The International Society for Pharmaceutical Engineering (ISPE) and The Pew Charitable Trusts (Pew) are launching a joint research project to explore the relationship between drug shortages of sterile injectable products* and U.S. market forces. ISPE’s earlier research focused on the technical, scientific, manufacturing, quality and compliance issues in a company’s supply chain that affected the ability to produce, and maintain a steady and stable supply of products at risk for drug shortages. This new research, which extends and builds on ISPE’s earlier work, will examine the interplay between external market considerations and internal decisions related to business continuity planning, supply chain management, and quality, and other related drivers in the pharmaceutical sector.

The research will consist of confidential interviews with industry stakeholders and a questionnaire. A report on this research will be publicly released in 2016, and will contain findings and potential business and policy insights for regulators, policymakers, and the pharmaceutical industry.

Study Approach: The study is divided into two information-gathering phases:

  1. Guided interviews
    The guided interviews will use a case study approach to better understand internal and external constraints that affect company decision-making around supply interruptions that lead to drug shortages, including the influence of larger market forces and economic drivers.
  2. Questionnaire
    Participating companies will also be asked to fill out a questionnaire which will be used to validate and confirm the findings generated by the guided interviews.

Participating Companies: Ideal respondents will include decision makers in supply chain, regulatory, quality, sales, purchasing, marketing, and/or manufacturing operations. Companies participating in interviews will have the opportunity to review written summaries to ensure no identifying information is included.

Participants will be drawn from a meaningful number of small, medium, and large cap manufacturers of branded and generic sterile injectable products sold in the U.S. market. The participants will not be named in the final report.

What is the advantage for my company to participate? This is a neutral and fact-driven opportunity for companies to share the realities of the aseptic manufacturing market with policy stakeholders and regulators in a positive and proactive way.

Confidentiality: ISPE and Pew have secured the services of PricewaterhouseCoopers to help design and conduct the research. PricewaterhouseCoopers will ensure strict confidentiality controls in order to maintain the anonymity of participating companies. No identifying information will be shared by PricewaterhouseCoopers with ISPE or Pew, nor will any identifying information appear in the ultimate report. The final report will only use de-identified data and it will not name participating companies.

Please let us know by 5 February 2016 if your company is interested in participating. We anticipate the interviews and questionnaire deployment will commence as soon as possible, so we would like to schedule the dates now. Our central point of contact is Sam Venugopal at PricewaterhouseCoopers. He can be reached at or (408) 396-9649.

Participating companies will receive a special preview of topline findings in advance of the report’s release.

*Scope: branded and generic sterile injectable products and intravenous (IV) formulations, including vaccines but excluding plasma products.

About Pew

The Pew Charitable Trusts is driven by the power of knowledge to solve today’s most challenging problems. Pew applies a rigorous, analytical approach to improving public policy, informing the public and invigorating civic life. Pew partners with a diverse range of donors and public and private organizations who share its commitment to practical, fact-based solutions and goal-driven investments to improve society.

Pew is a nonprofit charitable organization with offices located in Philadelphia, Washington, DC, Brussels, and London, and staff that span other regions of the United States and Australia. For more information, please see