Deadline mid-February for 2017 Hippocrates Open and Health Professional Awards for Poetry and Medicine

With 3 weeks to go to the midnight 14th February deadline, there have already been entries from 21 countries and 5 continents, from Australia and New Zealand to throughout the USA, for the Hippocrates Prize for Poetry and Medicine, which has an awards fund of £5,500 (~USD 7,500).

Click here to find out more about the Hippocrates Prize and to enter online.

In addition to the Awards Symposium at Harvard Medical School on Saturday 6th May, from 6.30pm Friday 5th May there will be a session at the Boston Museum of Fine Art (MFA) on "Poetry and Training the Eye" involving objects and paintings inspired by health and illness, followed by a Reception at the MFA, followed by the opportunity to stay on at the MFA to enjoy the collections.

The judges for the 2017 International Open and Health Professional Awards are Neal Baer, Harvard-trained American paediatrician and Emma-award winning ER producer, Pulitzer-Prize winning poet Jorie Graham; Scottish Makar (national poet) Jackie Kay; and Professor Owen Lewis, New York, USA.  The 2017 Hippocrates Young Poets Judge will be judged by poet Maya Catherine Popa, New York City, USA (see details about the judges).

In the UK, clinical pharmacologist and prize co-founder Donald Singer said: “We are delighted to have such a distinguished panel of poets and health professionals as judges for the 2017 Hippocrates Prize.”

Harvard physician and poet Rafael Campo added: “ The Arts and Humanities Initiative of Harvard Medical School is very pleased to be supporting this major international prize, and to be hosting the awards ceremony, which will for the first time be presented in the USA.”

The 2017 Hippocrates Awards are being organised in partnership with the Arts and Humanities Initiative of Harvard Medical School. The Awards will announced by the judges at a ceremony at the close of the 8th International Symposium on Poetry and Medicine, to be held at Harvard Medical School on Saturday 6th May 2017.

Now in its 8th year, the Hippocrates Prize has attracted over 8000 entries from around the world, from the Americas to Fiji and Finland to Australasia. All awards are for a single unpublished poem in English of up to 50 lines of verse on a medical theme.

The International Open category is open to anyone in the world to enter. There have been entries from over 60 countries since the Hippocrates Prize was launched in 2009, with winning poets from Australia, Canada, France, Germany, Israel, New Zealand, Norway, South Africa, the UK and the USA.

The International Health Professional category is open to any in the world who is a Health Professional  employees, a health student or working in a professional organisation or charity involved in education and training of health professional students and staff or in supporting the care of patients.

The international Young Poet category: anyone in the world may enter who is aged under 19 years and at least 14 years old on the date of the Awards (6th May 2017). This £500 (~690 USD) award was launched in 2012. The 2017 Hippocrates Young Poets Prize for Poetry and Medicine is supported by the healthy heart charity the Cardiovascular Research Trust.

Notes for editors
For more on the Hippocrates Prize and the 2017 judges, contact +44 7494 450 805 or email hippocrates.poetry@gmail.com

The 2017 Hippocrates Prize is supported by:
UK philanthropist Anthony Fretwell-Downing.
The Arts and Humanities Initiative of Harvard Medical School.
The Healthy Heart Charity the Cardiovascular Research Trust, founded in 1996, which promotes research and education for the prevention and treatment of disorders of the heart and circulation.

More on the Judges for the 2017 Hippocrates Prize

New drugs to lower cholesterol: PCSK9 inhibitors

Results from new studies on cardiovascular prevention are due to be presented in mid-March at the 2017 American College of Cardiology Congress in Washington DC – findings from very large studies to test the effects of powerful new drugs to lower cholesterol.

Patients with high blood levels of LDL cholesterol are at higher risk of heart attack, stroke and other serious vascular disorders. 

Healthy lifestyle lowers LDL cholesterol. The benefit for cholesterol lowering and the associated reduction in serious cardiovascular diseases is greater the more approaches to a healthy are followed, including Mediterranean-type diet, avoiding tobacco products, regular exercise and moderation in alcohol. 

Statins are the most effective current treatment available for patients for lowering LDL cholesterol. However not all patients respond to statins and some patients are unable tolerate statins because of troubling or serious adverse effects.

PCSK9 inhibitors (PSK9i) are a new class of powerful drugs that can cause a major fall in high LDL cholesterol levels: by up to 60% when combined with a statin.  

The key questions to be addressed in these studies are whether this "surrogate" end-point of reduced LDL cholesterol translates into clinical benefits for patients – and if so whether the benefits outway risks both to health and in terms of cost-effectiveness,  compared to existing treatments.
 
These biological drugs are given to patients as a treatment by injection because they are designed as monoclonal antibodies (MAbs), proteins which would be inactivated in the gut is swallowed. MAbs use the principle of the body's own immune recognition proteins, which are able to recognise and limit damage from foreign proteins such as are found in viruses or cancers.

There are usually receptors on liver cells that transport LDL into the liver for it to be broken down, thus keeping the circulating level of LDL cholesterol on check. PCSK9 (proprotein convertase subtilisin kexin 9) is a protein in the liver that inactivates these LDL-scavenging liver cell receptors.  
 
The fewer of these receptors that are present in the liver, the more LDL ("bad") cholesterol persists in the blood to contribute to the development of disease of the arteries.  
Thus PCSK9 inhibitors, by inactivating the PCSK9 protein, allow more receptors to be available to capture LDL for removal from the blood.

ADAPTSMART: Accelerated Development of Appropriate Patient Therapies

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 fashiion.

The European Medicines Agency has just hosted (17th - 18th  January 2017) 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 included:

- 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

- need for cross-border data-sharing and research

- international comparisons for consequences of inappropriate prescribing - non-compliance with treatment guidelines

- linkeing reimbursement to compliance with prescribing guidelines

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

Save the date: Hippocrates Prize for Poetry and Medicine to be awarded at Harvard on 6th May 2017

In a joint launch in the UK and in the USA, the judges for the 2017 International Open and Health Professional Awards have been announced as Neal Baer, Harvard-trained American paediatrician and ER producer, Pulitzer-Prize winning poet Jorie Graham; Scottish Makar (national poet) Jackie Kay; and Professor Owen Lewis, New York, USA.  The 2017 Hippocrates Young Poets Judge will be judged by poet Maya Catherine Popa, New York City, USA (see details about the judges).

There have already been entries from 14 countries for the 2017 Hippocrates Prize for Poetry and Medicine - deadline 12mn local time on 14th February.

The Hippocrates Prize for Poetry and Medicine, has an awards fund of £5,500 (~USD 7,500). To find out more about the Hippocrates Prize and to enter online, see hippocratespoetry.wordpress.com

In the UK, clinical pharmacologist and prize co-founder Donald Singer said: “We are delighted to have such a distinguished panel of poets and health professionals as judges for the 2017 Hippocrates Prize.”

Harvard physician and poet Rafael Campo added: “ The Arts and Humanities Initiative of Harvard Medical School is very pleased to be supporting this major international prize, and to be hosting the awards ceremony, which will for the first time be presented in the USA.”

The 2017 Hippocrates Awards are being organised in partnership with the Arts and Humanities Initiative of Harvard Medical School. The Awards will announced by the judges at a ceremony at Harvard Medical School in Boston, USA, on Saturday 6th May 2017.

There will also be a pre-Symposium Poetry and Medicine Workshop at the Museum of Fine Art in Boston: Friday 5th May – 6.30pm.

Download flyer for Symposium, awards, and pre-Symposium Poetry Workshop at Boston Museum of Fine Art.

Now in its 8th year, the Hippocrates Prize has attracted over 8000 entries from around the world, from the Americas to Fiji and Finland to Australasia. All awards are for a single unpublished poem in English of up to 50 lines of verse on a medical theme.

The International Open category is open to anyone in the world to enter. There have been entries from over 60 countries since the Hippocrates Prize was launched in 2009, with winning poets from Australia, Canada, France, Germany, Israel, New Zealand, Norway, South Africa, the UK and the USA.

The International Health Professional category is open to any in the world who is a Health Professional  employees, a health student or working in a professional organisation or charity involved in education and training of health professional students and staff or in supporting the care of patients.

The international Young Poet category: anyone in the world may enter who is aged under 19 years and at least 14 years old on the date of the Awards (6th May 2017). This £500 (~690 USD) award was launched in 2012. The 2017 Hippocrates Young Poets Prize for Poetry and Medicine is supported by the healthy heart charity the Cardiovascular Research Trust.

Notes for editors
For more on the Hippocrates Prize and the 2017 judges, contact +44 7494 450 805 or email hippocrates.poetry@gmail.com

The 2017 Hippocrates Prize is supported by:
- UK philanthropist Anthony Fretwell-Downing.
- The Arts and Humanities Initiative of Harvard Medical School.
- Healthy Heart Charity the Cardiovascular Research Trust, founded in 1996, which promotes research and education  for the prevention and treatment of disorders of the heart and circulation.

More on the Judges for the 2017 Hippocrates Prize

Views of No Man's Land

Ian McKellen as Spooner (L), and Patrick Stewart as Hirst in No Man’s Land.

Photo: Johan Persson

On 15th December, a remarkable live broadcast of the National Theatre's production of Pinter's play. The close-ups showed fine acting business beyond the experience of all but the front rows at Wyndhams' Theatre - and the occasional well-disguised mishap.
Read no more if you plan to see the play and wish to form your own view.

A stark first half was followed by fine comic display by the cast of four, the play closing with a return to themes implied by the title of the play. The Guardian's Michael Billington notes that the "beauty of Pinter’s play is that it is open to many interpretations and concludes that No Man's Land is "both desolate and funny and conveys, without peddling any message, the never-ending contrast between the exuberance of memory and the imminence of extinction." His earlier view was that play may give insight into dark professional fears of Pinter: the successful but lonely Hirst (played by Sir Patrick Stewart) the mirror image of failed poet Spooner (played by shabbily dressed Sir Ian McKellan). It less clear whether there is any autobiographical - or biographical - relevance to wealthy Hirst's two manservants, played with alternating menace, humour and compassion by Damien Molony as Foster and Owen Teale as Briggs.

A further obvious reading is that Hirst's distress is exacerbated by just-preserved insight into advancing disintegration of his mind - this evolving dementia perhaps accelerated by intensive use of a well-stocked drinks cabinet. Worth contrasting Pinter's reading with the formal portrayal of dementia by Florian Zeller in "The Father".

As shown in this production, No Man's Land, particularly given the historical setting of the play (mid-1970s), could refer to many taboo or inaccessible areas, ranging from the unwanted realms of dementia, dying and death, and to sexual politics, from homosexuality to (at least for these characters) the inscrutable minds of women.

Chamber Choir perform at Worsted Weavers' concert in support of CLIC Sargent

The University of Warwick Chamber Choir performed at St James' Church on the Packington Estate in support of children and young people with cancer at the third charitable musical evening organised by the Worsted Weavers' Guild. The outstanding Chamber Choir, led by its Conductor Lucy Griffiths, performed Spiritual and Shakespeare song cycles and A Child of Our Time. The programme was enhanced by an impromptu series of solos and duets by scholarship students within the Choir. The performance was followed by a reception in the Pompeiian room at Packington Hall, with wine, soft drinks and canapes. Use of St James' Church and the Pompeiian Hall was by kind permission of Lord and Lady Aylesford.

CLIC Sargent Fundraising Manager Lydia Buckmaster said: "It's great that the Worsted Weavers supported CLIC Sargent again with this fantastic event. 

Concert organiser and Past Master of the Worsted Weavers Guild of Coventry Donald Singer said: “The Guild supported CLIC Sargent for a 3rd year because of its excellent clinical and practical work, both nationally and locally, to help the whole family deal with the impact of cancer and its treatment on children and young people.

“Our guest musicians – the University of Warwick Chamber Choir and their conductor Lucy Griffiths – provided an outstanding musical evening in the dramatic setting of St James’ Church on the Packington Estate, which was made available through the generosity of Earl and Lady Aylesford. We are very grateful to everyone who supported the charity, both by coming to the event and by donations to CLIC Sargent. We look forward to our fourth charity concert, to be held in the summer of 2017, once again in support of CLIC Sargent.”

To find out how you or your company could help support CLIC Sargent, please contact CLIC Sargent Fundraising Manager Lydia Buckmaster on 01509 673 881 or email: lydia.buckmaster@clicsargent.org.uk

St James' Church

St James’ Church is a red brick building with four domes topped by finials in neo-classical style. The church was built in 1789 to a design by architect Joseph Bonomi for the Earl of Aylesford as a private family chapel and to celebrate the return to sanity of King George III. Its design was inspired by the Baths of Diocletian in Rome. The church houses an organ built in 1749 by Thomas Parker to designs by Handel in 1749 for his librettist Charles Hennens, who was the cousin of the 4th Earl of Aylesford. There is evidence to suggest that Handel himself played the organ. The church does not belong to a parish – it is owned and maintained by the Aylesford family. The church is a Grade I listed building. 

Joseph Bonomi

The church’s architect Joseph Bonomi was born on 19th January 1739 in Rome. He was the first of five children born to Giovanni Giacomo Bonomi and his wife Teresa Corbi and was christened Giuseppe [portrait by John Francis Rigaud (see below) - Public Catalogue Foundation]. He was educated at the Collegio Romano and studied architecture with Girolamo Teodoloi, a nobleman and successful Roman Architect. Bomomi was clearly talented and impressed Robert and James Adam when they visited Rome. This resulted in an invitation for Bonomi to move to London in 1767. Joseph Bonomi worked as a draughtsman for the Adam brothers and later as an assistant to the Architect Thomas Leverton. In 1775 he married Rosa Florini a cousin of the painter Angelica Kauffman. In 1783 Angelica persuaded Bonomi to move back to Rome where she was then living but it was only a short stay and he returned to London in 1784 with his family, remaining there for the rest of his life. 

In 1784 his earliest known independent work was carried out. From this date he became a successful designer of country houses in England. In 1789 he was elected an associate of the Royal Academy with the help of his friend Joshua Reynolds, President of the Academy. He exhibited a number of perspective drawings at the Royal Academy exhibitions.He is also nationally known for the Pyramid Mausoleum at Bickling Park, Norfolk for the Earl of Buckinghamshire in 1794. In 1804 he was appointed Architect of St Peter’s Rome but this was probably an honorary post as no evidence has been found of him working there. In 1808 at the age of 69 he died in London and was buried in Marylebone Cemetery. His son Ignatius Bonomi also became a successful architect. His work in Warwickshire includes: • Design of the gallery at Packington Hall for the Earl of Aylesford in 1772. • St James Church in Packington Park for the Earl of Aylesford in 1789-92 • The redesign of Barrells Hall at Ullenhall for the Newton Family in 1792.

The Pompeiian room

The Pompeiian room, hall, music room, staircase, dining room, library and small dining room all have schemes designed by Bonomi. The music room originally housed the organ (now in the church) which was played by Handel. The Pompeian room was intended as a sculpture gallery but was remodelled by Bonomi as a setting for the Etruscan vases collected by the 4th Earl. The Roman wall paintings in the Pompeiian Room are by John Francis Rigaud, a history, portrait and decorative painter of French descent who studied painting in Florence and in Bologna. Rigaud was born in Turin, his father’s family having first fled from Lyon to Geneva after the revocation of the Edict of Nantes. Within a year of arriving to work in England, Rigaud was made a fellow of the Royal Academy and went on in London to decorate Somerset House, the Guildhall and Trinity House. His portraits included paintings of Sir Joshua Reynolds, Lord Nelson and St James’ Church architect John Bonomi. Rigaud was elected to the Royal Society in 1784.

Capability Brown

2016 is the 300th anniversary of the birth of Lancelot 'Capability' Brown, the most influential English landscape gardener in history. “He changed the face of eighteenth century England, designing country estates and mansions, moving hills and making flowing lakes and serpentine rivers …” [1]. As epitaph Horace Walpole wrote [2]: “Brown shall enjoy unsullied fame For many a Paradise he regained” Brown is associated with more than 250 landscapes across England and Wales. He often described landscapes as having “great capabilities”, hence “Capability”. By using the sunken fence or ‘ha-ha’ he gave the illusion that discrete areas of parkland, though managed quite differently, were one. The 300 acres of magnificent parkland surrounding Packington Hall were landscaped by Capability Brown in 1751, at the height of his career, when in his mid-thirties. Packington Hall is one of a group of sites in Warwickshire at which Brown advised in the mid and late 18th century. These include Charlecote Park, Compton Verney, Combe Abbey, Newnham Paddox, and Warwick Castle. Lancelot Brown [portrait (in public domain) by Nathaniel Dance (later Sir Nathaniel Dance-Holland, Bt)] was baptised on 30th Aug 1716 at Kirkharle in Northumberland. 

 He was the fifth of the six children of yeoman farmer William Brown, and Ursula who worked in the big house on the Kirkharle estate, where Brown began work as a gardener. It was while working at Stowe gardens that he first became responsible for executing architectural and landscaping works. While at Stowe, Brown also began working as an independent landscape designer, contractor and architect. In 1744, he married Bridget Wayet, with whom he went on to have 9 children. In autumn 1751, the year he worked on landscaping the Packington Estate, he was able to move with his family to Hammersmith in London. Brown offered a range of options to clients: a) for a round number of guineas, a survey and plans for buildings and landscape, leaving his client to do the work; b) a foreman to oversee the work, carried out by estate labour. c) overseeing and refining the work himself, by visits for a certain number of days each year. By 1753, he was employing four foremen and by the end of the decade he had over twenty foremen on his books. In 1764 he was appointed to the gardens of Hampton Court, Richmond and St James, allowing him to move home to live in style at Wilderness House, Hampton Court. Throughout his life, Brown suffered from asthma, the possible cause of his death in 1783. 

1. Find out more at capabilitybrown.org

2. “Capability Brown” by Dorothy Stroud. 1975, Faber and Faber. ISBN 0 571 10267 0 

CLIC Sargent – the Children’s Cancer Charity 

The children’s cancer charity CLIC Sargent is the UK’s leading cancer charity for children and young people, and their families. CLIC Sargent provides clinical, practical, financial and emotional support to help them cope with cancer and get the most out of life. Lydia Buckmaster, Fundraising Manager for CLIC Sargent for Herefordshire, Northamptonshire, Warwickshire and Worcestershire said: “ Last year CLIC Sargent helped to support over 1100 children and young people with cancer in the Midlands. It costs CLIC Sargent around £4,000 to support each child or young person through their cancer journey. To continue to do this we must raise a significant amount of money each year and we can currently only support 2 out of 3 of these children and young people.” “Today, 10 children and young people in the UK will hear the shocking news that they have cancer. 

Treatment normally starts immediately, is often given many miles from home and can last for up to three years. Being diagnosed with cancer is a frightening experience and the emotional, practical and financial implications of treatment are intensely challenging for the whole family.” CLIC Sargent is the UK’s leading charity for children and young people with cancer. CLIC Sargent’s mission is to change what it means to be diagnosed with cancer when you’re young. We believe that children and young people with cancer have the right to the best possible treatment, care, and support, throughout their cancer journey and beyond. And they deserve the best possible chance to make the most of their lives once cancer treatment has ended. CLIC Sargent provides vital emotional, practical and financial support to young cancer patients and families during and after treatment, and we take what they tell us about the impact of cancer on their lives to service providers and policy makers to help change things for the better. 

Worsted Weavers’ Guild of Coventry 

The history of merchant guilds in Coventry goes back at least to 1267. The original roles of the guilds included providing training for their professions and ensuring the quality of what was produced. The National Archives record a Company of Worsted Weavers, Coventry, from circa 1448; and a Company and Fellowship of Worsted Weavers and Silk Weavers, City of Coventry, from 1628. In 1703 the worsted weavers of Coventry, whose trade was then improving, were separated from the silk weavers to form their own company as a member of the guilds of the city. In modern times the Worsted Weavers and other guilds of the City of Coventry continue in a charitable role. 
 

More at worstedweavers.wordpress.com

 

Adaptive pathways: new ways to assess treatments for serious unmet medical need

The European Medicines Agency hosted a stakeholder workshop on 8th December 2016 on 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 organised 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  

Safer Big Data for safer medicines?

14-15 November, 2016: The European Medicines Agency invited experts from the European Union and the USA to discuss 5 key perspectives to speak on Big Data at a workshop in London aimed at identifying opportunities from 'Real World and other "Big Data" to improve development of new medicines and surveillance of licensed medicines for safety, risk and effectiveness.

The 5 key 'stakeholder' perspectives? Patients and the public, health professionals, academia, regulators and policy makers, industry (both health sector and software/hardware) and payers (considering a change in strategy to payment for health impact rather than sales, as exemplified by the Health Impact Fund).

A pragmatic definition from Lu and his colleagues states that "Big data analytics (BDA) applications are a new category of software applications that process large amounts of data using scalable parallel processing infrastructure to obtain hidden value." There are many potential applications from planning for public transport flows to using large health record datasets to improve patient safety such as in the US FDA-Harvard Sentinel partnership.

The FAIR principles for Big Data, Finding, Accessing, Interoperability and Reuse of Big Data, have both general and special challenges and potential benefits when applied to healthcare.

For example, in a recent issue of Nature Reviews Cardiology, Rumsfeld and colleagues from Colorado and Boston outline 8 potential applications of big data analytics to improve cardiovascular care, including "predictive modelling for risk and resource use, population management, drug and medical device safety surveillance, disease and treatment heterogeneity, precision medicine and clinical decision support, quality of care and performance measurement, and public health and research applications".

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 themes:
- Patrick Ryan on which patients chose which treatments
- Sophie Louveaux discussing new EU regulation of data, meaningful consent and processing sensitive health data
- David Martin addressing challenges in Big Data analytics from FDA and PPP perspectives
- Julian Isla from the Dravet patient charity on making the patient the centre in digital health
- Baroness Helene Hayman on ethics, governance and public confidence
- Ronald Brand from the University of Leiden on informed consent v. opt out
- Nicolas Tatonetti from Columbia University, NY on data mining for medical discovery
- Nico Gaviola from Google on cloud data for safer medicines

See more on key threads and discussion points including on the European Open Science Cloud, new EU General Data Protection Regulations - from May 2018, replacing Directive 95/46, machine-learning for chemogenomics, challenges to implementing applications to precision medicines, access to the OHDSI community, social media to find new adverse drug event signals, FDA case studies using then Sentinel-HMO-Harvard collaboration,  opening access to the 28 EU independent national health care systems and more in due course when talks are made available on the EMA website for public access.

Antimicrobial resistance - a global public health threat

"Proper infection control practices and antimicrobial stewardship will be important to address this emerging threat" is the conclusion of a new publication from Sub-Saharan Africa on trends and reasons why resistance to antibiotics is becoming an increasing international problem.

The study, just published in the latest issue of the American Journal of Tropical Medicine and Hygiene, looked at data collected over a 5 year period on sensitivity of bacterial cultures to a wide range of WHO essential list as well as newer antibiotic medicines.

The data were collected in Kigali, Rwanda, at King Faisal Hospital, a major teaching and referral hospital for patients from throughout
Rwanda and from neighbouring countries.

The research team comprised international researchers from the USA (Yale AIDS Programme and the Department of Public Health, Philadelphia), the UK (Fellowship of Postgraduate Medicine, London) and SMBT Institute of Medical Science and Research Center in Nashik, India, in collaboration with clinicians from the King Faisal Hospital in Kigali, Rwanda.

"Differences in antimicrobial susceptibility between the first and fifth year of the study for each bacterial species was assessed using 2 test. Of 5,296 isolates collected, 46.7% were Escherichia coli, 18.4% were Klebsiella spp., 5.9% were Acinetobacter spp., 7.1% were Pseudomonas spp.,
11.7% were Staphylococcus aureus, and 10.3% were Enterococcus spp. Colistin and imipenem had greatest activity against gram-negative bacteria. 
Acinetobacter spp. showed the greatest resistance profile to antimicrobials tested, relative to other gram-negative bacteria. Vancomycin retained excellent activity against S. aureus and Enterococcus species (average susceptibility was 100% and 99.4%, respectively). 
Trend analysis determined that resistance to imipenem increased significantly among Klebsiella, E. coli, Pseudomonas, and Acinetobacter isolates; there was also rising resistance to colistin among E. coli and Pseudomonas species. 
Only E. coli demonstrated increased resistance to gentamicin. For gram-positive pathogens, vancomycin susceptibility increased over time for Enterococcus species, but was unchanged for S. aureus. Our data suggest that resistance to imipenem and colistin are rising among gram-negative bacteria in Rwanda."

Read the full article

Safer medicines in children and adults: video discussions from the international 2016 EACPT Focus Meeting in Opatija

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

In these videos, Donald Singer discusses with speaker Suzana Mimica Matanovic evaluation of drugs in the pediatric population with an update on the impact of recent initiatives from the European Medicines Agency and discusses with Janne Backman from Helsinki how to identify and minimise risk of drug-drug interactions.

 

Discussants

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

- Janne Tapio Backman: Professor in Clinical Pharmacology and Individual Medicine, University of Helsinki, Finland

- 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. 

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.