Research

The HIV Story: When Research Faces Setbacks, Look to Previous Advances for Inspiration

Last week marked the third meeting of the International HIV Treatment as Prevention Workshop. Bringing together stakeholders from policy, industry, academia, and civil society, the workshop examines priority areas of research and action related to the use of antiretroviral therapy (ART) and reduced HIV transmission.

Considering the Impact: A European Patent with Unitary Effect and Unitary Patent Court

After 40 years of false starts, a European Patent with Unitary Effect (the UP) and a Unitary Patent Court (the UPC) is expected in the near future. The biopharmaceutical industry strongly supports a unitary patent and court even though the UP and UPC will not launch in all EU Member States initially (Italy and Spain are yet to join) and with legal uncertainties that may see an incremental engagement of biopharma with the UP/UPC.

Red Tape Holding Back Innovation: Conference Highlights Need for Change

"We are losing a lot of research from Europe because of red tape" – these words of concern, voiced by Irish Health Minister James Reilly, were echoed by many at the Innovation and Patient Access to Personalised Medicine conference in Dublin last week. Their worries are justified: Personalised medicines have the potential to offer astounding solutions to some of our most complex healthcare challenges, from cancer to diabetes. But the current EU regulatory environment presents many hurdles to the development of these medicines.

Clinical Trials in sub-Saharan African countries:

High-Level EDCTP Conference: African and European policy-makers and EFPIA discuss the EDCTP-II program

13.11.2012, Brussels: The European and Developing Countries Clinical Trials Partnership (EDCTP) held a high-level conference this week to discuss its second programme (see below). The conference was hosted by the Department of Science and Technology of South Africa (DST) in collaboration with the European Union (EU) and EDCTP.

Clinical Trials

Introduction

A clinical trial is a research study conducted in human participants to evaluate the safety and efficacy of a medicine expected to improve patients health. Clinical trials can only be started after a compound has survived rigorous pre-clinical development work, which involves laboratory testing (chemical/biological/pharmacological/toxicological). It is only when these tests show favourable and promising results that a company can proceed to assess the medicine in humans.

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