Good data management means developing a systematic way to integrate and update data enterprise-wide and to share it with team members or partners as needed.
Data management is typically an afterthought for young biotech companies, but having a viable strategy to record, save, access and share data is a vital element in attracting investors and partners, as well as in working with regulators. Panelists explored this issue at the recent Demy-Colton Virtual Salon: “Biotech Companies Flourish or Fail by Their Data: How to Improve Your Outcomes.”
Good data management doesn’t mean endless, siloed Excel files, though. It means developing a systematic way to integrate and update data enterprise-wide and to share it with team members or partners as needed. This implies portability and Interoperability across multiple platforms, as well as forward compatibility in terms of file type, and – importantly – the ability to easily retrieve data, regardless of how or where it was stored.
“What you don’t know can really hurt you,” Amy Ripka, Ph.D., founder and CEO of Lucy Therapeutics said. “Getting the right data management tools before the data becomes unwieldy is a good investment. Young companies often don’t think about how to find the data later,” she pointed out. She recommended consulting a data management expert early on to ensure the data you are generating is properly cataloged and accessible.
“Founders don’t appreciate how quickly they can lose control of the data,” serial entrepreneur Robert J. Schneider, Ph.D., Albert Sabin Professor of Molecular Pathogenesis at the New York University School of Medicine, emphasized.
From a partnering and investing perspective, too, “It’s important to find data as quickly as possible, so organization is important,” Chris Vlahos, Ph.D., global head, rare disease external innovation at Ipsen Biopharmaceuticals, added. When evaluating possible partners, the inability to produce necessary data is a red flag, he said. “In many cases, it could cause us to walk away.”
When Ripka formed Lucy Therapeutics, “We asked our investors what they wanted to see. That sounds obvious, but knowing what they wanted helped us set up and map our data room.” The setup includes tools to monitor who is looking at which files and for how long. Having that insight can be used to ensure that the most sought files are easily accessible, she added.
“You’re running a business,” Ripka stressed. “That requires more organization than running scientific experiments.” Therefore, it’s important to plan for success initially, rather than after years of data has accumulated and some, inevitably, has fallen between the proverbial cracks.
Lucy Therapeutics began its data management strategy on a shoestring budget – $5,000 to $10,000. Its rudimentary platform used Google Drive and Backupify, because of easy portability to larger, more scalable platforms.
Electronic lab notebooks (ELNs) are the starting point for whatever system emerges, Vlahos said. “ELNs are all about organization and ease of use. Scientists must have their data in a searchable system and in a network so it can be shared within the team or with select partners. Think from end to beginning,” he advised, “rather than uploading data at the last minute.”
On the business side of things, data rooms, which house key data that can be accessed by potential partners or investors, also should be part of the data management strategy. There’s a caveat though: they must be well-organized and must protect proprietary data.
The first impressions viewers make when accessing poorly organized data rooms extend to impressions regarding the integrity of the data and the quality of the company, panelists agreed. Therefore, data rooms should have a map, as well as summaries of the data. They also need a way for approved parties to access original data, as well as links to any extremely large (typically image) files.
“Be very careful about what’s in the data room,” Ripka cautioned. For example, “The minutes of board meetings need to be in the room, but if the presentations to the board include chemical structures, for instance, those structures will get out to other groups.” She advised discussing the structure but not showing it as a way to protect intellectual property.
“Also,” Ripka added, “don’t let potential partners or investors (who are reviewing the data) perform the structural due diligence themselves. Make them hire trusted third parties.” Ipsen, for example, asks blinded third parties to review the structures to determine whether they are a good starting point and whether those structures have a good path forward.
For all data systems, forward compatibility should be considered. In some companies, “People have searched out very old computers to read some of the data,” Ripka said. Therefore, ensure you will have the ability to read the files 10 years from now when you are ready to file regulatory submissions.
“Several years ago, performing due diligence meant flying 20 people to a warehouse of data and sorting through it in the course of a week. Now that’s done remotely, in data rooms, so due diligence is faster and tremendously more efficient,” Vlahos noted.
“The presentation of the data…its completeness and the ability to retrieve what isn’t there at first glance…gives a sense of how careful the company is,” he continued. “For a long-term partnership, we need to believe the data is complete and generated with standard operating procedures so they are reproducible.”
Deals today “start with a look at a company’s data room, followed by a series of chats,” Schneider concluded. “That’s how deals are made now.” The implication is clear: Get your data in order early, to be ready for future deals.
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