Our Team
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Evelyn Kelly MPharm, MPSI, MBS
Evelyn has close to 20 years of experience in the pharmaceutical industry in both distribution and orphan drug companies, working across Supply Chain and Quality Assurance. Evelyn brings years of experience in manufacturing and distributing orphan drugs to over 50 countries globally.
Evelyn specializes in the management of supply via virtual, outsourced models and has been named as both a QP and RP on multiple licenses. She has also held various supply chain leadership positions in Shire, NPS Pharma and PTC Therapeutics and has designed and ran successful supply chains for different products.
Evelyn is also experienced in facilitating cross-functional strategic entity decisions, selection of vendors, and corporate activities. Evelyn founded Orphan Drug Consulting in 2017, with the vision of supporting organisations across keys areas such as Supply Chain, Quality Assurance, Technical Operations, Customs/VAT and Artwork.
Evelyn holds a Master of Pharmacy from Robert Gordon University and a Master of Business from the Irish Management Institute, as well as being an Adjunct Professor for the Trinity College Dublin School of Pharmacy. -
Jason Cameron
Jason Cameron is Chief Operating Officer for Orphan Drug Consulting with over 25 years’ experience in the pharmaceutical industry working across supply chain, distribution, manufacturing, and broader technical operations, with a particular focus on rare disease companies. Leading operational areas for multiple commercial product launches and global market expansions.
A core member of the Orphan Drug Consulting management team, Jason drives cross-functional excellence to support clients in an increasingly complex industry. Jason has held various senior leadership positions in companies such as Genzyme, Synageva and Amicus Therapeutics, where he most recently was Senior Vice President of Global Technical Operations with responsibility for overseeing product supply (CMC RA, process development, manufacturing, quality and supply chain functions) for Amicus’ first commercially launched product while also progressing process development and clinical product supply of the company’s clinical pipeline.
Jason gained his degree in Supply Chain via the Chartered Institute of Procurement & Supply. -
Mike Gannon BComm, FCA
Mike is the Chief Financial Officer with over 25 years of experience working in and supporting international organizations. Mike specializes in helping organizations grow and develop internationally as well as advising on optimum structures for finance, tax, treasury and business administration and support functions. Mike has held various leadership positions in finance and compliance functions including close to 10 years in UDG Healthcare plc, gaining significant experience supporting life science businesses achieve their growth and development strategies. Mike joined Orphan Drug Consulting as a consultant in 2020.
Having trained at Coopers & Lybrand (now PwC), Mike is a qualified Chartered Accountant (FCA) and holds a Bachelor of Commerce degree from the National University of Ireland in Galway. Mike also has a Diploma in Professional Accounting (DPA) from University College Dublin and has completed the Standford Executive Program in Stanford Graduate School of Business. -
Rob Grealis FCCA, FlnstLM
Rob is Company Secretary for Orphan Drug Consulting and has over 28 years’ senior management experience in multiple industries. Prior to joining, he has worked as a CEO and CFO in biopharma engineering services, professional services, market intelligence, distribution and SaaS businesses globally.
Rob has extensive experience in strategic and business planning, enterprise development, operations management, export development, financial planning and control, HR management, corporate governance, consultancy and advisory services in over 30 countries globally. Rob maintains the crucial links between our clients and our consulting team at Orphan Drug Consulting, ensuring the business operates efficiently and in accordance with good governance and best practice.
A business graduate from Galway-Mayo Institute of Technology, he is also a Fellow of the Association of Chartered Certified Accountants and the Institute of Leadership and Management. Rob also holds the position of Chairman of a Local Government Audit & Risk Committee in Ireland. -
Sharon Cullen MSc
Sharon Cullen is Head of Quality for Orphan Drug Consulting, she has extensive experience in senior leadership roles in the Life Science industry with a focus on the Pharmaceutical Quality System (PQS) including auditing, regulatory inspections, lean and continuous improvement, compliance, quality excellence, training, management review, CMO oversight, quality data integrity, analytics and enabling technologies, affiliate quality oversight, and global quality operations including QP responsibilities, QC laboratory and packaging.
Sharon is a core member of the Orphan Drug Consulting management team and brings applicable experience across quality management. Sharon has been an active EU Qualified Person (QP) for over 25 years. She has led multiple audits and regulatory inspections globally and has experience auditing across GCP, GVP, GMP, GDP, partners, suppliers, and service providers. Prior to joining the team, Sharon has held leadership roles in Organon, Merck, LEO Pharma and most recently was the Executive Director Quality and Commercial Operations in Jazz Pharmaceuticals where she built the Quality team, achieved licence approvals to support the rapidly growing business, facilitated supply chain activities to launch products globally and implemented various enabling technology platforms.
Sharon is focused on leading teams to develop quality systems that ensure regulatory compliance, product efficacy and patient safety from a pragmatic business driven perspective.
Sharon holds a Master of Science degree in Pharmaceutical Manufacturing Technology from Trinity College Dublin (TCD) and another in Organisation Behavioural Science from Dublin City University (DCU). She also holds an MBA from Open University in Buckinghamshire. -
Frances Pierce MSc
Frances Pierce is Head of Supply Chain with over 18 years of experience working in the pharmaceutical industry, having held roles in supply chain management, logistics and project management. Frances is a leading expert in Supply Chain with a proven ability to deliver results through her significant technical expertise coupled to her project management, and client relationship management abilities.
Working with Orphan Drug Consulting, Frances specialises in supply chain leadership, vendor management, project management and country specific product launches and routes to market for clients in multiple regions. Prior to joining the team, Frances worked in a wide range of companies within the pharmaceutical industry and most recently held the position of Global Trade and Customs Director in Mylan Pharmaceuticals.
Frances holds a Master of Science in Supply Chain Management from Technological University Dublin and is Prince 2 Certified Practitioner. -
David Crowley MPharm, MPSI, MSc
David’s role as Head of Client Delivery involves identifying where the Orphan Drug Consulting team can add the most value to clients and he fosters and builds this relationship from the outset. David works with clients to provide technical project planning and the provision of technical expertise in the scoping and programming of requirements to ensure operational success, as well as providing ongoing account and project management.
Prior to joining, David worked in a commercial capacity for a process research and development company where he led multiple projects across marketing, sales, and sales operations, in both Europe and the United States. He has also been involved in providing marketing solutions for the global electronics and animal nutrition industries, as well as a leading academic institution.
David is a registered pharmacist with the Pharmaceutical Society of Ireland and he formerly practiced in a community pharmacy prior to moving into a commercial role in the pharmaceutical industry. David carried out his undergraduate degree in Pharmacy at University College Cork (UCC) and holds a Master of Pharmacy from the Royal College of Surgeons in Ireland (RCSI) along with a Master of Science in Marketing Practice from the UCD Michael Smurfit Graduate Business School in Dublin. -
Grainne Higgins BSocSc, MSc, CPC
Grainne is an HR Consultant and Executive Coach with over 30 years’ experience in the global healthcare industry. She specializes in working across many facets of talent and organizational development for pharmaceutical and biotech companies to create and execute their people and organization strategy directly supporting their business goals. Prior to becoming a consultant and executive coach, Grainne most recently held the position of Vice President, Human Resources, Global Commercial Operations of Alexion, based out of Switzerland. Grainne also has an established leadership track record in Shire and Merck & Co. (formerly Schering-Plough) and has lived and worked extensively in Ireland, US, Switzerland and The Netherlands.
Grainne holds a Master of Science in Organizational Behaviour from Trinity College Dublin and a Bachelor of Social Science from University College Dublin. Grainne is a Certified Professional Coach, accredited with iPEC (The Institute of Professional Excellence in Coaching), as well as an Energy Leadership Index Master practitioner and a COR.E Dynamics Leadership Specialist. -
David Downey
David acts as a Consultant/Advisor for Orphan Drug Consulting having spent more than 25 years in the Contract Development and Manufacturing Services (CDMO) space. David specializes in helping organizations maximize their value by using his sales/marketing and client/product management knowledge gained through previous roles.
David has held various senior management/executive roles with Quintiles (IQVIA), Patheon (Thermo), Almac, and APC. David built international client teams with these companies in Project Management, Technology Transfer, Client Management and Business Development/Marketing, having led development, commercial product transfer, capital, and acquisition/build projects, cementing relationships with many pharma and biotech companies. Most recently David has been advising Private Equity on investment/acquisition opportunities in the CDMO and contract services space alongside conducting commercial and end to end due diligence.
David is a biologist and studied at the University of London and University of Reading. He has also completed various postgraduate executive leadership programs, most recently at University College Dublin Michael Smurfit Graduate Business School. -
William McConkey MEng, MBA
William is a Supply Chain Consultant with over 25 years of experience in the biopharmaceutical industry, focused on designing and optimising supply chains at both a site and global level working with companies including Regeneron, Allergan, Shire and Novartis. William specializes in global planning and distribution strategy, materials management, global supply management, project management, team leadership, warehousing and logistics. He has delivered global planning, product launch and distribution solutions for both small and large companies.
William holds master’s degrees in engineering (MEng) and business administration (MBA), along with a postgraduate qualification in organizational leadership from the Irish Management Institute. -
Donna McKenna BSc
Donna is a Quality Consultant based in Northern Ireland with over 20 years of experience in the pharmaceutical industry ranging from Drug Substances to Finished Drug Products across multiple dosage forms including non-sterile, sterile and biological products. She has been an active EU Qualified Person (QP) for over 10 years and is currently named as a QP on several Manufacturing Authorisations in Ireland and the UK. Donna is also eligible to act as a Responsible Person (RP).
She is experienced in GxP legislation in Europe, the USA, South America, and Asia and specializes in GMP and GDP Quality System Management, Regulatory Inspection Readiness, Auditing, and Training with a specialist area of interest in new product introduction and product launches. Donna spent much of her earlier career working for Almac Group as a Senior Manager and QP supporting the release of clinical and commercial products.
Donna has a Bachelor of Science Degree from the University of Ulster and underwent QP training at NSF Health Sciences in the UK. -
Eamonn Flood BComm
Eamonn is a Customs and Import VAT Consultant with over 30 years of experience in Customs and Trade and extensive expertise in all aspects of international customs and import VAT matters. Eamonn has significant experience in EU customs duty compliance and optimization projects.
Eamonn has extensive experience working with pharmaceutical MNCs and Orphan Drugs. He works closely with clients in re-structuring projects advising them on their EU Customs Duty and Import VAT requirements together with project managing these transitions. Eamonn also works and manages all external stakeholders in the client supply chain to ensure smooth customs clearance, in particular for temperature-controlled goods.
Eamonn holds a Bachelor of Commerce degree and was formerly the Director of the International Trade & Customs practice in PricewaterhouseCoopers (PwC). -
Celine McKenna MBS
Celine is a Supply Chain Consultant with over 25 years of experience in the global pharmaceutical, healthcare, and medical device industries. Celine has held various supply chain leadership positions in companies such as Aspen Pharma Group, Gilead Sciences, and Allergan Pharmaceuticals.
Celine specializes in global supply chain strategy and processes, focused specifically on global product availability for existing and new launch setups. She also has significant experience in vendor management, forecast and demand management as well as distribution and logistics across a wide range of manufacturing organizations. Celine has a proven record of delivering results through her expertise and cross-functional project/communication management.
Celine holds a Master of Business from University College Cork with a focus on risk management in the pharmaceutical industry and she also holds postgraduate qualifications in strategy, innovation, and business finance. Celine is also a qualified RP. -
Christy Webb BSc
Christy is a Quality Assurance Consultant based in North Carolina and brings over 26 years of Quality Assurance (QA) industry experience. Prior to becoming a consultant, Christy most recently held the position of Snr. Director, Quality Assurance in Synageva BioPharma and previously held senior positions in companies including Novartis, Biolex and Salix Pharmaceuticals. Christy’s subject matter expertise extends over both API and Drug Product, commercial and Investigational Medicinal Product (IMP). Her extensive experience includes supporting multiple formulations (sterile, solid oral dose, vaccines, DEA controlled substances etc.) with her wide-ranging QA oversight of GMP storage, manufacturing, testing, packaging, labelling, disposition, and distribution.
Christy has a Bachelor of Science in Biology from Campbell University in North Carolina and has completed coursework as part of a Master of Science in Clinical Research. -
Kevin Lyons MPharm, MPSI
Kevin has over 20 years of experience working in the pharmaceutical industry through his role as a registered pharmacist. As Senior Quality Assurance Manager, Kevin brings a unique insight arising from his time working in patient-facing roles as well as his experience and training in GDP and GMP. He has experience throughout the product supply chain from working with product owners right through to end-users.
A core member of the Quality Assurance team, Kevin helps clients to achieve and maintain compliance with both local and international legislation through building robust quality management systems (QMS) tailored to their specific needs as well as support in the preparation and acquisition of appropriate quality licenses such as a WDA. Kevin also acts as a Responsible Person/Deputy Responsible Person on behalf of clients. He is experienced in GxP legislation with a keen interest in New Product Introduction and Product Launches across Europe including in France, the Nordics, and across the CEE region. Kevin also conducts audits including remote/desktop audits across both EU and non-EU countries.
Kevin holds a Master of Pharmacy from Robert Gordon University as well as further training in GDP, GMP, and Lean Six Sigma and is a registered pharmacist with the Pharmaceutical Society of Ireland. -
Anne Farrell BSc, CLSSGB
Anne is a Quality Consultant with over 30 years’ experience in the pharmaceutical industry and an extensive track record in Bristol Myers Squibb. Anne specializes in quality systems implementation and control, documentation review, batch release, stability monitoring, GMP compliance, auditing, validation, packaging, labelling, serialization, transport qualification, quality metrics, continuous improvement having delivered these projects to global pharmaceutical companies. Anne has also participated in numerous competent authority audits.
Anne holds a degree in Chemistry from Dublin Institute of Technology along with a postgraduate qualification in Lean Manufacturing and Quality Systems and is a certified Lean Sigma Green Belt. -
Elaine Corry
Elaine Corry is Office Administrator for Orphan Drug Consulting and is an integral part of the team responsible for the maintaining the operations of the company.
Elaine’s career has involved multiple roles across finance, banking and IT in both Dublin and London, working with high-level executives and operations teams to ensure the smooth running of daily activities such as inbound and outbound invoice processing and vendor/supplier management. Prior to joining Orphan Drug Consulting, Elaine most recently was Office Administrator for a financial technology company’s EMEA headquarters based in Dublin and before this held roles in an event management organization and technology company. -
Katie Martin BSc
Katie Martin joined Orphan Drug Consulting as a Marketing Associate and is a key member of the Business Development Function, with a direct focus on Orphan Drug Consulting’s brand and market presence. Katie is responsible for the day-to-day implementation of the company’s marketing strategy, with a focus on digital activities and event organization.
Prior to joining Orphan Drug Consulting, Katie worked in the pharmaceutical industry for an international contract organization that specializes in commercial packaging and clinical services where she supported multiple projects and events globally while keeping the company’s overall strategy at the forefront of all decisions. Katie has also previously supported local entrepreneurial business owners in achieving increased visibility and sales in customer-focused markets.
Katie holds a Bachelor of Science in Marketing from Technological University Dublin (TUD), where she studied a wide range of complex issues impacting global corporations’ strategies and their operations. -
Leah Hall
Leah Hall is an Executive Assistant for Orphan Drug Consulting, with a key focus on supporting the company's operations.
Leah has worked in multiple global roles across the health and transportation industry. Leah’s experience brought her to the Middle East for 10 years prior to joining Orphan Drug Consulting. Leah worked in various managerial roles in clinical settings, focusing on rare diseases. She was manager of an Ophthalmic Clinic where she specialized in refractive surgery and intraocular lens and most recently held a managerial position in the clinical department of the Royal Victoria Eye and Ear Hospital, where she specialized in rare retinal genetic diseases.
Leah holds an NFQ level 7 in Dental Nursing from Trinity College Dublin. -
Nicola Martone MSc
Nicola is a Senior Quality Consultant based in The Netherlands with over 30 years of extensive experience in the pharmaceutical industry dealing with the manufacturing of APIs and Finished Dosage Forms, including Sterile and biological products. He is an EU Qualified Person since 2004.
Nicola has expertise in Quality Systems Management, including but not limited to Audit Readiness (FDA, EMA, Local Health Authorities, Customers), Sterility Manufacturing, GMP Compliance assessment, and a solid background in Analytical Chemistry.
Prior to joining Orphan Drug Consulting, Nicola has held key quality management and/or QP roles in several companies across Europe such as Pfizer, Sandoz (Novartis Company), Centrient (formerly DSM Sinochem Pharmaceuticals), and most recently he held the position of QA project lead in Johnson & Johnson. He has contributed to the design, implementation, and maintenance of effective pharmaceutical quality systems and executed multiple internal and supplier audits focused on GMP, GDP, and Regulatory compliance. Nicola holds a Masters's Degree in Chemistry from “Federico II” University in Naples, Italy. -
Raj Dhandwar MA
Raj Dhandwar is a Project Manager for Orphan Drug Consulting with over 15 years of experience in supply chain with a specialty in project management. Raj has applicable experience in forecast management and end-to-end Supply and Demand process, S&OP implementation, and development.
Prior to joining Orphan Drug Consulting, Raj held multiple supply chain roles, where she ran a number of inventory management projects developing their tools and processes. She most recently held the position of Supply Chain Manager in Amicus Therapeutics, Raj implemented the Global S&OP process and oversaw the global launch planning of their first commercial orphan drug and their biologic pipeline.
Raj holds a Master of Arts in Graphic Design from the University of Coventry. -
Martina White BSc, MPSI, PhD
Martina is a Quality Consultant with over 13 years of experience in the pharmaceutical industry working across multiple areas of quality assurance. Martina has expertise in Quality, Qualification, and Validation and is an experienced Qualified Person. Martina has also held roles in manufacturing development where she led technology transfer projects and coordinated the supply of investigational medicinal products. Martina has experience with commercial product launches from a quality and validation perspective and has supported regulatory inspections across all her previous roles.
Prior to joining Orphan Drug Consulting, Martina held various roles across LEO Pharma. Most recently she led a team responsible for the QA oversight of all validation and qualification activities and GMP projects across multiple manufacturing sites.
Martina is a registered pharmacist and has a Ph.D. from the School of Pharmacy at Trinity College Dublin. -
David McGovern
David is a Supply Chain professional with over 12 years of experience, with a specialty in Global External Manufacturing and 3PL distribution.
Prior to joining Orphan Drug Consulting, David held supply chain roles in Viatris (formerly Mylan) as a supply planner, David was an integral part of the setup of Vitalis’s EMEA HUB in Dublin. He has also held supply chain roles with MARS Foods and GSK as well as purchasing roles with Tesco and Microsoft.
Most recently David held the position of Senior Manager, External Manufacturing in Bausch & Lomb (formerly Bausch Health). He was responsible for a portfolio of over 80 external manufacturers who supplied a range of products globally to Bausch Regional Hubs and & 3rd Party Distributors. Products varied from OTC eye supplements, medical devices, oral solid dose, and capsule pharmaceutical treatments as well as lifesaving anaphylaxis injector pens. David managed a team of 8 supply chain professionals. He was responsible for all supply chain activities including but not limited to, Product Launches, Tech Transfers, Contract negotiations, EMO rationalization, etc. -
Anne Capplis BSc
Anne Capplis is the Lead Consultant for Australia, New Zealand, and APAC with over 35 years of experience in the pharmaceutical industry working across quality, supply chain, distribution, manufacturing, and company leadership teams. Anne brings considerable global experience across Australia, New Zealand, Asia, LATAM, Turkey, and Japan in all aspects of quality with a specialty in Product Security including start-ups and mid to large multinational pharmaceutical companies across medical devices, pharmaceuticals, and biotechnology.
Anne has broad extensive experience in senior leadership roles in the Life Science industry with a focus on Quality, Customer Operations, and Supply Chain. Prior to joining Orphan Drug Consulting, Anne held leadership roles in Johnson & Johnson Medical/Janssen-Cilag, AiMedics, Shire, and most recently was the Senior Director Quality International South Cluster Lead and Product Security at Alexion Pharmaceuticals Australia where she held a global role helping to build the commercial quality teams across the globe.
Anne holds a Bachelor of Science degree in Microbiology from the Institute (University) of Technology (UTS) Sydney and a Diploma in Education (Science) from the Australian Catholic University in Secondary Science – Biology and Chemistry.
Our Team
Evelyn Kelly MPharm, MPSI, MBS
Chief Executive Officer and Founder
Jason Cameron
Chief Operating Officer
Mike Gannon BComm, FCA
Chief Financial Officer
Rob Grealis FCCA, FlnstLM
Company Secretary
Sharon Cullen MSc
Head of Quality
Frances Pierce MSc
Head of Supply Chain
David Crowley MPharm, MPSI, MSc
Head of Client Delivery
Grainne Higgins BSocSc, MSc, CPC
HR Consultant & Executive Coach
David Downey
Corporate Consultant & Advisor
William McConkey MEng, MBA
Supply Chain Consultant
Donna McKenna BSc
Quality Assurance Consultant
Eamonn Flood BComm
Customs & Import VAT Consultant
Celine McKenna MBS
Supply Chain Consultant
Christy Webb BSc
Quality Assurance Consultant
Kevin Lyons MPharm, MPSI
Lead GDP Consultant
Anne Farrell BSc, CLSSGB
Quality Assurance Consultant
Elaine Corry
Office Administrator
Katie Martin BSc
Senior Marketing Associate
Leah Hall
Executive Assistant
Nicola Martone MSc
Senior Quality Assurance Consultant
Raj Dhandwar MA
Project Manager
Martina White BSc, MPSI, PhD
Quality Assurance Consultant
David McGovern
Supply Chain Consultant
Anne Capplis BSc
Lead Consultant, APAC
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