MPharm, MPSI, MBS
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.
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.
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.
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.
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).
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.
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.
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.
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.
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.
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.
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.
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.
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 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.