Outsourced Pharma Newsletter: Seven CEOs Say Outsourcing Advancing

Outsourced Pharma Newsletter | March 11, 2015

Industry Analysis Seven CEOs Say Outsourcing Advancing ... On Swirling Currents (Part 1) By Louis Garguilo, Executive Editor, Outsourced Pharma How's it going in the global biopharma outsourcing industry? I reached out to seven CEOs at global CROs/CDMOs for trends from the trenches — or at least the frontlines. FROM THE EDITOR: WIB Profile: Emerging Markets Drive Growth In Biologics By Ed Miseta, Chief Editor, Outsourced Pharma I was able to catch up with Daniella Kranjac, integration leader and head of commercial operations at GE Healthcare,, to discuss her position and the trends she sees occurring in the biologics market. » Discovery Research/Preclinical Development WHITE PAPER: Dermal Toxicology: A Multifaceted Approach To Meet Today's Research Needs By Lisa Craig, BS; Chris Papagiannis, BS; and Duane Poage, MS Developing a dermal NCE generally follows the same path as other small molecule NCEs administered orally or systemically, except that the dermal route is used in a nonrodent model. FROM THE EDITOR: Will Providers Compete With Hubs — And Pharma — For Drug Discovery Customers? By Louis Garguilo, Executive Editor, Outsourced Pharma Here’s hoping this doesn’t rise to the category of grandiloquent theories, but the convergence of two global trends in drug discovery should be considered by business strategists at outsourcing providers as well as pharma sponsors. » Drug Substance/Drug Product Manufacturing ARTICLE: Implementing A Vendor Oversight Quality Management System: Insights From Biogen Idec Data Management By Ed Miseta, Chief Editor, Outsourced Pharma As the volume and complexity of outsourcing increases it becomes important to implement a risk-based approach to vendor oversight. Regulatory agencies expect that sponsor companies will ensure qualified personnel are working on their behalf, follow GCP-compliant processes, and have adequate controls in place to ensure patient safety and data integrity. GUEST COLUMN: What Are You Really Outsourcing When Using Single-Use Systems? By Max Blomberg and Christian Julien As single-use adoption has advanced from a curiosity to an implemented business reality for many pharmaceutical companies over the past decade, it’s relevant to explore a few key concepts that should be addressed. » Packaging/Assembly/Logistics WHITE PAPER: 10 Tips For Contingency Planning And Crisis Preparation By Sue Lee, Technical Portfolio Manager, World Courier Before I leave for the office each morning I check the transport news. How is my local transport running? Are the trains on time? Do any tube lines have a problem? Is there a transport strike? Should I divert and get the river boat? WHITE PAPER: Shipping Qualification: What Is It And Why Is It Necessary? CASE STUDY: Quick International's Reliable Cold Chain Solution To Deliver Medical And Pharmaceutical Products CASE STUDY: Why The Cold Chain In Healthcare Is So Important, And How Technology Is Enhancing Patient Safety PRESENTATION: AT&T Cargo View With FlightSafe: M2M Solution SURVEY: Assessing The Future Of The Cold-Chain Industry EVENT: Leading Minds Seminar: Practical Approaches To Temperature-Controlled Pharmaceutical Logistics And Storage » Most Recent News FDA Approves New Antifungal Drug Cresemba AbbVie Acquires Pharmacyclics To Help Secure Future Cash Flows As Humira Biosimilars Loom UPS Expands Special Commodities Program To More Countries AstraZeneca To Participate In U.S. FDA Endocrinologic And Metabolic Drugs Advisory Committee Metrics Wins Multiple CMO Leadership Awards For Innovation And Regulatory Track Record