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Tuesday, 14 March 2017

Personalised Medicines: role of patients, consumers and health professionals

London, 14th - 15th March
The European Medicines Agency is hosting workshops for its Working Parties of  Patients', Consumers' and Health Professionals' organisations.

The 14th March workshop aims to create awareness among these organisations of how the work of the European Medicines Agency (EMA) relates to personalised medicines. 

The 15th March workshop provides updates on other EMA and relevant external acfivities including feedback on topic groups on Social Media and on Risk Minimisation from medicines, European Antibiotic Awareness, Action plans on Biosimilars, feedback from key EMA committees and synergies with other organisations.

Speakers included:  
- Sandra Kweder from the US Food and Drugs Administration, discussing  the US precision medicine initiative. She highlighted the need to personalise medicines with cancer a key driver - only 80% of patients estimated to respond better when individual genomic and proteomic information is available.

- briefings from EMA's Scientific Committees e.g.  PRAC chair June Raine discussing pharmacogenomics in pharmacovigilance e.g. preventing serious skin reactions to abacavir in HIV patients and limiting toxicity of anti-cancer agents e.g. 5-fluoro-uracil and capecitabine

- updates from research organizations e.g. Denis Lacombe from EORTC  (European Organisation for Research and Treatment of Cancer) on changing clinical research pathways, very expensive drugs and data-driven healthcare from "-omics" to "economics".

- developing diagnostics and treatments for rare diseases e.g. from Julian Isla on improvind management of Dravet Syndrome - a rare, catastrophic, lifelong form of epilepsy that begins in the first year of life with frequent and/or prolonged seizures. 

- Ulrich Jäger from the European Haematology Association on health professional perspectives on precision medicine, including practical challenges to applying precision medicine within a typical 7-12 minute consultation.  

- Dominique Monnet from the ECDC [European Centre for DiseasePrevention and Control] reported on progress in developing European Antibiotic Awareness days, held annually on 18th November. The ECDC is mandated to monitor current and potential future risks to human health from communicable disease. Individual EU member states are responsible for risk management of established incidence of communicable diseases.

- Camille Vlaminckx and Rosa Gonzalez-Quevedo from the EMA discussed progress by its Biosimilars Working Party and plans for making information about biosimilars available to health professionals and the public.  Copy versions of original biotherapeutics are called called 'similar biological medicinal products' (biosimilars) by the European Medicines Agency in the European Union (EU). Guidance for developing of biosimilars is now available for 7 classes of medicines. The number of eligible biosimilars is increasing as originally developed biotherapeutics leave data/patent protection.

A 3rd annual stakeholder workshop on biosimilars is to be held on May 5th 2017, organised by the European Commission.  

- Michael Berntgen from EMA discussed areas of potential synergies between regulatory and HTA issues on the pre-marketing, market entry and post-marketing phases for medicines.

EMA will publish the presentations, video recording and a workshop report.