CyberActa consortium of companies now offers a framework and platform to accelerate and maximize drug development with the use of Artificial Intelligence
BOSTON, MASSACHUSETTS, USA, October 25, 2023
The teams at Veridat, CyberActa, Sensoworks, and Frontiere are pleased to announce a framework that addresses the high failure rate of Artificial Intelligence (AI) solutions to secure regulatory approval. Machine and deep learning are powerful drivers of our current digital revolution and offer incredible value in making predictions, recommendations, or decisions influencing real or virtual environments. AI/ML-based medical systems can be purely software-based, acting in the virtual world (e.g., image analysis software) or they can be embedded in hardware devices (e.g., advanced surgical robotics or Internet of Medical Things applications). Trust is the key to the widespread adoption and success of AI. It is for this reason that AI products must adhere to the highest standards of ethics and prevailing regulations.
Veridat’s Chief Technology Advisor, Professor, and lead author of the textbook Introduction to Medical Software: Foundations for Digital Health, Devices and Diagnostics (Cambridge University Press 2022), Xenios Papademetris, Ph.D., explained that “unlike traditional techniques which rely on explicit modeling and understanding of data, modern AI/ML methods using deep learning can learn such models directly from prior measurements and extract more complex relationships that are almost impossible to construct/design manually. However, given the critical importance of the input data, pharmaceutical manufacturers need to have rigorous processes in place to ensure that the data is appropriately gathered, audited, and managed to ensure that the final result — whether an algorithm that is used to diagnose patients, or a model that is used to guide the drug discovery process – is free from overlearning and bias and that the whole process can be audited for quality and data provenance."
Our strategic collaboration is a bold declaration that the future of drug development lies at the intersection of technology, regulatory insight, and the transformative potential of IoT.”
— Niccolò De Carlo, CEO, Sensoworks S.R.L.
Associated solutions often fail to secure regulatory approval, when real-time adaptations in medical systems may challenge ‘static’ regulatory assessments, inspections, and audits. In many instances, AI/ML solutions are developed first, and regulatory aspects are only considered as a second step when compliance with regulatory agencies emerges as a major challenge. The product development process would benefit from including regulatory aspects from the start. “The partnership brings together the best in business and technology strategy, AI/ML development and regulatory compliance, and organizational change management to support drug developers through successful transformations to Industrial IoT as is customary to Frontiere”, said Alfredo Adamo, Frontiere, CEO.
The four companies bring together all the necessary expertise for a framework simplifying the AI-assisted drug development efforts: Integration of regulatory work into development improves outcomes (CyberActa), that are rendered immutable (Veridat). These immutable outcomes are built on personalized cutting-edge AI/ML tools (Frontiere), and on intelligent structural monitoring platforms (Sensoworks). This framework is led by a team of people with extensive experience in drug development, manufacturing, and oversight. The framework for Human-led governance, immutability, and transparency: regulated and personalized cutting-edge AI/ML development applied to healthcare and drug development can be found here.
“Regulatory aspects built-in by design into AI systems and devices can help bring therapeutic solutions closer to the patient quicker and more efficiently.” Dr Remco Foppen, Biotech Business Advisor, at Frontiere
"As the CEO of Sensoworks, I am proud to witness the Cyberacta consortium's unwavering commitment to innovation and excellence. Our strategic collaboration is more than just a partnership; it's a bold declaration that the future of drug development lies at the intersection of cutting-edge technology, regulatory insight, and the transformative potential of IoT. Together, we are pioneering a new era where the power of Artificial Intelligence and the Internet of Things (IoT) harmonize with regulatory expertise to pave the way for groundbreaking advancements in healthcare. Our shared vision is not just about providing a framework; it's about rewriting the very narrative of drug development, ensuring that every regulatory response becomes a stepping stone towards a healthier, brighter future, where IoT-enabled data streams enhance the precision and efficiency of our endeavors." said Niccolò De Carlo CEO at Sensoworks
“The ability of AI models and tools to process substantial volumes of data, and rapidly identify patterns where human researchers might take months or be unable to, makes it a potentially transformational technology for pharmaceutical development. Either through the development of new drugs, or the repurposing of existing ones, the technology could reduce the investment required to bring a drug to market; and bring personalized medicine closer to becoming a reality,” said John Giantsidis, CyberActa, President. “Nevertheless, the technology should not be viewed as a form of magic or as something that creates sentient machines capable of self-improvement and independent decisions. It is akin to other technologies: humans instruct a model or tool and use the outputs to inform, assist or augment a range of activities”
Sensoworks is a highly innovative software company that uses the most advanced technologies to monitor, predict, and control complex data from different sources in real time. Sensoworks is a centralized and integrated Internet of Things (IoT) solution that collects, analyzes, and distributes data from various devices and sensors. Driven by advances in IoT, we adopt federated learning as a machine learning technique, to release data and drive discovery at the edge while predicting the objects’ needs and lifecycle. Our solution is applied to smart cities (waste management, smart parking, smart lighting), civil infrastructures, smart buildings, and asset management. For further information on innovative end-to-end software solutions for intelligent monitoring, visit https://www.sensoworks.com/ or
Additional information on Sensoworks:
Niccolò De Carlo
Frontiere is a network of enterprises that was born with the aim of creating an ethical and sustainable ecosystem of open innovation. Frontiere helps companies become more agile, intelligent, and competitive in the digital age, allowing them to take full advantage of the opportunities offered by digital transformation, reducing the time to access new technologies and achieve long-term success. New humanism, sustainability, and accessibility are Frontiere’s founding elements, with a focus on a valuable Digital Experience that combines aesthetic and design elements typical of solutions ‘Made in Italy’. We create long-term partnerships with companies, aiming to provide innovative, high-quality solutions that meet their specific needs, using cutting-edge technologies and methodologies. We promote social and sustainable innovation, supporting initiatives and projects that aim to improve people's quality of life and address global challenges such as climate change and inequality.
Learn more at https://frontiere.io/ and
Additional information on Frontiere:
+39 347 2256852
CyberActa is a leading provider of data-driven digital, regulatory, cyber, and privacy solutions. The company's products and services are used by Fortune 500 companies, government agencies, and startups around the world. CyberActa is headquartered in Boston, Massachusetts.
Additional information about CyberActa, Inc., can be found at https://cyberacta.com/ and
Veridat is Driven by TrustTM. Our platform captures and verifies every step of a digital workflow - End-to-End. It offers a total solution that can be tailored for any company, any industry, anywhere. Our objective is to help clients build and expand their business in response to a changing environment, reduce risk in the face of growing complexity, and improve the processes and systems that protect brands, build trust, and add business value. The end goal is for trust and business performance to be one and the same – inextricably linked by a strategy, culture, and operating model that drives brand performance.
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Co-Founder & Government Affairs