PDA Letter Article

New Realities for Prefilled Syringes

by Mathias Romacker, Pfizer, Conference Scientific Program Planning Committee, with Rebecca Stauffer, PDA

The new business reality for prefilled syringes centers on self-injection delivery systems adapted to the needs of individual patients. This will certainly have a clear impact on the pharmaceutical market. At the same time, these new products will require new approaches to addressing the needs of regulators. The U.S. FDA has in recent years expressed concerns about errors related to self-administration by patients, necessitating more attention to human factors analysis during the development cycle (1).


Insulin Pen Prefilled

Lifecycle management during manufacturing will be critical to the success of self-administered injection devices. But how can manufacturers of prefilled products learn more about the latest developments in this area as well as gain a sense for the larger business and regulatory environment?

This year’s Universe of Pre-filled Syringes and Injection Devices will examine these issues. In the opening keynote presentation, Pfizer’s Simon Wilson and Amgen’s Sheldon Moberg will look at the issues of evolving perspectives on connectivity and patient-centered solutions, respectively. The talks in this session will cover outcome-based adaptive reimbursement. Such arrangements between payers and pharma have been made for multiple self-injected drugs. The subsequent drug delivery implications will also be discussed.

The conference will be split into three tracks: Patient-Device Interface, Manufacturing and Technology and Marketing and Business Development. The first session in the Marketing and Business Development track will cover lifecycle management, featuring a case study on how an off-patent IV drug was filled in a subcutaneous version using a patch pump. A second case study from Japan will describe the impact of a third-generation digital autoinjector for a growth hormone franchise.

The second day of the Marketing and Business Development track starts with a session on market trends and reimbursement. Attendees will receive an update on the latest overall market trends followed by presentations on reimbursement. The final presentation of the session will review evolving payer perspectives on the value of drug delivery devices. Results from conversations with payer executives will be presented on how to improve population health with the assistance of drug delivery technology.

The last session focuses on business strategies. The first talk will review lifecycle management for devices. Case studies will be presented, including one showing how to convert an off-patent heart failure drug from IV administration in a clinical setting to subcutaneous delivery at home using a patch pump.


  1. Baker, J. “Educating patients on self-administered drug injections.” Pharmaceutical Online. (January 20, 2014) http://pharmaceuticalcommerce.com/manufacturing-and-packaging/educating-patients-on-self-administered-drug-injections/ (accessed Aug. 30, 2017)