We had the pleasure of speaking with Bonne Adams, Vice President of Operations at Inhibrx Therapeutics, at the Veeva R&D and Quality Summit to discuss integrating technology into clinical operations and the future of the biopharmaceutical industry.
Moe Alsumidaie: How has Inhibrx established a robust technology foundation to support its growth?
Bonne Adams: I joined Inhibrx in November, and the CEO brought me on to build a more efficient operational model. Inhibrx had a hybrid model, managing medical writing and having their own CRAs, but they were still mainly outsourced to CROs and using CRO systems. Inhibrx decided to bring all of the GXP systems in-house. My experience setting up companies using Veeva software made me a perfect fit for this operational revamp.
We launched six new software applications, all integrated, in 4.5 months. During that time, we started our first clinical trial using those systems. The quality and cost savings are significant, but you need the right team to make it happen. For example, integrating these systems has allowed us to streamline processes, reduce errors, and improve overall efficiency, which is crucial for scaling our operations as we grow.
Moe Alsumidaie: How do you create a culture that supports this type of innovation within the organization?
Bonne Adams: The decision to change your operational model must come from the top. It would be best to have CEO-level buy-in to make things more efficient and communicate that message company-wide. Additionally, a robust quality team and IT support is essential. This top-down approach ensured that everyone in the organization understood the importance of the change and was on board with the new direction.
Moe Alsumidaie: What are some of the key challenges Inhibrx faced in integrating data across clinical, regulatory, and safety functions, and how did you overcome them?
Bonne Adams: The project team isn’t just oriented around a single system; it’s at the company level. Business process owners for each system must be best friends because data flows between systems. We created maps showing how data fields map from one system to another, which are part of work instructions for our team. Transparency and collaboration are essential. For example, we demonstrated how data from our clinical trial management system flowed seamlessly into our regulatory information system. These detailed maps and work instructions were essential in helping everyone understand how the systems work and how to work effectively within these technology systems.
Moe Alsumidaie: How is Inhibrx leveraging automation to streamline the flow of data across different systems, and what impact has this had on operational efficiency?
Bonne Adams: Automation is crucial. For instance, we automate our clinical supply distribution. The system automatically resupplies the drug to the site when a certain threshold is reached. Another example is the AI bot for eTMF filing, which is incredible, as it reduces the risk of error and ensures documents go to the right place. My experience with the TMF Bot has been excellent; the TMF Bot ensured that every document was filed correctly, significantly reducing the time and effort required for manual filing and minimizing errors. This automation allows our team to focus on more critical tasks, improving overall operational efficiency.
Moe Alsumidaie: Do you see this also integrating with study sites, where sites upload certain documents and both the sponsor and sites have access?
Bonne Adams: Veeva’s big push this year is Veeva Site Connect, enabling better communication between sponsors and sites. The challenge will be sites’ willingness to adopt this technology, especially academic centers with restrictive policies. One of the most significant barriers is data transfer from an electronic medical record (EMR) into electronic data capture (EDC). It’s ridiculous that lab data can’t automatically integrate into EDC. Site personnel should focus on saving lives, not re-entering data. I hope someone can fix this; If we could automate the transfer of lab data from an EMR to an EDC system, it would save significant time and reduce the potential for errors. This would allow site personnel to focus on patient care rather than administrative tasks.
Moe Alsumidaie: Looking ahead, how do you see Inhibrx’s technology landscape evolving? What are your top priorities for the future?
Bonne Adams: Being willing to adopt tech and taking advantage of new solutions is crucial. Having Veeva as a partner is vital because their solutions are connected. Executives need to have a background in tech because that is the future and the industry will be more efficient because of it. Our partnership with Veeva allows us to stay at the forefront of technological advancements in the industry. Their integrated solutions help us streamline our operations and improve efficiency. Our top priority is to continue adopting new technologies to help us achieve our goal of a more efficient cure for cancer.
This article is sponsored by Veeva
Moe Alsumidaie is Chief Editor of The Clinical Trial Vanguard. Moe holds decades of experience in the clinical trials industry. Moe also serves as Head of Research at CliniBiz and Chief Data Scientist at Annex Clinical Corporation.
