May 20th, 2015 – by Nuala MoranReal world evidence holds the potential to both increase efficiency in R&D and to bridge the gap between the proof of efficacy required to pass regulatory scrutiny and the demonstration of likely effectiveness needed to satisfy health technology assessment bodies, says Professor Sarah Garner, Associate Director for Science Policy and Research at NICE.
April 24th, 2015 – by Gary Finnegan Reinventing how medicines come to market demands new thinking from regulators, payors, patients and industry, says Professor Luca Pani, Director General of the Italian Medicines Agency. A full transcript of the interview can be downloaded via the link at the end of the article.
Arpil 21st, 2015 - by Alison Kilian On 15 April, thought leaders met in Lyon, France to take part in a panel discussion and Q&A on the potential of advanced therapies and the challenges we face in implementing them in Europe. The event marked the launch of the EBE and Vital Transformation report, “Europe’s Emerging Science: Putting Advanced Therapies into Practice to Deliver Better Health”, a guide to advanced therapies.
Feb 6th, 2015 - by Magda Chlebus While Europe is leading in the development of tools and methodologies in Medicine’s Adaptive Pathways (MAPPs) through the EMA live pilots and upcoming projects in IMI2, the key bottlenecks still holding back its implementation in Europe are gaining traction with the United States congress. This situation illustrates our need in Europe to move quickly and develop implementation strategies and foster political support for MAPPs whilst we still hold the drive and initiative.
Jan 15th, 2015 A new culture is needed to promote the equitable and open sharing of data, to advance science, whilst protecting the interests of all stakeholders, says the US Institute of Medicine The sharing of clinical trials data is clearly in the public interest, but huge effort is required to develop the policies and put in place the technical infrastructure and create a culture of openness, according to a new report from the US Institute of Medicine (IOM).
Dec 12th, 2014 - by Nuala MoranIn a ground-breaking collaboration, The UK’s Digital Catapult, The Fellowship of Post Graduate Medicine, IDEALondon, and Vital Transformation brought together the best and brightest minds in Europe working at the frontiers of research where Personalised Medicines and Health Technologies intersect. This round table demonstrated how next-generation technologies and social media will integrate with public health, thus facilitating the burgeoning market for personalised medicines. The sessions included disruptive start-ups and technology savvy practitioners finding common ground in the desire to bring stratified medicines to patients.
CONFERENCE REPORT: On October 21st, an international group of experts was invited to the Royal College of Physicians in London to discuss how new clinical regulatory pathways, sources of evidence, and evolving data on real world patients can be used both to expedite the development of drugs and improve their quality and access. Broadly called “MAPPs” (Medicines Adaptive Pathways to Patients), the goal is to speed patient access to needed therapies while increasing the productivity of industry R&D spending.
GASTEIN, AUSTRIA, 1 October 2014 – Medicines developed in clinical trials under controlled circumstances may perform differently in patients in the real world. To a large extent this is because clinical trial protocols exclude relevant groups, for example, the over 60s, those taking other drugs, people with co-morbidities.
Patients can bring unique insights to the medicines approval process. But how can regulators use patient preferences to inform decisions on innovative medicines?
While Europe is focused on large-scale national and regional health IT projects, the mobile health apps market of the US is a catch-as-catch-can of Angry Birds disruptive innovation.