Pharmaceutical Technology August Outsourcing
Resources Supplement

As of June 18, 2014
Featuring Jim Miller 2014 PharmTech-PharmSource Outsourcing Survey Results
Jim Miller, president of PharmSource Information Services 
This annual snapshot of business trends for contract services in drug development and manufacturing features the results of a comprehensive survey of contract manufacturing organizations and bio/pharmaceutical companies. The author assesses the impact of changing economic factors, outsourcing strategies and spending, and projections for future outsourcing projects.

Added Capacity and Capabilities in the Contract Services Market
The Editors of Pharmaceutical Technology
In the past year, some contract service providers have invested in new facilities, equipment, and instruments. Others have partnered with companies, or expanded capabilities through mergers and acquisitions. The editors summarize these capital improvements and strategic business arrangements for contract development, manufacturing, and analytical services.

The Evolving Role of Contract Services in Market Segments
Contract service providers will share insight into emerging drug therapies, formulation and development challenges, regulatory topics, quality issues, and the shifting roles of drug sponsors and contract services in key market segments:

  • Analytical Services
  • API Development and Manufacturing
  • Biologics Drug Development and Manufacturing
  • Parenteral Drug Development and Manufacturing
  • Solid/Semi-Solid Dosage Development and Manufacturing
  • Packaging and Supply Chain

The editors will summarize comments from representatives of contract service organizations on these topics.

Supply Chain Flexibility to Enhance Pharmaceutical Production
Michael Schmitz, Director Supply Chain Processes & Logistics, Vetter
Globalization has made the pharmaceutical supply chain more complex, with more customers and products. The ability to plan ahead becomes more difficult as the market demand is subject to strong fluctuations. The possibilities for structural optimization along the supply chain—such as outsourcing quality control of incoming goods to reduce lead times—is often limited or not an option in the pharmaceutical industry. However, drug manufacturers need to be flexible enough to react to demand changes and still maintain a high level of quality. The author will address ways companies can cope with increasing demand volatility, the impact on production planning and storage capacities, how timing in processes can be optimized, and how CDMOs meet these challenges.

Weighing Clinical Trial Outsourcing Options
Bryan Haas, Dave Agrella and Scott Maisto, PPD
Biopharmaceutical companies are facing increased research costs, along with the ongoing complexity of global regulations and market conditions create a wide range of needs in the outsourcing market. The authors examine the characteristics of full-service outsourcing, in which the partner company takes full ownership of the trial deliverables, and functional level services, which provides specific staffing solutions to meet global capacity requirements. They discuss an integrated outsourcing solution that encompasses the legal, contracting and execution expertise that enables clients to meet business objectives.

Europe’s Need for Early Development Pharmaceutical Manufacturing Expertise
Jon Sutch, manager of formulation and clinical trials manufacture, Patheon
Despite the growth of specialist companies with capabilities across various therapeutic areas in Europe, there is still a need for early development expertise with end-to-end pharmaceutical manufacturing capabilities. The author describes the need for a science-led approach from early- through late-phase development.

Possible articles.
API Contract Manufacturing market outlook:
A market research firm has been invited to summarize market trends and forecasts for small- and large-API contract manufacturing.  A response is expected by June 20.