Clinical Trials
Adaptive Trial Design
Enhancing the quality of clinical trials
Investment in pharmaceutical research and development has more than doubled in the past decade however the increase in spending for biomedical research does not reflect an increased success rate of pharmaceutical development Reasons for this include a diminished margin for improvement escalates the level of difficulty in proving drug benefits eas...
The Biomarkers Consortium
Advancing Biomarkers Research
Biomarkers have the potential to streamline and even revolutionise investigations of pathobiology the conduct of clinical trials and regulatory decisionmaking for drugs and therapeutics This promise serves as the foundation and impetus for a novel publicprivate partnership initiated in October and known as The Biomarkers Consortium BC BC partner...
Japans Step Towards Global Studies
In September Japans Pharmaceuticals and Medical Devices Agency PMDA released a new guideline for the biopharmaceutical industry entitled Basic Concept for International Joint Clinical Trials The PMDA issued the guideline in response to growing concern about the druglag challenge facing Japan As of now new biopharmaceutical products typically ente...
Offshoring
Cost-effective clinical research
These are very challenging times for the researchbased pharmaceutical and biopharmaceutical industry While profits have remained relatively high for many of the toptier companies stock prices have tumbled precipitously Since market capitalisation for the major companies has dropped cumulatively about US trillion In other words over the last seven...
Trifunctional Antibody Format
Concept and first drug candidate
Triomab antibodies represent a new generation of antibodies that incorporate a novel mechanism for the treatment of cancer Trifunctional antibody chimaeras consist of light and heavy chains originating from parental mouse IgGa and rat IgGb monoclonal antibodies each with different antigen binding properties One binding site for the interaction...
Optimising Development Costs
Executives have three levers available to them to manage clinical development operational costs such as Taking advantage of low cost countries in Asia and other areas around the world Outsourcing specific operational activities and Implementing lean clinical development practices
China\'s Clinical Trial Boom
A look at the linguistic and cultural challenges
Due to unprecedented economic growth and increased healthcare expenditures experts predict that by China will be the worlds fourth largest pharmaceutical market In addition to increased production and distribution by foreign pharmaceuticals China has become one of the regions primary locations for outsourcing clinical trials Growth in the clinical...
Paediatric Drug Development
Taking a practical approach
Its no secret that clinical research has steadily become more challenging and costly Patients are difficult to recruit regulations are more stringent and complex and patient expectations are very high However these realities of our field can be seen no more clearly than when attempting to develop medicines for children With the advent of legislatio...
Issues & Concerns in Conducting Clinical Trials in India
Indias strong value proposition has enticed multinational pharmaceutical companies to enter into or significantly expand existing operations in India in the fields of drug discovery contract manufacturing and clinical research In addition to huge internal market potential India presents an attractive destination for drug companies seeking to minimi...
Asian Clinical Trials
Managing patient reported outcomes
The process of bringing innovative medicines to market has become increasingly more difficult and complex in the last decade More rigorous regulatory requirements coupled with restrictive policies for drug reimbursement have slowed down the rate with which major pharmaceutical companies are able to reach patient populations with new molecules So...
