Archive for the 'Trends' 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.

Omega-3s Prescription Products: A Case Study of Innovation

Patricia Van Arnum PharmTech editor 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 Predictions Foretell Change, Positive Change

Angie DrakulichIMS 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 »

Winds of Change at the International Society of Automation Summit

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 »

Pharmaceutical-Based Cargo Security and Theft Prevention

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

Study ‘Confirms Economic Viability’ of Orphan Drugs

Julian Upton Pharm Exec EuropeOrphan drugs achieved blockbuster status in 2011, generating over $50 billion, and have the potential to generate as much lifetime revenue as drugs used for more common health conditions, according to a report from Thomson Reuters’ IP & Science division. Read more »

Generics Help Hold the Line on Healthcare Costs

Amy RitterImproving lives for less—that’s the tagline from the press release from the Generic Pharmaceutical Association (GPhA) describing the results of an IMS study of the savings produced by generic medicines. The study, Generic Drug Savings in the US, found an impressive $1 trillion in savings over a ten-year period (2002 through 2011). Read more »

Creative Solutions for Healthcare Recycling

The news that the London 2012 Olympic Games aims to be the first Olympics to be “zero waste to landfill” is an indication of the growing importance of finding new ways to fulfill the old mantra of “reduce, reuse, and recycle”.  Recycling is even finding new applications in the pharmaceutical and healthcare industries as more companies seek to reduce waste. Read more »

Atypical Visible Particles: Can Users and Makers Find Common Ground?

Angie DrakulichIn April 2012, industry experts discussed the issue of atypical visible particles in pharmaceutical raw materials, including excipients, at the joint International Pharmaceutical Excipient Council’s (IPEC) Regulatory Conference and ExcipientFest-Americas Conference in San Juan, Puerto Rico. This topic is key because a primary cause of drug recalls during the past year has been the presence of visible particles, that is off-colored particles or black or tan specs, in pharmaceutical products. The presence of visible particles affects both excipients manufacturers and users with regard to standard expectations for mitigating the atypical visible particles and with regard to decision-making about raw material acceptance criteria. Read more »

Increased Generics Spending in Pharmerging Markets Predicted

The pharmerging nations are expected to nearly double their spending on medicine by 2016, according to an IMS Institute for Healthcare Informatics report, The Global Use of Medicines: Outlook through 2016, the Institute said in a press release. Read more »

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