Whether ambitious young biotechs have their sights set on being the “world’s first” in their field, or a lucrative exit through a strategic company sale, starting out with reliable 360-degree product and process visibility will set them in good stead for the future they envisage. But how?
Start with What Not to Do
The temptation for any young and aspiring company is to look to more established players for how to keep records and achieve regulatory rigor, yet in life sciences the big players are not the best model to follow. These companies tend to have brought in technology systems on a targeted, need-oriented basis, often under a series of restrictions including “what was available at the time” and “what could be shoehorned most effectively into a complex legacy IT estate.”
Young, dynamic biotechs can bypass all of that and be data driven from day one.
If You Have to Do It, Do It Right
Up to now, excelling scientifically will have been the primary focus. At such an early stage, biotechs may not appreciate the need to capture information in a structured way or to invest in formal infrastructure.
Yet, even from day one these teams will be generating and compiling information anyway, such as in the form of lab reports. If this activity is unstructured (informal manual notes, spreadsheet-based readings, Word documents), the biotech will only be storing up problems for later.
Instead, collate all of that information to navigate product authorization. This is where they will begin to experience the first pains of poor information management, if they have not already established good habits.
Bring Science & IT Together in the Lab
It’s a good idea to appoint a “chief technology officer” or information/data “evangelist” early on and bring them to the table for even initial scientific discussions. This will help ensure that everyone understands the value and role of all of the information they capture in making everyone’s lives easier and bringing products to market in as frictionless a way as possible.
One of the important side benefits of establishing data/information management rigor from the start is that it promotes introspection, so that the team establishes and maintains a rich understanding of their product from every angle—something regulators strongly encourage.
Make Data Management a Mindset, Not an IT System
In the old pharma information management model, companies might have set out to internally develop or procure a specified IT system. Today, the goal should be to develop a data-based mindset and strategy which underpins everything the company does.
Although capturing rich chemistry, manufacturing, and controls (CMC) data won’t necessarily speed up product approval, getting into the habit of recording everything in a standardized, accessible, and combinable way will set the company in good stead for that 360-degree transparency all companies need to aim for. (And, of course, CMC records reflect a lot of the variation information that regulators will need.) Comprehensive clinical data, meanwhile, could support earlier review and approval of products—the Holy Grail for ambitious startups with important new advanced therapies under development.
Start with the Big Picture, Not the Immediate Use Case
Traditionally, big pharma has made information management the preserve of individual departments—e.g., Quality, CMC, or Safety—in support of a targeted use case: most notably marketing authorization holder (MAH) dossiers for regulatory submission.
Data flows in each silo to inform individual summaries, overlaid with a product description—when, logically, the information flow should be the other way round. Even then, the picture isn’t complete: information should be feeding into this picture from the earliest research stages, from lab-based substance management at a cellular level. Capturing every insight in a structured way would enable biotechs to track and report on every aspect of what they do, at any point now or in the future.
Think Optimized “Architecture,” Not Definitive IT Solution
To lay the right foundations for this data-driven ideal, companies should ideally take an architecture-based approach to the way they capture and manage information, rather than trying to find the optimum software application to meet all of their needs today and tomorrow. This involves embracing data standards, and ensuring that information can be exported and combined easily without risk of overlap or error.
Keep Pace With—And Play an Active Role In—Evolving Data Standards
One of the huge advantages biotechs have today with their greenfield setups is that they can capitalize on the immense amount of work that has gone into setting new data standards and data exchange mechanisms, such as CDISC and ISO IDMP, and start as they mean to go on.
They can and should also seize opportunities to engage proactively with industry consortia, which are working to promote standards-based data exchange and greater cross-sector collaboration, accelerating the safe delivery of product benefits to patients. Examples include Accumulus Synergy and Pistoia Alliance.
Beware the Promises of Platforms & “Data “Lakes”
Although individual software vendors are making the right noises about making it easier to combine and manage data, many promote systems that draw from data lakes—e.g., to generate dossiers on the fly. The trouble is these platforms often fail to make sufficient allowance for context/what the information will be used for. This is an oversight biotechs can overcome by taking more of an architectural view of how they’ll capture and use data, which in turn points back to the need to link their respective technology and data strategy with their scientific ambitions from day one.
Develop a Data Vision
The ultimate aim should ideally be a “living dossier” which tracks a product’s evolution from conception.
Rethinking the role of data as a young biotech isn’t so much a problem as an opportunity—to redefine what’s possible and get this right from the start. And the good news is that plenty of biotech-specific help is out there to ensure young companies set out on the right track.