Contract Services Playbook
Heavy Lifters: CMOs Bring the Braun and the Brains
Editor in Chief Steven Kuehn takes a high-altitude snapshot of the contract services landscape and shares his view on trends shaping this segment of the Pharma Industry.
CMO Leadership Strategies: A Series
Patheon's Jim Mullen
Patheon is one of Contract Pharma's emerging leaders, pursuing a growth strategy that is intent on being ready to manufacture tomorrow's complex compounds today. Patheon, a business unit of DPx Holdings B.V., continues to bolster its reputation for scientific and technical excellence. CEO Jim Mullen offers his insights into the strategic direction of this dynamic industry player.
WellSpring's Dave Mayers
WellSpring Pharmaceutical Canada produces more than 20 over-the-counter products including a range of topicals, compounds that can be very tricky to manufacture correctly. David Mayers, vice president and head of operations, offers his views on where he sees the industry heading and WellSpring's strategic response to the market's current and future trends.
West's Graham Reynolds
As one of the industry's most prominent suppliers of drug delivery devices, West occupies a special position in the Pharma industry, being both a supplier as well as a contract manufacturing solutions provider. Graham Reynolds, vice president of marketing and communications, for West offers his company's unique perspective on how it is positioning itself as an indispensable partner for those drug owners marketing sterile injectables and other compounds requiring delivery technologies.
Value Delivery's Next Chapter: Enabling Pharmaceutical Manufacturing Process Robustness
Though always a critical issue, process robustness--the ability of a manufacturing process to produce acceptable quality and performance levels despite variability in inputs such as raw materials or operator expertise--has become a mounting priority within the pharmaceutical industry. Boston Consulting Group's Phil Berk, Frank Cordes and Gideon Walter, walk us through the steps to assure robustness characterizes your processes.
Mission Possible: Excellent Clinical Logistics Insightful Integration of Contract Manufacturing Organizations into Clinical Trial Business
Jens Mattuschka and Henriette Frangillo-Engler, Clinical Logistics Services, PAREXEL International, maintain that the clinical trial supply chain is a conglomerate of many individual, sometimes multifarious, steps that must be reasonably assembled to form a stable chain. One significant supply chain challenge is properly incorporating third-party providers, such as manufacturing companies, focused on primary and secondary packaging of investigational medicinal products (IMPs) and other clinical trial materials (CTMs). The authors explore what it takes to successfully integrate CMOs into the important trial phase of drug owner's drug development activities.
How to "Justify" Innovation and QbD in Pharmaceutical Manufacturing: An Alternate Look
Girish Malhotra, president EPCOT International, understands that some companies in Pharma may never be able to "justify" adopting QbD financially because the payoff will never, ever be enough, especially if operational inefficiencies from not adopting the standard won't impinge too much on profit margins and other financial benchmarks. However, in this piece, Malhotra offers some alternatives that may pave the way to more innovation and less stagnation when it comes to instituting contemporary process and manufacturing quality practices.
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