Clinical trial development is experiencing a surge in scientific breakthroughs, thanks to the introduction of new technologies and services. As we celebrate the ten-year anniversary of our bioanalytical laboratory in Lenexa, Kansas, we reflect on the changes that have taken place in bioanalytical science.
To discuss the future of our laboratories in Lenexa and the Netherlands, we spoke with Jason Neat, Executive Director of Bioanalytical Services.
Congratulations on the ten-year anniversary of the lab in Lenexa. Can you give us a little background on the establishment of the lab, what services were provided back then, and how it has developed over the past ten years?
The Lenexa bioanalytical laboratory was PRA’s first and still only US laboratory. It was built from scratch in 2010 through technology transfer and know-how from our colleagues in the Netherlands.
We started with one employee and a 12,000 sq ft shell space. We’ve grown to more than 115 employees and 48,000 sq ft. We built this site close to our Phase I clinic in Lenexa, which is located just minutes down the road. Their close proximity allows for rapid lab support of sample analysis, which is critical for dose escalation and limited stability sample studies.
PRA therefore has a strategic advantage in enabling support of fast turn-around studies. There's so much to focus on with sample integrity, sample stability, and even turnaround time on data requirements, so having our labs close by helps us accelerate these drug programs and results to make them successful. Lab proximity also provides an additional connection point for our clients. As we strive to bring PRA’s vast array of assets to drug development, being closely connected to our phase I clinic colleagues and late phase study support colleagues improves communication and teamwork. This is directly measured in positive outcomes of our sponsors’ most critical programs, no matter which stage of development they are in.
When we started, we were a traditional bioanalytical lab. At the time, the lab was primarily focused on supporting the development of small molecule therapies. In this type of research, we primarily deployed expertise in chemistry and Liquid Chromatography Mass Spectrometry (LCMS) technologies for the support of pharmacokinetic/pharmacodynamic (PK/PD) clinical and preclinical research.
The industry has changed over time. It’s an exciting, technologically innovative time for us in the healthcare industry. New types of molecules and therapies have come into play, which require different techniques for analyzing and producing data. We’ve grown significantly in the last ten years in order to adapt to these changes. Our labs have developed globally to now support the vast array growing biologic endpoints and therapies, from protein-based to cellular in nature. With the onset of advancements in therapy segments such as Immuno-oncology, auto-immune, and cellular therapies, the technologies and expertise have widened.
We’ve certainly been keen to grow our services to support this shift. We broadened our focus from primarily meeting traditional PK/PD endpoints to include a fully deployed biomarker program, with technologies and internal expertise to support. These technologies include flow cytometry, Immunoassay platforms such as ELISA, MSD, ELLA, and SMC Pro. We recently implemented qPCR to also allow molecular assays.
To compliment this, we also recently launched new GMP Pharmacy and CMC Quality Control services in the US. These services will further increase the types of clinical studies we can support as an organization, as well as yield applications for large and small molecule drug substances and products.
The labs help the broader perspective of PRA’s transition to a global health intelligence partner. We help our clients with everything they need to take their assets from concept to compound to cure—ultimately driving better, more timely therapies for patients around the world.
We pride ourselves in having the most touch points from a division or unit perspective at PRA. We can stay with a drug through its whole development journey, from pre-clinical to post-marketing study activities. Once we develop a methodology and relationship with the client, keeping that frame of reference helps accelerate the program through later stages of development.
Can you tell us about the relationship between our labs in Lenexa and our colleagues in the Netherlands? How has that been fostered over the past ten years?
When we talk about ourselves here at the laboratory, we mean our whole team. Both the Lenexa and the Assen, NL teams refer to ourselves as a global laboratory solutions team. While we have a site in Lenexa and a site in the Netherlands, we view ourselves as a OnePRA lab team with 300+ expert scientists, analysts, and employees that support drug development together.
We lean on each other immensely, from technology transfers and methodology transfers to global strategic scientific steering for lab advancements. Our training programs are similarly harmonized; we often organize global specialists training sessions using a single expert for both laboratory locations. It’s a symbiotic relationship that multiplies the power of our abilities.
Over the last ten years, one of the areas we have really grown is in global scientific support. The key to great science is iterative learning cycles and building on our expertise. Now, with a strategically staffed team in both the US and EU, we cover specialty areas in chromatography, high-resolution MS, micro-sampling, stability, immuno-assays, anti-drug antibody assays, neutralizing anti-body assays, biomarkers, and even therapeutic consultation. Our team is present and active with many of the industry leading conferences and working groups in the areas above, including AAPS Biomarkers and Precision Medicine Community, GCC (Global CRO Council), EBF Expert members, as well as board members for a number of other scientific societies and BIO working groups.
Tell us a little bit about the people at the Lenexa laboratory. What drives them and what are they most proud of?
Everyone is connected here through their pride, passion, commitment, and the ability to do it right. Hearing how our contributions have made meaningful impact to so many therapies over the last ten years is one of the most rewarding parts of the business for all of our employees. In order to do that, we must lean on each other and communicate heavily.
For me personally, it’s watching our staff grow and achieve things together that they may not have thought possible. The last ten years are only possible with great people, empowering them and letting them work at what they do best. A great example of that is highlighted in this recent article about our large molecule scientific team.
I see a thirst and hunger towards doing things the right way in all of our people. Quality is everything to us. We even have a statement that says, “Behind every sample waiting to be analyzed, there's a patient waiting to be treated.” Our jobs require us do things with high quality and compliance, great science, and urgency in what we are doing. The word “patients” adds a lot of weight to why we’re all here.
Our Laboratories for Drug Development are managed, staffed, and supported by industry-leading experts who have the scientific knowledge and experience necessary to successfully deliver the most complex of studies. We offer the highest quality services for pharmacokinetic, immunogenicity, biomarker, and CMC analysis, utilizing a wide range of platforms for small molecules, large molecules, and cell-based entities.
Innovative Technology Solution for a 15 Year Rare Disease Gene Therapy Registry
A Top 10 pharmaceutical client required a mobile technology solution to collect safety and effectiveness data on a groundbreaking treatment for an…
Ask the Experts: What Does the Future Hold for CRISPR Gene Editing Technology?
Changing a living organism’s DNA sounds like something out of science fiction, but recent strides in genome (gene) editing have given scientists…
CRISPR Technology Offers New Hope for Patients with Devastating Diseases
Clustered Regularly Interspaced Short Palindromic Repeats (CRISPR) is a powerful new gene-editing tool with unprecedented implications for the future…