Don’t Believe the Hype – International Reference Pricing Will Cost Far More than 1% of R&D Budgets


By Duane Schulthess - 26 December 2018

It’s odd that a city like Brussels managed to carve itself out a niche as one of the major political centres of the world. The medieval site of a notoriously typhus infested bog, one of the main streets in downtown, ‘Rue du Marais’, literally means, “Street of the Swamp” and the name of the city itself comes from the old Flemish word Broekzele, which roughly translates to ‘settlement in the swamp.’ So, when one talks politically of draining the swamp, at least in Brussels, it carries a literal interpretation that is often distant from the current political climate in DC.

What goes without question is that both Brussels and DC are currently heaving under waves of increasing populist threats to drain political swamps. With the Brexit referendum followed by the election of President Trump, we also now have the Yellow Vest protests in France coupled with a letter accusing President Macron of treason signed by a dozen French generals and a former Minister of Defense. There is an air of anger against political institutions on both sides of the Atlantic, and increasingly, the heated rhetoric is being pointed at the price of medicines.

Investing in EU Biotech IP – What Works?

Vital Transformation released its newest research at the European Health Forum Gastein on October 4th, 2018. Our project analysed 116 EU biotech start-ups from the period of 2001 – 2007 through September 21, 2018 from the UK, Netherlands, Belgium, and Spain. We focused on companies developing medicinal products for human consumption. In this work, we compared the impact of IPOs (stock market listings), private investors, and direct EU funding on their success or failure.

DIA Global 2018: Value Pricing Bootcamp: A Crash Course in How to Use Real World Evidence to Better Measure Outcomes and Evaluate New Innovative Therapies


24th June 2018, Boston, USA

Duane Schulthess, Managing Director of Vital Transformation, and Luca Pani, former Director General of the Italian Medicine's Agency and currently a Faculty Member at the University of Miami, will run a 3 hour and 15 minute Short Course outlining how best to harness RWE to better understand the price, value, and impact of next generation therapies.

Real world big data for clinical research and drug development

30th December, 2017

The objective of this paper is to identify the extent to which real world data (RWD) is being utilized, or could be utilized, at scale in drug development. Through screening peer-reviewed literature, we have cited specific examples where RWD can be used for biomarker discovery or validation, gaining a new understanding of a disease or disease associations, discovering new markers for patient stratification and targeted therapies, new markers for identifying persons with a disease, and pharmacovigilance.

Medicines Adaptive Pathways to Patients (MAPPs): A Story of International Collaboration Leading to Implementation

21st October, 2015

After nearly a decade of discussion, analysis, and development, the Medicines Adaptive Pathways to Patients (MAPPs) initiative is beginning to see acceptance from regulators, industry, patients, and payers, with the first live pilot project initiated under the guidance of the European Medicines Agency in 2014.

Report: The challenges and changes needed to reengineer medicines development in the UK

9th March, 2015

A new report from the ABPI and Vermilion Life Sciences examines the challenges and changes needed for the UK to lead reengineering medicines development, and proposes a new methodology to achieve this.

TEMPEST mHealth : mHealth in 28 EU Member States

3rd November, 2014
By Wendy L. Currie and Jonathan J.M. Seddon One of the biggest health care challenges in the coming years is how technology can be used to improve health service delivery. With the steadily increasing average life expectancy across all of Europe expected to be over 80 by 2025 and 82.5 by 2050, new and improved processes need to be delivered to meet future health requirements.

Medicine adaptive pathways to patients (MAPPs): using regulatory innovation to defeat Eroom’s law

19th May, 2014
Abstract

Eroom’s Law is, literally, Moore’s law in reverse. The pharmaceutical sector invests $50 billion annually in research for new medicines but, “the number of new drugs approved per billion US dollars spent has halved roughly every 9 years since 1950, falling around 80-fold in inflation-adjusted terms”. Pharmaceutical companies have invested enormous sums in new molecular entities (NME) in the areas of unmet medical need identified by the World Health Organization (WHO), but the approval rates from phase I are only 7% for cardiovascular disease, dropping to 4% for Alzheimer’s disease.

Whole-Body Magnetic Resonance Angiography (WBMRA) as a tool for driving efficiency in the cost and treatment of Claudication Comorbities

12th September, 2013
Abstract

Whole-Body Magnetic Resonance Angiography (WBMRA) consists of a contrast-enhanced Magnetic Resonance Angiogram (MRA) scan of the entire body in a single step. In the diagnosis of cardiovascular co-morbidities in Peripheral Arterial Disease (PAD), the utilization of WBMRA can streamline the diagnostic process by minimizing the usage of MRA, CT, and Angiograms. In this work, the potential cost savings to the hospital by using WBMRA in PAD are modeled based on collected data that accounts for all interventions in the radiological department of a set of 50 patients with Claudication in the period 2008–2012 at Ninewells Hospital (NHS Tayside).

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