The New Life Science Solution and its Implications on Document Management for Pharmaceutical Companies

The European Medicines Agency (EMA) recently announced new pharmacovigilance legislation, more commonly known as “the pharmaceutical package”. In this package the EMA describes how to modernise its pharmacovigilance system, how to improve patient safety and how to supply health information to patients. Olaf Schoepke and Gerhard Neurauter at EXTEDO explain how agencies and pharmaceutical companies can address this new legislation, along with the respective consequences for their data management.

Read more

United Nations Summit on Non-communicable Diseases

The NCD epidemic is hitting vulnerable, socially and economically disadvantaged people the hardest. The World Economic Forum’s 2010 Global Risk Report lists NCDs as the second-greatest risk to global economic growth. One half of those who die from NCDs are in their productive years, making the social costs and economic consequences in terms of lost productivity considerable. Rebecca MORTON DOHERTY of Union for International Cancer Control (UICC) discusses that, by having the UN Summit and agreement on a political declaration on NCDs, the process of addressing NCDs globally has been set in motion in the most powerful way.

Read more

Personalised Medicine & Companion Diagnostic Device Development

Healthcare in the developed world is on the edge of a precipice. Populations are aging and healthcare costs are rising against the backdrop of uncertain economic times. Consulting the latest OECD figures shows the cost of healthcare as a percentage of GDP rising from 13.6% to 17.4%. Nick Rollings of Sagentia explores how the pharma industry itself is undergoing a period of intense change.

Read more

Moving to a Common Interpretation of eSubmission Validation Criteria?

2011 has been an interesting year for those using the ICH eCTD standard. Several agencies or groups of agencies have made changes related to their use of eCTD. The US FDA released new validation rules late in 2010 and now plans to implement them later this year. Health Canada has announced that it intends to release a new version of its Module 1 this year. In this article Charles Mathis of the LORENZ Life Sciences Group focuses on changes which have already been implemented by the European Agencies, with the implementation of new validation criteria.

Read more

Strategies for Protecting IP

In the life science industries the requirement for intellectual property rights to protect innovation is taken as a given. It is also taken as a given that those working in these industries know what intellectual property rights are and what they mean to the business. However, this is a complicated area and assumptions made may be turn out to be misguided. In this article Vicki Salmon of IP Asset LLP aims to provide an introduction to some relevant intellectual property rights and to give an indication as to how these can be strategically used for the benefit of different types of life science businesses.

Read more

Pharmacotherapy in older adults

Drug therapy plays a major role in healing or managing acute and chronic diseases to re-establish the health and wellbeing of individuals in our society. This has led to a significant increase in life expectancy over the past century, a fact acknowledged by the European Commission’s declaration of the “European year for active ageing and solidarity between generations 2012”. Sven Stegemann, Director for Pharmaceutical Business Development at Capsugel, takes a closer look at the future of drug therapy in older adults.

Read more

Phage in therapy and Prophylaxis ?History and Future Prospects

Bacteriophages are well known in the biopharmaceutical industry, mainly due to their destructive impact on productivity of bacterial-based fermentations. However, it seems that their positive role may soon dominate their rather grim reputation in the biopharmaceutical industry. Marcin Los, CEO of Phage Consultants, explains the reasons for the failure of phages at the beginning of the 20th century and their rebirth, and speculates on the future prospects of use of phages in health protection.

Read more

Berlin – europe’s leading life sciences region

Berlin, at the heart of Europe, is Germany’s premier biotechnological centre and one of the top five biotechnological centres in Europe. It has a unique scientific environment, and its strategic linkage of science, clinical research, healthcare and business leads to maximum research output and quick conversion into innovative products. Carolin Clement, Head of the Business Unit Life Sciences at Berlin Partner GmbH explains how these factors all make the city of Berlin one of the most important locations for life sciences in Europe.

Read more