Brian brings over 25 years of extensive technical leadership experience in the life science industry. As Managing Director of HiTech Health, Brian leads a team of technical experts who provide innovative technical solutions including i) helping companies to set up and grow their business, ii) new product introduction, technical transfers and due diligence activities and iii) helping companies to solve supply chain and operational issues. As VP of Chemical Development with Bristol Myers Squibb (BMS), Brian was responsible for the transfer, scale-up and registration of multiple new products in a range therapeutic of areas including oncology, virology and antibiotics. His achievements included undertaking the due diligence and successfully transferring an entire portfolio of drugs from a single manufacturing site and outsourcing the production to multiple different CMOs in a number of different countries. Brian has also significant operational expertise having been general manager of a manufacturing facility for BMS. Brian also supported Science Foundation Ireland (the Irish Government research funding organisation) in the effective management of funding programs across diverse areas including life sciences, ICT and sustainable energy. He also served as a pro bono Board Chairman of Debra Ireland, the charity supporting families and patients with the debilitating disease, Epidermolysis Bullosa (EB). Brian holds a B.Sc. and Ph.D. from University College Dublin, Post Doctorate from Emory University, GA, USA, as well as business qualifications in Management, Finance and Corporate Governance.

Aoife has over 18 years’ experience in Cell and Gene Therapy (Viral Vector and Cell Therapy), ATMPs, GMP manufacturing of ATMPs, Quality Control and Regulatory Affairs. Aoife was Production Manager at CCMI from 2010 to 2019. In 2013, Aoife played an essential role in getting the regulatory licence for the first approved ATMP manufacturing facility in Ireland to produce ATMPs. Aoife successfully led technical transfer, process development and clinical trial approvals for 4 clinical trials in Ireland and across Europe for various different ATMPs for different disease indications (critical limb Ischemia, osteoarthritis, diabetic Kidney Disease). She graduated with a BSc in Biochemistry from NUIG and then completed an MSc in Molecular Medicine from Trinity College Dublin and a postgraduate Higher Diploma in Quality Assurance from NUI Galway.

Publications:

1. 1. A 3-month Safety Assessment of Human Bone Marrow Derived Mesenchymal Stromal Cells Administered Once by the Intramuscular Route to Immunodeficient Mice.
2. 2. Purification of adenoviral vectors by combined anion exchange and gel filtration chromatography.
3. 3. Mesenchymal stem cell survival in the infarcted heart is enhanced by lentivirus vector-mediated heat shock protein 27 expression.
4. 4. Autologous bone marrow mesenchymal stromal cell therapy for "no-option" critical limb ischemia is limited by karyotype abnormalities.
5. 5. Adenoviral-mediated gene transfer of nitric oxide synthase isoforms and vascular cell proliferation.
6. 6. Recovery of cardiac function mediated by MSC and interleukin-10 plasmid functionalised scaffold.
7. 7. Generation of antioxidant adenovirus gene transfer vectors encoding CuZnSOD, MnSOD, and catalase.
8. 8. Distinct effects of high-glucose conditions on endothelial cells of macrovascular and microvascular origins.
9. 9. Purification of adenovirus and adeno-associated virus: comparison of novel membrane-based technology to conventional techniques.
10. 10. Autologous bone marrow mesenchymal stromal cell therapy for "no-option" critical limb ischemia is limited by karyotype abnormalities.

Catherine Hanley is HiTech Health’s lead Environmental, Health and Safety consultant. Catherine has over 20 years' experience in EHS, including 12 years with Hewlett Packard where she was directly involved in the start up of HP from a brownfield site to an operation of 4000 employees. To the HTH team, Catherine brings a great depth of knowledge in all EHS considerations when launching and suppling life science products in addition to excellent relationships with the regulatory authorities. Catherine works with clients to provide end-to-end advice to ensure that EHS regulations are complied with. Catherine obtained a BSc in Environmental Science from Sligo IT, an MSc in Environmental Management from University of London and holds diplomas in Business Management, Occupational Health & Safety and ISO 14001: 2015 and OHSAS 18001 lead auditor training.

Colin Henehan has over 20 years of leadership experience in various quality/operational roles. Having worked with CIBA, Allergan, Pfizer and Abbott, Colin has had multi-sector experience in nutrition, pharmaceutical and medical device manufacturing. Colin’s focus area is setting the right business strategy, obtaining organisational alignment to achieve operational excellence in order to improve profitability. Since joining the HTH team, Colin works closely with clients on due diligence and business planning. He holds a Ph.D. in Biochemistry from the University of Zurich, Switzerland, and he is a Qualified Person (Trinity College Dublin, Ireland). Colin has served on several boards including the Irish Medical Device Association (IMDA).

Damian has over 30 years of experience working in Ireland, U.S. and Europe in leading pharmaceutical and fine chemical manufacturing, developing and implementing manufacturing strategy and leading supply chain transformation. Damian has extensive senior leadership experience. He was Global Network Strategy Lead with Zoetis Animal Health, with responsibility for internal manufacturing and external supply of API, Biologics, Vaccines, Oral Solids, Aseptic and Diagnostics. He has held a number of roles with Pfizer, including Senior Director Network Strategy. Damian served on the Board of Directors of the International Society for Pharmaceutical Engineering (ISPE) and as Chairman of the ISPE International Board. Damian holds a B.E. Chemical Engineering from University College Dublin, an M.Sc. Chemical Engineering from University of Missouri-Rolla and a Diploma in Accounting and Finance from Cork Institute of Technology in Ireland.

As the Quality and Compliance Lead for HiTech Health, Julie-Anne leads Quality Assurance activities for HiTech Health as a service provider to clients. She works closely with clients to ensure that drug substance and drug products manufactured by clients are compliant with all relevant regulatory requirements as well as the client’s internal Quality standards. Julie-Anne also provides Quality support activities such as auditing and GMP training. She also fulfils the role of Qualified Person for clients to certify and release batches of medicinal product in accordance with EU Directives 2001/83/EC. A registered pharmacist with the Pharmaceutical Society of Ireland, Julie-Anne has extensive experience in both the primary care setting and pharmaceutical industry, specifically in the areas of sterile manufacture and aseptic processing. Her previous experience in Quality Systems has provided her with the skills and competencies to implement and maintain robust Quality Management Systems. She is also practiced in the area of data integrity and in the facilitation of regulatory inspections.

Leonora leads business development within HiTech Health, bringing over 20 years of experience working in the Life Sciences sector with start-ups, government organisations and academic institutions. Prior to joining HiTech Health, Leonora was a SVP in IDA Ireland, the Government agency responsible for inward investment. She also held senior positions in a number of biotech and medical device companies. Leonora is responsible for pursuing strategic opportunities and cultivating partnerships between HiTech Health and a wide range of organisations and academic institutions. Working closely with clients, Leo is committed to helping HiTech Health become the leading service provider to the Life Sciences in Ireland for the launch and supply of products. A graduate of University College Cork, Ireland (B.Sc.) and the University of New South Wales, Australia (Ph.D.)

Mary brings over thirty years’ experience, working across several areas of the pharmaceutical sciences, including industry, governmental and academic roles. Mary has over 18 years expertise as a regulator, having worked in the quality assessment of EU and National applications for the Irish Regulator, the Health Products Regulatory Authority.

Mary has represented the Irish regulator at various European Medicines Agency committees, including CHMP and the EU Working Group on Implementing Guidelines for the first EU Clinical Trials Directive. In industry, Mary held roles such as EU Qualified Person with Wyeth and as Senior Regulatory Affairs Manager at Pfizer. At HiTech Health, Mary drives the clients’ regulatory requirements supporting them in the development and launching processes. She holds a B.Sc. in Pharmacy from University College Dublin, Ireland, and an M.Sc. in Pharmaceutical Medicine from Trinity College Dublin, Ireland. Mary is a registered Pharmacist.

Michelle has over 25 years experience working in the pharmaceutical industry. In her early career, Michelle held various quality, operational roles including start up of a manufacturing facility and leading Health Authority inspections. Over the last 12 years, Michelle has worked within the external manufacturing environment focusing on quality and compliance and has significant experience working within the EU and US markets. With a strong background in Quality Management Systems, Michelle has used Lean Principles such as process mapping to support the building of quality processes which are focused on value add tasks and minimizing waste and has supported the configuration of QMS software programs. She holds a B.Sc. in Chemistry from University College Dublin and an M.Sc. in Industrial Pharmaceutical Technology from The Royal College of Surgeons in Ireland (RCSI).