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.
In the days of paper case report forms (CRFs), the accurate recording and review of subject data...
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.
Systems biology underwent a dramatic renaissance in 2000.
Information systems are the lifeblood of the new century.
Researchers seeking the "next generation" of therapeutics are taking novel—but undeniably risky approaches.
William Porter Jr. At a Glance Title: Senior vice president, business development, Asia-Pacific Company: VDDI Pharmaceuticals, Brentwood, Tenn. Education: BS and MS, Michigan State University Background: Porter has more than 30 years experience in the biopharmaceutical industry, education, project management, and government relations.
Raju Adhikari, Mbiochem, DPhil At a Glance Title: Pharmaceutical-biotechnology industry analyst. Company: Frost & Sullivan Healthcare Practice, Europe. Education: First Class Masters degree, University of Oxford, UK; Doctorate in immunology, University of Oxford, UK.
Ralph Garippa, PhD At a Glance Title: Research leader for Cell-based HTS and Robotics Company: Hoffmann-La Roche Inc., Discovery Technologies, Nutley, N.J. Education: PhD, pharmacology, Columbia University, New York; BS, biology, Fairleigh Dickinson University, Rutherford, N.J.
Lisa Minor, PhD At a Glance Title: Principal scientist, vascular biology Company: Johnson & Johnson Pharmaceutical Research and Development, Springhouse, Pa. Education: PhD, biochemistry, Pennsylvania State University, State College, Pa.; BS, zoology/botany, Oregon State University, Corvallis, Ore.
Phil Webster At a Glance Title: Pharma-biotech analyst for European Healthcare Practice Company: Frost & Sullivan
The problem of serious physical risks associated with pharmaceutical drugs is not going away.