Liese Barbier
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View article: A Fast Path from Innovation to Safe and Effective Medicines
A Fast Path from Innovation to Safe and Effective Medicines Open
Consistent progress in medicines development has allowed both for de novo treatment options and for the refinement of existing products that improve effectiveness or reduce harm. Nonetheless, unmet medical needs persist, particularly in ra…
View article: Toward Regulatory Convergence and Streamlined Biosimilar Development: Recommendations from an International Qualitative Study
Toward Regulatory Convergence and Streamlined Biosimilar Development: Recommendations from an International Qualitative Study Open
View article: Future-Proofing European Pharmaceutical Regulatory and Market Access Practices Based on EU Learnings from the COVID-19 Pandemic: Insights from Multi-Stakeholder Interviews
Future-Proofing European Pharmaceutical Regulatory and Market Access Practices Based on EU Learnings from the COVID-19 Pandemic: Insights from Multi-Stakeholder Interviews Open
Introduction During the COVID-19 pandemic, regulatory and market access actions were taken to expedite the market entry of COVID-19 medicines. This study aims to (i) capture multi-stakeholder views on these actions, and (ii) provide recomm…
View article: Unmet medical needs definition and incentives: stakeholders perspectives on the reform of the EU pharmaceutical legislation
Unmet medical needs definition and incentives: stakeholders perspectives on the reform of the EU pharmaceutical legislation Open
Introduction The 2020 pharmaceutical strategy for Europe stressed that rethinking regulatory policies to foster innovation in disease areas with unmet medical needs (UMN) is one of the European Commission’s (EC) priority areas. To understa…
View article: Do European regulatory measures accelerate national market access in Belgium? A retrospective analysis of medicines centrally authorised between 2015 and 2020
Do European regulatory measures accelerate national market access in Belgium? A retrospective analysis of medicines centrally authorised between 2015 and 2020 Open
Background At the European level, several regulatory measures (ie, priority medicines (PRIME) scheme, accelerated assessment, conditional marketing authorisation and authorisation under exceptional circumstances) are in place with the aim …
View article: Evolution of Eligibility Criteria in Inflammatory Bowel Disease Clinical Trials: A Clinical Trial Databank Analysis
Evolution of Eligibility Criteria in Inflammatory Bowel Disease Clinical Trials: A Clinical Trial Databank Analysis Open
Background Eligibility criteria in clinical trials have been criticised for being overly restrictive without clinical justification. Objective We aimed to investigate the types, evolution, and current status of eligibility criteria in clin…
View article: PD72 Are Patient Experience Data Currently Embedded In Reimbursement Decision-Making? An Analysis Of Belgian Reimbursement Documents
PD72 Are Patient Experience Data Currently Embedded In Reimbursement Decision-Making? An Analysis Of Belgian Reimbursement Documents Open
Introduction Stakeholders in the drug life cycle recognize the importance of integrating patient experience data (PED) into healthcare decision-making. PED includes patient input, patient reported outcomes (PROs), patient reported experien…
View article: OP33 Advancing Patient Experience Data Implementation In Reimbursement Decision-Making: Insights On Challenges And Opportunities From Multistakeholder Interviews
OP33 Advancing Patient Experience Data Implementation In Reimbursement Decision-Making: Insights On Challenges And Opportunities From Multistakeholder Interviews Open
Introduction Patient experience data (PED), encompassing patient preferences (PP), patient-reported outcomes (PROs), and patient input, play a pivotal role in understanding patient needs and informing healthcare decision-making, including …
View article: Mitigating the Nocebo Effect in Biosimilar Use and Switching: A Systematic Review
Mitigating the Nocebo Effect in Biosimilar Use and Switching: A Systematic Review Open
View article: Opportunities and Challenges in Cross-Country Collaboration: Insights from the Beneluxa Initiative
Opportunities and Challenges in Cross-Country Collaboration: Insights from the Beneluxa Initiative Open
National pricing and reimbursement agencies face growing challenges with complex health technologies, prompting European policy advancements. Beneluxa is a cross-country collaboration involving Belgium, the Netherlands, Luxemburg, Austria,…
View article: Heart failure patients' perspectives on treatment outcomes and unmet medical needs: A qualitative preference study
Heart failure patients' perspectives on treatment outcomes and unmet medical needs: A qualitative preference study Open
Aims Decision‐makers still predominantly focus on the perspective of non‐patient stakeholders, which may deviate from the unique perspective of heart failure (HF) patients. To enhance patient‐centred decision‐making, there is a need for mo…
View article: Personalized and longitudinal electronic informed consent in clinical trials: How to move the needle?
Personalized and longitudinal electronic informed consent in clinical trials: How to move the needle? Open
Changes in the clinical trials landscape have been driven by advancements in digital technology. The use of electronic informed consent to inform research participants and to obtain their consent electronically has the potential to improve…
View article: Testing and Practical Implementation of a User-Friendly Personalized and Long-Term Electronic Informed Consent Prototype in Clinical Research: Mixed Methods Study
Testing and Practical Implementation of a User-Friendly Personalized and Long-Term Electronic Informed Consent Prototype in Clinical Research: Mixed Methods Study Open
Background Over the years, there has been increasing interest in electronic informed consent (eIC) in clinical research. The user-friendliness of an eIC application and its acceptance by stakeholders plays a central role in achieving succe…
View article: How can patient preferences be used and communicated in the regulatory evaluation of medicinal products? Findings and recommendations from IMI PREFER and call to action
How can patient preferences be used and communicated in the regulatory evaluation of medicinal products? Findings and recommendations from IMI PREFER and call to action Open
Objective: Patients have unique insights and are (in-)directly affected by each decision taken throughout the life cycle of medicinal products. Patient preference studies (PPS) assess what matters most to patients, how much, and what trade…
View article: Recommendations on TNFα inhibitor biosimilar use in clinical practice: a comparison of European gastroenterology IBD guidance
Recommendations on TNFα inhibitor biosimilar use in clinical practice: a comparison of European gastroenterology IBD guidance Open
The majority of gastroenterology associations endorsed biosimilar use. The lack of (up-to-date) guidelines for some associations indicates an area of improvement to support biosimilar use in clinical practice.
View article: Informing a European guidance framework on electronic informed consent in clinical research: a qualitative study
Informing a European guidance framework on electronic informed consent in clinical research: a qualitative study Open
View article: Uncertainty management in regulatory and health technology assessment decision-making on drugs: guidance of the HTAi-DIA Working Group
Uncertainty management in regulatory and health technology assessment decision-making on drugs: guidance of the HTAi-DIA Working Group Open
Objectives Uncertainty is a fundamental component of decision making regarding access to and pricing and reimbursement of drugs. The context-specific interpretation and mitigation of uncertainty remain major challenges for decision makers.…
View article: HPR205 Future-Proofing European Regulatory and Market Access Practices Based on Learnings From the COVID-19 Pandemic – Stakeholder Perspectives
HPR205 Future-Proofing European Regulatory and Market Access Practices Based on Learnings From the COVID-19 Pandemic – Stakeholder Perspectives Open
View article: SA13 The Impact of the COVID-19 Pandemic on Collaboration and Innovation in Antiviral Drug Development: A Multi-Stakeholder Systems Dynamics Analysis
SA13 The Impact of the COVID-19 Pandemic on Collaboration and Innovation in Antiviral Drug Development: A Multi-Stakeholder Systems Dynamics Analysis Open
View article: How to balance valuable innovation with affordable access to medicines in Belgium?
How to balance valuable innovation with affordable access to medicines in Belgium? Open
Background: Countries are struggling to provide affordable access to medicines while supporting the market entry of innovative, expensive products. This Perspective aims to discuss challenges and avenues for balancing health care system ob…
View article: How to select a best-value biological medicine? A practical model to support hospital pharmacists
How to select a best-value biological medicine? A practical model to support hospital pharmacists Open
Purpose With the growing availability of biosimilars on the global market, clinicians and pharmacists have multiple off-patent biological products to choose from. Besides the competitiveness of the product’s price, other criteria should be…
View article: Biosimilar Use and Switching in Belgium: Avenues for Integrated Policymaking
Biosimilar Use and Switching in Belgium: Avenues for Integrated Policymaking Open
Background: By improving the affordability and accessibility of biologicals, biosimilar competition provides important benefits to healthcare systems and patients. In Belgium, biosimilar uptake and competition is limited compared to other …
View article: When Will American Patients Start Benefitting From Biosimilars?
When Will American Patients Start Benefitting From Biosimilars? Open
View article: Correction to: Interchangeability of Biosimilars: Overcoming the Final Hurdles
Correction to: Interchangeability of Biosimilars: Overcoming the Final Hurdles Open
View article: Regulatory Information and Guidance on Biosimilars and Their Use Across Europe: A Call for Strengthened One Voice Messaging
Regulatory Information and Guidance on Biosimilars and Their Use Across Europe: A Call for Strengthened One Voice Messaging Open
Background Beyond evaluation and approval, European and national regulators have a key role in providing reliable information on biosimilars and the science underpinning their development, approval, and use. Objectives This study aims to (…
View article: Perceptions About Biosimilar Medicines Among Belgian Patients in the Ambulatory Care
Perceptions About Biosimilar Medicines Among Belgian Patients in the Ambulatory Care Open
Background and objectives: Biosimilar medicines have been on the European market for 15 years. Despite the extensive and positive experience with biosimilars across Europe, their uptake remains limited in Belgium. One of the possible facto…
View article: Interchangeability of Biosimilars: Overcoming the Final Hurdles
Interchangeability of Biosimilars: Overcoming the Final Hurdles Open
View article: Community pharmacists' preparedness for substituting biologics and dispensing biosimilars – Lessons learned from a multinational survey
Community pharmacists' preparedness for substituting biologics and dispensing biosimilars – Lessons learned from a multinational survey Open
View article: Knowledge and perception of biosimilars in ambulatory care: a survey among Belgian community pharmacists and physicians
Knowledge and perception of biosimilars in ambulatory care: a survey among Belgian community pharmacists and physicians Open
Background With the approval of biosimilars for subcutaneously administered products, such as adalimumab, etanercept and insulin, biosimilars become increasingly available in ambulatory care. Little is known about the knowledge and attitud…
View article: Off-Patent Biologicals and Biosimilars Tendering in Europe—A Proposal towards More Sustainable Practices
Off-Patent Biologicals and Biosimilars Tendering in Europe—A Proposal towards More Sustainable Practices Open
Background: In Europe, off-patent biologicals and biosimilars are largely procured by means of tender procedures. The organization and design of tenders may play a key role in the evolving biosimilar market, and currently, it is not fully …