’s entrepreneurial character, I am involved in many aspects of what goes on, especially with my role as business analyst. My background as a scientist and user of ConturELN gives important input into product development and usability as well as following future trends, which is necessary for being at the forefront of the industry.

How does Contur ensure high quality in its products and processes?

– Contur has a quality plan which describes our method of working in all the stages of software design, development, testing, implementation and support. By following these clearly defined processes, we can ensure that high quality is maintained in all aspects of our business.

What are your responsibilities?

– My responsibilities are to ensure that we follow Contur’s quality plan. This means that I check and approve the documentation of our work processes, for example change requests, functional requirements and test specifications. I work closely with our test manager and product manager on the testing and release of new software, and I also follow our support requests to see how we are performing both with our support process and in the quality of our products. In addition, if I see aspects that can be improved, I update the quality plan.

In what way can ConturELN secure high quality in R&D documentation?

– At the most basic level ConturELN ensures that experiments are legible. The data is part of the experimental record, not a loose piece of paper than can easily be lost. The experiments are also in a form which makes them easy to search, retrieve and view. The records are also more secure as back-up copies are generated automatically. I would say that the use of ConturELN speeds up the whole research documentation process considerably, from entry of data through to the signing and witnessing process.