Calyx spins off medical imaging, eClinical solutions firm

Calyx—a UK-based company offering medical imaging, eClinical and regulatory services to clinical research clients—has shed the name Parexel Informatics in favor of its new moniker. After this strategic separation, the company will continue its work pursuing innovative technology intended to accelerate the discovery and development of new treatments.

With 250 new drug approvals in its history, Calyx has supported over 25,000 trials involving more than fourteen million patients. The company will continue its focus on providing innovative technology solutions and services to speed the discovery of new treatments.

Gavin Nichols (GN), Calyx CEO, spoke with Outsourcing-Pharma (OSP) about the newly named company, the evolution of medical imaging in clinical work, and what might lie ahead for the “nimble” new company.

OSP: Can you share an overview of how use of medical imaging, and the technology involved, has evolved in clinical research?​

GN: Medical imaging has evolved in relation to the changing needs of research. Over the last few decades, we have seen a shift from small molecule chemicals toward big molecule biologics. This shift has changed the assessment of efficacy more toward therapeutic effect. Thus, increasing the reliance on biomarkers for efficacy endpoints, as well as other endpoints.

From a patient perspective, the ability to utilize non-invasive biomarkers, such as imaging, over other biomarkers like biopsies is extremely advantageous. This also improves the overall conduct of the trial, through improved patient recruitment, adherence, etc.

In addition, one of the most dramatic shifts that has occurred over the past decade is related to the advancement of breakthrough therapies and accelerated approvals: sponsors need access to data faster to make critical go/no-go decisions. Traditionally, imaging results were provided at the end of the trial. By today’s standards this is just too slow. We are seeing more basket trials where imaging is being used as evidence of signals that help define a sponsor’s pipeline and regulatory trajectory.

With advances in functional imaging, medical imaging endpoints can now provide evidence for how drugs interact with target tumors or physiological functions. As such, medical imaging endpoints play different roles in documenting safety and efficacy in different phases of clinical development.

The value behind medical imaging is rooted in the output; what decisions can be made from this data? Medical imaging is an amalgamation of scientific expertise, processes, and systems.

While we are seeing a rise in the artificial intelligence space, we are not seeing the reduction of human evaluation. Studies benefit from expedition and quality through technology but require the scientific expertise and understanding of disease and radiologic findings to provide a truly valuable overall assessment to sponsors.

We are working on exploratory endpoints to identify future evaluations that can allow faster critical decision making.

OSP: Can you please share some of the advances and accomplishments Calyx (formerly Parexel Informatics) has achieved?​

GN: At Calyx, we have a long history supporting successful product development programs, including over 250 drug approvals. This is our greatest accomplishment.

We’re proud of the role we played in every one of them, especially the breakthrough therapies we helped our customers bring to successful approval. In fact, over the past two years we supported half of the oncology treatments approved by the FDA as breakthrough therapies.

For over 25 years we’ve been recognized as a leader in medical imaging, randomization and trial supply management (IRT), clinical trial management systems (CTMS), regulatory information management (RIM), and EDC. Our solutions have been repeatedly recognized by industry analysts for the value they deliver.

As an example, Calyx IRT was recently recognized – again – in the 2020 ISR survey of biopharmaceutical professionals as the industry’s preferred IRT solution due to its usability and flexibility, and our experience in simplifying complex trials.

And we’re continually developing innovative technologies to improve efficiencies throughout the development and life cycle of medicinal products. One recent example is our collaboration with Microsoft to deliver Azure-based solutions like Calyx RIM for Office 365, a robust SaaS platform that simplifies regulatory information management and improves productivity by surfacing key tasks and workflows directly within Microsoft Office 365.

OSP: What are some of the most notable pressures facing pharma companies and their research partners?​

GN: In the turbulence of the last year it’s become clear that the biopharmaceutical industry needs to improve efficiencies around the clinical research process in order to get new treatments to patients sooner. Yet, clinical trials continue to become more complex, putting more pressures on trial sponsors and CROs which in many cases extend clinical development lifecycles.

Examples of this complexity include increasing regulatory requests for imaging-related endpoints in clinical trials, the demands of monitoring and managing world-wide studies, and most recently, the unanticipated need for sponsors and CROs to ship trial medication directly to patients without breaking randomization blinds, in order to keep patients safe while ensuring study continuity during COVID-19 stay-at-home mandates.

Now, as a more nimble and independent company, Calyx is in a better position to deliver the innovation needed to solve these and other complex clinical trial challenges, drive improved efficiencies to accelerate clinical development, and help our customers get much-needed treatments to patients faster.

OSP: Does the Calyx team have any goals or targets for 2021 that it can share?​

GN: Our goal – our mission, really – is to shape the future of clinical research. As of today, we’re making substantial investments in advancing product development, strengthening operational delivery, and providing dedicated customer support resources to achieve this.

We’re also serving new markets – and embarking on new relationships with the clinical research organizations (CROs) that are such an important part of the clinical development ecosystem. What you’ll see as a result of these investments is a steady stream of pioneering solutions and services, based on customer needs and input, to better meet the industry’s needs and delivering “the next frontier” of clinical development.