The European pharma industry has been very quiet in the summer months, but September has seen a flurry of action (and press releases to my inbox) as companies start gearing up for one of the most important European events for the pharma industry: CPhI Worldwide. The show starts on 25 October, and I hope you’ve made your travel arrangements to Frankfurt (Germany) because some flights and hotels are fully booked! This show is one of the most important in many European companies’ calendars.

I’ve been reading a lot about CPhI this week as companies prepare their media campaigns and with the start of October looming, I thought I’d take a brief look at where the behemoth event started and where it’s going. 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 »

It’s no secret that large pharmaceutical companies are shedding internal R&D staff, and turning towards in-licensing of promising molecules to bolster their early-stage pipelines. Generally, in-licensing candidates are molecules for which preclinical efficacy and safety studies have been done, and increasingly, those that have completed early-stage clinical studies. Eli Lilly, instead of looking entirely at late-stage chemical entities, has expanded a program that looks externally to mine the scientific community for promising preclinical leads. 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 »

Partnerships and strategic agreements are common in the pharma industry. Flicking through my inbox of the last few days I see Bristol-Myers Squibb and Ono, Catalent and Toyobo Biologics… both very sensible. But one particular announcement this week gave me cause to raise my eyebrows and smile.

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The senate appropriations bill released on September 20, 2011 contained a modest $190 million cut in funding for the National Institutes of Health (NIH), but also contained language creating the National Center for Advancing Translational Research (NCATS), a branch of the NIH devoted to translating basic science into treatment and cures for diseases. The purpose of the new center is not to develop new therapeutics, but to develop innovative tools and methods for drug development that will accelerate the development of medical products. In this way, NCATS will complement, and not compete with, the work of the private sector and other NIH translational science efforts. 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 »

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 »