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Best Practices for Medical Information Global Response Documents from phactMI and MILE
Best Practices for Medical Information Global Response Documents from phactMI and MILE
Medical information departments within pharmaceutical companies play a critical role in addressing unsolicited healthcare ...
Shaping the Future of Evidence Generation: Real-World Data to Drive Healthcare Transformation and Patient-Centered Decisions
Shaping the Future of Evidence Generation: Real-World Data to Drive Healthcare Transformation and Patient-Centered Decisions
The increasing complexity of healthcare decision making and the demand for real-world evidence call for a transformation i...
Association Between Survival Benefits of Anticancer Drugs and Probability of US Food and Drug Administration Approval: A Systematic Review
Association Between Survival Benefits of Anticancer Drugs and Probability of US Food and Drug Administration Approval: A Systematic Review
Survival benefit constitutes the primary pillar of therapeutic efficacy in oncology. However, the survival benefits observ...
Development of a Taste-Masked, Dose-Flexible, Multiparticulate Pediatric Dosage Form: Case Study of Crizotinib, a Challenging Pediatric Formulation
Development of a Taste-Masked, Dose-Flexible, Multiparticulate Pediatric Dosage Form: Case Study of Crizotinib, a Challenging Pediatric Formulation
Developing pediatric dosage forms remains challenging, particularly for poorly palatable drugs, which can limit tolerabili...
Transformation of a Medical Information Department to Meet the New Healthcare Realities of the Post-Pandemic Era
Transformation of a Medical Information Department to Meet the New Healthcare Realities of the Post-Pandemic Era
The role of Medical Information in the pharmaceutical industry is undergoing a profound transformation, driven by evolving...
Paediatric Phase I/II Clinical Trial Assessments Under the New EU Clinical Trial Regulation: A Descriptive Analysis
Paediatric Phase I/II Clinical Trial Assessments Under the New EU Clinical Trial Regulation: A Descriptive Analysis
Children remain underrepresented in clinical research, despite regulatory frameworks like the EU Paediatric Regulation and...
Evaluation of the Quality Decision-Making Practices Utilized by the Zambia Medicines Regulatory Authority Technical Committees
Evaluation of the Quality Decision-Making Practices Utilized by the Zambia Medicines Regulatory Authority Technical Committees
A consistent and transparent approach is essential for quality decision-making in the review and approval of medicines. Th...
Regulating the Irregular: Phage Therapy and the Case for a Regulatory Sandbox Approach in Australia
Regulating the Irregular: Phage Therapy and the Case for a Regulatory Sandbox Approach in Australia
Bacteriophages (phages) are viruses that selectively kill bacteria and offer a promising option to address the growing glo...
A Framework for Standardising Toxicity Management Guidelines in Oncology Clinical Trials
A Framework for Standardising Toxicity Management Guidelines in Oncology Clinical Trials
For new investigational medicinal products (IMPs) entering clinical development, toxicity management guidelines (TMGs) can...
Language as an Eligibility Criterion in Pediatric Study Protocols Conducted in Europe (2007–2024) Reported in the ClinicalTrials.gov Database
Language as an Eligibility Criterion in Pediatric Study Protocols Conducted in Europe (2007–2024) Reported in the ClinicalTrials.gov Database
One of the challenges in accessing cross-border clinical trials involving international participants in Europe is language...
Embracing Digital as a Paradigm Shift in Medical Affairs
Embracing Digital as a Paradigm Shift in Medical Affairs
Digital transformation is increasingly shaping how the Medical Affairs (MA) function generates insights, engages ...
Animal Models for Drug Discovery in Schizophrenia: A Critical View from a Clinical Perspective
Animal Models for Drug Discovery in Schizophrenia: A Critical View from a Clinical Perspective
Schizophrenia is a complex neuropsychiatric disorder manifesting with diverse positive and negative symptoms as well as co...
Integrated Evidence Generation Planning: Why Medical Affairs is a Critical Partner
Integrated Evidence Generation Planning: Why Medical Affairs is a Critical Partner
In an era of rapidly evolving healthcare systems and escalating demands for value demonstration, pharmaceutical companies ...
Digital Transformation in Pharmaceutical R&D in a Midsized Company: Unlocking Innovation Through Human and Organizational Factors
Digital Transformation in Pharmaceutical R&D in a Midsized Company: Unlocking Innovation Through Human and Organizational Factors
Digital transformation presents a strategic imperative for the pharmaceutical industry, particularly within research and d...
Application of Actor Network Theory to Evaluate Supply and Demand Strategies Used to Encourage International Biosimilar Uptake
Application of Actor Network Theory to Evaluate Supply and Demand Strategies Used to Encourage International Biosimilar Uptake
Biosimilar medicines have the potential to reduce costs and expand patient access, yet uptake rate remains uneven world-wi...
Impact of Regional Healthcare Policy Interventions on Biosimilar Use: A 10-year Evaluation of TNFα Inhibitors Utilization in Italy
Impact of Regional Healthcare Policy Interventions on Biosimilar Use: A 10-year Evaluation of TNFα Inhibitors Utilization in Italy
Tumor neurosis factor alpha (TNFα) inhibitors are widely used for the treatment of immune-mediated inflammatory disea...
Empowering Medical Affairs Professionals in Their Critical Role in Integrated Evidence Generation Planning
Empowering Medical Affairs Professionals in Their Critical Role in Integrated Evidence Generation Planning
An integrated evidence generation plan (IEGP) can transform the effectiveness of how pharmaceutical companies demonstrate ...
Safety Warnings on the Same Harmful Effects of Medicines: A Comparison of Four National Regulators
Safety Warnings on the Same Harmful Effects of Medicines: A Comparison of Four National Regulators
Safety advisories provide critical information to clinicians and patients on the harms of medicines. Previous research has...
Pioneering the Future of Medical Affairs: A Strategic Transformation to Meet the Spanish Healthcare Ecosystem’s Evolving Trends
Pioneering the Future of Medical Affairs: A Strategic Transformation to Meet the Spanish Healthcare Ecosystem’s Evolving Trends
The role of medical affairs (MA) in the pharmaceutical industry is undergoing a profound transformation, driven by the inc...
Treatment Persistence in Rheumatoid Arthritis Before and After Etanercept Biosimilar Introduction: A Nationwide Australian Real-World Study
Treatment Persistence in Rheumatoid Arthritis Before and After Etanercept Biosimilar Introduction: A Nationwide Australian Real-World Study
Australia has one of the highest rates of rheumatoid arthritis (RA) worldwide. Etanercept, a widely used biologic for seve...
Utilization of Evidence Blueprint Initiative to Transform Capability Development in AstraZeneca Spain
Utilization of Evidence Blueprint Initiative to Transform Capability Development in AstraZeneca Spain
The role of Medical Affairs (MA) has shifted from traditional evidence dissemination to an integrated process leveraging r...
A Framework for Considering the Role of the Public Sector in R&D of Health Technology
A Framework for Considering the Role of the Public Sector in R&D of Health Technology
The development of health technologies involves complex, costly, and risky investments, with significant contributions fro...
Awareness and Experience of Direct Healthcare Professional Communication and Risk Management Plan Educational Material among Healthcare Professionals in Finland
Awareness and Experience of Direct Healthcare Professional Communication and Risk Management Plan Educational Material among Healthcare Professionals in Finland
Additional risk minimization measures (aRMMs), such as direct healthcare professional communication (DHPC) and risk manage...
Development of a Competency Framework for Medical Affairs Professionals in Australasia
Development of a Competency Framework for Medical Affairs Professionals in Australasia
Medical Affairs (MA) plays a critical role in bridging the gap between research, clinical practice and business strategy. ...
The Utility of Tissue-Agnostic Drugs in Lung Cancer Treatment
The Utility of Tissue-Agnostic Drugs in Lung Cancer Treatment
Tissue-agnostic therapies, which target molecular alterations across cancer types, have been approved by the US Food and D...
The Evolution of Medical Affairs Central Teams: Shaping Strategic Action and Driving Healthcare Transformation Through Scientific Interaction
The Evolution of Medical Affairs Central Teams: Shaping Strategic Action and Driving Healthcare Transformation Through Scientific Interaction
The evolving role of Medical Affairs (MA) has positioned this department as a key element in the development and lifecycle...
Studies of Cannabinoid-Based Products in ClinicalTrials.gov: A Scoping Review
Studies of Cannabinoid-Based Products in ClinicalTrials.gov: A Scoping Review
There is increased interest in using cannabinoid-based products for therapeutic purposes. Because of unique regulatory cha...
Publicly Available Clinical Trial Safety Data: Review and a Call for Standardization and Improved Reporting Practices
Publicly Available Clinical Trial Safety Data: Review and a Call for Standardization and Improved Reporting Practices
Comprehensible reporting of clinical trial safety data is essential for multiple stakeholders, including ongoing safety re...
P.O.L.A.R. Star: A New Framework Developed and Applied by One Mid-Sized Pharmaceutical Company to Drive Digital Transformation in R&D
P.O.L.A.R. Star: A New Framework Developed and Applied by One Mid-Sized Pharmaceutical Company to Drive Digital Transformation in R&D
Digital transformation has become a cornerstone of innovation in pharmaceutical research and development (R&D). Ph...
Evaluation of the Effectiveness of Additional Risk Minimization Measures for Ixazomib Citrate for Relapsed/Refractory Multiple Myeloma in Japan: A Web-Based Survey Among Pharmacists
Evaluation of the Effectiveness of Additional Risk Minimization Measures for Ixazomib Citrate for Relapsed/Refractory Multiple Myeloma in Japan: A Web-Based Survey Among Pharmacists
Ixazomib citrate (IXA) in combination with lenalidomide and dexamethasone (IRD therapy) has been approved for the treatmen...
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