In the concluding part of Pharma IQ’s conversation with SmartLab Digital 2020 presenter Unjulie Bhanot, Solution Owner (Biologics Development) at IDBS, Bhanot explains why scientists and IT team members need to work closer together to bring about real change within the lab. She also explains how the next generation of lab employees are bringing change with them and why the industry needs to think beyond technology and look to data to help remedy production problems.
Pharma IQ: What solutions exist for those struggling to build the right foundations to ensure data integrity and how can we ensure data integrity in the future?
Thinking about it in the longer term, many systems in use today have been around for a while, but the data integrity guidelines have since been updated.
Data that is now being captured in a structured, consistent format means it can be looked at years down the line and be read exactly the way it was recorded. Data will always be available if you need to check something or if you have a similar project.
We’re not quite there yet, but these are the types of things that can contribute toward data integrity. Technology wise, the industry is also changing. You have a lot more high-throughput instrumentation and more complex systems. Large volumes of data can be generated quickly and managing that through an electronic system is a lot better than trying to handle that via paper, Excel™ or someone’s manual intervention.
Pharma IQ: As different departments bring their digital plans together, what are the biggest hurdles to realizing digitalization at scale?
Bhanot: The way that data is captured in different departments, such as R&D and manufacturing, means it will be recorded differently – in different formats, different structures and to different standards. What is missing is the hook to be able to get data from R&D into a format that can then go into manufacturing without the need for manual intervention
We’re getting there, however. We’ve moved away from paper, we’ve moved away from a simple ELN, but that ability to pull data together and bring it together to be able to actually go to scale is still a work in progress.
Pharma IQ: With communication between different divisions being a much-cited obstacle to digital transformation, where would you like to see communication become more efficient?
Bhanot: There are roles that have been created in the industry in the last five years that would never have existed before because there just wasn’t the need for them. Ideally, you need people who have an understanding of the science, as well as what newer technologies are coming along and what problems they will solve.
What is difficult for someone with a purely IT background who has never worked in science is that they may have a great vision of what their software can do, but they may not know how to translate that into scientific problems or the daily problems scientists are facing in the lab.
Equally, a lab scientist won’t necessarily know what the best software is out there to solve their problems.
There is then a middle pool of people with a skill set in both areas which are key to bringing both groups together, whether that’s people in the lab who are fluent in science and software, external consultants with this knowledge or software organization like ours. Developing those skills in people is really critical to bridging that communication gap and we’re already seeing that with new entrants to the industry.
When I was at university, we didn’t record things electronically, as we did everything on paper. Today’s graduates are entering the field with a much better head start because they’re using digital systems and apps in their everyday life.
Pharma IQ: Will the industry be able to meet the expectations of a younger, more digital-savvy workforce?
Bhanot: There are enterprises out there that really want to change the world and there is a pool of people who are struggling to challenge the regulations for what they were designed for – paper systems.
Regulators are not there to make life difficult, - they are out there to make sure a drug is made safely, but they are aware that change is happening, and are slowly moving into the digital age.
Everybody has to work together to make sure they are aligned, but the regulations companies follow were written 15–20 years ago for paper-based systems and there is a hesitance in the community to challenge that.
Bhanot: For me, it’s about mapping out the journey of the data we’re collecting and not thinking about solutions that solve just one problem or challenge at a time.
If you look at the development of a product in the bio-dev space, it starts off as identifying the DNA, which encodes the protein, before going through a series of development steps to make the drug.
Similarly, the way you capture data, plus the amount and type of that data, can vary so much at each step of the development process that people can lose sight of their goal. I think you need a top-down vision of the whole landscape so you can work backwards from the end point of both the data and the product to see what strategy and systems need to be put in place – whether that’s connectivity between different platforms or throwing paper out in different parts of development. It’s there that I believe pharma will gain true value from embracing digital transformation, this year and in the future.