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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: Identifying and overcoming challenges in the EMA’s qualification of novel methodologies: a two-year review
Identifying and overcoming challenges in the EMA’s qualification of novel methodologies: a two-year review Open
The EMA Qualification of Novel Methodologies procedure qualifies methods, technologies and methodologies within a well-defined context of use in a pharma R&D context based on the evaluation of the presented scientific rationale and sub…
View article: Insights into Early Interactions on Innovative Developments with European Regulators
Insights into Early Interactions on Innovative Developments with European Regulators Open
Introduction The European Medicines Agency Innovation Task Force (ITF) acts as early point of contact for medicine and technology developers to enable innovation during early drug development stages through ITF briefing meetings. Aim To re…
View article: Enabling technologies driving drug research and development
Enabling technologies driving drug research and development Open
One of the strategic goals of the European Medicines Agency (EMA) and the European Medicines Regulatory Network is to support the research and uptake of innovative methods and technologies in the development of medicines. To promote this g…
View article: Biomarkers in Medicines Development—From Discovery to Regulatory Qualification and Beyond
Biomarkers in Medicines Development—From Discovery to Regulatory Qualification and Beyond Open
Biomarkers are important tools in medicines development and clinical practice. Besides their use in clinical trials, such as for enrichment of patients, monitoring safety or response to treatment, biomarkers are a cornerstone of precision …
View article: Biomarker Qualification at the European Medicines Agency: A Review of Biomarker Qualification Procedures From 2008 to 2020
Biomarker Qualification at the European Medicines Agency: A Review of Biomarker Qualification Procedures From 2008 to 2020 Open
Regulatory qualification of biomarkers facilitates their harmonized use across drug developers, enabling more personalized medicine. This study reviews various aspects of the European Medicines Agency’s (EMA’s) biomarker qualification proc…
View article: Biomarker and Companion Diagnostics—A Review of Medicinal Products Approved by the European Medicines Agency
Biomarker and Companion Diagnostics—A Review of Medicinal Products Approved by the European Medicines Agency Open
Background: An increasing number of medicines authorised in Europe recommend or require biomarker-based patient selection. For some of these the use of a companion diagnostic (CDx), a subset of in vitro diagnostics (IVDs), to identify pati…
View article: Commentary on ICH guideline on genomic sampling and data management‐enabling opportunities in drug development and patient treatment
Commentary on ICH guideline on genomic sampling and data management‐enabling opportunities in drug development and patient treatment Open
The ability to benefit from knowledge of human genomic data in medicine has been anticipated since the sequencing of the human genome. That promise has experienced some degree of realization, particularly in oncology where biomarker‐specif…
View article: Advanced Methods for Dose and Regimen Finding During Drug Development: Summary of the EMA/EFPIA Workshop on Dose Finding (London 4–5 December 2014)
Advanced Methods for Dose and Regimen Finding During Drug Development: Summary of the EMA/EFPIA Workshop on Dose Finding (London 4–5 December 2014) Open
Inadequate dose selection for confirmatory trials is currently still one of the most challenging issues in drug development, as illustrated by high rates of late‐stage attritions in clinical development and postmarketing commitments requir…
View article: The EU is ready for non-biological complex medicinal products
The EU is ready for non-biological complex medicinal products Open
This paper describes the existing European Union legislation and scientifi c guidance to adequately assess the quality, safety and effi cacy, as well as the lifecycle mana gement, of the group of non-biological complex drug (NBCD) products…
View article: Changes and determination of dosing recommendations for medicinal products recently authorised in the European Union
Changes and determination of dosing recommendations for medicinal products recently authorised in the European Union Open
Using modelling and simulation, pharmacogenomics, population pharmacokinetics, physiologically based pharmacokinetic models and drug-drug interaction studies in conjunction with well-designed clinical trials will improve the understanding …