Specifically, Boston leads the way in embracing new research models (for example, Research at the Broad Institute of Harvard and MIT) and, in building a new research culture that has strong roots in academia and the pharma sector. A recent contribution of US$650 million as the philanthropic donation to Broad is the true testimony. It […]
Pharma Events
Next Generation Pharmacovigilance
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 […]
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 […]
Validation Projects in China
Between 1997 and 2000 Pharmadule built a number of pharmaceutical manufacturing facilities in China for both domestic manufacturers and multi-national pharmaceutical companies, including Eli Lilly and AstraZeneca. The multi-national companies required GMP compliance and validation services comparable to the level that exist today. The facilities delivered for Chinese manufacturers would comply with international GMP requirements; […]
Innovation Challenges in Manufacturing
Regulatory agencies in charge of protecting the population against health risks have a large burden divided, mainly, between two large areas. The first is a direct consequence of the mission, that is, to effectively protect the population against health risks across the diverse industrial sectors and activities which might generate risks. This implies that the […]