11/03/2026
By Thomas Dugan

The Francis College of Engineering’s Department of Biomedical Engineering invites you to attend a doctoral dissertation proposal defense by Danielle T. Reynolds, titled “Investigating a Simulation-Based Method for Representing and Assessing Organizational Response in Regulated Biopharmaceutical Manufacturing.”

Details

  • Date: Monday, Nov. 16
  • Time: 1 – 1:50 p.m.
  • Location: Falmouth Hall, Room 302M

Committee members

  • Dr. Lara Thompson (advisor), professor/associate chair, biomedical engineering, University of Massachusetts Lowell
  • Dr. Walfre Franco, associate professor/chair, biomedical engineering, University of Massachusetts Lowell
  • Dr. David Claudio, associate professor, industrial engineering, University of Massachusetts Lowell

Abstract

High-consequence events in regulated biopharmaceutical manufacturing require personnel to interpret uncertain information, coordinate decisions, and act within established organizational responsibilities and decision authority; this requires technical knowledge, an understanding of where to obtain information, which functions to involve, and when to escalate. Although procedures, training, process monitoring, and quality systems support operational readiness, a current limitation is that they do not provide an integrated way to represent and assess these responses.

The proposed research investigates a requirements-based methodology, an Organizational Response Simulation Environment (ORSE), for representing and assessing organizational responses to high-consequence events, informed by Organizational Response Capability (ORC). ORC describes the collective ability to recognize, interpret, coordinate, decide, execute, adapt, and learn during high-consequence events, whereas the ORSE prototype represents selected organizational interactions through one participant in the Manufacturing Operator role and scripted cross-functional roles.

We will investigate the above through three aims, for which a suspected contamination event during mammalian cell culture manufacturing will serve as the bounded proof-of-concept application.

  • Aim 1 defines ORC requirements, operating conditions, performance standards, and observable measures through evidence review and structured subject matter expert (SME) review.
  • Aim 2 implements selected requirements in the ORSE, a controlled human-in-the-loop prototype that captures participant decisions, interactions, and actions. Selected digital twin principles inform the representation of changing operational conditions, information availability, organizational responsibilities, and decision authority, without modeling detailed biological kinetics or equipment behavior.
  • Aim 3 evaluates whether the resulting evidence supports requirements-based assessment and whether SMEs determine the integrated approach feasible and useful.

The proposed study distinguishes process performance and individual qualification from response behavior within an organizational context. The intended contribution of this research is a traceable connection between organizational response requirements, simulated decisions and actions, and structured assessment evidence. Findings will identify the potential and limitations of this approach within the defined proof-of-concept and provide a foundation for future studies of ORC in operational settings.