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 »
Archive for the 'Trends' Category
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.
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 »
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 »
The International Society of Automation’s (ISA’s) 7th Marketing and Sales Summit, held Aug. 15–17, 2012 in Austin, Texas, was themed “New Rules of Customer Engagement: Riding the Winds of Change”, and emphasized the need to adapt to the changing needs, expectations, and behaviors of marketplace decision makers, according to an Aug. 27, 2012 press release. Read more »
Cargo theft, for many years, was a problem that largely plagued the electronics industry, but criminals have recently shifted more attention to the far more lucrative pharmaceutical trade. In March 2010, thieves masterminded a heist of $75 million worth of cancer, psychiatric and blood-thinning drugs from a Connecticut warehouse by cutting a hole in the ceiling and dismantling alarms during a severe storm that masked their activities from the local authorities. To curb future cargo theft, it is imperative that pharmaceutical companies develop solid, globally applicable conveyance security programs.
Read about theft-preventing strategies in the August issue of PharmTech