This Pharma Magazine is the source for a plethora of unique Pharma articles. Several notable figures from top pharma organisations are featured in the R&D, Manufacturing and Clinical Trials sections, with their expert knowledge of the field.
The pharmaceutical industry appears to be at a nexus of its evolution It has been observed that new drug pipelines are less than adequate to continue its recent rate of growth and offtarget safety issues are causing critical postmarketing failures Added to this global economic pressures may impose greater constraints on drug pricing and the introdu...
Global Pharmaceutical Industry is at the crossroads On the one side market demand for novel and better medicines is getting redefined and growing due to demographic economic and epidemiological trends But at the same time pharmaceutical companies are finding it difficult to survive since they are unable to innovate and discover new molecules The pi...
The RD sites of most big pharmaceutical companies are undergoing significant change Historically Big Pharma has focussed on the development of small chemical molecules but in recent times investment has broadened to include the development of large molecule biologics such as therapeutic proteins and monoclonal antibodiesThe future is biologics...
One thing is for certain todays pharmaceutical marketplace is punctuated by change and uncertainty The pharmaceutical industry is facing a tough road ahead in the future market place Major products are facing patent expiry and pipelines are not replacing the ageing products Approvals of NMEs continue to decline while development and commercialisati...
The first complete human genome sequence was published in and laid the foundation for a more comprehensive understanding of human disease When this sequence was published many felt as though the era of personalised medicine was around the corner and that pharmaceutical companies should embrace this new knowledge to better design personalised the...
There is an urgent need for new drugs to treat tropical parasitic diseases like malaria leishmaniasis trypanosomiasis and schistosomiasis These diseases affect hundreds of millions of people and are major contributors to mortality and morbidity in the developing worldMalarial disease caused by the parasite Plasmodium falciparum is responsible f...
The FDA announced in August that it will form an internal FDA Nanotechnology Task Force The group responsibilities will be to establish regulatory approaches in the development of safe and effective FDAregulated products that use nanotechnology affecting virtually every product category that FDA regulatesfrom pharmaceuticals and devices to cosmeti...
The challenge to ensure early access to new drugs and their safe launch is growing globally particularly after a number of large scale Adverse Drug Reactions ADRs were identified and attracted much attention from public and blockbusters were withdrawn from the market US FDA intensified its authority of managing postmarket safety of new drugs but th...
At the outset we should challenge the basic dogma of receptor pharmacology ie one ligand one receptor texture and singular efficacy There is emerging evidence to the contrary ie one ligand differential pharmacology and multiple mechanisms of action GPCR drug hunters and thought leaders have started to accept this paradigm shift and I believe that s...
In a recent article in Scrip Anju Ghangurde reported on Eli Lilly and Companys efforts to effect transformation from a Fully Integrated Pharmaceutical Company FIPCo to a Fully Integrated Pharmaceutical Network FIPNet The foundational thinking in the move to FIPNet is simply that the current pharmaceutical development process is broken and does not...
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 moleculesSo...
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...
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
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...
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...
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...
The global pharmaceutical market has never been more competitive and therefore companies are searching for sources of sustainable value Consider the increased competition created by a flood of metoo drugs combined with everdecreasing rates of pipeline productivity and the need for the significant changes to healthcare delivery models As margins con...
Thirty years ago the semiconductor industry was a growing technologyfocussed industry and for the first time was beginning to face cost pressures For years the focus had been on superior technology and manufacturing was an afterthought As long as the products were manufactured as they were envisioned by their inventors there was little need to pay...
LeadershipMy teeth were chattering against one another with my uncontrolled shivering I was physically exhausted mentally drained after three days of continual marching thinking and worrying about walking off the edge of the mountain Everything was damp It had been raining all night and we hadnt been able to make a dry camp We had just heard the...
The absence of data interoperability and standardisation is just one of the challenges faced by the pharma industry today Data are expensive and difficult to collect with limited ROI after product registration Increasingly health authorities are moving to require a clearer understanding of product safety and efficacynot only earlier in the developm...
As the complexity of the biotechnology industry increased pharmaceutical companies have struggled to ensure that their IT organisations keep pace with the latest hardware and software applications Yet the need to maintain regulatory compliance while ensuring that an organisations IT infrastructure meet its everchanging business requirements is a si...
Informationrelated challenges are pervasive throughout modern drug discovery They are becoming ever more draconian as the industry leverages powerful new experimental capabilities to create novel therapeutics for unmet medical needs In parallel breathtaking advances in Information Technology IT make possible effective responses to these challenges...
