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 […]
Pharma Industry
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 […]
Prophylactic and Therapeutic Vaccines
The ideal goal of cancer vaccine is to elicit potent anti-tumour immune responses without any contributing side-effects. The major aim is to stimulate both innate and adaptive immunity that can recognise and subsequently eliminate the tumours mass. Cancer immunotherapy continues to be a field of intense research, especially the induction of active immunity. The existence […]
Improving Pharmaceutical R&D
The pharmaceutical industry now operates in a complex and dynamic global environment. The pace of change is much faster and far less predictable than ever before. To survive and prosper in today’s business environment we need to urgently rethink about how we operate. Specifically, we must challenge the thinking that created our current state and […]
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 […]
Biosimilar Medicines
Many of the blockbuster biological products that currently dominate the markets are coming to the end of their patent protection. The opportunity to provide more affordable “generic” versions is now attracting the interest of both generic and research-based pharmaceutical companies. The development of “generic” biological medicines referred to as “biosimilars” in Europe and increasingly in […]
Unconventional Micro and Nanofabrication
Organismic assays are better and more predictive for testing putative therapeutics than molecular assays, but it is difficult and expensive to work with animals, and the relevance of these assays’ results in humans is often low. Human cell-based assays-which are less complicated than many organismic assays-are an attractive option for drug screening because cells are […]
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 […]