As the challenges in production of cell therapies have grown more complex, new technologies have been developed that can improve performance in key areas including monitoring and coordination of the production process. How has Aastrom Biosciences maintained a constant focus on our production process at every stage of their development efforts? Ronnda L. Bartel, chief scientific officer of Aastrom Biosciences, explains.
Carbohydrates play a fundamental role in normal cell...
Why is the stem cell industry deserving of its love-hate relationship with the public? And are...
The use of hydrogels to enhance transdermal drug delivery may prove useful as an innovative...
Cynapsus Therapeutics recently developed a sublingual thin-film strip delivery system for apomorphine, which is similar in concept to Listerine breath strips. The strip dissolves in about 1.5 minutes, delivering the drug into the bloodstream in a similar time interval and concentration as an injectable dose.
Cancer arises as a result of the acquisition of a series of abnormalities and mutations, typically involving oncogenes and tumor suppressor genes, which ultimately confer a growth advantage upon the cells in which they have occurred. A wide spectrum of types of genetic alteration can contribute to the promotion of cell growth, ranging from single amino acid mutations to deletions and chromosomal translocations.
The challenge of delivering drugs to neurological targets has been a major roadblock to many promising therapies for treating diseases and disorders of the brain. The blood brain barrier blocks the vast majority of all small-molecules and virtually all large molecules from reaching therapeutic targets within the brain.
Despite improved efficacy and a reduced side effect profile, second-generation cancer therapies still suffer from the same major limitation associated with traditional chemotherapy drugs—the duration of any observed clinical benefit is invariably short lived, due to the relatively rapid acquisition of drug resistance.
In the fast-moving world of biopharmaceutical research, where scientists are trying not only to solve today’s analytical problems, but also to guess what’s around the next corner, the traditional models for developing new analytical technologies are no longer viable.
As cost-cutting and austerity measures sweep the globe, simply producing a safe treatment is no longer enough. Dr. Gliklich, President of Quintiles Outcomes, discusses how post-approval studies can help pharmaceutical companies improve their drug's chances of success in the age of effectiveness.
There have been significant advancements in needle-free injection technology, which aim to increase adoption of self-injectable therapies and adherence. Patients often lack the confidence to self-inject or are put off by the complexity, impacting their ability to incorporate these therapies into their lifestyle.
In the days of paper case report forms (CRFs), the accurate recording and review of subject data entered into the CRF and diaries was based entirely on trust. The investigator would sign the final page of the CRF to confirm that he or she had reviewed all data contained therein.
While physicians stay informed about the medications they prescribe to ensure that patients receive the best possible treatment, one question rarely asked is, “How was this medicine manufactured?” Doctors and patients alike tend to take it for granted that drug manufacturers have the right processes and controls in place.
Drug research scientists often face the challenge of juggling their own research and analytical needs with the needs of the larger institution. Research is variable, yet standardization often implies the need to conform to a process. Given these challenges, science needs a new approach for empowering scientists in drug discovery.
A recent survey of Drug Discovery & Development readers revealed what types of instruments and systems are behind the wheel of drug research programs.
GMPs and other guidelines can help suppliers and pharmaceutical manufactures improve product quality, with greater efficiency and reliability.
In spite of the ongoing urgency to develop HIV/AIDS vaccines, various research groups and small biopharma companies around the globe are encountering challenges in raising the levels of funding that are necessary to sustain effective research and clinical trials.
Often heard advice for the entrepreneurial set is: “Be a credible threat.” That of course is a tall order. The odds and costs are stark. Historically, only 1 in 10 lead candidates make it through to approval, and this number is likely to be lower in 2010. If this weren’t daunting enough, the failure-inclusive cost of developing that one drug is thought to be a billion dollars.
In order to ensure smooth operation during bioanalytical studies, a novel model, where a principal investigator with direct control over the entire study is the core of the project, has been developed.
The need for pharmaceutical R&D organizations to manage expanding volumes of data crucial will require a change in focus and approach.
Researchers attempting to establish immunotherapies have been challenged when dosing with TLR agonists. With a better understanding of how to optimize the schedule of administering TLR7 agonists in different disease states, they may be able to sculpt the immune response appropriately for different diseases.
In these tough times, the biotech job market looks promising, if you know how to sell your skills.
The question of when it will be possible to sequence a human genome is being replaced by concerns whether the average consumer will choose to have his or her genome sequenced.
For small biopharmaceutical companies, the mechanism of action approach may build the most attractive pipeline.
With $100 billion in patents expiring by 2011, pharmaceutical companies need new drug discovery and development routes. A "personal dose" model could be an alternative.
Obstacles to measuring gene expression have hindered the impact of genomics on drug discovery and the life sciences.
Patents are the intellectual property currency of the world of commerce.
In addition to the growing amount of genomic data, the diversity of data types in the bioinformatics domain are also increasing, and systems biology efforts emerge to integrate genomic data with proteomic, ionomic, metabolomic, biochemical, and pharmacological data to study various fundamental aspects of living systems.
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