EU Project for reliable and accessible information on cell and gene based therapies.
A consortium partner.
Soho Links ApS is a consultancy organisation comprised of experts who offer a wealth of experience in the field of substances of human origin (SoHO) used for therapeutic purposes. We provide multi-disciplinary teams of experts or, individual experts, to advise organisations on a broad range of specialist topics, including scientific, regulatory, technical, project management and IT needs.
Soho Links ApS has established a project team which is coordinating the development of an application as a partner to the EU project (ID: SC1-HCO-19-2020). A multi-functional website portal for the state of the art information on the quality and efficacy of cell and gene therapies for interested parties is to be achieved. Further information on the scope and status of this EU Project, can be registered here. here.
If you wish to learn more about this programme send us your general enquiry via “Contact Us” at this website.
We look forward to hearing from you.
The Project Team
Imogen has been involved in the regulation and oversight of substances of human origin (SoHO) for over 19 years. Imogen was the Head of Regulation for the Human Tissue Authority (HTA) for 10 years: with responsilities for leading several significant projects, including the establishment of a regulatory ‘one-stop-shop‘ for researchers/developers of Advanced Therapy Medicinal Products; and, public access to reliable, evidenced-based information for parents storing umbilical cord blood. Imogen has been active in many EU projects, such as SoHO Vigilance & Surveillance guidance, Eustite ‘EU Standards and Training for the Inspection of Tissue Establishments‘, and VISTART (Vigilance & Inspection for the Safety of SoHO). During her tenure at HTA, Imogen was the UK’s representative at EU Competent Authority meetings and has a proven track record in policy development, stakeholder management and the delivering of quality outcomes within deadlines.
Jamie is an experienced, and highly qualified Senior IT leader with a strong background in strategy, information governance, project management, business continuity and the cloud. He has a master’s degree in Information Systems and Management (specialising in semantic web technologies), Prince II and TOGAF certifications, and over twenty four years of broad industry experience. This includes public sector health and social care, foreign currency, event organisation, public relations, market research and retail. He has overseen several change management programs covering business process changes, major system changes and preparing organisations for transposed/new EU legislation including The Organ Donation Directive, The Coding and Import Directive and the General Data Protection Regulation.
Hazel has over 20 years experience related to cell and tissue therapy development, having worked for one of the UK’s first stem cell companies after completing her PhD researching bioartificial liver devices. Hazel has held active roles overseeing the HTA’s licensing and inspection operations and latterly, was Director of Regulatory Development. Hazel has been responsible for leading on horizon scanning, policy development, longer-term strategic planning, and the development of the organisation’s business technology and communication functions. Key achievements include the successful implementation of the EU Directives on Import and Coding, the EU Exit programme and a new strategy for the management of Digital, Data and Technology. Hazel is an independent consultant for regulatory affairs for tissue and cell therapy, training and advice on the UK’s human tissue legislation.
Sinéad has over 15 years experience in the SoHO sectors. She worked for the Health Products Regulatory Authority (HPRA) as Blood, Tissues and Organs Section Manager as well as a Lead inspector of Blood and Tissue Establishments. She has also been active in the implementation of the European and National Blood, Tissues and Organs Legislation. This included the management and continuous improvement of inspection processes in blood establishments, hospital blood banks, tissue establishments, assisted reproduction centres and organ centres. She has been the national representative at the European Commission meetings and an active participant in European projects, such as EUSTITE, SOHO V&S and VISTART. Sinéad is now working as an independent consultant and has collaborated with the European Commission on a series of other SoHO programmes.
Martin has over 20 years business technology experience predominately in the health sector working with numerous National Health Service trusts and the UK’s Competent Authority for the EU Tissue and Cells Directive, the Human Tissue Authority. Martin is a delivery focused individual having managed digital transformation programmes within the sector to improve regulation efficiency and stakeholder engagement. He was instrumental in delivering the UK’s online portal for the management of living organ donor assessments and the reporting capability for serious adverse events and reactions. Martin’s a certified Prince2 Practitioner and Agile Scrum Master and has extensive experience working with multi-disciplined teams.