Update session on biosimilars released by European Medicines Agency

The European Medicines Agency has just released an update on biosimilars - the latest in its series of multimedia briefing sessions. The videos were recorded at a joint briefing session for EMA's Human Scientific Committees' Working Parties with Patients’ and Consumers’ Organisations (PCWP) and Healthcare Professionals’ Organisations (HCPWP).

Sessions include
- an introductory briefing by Professor Sir Kent Woods
- an overview of the science behind biosimilars
- how they are evaluated by regulators
- how to bridge the scientific evaluation with clinical reality
- public acceptability of biosimilars
- promoting better understanding of biosimilars

View the videos: 


The European Association for Clinical Pharmacology and Therapeutics (EACPT) was founded 22 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.

The 12th biennial Congress of the EACPT is being held in Madrid from 27^th to 30^th June 2015.

2015 EACPT Lifetime Achievement Award to go to Professor Michel Eichelbaum

We are delighted to announce that the 2015 Lifetime Achievement Award of the European Association of Clinical Pharmacology and Therapeutics will go to Professor Michel Eichelbaum for his outstanding contribution to the national and international benefits of clinical pharmacology for medicine, health care and patient safety.

The Award, which includes the EACPT silver medal, will be presented to Professor Eichelbaum during the 12th EACPT Congress in Madrid on Saturday 27th June 2015.

Michel Eichelbaum is one of the most cited pharmacologists in in the world. He has published

Professor Michel Eichelbaum

nearly 500 articles, reviews and book chapters and numerous abstracts, and his work has been cited over 25,000 times by other authors. His primary research interest has been the pharmacogenetics of drug metabolizing enzymes and transporter proteins. He was also one of the pioneers of studying various aspects of the stereochemistry of drugs, the use of stable isotopes in clinical pharmacology and intestinal metabolism and transport of drugs. 

In 1975, he discovered a genetic polymorphism in the oxidation of the antiarrhythmic and oxytocic drug, sparteine, which later became known as CYP2D6 polymorphism. This is considered his single most important scientific discovery. Later, he became involved in research on factors involved in the regulation of drug-metabolizing enzymes and transporters with special emphasis on nuclear receptors. This basic research is supplemented by clinical studies in oncology with special emphasis on breast cancer treatment, HIV, psychiatry and organ transplantation in which the consequences of genetic polymorphisms of these proteins for drug effects and toxicity are explored.

He was born in Leipzig on 19 May 1941. He studied medicine at the University of Heidelberg between 1960 and 1966, and he defended his doctoral thesis at this University in 1968. During 1966 to 1968, he was an intern in Internal Medicine, Surgery and Gynaecology and Obstetrics. Between 1968 and1976, he was a resident in Internal Medicine at University Hospitals of Giessen and Bonn. From 1976-1985, he was attending physician and Associate Professor of Internal Medicine and Clinical Pharmacology at the Department of Medicine, University of Bonn.

He is a specialist in both Clinical Pharmacology and in Internal Medicine. From 1985 and 21 years onwards, he was the Director of the Dr. Margarete Fischer-Bosch Institute of Clinical Pharmacology, Stuttgart, Germany. Simultaneously, he was Professor and Chairman of Clinical Pharmacology at the University of Tübingen, and in 2001 he became Adjunct Professor at the University of Adelaide, Australia.

During his career, Michel Eichelbaum has obtained several Research Fellowships. During 1970-1971, he worked in the Laboratory of Chemical Pharmacology, National Heart and Lung Institute, National Institutes of Health, Bethesda, USA, together with Drs. B.B. Brodie and J.R. Gillette. From 1973-1974, he was working at the Department of Clinical Pharmacology, Karolinska Institute in Stockholm, Sweden, together with Professor Folke Sjöqvist, and from 1995-1996 he was a Visiting Professor at the Department of Clinical and Experimental Pharmacology, University of Adelaide, Australia. Michel Eichelbaum has received numerous awards and honours. This year, he was honoured with the Oscar B. Hunter Memorial Award in Therapeutics from the American Society of Clinical Pharmacology and Therapeutics. He is the third European to receive this prize. 

The EACPT was founded 22 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.

2015 EACPT Scientific Award announced

The 2015 EACPT Scientific Award for Professor Nicholas Bateman

The 2015 EACPT Scientific Award is to be conferred on UK Scientist Professor Nicholas Bateman for work on treating paracetamol overdose. The Award which includes a prize of 2000€ will be presented to Professor Bateman at the 12th EACPT Congress in Madrid on Tuesday 30th June 2015.

Professor Bateman's research, which was published in the international medical journal

Professor Nicholas Bateman

The Lancet, involved a clinical trial comparing a new regimen to treat paracetamol poisoning with the current one (which has been used for over 40 years). It is the first large-scale, properly powered and randomised controlled clinical trial conducted in paracetamol poisoning, a challenging environment for trial work. 

This work shows that it is possible to do trials in a group of patients in the emergency room, and across transfer to the wards, most of whom were intending self-harm. This work also shows that other key trials may be possible in this group of patients and in others with overdose. This work also shows how critical are the skills of clinical pharmacology to the design of good clinical toxicology studies.

Paracetamol poisoning is common worldwide and the current standard treatment is complicated and associated with adverse effects related to concentration. The result of Professor Bateman's trial shows that a shorter, simpler infusion regimen of acetylcysteine can cause a major reduction in adverse effects of this important antidote. 

In combination with new biomarkers, that allow identification of at risk patients, this offers the opportunity to simplify treatment, reduce adverse events and shorten hospital stays. The UK MHRA (Medicines and Healthcare products Regulatory Agency) is establishing a working group to take the results of this work forward.

Professor David Nicholas (Nick) BATEMAN BSc, MD, FRCP, FRCP(E), FBPhS, FBTS, FAACT, FEAPCCT, is Honorary Professor in Clinical Toxicology at the University of Edinburgh. His research interests are in clinical toxicology, poisons information systems, and toxico-epidemiology. He has been awarded the Louis Roche award from the European Association of Poisons Centres and Clinical Toxicologists and the Lilly Prize of the British Pharmacology Society. He has published over 160 original research articles, many reviews, edited The Oxford Desk Reference Toxicology and contributed 35 book chapters.

Professor Bateman qualified in medicine at Guy's Hospital Medical School, London. Trained in Clinical Pharmacology in Southampton, the Royal Postgraduate Medical School (Hammersmith Hospital) London, and Newcastle upon Tyne, UK, where he worked for 20 years. He moved to Edinburgh in 1998 as Consultant Clinical Toxicologist and Director, National Poisons Information Service Edinburgh unit (Scottish Poisons Information Bureau) (1998-2012), Royal Infirmary of Edinburgh. Professor Bateman was Chairman of the Poisons Board (UK Home Office) from 2012-2104 and was formerly member of the MHRA Sub-Committee on Pharmacovigilance; the Advisory Committee on Pesticides (HSE) and Chair Medical and Scientific Sub Committee; Veterinary Products Committee (VMD).

He is a Past-President of the European Association of Poison Centres & Clinical Toxicologists.  He was Editor-in-Chief of Clinical Toxicology 2009-11 and formerly managing editor of the European Journal of Clinical Pharmacology (2002-9) and executive editor of the British Journal of Clinical Pharmacology (1988-94). 

Special Recognition for researcher Dr Eva-Luise Hobl from Austria

The EACPT has also awarded Special Recognition to researcher Dr Eva-Luise Hobl from

Dr Eva-Luise Hobl

Austria for her work showing that the pain-killer morphine reduces the blood-thinning effects of the anti-platelet medicine clopidogrel. 

It had been observed that treatment with morphine may lead to poorer outcome after heart attack. Dr Hobl's work, published in the major US publication the Journal of the American College of Cardiology, showed that morphine reduces the absorption, blood levels and effects of the antiplatelet agent clopidogrel. This important drug-drug interaction could reduce the intended effects of clopidogrel to prevent heart attack and other serious vascular diseases. This work suggests that when morphine use is indicated after heart attack, alternative antiplatelet agents should be used.

Dr Hobl studied Pharmacy at the University of Vienna and obtained her Doctor of Applied Medical Science degree from the Medical University of Vienna. Between 2005 and 2008, she worked as a hospital pharmacist and started her studies at the Medical University of Vienna in 2007, where she is now postdoctoral research associate. Her main research interest is in drug-drug interactions of antiplatelet drugs. For this work, she has already received several awards; particularly noteworthy are the “Samuel A. Levine Young Clinical Investigator Award” from the American Heart Association and the “EPHAR Young Clinical Investigator Award 2014”.

Congress on Pharmacoeconomics and Outcomes Research: 23-26 April, 2015, Croatia

5th Adriatic and 4th Croatian Congress of Pharmacoeconomics and Outcomes Research: 23-26 April, 2015.

This important International Congress will be held in Šibenik, Croatia, from 23rd to 26th

Šibenik harbour

April 2015.

It is organised by the Section for Pharmacoeconomics and Outcomes Research of the Croatian Society for Clinical Pharmacology and Therapeutics, Croatian Medical Association and under the auspices of the EACPT, the European Association of Clinical Pharmacology and Therapeutics. 

Speakers include EACPT Chair Professor Gonzalo Calvo and EACPT Chair-Elect Professor Tabassome Simon. 

See the meeting website for more information on the Programme and how to register.

Still time to register for the EACPT Congress in Madrid

Plaza major, Madrid

The 12th biennial Congress of the EACPT is being held in Madrid from 27^th to 30^th June 2015. There is still time to register for the Congress.

Over 500 abstracts have been accepted for presentation as e-posters. 54 oral presentations will be eligible for an award for the best talk.

Listen to podcasts from the latest EACPT Congress in Geneva

2013 EACPT Lifetime Award winner Professor Carlo Patrono on platelets, cardiovascular risk & cancer

Podcasts with speakers at the 2013 EACPT Congress in Geneva
- Patrick Mismetti on clinical drug development of new anticoagulants
- Tabassome Simon discusses Clinical Pharmacology and the FAST-MI Registry
- Tabassome Simon discusses the origins and importance of the FAST-MI Registry
- EACPT Congress keynote lecturer Ziad Mallat discusses developing a clinical research career
- EACPT Congress keynote lecturer Ziad Mallat discusses immunotherapy against vascular disease

Comments from delegates on the 2013 EACPT Congress in Geneva
- Swiss Delegates from Zurich and Basel
- Jelena Vukovic from Serbia & Marija Bosilkovska from Geneva
- George Dugbartey and Sorayeh Moradi
- Sarawut Jindarat from Thailand
- Yukari and Ryuichi Ogawa from Tokyo
- Kristina Münch and Barbara Pfistermeister from Germany
- Lada Leyens from Switzerland

Update from Kiel on the EACPT

The EACPT Executive Committee has been meeting in warm and sunny Kiel in

Altstadt - the old centre of Kiel

Northern Germany over the weekend of 10^th-11^th April, in advance of the 12th biennial Congress of the EACPT, to be held in Madrid from 27^th to 30^th June 2015.

The final programme was discussed for the 2015 EACPT Congress in Madrid. Over 500 abstracts have been accepted for presentation as e-posters and as 54 oral presentations, eligible for an award for the best talk.

EACPT EC Meeting at University in Kiel

The 12th EACPT Congress in 2015 is an unparalleled educational forum where you will learn about the newest developments, innovative techniques, and advanced practices in topics such as drug discovery, drug development, pharmacology and pharmacotherapy.
The Congress gives you the unique opportunity to network with top ranking specialists in pharmacology and pharmacotherapy, from around the world, and learn from the best. Reviews and commentaries from the Congress will be published in the EACPT Official Journal - Clinical Therapeutics.
The Congress will provide excellent formal and informal networking opportunities, supported after the Congress through the new website of the EACPT, due to be launched within the coming month.

There is to be launch of a new Associate Membership category for the EACPT, included within registration for the Madrid June 2015 Congress. Associate Members will have discounts on registration for EACPT Congresses and Focus Meetings, online access to the official EACPT journal Clinical Therapeutics, and many opportunities to become directly involved in networking with fellow clinical pharmacologists from throughout Europe and further afield.

Nominations were discussed for EACPT Awards to be presented at the 12^th EACPT Congress in Madrid. The EACPT Lifetime Award is for significant achievement in clinical pharmacology and therapeutics, both for the benefit of science and also for the benefit and health of the specialty, over a whole working life. The EACPT Scientific Award is awarded for the best scientific paper on a topic relevant to clinical pharmacology published by a European clinical pharmacologist in the two years between EACPT congresses. The EPHAR-EACPT award is by the Federation of European Pharmacology Societies (EPHAR) and the EACPT - a joint initiative to award the best work in translational research in pharmacology. There will be 2 awards of 1,000 € each, that will be given in 2015 to young scientists who have published an outstanding research paper in the past two years.
There were reports on interaction with other professional organisations and societies, including the European Medicines Agency, IUPHAR, the International Union of Pharmacology and EPHAR, the European Federation of Pharmacology Societies. Plans with EPHAR, in addition to the above awards, include a joint session on immunopharmacology during the Madrid Congress in June.
Calls were agreed for future EACPT Focus Meetings, with a deadline 31^st May 2015 for bids for summer 2016 and summer 2017. The 2017 meeting will be held in Prague as a Satellite Meeting of the 2017 EACPT Prague Congress
Bids were discussed in outline for the 2021 EACPT Congress, for which proposals from the Dutch Society for Clinical Pharmacology and the Hellenic Society of Basic and Clinical Pharmacology have been short-listed. The 2017 EACPT Congress will be held in Prague and the 2019 EACPT Congress in Stockholm.
Register for the EACPT Congress in Madrid – 27th-30th June 2015
Clinical Therapeutics -  Official Journal of the EACPT
__________________________________________________________
Listen to podcasts from the latest EACPT Congress in Geneva
2013 EACPT Lifetime Award winner Professor Carlo Patrono on platelets, cardiovascular risk & cancer


Podcasts with speakers at the 2013 EACPT Congress in Geneva
- Patrick Mismetti on clinical drug development of new anticoagulants
- Tabassome Simon discusses Clinical Pharmacology and the FAST-MI Registry
- Tabassome Simon discusses the origins and importance of the FAST-MI Registry
- EACPT Congress keynote lecturer Ziad Mallat discusses developing a clinical research career
- EACPT Congress keynote lecturer Ziad Mallat discusses immunotherapy against vascular disease


Comments from delegates on the 2013 EACPT Congress in Geneva
- Swiss Delegates from Zurich and Basel
- Jelena Vukovic from Serbia & Marija Bosilkovska from Geneva
- George Dugbartey and Sorayeh Moradi
- Sarawut Jindarat from Thailand
- Yukari and Ryuichi Ogawa from Tokyo
- Kristina Münch and Barbara Pfistermeister from Germany
- Lada Leyens from Switzerland

UK efforts to improve patient safety through better prescribing

Friday 13 Feb 2015: Important roles of Clinical Pharmacologists include contributing to effectiveness and safety of healthcare through education and training about medicines, and assessment of prescribing skills.

A commentary on ‘Prescribing safety: ensuring that new graduates are prepared’ has today been published in the Lancet by authors from EACPT national member, the British Pharmacological Society.

The commentary describes recent efforts in the UK to minimise prescribing errors in modern healthcare, centred on development and validation over the past 5 years of a national Prescribing Safety Assessment by the British Pharmacological Society in partnership with the UK Medical Schools Council.

These efforts illustrate internationally relevant ways to improve patient safety and the outcomes of treatment with medicines.

See the Lancet to read the Commentary which is available free of charge.