Drugs can be discovered and developed in two very different ways: at an evolutionary pace and at a revolutionary pace. The “first revolution” in biological psychiatry took place in the 1950s, and now, in the 21st century, a “second revolution” of drug development and discovery is taking place, driven by repurposing. Read more...
To combat the rising costs of bringing a new drug to market, pharmaceutical companies have taken...
Biospecimens - and the genetic and genomic information derived from these...
One of the more exciting new technologies contributing to current advancements in cancer is droplet digital PCR (ddPCR), a method that is already being shown to track both favorable and unfavorable responses to therapy more rapidly than current imaging methods and to enable improved treatments. Read more...
The world’s brightest luminescent protein, a discovery dubbed the “Nano-lantern,” is lighting up the future of in vivo imaging– without the use of external light. This could benefit more advanced applications, such as high-throughput drug screening and single-cell tracking in live animals and plants.
With the biopharmaceutical market valued at $70 billion and counting, scientists need every improvement they can get to design and develop these drugs faster and more accurately. A novel technology that will bring synthetic biology to industrial scale promises to dramatically enhance the development pipeline.
Bone marrow transplants are the only potential cure for many blood cancers in older patients, but many in this group are ruled ineligible because the procedure is often deemed too harsh for older people. Since more than half of AML patients are over 65 years old, new tactics to prepare these patients for hematopoietic stem cell transplantation are needed.
To borrow a line from Robert Frost’s famous poem, for big and small patient populations, two roads are diverging in drug development. Traditional pharmaceutical developers tackle common problems affecting the many; orphan drug and personalized medicine developers target rare problems affecting few people. But which road is more traveled now? Find out...
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 functions as well as in major disease pathologies including cancer, cardiovascular disease and inflammatory diseases. So why is complex carbohydrate chemistry a key tool for addressing unmet medical needs in a variety of areas? David Platt, PhD, CEO of Boston Therapeutics Inc. explains.
Why is the stem cell industry deserving of its love-hate relationship with the public? And are the stem cell products that are closest to approval really stem cells? William R. Prather RPh, MD, senior vice president of corporate development at Pluristem Therapeutics Inc., explains.
The use of hydrogels to enhance transdermal drug delivery may prove useful as an innovative alternative to current drug delivery techniques and could have an widespread impact on medicine, says James Sapirstein, CEO of Alliqua Theraputics.
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.
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