Mindbreeze and Booz Allen Hamilton Join Forces to Serve the FDA
Mindbreeze, a leading provider of appliances and cloud services for knowledge management, and Booz Allen Hamilton, a leader in management and technology consulting, are collaborating with the Food and Drug Administration (FDA) to deliver enterprise search capabilities for the Center for Drug Evaluation and Research (CDER) regulatory review community. The intelligent Mindbreeze InSpire solution was successfully launched in October to provide broad search capabilities for critical review information and a decision-support mechanism to aid the review process for the Center’s regulated products.
“We are proud to partner with Mindbreeze and the FDA to deliver leading-edge search capabilities to support the Agency’s important public health mission,” said Dr. Roman Salasznyk, Vice President at Booz Allen. “Our team of technologists and enterprise search experts are committed to transform FDA’s human drug review process leveraging enabling technologies that ultimately help bring live-saving treatments to market with greater speed and efficiency.”
Mindbreeze InSpire supports the FDA staff in efficiently managing the drug review process with a solution that compiles more than 150 million submission documents, reviews, and communications into a single user interface and makes them available as a consolidated knowledge base. The solution combines the latest technological developments such as machine learning, natural language processing, and AI-supported search functions in an appliance that is easy to use and implement.
“Our partner Booz Allen Hamilton has built up a wealth of expertise about Mindbreeze in recent years. Their implementation skills and commitment make them the perfect partner for us and our efforts to accelerate future large-scale projects across the US government and life sciences sectors,” adds Daniel Fallmann, founder and CEO of Mindbreeze.
About Mindbreeze
Mindbreeze is a leading international provider of appliances and cloud services for enterprise search, applied artificial intelligence, and knowledge management. Mindbreeze’s global network of partners makes it possible to serve customers across time zones anywhere in the world.
You can find more information at www.mindbreeze.com or follow us on LinkedIn and Twitter @Mindbreeze.
To view this piece of content from cts.businesswire.com, please give your consent at the top of this page.
View source version on businesswire.com: https://www.businesswire.com/news/home/20200116005419/en/
Contact information
Ulrike Kogler
pr@mindbreeze.com
About Business Wire
For more than 50 years, Business Wire has been the global leader in press release distribution and regulatory disclosure.
Subscribe to releases from Business Wire
Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.
Latest releases from Business Wire
Sonrotoclax Data at ASH 2025 Confirm Foundational Potential Across B-cell Malignancies8.12.2025 01:00:00 EET | Press release
BeOne Medicines Ltd. (Nasdaq: ONC; HKEX: 06160; SSE: 688235), a global oncology company, today announced new data on sonrotoclax, a next-generation investigational BCL2 inhibitor, demonstrating meaningful clinical benefit as monotherapy and in combination across B-cell malignancies. These data were featured at the 67th American Society of Hematology (ASH) Annual Meeting & Exposition in Orlando, Florida. The five presentations highlight durable responses in heavily pretreated patients with relapsed/refractory (R/R) mantle cell lymphoma (MCL) and additional studies showing deep, rapid, and sustained undetectable minimal residual disease (uMRD) rates with sonrotoclax-based combinations in patients with treatment-naive chronic lymphocytic leukemia (CLL), highlighting the foundational potential of this medicine. “The data we’re presenting at ASH 2025 are redefining what physicians can expect from sonrotoclax as a next-generation BCL2 inhibitor,” said Amit Agarwal, M.D., Ph.D., Chief Medical
Hemato-Oncology Trials: AOP Health Presents New Results at Top Congress ASH7.12.2025 18:00:00 EET | Press release
AOP Health continues to advance its clinical research program in myeloproliferative neoplasms, a special group of rare blood cancers. The company, specialized in rare diseases, presented the results of two scientific investigations at the 67th American Society of Hematology Association (ASH) Annual Meeting 2025 held in Orlando, FL, USA. The results provide new insights in treatment strategies. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20251207587915/en/ Dr. Martin Steinhart, CEO AOP Health; Photo credit: AOP Health/Studio Koekart ROP-ET and BESREMI PASS One of the clinical studies, ROP-ET, examined the use of ropeginterferon alfa-2b in people with essential thrombocythemia (ET), a disease in which the body produces too many platelets. The trial, a prospective, multicenter, single-arm phase III study, investigated the safety and efficacy of ropeginterferon alfa-2b in ET patients unable to receive available cytoreductive th
CoMotion GLOBAL 2025 Launches in Riyadh: Global Mobility Leaders Unite in Saudi Capital to Chart Urban Future7.12.2025 14:00:00 EET | Press release
Riyadh is rapidly becoming one of the world's most ambitious urban mobility laboratories, where next-generation technologies move from blueprint to real-world deployment on city streets at unprecedented scale. CoMotion GLOBAL 2025, the world's most influential gathering of urban mobility leaders, opens today in Riyadh for a three-day summit bringing together innovators from Africa, Asia, Europe, the Americas, and the Middle East. Running December 7-9, the event will explore how electrification, autonomy, AI-enabled transport, and giga-project urbanism are reshaping cities worldwide. The summit will spotlight everything from high-performance EVs and breakthrough autonomous fleets to emerging-market transport solutions and new mobility models, demonstrating how the Kingdom is opening new pathways for global mobility leadership. Strategic Partnerships Powering the Summit CoMotion GLOBAL 2025 is hosted by the Saudi Conventions & Exhibitions General Authority (SCEGA), supported by key Saudi
Deciphera Announces Oral Presentation of Positive Topline Results from Phase 2a Study of Sapablursen in Polycythemia Vera at the 67 th American Society of Hematology (ASH) Annual Meeting6.12.2025 16:30:00 EET | Press release
Deciphera Pharmaceuticals, a member of Ono Pharmaceutical Co., Ltd. (Headquarters: Osaka, Japan; President and COO: Toichi Takino; “Ono”), today announced the oral presentation of positive results from the Phase 2a IMPRSSION study of sapablursen in patients with polycythemia vera (PV) at the 67th American Society of Hematology (ASH) Annual Meeting, taking place December 6-9, 2025, in Orlando, FL. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20251206361611/en/ The results were presented by Ionis Pharmaceuticals, who discovered and developed sapablursen and conducted the IMPRSSION study. In March 2025, Ionis and Ono entered into a license agreement in which Ono obtained exclusive global rights for the development and commercialization of sapablursen. “In the treatment of PV, phlebotomy and cytoreductive therapy are performed as treatments for preventing thrombosis. Phlebotomy is the most common treatment for PV, in which blood
Protagonist and Takeda Present Longer-Term Data at ASH 2025 Showing Rusfertide Delivers Durable Response and Hematocrit Control in Polycythemia Vera6.12.2025 16:30:00 EET | Press release
Protagonist Therapeutics, Inc. (“Protagonist”) (NASDAQ:PTGX) and Takeda (TSE:4502/NYSE:TAK) announce that new 52-week results from the pivotal Phase 3 VERIFY study evaluating rusfertide in patients with polycythemia vera (PV) will be presented in an oral presentation at the 67th American Society of Hematology (ASH) Annual Meeting and Exposition. These findings further reinforce rusfertide’s efficacy and safety and demonstrate durability of response, with 61.9% of patients continuously treated with rusfertide maintaining absence of phlebotomy eligibility from baseline to Week 52. “The 52-week data demonstrated the sustained efficacy of rusfertide, reducing the need for patients to receive phlebotomy while maintaining hematocrit control,” said Dr. Andrew T. Kuykendall, M.D., VERIFY Lead Investigator and Associate Member in the Department of Hematology at Moffitt Cancer Center. “The 32-week VERIFY primary results were already promising, and this deeper understanding of the durability of r
In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.
Visit our pressroom