Merck | December 22, 2021
Merck , known as MSD outside the United States and Canada, and Ridgeback Biotherapeutics today announced that the United Kingdom Government will purchase an additional 1.75 million patient courses of molnupiravir (MK-4482), an investigational oral antiviral COVID-19 medicine. In the U.K., LAGEVRIO® is the planned trademark for molnupiravir; the trademark for molnupiravir in other countries has not been approved. With this additional procurement agreement, which follows a previously announced agreement for 480,000 courses of treatment, the U.K. Government has now committed to purchase a total of 2.23 million courses of molnupiravir.
In early November, molnupiravir received conditional marketing authorization in the U.K. for the treatment of mild to moderate COVID-19 in adults with a positive SARS-CoV-2 diagnostic test and who have at least one risk factor for developing severe illness. Molnupiravir is currently available in the U.K. and patients have started to receive treatment. An application for Emergency Use Authorization for molnupiravir is under review by the U.S. Food and Drug Administration.
Merck has entered into advance purchase and supply agreements for molnupiravir with governments of more than 30 countries worldwide, including 21 agreements with countries in Europe.
About Merck’s Global Efforts to Accelerate Access to Molnupiravir Following Regulatory Authorizations or Approvals
Global access has been a priority for Merck and Ridgeback since the inception of their molnupiravir collaboration. The companies are committed to providing timely access to molnupiravir globally through our comprehensive supply and access approach, which includes investing at risk to produce millions of courses of therapy; tiered pricing based on the ability of governments to finance health care; entering into supply agreements with governments; and granting voluntary licenses to generic manufacturers and to the Medicines Patent Pool to make generic molnupiravir available in more than 100 low- and middle-income countries following local regulatory authorizations or approvals.
Supply: In anticipation of the results from MOVe-OUT and the potential for regulatory authorization or approval, Merck has been producing molnupiravir at risk and expects to produce 10 million courses of treatment by the end of 2021, with at least 20 million courses to be produced in 2022. To date, Merck has shipped molnupiravir to 12 countries; in countries where it is approved or authorized, patients have begun to receive the drug.
Supply agreements: Merck entered into a procurement agreement with the U.S. Government under which the company will supply approximately 3.1 million courses of molnupiravir to the U.S. Government, upon Emergency Use Authorization or approval from the U.S. Food and Drug Administration. Merck has entered into advance purchase and supply agreements for molnupiravir with governments for over 30 countries worldwide, including Australia, Canada, Korea, Japan, Thailand, United Kingdom and United States, pending regulatory authorizations, and is currently in discussions with additional governments. Merck plans to implement a tiered pricing approach based on World Bank country income criteria to reflect countries’ relative ability to finance their health response to the pandemic.
Voluntary licenses: As part of its commitment to widespread global access, Merck previously announced that it has entered into a licensing agreement with the Medicines Patent Pool to increase broad access for molnupiravir in low- and middle-income countries. Additionally, Merck previously announced that the company has entered into non-exclusive voluntary licensing agreements for molnupiravir with established generic manufacturers to accelerate availability of molnupiravir in more than 100 low- and middle-income countries following approvals or emergency authorization by local regulatory agencies.
Merck continues to discuss additional measures and collaborations to accelerate broad, global access to molnupiravir.
Molnupiravir (MK-4482) is an investigational, orally administered form of a potent ribonucleoside analog that inhibits the replication of SARS-CoV-2, the causative agent of COVID-19. Molnupiravir has been shown to be active in several preclinical models of SARS-CoV-2, including for prophylaxis, treatment, and prevention of transmission. Pre-clinical data suggest that molnupiravir has a high barrier to the development of resistance.
XOR Security | May 25, 2022
XOR Security LLC (XOR) recently announced that it won a $31.4 million single-award task order to provide Cybersecurity Operations Support Services to the United States Patent and Trademark Office (USPTO) within the Department of Commerce. The USPTO Office of the Chief Information Officer [OCIO] delivers information and technology to enable innovation, and these services are critical to USPTO's ability to achieve its mission, goals, and objectives, and its Cybersecurity Division (CD) is responsible for all aspects of USPTO Information Technology Security. These include leading and operating a state-of- the art security operations center, which manages responses to a wide range of security and system performance indicators on USPTO's information systems, network infrastructure, and software systems.
Under this task order awarded by USPTO under General Services Administration (GSA) Highly Adaptive Cybersecurity Service (HACS) as a full and open opportunity, XOR will provide services typically associated with cybersecurity operations programs, and will help USPTO to ensure program alignment with Strengthening the Cybersecurity of Federal Networks and Critical Infrastructure, Executive Order (EO) 13800. Award of this task order does not constitute an endorsement by USPTO of XOR.
XOR is committed to supporting our federal government agencies who face evolving cyber threats from a dynamic set of actors. We have over a decade of experience developing and supporting cyber operations and engineering platforms which enables us to deliver the most advanced technology and cybersecurity solutions for our customers."
Razwan Raja, XOR Founder and Principal
Wasif Shakeel, XOR Partner for Cyber Operations, added, "XOR is very excited to kick this project off. I want to thank USPTO for placing their trust in us and give special thanks to our entire team for their hard work leading up to this contract award."
About XOR Security
XOR Security is a small business leader delivering Security Operations, Security Engineering, Cyber Analytics, Cyber Intelligence, and Cyber Offense services across a portfolio of approximately 30 federal and commercial cybersecurity programs, including six Security Operations Centers which we currently lead as Prime contractor. Our highly technical cyber operations and engineering professionals are on the front lines of the cyber battlefield, helping to protect our nation's critical infrastructure. The greatest risk is the one that goes unseen. At XOR Security, we shed light on the shadows.
NCI Information Systems | June 10, 2022
NCI Information Systems, Inc., a long-time technology provider to U.S. government agencies, announced that it has become Empower AI. The transformation reflects the successful adoption of the Empower AI Platform across federal defense, civilian and health care agencies, and leverages Empower AI’s all-inclusive AI-as-a-Service (AIaaS) approach.
Empower AI is declaring what we know to be true: AI is the most transformative technology of this era. AI represents the single biggest opportunity to enhance productivity of the federal workforce. By aggregating and synthesizing data quickly and more effectively with AI, we can elevate mission success for every government agency.”
Paul A. Dillahay, president and CEO of the new Empower AI
According to December 2021 research from Deloitte, 92% of federal agency leaders believe AI is important to their mission outcomes but the lack of technology supporting artificial intelligence is the top barrier to taking advantage of it. With nearly half of mature government organizations still beginners at AI, according to the same study, Empower AI’s AIaaS model makes government adoption easier by reducing risk and focusing on the “human development” aspects through integrated development, implementation, maintenance, and performance services at a fixed, inclusive cost.
Empower AI Platform built for the government ecosystem
The company’s flagship product, the Empower AI Platform, introduced in 2020 and continuously enriched, is built on decades of mission experience and tailored specifically for government challenges. The platform gives government agency customers the insights and tools necessary to make critical decisions faster.
“Our deep knowledge and understanding of our federal clients featured prominently in the development of the Empower AI Platform,” Dillahay said. “We designed it specifically for the unique ways in which government works, and in accordance with its strict requirements for security and transparency.”
The platform’s components include an AI framework, hyper-automation tools, and digital assistant:
Empower AI Works: A suite of hyper-automation tools helps shift focus to the most impactful work by automating time consuming tasks with AI, without the need for human intervention.
Empower AI Advises: A side-by-side AI assistant that accelerates human decision-making and increases productivity.
Empower AI Leads: A comprehensive AI management system that equips mission leaders to make better, faster decisions and achieve meaningful digital evolution through a unique and streamlined view of objectives, projects and tasks updated in real-time as work is accomplished.
Empower AI’s commitment to the transformative power of AI has already yielded results. The company has secured more than $1.5 billion in AI-enabled work and more than 75% of its customers have implemented the Empower AI Platform to recognize the exponential effectiveness of their AI-enabled workforce.
About Empower AI
Empower AI is AI for government. Empower AI gives federal agency leaders the tools to elevate the potential of their workforce with a direct path for meaningful transformation. Headquartered in Reston, Va., Empower AI leverages three decades of mission experience solving complex challenges in Health, Defense, and Civilian missions. Their proven Empower AI Platform provides a practical, sustainable path for clients to achieve transformation that is true to who they are, what they do, and how they work, with the resources they have. The result is a government workforce that is exponentially more creative and productive.
CNSI | June 14, 2022
CNSI, a leading provider of innovative healthcare technology products and solutions, announced the formation of its new Board of Directors, following the company's acquisition by investment funds affiliated with global investment firm Carlyle in December 2021. The Board includes several industry leaders with extensive experience in government technology and healthcare, including: Donna Morea (Chair), Lawrence B. Prior III, Penny Thompson, and Tom Weston.
As a Carlyle portfolio company, CNSI is very pleased to be working with the outstanding team of health and IT industry experts who have joined our new Board of Directors. I am excited for the journey ahead as we work together to further strengthen CNSI's market-leading products and solutions while also accelerating key investments that will help us bring even greater value and innovation for our state and federal healthcare clients."
Todd Stottlemyer, CEO, CNSI
Donna Morea serves as Board Chair; she is the former President of CGI, where her clients included many of the world's largest and most complex organizations in federal, state and local government, healthcare, and financial services. Since 2016, she has served as an Operating Executive with Carlyle, advising portfolio companies on strategic and growth initiatives. Morea also serves as a Trustee of Inova Health System, the largest healthcare system in Northern Virginia, and she is a Chair Emerita of the Northern Virginia Technology Council, which is the nation's largest technology council.
"Having worked with Todd Stottlemyer and other CNSI executive leaders throughout my career, I know the team's drive and commitment to be a trusted partner to their clients, a best place to work, and a good corporate citizen within the community," said Morea. She added, "With exceptional products, people, and processes already in place, CNSI is poised for tremendous growth, and I'm looking forward to helping them maximize their full potential."
In addition to Morea and Stottlemyer, CNSI's Board of Directors includes the following members:
Dayne Baird – Managing Director at Carlyle, who leads the firm's efforts in the government services sector.
Michael Echemendia – Vice President at Carlyle, with a focus on investments in the aerospace, defense, and government services sectors.
Michael Gozycki – Managing Director at Carlyle, with a focus on a broad range of growth, middle market, and large cap technology investments.
Lawrence B. Prior III – Carlyle Operating Executive, with a focus on government services, and the former CEO of CSRA Inc.
Penny Thompson – Healthcare Advisor and former Chair, MACPAC Commission; former CMS Deputy Director, Center for Medicaid and CHIP Services.
Tom Weston – Former Executive Vice President, Chief Financial Officer, ECS Federal, LLC.
CNSI delivers a broad range of health information technology enterprise solutions and customizable products to a diverse base of state and federal agencies in the United States. CNSI aligns, builds, and manages innovative, high-quality, cost-effective solutions that help clients achieve their mission, enhance business performance, reduce costs, and improve the health of individuals and communities. Headquartered in McLean, Virginia with a major technology center in Chennai, India, CNSI employs a world-class team of technologists, program managers, and subject matter experts with large-scale, mission-critical information technology implementation experience.