THANK YOU FOR SUBSCRIBING
Pharma Tech Outlook Weekly Brief
Be first to read the latest tech news, Industry Leader's Insights, and CIO interviews of medium and large enterprises exclusively from Pharma Tech Outlook
Kamal Biswas, President & COOXybion addresses four key challenges that had always hindered labs from going digital and paperless in a holistic and compliant manner. First, the solution helps pharmaceutical labs to ensure data integrity and is fully GDPR and 21 CFR Part 11 compliant, Xybion also provides an entire validation package. Secondly, Xybion solves the problem of massive expenditure. “The digital solutions should be simpler, easy to implement, manage and improve the productivity and efficiency of labs. To meet business and compliance requirements, companies need to buy several systems such as quality management systems, document management system, data management & analytics systems with a LIMS. Our cloud-based lab management solution reduces the burden of buying four or five different systems or displaces several existing systems with one platform and can be configured with their existing process. The investment payback period is mostly one year,” says Biswas. In today’s volatile business scenarios, solutions must be well acclimatized to changes. Xybion’s solution, being low-code and cloud-based, renders a higher degree of flexibility and customizability. Lastly, it streamlines the whole data management process for its clients. Historically, the idea of data centralization via data lakes has been rather alien to labs. Biswas points out, “Our system ensures that lab instruments are connected to the Lab Data Lake.
Your Process, Your Way—is our motto and our ability to address client-specific problems differentiates us in the market
Xybion’s U.S. Patent Pending Compliance Predictor solution–that leverages internal audit results for predicting business risks and setting up plans for being always “Audit-Ready” is another key differentiator. With almost 50,000 records of 483s, citation documents, internal audit databases, Department of Justice fines and settlements, and a country business risk database, it ensures real-time reporting and empowers its clients in the life sciences space to mitigate business risks associated with financial penalties and delayed product launches.
Such unique solutions have enabled Xybion to etch a niche in this space, attaining a number of clients—from large companies to start-ups. In one instance, a large pharmaceutical company lacked a standardized solution to create, review, and manage protocols for internal and external researchers. Engaging with the client, Xybion configured a protocol management system within weeks that is being used by more than several thousands. Protocol standardization became an easy feat. In another instance, a large diagnostics lab had a constant struggle to customize a traditional LIMS to meet their business changes and making their customers happy. Xybion’s digital lab solution made their processes simple, easy to change, and also provided access to their customers for a real-time status update of their work. “Xybion offers Digital Lab Solution on a Build-Operate-Transfer (BOT) model for start-up companies that do not want to make large IT investment,” Biswas added on explaining working models with the start-up or smaller companies.
Motivated by such nonpareil instances of client success, Xybion is pushing its solution to diverse labs— research labs, development labs, quality control labs, diagnostics labs, and more. Striding ahead, the company is looking for reaching different market segments to serve a large clientele. Apart from this, the company plans to expand beyond the U.S. and Canada, with a specific focus on the markets of Europe, India, China, and South Korea. Also, the company is in the process of opening its full-time office in Europe this year. “Our motto—Your Process, Your Way—always drives us to address specific problems of each client, and this differentiates us in the market,” Biswas concludes.
Company
Xybion
Management
Kamal Biswas, President & COO and Dr. Pradip K. Banerjee, Chairman & CEO
Description
It can be challenging for lab-setups in a highly regulated life sciences industry to embrace cloud-based workflows and enjoy its multi-faceted benefits while being compliant with the local and international regulatory requirements. Traditional Laboratory Information Management System (LIMS) and Electronic Laboratory Notebooks (ELN) systems lack the flexibility to adapt to the constant business changes through frequent upgrades or customizations. Xybion addresses four key challenges that had always hindered labs from going digital and paperless in a holistic and compliant manner—data integrity, massive expenditure, customizability, and data management
Contemporary laboratory operations are undergoing a significant shift towards digitalization, generating substantial volumes of data that hold the potential for predictive insights. However, the utilization of separate technological solutions within these laboratories often impedes the realization of this potential. In a collaborative effort, Xybion and Certara are working together to surmount these challenges. They are integrating their respective products to facilitate the planning and execution of studies, while also enabling the management, analysis, and visualization of data. This integration aims to expedite the process of predicting the safety and efficacy of drugs.
Pristima® XD, a preclinical Laboratory Information Management System (LIMS) software, establishes a comprehensive digital laboratory execution ecosystem. This system offers the flexibility required to manage various types of studies conducted in both GLP and non-GLP laboratories. On the other hand, Certara's SEND Explorer™ Product Family is a leading data warehousing and visualization application. This application possesses the capability to ingest nonclinical study data in a diverse array of formats, which include SEND datasets (Standard for Exchange of Nonclinical data), static spreadsheet formats, and a direct link to Xybion's Pristima data collection system, or the Savante data repository. This integration empowers organizations to monitor ongoing studies, as well as to visualize and query data from ongoing and completed studies. Such capabilities prove invaluable in the assessment of compound safety.
"Our partnership with Xybion allows us to help scientists to improve their ability to monitor, query, and visualize non-clinical study data to better assess compound safety and make well-informed decisions based on these data," said Leif Pedersen, President, Software, Certara. "Combined strengths of Pristima, Savante, and SEND Explorer will allow organizations to expedite data review, gain insights from their nonclinical research investments, support scientific curiosity, and promote a culture of analytic excellence."
Dr. Pradip Banerjee, the CEO and Chairman of Xybion Digital, expressed his pride in the partnership with Certara, emphasizing the collaborative effort to enhance digital capabilities and provide significant value to stakeholders involved in Nonclinical R&D. He highlighted the global applicability of their joint solutions, underlining their relevance across diverse geographical locations. He also mentioned the intention of this partnership to offer solutions on a global scale.
The combined suite of products from Certara and Xybion offers a comprehensive range of features, which include:
• Planning of studies
• Management of protocols
• Execution of studies and collection of data
• Management of quality, compliance, and deviations
• Data management
• Visualizations for ongoing studies
• Visualizations spanning multiple studies
• Identification of patterns and trends within individual studies or across multiple studies
• Proactive addressing of regulatory concerns
• Facilitation of scientific collaboration and effective communication of findings
• Utilization of historical data to inform drug development decision-making
• Validation of data and preparation for SEND submission
"Data-driven decision making and sharable knowledge and insights using multiple-study data is going to enhance the performance of nonclinical labs. Our combined technologies will make this process seamless and significantly improve the quality of data for more accurate insights," adds Kamal Biswas, President & COO, Xybion.