United BioSource Consolidates Leadership in Pharmaceutical Risk Management
Acquisition of Gigamoto Technology Partners, Inc. Further Expands UBC's Leadership in Drug Safety
BETHESDA, Md.--(BUSINESS WIRE)--United BioSource Corporation (UBC) today announced the acquisition of Gigamoto Technology Partners, Inc. (Gigamoto), a Pennsylvania-based software development company providing leading-edge technology solutions in support of drug safety and risk management programs for the life sciences industry. The acquisition is part of UBC's strategy of building integrated capabilities in risk management and drug safety by combining leading-edge technology with world class scientific, consulting and operational expertise. This transaction represents UBC's second acquisition this year to meet the growing demand for consulting and implementation of risk management programs on a global basis.
Gigamoto software powers several high-profile and highly complex risk management programs, including the largest and longest operating FDA mandated program - iPLEDGE. The program is an interactive, computer based distribution center that monitors pregnancy in women on isotretinoin therapy, also known by the brand name of Accutane, which has been known to cause birth defects. iPLEDGE was made mandatory by the FDA in 2006 and the most recent public data shows that this complex risk management system has registered multiple stakeholders including wholesalers, over 40,000 pharmacies, over 16,000 prescribers and over 300,000 patients, and today continues the ongoing successful enrollment and re-enrollment of patients. Gigamoto software has set the standard for integrating voice and web technologies to deliver risk management programs that link pharmacies, physicians, patients and payers to support prescription drug therapies with the goal of providing medication to patients who can most benefit from them, while at the same time ensuring risk reduction.
"Managing drug safety for increasingly complex drugs and biologicals requires world class scientific expertise, strong operations and demands state of the art technology," said Ethan Leder, CEO of United BioSource. "The acquisition of Gigamoto enhances and accelerates our technology platform to include more top notch FDA approved technology solutions for complex post-approval programs." Leder added, "Gigamoto's experience with performance-linked access programs has ‘set the bar' for high risk, data intensive programs."
UBC's global drug safety and risk management services include the development and implementation of risk evaluation and mitigation (REMS) programs, including those with Elements to Assure Safe Use (ETASU), periodic safety update reporting (PSUR), European risk management plans, case processing, and integrated pharmacovigilance services. These services are provided with dedicated and integrated resources around the globe. Gigamoto provides further scale and commercial website functionality to UBC's multi-stakeholder risk management systems.
"We are very excited to be part of UBC," said Jason Leedy, founder of Gigamoto. "After building the best technology platform in the industry, we are ready to join the industry-leading provider of comprehensive safety and risk management programs." Leedy added that, "We have always had the conviction that dedication, know-how and commitment to customer service would best serve our clients; we can now do so across the entire scientific program and not only the technology component."
Gigamoto is a specialized software development company that specializes in the definition, creation, validation, and operation of life sciences applications. In addition, Gigamoto has unmatched credentials in the unique demands of developing and operating the technology solutions necessary for FDA-mandated Risk Evaluation and Mitigation Strategies (REMS).
UBC accelerates the generation, analysis, and communication of real-world evidence by integrating scientific and operational expertise with innovative technology solutions to support global development and commercialization of medical products for life science companies.