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Tuesday, 17 January 2017

ADAPTSMART: Accelerated Development of Appropriate Patient Therapies -

London, EMA, 17th January 2017: ADAPT SMART is a  platform funded by the European Union's IMI (Innovative Medicines Initiative) for the coordination of Medicines Adaptive Pathways to Patients (MAPPs) activities, involving multi-stakeholder approaches from research through to treatment outcomes.

MAPPs seek to foster access to beneficial treatments for the right patient groups at the earliest appropriate time in the product life-span in a sustainable fashion.

The European Medicines Agency is today hosting at Canary Wharf in London an expert workshop on ADAPTSMART, with delegates from throughout the European Region, from the Japanese medicines agency and elsewhere.

Topics include:

- appropriate use of medicines

- timely access to innovative medicines and other interventions

- early access medicine schemes

- protected therapeutic schemes e.g. cancer access funds

 - compassionate use

- expanded access pathways

- shortened timelines for approvals

- international comparisons for consequences of inappropriate prescribing - non-compliance with treatment guidelines. Differences will be considered where reimbursement is linked to compliance with prescribing guidelines.

See more on the ADAPTSMART website about key work packages and other aspects.

Wednesday, 4 January 2017

EACPT supports first study of essential competencies in prescribing among European medical students


EACPT has funded the first study of Essential Competencies in Prescribing among European medical students. The study was led by the Working Group on Education of the EACPT and involved 895 Final-Year Medical Students attending 26 medical schools in 17 European countries.  
European medical students should have acquired adequate prescribing competencies before graduation, but prior to this study it was not known whether this is the case. In this international multicenter study, the researchers evaluated the essential knowledge, skills, and attitudes in clinical pharmacology and therapeutics (CPT) of final-year medical students across Europe. In a cross-sectional design, 26 medical schools from 17 European countries were asked to administer a standardized assessment and questionnaire to 50 final-year students. 

Although there were differences between schools, results showed an overall lack of essential prescribing competencies among final-year students in Europe. Students had a poor knowledge of drug interactions and contraindications, and chose inappropriate therapies for common diseases or made prescribing errors.

These important findings results suggest that undergraduate teaching in CPT is inadequate in many European schools, leading to incompetent prescribers and potentially unsafe patient care. A European core curriculum with clear learning outcomes and assessments should be urgently developed.



The EACPT was founded 24 years ago and now includes as members all national organisations for clinical pharmacology in Europe, as well as organisations from further afield internationally. The EACPT aims to provide educational and scientific support for the more than 4000 individual professionals interested in clinical pharmacology and therapeutics throughout the European region, with its congresses attended by a global audience. The EACPT also advises policy makers on how the specialty can contribute to human health and wealth.

Thursday, 8 December 2016

Adaptive pathways for medicine evaluation and unmet medical need: the access v. evidence dilemma


adaptive pathways at its Canary Wharf London headquarters: a hot topic with around 150 delegates from healthcare, patient and consumer organisations, academia, industry and regulatory bodies.



The European Medicines Agency is organising this workshop in collaboration with the European Commission to gather views and proposals from stakeholders on the adaptive pathways approach, in light of the practical experience gained during the pilot project EMA ran between March 2014 and August 2016, and to plan the next steps in the exploration of this concept. 



The basis for considering adaptive pathways for evaluating medicines is to meet the challenges underlying how to resolve high unmet medical need with then aim of licensing products likely to have a major impact on patient morbidity and/or life expectancy.



The desire is to find ways to reduce unavoidable uncertainties as rapidly as possible for serious/rare debilitating and life-shortening illnesses. There are clear ethical and scientific challenges in using novel approaches to evaluate medicines without a decline in the quality of evidence on the effectiveness and safety of new treatments. 



Products which might be considered for use of adaptive evaluation pathways include both conventional medicines and advanced therapy medicinal products (ATMPs). ATMPs are medicinal product which involve either a gene therapy medicinal, a somatic cell therapy or a tissue engineered product [see more on ATMPs at Directive 2001/83/EC as amended by the ATMP Regulation 1394/2007].



Adaptive pathways contribute to an expanded  toolbox for evidence generation where conventional randomized controlled trials are not-appropriate or practical. Principles include using processes to allow rapid reaction to uncertainty by iterative development based on ongoing analysis of  pathway data [“rapid cycle analysis”]. As secondary end-points are welcomed, these pathways require pre-planning across the entire product life-span, including the post-marketing paths ie active monitoring and management of on-market use.

The adaptive pathway approach is dependent on earliest stage and ongoing multi-stakeholder networking, underpinned by risk management plans. 



Critical issues include

- resolving scientific trust in real world data and the need to develop mature, robust registries

- defining and prioritising unmet medical needs

- agreement on acceptable risks and benefits early access worth it (vs.

- maintaining safety standards

- ensuring that benefits outweigh risks

- avoiding unrealistic expectations

- establishing practical criteria for reimbursement, especially when secondary outcome measures form the basis for market authorization   











The EACPT was founded 24 years ago and now includes as members all national organisations for clinical pharmacology in Europe, as well as organisations from further afield internationally. The EACPT aims to provide educational and scientific support for the more than 4000 individual professionals interested in clinical pharmacology and therapeutics throughout the European region, with its congresses attended by a global audience. The EACPT also advises policy makers on how the specialty can contribute to human health and wealth.


Tuesday, 15 November 2016

Opportunities from Big Data for safer medicines

14-15 November, 2016: The European Medicines Agency is hosting a web-casted workshop in London on identifying opportunities from "Big Data" in development and regulation of medicines. There has been such strong interest that a much larger venue is being used than available at its usual Canary Wharf centre, with perspectives from EU and USA policy makers, regulators, academia, health professionals and industry.

The EMA note: "Rapid developments in technology have led to the generation of vast volumes of data, which have the capability to transform the way the benefit-risk of medicinal products is assessed over their entire life cycle. However, it is recognised there are multiple challenges in the exploitation of these data. These range from the fundamental need to establish methods to enable the access to, integration and analysis of heterogeneous datasets to understanding the limitations in its use. Importantly, robust and transparent mechanisms to protect patient confidentiality are key to secure patient trust. It is important for the European Medicines Agency and the European Union medicines regulatory network to gather information on the latest developments in big data from the perspective of all stakeholders in order to identity how and when the multitude of data sources may contribute to medicinal product development, authorisation and post-marketing surveillance."

Some key threads and discussion points:
- the importance of the FAIR principles (data should be Findable, Accessible, Interoperable and
- Reusable)
- access for health professionals and researchers to the European Open Science Cloud
- a major EU initiative to promote data curation
- the power of the Cloud for cross-platform data sharing
- Big Data applied to precision medicine and pharmacogenomics
- bias in datasets
- Big Data and new EU General Data Protection Regulations - from May 2018, replacing Directive 95/46
- machine-learning for chemogenomics
- challenges to implementing applications to precision medicines in 'time poor' clinical practice
- OHDSI comumity - access to international health record data sources
- twitter not designed as a health app but may provide complementary insight into unexpected adverse effects of medicines to that obtained through traditional pharmacovigilance routes
- transferable learning - e.g. from use of Big Data in transport networks
- case studies in the EU and USA
- trade-offs: methods might be rapid, unbiased and accessible/usable by the inexperienced: but not all three
- challenges in the European Region to maximise learning from Big Health Data when there are 28 independent national health care systems with barriers and challenges to data-sharing

All talks are due to be made available on the EMA website for public access.

Friday, 21 October 2016

Safer medicines for children

From the EACPT Focus Meeting on How to Assess Medicines, Opatija, 6-9 October 2016. 

In this video, Donald Singer discusses with speaker Suzana Mimica Matanović evaluation of drugs in the pediatric population.

Discussants

Suzana Matanović: Assistant Professor of Clinical Pharmacology, School of Medicine, University of Osijek, Croatia and PCO alternate delegate at the European Medicines Agency.

Professor Donald Singer: member of the Executive Committee of the European Association for Clinical Pharmacology and Therapeutics and EACPT delegate on the European Medicines Agency Health Professionals Working Party.



 
The next EACPT biennial congress will be held in Prague Congress from 24th - 27th June 2017. The programme will provide an international scientific and educational forum for discussion of clinical pharmacology and therapeutics, including personalised pharmacotherapy. See more on our website

Anyone from anywhere in the world with a professional interest in clinical pharmacology and therapeutics can now join the EACPTas an Individual Associate member.
Membership benefits include:
* Access to videos of talks from EACPT Meetings
* Discounted registration fees for EACPT meetings
* Online access to the Official EACPT Journal - Clinical Therapeutics
* Access to the EACPT’s worldwide network of Individual Associate Members
* Active involvement in EACPT  

The EACPT was founded 24 years ago and now includes as members all national organisations for clinical pharmacology in Europe, as well as organisations from further afield internationally. The EACPT aims to provide educational and scientific support for the more than 4000 individual professionals interested in clinical pharmacology and therapeutics throughout the European region, with its congresses attended by a global audience. The EACPT also advises policy makers on how the specialty can contribute to human health and wealth.

Wednesday, 19 October 2016

WEB-RADR - innovative use of mobile technology and social media to monitor safety of medicines

The European Medicines Agency is today hosting an update workshop on the 3 year

Innovative Medicines Initiative WEB-RADR project, which was launched in September 2014.
 
The project includes a series of work packages for partner organisations in Europe and the USA aimed at developing and evaluating use of mobile technology and social media as tools to monitor the safety of medicines.
 
Patients experiencing suspected adverse reactions to medicines can report these to their physician or pharmacist. In the UK and since 2014 throughout the European Union, patients can now also report suspected drug reactions direct to their national medicine safety authority. However reporting is inconsistent and important adverse side-effects may not be detected until a large number of patients have already been exposed to risk from a medicine.

Three countries in Europe - the UK, the Netherlands and Croatia - are now to evaluating a WEB-RADR mobile app for reporting suspected adverse drug reactions (side effects). The app allows patients and health professionals to reports suspected adverse drug reactions securely to the relevant National Medicines Regulatory Authority.

The Workshop is reporting on experience so far of app-based safety reporting, perspectives and expectations from patients and health professionals and data protection issues.


Wednesday, 12 October 2016

Clinical drug-drug interaction studies: methods, pitfalls and interpretation

From the EACPT Focus Meeting on How to Assess Medicines, Opatija, 6-9 October 2016. In this video, Donald Singer discusses with Janne Backman from Helsinki how to identify and minimise risk of drug-drug interactions.


Discussants
Janne Tapio Backman: Professor in Clinical Pharmacology and Individual Medicine, University of Helsinki, Finland
Professor Donald Singer: member of the Executive Committee of the EACPT and member  of the European Medicines Agency Health Professionals Working Party.


Here is a summary of the key points from Professor Backman's  talk at the EACPT Focus Meeting in Opatija: 

Drug-drug interactions can either markedly reduce or enhance the therapeutic or adverse effects of drugs by causing alterations in the pharmacokinetics or pharmacodynamics of drugs. If such interactions are not understood or accounted for in patient care, they can have harmful, even hazardous clinical consequences. 

Drug-drug interactions have been a major cause of drug withdrawals from the market. Regulatory agencies, including the European Medicines Agency (EMA) have therefore published guidance documents that are designed for the industry to guide their DDI studies during drug development. In particular, detailed scientific recommendations can be given concerning pharmacokinetic interactions, because such interactions can be mediated via mechanistic changes in absorption, distribution, metabolism and excretion of drugs. 

Specific approaches are suggested concerning cytochrome P450 enzymes (CYPs), non-CYP enzymes and membrane transporters. In addition, current guidance also recommends use of modelling approaches, such as physiologically based pharmacokinetic (PBPK) models to design and extend the interpretation of preclinical and clinical drug-drug interaction studies. For designing clinical drug-drug interactions studies, detailed preclinical in vitro and early clinical pharmacokinetic information is necessary. 

Despite detailed guidelines, there are many challenges in characterization of the interaction potential of a drug, both as a perpetrator and as a victim of the interaction. Such challenges arise from complex interaction mechanisms, eg, simultaneous involvement of transporters and drug metabolizing enzymes, autoinhibition and autoinduction of metabolism, time-dependent inhibition and involvement of major drug metabolites. 

Understanding the challenges and pitfalls of drug-drug interaction studies is thus necessary in interpretation of the results of studies. In this lecture, basic methods of clinical drug-drug interaction studies will be reviewed, with examples of potential pitfalls and basic principles of interpretation.
  
The next EACPT biennial congress will be held in Prague Congress from 24th - 27th June 2017. The programme will provide an international scientific and educational forum for discussion of clinical pharmacology and therapeutics, including personalised pharmacotherapy. See more on our website

Anyone from anywhere in the world with a professional interest in clinical pharmacology and therapeutics can now join the EACPT as an Individual Associate member.

Membership benefits include:

* Access to videos of talks from EACPT Meetings
* Discounted registration fees for EACPT meetings
* Online access to the Official EACPT Journal - Clinical Therapeutics
* Access to the EACPT’s worldwide network of Individual Associate Members
* Active involvement in EACPT  
The EACPT was founded 24 years ago and now includes as members all national organisations for clinical pharmacology in Europe, as well as organisations from further afield internationally. The EACPT aims to provide educational and scientific support for the more than 4000 individual professionals interested in clinical pharmacology and therapeutics throughout the European region, with its congresses attended by a global audience. The EACPT also advises policy makers on how the specialty can contribute to human health and wealth.