An initiative to develop consensus-based industry standards to identify and define green chemicals and process technologies is underway. The move is a helpful step toward more sustainable practices for the chemical and pharmaceutical industries, but it raises larger questions. Can the pharmaceutical industry be more proactive in becoming green? And can regulatory authorities do more to encourage process improvement for green pharmaceutical manufacturing? Read more »

One measure of changing public focus is when words become part of our common lexicon. The addition of “carbon footprint” and “green collar” to the latest edition of the Merriam Webster dictionary, released last month, reflects not only the acceptance of “greenspeak” in our communication, but more importantly its integration into mainstream activities. That sentiment was evident at the Green Pharma Summit, which was held last month in Philadelphia, where pharmaceutical and government officials shared their involvement in sustainability practices for pharmaceutical manufacturing and drug-product life-cycle management. Read more »

Relationship building and the benefit of deepening collaborative business models between excipient manufacturers and pharmaceutical companies in support of formulation development and manufacturing in a quality-by-design (QbD) paradigm and enhancing supply-chain practices was a key takeaway from ExcipientFest Americas, which was held in San Juan, Puerto Rico, this week. ExcipientFest Americas is operated by the Drug, Chemical and Associated Technologies Association (DCAT). ExcipientFest Americas is an exhibition and educational program that addresses technical considerations in excipient selection and formulation development as well as sourcing and supply-chain issues for excipients. Read more »

Pfizer announced this week that following a successful completion of its $68-billion acquisition of Wyeth, it will divide its research activities into two separate organizations, one for small molecules and one for biologics and vaccines. The reorganization is but a microcosm of Big Pharma’s larger strategic interest to strengthen its position in biologics with the hopes of improving its return on research and development (R&D). But is the calculus of intensifying R&D into biologics correct? Read more »

Janet Woodcock, director of the Center for Drug Evaluation and Research for the US Food and Drug Administration, spoke at the Drug, Chemical, and Associated Technologies Association (DCAT) annual dinner earlier this month, emphasizing the need of regulators and industry to meet the challenge of securing an increasingly complex global pharmaceutical supply chain. Her words were very well taken and show the recognition not only by FDA and other regulatory authorities, but also of pharmaceutical manufacturers and their suppliers, that the elongation of the global supply chain brings with it new responsibilities and ways of doing business. Read more »

A recent article in the New York Times describes the results of a study by Steven Woloshin and Lisa Schwartz, two researchers from the Dartmouth Institute for Health Policy and Clinical Practice, which showed that a drug-fact box improved US consumers’ knowledge of prescription drugs’ benefits and side effects. The researchers presented their findings at a recent meeting of a FDA Risk Communication Advisory Committee, urging the committee to adopt a drug-fact-box labeling system (similar to nutrition-fact panels on food packaging), which would be used in print prescription drug advertisements to quantify the benefits and risks of taking a drug. Read more »

At the moment, the pharmaceutical industry is preoccupied with financial concerns, mainly because of patent expirations, weak pipelines, and our limping economy. But before the current crisis, many companies were devoting greater attention to minimizing the harmful environmental effects of their processes. What if there were a way to address these two concerns at once? Read more »

The mood at the 2009 installment of InformEX, the exhibition of custom and batch manufacturers, which was held in San Francisco last week, had a decidedly subdued tone. The culprit: the uncertainty of the economy and its implications on spending and financing, particularly for small- to medium-sized pharmaceutical companies. Read more »

The US Food and Drug Administration was buffeted by questions and criticism last year after the emergence of contaminated heparin. Lawmakers questioned whether the agency had investigated the problem thoroughly and been forthcoming about its findings. Several of FDA’s recent measures provide reassurance that it is attempting to protect American patients from contaminated drugs produced abroad. Read more »

As Congress begins a new session, the Synthetic Organic Chemical Manufacturers Association (SOCMA) is making its legislative priorities known. SOCMA is the US-based trade association of batch and custom manufacturers, which includes contract manufacturers of pharmaceutical intermediates and active pharmaceutical ingredients (APIs). Through its “First 100 Days” initiative, SOCMA says it plans to meet with new agency heads and key Congressional members to share the priorities of the specialty and batch manufacturing industry and to seek bipartisanship wherever possible. Read more »