Dr. Paul Denny-Gouldson is a scientific informatics and data innovator with diverse domain experience encompassing Pharma & Biotech, Food & Bev, Speciality Chemicals and FMCG industries across research, development and manufacturing. In a career spanning over 25 years, he has significantly contributed to drug discovery, biotechnology, product development and precision medicine, showcasing exemplary leadership in various commercial and not-for-profit science-based enterprises.
Radek has been involved in the Pharmaceutical industry for the past 15 years holding various operational and commercial roles. Currently he is the Head Of Sales EMEA for SkyCell AG where he leads a team focused on delivering safe, secure and sustainable solutions to the pharmaceutical clients. Radek has a passion for development of long lasting, sustainable and mutually beneficial relationships. Prior to joining SkyCell AG Radek worked for Expeditors International where he was responsible for development of the GDP compliant service offering in the Northwest Europe. He lived in Poland, Scotland, England, Republic of Ireland. Currently he is based in the Netherlands. Privately, he is a skilled chef but most importantly he is a father to Nell, husband to Agata and owner of a dog called Dante.
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Sean O'Reagain is Deputy Head of Unit, "Industry 5.0" at the European Commission's Directorate General for Research and Innovation (DG RTD).
In DG RTD, Mr. O'Reagain was previously responsible for policy and actions to promote sustainable industrial innovation and for the Joint Technology Initiatives with industry and the European Technology Platforms. Prior to that, he managed the benchmarking for competitiveness and innovation programme in the Commission's DG GROW.
Professor Nolan was previously President of Maynooth University, from 2011 – 2021, which saw unprecedented growth and diversification of teaching and research, and a doubling of the research capacity of the University.
Professor Philip Nolan earned his degrees in Physiology (1988) and Medicine (1991) at University College Dublin (UCD) and was subsequently awarded a PhD in Physiology for his research on the control of breathing and the cardiovascular system during sleep. He joined the academic staff of the Department of Human Anatomy and Physiology at UCD in 1996 and was appointed Director of the UCD Conway Institute for Biomolecular and Biomedical Research in 2003, before becoming Registrar and Deputy President at UCD, from 2004 to 2011.
During 2020 and 2021, Professor Nolan was centrally involved in the management of the COVID-19 pandemic, as a member of the National Public Health Emergency Team, chairing its disease modelling subgroup.
Dr. Stelios Tsinontides is Director of the Office of Pharmaceutical Manufacturing Assessment (OPMA) under the Office of Pharmaceutical Quality (OPQ) in CDER. Dr. Tsinontides has over 25 years of experience in the pharmaceutical industry. OPMA evaluates facilities, process design, and control strategies to assess capabilities of manufacturers to produce quality pharmaceutical and biotechnology products at commercial scale and provides leadership and technical expertise to Agency components internal and external to the Office of Pharmaceutical Quality regarding manufacturing quality issues.
Prior to joining the FDA, Dr. Tsinontides served in senior-level positions in the pharmaceutical industry - most recently as Shire’s Head of Small Molecule Drug Product Technical Services. His group was responsible for providing scientific and technical expertise for SM Drug Product scale-up and commercial manufacturing activities worldwide, to ensure establishment of commercial robust manufacturing processes and a continuous supply of product to patients.
Dr. Tsinontides holds a B.E. in Chemical Engineering from City College of CUNY and an M.A. and Ph.D. in Chemical Engineering from Princeton University. He has also attended the Wharton Management Program at the University of Pennsylvania. Dr. Tsinontides was elected Fellow at the American Institute of Chemical Engineering (AIChE) in 2016.
Dr Ian Jones is the Founder and CEO of InnoGlobal. He has worked for the past 25 years supporting high-tech manufacturing where he has become a global thought leader on Industry 5.0 and the associated technologies and skills strategies to drive the digital transformation of these key industries. Ian holds a PhD in Process Analytical Technologies from Technological University Dublin and has studied Strategy, Leadership and Innovation at the Harvard Business School, Boston and Accelerated Growth Strategies at Judge Business School, Cambridge, UK. Ian also sits as an adjunct Professor within the Department of Chemical Sciences, Faculty of Science and Engineering at the University of Limerick, Ireland. Ian is driven by the mission to help people, governments and businesses succeed in digital and green transformation.
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Padraic O’Neill is Vice President of Global Business Services for Pfizer. He is the Dublin site leader with responsibility for Pfizer’s Global Centers of Excellence for Statutory Audit, Accounts and Market Finance Operations, Operational Transfer Pricing, Indirect Tax, Treasury operations and Intercompany accounting.
Padraic joined Pfizer in 2008 and is a Fellow of the Institute of Chartered Accountants in Ireland and an Associate of the Institute of Taxation in Ireland.
As Director of Compliance at the HPRA since 2022, Ms. Power provides strategic and operational leadership to the Compliance department to oversee the inspection, facility licensing, market compliance and enforcement activities of the HPRA. This involves work at national, European and international levels through oversight of HPRA participation and contribution to relevant committees and working groups at the European Medicines Agency (EMA), European Commission, Pharmaceutical Inspection Cooperation Scheme (PIC/S), Heads of Medicines Agencies (Working Group of Enforcement Officers) and Official Medicines Control Laboratories (OMCL) Network. A key focus for Ms Power is to support Ireland’s position as a key global location for pharmaceutical and biopharmaceutical manufacture and export through delivering an expert, robust and agile inspectorate.
Prior to this role, Ms Power was Director of the HPRA’s Human Products Authorisation and Registration department from 2018, where her responsibilities included the assessment and licensing of human medicines, together with clinical trials authorisation for the Irish market. This role involved the development of the organisation’s scientific profile in medicines assessment within the European network whilst managing the impacts of Brexit, COVID-19 and the introduction of the new Clinical Trials Regulation.
With over 25 years’ experience in leadership roles across the Irish pharma/biopharma manufacturing sectors, she has relevant experience of quality operations, systems and compliance.
Ms Power studied Biotechnology at Dublin City University and holds graduate diplomas from Trinity College Dublin in Pharmaceutical Manufacturing Technology and University College Dublin in Business Studies. Ms Power is the HPRA Representative on the Council of the Pharmaceutical Society of Ireland.
Brian Killen has worked with MSD in the Biopharmaceutical industry in Ireland and internationally for over 25 years. He is currently leading MSD’s Global Manufacturing Digital Transformation. Brian has held a number of leadership positions across MSD and Merck, including Global Small Molecule External Manufacturing, as well as Plant Manager for the Antibiotics facility in Danville PA, and his home site in Ballydine, Tipperary which he joined as a graduate Chemical Engineer from Queen’s University Belfast.
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WuXi Biologics is a global Contract Research, Development and Manufacturing Organization (CRDMO) offering end-to-end solutions that enable partners to discover, develop and manufacture biologics. WuXi Biologics, Ireland, located in Dundalk mid-way between Dublin and Belfast, the facility is less than an hour’s drive from Ireland’s two largest cities.
In 2022, Eimear joined WuXi Biologics as the Senior Director of site Quality and is a key member of the site leadership board. She successfully led this green field start up site through their first MIA and IMP inspection for Commercial and Clinical Release testing. She continues to play a key role in setting out the regulatory framework for a multi-client manufacturing facility.
Prior to this, Eimear held various senior leadership roles with increased responsibility across Janssen Sciences Ireland and GE Healthcare. Utilizing her technological and leadership experience, she has driven innovation and change within the teams she has led. Her experience has allowed her to be awarded a Lean Six Sigma Blackbelt in the Clinical and Commercial Release of Drug Substance products.
Eimear received her graduate degree in Biological & Animal Science from Queen’s University Belfast. Following this, she completed her PhD in Biotechnology from University College Cork and more recently received a Diploma in Financial Management.
Rachel Shelly is Divisional Manager, Life Sciences & Food and Talent, Transformation & Innovation at IDA Ireland and a member of IDA’s Executive Committee. From 2018-2023 Rachel held global responsibility for IDA’s Medical Technologies & Healthcare Services, leading the development and execution of departmental strategies across the MedTech sector, including new business development, strategic client management and transformation (across Talent Development, Innovation, Digitalisation and Sustainability) to enable and support foreign direct investment.
Rachel represents IDA in several fora including the Board of Digital Manufacturing Ireland, the Health Innovation Hub Ireland National Oversight Group, and BioInnovate Advisory Board.
Prior to joining IDA Ireland, Rachel spent 15 years in the Private Sector, in a number of marketing and management roles within the Health/Tech industry.
Rachel holds an MSc. in Strategic Management, a BBS in Marketing Management and a Professional Diploma in Change Management.
Paul has worked in the Pharmaceutical sector for more than 30 years holding several operational, strategic and leadership roles, working in Global Multinationals and Indigenous SMEs.
He is current Vice Chair & previous Chair of Ibec BPCI and has consistently demonstrated a passion for building Ireland’s strategic position in the global BioPharma sector, including the development of the current BPCI 4 year strategy.
He also has a strong focus on improving gender balance in business holding roles such as 30% Club Ireland Steering Committee Pharma Rep, Co-Chair of Ibec BPCI D&I Working Group and member of the DCU STEM Trainee Internship Advisory Board.
Joyce Fitzharris is the President of SK Biotek Ireland who has 30 years’ experience in the Pharmaceutical Industry. She began her career working in the small molecule manufacturing business for an Innovator Pharmaceutical Company and has held multiple roles in EHS, Supply Chain, Operational Excellence, PMO and Strategy. In more recent years Joyce successfully led the transition and integration of an API Manufacturing Site from a Large Pharma Organisation to a stand-alone CDMO Business.
Amongst Joyce’s qualifications, she holds a B.Sc Analytical Science from Dublin City University and M.Scs in Emergency Management and Environmental Protection.
Matthew Moran is Director of BioPharmaChem Ireland. He graduated in Chemistry at Trinity College Dublin in 1980 and in Chemical Engineering at University College Dublin in 1981; he holds an MBA also from University College Dublin (Smurfit School of Business). He worked for over ten years in the pharmaceutical industry where he held a number of management positions both in active ingredient and dosage form manufacture. He is a member the European Chemical Industry Council (CEFIC). Matthew Moran is a Board member of the Active Pharmaceuticals Ingredients (API) Committee of CEFIC (CEFIC/APIC) and The European Association for Bioindustries (Europabio)
BioPharmaChem Ireland represents the interests of the biopharmachem sector in Ireland. CEFIC/APIC represents the European API Industry. Europabio represents the European Biotech Sector.
Sarah studied Chemistry in Trinity College Dublin and did a research masters on the synthesis of a family of Re (I) metal complexes and a study of their photophysical properties with Prof John Kelly. Her PhD in the University of Limerick focussed on the immobilization of enzymes onto novel mesoporous supports and their catalytic properties with Prof Edmond Magner, Prof Kieran Hodnett and Dr Jakki Cooney.
She secured a Marie Curie Outgoing International Fellowship to work with Prof Robert Langer in MIT, USA. There she developed in situ crosslinkable hydrogel systems for cartilage regeneration and drug delivery, and she also studied the biocompatibility (in vivo and in vitro) of micro- and nano- mesoporous silica particles. After this fellowship, Sarah worked in Waterford Institute of Technology on the identification of the mechanisms and causes of tablet splitting within the Genzyme Ireland facility. Since November 2011, Sarah has been a lecturer in Chemistry in the Department of Chemical Sciences and a researcher in the Bernal Institute in the University of Limerick.
Since graduating with her PhD in 2006, Sarah has secured over €6m in funding from EU, Exchequer and industrial funding. Most recently she is the lead PI from UL (a partner) in a Disruptive Technologies Innovation Award lead by Cala Medical which will bring €3.4m into the Bernal Institute in UL in 2019. This project will be based in the Biologicals Process Infrastructure Testbed, BioPoint. BioPoint was created and officially opened in 2018 from a Science Foundation Ireland (SFI) Infrastructure Award which Sarah also lead.
Sarah is also in the last year of her Career Development award which she was awarded from SFI in 2013. Sarah has been a funded investigator in the SSPC since 2013. Her research focuses on the manipulation of the physicochemical properties of small and large active molecules to improve their stability, solubility and dissolution rates with the ultimate goal of improving the bioavailability of active pharmaceutical ingredients.
Dr. Rabah Mouras joined the Pharmaceutical Manufacturing Technology Centre (PMTC) in 2019 as leader of the Pharmaceutical Plant cleaning theme within the Centre. In 2021, he was appointed as the Research Centre Manager, where he led, and designed the centre’s research program. Since June 2023, he is the interim director of the Centre.
Rabah holds a PhD in Physics from the University of Lorraine, France. His interests are in the development and implementation of new methodologies and rapid analytical tools based on linear and non-linear optical micro-spectroscopy for in/online line real-time process monitoring. These techniques have a wide appeal in both biotechnology and (bio)pharmaceutical manufacturing and continue to prove their usefulness as process analytical technologies (PAT).
Andrew is a Deputy Director in the Office for Life Sciences (OLS), a joint unit between the Department for Health and Social Care and the Department for Science Innovation and Technology. Andrew is responsible for Manufacturing, Access to Finance and Skills and has led OLS’ work to deliver its three capital grants programmes to incentivise investments in Life Sciences manufacturing. Andrew has worked in OLS for over five years and previously had roles working on Brexit, international trade and regulation. Before joining the Civil Service, Andrew worked as a Management Consultant and a Solicitor.
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As Secretary General, Declan Hughes advises Government and leads the Department and its offices and agencies in promoting the creation of high-quality and sustainable full employment; by championing enterprise, supporting, and incentivising a competitive and innovative research and enterprise base, negotiating international trade agreements, and promoting fair and competitive employment and markets.
Declan has served as a Board member of IDA Ireland, SFI and Enterprise Ireland. He was also a member of National Competitiveness Council, the Interim Public Procurement Reform Board and Food Wise Implementation Committee and Chair of the Disruptive Technologies Innovation Fund Committee. He has served on EU and OECD committees.
Declan joined the Department in 2014 as Assistant Secretary, heading the Strategic Policy Division and subsequently had responsibility for policy development and funding programmes for Inward investment and Enterprise Innovation and for Indigenous Enterprise, SMEs, and Entrepreneurship Divisions. He was formerly on the Executive Committee of the enterprise, trade and science and technology advisory agency, Forfás. He has led a range of national and regional policy and funding initiatives, including on ecommerce, enterprise and trade strategies, skills and research prioritisation, regional enterprise plans, the Action Plan for Jobs and Brexit and COVID business supports.
Declan is a Bachelor of Commerce graduate and holds a Masters and Postgraduate Diploma from the Smurfit Graduate School of Business, UCD. He has completed executive programmes at Wharton School of Business, Roffey Park Institute and Singapore Civil Service College. He is a member of Institute of Directors.
Darrin Morrissey was appointed CEO of NIBRT in June 2020. Immediately prior to joining, Darrin was the CEO at the Health Research Board (HRB), Ireland’ primary funder of health and health system research. Previously Darrin was the Director of Programmes and Investments with Science Foundation Ireland (SFI), where he led the delivery of STEM research funding to the Irish research institutions.
Darrin’s past experiences also includes 16 years in the pharmaceutical industry – with GSK, Sanofi and others – in a variety of senior roles spanning across clinical research, commercial and manufacturing. Darrin qualified with a BSc in Microbiology and a PhD in Cancer Biology from University College Cork.
Over recent years Darrin has been a member of numerous national and international policy and decision-making bodies, including the governing board of Science Europe, the British Irish Chamber of Commerce Higher Education & Research Steering Group, Knowledge Transfer Ireland Stakeholder Forum and Enterprise Ireland’s Industrial Research and Commercialisation Committee.
Brian graduated from the University of Newcastle upon Tyne with a BEng in Chemical and Process Engineering and an MSc in Clean Technology and Environmental Management. He began his pharmaceutical career as a process engineer on the Dudley site when it was ChiRex in 1997.
He moved on to work in process safety management and in 2004 took a position with Pfizer in Morpeth which transitioned to the CDMO Piramal Healthcare, where he led site EHS Management. From 2013, Brian was Corporate EHS Manager at Aesica until returning to the Dudley site in 2016 to take up the role of HSE Director and is now VP-EHS in the Sterling organisation.
Brian has been instrumental in building the Dudley site EHS team and moving the site and the wider Sterling group towards it’s Environmental, Social and Governance (ESG) aspirations and ISO certifications, whilst ensuring Sterling remains a safe and healthy place for our employees.