Proceedings: DIA 2019 Global Annual Meeting

What is the Impact of Patient Engagement on the Biopharmaceutical Industry?
Kinari shah

he role of the patient in drug development has grown, and patient-centric initiatives can be seen across industry and regulatory bodies. Two sessions at DIA’s Global Annual Meeting centered on how patient engagement has transformed the biopharmaceutical industry, and how to measure the impact of patient engagement. The lessons learned from these two sessions show how crucial it is to incorporate patients at every stage of the drug development process while establishing the importance of assessing patient engagement to understand best practices.

This summary covers two sessions from the Patient Engagement track at this year’s Global Annual Meeting: Measuring the Impact of Patient Engagement Activities in Medicines R&D: A Way to Sustain Cultural Change? and Impact of Patient Engagement on the Biopharmaceutical Industry’s Business and Organization.

Key Takeaways

  • Building effective tools for measuring the impact of PE involves a framework focused on monitoring, evaluating, learning.
  • Some tenets of patient engagement include involving patients at every stage, engaging and incorporating patient views in all stages of drug development, developing research methodology that incorporates the patient preference, and ensuring patient voice for determining research priorities.
  • Engaging all critical stakeholders across the healthcare environment is critical to make effective patient engagement a reality.

Measuring the Impact of PE Activities in Medicines R&D: A Way to Sustain Cultural Change

This first panel covered ground on various existing projects and initiatives that have established the role of PE in drug development thus far. Based on analyses of patient-centric trials, the development and recruitment pipelines show added value. An overarching theme across all speaker presentations was the presence of many patient-centric initiatives, a lack of alignment across stakeholders on value, and – the focus of this panel – few measures of value and impact. The panel represented Patient Focused Medicines Development (PFMD), the Clinical Trials Transformation Initiative (CTTI), IMI’s PARADIGM, and DIA.


Measuring the Impact of Patient Engagement Activities in Medicines R&D

Mathieu Boudes, PARADIGM Coordinator, European Patients’ Forum (Chair)

Nicholas Brooke, Executive Director, Patient Focused Medicines Development (PFMD), The

Debra Michaels, Associate Director, Scientific Programs & Patient Engagement Lead, DIA

Jaye Bea Smalley, Director, Global I and I Patient Advocacy and Life Cycle Management, Celgene Corporation

Lidewij Eva Vat, Researcher and Lecturer Meaningful and Sustainable Patient Engagement, Vrije Universiteit (VU)

Impact of Patient Engagement on the Biopharmaceutical Industry’s Business and Organization

K. Kimberly McCleary, Founder and Chief Executive Officer, The Kith Collective, LLC (Chair)

Joel Beetsch, Vice President, Global Patient Advocacy, Celgene Corporation

Nikki Levy, Vice President, Patient Engagement, Alkermes

Jan Nissen, Vice President, Patient Innovation & Engagement, Merck & Co., Inc.

Jessica Riviere, Senior Director of Global Patient Advocacy, Biogen

Angie Wilson, Director, Alliance and Advocacy Relations, BioOncology, Genentech, A Member of the Roche Group

CTTI’s initial foray into patient engagement established a timeline for industry to recognize the gap in understanding how to interact with patients, and the need to establish empirical evidence and guidelines for best PE practices. A next step from establishing best practices is actionable recommendations and metrics, translated into value and impact, and where along the clinical trial continuum to include patients. A key piece of CTTI’s project includes the development of a publicly available prioritization tool for sponsors and patient groups to effectively collaborate. Through a process of identifying engagement opportunities, evaluating the required investments, perceived benefits, and weighting them, the best mutually beneficial activities can be identified and implemented.

From DIA-PCORI initiatives, a proposed “return on engagement” toolkit linked to developing metrics for assessing patient engagement encompasses long-term drug development portfolios, outreach, study volunteer engagement, and trial performance. Through PCIs (patient-centric initiatives), such as patient advisory boards, telemedicine, social media, and patient counseling and education, cost and return metrics can be developed to assess the impact of these initiatives. To tie existing tools and frameworks together, IMI’s PARADIGM presented the need for coherent monitoring and evaluation frameworks to “connect the dots” between patient engagement activities, the impact, and the developed metrics.

Impact of Patient Engagement on the Biopharmaceutical Industry’s Business and Organization

In tandem with being able to measure the impact of patient engagement on the R&D side, considering the importance of patient engagement has impacted how biopharmaceutical organizations embed these practices in each function. The incorporation of patient engagement stems from a cultural shift, while varying across organizations.
The main theme with the emergence of patient engagement is the cultural shift from a paternalistic focus to a patient-centered approach in medicines development. The focus of the industry has moved towards building trust and relationships with patients, including supporting patient and caregiver programs, and partnering on policy and access to improve healthcare and access to care.

Patient engagement and advocacy functions are akin to relationship management and require multidisciplinary approaches to consider psychosocial and biomedical aspects as well as communication and dissemination. While the research and science side of the industry emphasizes prioritizing patients and designing clinical trials around the patient, certain disease spaces call on the need for social work and community perspectives once underrepresented in the industry.

An underlying theme from this session was a bell curve describing the adoption of patient-centric practices. How do we shift the curve towards Innovators and Early Adopters, as opposed to Late Majority and Laggards? This question is critical to bolstering patient engagement in the industry, and ties to the importance of being able to measure the impact and create tools and frameworks that enable seamless and effective adoption of these practices. Connecting the impact of patient engagement from R&D to organizational structure in a measurable, meaningful way shows promise to truly place patients at the center of the field. These two sessions from the Patient Engagement track shed valuable light on the steps to do so.