Clinical Trial Supply Chain
Key to success
One of the most important factors in successfully conducting clinical studies is the efficient management of clinical study supplies
Drug Development Challenges
The drug development model today is under increasing pressure as the number of drugs approved for marketing has dwindled to an all time low Drug developers must acknowledge this trend before initiating the development process However for a developing..
Indian Patent Law
Relevance to global pharmaceutical industry
The Section 3 of Indian Patent Act is considered as a roadblock for patenting invention by many global pharmaceutical industries Here is the brief analysis of this section and its impact on the global pharmaceutical industry with some recent case ill..
Sustainable Drug Discovery
Galapagos’ alliance strategy
Alliances can capitalise on the synergies between biotechs innovations in drug discovery on the one hand and the pharma expertise in moving novel candidate drugs from the clinic to registration and product launch on the other..
Getting from Challenge to Change
How far, how fast?
Metrics for cost time and success rates show that the current level of investment is challenging industrys viability Success rates are an attractive target for effecting overall change Getting from challenge to change however will demand migration fr..
Global Risk Management
Meeting the challenge
A changing regulatory environment and difficult targets present significant challenges for biopharmaceutical companies seeking a balanced approach to risk management..
Research & Development
Enhancing Antibody-based Cancer Therapy
Antibody combinations and dual-targeting bispecific antibodies
Monoclonal antibodies are becoming an important class of antitumour agents as they have been shown to enhance the efficacy of various therapeutic regimens without significantly increasing systemic toxicity Combination of antibodybased therapeutics ma..
Shortening the development timelines
Formulators are faced with an increasingly competitive industrial environment and very challenging compound properties Smart development strategies like frontloading are needed in order to increase the RD productivity and to bring new chemical entiti..
Next stage of rational vaccine design
Although vaccines helped in improving healthcare globally significant disease challenges still remain As such new solutions are required where classical vaccine approaches are insufficient to provide optimal protection for specific populations and ag..
Photosensitiser conjugated gold nanoparticles
Biocompatible gold nanoparticles have been explored as a new vehicle to deliver photosensitiser to tumour cells The use of gold nanoparticles can significantly increase the accumulation of photosensitiser in tumour cells and lead to a high efficiency..
New antibacterial drugs have been few and far between due to a slump in the RD activities and also due to many unique challenges in this area However of late there is renewed interest in this field and many innovative concepts and targets are being l..
Outsourcing CRO Services to China
The staffing challenge
The ability to utilise Asiabased CRO capabilities can make it easier and more costeffective for pharmaceutical and biotech companies to develop and market new products for the burgeoning pharmaceutical market in Asia..
Human Antibody Discovery
VelocImmune - A novel platform
The direct replacement of the unrearranged genomic DNA encoding in the variable regions of the mouse heavy and kappa light chain with the equivalent human genomic sequences creates a more efficient platform for the discovery of antibody therapeutics..
Global Clinical Development
Reducing Japan’s drug lag
Japans Ministry of Health Labour and Welfare is adjusting its policies to accommodate the current trend of global clinical development to promote public health of the Japanese especially in terms of quicker delivery of new drugs to patients..
Transforming drug development
The success of many investigational drugs is dependent on matching treatments with the appropriate target populations Such personalised medicine is now possible with recent advances in proteomics for the discovery and validation of biomarkers of dise..
Hitting the mark
The concept of Personalised Healthcare PHC is being driven by the idea of improved patient outcomes and also to contain soaring healthcare costs It is only when the right patients receive the right treatment that the true value of PHC is realised To ..
Adapting to trial demand
In todays clinical trial environment change is at the front lines acting as an obstacle to the success of a clinical supply plan How many times has the clinical trial design changed after supplies are already packed and labelled Preparing clinical su..
Unleashing the Industry’s True Potential
Closed loop clinical trial supply chain
Clinical trial supply chain will play a significant role in launch of new products in a globalised environment of clinical trials and clinical supplies manufacturing..
Process Analytical Technology
Application in precipitation processes
Precipitation is a commonly used purification method when a pure crystalline Active Pharmaceutical Ingredient excipient or intermediate with specific particle properties needs to be isolated from a multicomponent process solution after a synthesis ex..
Controlling Production Process
Incorporating analytical methods
Taking new regulative guidance into account the motivation for increasing process analytical technology systems from a scientific and administrative point of view is addressed here Based on freezedried macromolecular systems the current gains and cha..
Moving from R&D to Manufacturing Excellence
Relative separation of manufacturing and RD siloed thinking continues to characterise the pharmaceutical industry Managing operations in a holistic manner by investing on a common platform that meets the existing standards and integrates innovative t..
Business Intelligence in Pharma
A key enabler of industry transformation
Business intelligence solutions proven in other industries offer the troubled pharmaceutical industry the potential to enable both operational excellence and better technical management to support drug development for the future..
Clinical Trial Supply Chain
Streamlining information management
Consolidating and integrating data across systems and relationships can help manage some of the challenges associated with supplying investigational and comparator drugs for clinical trials..
Public Private Partnerships
PPPs is being seen as an effective strategy to reduce pipeline stress and also keep the spiralling cost of drug discovery and development under control..
Asia is emerging strongly in the area of biopharmaceutical manufacturing More and more companies are confident of offering quality products and or services In the span of past two years the perception of having an Asian manufacturing partner has bee..