Covering ground: from the negotiating table to the lab to the production line, we've got it covered.
The topic got me thinking that it's sort of what we do here at Contract Pharma: provide our readers with glimpses and insights into the market from one end to the other and this issue is a perfect example. We cover a lot of ground, all the way from the negotiating table, to development in the lab, to manufacturing operations and drug delivery trends all the way to tracking and tracing products once they leave the warehouse and make their way to the shelf.
In "Solid Dispersions: A universal formulation strategy for poorly soluble drugs?," Robert Harris, chief technical officer of Juniper Pharma Services discusses how drug solubility continues to be a challenge for pharmaceutical scientists. He says many of the new drug compounds emanating from drug discovery pipelines are poorly water-soluble and in fact, he says it is estimated that up to 80% of new small molecule drugs in development can be regarded as poorly soluble. Beginning on page 32 Mr. Harris talks about several techniques that can be used to improve drug solubility.
Experts from PharmaCircle LLC (page 46) explore the trend of pharma increasingly embracing injectables as a preferred form of delivery. In "Injectables: The New Oral?," the authors explore the trends behind this sharp move towards injectables saying, in fact, seven of the top 10 pharmaceuticals by sales in 2014 were injectables, when only a decade earlier there was only one, Amgen's Epogen.
In the complex world of contract negotiations, negotiating supply agreements between biopharma CMOs and their clients is typically long and costly. Beginning on page 42, in "Biopharmaceutical Contract Manufacturing Contract Negotiations,"William Downey, president of HighTech Business Decisions, offers valuable insight into the most difficult areas in these contract negotiations as seen from the perspective of executives at a number of pharma and biotech companies as well as CMOs.
Moving on, in "CMO Systems" (page 52), Phil Burns, cofounder of CRO-Consulting defines how to establish and maintain the internal systems for a company's CMO activities. Highlighted are regulatory, technical, compliance and operational systems for any CMO activity and the article also explores how to pursue innovation during the efforts.
Another current hot topic in the pharma world is continuous manufacturing, which we cover beginning on page 37. Girish Malhotra, president of EPCOT International, gives us a close look at the unique characteristics of continuous processes in pharmaceutical manufacturing and addresses key points that pose challenges with continuous manufacturing and regulatory compliance. He says in addition to continuous processes having very unique characteristics compared to any other manufacturing process, they also have a very stringent demand: qualify has to be built in the process from the start.
As always, in an effort to bring you the relevant and important information to help with your business endeavors, we've covered a lot of ground in this issue. If there are any topics and/or ideas you have for articles or want to read about, drop me a line.
Tim Wright, Editor
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|Title Annotation:||FROM THE EDITOR|
|Date:||Apr 1, 2016|
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