“Using registries in real world evidence: Paving the path for success” by Emma Du four and Chris Chinn

October 2106 – By Emma Du Four, Senior Director Regulatory Policy & Intelligence at AbbVie and Chris Chinn, Head of Real World Investigations, SanofiOn 28 October 2016, the European Medicines Agency (EMA) will hold the EMA registries workshop regarding the use of registries in real world evidence. In advance of this discussion, Emma Du Four, […]

By |October 4th, 2016|News|0 Comments

“Advances in science and technology are there—It’s up to us to keep up with them”: An Editorial From Sarah Garner of NICE

June 2016 – by Sarah Garner

As the keynote speaker in the EMIF Conferences, E-managing the Future of Health Data, Dr Sarah Garner spoke on a number of initiatives making use of real world evidence—specifically highlighting the significance in RWE in furthering the conversation on MAPPs. Here, she reflects on how the opportunities changes in technology allow us […]

By |June 21st, 2016|News|0 Comments

EMA’s PRIME can help speed delivery of new medicines to patients – by Susan Forda

1st March 2016 – by Susan Forda

Last week, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) adopted the Priority Medicines (PRIME) scheme. PRIME is a welcome step towards connecting healthcare decision-makers to expedite patient access to new medicines – but what sets it apart from other mechanisms with similar aims? The […]

By |March 1st, 2016|News|0 Comments

Event Report and Video: New Paths to Personalised Medicine – A Live Webstream from the European Health Forum Gastein

On 30th September, thought leaders in the field of personalised medicine from Europe, the United Kingdom and the United States met in Bad Gastein, Austria to discuss how Medicine’s Adaptive Pathways to Patients (MAPPs) and breakthrough designation will impact patients. In a moderated discussion with the experts, the audience and live participation from the public […]

By |October 5th, 2015|News|0 Comments

Interview with Sabine Atzor: Examining the Building Blocks of MAPPs

September 30th – by Alison Kilian

 

 

 

 

 

 

 

To truly understand Medicines Adaptive Pathways to Patients (MAPPs) from a regulatory perspective, it’s essential that we take a closer look at the building blocks – both old and new – that are paving the way for its implementation, says Sabine Atzor, Director Regulatory Affairs, part-time seconded from F.Hoffmann-La Roche […]

By |October 1st, 2015|News|0 Comments

Interview: US Personalized Medicine Coalition – Exploring Pathways Towards Patient-Centred Healthcare

July 31st, 2015 – by Alison Kilian

Adaptive pathways are among the possibilities being examined for incentivising medicine and future innovation in the United States, says Amy M. Miller, Ph.D., Executive Vice President of the Washington DC-based Personalized Medicine Coalition. But some key hurdles remain, not only from a scientific view, but also from a policy perspective. Dialogue […]

By |July 31st, 2015|News|0 Comments

MAPPs and New Benefit Risk Models: IMI2 Leads with Patient Engagement

July 10th, by Magda Chlebus

The Innovative Medicines Initiative (IMI) yesterday launched its 5th Call for proposals under the IMI 2 programme (http://www.imi.europa.eu/content/stage-1-16).  Topic 1 addresses one of the key enablers of adaptive pathways – developing methods to incorporate the input of patients into the assessments of benefits and risks of new medicines at all stages […]

By |July 13th, 2015|News|0 Comments

Event Report – MAPPs: Saving Time, Saving Lives

EFPIA General Meeting Highlights Enormous Gains Made by MAPPs and Carves a Path for the Future
17th June 2015 – by Duane Schulthess
While progress is often slow and laborious when trying to gain traction for new ideas in the ‘Brussels Bubble’, there was much to be optimistic about in the Medicine’s Adaptive Pathways to Patients (MAPPs) meeting […]

By |June 16th, 2015|News, Uncategorized|0 Comments

Interview: Get Real – Using real world data for decision-making in R&D and health technology assessment

Real 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

By |May 13th, 2015|News|1 Comment

Top Drug Regulator: Adaptive Licensing is a New Paradigm – for Everyone

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.

By |April 23rd, 2015|News|0 Comments