One of PharmTech’s columnists recently wrote about individuals working in quality assurance and how, after becoming more sensitized to a problem, they significantly increased their performance. Specifically, the employees were in charge of identifying spots on finished vials—if they found a spot of a certain size, they rejected the vial. When one employee starting finding more spots than usual and bragged to his colleagues, they all started finding more spots until the team was rejecting 20% of the finished vials. Read more »

Pfizer Global Engineering and Manufacturing has been working with students and faculty from Rowan University’s chemical engineering department to investigate green approaches to drug manufacturing, according to a July Rowan press release. The partnership is aimed at analyzing and quantifying the economic viability and environmental benefit, respectively, of investing in a small solvent-recovery system. Such a system provides an alternative to incineration for small volumes of waste.   Read more »

It’s been a few months since President Obama signed into law the Patient Protection and Affordable Care Act (H.R. 3590). The bill includes a provision to “address gaps in quality, efficiency, comparative effectiveness information, and health outcomes measures and data aggregation techniques.”

Last week, the Partnership to Improve Patient Care (PIPC), which includes a wide range of healthcare organizations working to support the government’s role in and awareness of CE research, held a forum about delivering patient-centered comparative effectiveness (CE) research. Senator Max Baucus (D-MT) was the forum’s keynote speaker.

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The European Union had all the right goals in mind when they launched the Innovative Medicines Initiative* (IMI) in 2007.  In an effort to boost the floundering pharmaceutical sector, leaders decided to bring together public and private scientists across Europe to research and develop new drugs.

 According to an analysis of the program in the July 13 issue of Nature, IMI received 138 “expressions of interest” from universities and research institutes when it first called for research-project proposals.  The second call turned out 124 proposals.  IMI’s executive office in Brussels believes these numbers are a “resounding success,” says the Nature report.  But a joint letter from a group of 11 university and research organizations, including EARTO —which is the European trade association for more than 350 research and technology organizations—states otherwise, calling the first two call responses “well below potential.”

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Seven years ago, industry was left quite confused when FDA withdrew five draft guidances associated with 21 CFR Part 11, the regulations that focus on electronic records and submissions. The agency issued a Scope and Application guidance a few months after the withdrawals, in August 2003, to help define how it planned to interpret and enforce Part 11 (enacted in 1997) while regulators worked out a more final revision to Part 11 based on industry feedback. That revision has yet to make its debut.

This morning, however, officials from FDA’s Center for Drug Evaluation and Research Office of Compliance shed some light on the status of Part 11 via a press briefing.

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FDA’s Jesse Goodman, chief scientist and deputy commissioner for Science and Public Health, testified before the US Senate Agriculture, Rural Development, FDA, and Related Agencies’ Appropriations Subcommittee last week. He brought good news regarding the agency’s research and technological efforts toward finding treatments for rare and neglected diseases. Read more »

It looks as though pharma is following GlaxoSmithKline’s lead in increasing efforts to provide people in developing countries with access to needed medications. GlaxoSmithKline (GSK, London), led by CEO Andrew Witty, has been on the forefront of this effort for some time—its largest contribution being the availability to the public of 13,500 malaria compounds for research and development (see  back story, “GSK Promotes Open Innovation, Help for Developing Countries”). Read more »

As more and more tidbits about Johnson & Johnson’s product recall crisis fill the news waves, concerns over supply-chain security and drug safety are rising yet again. Consumers, not to mention Congress, have not forgotten contamination issues with toothpaste, pet food, infant formula, heparin—the list goes on—and the pharmaceutical industry has been pounded with questions about how it’s managing its manufacturing process as well as how it’s monitoring its supply and distribution channels. There should be light at the end of the tunnel given the numerous efforts made by standard-setting and regulatory bodies on this issue.

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It’s been four years since the International Conference on Harmonization adopted ICH Q3B(R2), which harmonizes the content and qualification of impurities in drug substances, including extractables and leachables (E&L) produced by the interaction of a drug substance and its container-closure system. And yet, there still seem to be a huge amount of questions surrounding these degradation byproducts, stability testing, thresholds, and reporting requirements.

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No matter what governmental bodies do—be they at the state, national, or international level—there is always a group against them. Of course, this is one reason politics and political parties exist—to sort out disagreements among individuals and organizations and, ideally, to find compromise. Political and ethical issues are now surrounding the World Health Organization (WHO) and its handling of the H1N1 swine-flu, which appeared in 2008/early 2009 and quickly spread around the world. WHO declared the situation a Phase 6 pandemic in June 2009. (There are six official pandemic alert Phases with Phases 6 being the highest level, based on human-to-human spread of the virus in at least two countries in one WHO region and at least one additional country in a different WHO region. The Phase descriptions are on the WHO website). Read more »