Articles in this Issue

• Conducting Release and Stability Studies for Blinded Comparators

  Denise Hager, James Kelly, April Tolliver, David Healy
  Due to the limited guidance available for release and stability testing of comparators, strategies are left to the discretion of individual pharmaceutical companies.

• Evolutionary Thinking: Pfizer Continues to Set a New Pace for Drug Development

  Chris J. Hilton, M.Sc., B.Sc.
  Pfizer’s Worldwide Development Operations (Dev Ops) group stands at the forefront of a continuing evolution in drug development that is yielding dividends in the currency that matters most to the pharmaceutical industry – improvements in quality, speed and cost.

• Off-shoring Stability Testing Conducting Cost-efficient Compliant Long-term Stability Studies...

  Tila Balasuriya, Graham Clarke, Ph.D., Andrea Panaggio, Ph.D., Barry Scheer, Ph.D., Pankaj Shah, Ph.D., Peter Timmins
  The research-based pharmaceutical industry has always accommodated change, and like other businesses, is increasingly becoming cost constrained due in part to the rising investment required to develop new medicines and the global economic environment.

• Biopharmaceutical Contract Manufacturing Market: Outsourcing – What Services are Biomanufacturing...

  William Downey, Scott M. Wheelwright, PhD
  As the world economy and financial markets contracted in 2009, so did the market for biopharmaceutical contract manufacturer services.

• Supply Chain Security Programs: A Positive Impact for Shipper

  Brad Elrod
  CTPAT, CCSP, CSI, FAST, ISF and AEO; what do these collection of letters all have in common? Security; specifically they are all government-sponsored supply chain security programs.

• One Man’s Opinion

  Max S. Lazar
  After 45 years in the drug and API industry, I have seen and experienced many things both as a member of the FDA’s regulated industries and as an active participant and I trust, contributor to the development of policies and practices used to positively impact our society and the Good Manufacturing Practices and other standards that are used for Active Pharmaceutical Ingredients (API), excipients, drug products, and other regulated materials.

• Governance Committees: Considerations for Pharmaceutical and Contract Research Organizations

  Karen Zuklie
  In our day-to-day lives, we encounter a myriad of individuals from different walks of life. Some become life-long friends, others a casual acquaintance and some merely pass by. It is easy for us to understand when a person is a good fit in our personal life as our judgment is fundamentally rooted in our individual preferences, personal values, and interests.