This post was written by Eric Langer, Managing Partner, BioPlan Associates, Inc.

Yes, doing surveys is a pain.  So there’d better be a darn good reason.  Here’s a survey with 7 good reasons that I consider worth the effort.  The industry and participants benefit from the 9th Annual Report and Survey of Biopharmaceutical Manufacturing, and here’s why. Read more »

FDA Commissioner Margaret Hamburg held a special press briefing this morning on Genentech’s Avastin drug and its indications for metastatic breast cancer. She announced that the agency is revoking that indication based on FDA follow-up studies which did not show promising results. Read more »

Biopharmaceutical characterization—especially of unknowns—is becoming far more complex and far higher on the regulators’ radar.  Of particular interest for industry is compliance with harmonized guidelines that address FDA’s concept of a “well-characterized biological product,” which involves being able to measure and control the product’s identity, purity, impurities, potency, and concentration. Read more »

Consortiums are nothing new, but they do seem to be popping up more than usual throughout the pharmaceutical sector lately. Rx-360 and its supply-chain efforts come to mind, as does the IQ consortium on advancing innovation in the quality of pharmaceutical development. There’s also an international pharmaceutical privacy consortium, a consultants consortium, and more.

The fact is, industry seems to be tired of waiting for standard-setting bodies and regulators to take action on solving key challenges such as counterfeiting, economically motivated adulteration, the implementation of quality by design, and so forth. It’s not that the agencies and organizations aren’t working on these issues, but they have to do deal with more legal and governmental bureaucracy than do representatives from various companies sitting around a table over coffee or drinks. Read more »

The malaria vaccine candidate RTS,S is looking even more promising, according to preliminary clinical trial results published in the New England Journal of Medicine . Early data from a large-scale Phase III trial conducted in seven African countries show that the vaccination regimen “can reduce the risk of clinical malaria by more than half in African children aged five to 17 months during the 12 months after vaccination.” Read more »

Everyone wants to know what their equivalents in the market are making, whether they are a QA professional, a lab chemist, a supply-chain manager, a procurement officer, a division leader, or even a CEO. But salaries aren’t all that make job satisfaction possible. Factors such as proper staffing, level of outsourcing, mergers and acquisitions, training, benefits, company culture, and more contribute to one’s willingness to stay put–or seek other employment. We’d like to know what’s going on in your field, so please take our annual employment survey. The results will be reported in the December print issue of Pharmaceutical Technology and Pharmaceutical Technology Europe.

I’m here in Seattle at the USP Science and Standards Symposium, which is focusing on all things biologic and biotech. Representatives from a majority of the pharmacopeia’s expert panels are here, as are a few FDA officials, and industry members from around the world–some 30 countries are represented in fact. Various new approaches by USP are aiming to help industry better understand, develop, test, and manufacture biological products, including biosimilars. Read more »

Written by Ben Comer for Pharmaceutical Technology

R&D departments and payers need to communicate early in the drug development process: If pharma is a day late, then payers are likely to be a dollar short, according to panelists at the Galien Forum on Tuesday. Read more »

FDA’s Steve Wolfgang led a talk about supply chain concerns and regulatory considerations at today’s PDA-FDA Joint Regulatory Conference in Washington, DC. We all know that the percentage of drugs manufactured abroad is growing as are the number of foreign manufacturing establishments abroad. These changes and globalization in general have led to more complex supply chains and the greater need for scrutiny. Among some newer supply chain challenges industry has to worry about, noted Wolfgang: certificate of analysis laundering, shadow and show factories, dietary supplements spiked with APIs, diversion of legitimate product (e.g., cargo theft), and illegal distribution (e.g., internet sales of drugs). Wolfgang touched on other supply chain challenges as well in today’s session.

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This morning’s session at the PDA-FDA Joint Regulatory Conference in Washington, DC, honed in on common CMO-based questions about regulatory expectations, corporate responsibility, and sub-suppliers. Several audience members wanted to know what the agency has in mind in this area of contract manufacturing. Read more »