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Biopharma & Life Sciences Connected Live January 25th 2024 Radisson Blu Hotel & Spa, Cork Register Contact us Navigation * Home * Agenda * Speakers * Associations * Exhibitors * Sponsors * Media * Partners * Video Gallery * Orca Scanner * Register * Accommodation * Home * Agenda * Speakers * Associations * Exhibitors * Sponsors * Media * Partners * Video Gallery * Orca Scanner * Register * Accommodation BioPharma & Life Sciences Connected Live January 25th 2024 | Radisson Blu Hotel & Spa, Cork REGISTER -------------------------------------------------------------------------------- Book your place at the Biopharma & Life Sciences Connected conference and exhibition to hear from leading national and international experts in pharmaceutical manufacturing. The biopharma sector in Ireland is experiencing significant challenges around supply chain issues, digital transformation, automation, carbon reduction and regulatory changes.. The central theme of this event is to hear directly from industry leaders and stakeholders who are willing to share challenges and solutions in practice. That means, the spotlight in presentations will be on case studies from pharmaceutical companies - allowing you to benefit from the speakers' experience in their everyday practice. Over 75 leading speakers involved in the development & manufacturing of biopharmaceutical & biotech products & technology will participate in a full day's schedule of keynote talks & panels on the topics shaping the sector. Why Attend * Listen to over 75 expert talks and panel debates on the latest industry issues facing the biopharma & life sciences sector. * Avail of the excellent networking opportunities with peers throughout the day * Network with over 70 exhibitors displaying the latest technology and research * Meet with government support agencies and associations * Join our Q&A with industry thought leaders Key Topics Include * Research & Innovation * Automation * Vaccine Manufacturing * Process Optimization * Tech Transfer * Digitalization * IoT & Industry 4.0 * Covid 19 – Impact to the market * Hybrid Systems – Single Use and/or Stainless Steel * Biosimilars – Best-Practice * Ultrafast Project Execution * Turnkey * HVAC & Cleanroom Engineering * Cell & Gene Therapy Call for Speakers To speak, sponsor and or exhibit at the event please email info@biotransformationevent.com SPEAKERS CONFIRMED UNA FEENEY GLOBAL OCCUPATIONAL HEALTH AND WELLBEING STRATEGIST - ELI LILLY Speaker Bio Una oversees the planning, development, implementation, and monitoring of the Global Occupational Health framework at Eli Lilly. In her role she works across different global facilities to monitor and track the specific occupational and personal health opportunities and metrics unique to each country. She supports OUS manufacturing sites and affiliates to deliver wellbeing programs that create awareness, enhance motivation, and provide tools to employees that help them adapt and maintain a well-rounded healthy lifestyle. Supports occupational health operations in technical assistance with project development, implementation of employee health service-related projects and tasks. Una is the National chairperson for INMO OHN section and represents Ireland as a Board member on the Federation of Occupational Health Nurses EU (FOHNEU). Una is a guest lecturer on the MSc Occupational Health UCC. DR. IAN JONES FOUNDER & CEO - INNOGLOBAL Speaker Bio 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. SINEAD KEOGH HEAD OF SECTORS AND DIRECTOR - BIOPHARMACHEM IRELAND "BIOPHARMA SECTOR IN IRELAND: PRIORITIES, CHALLENGES AND OPPORTUNITIES." Speaker Bio Synopsis Sinead is the Director of the Ibec’s Medtech and Engineering Sectors , which includes the Irish Medtech Association. A number of Government Funded Skills Networks (Skillnets, Apprenticeships and Springboards) fall under her remit. Sinead currently sits on a number of national and international boards including the Advisory Industry Board for Enterprise Ireland funded BioInnovate Ireland and the Governance Board for Science Foundation Ireland funded Irish Photonic Integration Centre (IPIC). She is a member of the National Executive Committee at Medtech Europe. Prior to Ibec Sinead held technical roles at 3Com Technologies, and lectured part-time at DIT, Kevin St. She holds a Ph.D. in the Physics of Molecular Materials/Nanotechnology and B.Sc. (Hons.) in Applied Physics, DIT Kevin St. The biopharmaceutical sector in Ireland has experienced significant growth in recent years, establishing itself as a key player in the global biopharmaceutical industry. With €100bn+ in annual exports, 84,000 people directly and indirectly employed and a further 10,000 jobs to be created over the next 5 years, recent Ibec research indicates that confidence remains high within the established base here. The sector’s growth is driven by a highly skilled workforce, a collaborative ecosystem, strategic location, and a supportive government. To maintain its position, the sector must adapt to the emerging landscape [technological, regulatory, trade..….] and address workforce and infrastructure challenges. With increasing investment in R&D, capital infrastructure, digitilisation and sustainability anticipated, we must ensure we have the right talent mix, especially in a tight labour market, to sustain the industry and facilitate its transition. This presentation will cover BioPharmChem Ireland’s strategy 2027 as well as recent sentiment data, priorities, challenges, and opportunities in 2024. CONOR MCALONAN MAINTENANCE PLANNER - MSD IRELAND "BEING THE GATEKEEPER: THE NEW INDUSTRIAL AGE AND HOW TO KEEP PHARMACEUTICAL SUPPLY CHAINS MOVING." Speaker Bio Conor McAlonan is an accomplished and dedicated professional with a diverse background in the biopharmaceutical industry. Hailing from the vibrant city of Philadelphia, Conor brings a unique perspective to the table as a US Army Veteran, chef, and in biopharmaceuticals. With over 20 years of experience as a chef, Conor understands the importance of precision, attention to detail, and the necessity for seamless processes. This culinary background sparked his interest in the operational aspects of the industry, leading him to pursue a Bachelor's (Hons) degree in Global Supply Chain Management from Munster Technological University. Conor's journey in the pharmaceutical sector has been an impressive one. He has worked across multiple domains, including Supplier Quality Management, Supply Chain, and Warehousing, acquiring a holistic understanding of the intricacies involved in delivering pharmaceuticals efficiently and effectively. Conor's ability to streamline operations and optimize supply chains has been instrumental in increasing productivity and reducing costs. Currently, Conor serves as a Maintenance Engineer in the pharmaceutical sector, where his vast knowledge in digital strategy and process improvement plays a pivotal role in maximizing operational efficiency. His expertise and innovative thinking have led to the successful implementation of many digital solutions in various organizations, propelling them towards a more technologically advanced and optimized future. With a genuine passion for his field, Conor strives to inspire and empower others to embrace digital strategies and process improvement techniques to enhance their organizations' overall performance and contribute to the advancement of the biopharmaceutical industry. PAUL MCCABE CHIEF OPERATING OFFICER - VLE THERAPEUTICS JOHN MCKEON FOUNDER & CEO - GALLARUS INDUSTRY SOLUTIONS Speaker Bio John McKeon is the founder and Chief Executive Officer of Gallarus Industry Solutions limited. Leading the company in its vision and mission, to deliver innovative services and solutions to our clients, supporting a seamless transition in the complex evolution of Industry 4.0. In recent years, John’s focus has been primarily on leading design changes and technological innovation in the pharmaceutical sector. His mindset is very much tuned to solving a business need with innovative and tailor-made solutions. He has achieved over 25 years as an engineer in the international marketplace bringing a unique blend of leadership spanning several major sectors in engineering and technology. Among them; aviation (heavy air-frame maintenance), semiconductor manufacturing , medical device manufacturing, large scale pharmaceutical finishing plant infrastructure, production line equipment engineering, and design. MATT MORAN CONSULTANT & FORMER DIRECTOR - BIOPHARMACHEM IRELAND "SHAPING THE FUTURE: DYNAMIC TRENDS AND CHALLENGES IN IRELAND'S BIOPHARMA MANUFACTURING SPHERE AND Q&A" Synopsis Matt will be moderating a panel on "Shaping the Future: Dynamic Trends and Challenges in Ireland's Biopharma Manufacturing Sphere and Q&A" with panellists Ian Jones, Founder & President, Innoglobal, Vikram Kunnath, Technology Consulting Partner, EY, Paul McCabe, Chief Operating Officer, VLE Therapeutics & John O’Brien, Head of Engineering, Biomarin JOHN O'BRIEN DIRECTOR OF ENGINEERING - BIOMARIN Speaker Bio John is a passionate leader with over 20 years of experience in engineering within the pharmaceutical and biotechnology industries. Director of Engineering at BioMarin, a global leader in developing and commercializing innovative therapies for rare diseases. John leads a team of engineers and technicians responsible for end-to-end support of manufacturing and laboratory operations at the BioMarin Shanbally Ireland facility. John joined BioMarin in 2011 when the Shanbally facility was purchased. He has worked in various technical and leadership roles in Engineering. In 2019 he moved to California to work at BioMarin's manufacturing campus in Novato California heading up the Automation, Process Engineering and Capital Project functions. I returned to Ireland in 2022 to take up the role of Director of Engineering at the Shanbally facility. Before joining BioMarin, he spent 7 years at Pfizer, working at two of their facilities: Pfizer Shanbally Biotechnology and Pfizer Loughbeg API (Active Pharmaceutical Ingredients). He has a Bachelor of Science in Process Plant Technology and a Bachelor of Engineering in Mechanical Engineering. He started his career as an apprentice mechanical technician at Pfizer Loughbeg. Throughout Johns career, he has remained an advocate of apprenticeship programs in the industry. DR. CIARÁN SEOIGHE DEPUTY DIRECTOR GENERAL - SFI "THE CRITICAL ROLE OF RESEARCH IN BUILDING A SUSTAINABLE FUTURE" Speaker Bio Synopsis Dr Ciarán Seoighe joined SFI as Deputy Director General in January 2018. In his role, Ciarán is responsible for Organisational Strategy, Corporate Communications and SFI’s International team. In addition, he deputises for the Director General, as required. Ciarán joined SFI after nearly two decades in management consulting with Accenture. In his time with Accenture, in both Ireland and South Africa, Ciarán has worked with some of the world’s largest and most successful organisations. He holds a BA (Mod) in Natural Science and PhD in Quantum Physics from TCD. Since joining SFI, Ciarán has led the development of SFI’s new strategy and been a regular contributor to national strategies and initiatives including the Disruptive Technologies Innovation Fund Advisory Board, the Public Service Innovation Advisory Board and the Creating Our Future public consultation initiative. He brings a wealth of experience across a variety of sectors executing large-scale transformation, innovation, strategic and change initiatives. Research has a key role to play in creating a better future for all. As humanity faces a collective climate crisis, research and the talent it develops are more important than ever. It is essential that the research itself is carried out sustainably and that the talent and knowledge move through our society and economy. Our vision is for the Irish public and private sectors to be leaders in sustainable and environmentally sound practices because they are research-enabled in their decision-making. PHILIP CONNOLLY ASSOCIATE DIRECTOR - SUSTAINABLE FUTURES - KPMG IRELAND "DECARBONISING HIGH TEMPERATURE HEAT WITH BIOMETHANE" Speaker Bio Synopsis Philip is an associate director in the KPMG Sustainable Futures team. Philip has 9 years experience in the Irish energy industry, working in large utility companies and with the Department of Environment, Climate and Communications on a wide variety of decarbonisation technologies such as biomethane, carbon capture and storage, hydrogen, compressed natural gas and future fuels such as ammonia and sustainable aviation fuel. Philip has a deep understanding of Ireland’s current energy and climate plans and specialises in biomethane. Philip has recently worked with DAFM on drafting Ireland’s National Biomethane Strategy. To meet decarbonisation goals by 2030, Pharma and high temperature heat users in Ireland will have limited decarbonisation options. Biomethane offers a solution to assist on the pathway to decarbonisation. Ireland has ambitions to produce up to 5.7 TWh of biomethane by 2030. While demand is likely to outstrip supply, I will discuss the importance of biomethane to the Pharma and Lifesciences sectors. MIKE DINGLE SENIOR PRODUCT SPECIALIST - TSI INCORPORATED "BIOFLUORESCENT PARTICLE COUNTING – A SOLUTION FOR MEETING ANNEX 1 VIABLE AIR TESTING REQUIREMENTS" Speaker Bio Synopsis Mike Dingle is a Senior Product Specialist at TSI where he provides application support for the BioTrak Real-Time Viable Particle Counter and other TSI products used to test and monitor controlled environments. Prior to joining TSI, Mike worked as a QC Microbiologist in the pharmaceutical and medical device industries for over 20 years where he developed and managed environmental monitoring programs for a wide variety of controlled environments. Annex 1 of the European Good Manufacturing Practices is the most widely followed guidance in the world for the monitoring of pharmaceutical cleanrooms. After numerous drafts and pandemic related delays, an update was released in 2022. A push for modernization is a theme throughout the document. This is viewed as a way to not only avoid shortages through increased production, but to also improve quality. Biofluorescent Particle Counters (BFPC) are a modern method for viable air monitoring in Grade A environments that is fully automated and provides results in real-time. Implementing their use in place of traditional microbiological methods increases process understanding and eliminates interventions that interrupt production and introduce risk. GUGLIELMO IOZZIA ASSOCIATE DIRECTOR – APPLIED MATHEMATICS AND MODELLING DATA SCIENCE – ML/AI - MSD "REASONS WHY YOU COULDN’T (OR SHOULDN'T?) USE GENERALIST LLMS IN THE PHARMA SPACE" Speaker Bio Synopsis Guglielmo is a Biomedical Engineer with an extensive background in Software Engineering and ML/AI applied to different contexts, such as Biotech Manufacturing, Healthcare and DevOps, just to mention the latest, and a lifelong learner. At MSD, as part of the Data Science and Applied Mathematics Team he is currently busy unlocking business value in the lab and manufacturing through ML/AI initiatives. He is also an international speaker and author: currently he is writing his second technical book for Manning Publications, where he is going to share his field experience on implementing domain-specific Large Language Models that can be also executed offline, on private data and on commodity hardware Generalist Large Language Models (LLMs) are available as a service from multiple providers (OpenAI, Microsoft, Google, etc.) and show emergent capabilities that can address diverse and more or less complex tasks. But they come also with challenges and risks, in particular when they have to deal with domain-specific and regulated industries, such as any in Life Sciences. This talk explores the risks associated with generalist and closed source LLMs and showcases which alternatives exist for domain-specific tasks in Pharma, to mitigate risks and reduce the financial impact for adoption DAVID KENIRY CONSULTANT - KENIRY ADVISORY SERVICES Speaker Bio David advises on opportunities in the delivery and management of infrastructure, energy, and housing projects. Based in Cork, David is also a consultant to the Association for the Improvement of American Infrastructure (AIAI), an industry body which serves as a resource for public and private sector leaders as they consider public-private partnerships as an alternative solution to address infrastructure. TONY CLARKE SVP OF IT DIGITAL OPERATIONS - ICON CLINICAL RESEARCH "GENAI USE WITHIN BIOPHARMA AND LIFE SCIENCES INDUSTRIES" Speaker Bio Synopsis Tony is SVP of IT Digital Operations at ICON Clinical Research who provide clinical trial solutions and employ 43,000 staff in 46 countries. Prior to joining ICON he was VP of IT operations at Marken who are part of the UPS family. Tony started his career in electronics and transitioned into Information Technology where he began to focus in cybersecurity. Tony worked in consultancy for several years providing IT services and building environments for banking, telecoms, government, UN and EU agencies. Over the last 20 years, Tony has provided IT & security services to several organisations across a wide variety of industries before specialising in healthcare. His previous role was CISO with ICON Clinical Research where he led a global security team and won several Cybersecurity awards. He is a strong believer in contributing to the information security community and is currently co-chair of the Health-ISAC European Council and sits on the Health-ISAC Global Threat Intelligence Committee. Tony has been a speaker and expert panel participant discussing cybersecurity topics across European and US security conferences including Health-ISAC & ISACA events. He holds a M.Sc. in Security and Forensic computing and an M.Sc. in Artificial Intelligence, a post-graduate certificate & M.Sc. in Artificial Intelligence, drug development and numerous IT, cybersecurity, privacy and artificial intelligence qualifications. This session will explore risks associated with Generative Artificial Intelligence and outline examples of GenAI can be used to derive benefit while minimising risks. CHRISTOPHER NEASHAM GLOBAL PROCUREMENT MANAGER - ALMAC GROUP "IMPACTING CHANGE IN OUR SUPPLY CHAINS FOR SUSTAINABILITY GAINS" Speaker Bio Synopsis Chris has over 10 years' experience in pharmaceutical and laboratory procurement and is currently responsible for all procurement activities in Almac Sciences and Arran Chemical Company. He is MCIPS qualified having studied procurement and supply chain with the Chartered Institute of Procurement & Supply. How we can take ownership of our internal business practices to create tangible supply chain environment improvements, whether from the materials we consume or the processes we are responsible for. SIOBHAN FLEMING PHARMACEUTICAL DIGITALISATION CONSULTANT - SIEMENS Speaker Bio Siobhan brings over two decades of experience in the pharmaceutical industry, spearheading the adoption of cutting-edge technologies within the life sciences sector. In her role with Siemens, she is a leading figure in the implementation of digital consulting solutions for the pharmaceutical industry, with a primary focus on simulation, digital twin applications, and process development. Siobhan's responsibilities include overseeing and optimizing operations throughout the end-to-end pharmaceutical product lifecycle from process design to engineering to operations. Her role encompasses a strategic emphasis on employing advanced data analytics to enhance efficiency, quality, and innovation across diverse processes. SUSAN COSTELLO SKILLNET NETWORK DIRECTOR - BIOPHARMACHEM SKILLNET Speaker Bio Susan has over 25 years’ experience in Learning and Development and 17 years as a Skillnet Network Manager. Susan works with a variety of companies to establish and integrate learning and development as part of the organisations strategic plan, developing skill sets and helping businesses in the sector overcome the challenge of sourcing, developing and retaining talent. EVIN ALLEN LECTURER IN INDUSTRIAL PHARMACEUTICS - UNIVERSITY COLLEGE CORK "THE DEVELOPMENT OF A MULTIDISCIPLINARY PROGRAMME AND T-SHAPED GRADUATE TO MEET INDUSTRIES NEEDS" Speaker Bio Synopsis Evin is a pharmacist with a doctorate in microneedle vaccine development (PhD, UCC) as well as a special purpose award in Lean Sigma (Blackbelt, MTU). Evin has considerable industrial experience working with a number of multinational (bio)pharmaceutical companies both in Ireland and internationally in technical leadership roles. Evin is experienced in drug product manufacture for biopharmaceuticals, product characterization and knowledge management as well as process troubleshooting. Evin was appointed as lecturer in Industrial Pharmacy in the School of Pharmacy as part of the iEd Hub project in 2022 and is the programme director for the MSc in Industrial Pharmaceutical Sciences, Operations and Management and MRes in Industrial Pharmaceutics in UCC. The School of Pharmacy UCC & iEd Hub have launched a new MSc programme in partnership with regional pharmaceutical companies. The objective of this programme is to develop a T-shaped graduate with deep sectoral technical knowledge complemented with broad transverse skills. The programme, curricula and delivery has been specifically designed to ensure graduate employability and minimise graduate time to competency in the workplace. A multidisciplinary programme team from Pharmacy, Management & Marketing and Business Information Systems was formed to deliver this objective. A key pillar of the teaching delivery is the experiential learning through laboratory practicals where students were assigned to work in teams to install, operate and optimise pilot scale pharmaceutical equipment in simulated environments in the School of Pharmacy JENNIFER BAILEY SENIOR TECHNICAL WRITER - TWI "HOW INTELLIGENT CONTENT CAN SUSTAINABLY UNDERPIN INDUSTRY 5.0 MANUFACTURING" Speaker Bio Synopsis Jennifer has over 15 years project management and technical writing experience in pharmaceutical and medical diagnostic cGxP environments. She has worked for companies such as Amgen Technology Ireland, Abbott Ireland Diagnostics Division, Allergen Ireland and Trinity Biotech across the Manufacturing, Quality, Technical Transfer, Product Development, Regulatory and Maintenance and Engineering Departments. In addition to technical writing, her main areas of expertise include workflow management, process improvement, root cause analysis, impact assessment, change control and risk assessment. Jennifer joined the team at TWi in 2023 to combine her knowledge of the life sciences manufacturing sector and passion for continuous process improvement with TWi’s intelligent content authoring solutions for the Biopharma and Life Sciences sector. In this talk, we embark on a journey through the evolving landscape of digital transformation in the life sciences sector, where Industry 5.0 principles and the synergy of human intelligence and machine capabilities transform your content from static to intelligent assets, while also becoming a driving force in addressing content-related challenges resulting in significant commercial savings for your business, while also supporting sustainability initiatives. After years of digital transformation projects within life sciences companies and many moving from paper to digital, the creation of SOPs and other documentation in MS Word remains largely unchanged since the 1990’s. As Industry 5.0 emerges, there is a strong focus on humans and machines working together to drive more resilient and sustainable manufacturing practices. In a demanding business world where there is increased pressure to shorten the time to bring new products to patients in a profitable and sustainable way, while satisfying increasing regulatory requirements, intelligent content is a game changer that most life science companies are only discovering today! For well over a decade, technology companies across many industries, including highly regulated sectors such as finance, have experienced the positive impact of intelligent content. Traditionally, these companies had large silos of thousands of documents that were inefficiently created by hundreds of people dispersed all over world using tools such as MS Word. Today, the principles of Industry 5.0 support companies not only to embrace intelligent content but also in the efficient development of content that can be easily and seamlessly re-used across the entire business establishing a ‘single source of truth’. As Gartner predicted, life science companies are now starting to adopt this well-established combination of technology, process, and content strategy to implement intelligent content as part of their digitalisation efforts. At the end of this talk, you will gain insights into how intelligent content can solve not only your content related challenges, but also contribute to resolving operational, regulatory, and business issues. Additionally, you will be equipped with valuable information on where to seek further guidance in this transformative journey. RAHEL BAILIE CONTENT SOLUTIONS DIRECTOR - TWI "HOW INTELLIGENT CONTENT CAN SUSTAINABLY UNDERPIN INDUSTRY 5.0 MANUFACTURING" Speaker Bio Synopsis Rahel is the Content Solutions Director at TWi. She brings with her a strong background in developing successful digital content strategies, tackling the complexities of managing content for clients globally. With an aim of using content to deliver better experiences and increase the ROI of product lifecycle content, she applies the principles behind intelligent content to deliver operational efficiencies in a scalable, sustainable way. In her 20+ years of consulting, Rahel has worked with many global companies, including Welch Allyn and A-dec Dental. Rahel is a recognised thought leader, having authored and contributed to several industry books, magazines, and academic journals. She presents at events worldwide and also teaches in the Content Strategy Master’s Program at FH-Joanneum in Austria. In this talk, we embark on a journey through the evolving landscape of digital transformation in the life sciences sector, where Industry 5.0 principles and the synergy of human intelligence and machine capabilities transform your content from static to intelligent assets, while also becoming a driving force in addressing content-related challenges resulting in significant commercial savings for your business, while also supporting sustainability initiatives. After years of digital transformation projects within life sciences companies and many moving from paper to digital, the creation of SOPs and other documentation in MS Word remains largely unchanged since the 1990’s. As Industry 5.0 emerges, there is a strong focus on humans and machines working together to drive more resilient and sustainable manufacturing practices. In a demanding business world where there is increased pressure to shorten the time to bring new products to patients in a profitable and sustainable way, while satisfying increasing regulatory requirements, intelligent content is a game changer that most life science companies are only discovering today! For well over a decade, technology companies across many industries, including highly regulated sectors such as finance, have experienced the positive impact of intelligent content. Traditionally, these companies had large silos of thousands of documents that were inefficiently created by hundreds of people dispersed all over world using tools such as MS Word. Today, the principles of Industry 5.0 support companies not only to embrace intelligent content but also in the efficient development of content that can be easily and seamlessly re-used across the entire business establishing a ‘single source of truth’. As Gartner predicted, life science companies are now starting to adopt this well-established combination of technology, process, and content strategy to implement intelligent content as part of their digitalisation efforts. At the end of this talk, you will gain insights into how intelligent content can solve not only your content related challenges, but also contribute to resolving operational, regulatory, and business issues. Additionally, you will be equipped with valuable information on where to seek further guidance in this transformative journey. PETER BLENNERHASSETT CEO & CO-FOUNDER - BLYNKSOLVE "A UNIFIED KNOWLEDGE SPACE - ACCELERATING TECH TRANSFER" Speaker Bio Synopsis Peter Blennerhassett is the CEO and Co-Founder of Blynksolve, a software company based in Dublin. Peter graduated from Chemical and Bioprocess Engineering UCD and has worked as a Process Engineer in Pfizer and MSD in roles such as TechOps, Person-in-Plant and Tech Transfer. He is driven by scalable simplification of Pharma Manufacturing and the smart use of technology to achieve this. The concept of a Unified Knowledge Space developed by Peter and Blynksolve was awarded “Innovation of the Year” at the 2023 Pharma Industry Awards. Peter is also proud to serve as a committee member of the ISPE Irish Affiliate and Engineers Ireland Chemical and Process Division. In this presentation, Peter Blennerhassett CEO of Blynksolve will explore the concept of a Unified Knowledge Space (UKS) for Pharmaceutical manufacture. The novel concept of a UKS was recently awarded "Innovation of the Year" at the Pharma Industry Awards 2023 voted by industry peers. Peter will examine current challenges in the Pharma industry, how other industries have addressed these challenges and how a UKS can help make Pharma Production more agile, resilient and efficient. SEAMUS BUTLER MANAGING DIRECTOR - ACS DRIVES "HARMONICS AND POWER QUALITY IN LIFESCIENCES" Speaker Bio Synopsis Seamus Butler: Managing Director for ACS Drives and Control Systems, Ltd - the leading Drives solutions provider to Irish industry. ACS Drives and Control Systems are a Gold Standard member of ABBs Authorised Value Provider Program, which is a global network of approved and certified ABB Partners. We offer the complete range of ABB Variable Speed Drives as well as installation, commissioning, maintenance and lifecycle support. ACS Drives and Control Systems are also Ireland's only ABB certified commissioning and repair specialists and through our recently launched Digital Transformation Hub, we will be developing and delivering the ABB Ability Powertrain suite of digital solutions in Ireland. The ABB Ability™ Digital Powertrain includes devices, software and services, combining connectivity and data analytics with ACS Drives expertise and superior services to render their clients' operations more efficient, predictable and safe. Through our unique and extensive experience across sectors, we offer unrivalled solutions and support at every stage of a construction project; from specification and design, through installation and commissioning, and ongoing maintenance by the most responsive service division in the sector from our central strategic base in Mullingar. Our team is acknowledged as the best in the business and have experience in all industrial sector, from Cement and Chemical to Pharma, Food and Beverage, Utilities and Tech. What are harmonics. Where do they come from. Side effects, consequences, efficiencies. Power quality. Harmonic Mitigation techniques. Comparisons. standards. GER CARTON CEO - PLANTQUEST "VISUALISING THE BROWNFIELD" Speaker Bio Synopsis Ger Carton is the co-founder and CEO of PlantQuest, a software company enabling the world’s largest pharmaceutical companies and other large process facilities to digitally transform their asset management operations through the provision of intelligent asset mapping and geo-optimized workflows. Prior to this, Ger gained over two decades of experience working across a range of disciplines within the leading Pharmaceutical, Medical Devices, and Oil & Gas companies. No stranger to the challenges and opportunities faced in digitizing and bringing visual context to a range of brownfield facilities, Ger shares his learnings and experiences in the matter from both the perspective of the buyer and the vendor. In a landscape where the premium digital solutions are focused on new facilities, Ger Carton highlights some of the key challenges facing brownfield facilities. These large, complex facilities are marked by their use of diverse, often isolated systems and high worker turnover, leading to fragmented data, a lack of unified decision-making, and a loss on operational efficiency. Ger highlights the challenges of visualizing this data and shares insights from both the end-user and vendor perspective. Emphasizing the criticality of visualization, Ger discusses its tangible ROIs, the value proposition, and the anticipated timelines in bringing visual context to workflows in this landscape. He offers guidance for end-users, ensuring positive outcomes from visualization initiatives, and concludes by suggesting actionable next steps for organizations aiming to enhance their brownfield visualization and digitization efforts. DAMIEN COSTELLO DIRECTOR OF LIFE SCIENCES - EXPLEO GROUP PAUL COYNE VICE PRESIDENT - BUSINESS DEVELOPMENT - ENVETEC SUSTAINABLE TECHNOLOGIES "RETHINKING WASTE: SUSTAINABLE TREATMENT OF BIOHAZARDOUS MATERIAL" Speaker Bio Synopsis Paul Coyne is Vice President of Business Development for Envetec. Envetec is an Irish company with a global vision to create clean change. Paul gained his BSC from UCD and moved from University to roles covering both Laboratory and QA with the Kerry Group. Following this he joined Technopath Distribution in 2005 as a Technical Sales representative and ultimately covered roles of increasing responsibility before becoming Business Development Manager. In 2015 Paul joined IDEXX Laboratories where he was Sales Manager for Europe and various Distribution territories. His experience includes Pharma, Med-Device ,Food And Beverage as well as extensive knowledge of the Veterinary sector. Paul is passionate about creating clean change and is confident that we can have positive environmental impact by responsible treatment of Laboratory Biohazardous waste. Paul joined Envetec in 2022 and has recently become a My Green Lab Ambassador and a member of the International Solid Waste Association. In the interest of efficiency, accuracy and infection control the Life Science sector has become reliant on single-use materials. While this material presents a lot of benefits it also creates a lot of significant issues, specifically in it’s disposal. Currently, this material is treated as waste once used and therefore is disposed, usually through extremely Carbon intensive methods. Envetec are tackling this issue head on by looking at this used biohazardous material as a resource. Through the use of innovative technologies it is now possible to unlock opportunities such as recycling for this used material all while treating it in an effective and sustainable manner. NEEHARIKA DAYYALA PRINCIPAL BUSINESS CONSULTANT - EXPLEO GROUP "AI & BEYOND: EVOLVING CSV & CQV" Speaker Bio Neeharika Dayyala is an MBA and a Biomed graduate with over 10 years of experience in Life Science industries while also being exposed to different cultures and people from different countries. Neha has previously worked in Deloitte India in the Life Sciences and Healthcare Industry before moving to Deloitte Ireland to be part of their still new Life Sciences practice. Neha has worked in resolving various aspects of the workspace in improving the safety and quality for people. Neha has also authored an Agile POV, which is published on the Deloitte Website and a blog for Expleo on the future of automation in validation. PAUL DENNY-GOULDSON CHIEF SCIENCE AND TECHNOLOGIST - ZIFO "TRANSFORMING ELECTRONIC BATCH RELEASE – PROCESS ORCHESTRATION AND INTEGRATING ERP, QC LABS TESTING AND PRODUCT RELEASE - EFFICIENCY AND PROCESS INSIGHTS." Speaker Bio Synopsis Paul has built up extensive experience in a broad range of scientific informatics and data management domains spanning research, development, manufacturing and clinical studies in Pharma/Biotech, FMCG, Chemical, Food & Bev and Oil & Gas organizations. He has over twenty years of experience with global scientific informatics products, during which time he also founded several companies focused on combining science & technology. He started his career as a Post Doc and subsequently Senior Scientist at Sanofi-Synthelabo Toulouse (now Sanofi) for just under five years, where he managed a multidisciplinary molecular and cell biology group. Paul obtained his Ph.D. in Computational Biology from Essex University. Discussions, case studies and ideas on how BPMN technology can help orchestrate existing processes, leverage existing infrastructure and provide great insights into the EBR process. DAVID DOYLE SALES ENGINEER - BUTLER TECHNOLOGIES "SEE WHAT YOU CANT SEE AND CANT REAR." Speaker Bio Synopsis David Doyle, level 3 thermographer, level 1 ultrasound, 18 years with Butler Technologies providing training in thermal imaging and ultrasound testing Using thermal imaging cameras to see heat coming from equipment and products before they get to temperatures that would damage them. Use ultrasound to see where leaks in pressurised pipelines or room seals are leaking. PATRICK FALVEY PRINCIPAL CONSULTANT - LATHAM BIOPHARM GROUP "ECO-FRIENDLY MANUFACTURING" Speaker Bio Patrick Falvey has over 30 years of research, managerial and technical experience in the Pharmaceutical and Biotechnology Industries. He has enjoyed various positions of responsibility and leadership in Operations, Quality Assurance, and Compliance and believes in collaboration among individuals and groups to effect positive change and improvement. Patrick has previously been a Senior Team Lead for Pfizer with responsibility for the manufacture of Prevnar 13 vaccine, (prevention of pneumococcal meningitis) one of the world’s most successful vaccines. He has hosted and responded to various agency audits including FDA, EMA, SFDA (China) and was responsible for overall Department Inspection Readiness program. He has led and been responsible for a team of Investigation and Compliance specialists that closed hundreds of investigations and commitments to maintain state of compliance. He has onboarded & designed GMP training programs for new college graduates for introduction to Aseptic & Cleaning Qualification programs to support multiple aseptic manufacturing lines and has managed site GMP Training/Safety programs. Patrick has worked with a variety of companies ranging from large pharmaceutical companies to start-up ventures. Patrick received his Bachelor of Science in Biochemistry from University College Cork in Ireland, Masters of Science (Industrial Pharmacy) from Long Island University in Brooklyn, and his Master of Business Administration from Iona College in New Rochelle NY. STEVEN FLYNN CHIEF PILOT EU - SPRIGHT "DRONES IN HEALTHCARE AND PHARMA" Speaker Bio Synopsis One of Ireland’s first commercially licensed drone pilots, Steven has spent the last 11 years leading some of Ireland’s cutting edge drone operations including delivering a parcel for An Post in 2018 (5km), Diabetes Medicine to the Aran Islands (18km) in 2019, and high-end filming for major motion pictures and broadcast networks. He has spoken on compliance and safety in the drone industry at conferences around the world, and is now Chief Pilot for Spright’s EU operations. Drones have long been touted as the next great thing in logistics but to date have not lived up to the hype. 2024 will be the year we see unmanned cargo aircraft begin to have real impacts on healthcare and critical healthcare industries like drug manufacturing and distribution. Learn about what’s happened in the sector and how unmanned medical drones can impact healthcare in Ireland. DR. MATTHEW HALEY ACCOUNT MANAGER - DUBLIN & NORTH-WEST UK - ZEISS "SOLUTIONS, TOOLS AND TECHNOLOGY DEVELOPMENT FOR BIOTECH AND PHARMA COMPANIES BOTH OLD AND NEW" Speaker Bio Synopsis Dr Matthew Haley, is the ZEISS Account Manager for Dublin and North-west UK, since 2016. Matthew has a PhD in Physiology and years of experience connecting industry requirements with powerful research solutions. ZEISS has a host of solutions that enable pharma and biotech companies to overcome difficulties, boost productivity and innovate discovery. This talk provides an introduction to advanced automated microscopy imaging systems and powerful vendor-agnostic image analysis software with Deep Learning A.I. tools. Furthermore, ZEISS can provide optical components for your products, or customize software solutions, and even invest in technology-driven start-ups in this sector. BRIAN HARRISON MANAGING DIRECTOR - HITECH HEALTH "ARE ADVANCED MEDICINES INCLUDING CELL AND GENE THERAPIES THE FUTURE OF MEDICINE?" Speaker Bio Synopsis Brian Harrison is Managing Director of Hitech Health , A CDMO with a focus on the development and manufacture of Advanced Medicines including Cell and Gene Therapy Products. Brian was previously an executive at Bristol Myers Squibb where he was VP of Development based in the US. He also was General Manager of a Biopharmaceutical Manufacturing plant for Bristol Myers Squibb in Ireland. Brian holds a BSC and PH.D from University College in Dublin and also carried out Post Doctorate research at Emory University, Atlanta, GA USA Advanced Medicines make up more than 10% of total new drug approvals in the US as of early December. These novel therapies can transform peoples lives often with as little as a single dose. However, there are many challenges before these new medicines will become standard of care, not least of which is the extremely high cost per dose which can extend to >$3M dollars for the most expensive treatments. This presentation will give an overview of advanced medicines, outline some of the challenges but also opportunities provided by this fast growing area of new medicines PADRAIG HYLAND CEO - THE CORE STORY Speaker Bio Padraig is passionate about what he does and leans naturally to facilitating, producing and delivering keynotes at international conferences and events worldwide. His unique blend of human insight, extensive business career and background as a comedian makes him truly unique. Padraig is a TEDx Speaker and has featured on BBC and TV3. He has written and presented 22 episodes of the Ninja Leadership Academy for Meet The Boss TV. Padraig is a story marvel and is the driving force behind The Core Story, a company that works with global organisations around transformational change while helping leaders reimagine their business in the context of new change drivers such as ESG, Sustainability, and the Pace of Change. In the Bio Pharma world, The Core Story focuses on change, 360-style, taking their clients through an innovative process, enabling them to tell their authentic story in a way that connects with the hearts and minds of all stakeholders. Padraig's experience spans twenty years as an international business professional in Asia, USA and Europe for global organisations such as Baxter Healthcare and his work continues today to include companies like illumina, Takeda, Janssen. He passionately believes that we need more heart in business strategy and guides leaders and organisations on how to reimagine their business in a way that opens up new possibilities for the future and changes performance. Padraig and his team have developed innovative and unique frameworks and tools that have evolved alongside global clients. These have been successfully applied in various scenarios, empowering organisations from all corners of the business world to thrive in a fast-changing world. PETER KELLY CEO - PHARMAFILTER GROUP HOLDINGS "PHARMAFILTER ADVANCED PURIFICATION OF PHARMACEUTICAL WASTEWATER AND DECONTAMINATION OF WASTE ON-SITE." Speaker Bio Synopsis He worked with Heineken and Guinness in senior commercial roles and with Metabolix/ADM in a global technical and commercial role in the Bioplastic sector on applications in the Agriculture, Horticulture, Marine, Erision Control, Wastewater, and other sectors, including working with several US Universities on contamination of soil. His educational background covers business administration, advanced polymer sciences, the conversion of second-generation feedstocks to green chemicals, and the environmental impact of wastewater. He has published several white papers, of which his latest in 2023, "Contamination of Hospital Wastewater," he is a fellow of the All Ireland Business Foundation. Pharmafilter advanced purification of Pharmaceutical and Hospital wastewater and decontamination of waste on-site. The outbreak of the COVID-19 pandemic directed global attention towards monitoring viruses and other infectious pathogens in hospital wastewater and waste, and yet this effluent continues to impose a serious and escalating threat to public health. The concentration of analgesics, antibiotics, β-blockers, hormones in hospital effluent has been found to be much higher compared to their concentrations in domestic wastewater. The presence of various recalcitrant organics and pharmaceutically active compounds in healthcare wastewater also imparts a complex pollution load to water resources and ecosystems. In their day-to-day business, hospitals discharge wastewater containing large amounts of pharmaceuticals, metabolites and cytotoxins as well as pathogenic contamination. Many of the micropollutants present in hospital wastewater are highly toxic and what's more, their strong chemical compounds often and their way, untreated, into the public infrastructure, where they remain biologically active. The interaction between these discharges including, untreated Pharmaceutical production discharge wastewater, to local wastewater treatment plants and their broader environment, is an area of growing concern, particularly in the context of eco-toxicity and antibiotic-resistant bacteria. Due to technical and economic constraints, it is not possible to remove this contamination at a receiving wastewater treatment plant because of the specialist removal techniques required. Since pharmaceuticals are, by design, intended to interact with living organisms, even very low environmental concentrations are a concern. JASON KELLY APPLICATIONS DIRECTOR - LIGHTHOUSE WORLDWIDE SOLUTIONS "EU GMP ANNEX 1: CONTINUOUS ENVIRONMENTAL MONITORING CHALLENGES IN THE CLEANROOM" Speaker Bio Synopsis Jason Kelly is Director of Applications at Lighthouse Worldwide Solutions and is based in Oregon USA. With over 28 years’ experience in providing Cleanroom Monitoring Solutions to the Cleanroom Industry, Jason specializes in Pharmaceutical, Medical Device, Life Science, Semiconductor, Aerospace and Military Cleanroom applications. Jason presents worldwide on current cGMP, cleanroom standards and Environmental Monitoring Systems from risk management, system designs, using GAMP protocols, system installations, validation processes, customer training and system service support SLA’s. He is a faculty member of the Institute of Environmental Sciences and Technology USA (IEST) and delivers regular IEST training courses and presentations on Cleanroom Standards and technologies concerning environmental monitoring and contamination controls in cleanrooms. Jason is a new committee member of PDA Ireland, an ISPE member and volunteer as well as a committee member of the Irish Cleanroom Society and a member of the International Confederation of Contamination Control Societies (ICCCS) working on ISO 14644 family of standards. Review of EU GMP Annex 1:2022 Environment Monitoring requirements and the challenges of meeting continuous manufacturing and moving into a Pharma 4.0 and beyond. This presentation will look at existing and new EM monitoring technologies in Aseptic Sterile Processes. How do we move forward into the digital age and how do we obtain meaningful EM data and mitigate against product contamination. How are we monitoring today and how are we intending in monitoring tomorrow to fit into a Contamination Control Strategy. Learn how to apply current ISO standards and how to develop a continuous EM program and EM system. This presentation will also review ISO 14698, EN17141 and provide an update on the draft ISO 14644-20 standard on Microbial Contamination Control. VIKRAM KUNNATH TECHNOLOGY CONSULTING PARTNER - EY Speaker Bio Vikram Kunnath is an Technology Consulting Partner at Ernst and Young in Ireland based in Cork. He leads up EY'S Digital Manufacturing Practice for UK & Ireland supports Manufacturing / Supply chain initiatives for clients in the Lifesciences industry . Vikram has around 26 years of work experience with Global Lifesciences clientele having lived in Asia, Germany, US and now calls Ireland his home. He possesses strong Process background in the Manufacturing realm with in-depth understanding of Lifesciences API, Formulation, Vaccines space and. He and his team support work for Lifesciences clients in Europe around themes like IT/OT convergence, Industry 4.0 Digital maturity assessments and Consulting/Implementation of shopfloor technology like Manufacturing execution systems, Distributed Control systems, Laboratory information management systems, Quality management systems, OT Cybersecurity, Manufacturing analytics, AR/VR technologies among others. Prior to joining EY 2 years ago, Vikram has incremental stints in with global consulting and product firms like Siemens, Tata Consultancy services and Cognizant and also worked with GE Healthcare Lifesciences division ( Cytiva now ) for few years supporting their Bioprocessing units TERRI LOVE SENIOR MSAT BIOMANUFACTURING ENGINEER - MERCK LIFE SCIENCE "IMPACT OF INTENSIFIED BIOPROCESSING ON SUSTAINABILITY" Speaker Bio Synopsis Terri Love is a Senior Biomanufacturing Engineer within the Manufacturing and Sciences Technology team at Merck KGaA, based in Ireland. Following a BSc degree in Industrial Biochemistry from the University of Limerick, Terri worked for Lonza Biologics in the UK before returning to Ireland to work with Merck. Terri has been employed within the biopharma industry for the past 21 years, and she has been working for 18 years as a field-based Biomanufacturing Engineer at Merck in Ireland. During her time at Merck, Terri has been collaborating with Irish biopharma customers on their technology transfers, scale-up and implementation With the move of the biopharmaceutical manufacturing industry towards Biopharma 4.0, the focus has also been on increasing the efficiency and utility of such processes. This has led to a drive towards continuous processing in the long term for processes where it is appropriate and an intensified bioprocessing approach to the others. Whilst the economic impacts are well understood with such approaches, there is limited data on how these new efficiencies contribute to sustainability metrics. This talk will provide an overview of the sustainability metrics commonly used, key sensitivities and a case study with a downstream intensified process. DESMOND O'SULLIVAN VP BUSINESS DEVELOPMENT - OPTEL GROUP "THE FUTURE OF GLOBAL SUPPLY CHAINS" Speaker Bio Synopsis A professional with over 35 years’ experience working at the highest level in the Pharmaceutical, Lifesciences, Warehouse and Logistics, Food and Beverage, CPG industries. I am responsible for the Global PMO at Optel Group but now due to the Climate Crisis I am involved with Business Development with specific responsibility for the Climate Change Strategic alignment within the EMEA region. Presentation to discuss Global Supply Chain challanges and opportunities for Business. MARTIN O’NEILL ASSISTANT LECTURER - ATLANTIC TECHNOLOGICAL UNIVERSITY "COMPARISON OF MACHINE LEARNING AND CLASSICAL STATISTICS IN PREDICTING HEALTH OUTCOMES IN A LIFESTYLE MODIFICATION PROGRAMME FOR OBESITY." Speaker Bio Synopsis Martin O’Neill is an experimental neuropsychologist by trade: he was awarded an Honours Degree in Neuroscience from the University of Glasgow (2000) and a PhD in Psychological Science from the University of St Andrews (2005), Scotland. Following his studies, Martin was a Research Associate at the University of Cambridge (2005-2014), a Senior Research Associate at the University of Oxford (2014-2019), and a Research Fellow in Neural Data Science at the University of Nottingham (2020-2022), England. Following on from a six-month stint as an Assistant Lecturer in Psychology at IT Sligo (2021-2022), he is now Assistant Lecturer in Population Health Informatics and Statistics at ATU Sligo (since 2022), Ireland. Martin's research focuses on the neural mechanisms underlying learning and decision making. He is currently analysing a large-scale neural dataset collected while in Oxford with the analysis techniques developed while in Nottingham. While in Oxford, Martin was a Lecturer in Psychology at St Hugh’s College (2016-2021) and Brasenose College (2019-2021) and accredited as an Associate Fellow of the Higher Education Academy (HEA). At ATU Sligo nowadays Martin teaches statistics, IT, and data science in the Dept of Health and Nutrition. Obesity rates are rising globally as are the associated healthcare and societal costs. Lifestyle intervention programs have been accepted globally as a suitable population-level approach to obesity and its complications. We compared machine learning techniques with classical statistical models in predicting health outcomes in a structured lifestyle modification programme to determine whether machine learning could be a useful adjunct in obesity research. Machine learning analysis was largely in agreement with the standard statistical models, with both indicating gender, age and distance travelled to the intervention centre positively predicting weight loss. However, in addition, factors worthy of future investigation were identified by machine learning including BMI; depression; number of days between being referred and starting the intervention. We propose a potential hybrid approach combining the strengths of traditional statistics with the advantages of machine learning as adjunctive tools in obesity research. GRAHAM O’REILLY PROJECT MANAGER - CAMFIL "FAN FILTER UNITS FOR CLEAN PROCESSES" Speaker Bio Graham has been with Camfil for over 25 years and has been involved in all aspects of the air filtration industry during this time. He is presently project manger and product manager for the Life science industry. He is heavily involved in clean process design from cradle to grave in conjunction with all the engineering houses and then continuing the processes on site with both the contractors and end users (Pfizer, Abbvie, Takeda, BD, Regeneron, Amgen, West pharma). Recent projects involving fan filter units included the turnkey package of ceiling grid, FFU’s, Filters and most importantly the controls systems. Graham is extremely knowledgeable on all the controls used in driving these units from Modbus to LON. BARRY O’SULLIVAN CHAIRMAN - SHANNON ESTUARY ECONOMIC TASKFORCE FRANK SAGE EU BUSINESS DEVELOPMENT MANAGER - EXERGY LLC "SAFE, STERILE, SUSTAINABLE & SMART WFI DISTRIBUTION WITH EXERGY POINT-OF-USE COOLING SYSTEMS" Speaker Bio Synopsis Frank has over thirty years’ experience in the Specification of Fluid Handling Equipment for the Pharmaceutical and Process Sectors in Ireland and the EU. Fulfilling the detailed specification, supply, and regulatory requirements of new fluid handling technologies, on major Biopharmaceutical and Process Projects from conception to final qualification. A fresh look at why, choosing a Zero-Ambient WFI Loop, is proving to be the best solution to address the competing demands of Regulatory Compliance, Employee Safety, Sustainable Manufacturing, and Return on Investment. BHARAT SHARMA CEO & FOUNDER - MONSOON CONSULTING "THE DIGITAL SHIFT: ACCELERATING B2B COMMERCE IN BIOPHARMA" Speaker Bio Synopsis Bharat Sharma is the Founder and CEO of Monsoon Consulting, Europe’s leading Digital & eCommerce agency with clients including Uniphar, Heat Merchants, and Sysco Ireland. Bharat is a leading figure, author and frequent speaker at events across Europe and India relating to eCommerce technology, industry trends, and government sectors. Unlock the power of digital transformation in biopharma and life sciences eCommerce. Tailored for B2B commerce leaders, our talk brings decades of enterprise digital expertise to the forefront. We'll showcase how strategic digital integration can boost revenue, streamline sales, and future-proof your business. Don't miss this chance to reshape your B2B strategy with cutting-edge insights. LEE SHERLOCK CEO & CO-FOUNDER - META-FLUX Speaker Bio Lee Sherlock is the CEO and Co-founder of Meta-Flux, a group that is focusing on enhancing the interface between AI and systems biology in drug development settings with an emphasis for oncology. Prior to Meta-Flux, Lee spent multiple years as a biochemist aiding in drug development. Lee has a particular interest in AI and personalised medicine with recent publications in Frontiers of medicine. LAURA STAKELUM MANAGING DIRECTOR - STAKELUM CONSULTANCY RONAN STAUNTON MANAGING DIRECTOR - HEALTHFIELD CONSULTING "THE MICE PRINCIPLE. 4 PRACTICAL WAYS TO BUILD A SUSTAINABLE SUPPLY CHAIN IN HEALTHCARE" Speaker Bio Synopsis Ronan Staunton has over 20 years of experience in the healthcare sector, leading projects for Global brands such as Nutricia Medical, Abbott, Medtronic & others. Ronan spent 7 years as The Global Head of the Critical Care Division for Nutricia Medical, which is a division with €700m revenue and covers a range of tube feeding products, medical devices and digital technologies. Following this, he spent 3 years as head of the MedTech Division of PCH International, a Global Product Development business with offices in Ireland, The USA and China. In 2023, Ronan set up Healthfield Consulting which is a Global consortium of supply chain consultants supporting MedTech & Healthcare companies to optimise their supply chain and reduce their carbon footprint. Ronan is a consultant member of international advisory boards on sustainability and is Policy Advisor for Smart Grid Ireland, an All-Ireland representative body for the Irish energy sector. Just 7 hours of anesthesia with desflurane is the equivalent of a 15,700 km car journey in terms of emissions! The unique requirements of the healthcare sector (single use items, sterile packaging, vast volume supply chains) means that the industry has a hugely negative impact on the environment and 80% of Carbon emissions from the sector come from its supply chain. While all Medical and healthcare companies have an obligation to limit their environmental impact, this must be balanced by the regulatory requirements of the sector & commercial goals. There are 4 simple principles to MICE and applying these can bring practical changes to supply chains and have a really positive impact on emissions. M – Measure: If it’s not measured, it’s not managed! I – Investigate: Every organisation is different. Where are your environmental problem areas? C – Communicate: Effective communication is critical for sustainable success E – Engage: Work in collaboration with partners (manufacturers, sub-contractors, freight forwarders) for optimal results DONAL SULLIVAN CEO - COMPUCAL CALIBRATION SOLUTIONS "GO DIGITAL & MOBILE FOR COMPLEX WORKFLOWS" Speaker Bio Synopsis Donal Sullivan is CEO of CompuCal Calibration Solutions - SaaS calibration & maintenance management specialists. A highly experienced and successful business leader, he has spent 25 years+ in the technology sector with Apple, Flextronics and Johnson Controls, where he led the Ireland organisation, establishing a global business services center and a digital engineering function. Donal has built a number of digital businesses, run complex global operations, delivered smart buildings and campuses globally. An expert in SaaS/AI offerings and solutions for end clients he has assisted global corporations with their digital transformation needs. Donal now leads CompuCal - a world leader in instrument calibration, maintenance and validation management working with some of the largest global brands and manufacturers, servicing SMEs to Fortune 500 companies within the regulated industry sector as well as calibration service companies. In addition to this, Donal is the current Chair of MCCI (Microelectronic Circuits Centre Ireland) - a large scale microelectronics technology centre, hosted at Tyndall National Institute, focused on delivering high impact microelectronic research, driven by global industry application needs. To enable digital transformation and to take paper out of complex processes, you need some key enabling technology Cloud architecture and platform Ability to profile and capture the complex workflows, logically and digitally Real-time processing of data Useful tools and technology at point of use Bring context to the user in real time Enable the use of mobile phones as a digital tool, while protecting data privacy & security, KIERAN TOWEY HEAD OF APPLIED INTELLIGENCE - KPMG IRELAND "DATA & AI, THE NEW SILVER BULLET?" Speaker Bio Synopsis Kieran Towey, Managing Director Data Scientist and KPMG Analytics lead Kieran has 25 years’ experience working as a Data Scientist, delivering data powered solutions to large global and domestic clients. Kieran has a mathematics and statistics academic background and 20 years experience working as a Management Consultant in the field of Advanced Analytics & AI. Kieran’s particular expertise lies in designing and delivering data powered solutions that maximise the client value. Of late, Kieran is working closely with clients to understand the applications of AI and in particular Generative AI and how these capabilities may impact the future of work and can deliver business value. The talk addresses the potential of AI to transform the industry. Going beyond the hype, what are the keys to unlocking business value. GARY TYNE DIRECTOR - PRO-RELIABILITY SOLUTIONS LTD "IS YOUR ASSET STRATEGY OPTIMIZED FOR LOWEST COST AND RISK?" Speaker Bio Synopsis Gary boasts an extensive 38 year-career in the Maintenance and Reliability field. Beginning as an apprentice maintenance technician with Imperial Chemical Industries (ICI) UK, Gary was seconded to the ICI MT group where he became trained in RCM, RCA and TPM techniques. Gary left ICI after 15 years and emigrated to New Zealand where he became a site reliability engineer at Shell Todd Oil Services. This was followed by five years in Australia working as a Reliability Consultant in the Mining and Refining sectors. In 2009 Gary returned to the UK, were he spent two years with Syngenta as a site reliability engineer. Here he implemented the Root Cause Analysis process and used the Isograph AWB software for reliability improvement and facilitated studies both in the UK and Switzerland. In 2018, Gary started his own company Pro-Reliability Solutions, and they now have offices in the UK, Ireland, and the Middle East. Gary has delivered various reliability studies, root cause analysis investigations, and maintenance and reliability training courses around the world. These are within numerous industry verticals such as oil and gas, pharmaceutical, water, food and beverage, chemical, automotive, and general manufacturing companies. This presentation from Pro-Reliability Solution will look at how water utility companies are modeling their asset base using well known ‘Reliability’ techniques that will return optimized costs at lowest risk. If your maintenance budget is out of control or you are experiencing unexpected failures of critical assets then this presentation will take you through some key steps that focus on reversing this situation. We will step through the process of how to develop an optimized strategy for both new designs or existing plant, and discuss some case studies where others have performed these activities for maximum return. BARRY WALSH COUNTRY MANAGER – IRELAND - EUROPEAN ENERGY A/S Speaker Bio Barry qualified as a Chemical & Process Engineer from CIT in 1997 and spent the first 15 years of his career working on bulk pharma and biotech projects from design to commissioning for a range of multi-national companies. Seeing the future importance of sustainability, he ‘pivoted’ around 2010 to get involved in clean tech start-ups, and transitioned fully into the development of Solar PV with a role in Temporis Capital from 2015. He subsequently moved into a role on the Investment Management team of the Aurora Fund, a renewable energy development fund backed by ISIF. In 2022 he moved to the Country Manager role for EE’s expansion into Ireland and has been progressing wind, solar and Power-to-X projects from inception through to construction since then. European Energy A/S (known as EE) is a Danish based renewable energy developer founded in 2004 and active in over 30 countries worldwide. EE has over 30GW of project in development across Onshore and Offshore Wind, Solar PV and more recently in construction of the worlds largest Green Methanol plants (Power-to-X) DAMIAN WHITE CHIEF TECHNOLOGY OFFICER - DATALOGIX "OT CYBERSECURITY RESILIENCE IN PHARMACEUTICAL MANUFACTURING" Speaker Bio Synopsis Damian White CTO @ DataLogiX Damian White is an expert in the field of securing Operational Technology Networks and is the Chief Technology Officer of DataLogiX, a leading company specialising in OT cybersecurity for global organisations. With over 25 years of experience working closely with multinational pharmaceutical companies, Damian possesses an in-depth understanding of the unique challenges faced by industries such as life science manufacturing. His expertise in OT security has been instrumental in safeguarding the uptime, security, and safety of industrial environments and critical infrastructure worldwide. DataLogiX's vendor-independent status has empowered Damian and his team to design, configure, deploy, and support operational technology networks for major global pharmaceutical companies, ensuring their operations remain resilient against cyber threats. Known for his passion for innovation and dedication to delivering unparalleled results, Damian's leadership at DataLogiX has solidified the company's position as a trusted partner in the world of OT cybersecurity. His commitment to excellence and driving transformative solutions has earned him a reputation as a sought-after thought leader in the industry. The intersection of IT (Information Technology) and OT has significantly transformed the landscape of pharmaceutical manufacturing. As Operational Technology becomes increasingly integrated with digital networks and systems, the potential attack surface for cyber adversaries expands. A successful cyberattack on OT systems can lead to devastating consequences, including production disruptions, compromised product quality, safety hazards, and even threats to human health. In my talk, I will delve into the key reasons why the Life Science sector must prioritise cybersecurity for Operational Technology to build resilience against Cyber Threats. The pharmaceutical manufacturing process relies heavily on interconnected and automated systems. Implementing robust cybersecurity measures becomes imperative to safeguard against malicious attacks, ensuring the uninterrupted production of life-saving medications. In my presentation, I will also discuss best practices and practical strategies to enhance OT cybersecurity resilience in pharmaceutical manufacturing. I aim to highlight real-world case studies and lessons learned from the industry, empowering the audience with actionable insights to tackle the cybersecurity challenges they face. 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