In an environment where development costs have increased exponentially while filings and launches have dropped drastically, the pharmaceutical industry and drug regulators face numerous challenges in Pharmacovigilance (PV), patient safety and in addressing areas of unmet medical needs. This combination of issues not only adds unsustainable access restrictions and costs in the long term, but […]
Pharmaceutical Information Technology
Breaking Down Borders
If you had run into Mark Engel, CEO and founder of Excel PharmaStudies, at the recent 2008 China Pharmaceutical R&D Summit at Shanghai, you would realise that even the young biotech industry in Asia is not immune to the rapid globalisation of drug discovery and development. Excel, a leading CRO, was started by a western […]
Metabolic Biomarker and Target Discovery in Obesity-Associated Comorbidities
Millions of adults are diagnosed as obese each year worldwide. Many of these people suffer from a disorder known as metabolic syndrome, which includes symptoms such as hypertension and elevated blood cholesterol. They are also at risk of developing additional diseases, such as heart disease and diabetes mellitus. Obesity may, in fact, be a major […]
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Outsourcing preclinical and clinical R&D to China
China has emerged from the shadows of isolation to become a world economic power with a staggering growth rate (8% per annum for the past five years) that will soon eclipse the likes of France and England. Low-cost manufacturing and the availability of inexpensive and abundant labour have fuelled this growth. However, in order to […]
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The Arab Drug Industry
In response to the 21st century challenges to the health sector, WHO established an important global commission on Macroeconomics and Health. One of the important conclusions of the commission report indicated that by the year 2015, the world could save up to 10.5 million lives every year by scaling up access to existing health interventions […]
The Six Great Shifts
Many languages have an equivalent to the expression “Seeing the forest for the trees”, meaning the ability to discern the big picture from little details. That ability is important in life but especially true for leaders of life sciences sector. Every day we are bombarded with news of innovative technology, tighter regulation and new approaches […]
Contract Research organisations
Financial performance of large innovative pharmaceutical companies in 2010 indicated a gloomy prospect for these well-established leaders in their domain. This trend is expected to grow as many drugs are going off-patent in time to come, and with very few blockbusters drugs entering to market due to strict FDA regulations. For instance, Pfizer, stands to […]
Sustainable Antibiotics
Antibiotic resistance Antimicrobial Resistance (AMR), also called antibiotic resistance is a reality. AMR renders antibiotics ineffective, meaning they can no longer fight bacterial infections and ultimately become useless. Every year, AMR is responsible for nearly 50,000 deaths in the US and EU alone. In India, annually nearly 60,000 babies die from sepsis caused by bacteria […]
Demystifying Biomarker Discovery
Proteomics is an emerging field that is frequently used for clinical biomarker discovery. For this article, proteomics is defined as a mass spectrometry-based approach used to identify proteins. The biomarker discovery process is distinct from biomarker validation or the development of a clinical test. The development of a clinical biomarker incurs heavy expenditure and also […]