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March 2012

Hedley Rees

The "Supply Chain" Patient is Sick: Is There a Cure for the Pharma Supply Chain? - Part II

by Hedley Rees
Consultant and Owner of Biotech PharmaFlow

Is there a treatment option for the pharmaceutical supply chain? Yes, I would say there is; and the regulators certainly think so too, having been pressing the industry for nearly 10 years to adopt more modern processes by which to develop, manufacture and supply drugs. Dr Janet Woodcock of FDA, in launching the FDA's modernization initiative in 2002, challenged the industry to create a significantly more efficient and high quality supply chain without extensive regulatory oversight.

In concert with the FDA, the International Conference on Harmonization (ICH - Japan / EU / U.S.) laid out guidelines (ICH Q8-10) outlining a preferred approach based on research into a range of other sectors (e.g. semiconductor, aerospace, automotive) that were successfully translating product concepts into marketed products with high quality supply chains. A decade later, regulatory oversight is as strong, if not stronger, than ever and quality concerns have never been greater.

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Kate Hammeke

Outsourcing Trends for 2012 - Top Services by Customer Segment

by Kate Hammeke
Research Manager, Nice Insight

With the goal of optimizing collaborations in the drug development industry, Nice Insight developed a quarterly survey to measure customer awareness and customer perception across 300+ contract research and manufacturers. Nice Insight's Q4 Pharmaceutical and Biotechnology Outsourcing Survey generated responses from 2,619 outsourcing-facing executives from big pharma (29%), specialty pharma (17%), emerging/niche/start-up pharma (22%), biotechnology (25%), and emerging biotechnology (7%). In addition to creating a research tool that aids sponsors in the outsourcing partner selection process and enabling CROs and CMOs to understand their position within the industry, Nice Insight also garners broad industry trends from its survey data.

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Patricia Santos-Serrao

Clinical CAPA: CAPA Isn't Just for Manufacturing Anymore

by Patricia Santos-Serrao
Senior Product Manager, Pharmaceutical Industry, MasterControl, Inc.

Most of us in the pharmaceutical and biopharmaceutical industry are very familiar with the terms Corrective Action & Preventative Action (CAPA) and commonly associate them exclusively with quality and manufacturing. However, CAPA can be applied to many different business areas within an organization, including clinical research. A CAPA consists of a collection of tasks and actions executed to ensure and sustain quality and compliance in day-to-day processes. In clinical research, noncompliance can be extremely costly both directly and indirectly.

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FDA Issues Draft Guidance on Biosimilar Product Development

by PharmaManufacturing.com

The U.S. Food and Drug Administration today issued three draft guidance documents on biosimilar product development to assist industry in developing such products in the United States.

"When it comes to getting new biosimilar products on the market, FDA has taken an innovative approach to supporting their development at every step of the process," said Janet Woodcock, M.D., director of FDA's Center for Drug Evaluation and Research. "These draft documents are designed to help industry develop biosimilar versions of currently approved biological products, which can enhance competition and may lead to better patient access and lower cost to consumers."

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Did you know that the European Medicines Agency has launched a pilot of electronic application forms for the submission of centralized marketing authorization applications? "The pilot, which runs for four months until mid-July 2012, allows pharmaceutical companies to apply for initial marketing authorization applications for human medicines..."
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