Breaking the Mould: Reimagining the role of advocacy following a regulatory decision

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Breaking the Mould: Reimagining the role of advocacy following a regulatory decision

The Healthcare Communications Association (HCA) and AXON worked together to bring you an insightful panel discussion exploring how we can optimise relationships and ways of working between Patient Advocacy Groups (PAGs) and the pharmaceutical industry following a regulatory decision. In recent years, collaboration between pharma and PAGs during clinical trials and regulatory reviews has become increasingly recognised as an integral part of the drug development process, with the US Food and Drug Administration and European Medicines Agency setting out clear guidance on how patient’s experiences, needs and perspectives can be captured and meaningfully incorporated into drug development and evaluation.

However, the role of PAGs following a regulatory decision is less well-defined – how can PAGs and pharma continue to meaningfully collaborate following a regulatory decision, and how is this impacted by the decision outcome?

We were delighted to be joined by a multidisciplinary panel of experts, who shared their perspectives on the evolving role of PAGs in regulatory reviews, and how PAGs and pharmaceutical companies can continue to work together following a regulatory decision:

  • Barbara McLaughlan, BMcL Consulting, Former Senior Director Government Affairs, Astellas Europe and Head of Patient Advocacy, Government Affairs & Comms at Novartis UK
  • Sophie Wintrich, Patient Advocate
  • Robert Mitchell-Thain, Patient Advocate and CEO of PBC Foundation
  • Sam Robinson, Communications & Advocacy Lead, AXON  

Watch back to hear our expert panellists discuss how we can do better as an industry in the wake of a regulatory decision:

  • The current landscape: The evolving role of PAGs in clinical trials and regulatory reviews
  • What comes next: Paving the way for meaningful collaboration following a regulatory decision
  • The elephant in the room: The aftermath of a negative regulatory outcome
  • From approval to action: How PAGs and pharma can optimise collaboration following approval

About AXON

AXON is a global healthcare communications agency that ignites change in healthcare. Through the power of life-changing communications, we contribute to medical advances that improve lives. At the core of every scientific innovation and advancement, there is a simple and compelling story to be told. We know how to tell that story, how to use the right tools to reach the right audiences at the right time, to provoke meaningful change.  

We specialise in advising clients on medical affairs, clinical studies, real-world evidence, marketing, advocacy and communications, all underpinned by insights and creative strategy. AXON has an international reach, with offices in Copenhagen, London, New York and Toronto, and a worldwide affiliate network. Established in 2002, we have a deep heritage and expertise in healthcare strategy and communication, and we continue to learn and grow in the fast-changing healthcare sphere. AXON is proudly an AVENIR GLOBAL company.



Breaking the Mould: Reimagining the role of advocacy following a regulatory decision

2025-03-20

58 minutes