In attending CPhI this week in Frankfurt, one theme that repeatedly emerged was the increasing importance of CROs, CDMOs, and CMOs to build more strategic, deeper, and collaborative relationships with pharmaceutical companies as a way to meet the evolving needs of the industry and as a a mutual tool in value creation. Read more »

AstraZeneca’s announcement this week that it is investing $200 million in a new manufacturing site in China, the largest investment by the company in a single manufacturing facility, reflects not only the ongoing trend on pharmaceutical industry investment in emerging markets, but also speaks to the larger issue of ways to stimulate manufacturing investment in the United States. As President Barack Obama looks for support for his jobs bill from Congress and the public, a basic question is whether federal policy is on the right track to stimulate business investment in the US. Read more »

Drug shortages are an acute problem that keeps getting worse. Last year, about 211 drugs were in short supply, which was a new record. This year, the number of new drug shortages already has reached 213, according to the University of Utah Drug Information Service. As a result, many patients now have limited access to crucial drugs, such as cancer therapies and medicines for potentially lethal infections. And a Congressional committee is now investigating what appears to be an insult added to this injury. Read more »

Concern about pharmaceuticals in our water supply has been in the public consciousness for a few years now. In 2009, the Environmental Protection Agency found traces of various drugs in fish caught in rivers that receive effluent from wastewater-treatment plants. The drugs were believed to come from doses that people had excreted or flushed down the toilet. In response, FDA updated its guidelines for disposing of drugs. New research, however, shows another potential source of drugs in our waterways. Read more »

Improving the solubility of poorly water-soluble drugs is of crucial importance for developing and successfully commercializing new drug compounds. Combinatorial chemistry and high-throughput screening methods in drug discovery has increased the number and diversity of molecules of potential interest in drug development. That larger pool of candidates, although potentially beneficial, also creates challenges, namely more compounds  of poor solubility. According to some industry estimates, approximately 70% of new chemical entities under development may be classified as BCS Class II compounds (i.e., high permeability and low solubility) (1). An upcoming webcast by Pharmaceutical Technology examines one technology to address low bioavailability: pharmaceutical melt extrusion. Read more »

The Pharma ChemOutsourcing conference, an annual event that brings together pharmaceutical companies, CROs, and CMOs to discuss industry trends and perspectives, was held in Long Branch, New Jersey, last week. The central question at the heart of many of the discussions was a fundamental but important one: where is the opportunity in pharmaceutical outsourcing, specifically in pharmaceutical chemical development and manufacturing? Read more »

As I wrote last week, the market for vaccines is expanding, and the newswires have stories about these products almost daily. Sanofi and GlaxoSmithKline, to name just two major players, are increasing investments in research and manufacturing capacity for these therapies. Kalorama Information predicts that sales of pediatric vaccines will grow even more quickly than sales for adult vaccines. Yet drugmakers have surely noticed that not all publicity about vaccines has been positive. Read more »

The recent volatility in financial markets, combined with reports of stagnant US economic growth, point to less-than-optimistic prospects for a recovery. The underlying weakness in the US economy reveals structural flaws, which are not likely to be amerliorated in the short term, one of which is a lack of private-sector investment in domestic manufacturing. Are there lessons that can be learned from emerging markets in fostering growth in domestic manufacturing? Read more »

Even more than visiting the exhibit floor, I enjoy attending the presentations at INTERPHEX, which will take place next week in New York. The sessions always reflect the current hot topics within the pharmaceutical industry, and this year is no exception. Observers have been predicting that vaccines will be the industry’s new growth area, so my eye was drawn to the various biopharmaceutical talks listed on the INTERPHEX schedule of events. Read more »

Beginning in September 2009, I watched with increasing surprise as Johnson & Johnson (J&J) recalled more and more of its products. As the recalls kept coming, my surprise turned to amazement that some of the company’s facilities (particularly the one at Fort Washington, Pennsylvania) could have been maintained and run in such an apparently haphazard way. As time went on, my amazement ebbed, and the continuing stream of recalls elicited little more than a shrug. Read more »