The snippets of the conversation with Raja Ramesh Tummala, Chief Architect & Technologist.

In the realm of pharmaceutical and life sciences where precision, innovation, and reliability are the cornerstones of progress, Pointcross Life Sciences has risen as a true technology trailblazer. Its Xbiom platform technology traces its origins back to 2009 when it harnessed technology initially developed for analyzing vast datasets within natural processes, such as geology and biology. The company's early endeavors were centered around creating a groundbreaking technology platform aimed at toxicology and drug safety. This platform revolutionized the analysis of nonclinical study data for both major pharmaceutical companies and regulatory bodies like the FDA. These pioneering efforts resulted in the implementation of Study Data Standardization, employing widely accepted exchange standards such as CDISC’s SDTM and SEND.

In 2019, Pointcross embarked on an ambitious journey to leverage its Xbiom technology platform for Translational Medicine. This involved the seamless integration of omics and immuno-assay biomarkers with real-world patient endpoints obtained from clinical trials. Recognizing that the primary obstacle to achieving ‘Analysis-Ready Clinical Data’ lay in the arduous process of digital standardization, the company embarked on a paradigm shift. They automated data standardization, mapping, control terminology, and introduced machine intelligence to offer recommendations, replacing traditional programming and bio-statistical analysis methods. This innovation led to the automated generation of SDTM and ADaM sets, along with the creation of a future-proofed, dynamic, knowledge repository for advanced therapeutic development.

Pointcross' core technology, including robust security measures and data privacy safeguards, originated from extensive experience in diverse sectors,

including defense and oil and gas industries. The company has seamlessly integrated these elements into its product platform while tailoring specific solutions to meet the unique demands of the pharmaceutical industry. In addition to development of the Xbiom platform, the company has recognized the need for a highly specialized but non-traditional form of service referred to as 'Data Concierge', through which they provide BioTech and Pharma companies with a team of technology-enabled virtual experts in data science, clinical research, biomarkers, and bio-statistics who act as seamless extensions to internal scientific teams. Let’s speak with the Chief Architect, Raja, and understand more about the organization.

insights and automated SDTM generation within a day or two at a small fraction of the traditional costs.

What truly sets Pointcross apart is our commitment to data transformation. Unlike the industry norm of constantly adapting to evolving exchange standards, we create a permanent, time-invariant, universal repository model. This ensures that data remains standardized and invariant, regardless of future changes to how that data is needed for submission. This unique approach reduces labor and time requirements by 30 percent or more, making it an ideal fit for today's biologics-focused industry.

How do you ensure that sensitive clinical data is handled responsibly on security?
Pointcross Life Sciences places the utmost importance on ethical considerations and data privacy. We follow European GDPR principles. Our platform, developed over two decades ago, was originally designed to meet the highest security classifications required for defense. We've successfully tested it in various industries, including oil and gas, where it withstood serious security challenges. Meanwhile, our customers have the option to manage their data independently, with complete control and security. We prioritize data segregation, double-blind processes, and strict role based access controls to safeguard sensitive clinical data while maintaining transparency and trust with our clients.

How does Pointcross Life Sciences foster an innovative learning culture within its teams?
When we started, we were aware that our design and operating culture could not be conventional. We foster an innovative learning culture by encouraging experimentation and celebrating learning from failures just as much as successes, minimizing bureaucracy, and cross-disciplinary collaboration. Our teams focus on contributing to and delivering results without consideration for when they clock in or clock out of an office. We build our cross-disciplinary teams from within, usually starting with people with very little experience but a lot of ambition and purpose.

We are members of the CDISC consortium; the PhuSE collaboration forum among others, and we actively attend and present our works at conferences and industry events. We also ensure that all the employees are learning, getting trained, and current on the latest in science, data science and standards.