Phil Beccue applies best-practice approaches based on decision analysis to strategy creation, portfolio optimization, asset valuation, and risk management in the bio-pharmaceutical industry. As leader of the Strategy and Portfolio Management function at Baxter BioScience, Phil designed and implemented a global R&D portfolio management process. Phil also led the Decision Sciences group at Amgen and played a key role in institutionalizing decision analytic processes throughout the organization. 

Dave Clark has over 40 years of experience in product development and lifecycle management, with expertise in viral vaccines and monoclonal antibodies. He has held positions of increasing responsibility across a range of areas including Product Development, Process Development, Quality Control, CMC, Technology Transfer and Technical Services for pilot plant operations, clinical supply units, and full commercial manufacturing. Prior to joining Primecore, Dave served as the VP of Technical Services for AstraZeneca, where he worked with R&D to develop and license four new, novel monoclonal antibodies. He also previously held leadership roles at Johnson & Johnson and Wyeth Vaccines. Dave has been a panel member with the NIH and has co-authored several publications.

Claire Comerford is an Operations Leader with over 30 years’ experience of site operations with a global multinational company in the Pharmaceutical and Biotech industry with a proven track record of delivering results and building capable teams. Her expertise spans plant start up, technical transfer, operations, compliance, planning and program management. Experienced in a network role, Claire has been responsible for the successful deployment of transformational programs at a number of sites, delivering sustainable improvement through the adoption of new ways of working and embedding a continuous improvement culture. Claire is an excellent communicator and relationship builder with a collaborative inclusive approach and a talent for managing change. 

Eileen Counihan is a Pharmaceutical Compliance professional with over 34 years of experience previously working for Merck Sharp and Dohme (MSD) in various leadership positions of Quality Assurance Management, Site Quality Director and as Regional Compliance Director for EMEA.

For the last seven years, she’s had extensive experience as a consultant leading quality improvement projects, due diligence, GMP assessments and audits, at manufacturing sites worldwide, to ensure organizational fitness, inspection readiness and improved quality management systems (including Laboratory controls, testing, and instrumentation management). She has deep knowledge of EU and FDA cGMP requirements, interpretation and application as well as current industry practice. 

Brad Crisel has 25 years of experience in the pharmaceutical industry with significant experience leading capital programs, process engineering and manufacturing. Before joining Primecore, Brad was the Global Capital Program leader for plasma manufacturing at Takeda where he led a multi-site capital program that significantly increased the capacity of Takeda’s primary plasma products. Brad’s experience at Takeda also included comprehensive program leadership for a $450 MM manufacturing building at a greenfield facility. He has also held leadership positions in capital projects, process engineering and manufacturing at Eli Lilly and Grifols (formerly Talecris). 

Elizabeth Dunne leads the finance operations for Primecore. In this role Elizabeth has responsibility for our key performance indicators (KPIs), procurement, accounts payable, and for the generation of the Quarterly Financial Accounts. She is the key customer contact for our financial services and is a qualified bookkeeper and payroll technician.

Martin Felgenhauer leads CMC programs with an expertise in manufacturing strategy, tech transfers and product life cycle management. He previously was a Senior Director at Baxter and Baxalta and has over 25 years of experience. Martin has a strong background in engineering, process development, project, and program management. He was project director for a vaccine plant in the Czech Republic, a recombinant plant in Singapore and several smaller projects in Austria, Switzerland, and U.S. He led technology transfers to CMOs and to licencing partners in Japan and Brazil. He also led CMC teams for market introduction of Baxter’s pipeline portfolio. 

Colette Hawkins has over 20 years of experience in financial and operational roles within tech and pharma companies, including Hewlett Packard and Puritan Bennet. Colette brings a strong business and financial background in operations, customer services and finance in high-tech multinational environment. She has highly developed skills in team and change management as well as data analytics and project cost controls. Colette has held management roles within manufacturing operations environments as well as IT technical support teams. As a Senior Partner with Primecore, Colette has supported companies with the development of their Operational Finance, Capital Reporting and Portfolio management and has built a team to provide core monthly reporting services to clients.

Roy Johnston brings over 25 years of multinational pharmaceutical experience with Merck/MSD during which he held leadership roles in a variety of functions including automation, safety and security, warehousing and logistics. He is an accomplished and influential Senior Logistics Professional with extensive operations and compliance leadership experience on multiple sites across EMEA. His expertise spans greenfield site start-up; controlling a multi-site/multi-million Euro budget; post-merger integration of legacy operations to global organizational standards. Roy is a commercially minded professional with experience in driving strategy, leading high value change projects in both dynamic and challenging economic environments. He is an excellent communicator with exceptional leadership and relationship skills.

Helen Kelleher is a highly experienced Program and Project Manager with over 25 years’ experience, who brings strong technical and people management capabilities to bear in her leadership of all aspects of capital programs. Helen is an excellent communicator and team leader with experience across a variety of Pharmaceutical areas and other high-tech industries, and who has operated in the both the roles of owner and consultant Program or Project Manager. 

Dara Kernan is an experienced Program Manager with over 20 years of experience managing large Bio-pharmaceutical projects on behalf of established companies such as Bristol Myers Squibb, Warner Lambert and Wyeth. Dara’s approach to Program Management is business focused and inclusive of the wider project stakeholder team. He promotes the execution of programs in a structured and phased manner – placing emphasis on the importance of early program phase development. In addition to executing large capital projects on behalf of client companies, Dara has also spent a number of years executing pharmaceutical projects on behalf of engineering and construction management firms. In more recent years Dara has provided consultant support to companies seeking to execute large capital programs in line with current program management ‘best practices’. 

Sergey Kutyev is a PMP Certified Project Manager with experience leading teams, negotiating terms, developing and managing project documentation, schedules, budgets, and costs. He is focused on keeping projects to their timeline following Lean Six Sigma principles and using the full suite of software products to track progress. Sergey has a background in a multi-disciplined international environment with projects up to $250 million and a proven aptitude for maximizing safety, delivering results, and reducing costs in both urgent and long-term projects. He has held different roles during his career and collaborated with internal and external stakeholders, including senior leadership, finance, IT, legal, procurement, sales, and different End User Groups.

Antoinette McTigue’s strengths lie in combining an entrepreneurial and innovative spirit to drive multifunctional projects, with a talent for troubleshooting difficult business issues to overcome obstacles and achieve business results. She has extensive management experience in the pharmaceutical, biotech, and cell and gene therapy industries. Since joining Primecore, Antoinette has supported many companies struggling to capture their business needs up front and to charter programs to deliver these needs effectively. Much of this work was done through the development and emphasis on defining a comprehensive set of End User Requirements for her clients. This approach has proven valuable by ensuring all necessary requirements are understood, communicated, and documented early in the process, which in turn leads to more effective program design and execution. Prior to joining Primecore, Antoinette was the company director and a leading member of a management buyout team for ANSAMed Ltd.

Jay Modha has 25 years of experience in cross-functional senior R&D and CMC roles.  He has worked with numerous biotech companies, adopting a Quality by Design (QbD) approach to develop, scale-up, transfer and qualify bioprocesses for GMP production of conventional biologics and cell and gene therapy products (ATMPs). He has an excellent understanding of the technical, quality and regulatory issues around process, analytics and product development, specification and control.  His CMC knowledge and experience enable him to overcome technical hurdles and to develop phase-appropriate and pragmatic approaches to satisfy the regulatory requirements. 

Kishor Modha has directed and managed biotherapeutic programs from early pre-clinical studies through clinical development. He has over 20 years’ drug life-cycle management experience, effectively translating strategic development plans into defined operational projects meeting with the ICH guidelines for approval in USA and the EU. He is adept at managing cross-function teams and leading technical discussions with operatives in analytics, process development, and cGMP manufacturing. He has worked with start-ups and SMEs developing biologics and therapeutics of diverse nature; peptides, complex glycoproteins, and more recently cell-based therapies. 

Ben Spink is a manufacturing and operations leader with experience in pharmaceutical, diagnostic and life science products at all stages of development from concept to commercialization. His expertise spans a wide range of areas including global strategic planning and execution; strategic partnerships; large scale operations; manufacturing systems, processes and best practices; future capacity planning and modeling; data visualization and data-driven decision analysis; continuous improvement; tech transfer; and regulated manufacturing. Prior to joining Primecore, Ben served as VP of Global Manufacturing and Quality Control at 10x Genomics. He also previously held leadership roles within operations and process development at Personalis, Shire, and Baxalta.

Maria Stynes coordinates all aspects of project cost controls for our clients including reporting, cost control, progress measurement, schedule development and schedule control. She monitors contractor’s execution and provides advice as necessary to make sure the Client’s project objectives are achieved. In this role, she typically issues weekly and monthly project reports, leads project review efforts, ensures accuracy of contractor provided data while monitoring cost and schedule implications of changes. Maria is a strategic thinker, highly organized with strong communicational skills and is excellent at building genuine relationships.

Michael Sweetman has over 25 years of experience in pharmaceuticals, including leadership roles in above-site supply chain management, CMO management, ERP implementation and capital projects. He led multiple global Value Chain Management Teams at Merck (MSD), and managed CMOs based in Europe, UK and U.S. for multiple franchises. He has also led business case analysis and risk assessments, as well as demand, supply and inventory planning.

Marian Walsh is a Program Manager with over 25 years of experience in the areas of Project Management, Project Controls, Cost Engineering, Scheduling, Risk Management, Estimating, Sub-Contracts Management, Validation Planning, IT/automation planning, and field engineering in the life sciences. Marian’s experience extends to bulk chemical, biopharmaceutical, sterile production facilities, cell & gene therapies and laboratory projects. Her international experience includes the UK, France, Spain, Switzerland, Germany, Ireland and Puerto Rico and has achieved excellent program outcomes working in different cultures and languages.

Joe Wardle has over 35 years of experience in process design, project management, capital programs and construction management. His experience includes design and construction of BDS, API and fill finish facilities including high speed cartridge filling, lyophilization, syringes and device and pen assembly. Joe has executed full project life cycle from concept to regulatory licensure through production ramp-up. He has also led tech transfers of biologics including the analytics.