Evelyn Kelly MPharm, MPSI, MBS
Chief Executive Officer and Founder
Evelyn has over 15 years 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.
Chief Operating Officer
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.
Rob Grealis FCCA, FlnstLM
Chief Financial Officer
Rob is Chief Financial Officer 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
Head of Quality
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.
David Crowley MPharm, MPSI, MSc
Business Development and Technical Manager
David’s role as Business Development and Technical Manager, leading the Business Development function, includes technical project planning and the provision of technical expertise in the scoping and programming of Client requirements.
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.
Frances Pierce MSc
Supply Chain Consultant
Frances Pierce is a Supply Chain Consultant with over 18 years’ 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.
William McConkey MEng, MBA
Supply Chain Consultant
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
Quality Assurance Consultant
Donna McKenna is a Quality Consultant with over 18 years’ experience in the pharmaceutical sector ranging from Drug Substance to Drug Product across multiple product types, including non-sterile, sterile and gene therapy. She has been an active EU Qualified Person (QP) for over 8 years and is eligible to act as a Responsible Person (RP). She is experienced in GxP legislation in Europe, USA, South America and Asia with a specialist area of interest in new product introduction and product launches. Donna spent much of her career working for Almac Group as a QP supporting release of clinical products as well as the commercial launch of multiple orphan and niche drug products.
Donna holds an honours degree in Biological Sciences from University of Ulster and obtained her QP training from NSF Health Sciences. She is currently named as a QP on several Manufacturing Authorisations in Ireland and the UK.
Eamonn Flood BComm
Customs & Import VAT Consultant
Eamonn is a Customs and Import VAT Consultant with over 25 years’ 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 with expertise in the multinational pharmaceutical sector. 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 holds a Bachelor of Commerce degree and was formerly the Director of the International Trade & Customs practice in PricewaterhouseCoopers (PwC).
Mike Gannon BComm, FCA
Financial & Entity Planning Consultant
Mike is a Finance Consultant 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.
Grainne Higgins BSocSc, MSc, CPC
HR Consultant & Executive Coach
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.
Tanya Quinn BSc, MBA
Supply Chain Consultant
Tanya is a Supply Chain Consultant based in the New York/New Jersey-Metro area with over 20 years industry experience working as both a consultant and in senior leadership positions. Prior to becoming a consultant, Tanya held senior global roles in organizations including The Medicines Company where she was the Vice President for Global Distribution and Customer Service, and Reliant Pharmaceuticals as Director of Supply Chain Management.
Coupling a strong supply chain industry background with consulting client management, Tanya has a wealth of experience in getting medicines to market, both in the US and internationally, having expertise in global product launch management, sales and operations planning implementation, strategic inventory review and right-sizing, vendor management enhancement, contract negotiations, and customer distribution solutions.
Tanya holds both an MBA from Fairleigh Dickinson University and a BSc in Finance from Ithaca College.
Celine McKenna MBS
Supply Chain Consultant
Celine McKenna is a Supply Chain Consultant with over 15 years’ experience in the pharmaceutical, healthcare and medical devices industries holding senior positions in companies such as Aspen Pharma Group, Gilead Sciences and Allergan Pharmaceuticals. Celine specializes in global supply chain strategy and processes, existing and new market setup focused on global product availability. She also has significant experience in vendor management, forecasting and demand management, distribution and logistics across a wide range of manufacturing organizations.
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.
Patrick Sabourin MSc
Quality Assurance Consultant
Patrick is a Quality Assurance Consultant based in North Carolina and brings over 40 years of Quality Assurance (QA) and GMP Compliance practical and international industry experience (North America, Europe, Asia). Prior to becoming a consultant, Patrick most recently held the position of Head of Quality in BioDelivery Sciences International and previously held senior positions in companies including Novartis, Sanofi and consulted for most of the largest Pharmaceutical Companies.
Patrick’s subject matter expertise extends over both API and Drug Product, commercial and Investigational Medicinal Product (IMP). His extensive experience includes supporting multiple formulations (sterile, solid oral dose, vaccines, blood products, monoclonal antibodies, cell culture / virus expression and DEA controlled substances) with a wide-ranging QA oversight of GMP storage, manufacturing (especially aseptic processing and lyophilization), testing, packaging, labelling, disposition, and distribution.
Patrick has a Bachelor of Science in Pharmaceutical Technology, and one in Industrial Biology as well as a Master of Science in Industrial Biology from the Conservatoire National des Arts et Metiers in Paris, France.
Kristine Woessner MSChE
Supply Chain Consultant
Kristine Woessner is a Supply Chain Consultant with over 18 years’ experience in the pharmaceutical industry, having roles in formulations development, clinical manufacturing, and clinical supplies management. She specializes in supply chain/drug logistics and managing various CMO’s within the supply chain (API, DP, packaging and labelling).
Kristine has worked extensively in managing global clinical trials supplies for Elan Pharmaceuticals and as a consultant for multiple clients and products. She is experienced in initiating and planning new studies (clinical, ISTs, EAPs), forecasting, managing packaging and labelling CMO’s, overseeing distribution and logistics, and setting up supply chain systems and processes.
Kristine received her Bachelor of Science in Chemical Engineering from the University of Iowa in the United States before going on to complete her master’s in Chemical Engineering at San Jose State University.
Christy Webb BSc
Quality Assurance Consultant
Christy is a Quality Assurance Consultant based in North Carolina and brings over 24 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
Senior Quality Assurance Manager
Kevin has over 15 years’ 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 supporting in the preparation and acquisition of appropriate quality licenses such as a WDA. Kevin is also eligible to act as a Responsible Person/Deputy Responsible Person on behalf of clients.
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
Quality Assurance Consultant
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 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.
Lorraine McGuinness MSc
Project Management Associate
Lorraine’s role as Project Management Associate focuses on supporting the ongoing business requirements of Orphan Drug Consulting through the provision of project management support to existing and future clients. Lorraine works closely with the Business Development team, as well as both Consulting and Management teams to successfully facilitate the delivery of client expectations.
Prior to joining, Lorraine worked in the medical supplies industry for a company that provides products and services to the non-acute Irish healthcare market, where she supported in different capacities retail, logistics and technical teams. Lorraine also has experience in a multinational beverage manufacturing plant, where she was part of the sensory QA team that supported the business units and bottling operations by performing various testing of raw materials, packaging, and manufactured goods to ensure GLP and GMP standards were met.
Lorraine holds a Bachelor of Science in Bioscience from the University of Limerick (UL) and a MSc in Business and Biotechnology from UCD Michael Smurfit School of Business.