In about 20 years and with a cost of around $10 billion. That’s the estimate given by researchers at the Beth Israel Deaconess Medical Center in the US who used quantitative modelling to forecast how much time and money would be required before pharmacogenomics could be expected to be used in clinical care. Read more »
Archive for the 'Trends' Category
A new year has started in the world of pharmaceutical manufacturing and technology, and 2013 looks to bring plenty of innovation. PharmTech’s January issue highlights what the pharma industry can expect in the upcoming year.
Look for a discussion with FDA on the changing scope of regulatory science and its effect on drug reviews, site inspections, and approvals as well as academia’s role in the future of pharmaceutical manufacturing. We will also have a look at the future of CMOs and ISPE’s view on the future of the quality laboratory.
We would also like to know what you think the new year will bring! Please leave your comments on what your company’s goals and innovative projects are for the new year, and be sure to let us know what you would like to see us cover in the year to come!
Passengers travelling via Air France this December will see an in-cabin movie made by Sanofi to raise awareness about the dangers of counterfeit drugs.
According to Sanofi’s video, up to 10% of the world’s medicines can be counterfeit. In industrialised countries, counterfeit medicines are rare and many patients and consumers may not be fully aware of the dangers. In other locations, however, such as some countries in Africa, Asia, Latin America and in emerging markets, counterfeit medicines may comprise 20–30% of the market. Travellers are not always aware of the risk when venturing to another country. Read more »
A golden era of productivity awaits the pharmaceutical industry in 2020, according to a report from PricewaterhouseCoopers (PwC). In an industry that seems to be dominated by headlines of job cuts and low growth, it’s a relief to hear positive news that suggests there’s light at the end of the tunnel. Read more »
As an industry that is constantly being scrutinised, pharma is now under pressure to openly publish all data from clinical trials, including negative results such as failures of medicines during phase I–III evaluation. From January onwards, the British Medical Journal (BMJ) will only publish studies on drugs and devices, whether industry funded or not, where there is a commitment to “make the relevant anonymised patient level data available on reasonable request.” The move was fully supported by GlaxoSmithKline (GSK), who is already posting results from all its clinical trials on the company’s website. In a press release, Patrick Vallance, the president of pharmaceuticals R&D at GSK, said, “Moves like this should help medical research by allowing scientists to study the detailed results of clinical trials and increase understanding of current and new medicines.” Read more »
The editorial offices of PharmTech are based in New Jersey, so when Hurricane Sandy hit last month, we were all affected. Flooding and high winds destroyed many coastline homes along with well-known destinations across Atlantic City, the Jersey Shore, and the neighboring Manhattan boroughs. Suburban communities and businesses (including many US biopharma manufacturing headquarters) across the state were without power for days and schools were shutdown for a week or more in several counties. President Obama declared the state, along with New York, a major disaster area. The entire ordeal was quite surreal, and our team considers ourselves to be lucky that we made it through unscathed. Our thoughts go out to those who are still recovering from the storm and trying to get back to normal. Read more »
Laboratory best practices for meeting regulatory and compendial requirements are changing. FDA’s emerging expectations on data integrity, operational qualification report generation, along with the ISPE GAMP Good Practice Guide for Validation of Computerized Systems have provided the industry with new ways to approach laboratory compliance. In addition, the status of USP Informational Chapter <1058> on analytical instrument qualification is being discussed across the industry and the pharmacopeial body. A stimulus paper is being written on this chapter, offering some revision proposals.
Paul Smith, EMEA and India Compliance Program Manager at Agilent, spoke about these issues and offered some best practices for moving forward in an educational webcast. You can watch the webcast for free on demand here.
Earlier this year, the concept of solar-powered aviation was further propelled from its proverbial runway, testing many limits that had not been previously realized in the realm of energy-efficient transportation. However, as is the case with virtually every achievement since the dawn of civilization, the question remains the same: Where do we go from here?
From May–July 2012, Solar Impulse—with the help of several sponsors, including Bayer MaterialScience, the subsidiary of the pharmaceutical manufacturer Bayer—successfully completed a series of flights (known as Crossing Frontiers) as part of a round-trip journey from Switzerland to Morocco, setting several world records, according to the World Air Sports Federation, in the solar-powered subcategory (including for free distance along a course, and for straight distance with predeclared waypoints). In addition, the mission included the first solar-powered intercontinental flight linking Europe to Africa when Solar Impulse’s HB-SIA plane crossed the Strait of Gibraltar.
A new report has forecast that the global biopharmaceutical market will be worth more than $320 billion by 2020, up from just $138 billion in 2011. According to global business intelligence firm GBI Research, annual revenues for biopharmaceuticals have been rising year on year since 2001. In 2011, biopharmaceuticals accounted for 15.6% of the total pharmaceutical market. Read more »
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.