Our clients operate in dual environments - life science and business - and we shape our teams around the common challenges facing these segments. Valid Insight experts draw on decades of market access, medical and relevant commercial experience.
BSc (Hons.), MB BChir, MRCOphth
Steve Bradshaw is Founder and Managing Director of award winning global market access consultancy – Valid Insight. He has two decades’ experience in market access consulting and healthcare. He has developed price and access strategies and value communication tools for many well-known products on the market, and has supported numerous companies on many aspects of market access, pricing, tendering, contracting, value communication and operational excellence.
Steve’s career includes being Editor at Nature Clinical Reviews, Ophthalmic Surgeon UK National Health Service, and various positions to senior executive level in market access consulting firms including United BioSource Corporation, Evidera and Market Access Solutions LLC, prior to launching Valid Insight. His education includes a first-class BSc in Biochemistry, degrees in Medicine and Surgery from Gonville and Caius College, Cambridge, and a postgraduate diploma in Ophthalmology.
Steve writes and speaks regularly on the challenges facing the global healthcare environment; he presents widely at conferences and expert panels, and has authored over 30 publications. His research interests span multiple therapy areas across drugs, devices and biotechnologies, including innovative medicines for rare diseases. He is a peer reviewer for several medical journals, Editorial Board Member for the journal Medicine Access @ Point of Care, Advisory Board Member at Pharma-IQ and the Global Pneumonia Prevention Coalition, and has been quoted in publications such as BioPharm Insight, Hospital Pharmacy Europe, and Reuters.
Raf De Wilde
Senior Executive Advisor
Raf De Wilde is Senior Executive Advisor at Valid Insight. He is a global expert in life science market access, having over 39 years’ experience in the pharmaceutical industry and over 29 years in global market access.
Raf became the head of International Marketing Services within Janssen Pharmaceutica (a Johnson & Johnson (J&J) company) in 1991, introducing Health Economics at J&J that year. Raf was Chairman of EPhMRA Primary Research and Methods Committee (1993-1995). He became VP of EPhMRA in 1994 and 1997 and President in 1995 and 1998.
In 1997, he joined Peter Lauper’s team that pioneered the ‘biosimilars’ concept and the first patient access schemes. Raf led a specialist oncology, real-world evidence and virology group between 2002 and 2004, where he created a centre of excellence for oncology pricing and specialised in biologics while leading the HEOR function at CENTOCOR. Raf was VP of Market Access at J&J leading teams working on oncology, cardiovascular and biotech products from 2004 to 2010.
Raf joined United Biosource Corporation (UBC) as Associate VP in early 2011 and stayed with Evidera until 2015, prior to joining Valid Insight in 2016. In his consulting career he has led nearly 200 global market access projects, including value strategies, price finding research, patient access schemes, negotiation tactics, tendering and contracting, WHO classification and naming strategies. He has moderated over 150 training workshops in Asia, Asia-Pacific, Europe, North America and Middle-East, and led the life sciences pricing training of the European Pricing Platform from 2011 to 2014.
Raf continues to teach the sessions on PROs and evidence-based medicine at the Master of Science in Pharmaceutical Medicine course of the University of Duisburg-Essen in Germany.
Bpharm. Grad.Dip.Sc(Pharm). MCom
Sue Caleo-Naeyaert is a senior international executive in the areas of Pricing, Market Access, Health Economics, Government Affairs and Policy who has lived and worked in Europe, Switzerland, Asia, and the United States with experience spanning 26 years. Sue began her career as a community pharmacist, but soon decided to further her studies and work experience at the University of Sydney specialising in the area of health economics.
In 1998, Sue was awarded a research fellowship by the EORTC (European Organisation for Research and Treatment in Cancer) in the health economics of cancer, based in Brussels, Belgium. This was followed by her move into the pharmaceutical industry, where she worked in Australia for Janssen, and then at a Global level with J&J based back in Belgium for 5 years. In 2009, Sue moved with Merck Serono to Singapore to set up their Regional Pricing and Market Access department for Asia-Pacific. After 3 and 1/2 years, Merck asked her to move to Switzerland as Global Head Pricing and Market Access for their Biosimilars Unit. Here Sue expanded her role to include the Government Affairs and Policy areas, with a 14-month secondment to Washington DC. During 2017, Fresenius Kabi bought the Biosimilars Unit of Merck KGaA and Sue continued in her role as Global Head of Government affairs, Policy and Pharmacoeconomics.
Sue is now a Senior Advisor for Valid Insight whilst being a regular guest speaker at conferences across the globe, and having numerous peer-reviewed publications. She has a Bachelor of Pharmacy, a Graduate Diploma of Pharmacy (with a specialisation in health economics) and a Master of Commerce with an Advanced Specialisation in Business Economics and Statistics.
Frank Cousins is Senior Director at Valid Insight. He has over 20 years’ experience as a consultant to the pharmaceutical industry. Before joining Valid Insight, Frank’s career started with over 10 years in healthcare and medical communications, both educational and commercial, followed by 10 years with Quintiles Consulting working in a range of senior market access and commercial consulting positions to Principal level. His experience is end-to-end from evidence generation and clinical trial optimisation projects through to launch and eventual loss of exclusivity, across many therapeutic categories, particularly oncology, haematology, immunology, and mental health.
His consulting experience has focussed on delivering diverse and complex multifaceted programs that have included organisational design, alliance and partnership evaluation, market evaluation, payer and pricing strategies and eHealth initiatives. Frank’s interests focus on the integration of regulatory strategy, evidence generation (including clinical studies, real world evidence, and patient centric and PRO data), and market access for optimal launch and commercial planning. He has developed a high level of expertise in early regulatory approval and its implications for evidence generation, HTA, and market access, pricing and reimbursement.
Frank has a BSc (Hons) in Biology from St Andrews University.
James Wright is a Director at Valid Insight and has over twenty years’ experience in the healthcare industry and consulting. He joined Valid Insight after 13 years at IQVIA.
James has provided market access support to most of the top 25 pharmaceutical companies and has extensive experience in HTA optimisation, evaluation of strategic pricing and market access implications for new launches, and product/portfolio lifecycle optimisation. James’ experience covers all major therapy areas, including rare and orphan disease, plus extensive work in biologics across established and emerging markets. James also specialises in clinical trial assessment, payer positioning, value and pricing strategy and lifecycle management.
James has an MSc in Health Economics and Pharmacoeconomics from Universitat Pompeu Fabra.
BA, MA, MSc, DPhil
Crispin Jenkinson is Senior Advisor at Valid Insight. He is Professor of Health Services Research, Director of the Health Services Research Unit at the Nuffield Department of Population Health, and a Senior Research Fellow of Harris Manchester College at the University of Oxford. He graduated from Bedford College (University of London) before coming to Oxford where he gained an MSc in Psychology and then undertook research on the psychological impact of long-term illness for a DPhil. His main research interests include patient reported outcomes (PROs) and health status measurement, the evaluation of patient experiences of medical care, and methodology. He has extensive experience of developing and validating outcome measures and, in collaboration with others, has conducted randomised controlled trials in which such instruments have been primary end-points. This work has led to the development of several internationally recognized PRO measures including the Parkinson’s Disease Questionnaire (PDQ), Amyotrophic Lateral Sclerosis Questionnaire (ALSAQ), and the Endometriosis Health Profile (EHP). He has written and edited many books as well as having authored over 230 peer reviewed publications.
Crispin helps our clients develop fit-for-purpose PRO and other health status instruments.
Carole Alison Chrvala
Carole Chrvala is Senior Advisor at Valid Insight. She has nearly 30 years’ experience as an epidemiologist and HEOR researcher. Her work spans collaborations with government health agencies, payers, academic institutions, pharmaceutical and medical device companies, medical education and communication organisations, and healthcare professional societies located in the US, UK, EU, and Israel. Carole is highly experienced in epidemiologic consulting, biostatistical support, strategic competitive analysis, medical intelligence, medical writing and publication planning services in diverse therapeutic areas including oncology, cardiovascular disease, diabetes mellitus, infectious diseases, musculoskeletal disorders, neurologic disorders, pain, psychiatric disorders, rare diseases, respiratory disorders, rheumatologic disorders, and women’s health.
Carole has developed and validated risk prediction models for various chronic and infectious diseases, analysed health care resource utilisation and economic burden, determined projections for the global epidemiologic burden of diverse health conditions, developed prospective and retrospective research studies to examine the impact of clinical interventions and developed statistical analysis plans for retrospective and prospective case-control studies and randomised clinical trials.
Carole was director of Cancer Prevention and Control for the Colorado Department of Public Health and Environment (CDPHE), before setting up her own independent company. She joined the US Food and Drug Administration as a Senior Scientist and later joined the National Academies of Science as a Senior Program Officer. She has written and presented on epidemiology, health economics and outcomes research, and diverse health topics to more than 75 professional audiences and organisations.
Alia Karaouni is Senior Advisor at Valid Insight. She is an experienced strategy consultant and foresight expert. Alia has a proven track record in decision support for senior pricing and market access management in the pharmaceutical industry. Her in-depth knowledge of biotech and pharma stems from 15 years of consultancy work, as well as work in the industry, on issues related to pricing strategy, market access, portfolio analysis, cost-benefit assessment, commercial planning and valuation, among others.
Alia has over 20 years’ experience helping clients tackle complex management decision-making in highly-uncertain, rapidly-changing environments, through issue framing, discussion facilitation and simulation-tool building. Alia was head of market access for three years ad interim at Onxeo, a Paris-based small biotech company with several orphan oncology drugs in development. Prior to this, she worked for the World Economic Forum in Geneva, as deputy head of scenario planning. Here she directed several year-long scenario projects exploring the future of industries and regions, with the outcomes made public at the annual Davos meeting. She has also worked as a management consultant in Brussels for IBM Business Consulting Services and PricewaterhouseCoopers, before setting up her own independent company, using her expertise in the field of systems thinking and business modelling to support business strategy and decision-making
Alia holds a PhD in Economics from MIT, a Master’s degree in Econometrics and a Bachelor’s degree in Economics from Université de Montréal.
BSc (Hons), PGCert Health Economics
Associate Director – Value Comms
Carolyn has 30 years’ experience in the healthcare industry, comprising 15 years in pharmaceuticals, 13 years in consultancy and 3 years in diagnostics. Over 20 years of this time has been spent working in HEOR and Market Access where Carolyn gained considerable experience in developing: value dossiers and key value messages, market access strategies, value communication tools, health economic data to support pricing and reimbursement and outcomes research studies.
Carolyn worked for many years in consultancy as an independent consultant in the area of HEOR and value communications, and for several years in market access consultancy. Carolyn has managed numerous projects working with large global pharmaceutical companies to smaller diagnostic manufacturers delivering high quality deliverables across a wide range of therapy areas including; oncology, infectious diseases, neurology, ophthalmology, medical devices (insulin pumps, gastric bands) and in-vitro Diagnostics (biomarker testing for cancer, molecular assays for infection).
Carolyn has an honours degree in Biology from Strathclyde University and a postgraduate certificate in Health Economics from Aberdeen University.
Federica Benassi is a Consultant at Valid Insight. She began her career as a Policy Officer at HOSPEEM in Belgium, an organisation that represents national hospital and healthcare sector employers’ associations at the European level, where she worked on projects financed by the European Commission. She then gained deep experience in European healthcare policy, pricing and reimbursement in consulting roles at IHS Markit, QuintilesIMS then IQVIA, prior to joining Valid Insight.
Federica has worked with many clients managing the execution of market access projects from proposal through to delivery, on numerous therapy areas including oncology, haematology, ophthalmology, cardiovascular and CNS. Federica has worked on many pharmaceuticals, devices and advanced therapy medicinal products. She specialises in healthcare policy, pharmaceutical pricing and market access strategy.
Federica has a MSc in Health Policy, Planning and Financing from the London School of Economics and Political Science and the London School of Hygiene and Tropical Medicine, and she has an MA in Organisation and Governance from the University of Bologna. Federica is bilingual in Italian and English.
Esther Miralles Simó
Esther Miralles Simó is a Consultant at Valid Insight. Prior to joining Valid Insight, Esther worked at Karolinska Development, a venture capital organisation, where she was involved in a range of projects in the business development area, including pricing and reimbursement landscaping, market sizing and in competitive intelligence activities.
Before this Esther worked as an Analyst at Synergus AB where her experience included pricing and reimbursement analysis and strategy planning for pharmaceuticals, medical devices and in vitro diagnostics in European countries.
Esther has a MSc in Bioentrepreneurship from the Karolinska Institutet in Sweden and speaks Spanish, Catalan, English and Swedish.
Jordy Van Enkhuizen
Jordy van Enkhuizen is a Consultant at Valid Insight with extensive experience in the healthcare industry. Prior to joining Valid Insight, he gained experience in value communications at Evidera and ICON. Jordy also worked as a hospital pharmacist in the Netherlands, dealing with a broad range of therapeutic areas and being involved in decision-making processes required for administration of high cost treatments. In between, he worked with the NGO Médecins Sans Frontières and supervised all aspects of two pharmacies in the Democratic Republic of Congo.
He has extensive experience in value proposition and message development, Global and European core value dossiers and the creation of tools and communication materials that drive effective payer engagement. Other areas of expertise include objection handlers, internal training sessions for roll out of value communication deliverables and various other global market access materials.
Jordy has authored over 15 publications in peer-reviewed scientific journals and presented at international conferences. He is fluent in Dutch, English and speaks French and Spanish. Jordy has a BSc and MSc in pharmaceutical sciences from the University of Utrecht and a PhD in behavioural pharmacology from the University of California San Diego.
BSc, MRes, PhD
Stephen is a Consultant at Valid Insight. He began his career working as a postdoctoral researcher in Neuroscience, and worked for 2 years at Newcastle University, before working for 7 years as a Wellcome trust researcher at the University of York. Stephen’s work examined the underlying disease pathologies in a wide range of neurological conditions, including epilepsy, Alzheimer’s disease, autism, schizophrenia and encephalopathies. He has published 8 research articles in high impact journals, has presented at numerous conferences and won several awards for his research.
More recently, Stephen worked as the Knowledge Exchange Associate at the NIHR Innovation Observatory, the UK’s national horizon scanning centre. Here he prepared documentation for health technology submissions to NICE, which initiate the technology appraisal process in the UK. He has also worked closely with the NICE topic selection group to communicate the in-depth details underpinning health technology assessments in the UK. This has involved leading online webinars and delivering presentations at a wide range of international conferences.
Stephen has a BSc in Pharmacology from Sunderland University, a MRes in Medical and Molecular Biosciences from Newcastle University and a PhD in Neuropharmacology from Newcastle University.
PhD, MSc, MChem
Darryl has extensive experience in conducting PRISMA/Cochrane-standard systematic literature reviews and targeted literature reviews for HTA submissions and real-world evidence generation. He has experience in multiple project types including epidemiology and clinical/humanistic/economic burden of illness reviews, HTA process reviews, analysis of modelling outputs, production of training and presentation materials for both internal and external circulation and preparation of manuscripts.
Darryl has disease area experience in oncology, muscle wasting diseases, inflammatory diseases and epilepsy.
Darryl has authored several publications in peer-reviewed scientific journals and presented at international conferences. He holds a PhD in Biomedical Sciences (Neurobiology) and a MSc in Neuroscience from the University of Edinburgh, as well as an MChem from Durham University. Prior to joining Valid Insight, Darryl worked at PHMR as a Systematic Review Scientist and has also previously worked in the pharmaceutical research industry as a medicinal chemist.
Ejike Nwokoro joined Valid Insight. Prior to that he worked at Cogora Ltd as a Senior Insight & Market Access Analyst focusing primarily on Payer and KOL engagement. Before Cogora he worked as an Advisor on Global Pharmaceutical Policy at the Norwegian Institute of Public health, and as a Researcher with the Oslo Group on Global Health Policy (University of Oslo, Norway) with specific interests in Health Technology Assessment(HTA) models and global collective action for health system strengthening.
Other Market Access related experience includes: Prescribing data analysis; Advisory boards for development and pressure testing of value strategies and assessment of new contracting models for product manufacturers; Payer research to support market entry and product positioning, and key customer identification projects to support launch and salesforce planning.
Ejike has been part of a multinational research project sponsored by the European Commission and the European Pharmaceutical Industry Association (EFPIA) focusing on economic models that incentivise reinvestment in R&D while advocating responsible antibiotics use. At the University of Bergen, he led a research project that sought to identify future options with respect to funding mechanisms for Global Public Goods for Health. Ejike is a medical doctor by background and has a master’s degree in Public Health from the University of Wolverhampton, UK as well as Postgraduate Education in Health Economics, Quality Improvement and Healthcare Management from the University of Bergen, Norway. He is fluent in Norwegian and English.
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