Xybion to Showcase New Preclinical Software Modules for Pristima Suite at the Annual SOT Meeting and Expo in San Francisco

Xybion, the makers of Pristima Suite, an industry-leading preclinical data management software solution, announced it will showcase three new modules for FDA SEND, document management and Peer Review at the SOT Meeting and Expo in San Francisco.

Bensalem, P.A., March 8, 2012 /24-7PressRelease/ — Xybion Corporation announced that its Pristima Preclinical Software suite will be featuring several new, preclinical software modules at this year’s SOT (Society of Toxicology) Annual Conference in San Francisco, March 11-15th.

Pristima Suite is an enterprise-class preclinical software and data management solution designed to automate and optimize the end-to-end preclinical drug discovery process. Designed to be used by Pharmaceutical and Biotechnology companies, CRO’s and university research departments, Pristima Suite is a leader in technology and process management for Toxicology and Pathology professionals.

Pristima Suite will be prominently featured at this year’s SOT meeting. The event is an annual meeting for the Society of Toxicology, a global industry association for the advancement of Toxicology as a profession and research practice. Xybion announced the release of three new modules within the Pristima Suite that will be featured at the meeting. The new modules extend the already powerful capabilities of the solution to encompass key processes.

The new Pristima Suite modules to be featured at SOT are listed below and data sheets for each module can be found at https://www.xybion.com/pristima-xd/core

– Pristima for SEND – Standard for Exchange of Non-clinical Data (SEND) is the content standards set by the FDA for the submission of preclinical safety assessment data. By creating a recognized standard for submission data, SEND facilitates communication between research organizations, sponsors and regulators. The Pristima SEND Conduit (SCC) is fully integrated with the full Pristima Data Management Suite is designed to comply with the FDA regulatory guidelines and standards. Acting as a channel to concentrate and format preclinical data, the Pristima SCC module is designed to support SEND compliant data submissions to the FDA from a variety of data sources, including Pristima , Xybion’s legacy PATH/TOX SYSTEM and other third party data management systems such as those used for toxicokinetic data management.

– Pristima DoCs – Built on Microsoft Office, Pristima DoCs is powerful, but easy to use. Formatting and managing comprehensive toxicology data collected by Pristima and other third-party management systems the DoCs module can create final reports which contain narrative sections detailing the study design while importing study protocol fields and numerous data tables directly from the Pristima database. The module will render all of the graphs, tables and statistics functions associated with the data and incorporate these attributes directly into a Microsoft Word Document and protects tables from editing, maintaining GLP data integrity. A template-driven application, Pristima DoCs allows the user to create document templates to standardize the reporting format, permitting the organization to create a consistent, familiar reporting system for contents, appendices, tables and graphs; providing the most rapid and cost effective approach to completing a final report.

– Pristima Peer Review – The module assists participants in the design and development of the peer review plan and facilitates the steps of the entire review process. Flexible, configurable, robust and following peer review best practices, the application allows the laboratory to determine the mode, sampling and timing of the review procedures. To keep the results unbiased and unaltered the primary study pathologist cannot make any further entries or changes to their findings during the peer review process. Once the peer review data entry is completed, reconciliation reports are available. Any differences are reconciled online through the discussion phase and any changes or new findings may be recorded with a reconciliation comment.

Said Carlos Frade, Vice President, Preclinical R&D solutions; “The new modules represent a great advance forward for our customers and prospective clients in the management of data that is key drug in development processes. We continue to expand the platform to stay ahead of the curve with respect to new and valuable technologies to support drug discovery. These new modules reflect our commitment to being the leading provider of preclinical data management software”.

Xybion will be presenting the new modules at its booth and will be hosting a reception for clients, partners and prospective clients at the meeting. You can learn more about these modules at https://www.xybion.com/pristima-xd/core/#core

About Xybion Corporation:

Xybion Corporation is a global leader in the development and delivery of critical enterprise solutions to highly regulated industries. Xybion offers a comprehensive portfolio of interconnected solutions for Preclinical R&D data management, quality/ governance/risk/compliance, Enterprise Asset Management and Enterprise Content/Records Management. Xybion compliments its product portfolio with its Global Development Center, providing broad range of professional services including validation, testing, implementation, project management and custom application development

Xybion provides enterprise solutions for mission critical business processes for highly regulated industries. Xybion supports its global, multi-industry client base with a comprehensive portfolio of interconnected solutions that include:

Quality/governance/risk/compliance Enterprise Asset Management, Enterprise Content & Information Management, Preclinical Data Management

To support Global deployments, our Professional Services include; validation, testing, migration, integration, custom application development, business intelligence, project management, training and global support. Our business partners include: EMC, OpenText, IBM and Microsoft. Our Value Proposition is to lower our client’s Total Cost of Ownership (TCO) for essential business processes, mitigate risks, accelerate growth and maintain regulatory compliance.

Contacts

Media
Joseph Kalina
Xybion Corporation
609-512-5790 x 316
[email protected]

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Heidi Krueger

Head of Quality Assurance

Heidi leads Xybion’s Quality Assurance practice. She has over 20 years’ experience in designing and implementing quality assurance policies. Since joining Xybion in 2000, Heidi worked with several clients to design quality policies and ensure compliance. She is responsible to hosting Xybion customer audits. Heidi has a BA degree in Biology from The King’s College.

James Castonguay

Product Technology Lead

James provides leadership to Xybion quality management systems including product design, development and client delivery. James started working with Xybion in 2002 in its Canadian division. He is now managing product delivery from the United States. James has a master’s degree in mathematics and minor in informatics from the University of Sherbrook, Quebec, Canada.

Dave Chiaramonte

Enterprise Assets and HSE Leader
Dave brings diverse and deep expertise to his leadership role as the leader of Enterprise Asset Management (EAM) and Employee Health & Safety line of business. Dave has over twenty years of experience within the Information Technology industry including development, implementation and integration of complex Enterprise Systems in large corporate environments. He is a highly regarded technology leader in IBM’s Maximo Asset Management Product implementation. Dave worked with BMS and Dupont pharmaceuticals before joining Xybion in 2004.

Tom Klapmuts

Digital Lab Solution Leader

Tom provides leadership in design, delivery and revenue growth of Xybion digital lab solutions. He is an experienced client solutions manager with a demonstrated history of working with many clients globally to solve their business problems. Tom has training in U.S. Food and Drug Administration (FDA), Good Laboratory Practice (GLP), Life Sciences, CRO Management, and Clinical Development. Before joining Xybion, Tom worked for pharmaceutical companies such as Merck and Schering Plough. Tom is a Purdue university alumnus.

Priya Rajesh

Head of Sales: APAC & EMEA

Priya is responsible for Xybion business growth in APAC and EMEA region. She brings over 18 years of experience in Business Consulting and Operations Management. Her deep expertise in diversified areas, including strategic alliance and partnership management, diversity and inclusivity initiatives and employee development, will amplify Xybion’s global strategic relationships and will strengthen the company’s executive leadership in India. In her last role at Conduent, she served as Director-Marketing & Bid Management. Prior to this, Priya has worked with Infosys and Covansys (now CSC). Priya holds degrees in microbiology & health management.

Raji Bijur

Head of Quality Control & CSV

Raji leads Xybion Quality Control function. She has over 22 years of experience in software quality management, CSV, SQA, software process & KPI development and industry benchmarking. She has strong process implementation knowledge including ISO, CMMI, Agile, Scrum, Six Sigma, Lean. Certified CSQA, CSV, GCP, and GAMP. Raji has led implementation of QC processes in Robotic Process Automation (RPA) projects. Before coming to Xybion in 2019, she worked with IQVIA (Former Quintiles), Infosys, Aris Global, Mphasis and serving clients across different market segments. Raji has a bachelor’s degree in information science & technology and MBA from Indian Institute of Management, Ahmedabad.

Bob Friedman

Chief Solution Architect

Bob Friedman has over 25 years of experience in Preclinical information systems at Xybion Corporation as a developer, development manager and Chief Solution Architect. He has been an active member of the CDISC SEND standards consortium for five years as well as the PhUSE / FDA Industry Collaboration. Bob has previously worked for Synthes Orthopedics, NYU Medical Center and the New York State Department of Health. He has a master’s degree in Biomedical Engineering from Rensselaer Polytechnic Institute.

Gokul Panda

Head of Platform and Product Development

Gokul is the Head of Platform and Product Development, responsible for developing new and critical platforms and products. He has over 20 years of enterprise software development in the life sciences industry and related fields. Gokul holds both a Bachelor’s Degree and Master’s Degree in Engineering from the Indian Institute of Engineering, Science, and Technology. Gokul’s unrivaled expertise in enterprise software architecture and solutions provides Xybion’s clients with leading product functionality, innovation, and platform stability.

Anu Roy

Chief Solutions Delivery Officer

Anu manages project delivery and relationship. She has over 18 years of Life Sciences industry and IT services experience. Anu has a strong track record of designing and developing digital solutions, management consulting, quality & compliance Management, CLM, process & key metrics design, program execution & improvement and account management. Anu is a recipient of the STEM WOC ‘Technology Rising Star ‘by US Women’s magazine in 2014. She has received several other awards including Infosys Consulting Architect Award for outstanding achievement in 2011, RCL Crown Golden Brain Award in 2013. Anu is a guest columnist at Pharmaceutical Compliance Monitor and published in several international business magazines. Anu has a bachelor’s degree in Biochemistry and MBA in marketing.

Keith Dempsey

Chief Information Officer

Keith Dempsey has joined Xybion as our global CIO. He brings 20+ years of progressive Information Technology experience from Merck, AIG, Barclays and PriceWaterhouse. Focusing his career on building global strategies that capitalize on progressive technologies that scale in accordance to realized business growth. His experiences range from introducing new technologies that facilitated a competitive advantage for Merck, introduced new and scalable technologies for AIG Investments, and created progressive global organizational improvements for Barclay’s Capital. Keith has a degree in Chemical Engineering from Clarkson University and an MBA from William Paterson University.

Steve Porfano

Executive Vice President & Chief Financial Officer

Steve manages Xybion corporate function which includes Finance, HR, Legal and QA. Steve joined Xybion in 1989 as Corporate Controller and was promoted to Chief Financial Officer in 1991. As Chief Financial Officer, Steve is responsible for the establishment, enhancement, coordination and administration of the Company’s financial systems, internal controls, and related areas. Additionally, he is the corporate liaison to the Company’s bank, independent certified public accounting firm and governmental compliance and financial auditors.

Kamal Biswas

President & Chief Operating Officer

Kamal joined Xybion as its President and Chief Operating Officer in 2018. He is an acknowledged leader in the life sciences industry and has over 20 years’ experience in management consulting and pharmaceutical business. Very recently, Kamal was a Partner and leader of the global Life Sciences practice at Infosys Consulting. Before that, he spent several years working with pharma companies including Novartis Pharma and Ciba Geigy to manage manufacturing and late-stage R&D functions.

Pradip K. Banerjee, Ph.D., MBA

Chairman of the Board & Chief Executive Officer

Dr. Banerjee is an entrepreneurial senior executive with 30+ years of in-depth experience in the global Life Sciences, Healthcare and Services industry in global operations, strategic management, business development, investments and new ventures creation, M&A and Buy-outs. Prior to acquiring Xybion in 2008, Pradip served as President and CEO of Science Center in Philadelphia focused on creating, incubating, managing and investing in science based new companies. He was the Partner-in-Charge of the pharmaceutical Research & Development unit of Accenture where he created the R&D consulting unit and had grown it to become $100+ million worldwide business. Dr. Banerjee holds a Ph.D. in Pharmaceutical Sciences from University of Wisconsin-Madison and an MBA from the Wharton Business School of University of Pennsylvania.

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