Articles in this Issue

• Using Quality-by-Design to Enable CMO Manufacturing Process Development, Control and Improvement

  Ronald D. Snee, Ph.D.
  Pharmaceutical companies are increasing their use of outsourcing of manufacturing processes as a strategy for remaining competitive in the global marketplace.

• Outsourcing Clinical Biomarker Development: A Pragmatic Approach

  Robert Lykins, Sunil Kadam, Ph.D., Catherine Leppert, Anita Pascarella-Hallett
  The Pharmaceutical Industry is in the midst of significant change as it looks to balance the cost of developing new medicines while meeting the expectations of patients, healthcare professionals, payers, regulatory agencies and shareholders [1].

• In-house Contract Research and Manufacturing

  Hemant N. Joshi, Ph.D., MBA
  Many pharmaceutical companies, big and small, have been outsourcing work to contract research organizations (CRO’s) and contract manufacturing organizations (CMO’s).

• Is It Worth the Risk without Temperature Monitoring?

  C. Ray Goff, Jr.
  Temperature-sensitive medicinal products deliver unique value to the end-user while introducing several logistical risks to the shipper.

• Regulatory Strategy for the Submission of CMC Information to Support the Use of Radiolabeled...

  Robert H. Seevers, Ph.D., William F. Kluttz, Richard D. Hoffman
  This paper addresses the use of radiolabeled compounds in clinical research, in particular the considerations involved in regulatory submissions where radiolabeled compounds are used.

• API Roundtable

  Mark Krook, Ph.D., Kirk L. Sorgi, Ph.D., Mark Sawicki, Ph.D., Max S. Lazar, Brian Scanlan, Derek Hennecke
  What, in your opinion, is currently the single largest trend with respect to active pharmaceutical ingredients outsourcing and manufacture?

• An Interview with PPD

  Magdalena Mejillano, Ph.D.
  What is the current business environment for analytical testing services?