The Disruptive Technologies Innovation Fund (DTIF) is a €500 million fund established under Ireland’s National Development Plan (NDP) in 2018. On Thursday 23rd November, Ireland’s Minister for Enterprise, Trade and Employment, Simon Coveney TD, Minister for Further and Higher Education, Research, Innovation and Science, Simon Harris TD and the Minister of State for Trade Promotion, Digital and Company Regulation, Dara Calleary TD, today announced funding of a further €58.8 million to 12 new projects under the DTIF.
The purpose of the fund is to drive collaboration between Ireland’s world-class research base and industry as well as facilitating enterprises to compete directly for funding in support of the development and adoption of these technologies. The aim is to support investment in the development and deployment of disruptive technologies and applications on a commercial basis.
HiTech Health (Déantúsaíocht Sláinte Hitech Teoranta), University of Galway (UG) and Odyssey Validation Consultants Ltd have been awarded €6,579,772 as part of the DTIF for a CellConnect project. CellConnect will capture data from every stage of the cell manufacturing process and empower Ireland’s cell-based therapeutic manufacturing revolution by developing disruptive methods to automate processes and transport cell products.
Dr Brian Harrison, Managing Director of HiTech Health, said “We are delighted to have been given this prestigious DTIF award and look forward to working with our partners, the Duffy Laboratory in University of Galway and Odyssey Validation Consultants to bring this exciting CellConnect project to reality. Cell Therapies really are life changing medicines and Hitech Health are currently working with several client companies who are bringing new therapies to patients many of whom suffer from rare diseases. This CellConnect platform will provide a significant step forward in the automation of processes, many of which are currently paper based. This project will also build capability in Ireland in this rapidly growing area of ‘Advanced’ medicines which is leading to treatments that can transform patients’ lives”.
Hitech Health is delighted to be attending Advanced Therapies Integrates in Stevenage, England on the 30th November. This event aims to drive the translation of cutting-edge research and disruptive innovation into the wide-spread adoption of Advanced Therapies, delivering improved patient outcomes and a revolution in healthcare economics. Advanced Therapies Integrates will bring together innovators, regulators, supply chain partners, equipment & technology providers, academia, industry associations, together with a wide array of government funding bodies and government supported pharma-focused initiatives.
The genomics revolution and other advances have led to the emergence of highly effective, but extremely complex therapeutics, with cell and gene therapies, regenerative medicines and tissue therapies now transforming the prospects of patients and healthcare providers around the globe. As a full service CDMO for advanced medicines, Hitech Health is well positioned to work closely with you to support the successful development and manufacturing of new therapies.
To learn more about our cell and gene therapy services by clicking here
Afortiori Development and HiTech Health Forge an Important Collaboration to Support the Clinical Research and Product Development of Groundbreaking Cell and Gene Therapies.
Galway, November 9, 2023 – Afortiori Development, a premier full-service Clinical Research Organisation, is thrilled to announce its latest partnership with HiTech Health, a leading Contract Development and Manufacturing Organisation (CDMO) for Advanced Therapy Medicinal Products (ATMP) including Cell and Gene Therapies (CGT) (Europe/UK/Ireland/US). This strategic alliance aims to provide an integrated suite of services to companies conducting research in the ATMP and CGT areas. The two companies believe that by seamlessly integrating clinical trial expertise with cutting-edge product development and manufacturing capabilities, this will provide the calibre of service required by companies conducting research, ensuring that their clinical research journey is enhanced overall.
Afortiori Development’s unwavering commitment to providing expert, flexible and economically viable clinical trial design and clinical trial management services perfectly complements HiTech Health’s extensive knowledge and expertise in product development, manufacturing and supply chain. By joining forces, these industry pioneers are in a strong position to deliver unparalleled support, enabling clients to optimise their clinical research processes, enable faster trial start up and drive ongoing support of their revolutionary products while research is in progress.
“Our approach has to evolve to deliver the cutting-edge services that clients innovating in the advanced therapy space require. Aligning our services with companies like HiTech Health means that we can ensure timely and high-quality supply of products required for trial needs. A critical requirement for many of these advanced cell and gene therapies,” emphasised Dr Nicola Wall, CEO at Afortiori Development. “We understand the paramount importance of obtaining high-quality IMP that is available when needed for researchers and meets the quality standards. Through our collaboration with HiTech Health, we are poised to provide unmatched expertise and support to our clients running these types of clinical trials.”
Afortiori Development and HiTech Health represent a combined team of seasoned experts who work closely with clients, offering flexible, scalable, and tailored solutions to each trial’s specific needs. Throughout the entire process, these industry leaders remain dedicated advocates for their clients, ensuring they benefit from the optimal clinical trial delivery services that generate actionable insights for safety, efficacy and regulatory compliance.
“The success of the clinical trial is deeply affected by the timely availability of high quality products, supported by the right processes, systems, and experts,” added Dr Brian Harrison, CEO of HiTech Health. “Through our collaboration with Afortiori Development, clients can leverage the combined strength of a team that knows exactly what needs to happen and when, ensuring our projects meet timelines and expectations overall.”
Both companies encourage clients to explore the combined team’s extensive knowledge and capabilities in trial design, trial delivery operational planning, product development and Chemistry Manufacturing and Controls (CMC) operational activities. With HiTech Health’s state-of-the-art laboratories and GMP manufacturing facilities equipped for process and analytical development, clients can rely on their cutting-edge cell and gene therapy expertise to accelerate product development timelines.
Afortiori Development and HiTech Health invite clients and industry professionals to get in touch to discuss their current and future needs. Engaging with their dedicated teams of experts will unlock new possibilities and propel clients towards success on this exhilarating path.
About Afortiori Development:
Afortiori Development is a full-service Clinical Research Organisation specializing in the design and management of clinical trials and post-market clinical follow-up studies. With a flexible, scalable, and client-centric approach, Afortiori Development provides critical support to clients to facilitate the right clinical trial.
About HiTech Health:
HiTech Health is a CDMO focused on product development and GMP manufacturing of advanced medicines including cell and gene therapy products.. Their specialized knowledge and state-of-the-art facilities enable efficient and cost-effective development and manufacturing solutions for clients.
To learn more about our cell and gene therapy services by clicking here
In Europe, no batch of medicinal product can be released prior to certification by a Qualified Person (QP). Due to the rapidly evolving Advanced Therapeutic Medicinal Products (ATMP) landscape, it’s important to have up-to-date knowledge, expertise as well as years of experience managing Quality aspects of product and process development, to successfully release CGT product to clinical trials or to market in the EU, US, UK, and RoW.
QP batch release is required to be in accordance with EU requirements (Commission Delegated Regulation (EU) 2017/1569 and Regulation 536/2014) on Investigational Medicinal Products (IMP) covering both sterile and non-steriledosage forms. QP and Quality Services offered by Hitech Health include contractual QP services, for both general Quality consultancy and batch release, for short and long-term contracts.
The QP and Quality Services include:
Supporting and maintaining all aspects of Quality Management System (QMS) compliance.
Designing and implementing a robust supplier qualification program and effective management of this process.
Importation and QP Certification.
With Hitech Health holding the Manufacturer’s/Importer’s Authorisations (MIAs) for the importation and QP certification of both Commercial and Clinical products within the EU, CGT products can be imported and released to EU clinical trials in a matter of months.
Hitech Health has QPs specialising in the CGT and ATMP field and can offer quality support for the successful release of your CGT product. By partnering with us and working with our experienced cross-functional team under our already approved MIAs, you reduce personnel and regulatory cost, thereby making considerable financial and time savings in getting your product to the clinic or market.
To learn more about our cell and gene therapy services by clicking here
Hitech Health’s Cell and Gene Therapy Operations Manager Aoife Duffy and Global Head of Commercial Clare O’Sullivan will be attending Phacilitate’s Advanced Therapies Week 2023 in Miami from January 17th – 20th. Advanced Therapies Week is the destination for developers, investors and solution providers whose goal is to bring cell and gene therapies to patients. We are really looking forward to the event and will be available for partnering meetings to discuss how we can help your advanced therapy processes and reach your goals.
Hitech Health is delighted to announce the appointment of Clare O’Sullivan as Global Head of Commercial. Brian Harrison, Managing Director of HiTech Health, commented on Clare’s appointment: “I am pleased to announce the appointment of Clare O’Sullivan as Global Head of Commercial for Hitech Health, effective 1st December 2022. In this role, Clare will lead the Business Development and Marketing for Hitech Health, providing the full Contract Development and Manufacturing Operations (CDMO) services for Cell and Gene Therapy Drug Development.”
Brian adds: “Clare has over 20 years industry experience and has held various roles in QA, QC, Regulatory Affairs as well as Operational Leadership. The majority of her experience has been in clinical drug development with an additional 2 years spent working in a GMP setting. Most recently she led the global Business Development teams for two divisions of a Global CRO.”
