Author: lucian

Adrian has graduated as a pharmacist at the University of Utrecht, The Netherlands. He is currently working as a Regulatory Affairs Consultant. Until March 2004 he has been Head of the Oncology Group within Global Regulatory Affairs at Bayer AG, Wuppertal, Germany, and Bayer Corporation, West Haven, CT, USA. Between 2001 and 2003 he was Director of Regulatory Affairs at Micromet AG, a biotech company in Munich, Germany. Prior to joining Micromet he has worked during four years as a Project Manager for Oncology Projects at the European Medicines Agency in London, United Kingdom. He joined the European Medicines Agency from Novartis AG, Basel, Switzerland, where he was Regulatory Affairs Project Manager in the Oncology group in 1996 and 1997. Before 1996 he was Head of Drug Regulatory Affairs for six years at Ciba-Geigy in the Netherlands, and has worked as Manager Regulatory Affairs at Glaxo, also in the Netherlands....

Armand Brevig is a senior procurement and supply chain leader who creates superior value through a powerful combination of: (1) business acumen; (2) consulting skills; (3) cross-functional team leadership; and (4) international experience. Armand is a hands-on problem solver with a pragmatic strategic approach. His leadership style is inclusive, yet decisive. He is a procurement professional who understands the wider business context, and therefore thinks like a business leader. He has leveraged his strategic sourcing and category management expertise to deliver transformative projects for companies such as AstraZeneca, Takeda Pharmaceuticals, Ipsen and Purdue Pharma L.P. Armand has also worked as a Global Director of Sales for an information industry company selling into the pharma sector....

Julianne has over 25 years’ clinical development experience and has held global leadership roles in vendor management/outsourcing and clinical operations for large and medium sized pharmaceutical companies (Pfizer, Wyeth, Marion Merrell Dow, Biogen Idec and Ipsen). She has been an accomplished manager and motivator of staff based in China, India, Japan, Europe and the US. At Wyeth, she developed, implemented and managed the key cross-functional governance body to drive successful delivery for inspection ready clinical trials. In 2003, she strategically developed and implemented unique, quality and cost effective clinical data management outsourcing methods, which helped establish the ground breaking Wyeth Accenture strategic alliance. In 2010, she had business and operational oversight of the Wyeth/Accenture alliance through Pfizer’s acquisition of Wyeth. She had critical roles at Wyeth, Biogen Idec and Ipsen to develop and implement effective service provider governance. She is an active member of the Drug Information Association, having been programme chair of the clinical forum in Paris in 2015 and receiving...

Marcus is an MBA-qualified quality assurance professional with extensive knowledge and 28 years of GLP/GCP expertise in quality management systems in the research, manufacturing and pharmacovigilance sectors of the pharmaceutical industry in Europe, Asia and the US. He has worked for contract research organisations and pharmaceutical companies and is often able to see issues and hence create solutions, from many angles. He is a Fellow of The Research Quality Association and has implemented 7 Quality Management Systems and audited many more. He has hosted more than 12 Department of Health inspections. He is regularly invited to present at international conferences, round tables, UK and French university postgraduate courses on GLP/GCP, validation of computer systems, quality assurance tools and risk-based-quality where his laconic style is much appreciated. He has hands-on laboratory experience in developing methods for cryopreserving cells and tissues in the US and the UK....

Cliff has 25 years’ experience in the Pharmaceutical Industry, initially as a clinical researcher in MSDRL and GlaxoWellcome, followed by terms as a Decision Scientist at GSK and as Director/team Leader in the Portfolio & Decision Analysis Group at Pfizer. He has experience helping project teams make development decisions, and guiding budget holders and governance in allocating their scare budget and resource across a portfolio of opportunities. Cliff is skilled at modelling business problems, both at a strategic and operational level. In 2011 he completed a MSc in Management Science at the University of Kent; his thesis was on R&D portfolio allocation modelling.  His doctorate was in the field of physiological psychology....

Duncan is a senior medical writer with 20 years’ experience in large pharmaceutical companies and contract research organisations with a record of achievement delivering a range of high quality regulatory documents within tight deadlines and budgets. Previous employers include H Lundbeck, Pfizer and Pharmaceutical Product Development. He previously worked in academic research as a clinical pharmacologist at Surrey University and Dundee University, UK. His key strengths include writing clinical study reports across all clinical phases that fulfil regulatory requirements. He has authored high-quality protocols that underpin clinical research projects; compiling safety narratives to report serious adverse events; assembling investigator brochures to supply study sites with high quality and up-to-date study drug information; and preparing advisory board reports that capture all key information obtained from healthcare professionals. He is the owner and Director of Maze House Medical Ltd. The company supplies quality medical writing to clients, specialising in regulatory medical writing, at the required speed and at a competitive price....

Brigitte has more than 20 years’ experience in global regulatory affairs with the biotechnology company Serono and the pharmaceutical company Merck Serono. Her expertise covers a broad range of therapeutic areas including metabolic endocrinology, dermatology, oncology and auto-immune/inflammatory diseases and orphan drug development. She has worked on new drugs, biotechnology product development and full marketing authorisation applications. She has also managed product life-cycles, including device Conformité Européene marking, in the European Union, Switzerland, Japan, Canada, Australia and the United States. She has had successful interactions with international health authorities for marketed products and development compounds. She has a strong scientific background and is able to bridge the gap between research and development. She is a lecturer for diploma courses at the University of Geneva and postgraduate courses at the Swiss Federal Institute of Technology in Zurich. She has created Happ-Consulting, which offers strategic and operational regulatory expert advice to small and medium-sized biotechnology, pharmaceutical and medical technology companies....

Rowan has years of experience working in many different scientific environments, both within the UK and internationally. Rowan is excellent at both working independently and as part of a team to achieve results. Most of his experience is in guiding and managing projects from start to completion as a subject matter expert, to achieve change. Rowan has experience in utilising Lean Six Sigma tools and methodology such as defining the project, designing the workflow, identifying measures (quality assurance and quality control) as well as implementing and identifying control points in order for the project to be continuously monitored to ensure compliance. Rowan has also worked in regulatory compliance within the pharmaceutical industry. This involved change management and identifying areas of improvement by working with stakeholders to define and agree plans for the assessment, update, and implementation of license updates in line with local regulatory requirements. Much of Rowans client support experience includes scientific and strategic consultation, publications planning, managing professional relations with...

Pauline has over 25 years’ experience in the pharmaceutical industry with roles in clinical research, project management and portfolio management. After managing drug development projects in several therapeutic areas and all phases of development, Pauline spent 7 years as a portfolio director responsible for the respiratory portfolio at GSK.  Moving back into project management to become the VP of Global Project Management she had a significant line management role as well as leading a major change initiative to define the practices and processes associated with the implementation of an enterprise project management system across R&D. She has a special interest in the critical role of people in delivering projects and has been consulting since 2012 within the life science sector but also worked in finance, IT and education, regularly running in house master classes on many aspects of project management. Pauline graduated in Nutrition at University of Surrey, has a PhD in Biochemical Nutrition from University of Cambridge and chairs the Pharmaceutical...

Julie is an enthusiastic and dynamic individual who embraces change and relishes new challenges; a dedicated champion for continuous improvement to drive performance and delivery to better meet the needs of the customer. She is an accomplished project/programme manager, both leading and delivering through others in the effective coordination and prioritisation of resources to facilitate both strategic and operational planning to achieve timely delivery against targets and deadlines. Julie is a confident external speaker, facilitator and perceptive communicator who cultivates excellent interpersonal relationships and actively encourages collaboration and commitment through the identification and development of supportive and effective solutions to mutual advantage. An analytically minded problem solver and mediator who takes an objective overview, combined with diplomacy and an empathetic approach and a genuine desire to help. Julie has 25 years’ experience working across the Pharma industry, from R&D to Operations, Commercial & Corporate IT. She graduated from Manchester Metropolitan University with a BSC in Applied Biological Sciences, followed by an MPhil...

Mark is a chemist with more than 20 years’ experience spanning the Chemicals & Pharmaceutical industries. A results oriented senior business leader who expertly brings people and processes together from across organisations to deliver sustainable business results. Consistently delivering results within the Pharma industry in senior roles with expertise in leading global, cross functional project teams within Drug Development. During 11 years with AstraZeneca, he held positions of increasing seniority in operations, procurement and R&D functions. With strong commercial and business relationship expertise, he has established and managed new supply chains with strategic CMO & CRO suppliers and transformed existing relationships with key suppliers, enabling a step change improvement in project delivery and delivery performance. Achievements include creating competitive advantage through the successful delivery of a strategically important $60 million project to outsource a key clinical delivery service, exceeding deal value expectation within challenging timelines and organisational change. As an Alliance and Integration Director, he played a key role in AstraZeneca’s drive to...

Jeff Duke has over 20 years’ pharmaceuticals industry experience in both human and veterinary health in a wide range of Chemistry, Manufacturing and Control functions. Prior to becoming an independent consultant, Jeff held positions with a top ten pharmaceutical company such as Executive Director European Analytical Research & Development, Head of Strategy & Implementation for Pharmaceutical Sciences Asia Business Development, Head of Global Material Science and Oral Products as well as Director, European Analytical R&D Full Development. Jeff was involved in bringing 6 NCE drugs to the market. As a consultant Jeff provides consultancy and interim management services in the following areas: CMC Strategy Development, Release testing strategies for drug products and API, Analytical method development, validation and inter laboratory method transfer, Integration of API & Drug Product strategies through development of Materials Science approaches. Supporting and optimising the R&D to manufacturing interface Change management within departments, particularly organisational and workflow design, upsizing, downsizing, continuous improvement initiatives and staff development, Selection...

John has extensive experience in the pharmaceutical industry gained over his years in the industry. This ranges from project management of new facility construction, facility, equipment and process validation, and staff training to operating manufacturing facilities and delivering quality compliance systems. He has managed steriles product development and formulation, manufacturing / business development, and spoken at conferences. He works in interim management, Quality Systems support, Good Manufacturing Practice (GMP) consulting, and compliance. His specialties include: GMP, Parenterals, Aseptic Manufacture, Terminal Sterilisation, Lyophilisation, Formulation Project Management, Business Development, conference speaker, Quality Systems, Interim Management and Consultancy, Training....

Fraser has led effective programme management, supply chain and continuous improvement delivery in small operating sites and large global organisations for 20+ years. He helps clients to accelerate and maximise their return on investment from business and organizational change, typically associated with the introduction of new processes, systems and ways of working. He has an inclusive, hands-on approach which draws out the best in others whilst generating engagement and buy-in at all levels in a company. Delivery skills include Workshop design and facilitation, End to end process capability mapping, metrics and measurement / Problem solving / risk identification and minimization / Project prioritization, initiation and management / Individual and team coaching and facilitation / Strategy definition and deployment / Culture and capability development / Lean manufacturing and change readiness assessment and Lean / supply chain awareness. Personal scorecard: 14 years supply chain programme and change management; 3 years supply strategy / design and new product introduction; 7 years manufacturing process design,...

Richard qualified in medicine at St Mary’s Hospital Medical School, now Imperial College in London. After several posts in the NHS, he joined Pfizer as a medical advisor responsible for rheumatology and infection. After obtaining an MBA from Kingston Business School, he set up the Outcomes Research Group at Pfizer. In 1999, he founded the Goffin Consultancy to provide evidence-based health economics and data review for the healthcare industry. His clients have ranged from start-ups to blue chip pharmaceutical companies as well as OTC companies, medical device companies and private equity houses wanting to review potential investment opportunities. He brings a wide background in clinical studies, economic analyses and meta-analyses following nearly 29 years in the pharmaceutical industry as well as wide experience in presenting clinical and health economic studies both in print, at symposia and for training purposes. He has worked with several companies in the health technology assessment, pricing and reimbursement and market access fields. He is the author...

Steve began his career as an R&D analytical development scientist. He continued his extensive career within the pharmaceutical R&D environment attaining the position of Director of Product Development for small molecules and was responsible for all CMC aspects of drug substance and drug product development, including authoring the quality sections of regulatory submissions. He moved on from the pharmaceutical industry to become a consultant offering CMC project management services and subject matter expertise in product development and analytical chemistry. Steve is adept at managing local, EU, global and Alliance CMC projects ensuring appropriate engagement with key stakeholders and cross functional representatives to achieve common objectives. He has broad technical and scientific reach, able to support all CMC activities from pre-clinical phase through to commercialisation. Steve has executed global & European in-house and outsourced drug development projects and product projects across drug delivery platforms ensuring technical success of oral solid dose (immediate and sustained release), transdermal, parenteral, and oral mucosal thin film products. www.linkedin.com/in/steve-whitelock...

Fraser has extensive knowledge of the pharmaceutical industry gained from 25+ years in senior leadership positions in Pharmaceutical Development, Manufacturing and Supply Chain in a top 10 Global pharma company. He has significant project management, line management and organizational development experience gained through leading global teams to introduce new products onto the market and optimize their manufacturing performance. Fraser’s principle expertise is in process development, scale-up, manufacturability, outsourcing and project leadership. He is a Fellow of the Royal Society of Chemistry and a SME business coach for European Commission Horizon Europe Programme. Fraser has undertaken due diligence assessments in support of early phase assets and manufacturing site acquisitions; provided project leadership for process development, scale up, supplier selection and outsourcing activities; developed CMC plans for early phase projects; supported the introduction of a new Project Operating Model for a medium sized pharma company; supported client transition from CRO to CDMO www.linkedin.com/in/fraserwkerr...

Bruce Williams is the Director and founder of Gatehouse Pharma Services Limited. Bruce is a team orientated, delivery focused Clinical Operations Expert (Project Management Institute Project Management Professional qualified) with 14+ years’ experience of relationship building and matrix team leadership in Clinical Development and IT project delivery. Most recently in a 30-year career in the Pharma Industry Bruce worked for Pfizer R&D UK Ltd as a Clinical Study team Lead in Oncology delivering a Multiple Myeloma Phase II Registration Study. Bruce has experience in a broad range of Therapeutic areas: Respiratory, Allergy, Gastrointestinal, Pain, Genitourinary, Oncology & Ophthalmology, across Phases I to IV as well as NCE, Generic and Biosimilar experience.. Specialties: Relationship Building, Clinical Project Management / Project and Portfolio Management – PMI PMP Qualified (Budget/Quality/Timeline/Risk Management), Matrix Team Leadership, Deep Knowledge of ICH-GCP, Yellow Belt CI, Business Process Mapping, Data Retrieval, Manipulation, Analysis, Visualization and Mining. At Mylan Pharma UK Ltd as a Director for Clinical Operations, Bruce was accountable...

After an early career in engineering Graham completed a higher degree in Operation Research and pursued a new path in the pharmaceutical industry applying decision science methods within the research, development and commercial areas. Now with 20 years experience Graham now supports pharmaceutical and biotech groups as well as the not-for-profit sector Graham has specialist skills in project and portfolio planning and strategy, forecasting, commercial analysis, valuation, licensing and acquisition, business case and funding proposal development. He has a demonstrated ability work across functions to build solutions to challenging business strategy questions and investment decisions in complex environments.  Graham has supported the growth and change of biotechs, commercial pharma groups and not-for-profit organizations Graham leads Phetairos’ Product Optimisation, Evaluation and Maximisation (POEM) practice and is a member of the Project and Portfolio Management practice. LinkedIn...

Preeya is a Director with 23 years’ experience across the pharmaceutical, CRO, chemical and tobacco industry. She has led regulatory projects across the entire product lifecycle in various therapeutic areas. Preeya has held roles at PAREXEL, GSK, Pfizer, JNJ, Ipsen, DOW Chemicals, BAT and worked with many other organisations as part of her client base and professional network. Preeya has extensive industry experience and insights to lead and support teams across regulatory and compliance functions. Preeya has undertaken many large strategic and operational projects to help organisations reach operational effectiveness and increase regulatory compliance. Some examples include: expansion of product regulatory strategy to include new EU countries in a centralised procedure registration, sustained improvement in lead times by 30% for secondary packaging development; integrating knowledge and resources to allow early product launch ahead of competitor; standardisation of global submission management processes; designing and establishing risk management and governance frameworks; collaborating in a change network to enhance e2e labelling change management processes...