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 »

The development of an HIV vaccine is an important, but difficult goal, but researchers at the Massachusetts Institute of Technology (MIT) recently reported on an important advance in this area. One challenge in developing an HIV vaccine has been the difficulty in measuring how effective a vaccine is in producing an immune response. The MIT researchers have resolved that challenge by developing a high-throughput automated assay to evaluate individual T-cell response. 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 »

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 Congress returns from summer recess, and national campaigns begin, job creation is undoubtedly the theme for the near term. Debates over the role of government in stimulating economic growth through fiscal and regulatory policy are inviting opinions from all sides of the political spectrum. Despite all the contention that is and will continue to ensue, there is generally one agreed-upon precept: innovation is a valuable tool to create and sustain economic growth. But how does the quest for innovation square with government regulation? That debate is taking shape not only broadly but in the nascent field of synthetic biology, where scientific, public-health, and business interests are converging. Read more »

Roche took a step forward in personalized medicine with the approval earlier this month of a new drug and related diagnostic to treat certain forms of metastatic melanoma. Roche’s strategy of developing drugs and related diagnostics shows the potential business and therapeutic value of personalized medicines. Read more »

Good news on the drug-approval front. Through the end of July, FDA’s Center for Drug Evaluation and Research had approved 21 new drugs (new molecular entities and new biologics license applications), which equals the total number of new drugs approved in all of 2010. Although not enough to claim a reversal of the recent downward trend in drug R&D productivity, the numbers are a good sign for the industry. 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 »

Identifying influenza strains each year and developing the appropriate vaccines to combat those strains has been the strategy of combating influenza, including potential pandemics. Finding a way to develop a universal vaccine has been a desired, but elusive goal, but several researchers have recently reported on promising developments for developing a universal influenza vaccine. Read more »