Adriaan Fruijtier, MSc

Adriaan Fruijtier, MSc

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....
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Armand Brevig, M.Eng., MBA

Armand Brevig, M.Eng., MBA

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....
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Julianne Hull BSc, MSc

Julianne Hull BSc, MSc

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...
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Marcus Benton BSc, MSc Quality, MBA

Marcus Benton BSc, MSc Quality, MBA

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....
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Cliff Preston MA DPhil MSc

Cliff Preston MA DPhil MSc

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....
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Duncan Currie BSc, PhD

Duncan Currie BSc, PhD

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....
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Brigitte Happ PhD

Brigitte Happ PhD

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....
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Rowan Nidd, BSc, MSc

Rowan Nidd, BSc, MSc

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...
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Pauline Stewart-Long BSc PhD

Pauline Stewart-Long BSc PhD

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...
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Julie Evans, BSc, MPhil

Julie Evans, BSc, MPhil

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...
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Mark Blanchard BSc, CA-AM, MCIPS

Mark Blanchard BSc, CA-AM, MCIPS

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...
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Jeff Duke MSc C.Sci CChem FRSC

Jeff Duke MSc C.Sci CChem FRSC

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...
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John Seagrief, BSc, MBA

John Seagrief, BSc, MBA

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....
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Fraser Penny, BEng Chemical Engineering

Fraser Penny, BEng Chemical Engineering

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,...
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Mike Florence PhD MBA

Mike Florence PhD MBA

Mike Florence has over 20 years’ experience in Pharmaceutical and Chemical industries delivering step change improvements and projects across manufacturing, supply chain, Research and Development and marketing companies. Mike is a winner of the European strategic risk award for building risk and lean into portfolio management and a sustainable business cycle. Previous roles include Global Project Manager accountable for leading cross functional teams to deliver large and complex portfolio of projects to decision points on time and budget. He is a full member of the Association of Project Management and the Institute of Risk Management. Mike gained a PhD from the University of Edinburgh, MBA from the Open University and is a registered practitioner of Prince2 and Management of Successful Programmes....
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John Bennett BSc PhD

John Bennett BSc PhD

John has over 30 years of experience in drug discovery and development. He started his career in the cardiovascular biology research group at Pfizer before moving to drug development as a project manager. He has supported and led candidates across many therapeutic areas and at all stages of development. He spent 10 years as a Portfolio Director – initially for projects in early development and then for the pain, GI, GU and respiratory therapeutic areas. In that time he was instrumental in the development of therapeutic area strategies that spanned the research, development and commercial areas. He also led and contributed to a number of global initiatives that designed and implemented project management, knowledge management, risk and resource and finance management processes and systems for Pfizer globally and managed a global organisation focused on project management excellence, operations and development. John left Pfizer in 2009 and began a new career in Project, Programme & Portfolio Management consultancy and has worked with a...
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Dr Richard Phillips MBBS MFPM MBA

Dr Richard Phillips MBBS MFPM MBA

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...
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Steve Whitelock CChem FRSC

Steve Whitelock CChem FRSC

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...
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Fraser Kerr PhD FRSC

Fraser Kerr PhD FRSC

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...
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Bruce Williams BSc (Hons)  PMI PMP

Bruce Williams BSc (Hons) PMI PMP

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...
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Global Biopharmaceutical Company, Head of Analytical Development

Our company worked with Phetairos consultants for about 12 months to help us manage a business critical, high risk project. Thanks to the strength and depth of their expertise in different areas (GMP, people & project management), they helped us manage very effectively with both the situational assessment and the remediation. The consultants proposed by Phetairos are highly experienced industry professionals and their leadership was a key asset for the success of our project. ...
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Graham Finch BSc BEng MSc

Graham Finch BSc BEng MSc

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...
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Preeya Beczek BSc Hons. MSc.

Preeya Beczek BSc Hons. MSc.

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...
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Chris Williams PhD FBPhS MBTI cert.

Chris Williams PhD FBPhS MBTI cert.

Chris has had a long standing scientific leadership career in the pharmaceutical industry where she has led teams conducting early research in to small molecule and antibody therapeutics. Through this, and her subsequent transition in to more operational roles within pharma and the NHS, she has developed experience in process optimization, project and portfolio management and change leadership, as well as individual and team effectiveness. Chris has a broad understanding of drug discovery at both a strategic and operational level. She has worked at Board level, as Chair, Trustee or Advisor and her operational  specialisms are in assay development and screening processes, team interfaces and dynamics, individual and team effectiveness and culture change. Chris has supported spin outs, Biotechs and mid- to large size pharma to deliver culture change projects; optimise compound management, data integrity and screening practices,  support organizational design and recruitment; the design and delivery of bespoke workshops to facilitate team effectiveness, strategic planning and objective setting and provision of...
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John Faulkes MCIPD

John Faulkes MCIPD

John began his career as an immunology scientist in GSK. He moved after some years to a new career in human resources as a trainer, team coach and eventually a learning and development Business Partner. He left employment to become a consultant offering organization development and team building services, personal skills training courses and doing instructional design and coordination. John’s principal expertise is in helping people to collaborate across complex structures. Developing cross-functional leadership and helping to build dynamic, engaged teams. Also to encourage productive relationships across organization partnerships and alliances. In addition John is an expert in digital learning and consults in the use of technologies in L&D. John has helped to transform several medium sized pharma / services companies’ project systems; helped build outsourcing culture and systems. John co-leads Phetairos’ Life Science Leadership practice. https://www.linkedin.com/in/johnfaulkes/...
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The Benefits and Pitfalls of Repurposing Drugs

The Benefits and Pitfalls of Repurposing Drugs

The interest in drug repurposing has grown, as the effort required to bring new drugs to market has increased. When the cost of failed projects is taken into account, it costs c. $2.6bn and 10 years for each new marketed product and these estimates are increasing. Historically, new used for some drug molecules have been found by accident. But in this era, a deep understanding of biological disease processes enables a rational investigation process, to develop an 'on target' repurpose (based on the same biological mechanism) or an 'off target' one (based on the API acting on a different mechanism). This paper discusses the screening of molecules that have failed during development; shorter development paths for repurposed use and the regulatory and IP opportunities.   INTRODUCTION It has been estimated that it costs approximately US$1 billion to bring a drug from the laboratory to market and takes about 10 years on average1. However, when the costs of failed projects are taken into account,...
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Is Orphan Drug Status the answer to everyone’s prayers?

Is Orphan Drug Status the answer to everyone’s prayers?

Developing orphan drugs is a risky business. Small numbers of patients, despite high prices, may not lead to high revenue and there is a high risk of failure to reach the market. But there are advantages. There may be grants available; regulatory processes are simpler. patients and physicians are very eager to try new treatments. Also, small companies may be attracted by the smaller size of clinical trials and shorter development times. There are an estimated 7000 rare diseases, affecting 350 million people globally - and this paper described the landscape of this work in detail.   Orphan drug development is a risky venture. The small number of patients, despite the premium price, may not lead to huge revenues and there is a significant risk of failure to reach Proof of Concept. There is no doubt that orphan drug development is highly suited and can be extremely profitable to smaller companies and larger ones looking to expand their product portfolios. While the...
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Double-Edged Sword

Double-Edged Sword

Consequences for Medical Devices in case of a no deal Brexit. Over the Counter (OTC) remedies may not seem like an obvious destination for medical devices, but the self-care medical device market faces change and uncertainty impacting products sold in both the UK and Europe. The rules governing medical devices are changing and with them the role and responsibility of Notified Bodies –often the first regulatory point of contact for device manufacturers. Layered on top of this is Brexit and a potential no deal scenario affecting the sale of CE marked devices for the UK and European markets. The Medical Device Directive(MDD, 93/42/EEC) was implemented 14 June 1993. This guidance has been revised and replaced by the Medical Device Regulation(MDR, EU 2017/745) on 26 May 2017. Many of the amendments have been driven by safety and the need to protect the consumer. PIP silicone breast implants were a trigger that change was required. Today the rules are in transition, with the MDR fully...
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From Conflict to Opportunity 1 – why does conflict occur and why it’s important to understand this

From Conflict to Opportunity 1 – why does conflict occur and why it’s important to understand this

This is a series of articles about managing conflict, specifically in partnerships and alliances, but the principles apply to any team or project situation. There are three parts: The first talks about how we may need to think through and understand that there are many reasons why you may be in conflict - and if you second guess wrongly, you can end up chasing the wrong way.   CONFLICT TO OPPORTUNITY A 3-part series helping you to build collaboration into complex teams and partnerships   Part 1 – Why does it happen? Conflict in business is a daily occurrence. We're not short of choice for examples and illustrations. One example relevant to the focus of this article is in CRO outsourcing. Sponsors constantly get irritated that despite apparently clear contracts, in their view CRO teams don't do what they've agreed to. Another is common in Alliances: decisions are made suddenly by one partner with no apparent justification, or warning. There are many more, internally as well as across partnerships. Managing...
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Quality Metrics and the link to Operational Excellence

Quality Metrics and the link to Operational Excellence

The journey toward provision of 'quality metrics' to regulatory authorities has been a slow process, but it is becoming adopted as a mandatory requirement. Linking quality metrics to performance indicators across an organisation will deliver process and supply chain robustness. This paper describes the FDA’s initiative and the industry reaction so far. The FDA is driving the development of a culture of quality across the pharmaceutical industry. Currently, they request the voluntary submission of summary ‘Quality Metrics’ (QMs). This request has been likely to become a requirement since a while. Linking QMs to performance indicators across an organisation will drive focused improvement initiatives, delivering process and supply chain robustness. As a result, this will lead to reduced quality issues, reduced costs and increased profitability. In addition, Quality and Operations executives will have more time to work on strategy rather than day-to-day problem solving.   THE SITUATION The pharmaceutical industry’s ‘Quality Metrics’ journey has been a slow, continuous process of growth, but it is clear that...
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Supply continuity in the current Covid-19 crisis

Supply continuity in the current Covid-19 crisis

In the current pandemic we have facilities but we don't necessarily have the materials or the people with necessary skills to produce everything that we would like to. In these times it's about knowing what's important. To all those small and medium sized businesses out there who are working hard to recover and protect their supply chains and customers in the current Covid-19 pandemic. We salute you! If you have limited experience of a previous continuity emergency, then get in touch and we can offer support and advice. Phetairos has a team of experienced supply chain and OPEX professionals. A few of us met for a virtual coffee. Our conversation explored the effects of the Covid-19 situation on supply chain risk management and business continuity. Here’s what we had to say: In these times, it's about knowing what's important. The minimum that our supply chains need to survive. What products are our priority, which products will we reduce or pause, and who will...
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Managing performance without direct authority

Managing performance without direct authority

This is a video of a webinar given in the run-in to the European Partnerships in Clinical Trials conference. It highlights difficulties in contributing to the performance management of cross-functional team members. It explains the source of authority that the leader can tap into, ways to build confidence to do it properly and some useful techniques that will help. Written by John Faulkes  ...
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Mobile Leadership 1 – why is it so important?

Mobile Leadership 1 – why is it so important?

A project-centric way of working is so fundamental to the life science world, you would think that employees    would be trained in its disciplines from day one? This may be happening in some organisations, but in very many, it does not. This and subsequent articles focus on the importance of developing the critical skills needed to thrive in this environment. Something we term ‘mobile leadership’.   A key to success for life science in the coming decade When someone in the life science sector has reached a position of responsibility, let’s say as a team leader or section head, they may get an experience that is their first really scary one: leading a cross-function activity. A project or a working group with a team drawn across many company functional silos and locations. Yet this project-centric way of working is so fundamental to the life science world, you would think that employees would be trained in its disciplines from day one? This may be happening in some organisations, but...
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Mobile leadership 2 – what is the mindset?

Mobile leadership 2 – what is the mindset?

What needs to change in our heads for us to be able to lead cross functional teams effectively? Sometimes we need to unbutton unbundle years of traditional thinking. No longer can we be the supreme expert. We need to act with humility but still with a drive and sharp focus on goals.   A key to success for life science in the coming decade Part 2 – The mindset of a mobile leader So far in this series we have discussed the drivers behind the need for effective cross functional leadership and some of the barriers to achieving this. In this article we’re going to focus on what needs to change in our head to drive the behaviours of a mobile leader. Challenging our patterns of thinking "One of the most basic problems of modern management is that the mechanical way of thinking is so ingrained in our everyday conception of organisations that it is often difficult to organise in any other way" Gareth Morgan It is not uncommon...
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Mobile leadership 3 – what are the skills to develop commitment and trust?

Mobile leadership 3 – what are the skills to develop commitment and trust?

How can a leader build commitment in a cross functional team? Leaders may come into this position having a strong feel for team consensus and a harmonious working style. Yet this may not be quite enough a degree of toughness with goals is necessary and the mix of these approaches is quite difficult to achieve.   A key to success for life science in the coming decade Part 3 – The skills of gaining team commitment and trust Closely related to the mobile leadership mindset, are the skills needed to work in a cross functional environment. There is overlap between this skillset and those that many functional team leaders have been trained in earlier in their careers. But there are some specific capabilities over and above that required for traditional line management. An incoming leader will often have to address team performance problems – and in a cross functional situation these are much more likely. Lencioni’s ‘5 dysfunction of teams’1 (see left) illustrates the typical challenges to...
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Mobile leadership 4 – developing the skills

Mobile leadership 4 – developing the skills

Cross functional leaders who have up to now worked in expert functions, are accustomed to learning more about their specialism - increasing 'depth' of knowledge. Now they must acquire more 'breadth'. They also must learn to balance seemingly conflicting mindsets and this is rarely an easy transition. We must think carefully about how we design their learning.   A key to success for life science in the coming decade Part 4 – Developing the skills Key takeaways in this article: • We usually need to engage and inspire leaders’ behaviour change before culture change in the organisation • People need to experience and get feedback to shift their mindset – not just be told to change it • Leaders can learn from team members’ feedback – live, not just from 360 analysis In the previous articles we discussed the importance of mobile leadership and the mindset and critical skills that it requires. In this article we look at how we develop that mindset and the skills people require...
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Mobile leadership 5 – who is your customer?

Mobile leadership 5 – who is your customer?

It is common to find that teams do not analyse their internal customers/stakeholders, which can lead to a confusion in purpose and focus. Cross-functional 'mobile' leaders should encourage and lead this activity which can break down barriers and disrupt silo-based thinking.   A key to success for life science in the coming decade Part 5 - Who is your customer? Key takeaways in this article: • Stakeholder mapping - especially Internal stakeholders, is often done poorly and can help break down silos. • Project centric leadership can actively break down barriers. • Assessing Internal customer satisfaction can help give teams directions for Improvement. The immediate answer to the question “Who is your customer?” may seem obvious on first pass but it is not always as simple as it seems. In recent years, much emphasis has been placed on sustained success in business being driven by a focus on your clients’ needs in order to stay ahead of your competitors. As a consequence, many organisations have undertaken a customer focus...
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Large FMCG, Head of Biosciences

"In our industry, with the advent of novel products, there is a need to create science packages that substantiate their reduced risk potential, as well as be acceptable to both regulatory and public health scientists. Phetairos have been a key partner to creating a strategy and implementing the required business processes, systems and standards which will help us realise this goal.” ...
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Small Biotech, CEO

"We have been working with Phetairos for c. 12 months they have been instrumental in providing clinical and regulatory support as we progress our lead compound into first in human studies both in healthy volunteers as well as patients. Phetairos have supported us with MHRA discussions, protocol design, selection of an appropriate phase 1 unit and CTA application. We look forward to continue working with Phetairos during the development of our lead compound."...
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Thi Hanh Cao, Head External Relations, Drugs for Neglected Diseases initiative

"The fundraising department at DNDi worked with Phetairos when preparing a proposal for a major donor. Phetairos were instrumental in clarifying the budget and expected delivery over time for a programme composed of a bundle of projects aimed at a single disease area. Phetairos also provided guidance on project and portfolio decision making in order to proactively manage the downstream portfolio including variable attrition rate hypothesis.This strengthened the breadth, depth and quality of our proposal and helped support a successful application. We look forward to working with Phetairos on future projects." ...
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From Conflict to Opportunity 2 – Dealing with conflict – mindest and tactics required

From Conflict to Opportunity 2 – Dealing with conflict – mindest and tactics required

Dealing with conflict - you may be stuck with traditional responses -combat or avoidance. We need to think about this differently in future and do perhaps the hardest thing - get into the perspective of our opposite numbers. CONFLICT TO OPPORTUNITY A 3-part series helping you to build collaboration into complex teams and partnerships   Part 2 – Dealing with conflict In the first part of this series we asked you to pause, sit back and think about why the responses of another party might not be as you would expect. The point of this is not to enable you to better deduce what's in the other party's mind. It's is to force your brain into a receptive, rather than attacking mindset. What is the appropriate mindset for dealing with conflict? If you're calm and rational, you could probably tell us! But when you're in the heat of the moment this common sense all but disappears. There is a a psychological reality for most of us in any...
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Separating the wheat from the chaff – mapping your suppliers

Separating the wheat from the chaff – mapping your suppliers

Who are the stars and the poor performers in your supply chain suppliers? Which from these are the critical suppliers but you can't afford to fail? This article looks at ways you could've map and classify suppliers to maximise the resilience of your supply chain. Mapping your supply chain suppliers Key takeaways in this article: • A number of models can help us identify where the key risks and opportunities may lie within our supply chain • The procurement professionals can analyse  their supply chains and build supply chain resilience and sustainability In business, just as in our personal lives, times of adversity show us who our real friends are and those relationships that will endure and strengthen. We're all reading and hearing about how the pandemic is shining a spotlight on the fragility of what we thought were pretty robust supply chains. In this article we’ll describe some immediate actions you can take to identify where the big opportunities and threats lie within your supply...
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Teambuilding without travel

Teambuilding without travel

As of mid 2020 the business world is communicating remotely. But can you run a team building event in this way, or keep people engaged with a brainstorming session? Perhaps so!   It is no surprise that plans for strategy events, conferences, learning events, team building workshops and any other reasonably large and/or international gatherings are being put on hold. The delays to getting these sorts of events rebooked could be many months yet. But in this day and age, why not run them remotely? Well, there are all sorts of very good reasons why not. Team building days and strategy events feature certain critical components, which it’s natural to think really need to be done face to face. Airing of opinions and ideas - many of which maybe opposing viewpoints; exchanging feedback - positive and negative; team tasks such as brainstorming or risk assessments which often get off track. These usually need sensitive handling. It will typically need a facilitator to keep the group focused and encourage...
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Mobile leadership 6 – seeking sponsorship

Mobile leadership 6 – seeking sponsorship

There are practical ways to develop this sort of leadership mindset and skills, but internal project office / L&D people often find that making it happen is difficult; internal confusion and an unconvinced senior management means progress is slow. It's easy to talk about how to break this deadlock, harder to do it in practice. But this article at least shares a few ideas and an invitaton to talk further. A key to success for life science in the coming decade Part 6 – Seeking sponsorship for development activities Key takeaways in this article • Build internal alliances with various improvement groups – and develop common ground • Establish a jointly agreed set of capabilities • Build a business benefits-led case for development activities We have been attempting to develop impactful leadership in our society for decades. It’s been a mixed experience. A recent survey by Skillsoft found that just 22% of organisations believed they had an adequate leadership culture. This relates to general people leadership skills. If...
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Commercialisation (VPAC)

A non-European medical device company had developed a medical device for helping patients with osteoarthritis of the knee. While it was being used in a number of private hospitals in the UK, the company hoped to expand its usage into the NHS and so needed evidence to assist in negotiations. CASE STUDY 1 SITUATION A non-European medical device company had developed a medical device for helping patients with osteoarthritis of the knee. While it was being used in a number of private hospitals in the UK, the company hoped to expand its usage into the NHS and so needed evidence to assist in negotiations. SERVICE Using available clinical trial data and publicly-available databases, a budget impact model was developed. The model allowed for estimating the potential savings at country, region and CCG levels. RESULT The model provided important evidence of the economic benefit of the medical device and was used extensively with NHS decision makers. CASE STUDY 2 SITUATION A blue chip company was working with European patient...
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Quality Management & Regulatory Compliance (QMRC)

A pharmaceutical company were looking to move to disposable systems and change their primary packaging. CASE STUDY 1 SITUATION Pharmaceutical operations remediation to restore licence to manufacture from the regulatory inspectors. SERVICE Operations management. RESULT The remediation team working to deliver operations and engineering systems remediation from an operations perspective as part of a Quality Management programme to pass an inspection to regain a manufacturing licence. CASE STUDY 2 SITUATION A pharmaceutical company looking to move to disposable systems and change the primary packaging. SERVICE Project management of feasibility studies. RESULT The feasibility studies collated operational information, timelines, impacts and costs which allowed the management to decide on the acceptability of the projects....
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Product Opportunity Evaluation and Maximisation (POEM)

A new therapeutic about to enter the clinic with a range of possible different indications and disease populations needed to determine the best development path and target product profile, as well as explore the risk/reward balance between the various development options and pricing implications. CASE STUDY 1 SITUATION A new therapeutic about to enter the clinic with a range of possible different indications and disease populations needed to determine the best development path and target product profile, as well as explore the risk/reward balance between the various development options and pricing implications. SERVICE Built and executed a clear process to brainstorm and prioritise disease populations, identify key decision criteria, and test the sensitivity of those disease population options to the decision criteria, before hybridising the most preferred populations to test the risk/return trade-offs. RESULT A clear development path with an early proof of concept in a niche population that built confidence so that an acceptable risk/return ratio was achieved in a broader disease population. CASE STUDY 2 SITUATION A European...
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Pharmaceutical Science (PHARM SCI)

Phetairos's client had developed a new manufacturing process for a biotech drug substance, which improved the yield, reduced the cost of goods and removed the raw materials of animal origin. However, a lengthy regulatory approval process needed to be avoided. CASE STUDY 1 SITUATION The client had developed a new manufacturing process for a biotech drug substance, which improved the yield, reduced the cost of goods and removed the raw materials of animal origin. However, a lengthy regulatory approval process needed to be avoided. SERVICE Through careful assessment of the whole manufacturing process and its regulatory implications, restricting the changes only on critical process steps, maintaining the control tests and specifications and eliminating the need for additional clinical studies, the improved process was validated. RESULT The client had a clear regulatory strategy of how to present and submit the manufacturing process improvement successfully as a minor regulatory process modification only. As a result, it was approved in short assessment time by all major health authorities...
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Product Development – Clinical and Regulatory (PDCR)

A mid-sized pharmaceutical company was in the middle of a de-centralised regulatory procedure when it suddenly needed additional expertise to complete the on-going procedure. There was a need to respond to questions, finalise the labelling and manage an unexpected complication due to a member state having raised national health concerns at the end of the procedure. CASE STUDY 1 SITUATION A virtual UK-based biotech company with limited knowledge of GCP requirements needed to source a service provider qualified to deliver their Phase I study with a potential biologic analgesic. They were unaware of the regulatory risks associated with lack of compliance, delivery, quality and cost when insufficient due diligence was ensured through a non-rigorous selection and capability assessment process. SERVICE Phetairos worked with the client to define the critical success criteria for the selection of a fit for purpose phase I unit. They acted as the outsourcing department of the client developing a request for proposal versus the study requirements and critical criteria. In addition,...
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Project and Portfolio Management

A not for profit group was looking to understand how they should make project selection decisions for projects entering into the clinical phase, and how the priority of these incoming projects could be seen against those already in the portfolio. CASE STUDY 1 SITUATION A not-for-profit group had conflicting ideas on how they should select projects to enter clinical phases​. There was no common view on project value, and many funding decisions were “champion led”​. Consequently, there was confusion on how the priority of these incoming projects could be seen against those already in the portfolio SERVICE Phetairos worked with the client to understand what critical aspects of a project were valued by the organisation and stakeholders. These were used to form the basis of a small number of criteria against which incoming, and existing, projects were judged. A model was developed that could not only score these projects against these criteria, but which could also explore project ranking sensitivities, “what if” analyses, and critical strengths and weaknesses...
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Operational Excellence (OPEX)

A mid-sized pharmaceutical company was driving to reduce lead times from discovery to launch. The requirement was to understand where the bottlenecks and slow moving processes were and what current improvements could be made. CASE STUDY 1 SITUATION A mid-sized pharmaceutical company was driving to reduce lead times from discovery to launch. The requirement was to understand where the bottlenecks and slow moving processes were and what current improvements could be made. SERVICE Through a combination of structured interviews and workshops with stakeholders across R&D, a top level value chain was mapped, and digitally recorded, from Discovery to Launch. Current metrics, timelines, bottlenecks, slow processes and major changes were mapped. A level 2 process map identified the phase specific accountabilities, metrics and issues. On-going company-initiated change initiatives were analysed and relationships identified; the plans co-ordinated were put in place to ensure maximum synergy between initiatives. RESULT On presentation to the R&D board, the digital value chain and linked level 2 processes, issues and projects were enthusiastically...
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​Life Science Leadership (LSL)

Phetairos's client had a need to re-engage staff following a major re-organisation of a global pharmaceutical company into therapeutic business units. CASE STUDY 1 SITUATION A need to re-engage staff following a major re-organisation of a global pharmaceutical company into therapeutic business units. SERVICE Multi-strand programme to engage staff at all levels in the vision and mission of the TA BU, including a highly interactive process and customer focused improved activities, internal customer service level agreements, partnership behaviours and cross-level information exchanges. RESULT Successful and productive TA BU with outstanding employee survey ratings for culture, leadership, satisfaction and involvement. CASE STUDY 2 SITUATION Requirement to improve team working and planning to support faster project delivery. SERVICE Working with a number of cross-functional teams within a large pharmaceutical company to critically examine project plans and team behaviours to support improved problem solving, team communication (internal and with key stakeholders) and decision making. RESULT Faster and more efficient delivery of project goals....
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