Ten biopharmaceutical companies announced the formation of a nonprofit organization called TransCelerate BioPharma, the mission of which is to accelerate the development of new medicines by identifying and solving common drug development challenges. The ten founding companies include Abbott, AstraZeneca, Boehringer Ingelheim, Bristol-Myers Squibb, Eli Lilly and Company, GlaxoSmithKline, Johnson & Johnson, Pfizer, Genentech a member of the Roche Group, and Sanofi. Read more »
Archive for the 'R&D' Category
MIT Survey Aims to Correlate Product Lifecycle and Manufacturing Site Characteristics with Product Deviations
In the September PharmTech issue, researchers from MIT’s Center for Biomedical Innovation (CBI) describe the interim results from recent research into 34 commercial-scale biopharmaceutical products at 11 international sites. The comprehensive survey on topics related to site characteristics, quality approaches, quality activities, perception of relative consistency of regulators, product-level process details, and product-level compliance performance was deployed over the past 18 months as a secure web-based questionnaire directly to biopharmaceutical manufacturing sites through several different channels. The individuals targeted for inclusion as survey respondents have been manufacturing plant managers or their representatives.
Read the interim results and if you haven’t yet, the survey can be taken on behalf of a biomanufacturing site usin this link.
Earlier this week, on Sept. 12, 2012, the Pharmaceutical Research and Manufacturers of America (PhRMA) honored nine individuals for their research into and fight against Alzheimer’s Disease (AD) as part of the association’s new Research and Hope Awards. The event was at the Washington, DC, Newseum and featured as keynote speakers Marc Kennedy Shriver, who wrote a book about his father’s experience with Alzheimer’s, and Meryl Comer, an Emmy award-winning journalist.
The evening was about inspiration and motivation to keep up the fight against AD, whether as caregivers, patient advocates, health professionals, or scientists. Read more »
Researchers are trying to find better, cheaper ways to produce biodegradable and bio-based polymers. Although one of the main drivers for this research is to compete with fossil-fuel-based polymers in large-volume, consumer plastics applications, medical applications, such as microcapsules for drug delivery, may also benefit. While it seems odd, the researchers found that waste oil from cooking fried food can be used as a raw material in the polymer production process. Read more »
Innovation is the cornerstone of the pharmaceutical industry. The challenge to innovation not only entails identifying drugs with clinical efficacy but also in being able to produce and deliver the desired drug compound. An upcoming Pharmaceutical Technology webcast, Omega-3 Innovations in Pharmaceutical and Diagnostic Markets, will examine the latest developments for omega-3 prescription drug products, their regulatory status, and recent advances in softgel drug-delivery technologies for omega-3 products. Read more »
On Sept. 12, 2012, the Pharmaceutical Research and Manufacturers of America (PhRMA) will honor nine individuals for their research into and fight against Alzheimer’s Disease (AD) as part of the association’s new Research and Hope Awards. The statistics surrounding AD have been plaguing families for decades. The disease is the sixth leading cause of death in the US today, according to the Alzheimer’s Association, with 5.4 million people currently affected. By the year 2050, one American will develop AD every 33 seconds.
The costs surrounding AD, from both a financial and time perspective, are also disheartening. The Alzheimer’s Association notes that the US spends an estimated $200 billion on AD per year, and families across America and around the globe are all too aware of the intense care and attention that AD patients require. These are just some of the reasons why PhRMA has focused on AD for its award program, which launches this year, replacing the PhRMA Discover’s award program. Read more »
A federal appeals court has ruled that the National Institutes of Health (NIH) can continue to fund embryonic stem cell research, upholding a July 2011 ruling that found that such research does not violate the Dickey-Wicker Amendment prohibiting federal funding for research in which a human embryo is destroyed. Read more »
IMS Health released its latest global spending report over the summer, confirming that times for the pharma market are indeed changing. The dreaded “patent cliff” that has likely been haunting the dreams of pharma business leaders for the past few years may still exist, but there is more to look forward to. Estimates from IMS Health seem to demonstrate that the industry has not only been planning ahead to ensure that the plague of patent expiries doesn’t kill business altogether, but has done quite a good job at having a backup plan. Take a look: Read more »
Chips for drug discovery are not new—gene chips, which are microchips containing snippets of DNA, have been in use for a number of years as diagnostic tools or tools to study gene expression. But a few recent initiatives suggest that the combination of silicon and biology can be expanded even further.
A publication in the Aug. 19, 2012 online issue of Nature Medicine highlights a collaboration between researchers at the Stanford University School of Medicine and Intel Corp. to create a peptide chip. In an interesting marriage of wafer fabrication and biochemistry, the researchers were able to synthesize short polypeptide chains directly on the chip, rather than synthesizing the peptides separately and then affixing them to the chip.
In this instance, the chip was designed to detect antibodies recognizing amino acid sequences from a DNA-packaging protein called histone 2B. The chip included every possible overlapping sequence of every length from the last 21 amino acids of the histone 2B protein, and was used successfully to identify lupus patients with high levels of antibodies against histone 2B. In an accompanying press release, the researchers indicate potential uses for the technology in addition to that as a diagnostic tool for lupus. The chip technology could be used to better understand protein-protein interactions or to help design influenza vaccines that elicit a strong immune response.
On a larger scale, the National Institutes of Health (NIH) and the Defense Advanced Research Projects Agency (DARPA) are investing heavily in tissue chips to more accurately detect drug safety signals. Tissue chips are microchips ranging from the size of a quarter to the size of a house key lined with living tissue. The goal is to accurately model the three-dimensional structure and function of human organs, reproducing the complex interactions, both chemical and biomechanical, that occur among different cell types within an organ system. The chips could then be used to predict drug toxicity and efficacy more accurately and at lower cost than current methods.
NIH is providing more than $70 million in funding over 5 years to develop this technology, with part of the funding coming from the recently established National Center for Advancing Translational Science. DARPA is conducting a separate but parallel program. It has awarded two grants, one to the Wyss Institute at Harvard University and the other to MIT, both of which also are NIH tissue chip grant recipients, to develop engineering platforms capable of integrating 10 or more organ systems.
PhRMA Senior Vice-President Matthew Bennett released a statement today on the state of the biopharmaceutical industry, in response to an analysis in the British Medical Journal. Bennett states that while the US may be lagging behind in spurring innovation programs, he believes the passage of the Prescription Drug User Fee Act (PDUFA) will improve the situation.