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CPO CLARION CALL

Writer's picture: Emma SutcliffeEmma Sutcliffe

Updated: Jan 27

Leadership thoughts for ISPEPpers from your Chief Patient Officer


Should every pharma, biotech and CRO have a Chief Patient Officer? The simple answer is YES -- to deliver an organisation's commitment to 'patient focussed medicine development', The longer answer is, of course, also YES -- and there are three drivers that humanise the business of developing medicines that work for patients.




The dynamics and drivers for decades of transformative patient engagement

It has been 40 years since the eponymous ‘Ward 5b’ opened in the US which formally marked the start of patient-centred thinking in any healthcare system. Providing a new way to care for people dying from AIDS, this was a formal departure from the patriarchal medical model; unlimited visiting hours, unrestricted visitor numbers and being able to talk directly with patients and their caregivers became the new ‘medical norm’. This was accompanied by HIV activist groups insisting on new approaches to drug development. This era re-defined what it meant to be a patient and outlined the importance of patient advocacy and patient community groups. The first driver for transformative patient engagement was from the need to re-humanise healthcare systems.

 

It has also been 40 years since the Orphan Drug Act was introduced, five years since the FDA launched its Patient Listening Session Programs and 2 years since the FDA circulated its guideline draft inviting industry to prepare for the routine inclusion of Patient Experience Data (PED) in New Drug Applications (NDAs). Hence the main driver for the next transformative phase of patient engagement is transformation firmly within the walls of our biotech and drug development organisations. Specifically, for a pharma company, transformative patient engagement is critical, end-to-end within an organisation -- in R&D, Clinical Operations and Patient Affairs. Patient engagement must now integrate into the entire business model, as early as possible in product development under an aligned Patient Experience Data Strategy to provide a robust evidence pack with PROs, PerfROs and PREs that are meaningful to patients. Meaning is key when people participate in clinical trials; it is about more than the potential new medicine. There needs to be a worth to participation that can be conveyed to the regulators and is more than proving the efficacy and safety of an asset but also considers the holistic benefit of understanding the impact of a condition on a person’s life and the motivation to contribute to a company’s business model. This transformative driver is about humanising the pharma R&D system.


The third driver is then, logically, how a pharma company ‘pays it forward’. This is the expectation from society that pharma will think beyond the business and harness their immense knowledge, information and financial power to contribute to considering ‘Social Determinants of Health’ (SDOH) – the elements of a person’s life that assists or blocks their activation and ability to seek, access, receive and benefit from better healthcare. This includes aspects such as health literacy, ethnicity, educational status and location. All these SDOH criterion impact on how people seek and participate in healthcare. What this means at ground level is R&D/ClinOps/Patient Affairs teams are naturally expanding as pharma and society needs to scientifically assemble and implement patient experience datasets and insights.  This is the 'humanising business' driver. Patients, Patient Groups, Governments and Society expect this.

 

In summary, the role of patient engagement has evolved with significant milestones along the way culminating in an era of regulatory demand for patient experience data as the new normal. It is now imperative that a robust patient engagement programme is in place within a pharma company to ensure both the commercial and reputational success of the organization and its assets. Accordingly, patient engagement strategy is become part of Asset-Centric business modelling from the outset. Furthermore, because patient engagement has demonstrable ROI and is trusted to boost patient self-care and reduce the financial burdens on overstretched public and private healthcare provision, the availability of patient engagement programmes, accompanying an asset or as part of broader health literacy campaigns can be directly linked to an organisation’s ESG reporting and responsibility. As such, patient engagement programmes now must be strategically constructed, validated with patient partners and delivered with operational excellence as part of routine pharma/CRO business practice. This new end-to-end patient engagement era encompasses medical and legal accountability for good patient engagement practices and patient safety alongside the regulatory requirement to demonstrate ‘patient-focused drug development’ in new drug applications.

 

 

ISPEP: elevating the importance of the Patient Engagement Expert

In parallel to the care and business transformations, Patient Organisations have continued to expand their scientific and clinical remits and resources; hence, patient engagement practices are now co-developed with, and the outcomes are shared in, long-term pharma-patient partnership models. Accordingly, ISPEP was founded to assemble global Subject Matter Experts, to drive exemplar provision of robust patient practices and to upskill the practitioners– the PEPs – who can deliver those practices through peer learning, training and professional certification programmes. ISPEP proactively partners with patient communities and patient advocacy groups and with local, regional and global healthcare systems and infrastructures to ensure global expertise alongsode regional nuances..

 

ISPEP works with all biopharma and device companies to facilitate development of comprehensive patient engagement frameworks, linking the organization and delivered by Patient Science Experts to align internal and external stakeholders.

 

The resourcing of patient engagement programmes within a pharma organization has evolved substantially within the past decade as the external ecosystem has placed increasing importance on PFDD. As such, organisations invest in resourcing in one of three models depending on the pipeline and size of the organisation. The three disciplines that have specific patient engagement functions are Patient Affairs, Patient Access and Patient Advocacy; each Patient Practitioner has a different set of qualifications and objectives that they bring to the individual role; it is the responsibility of a Chief Patient Officer within an organisation to oversee the resource allocation delivers on the companies overall patient engagement strategy.

 

This ensures that the patient voice is heard from the outset so that medicines are developed that are fit for purpose and broader unmet patient needs in healthcare systems are met. In larger organisations there is scope for these three functions to align under a CPO. In smaller organisations or when industry re-purposes internal resources, these core business functions still need to be met but companies have to outsource patient engagement strategic programmes to make FTE savings. Hence, ISPEP provides a community and opportunity for economic efficiency with operational expertise.



Founding ISPEP: future partnerships, future leaders, future drivers

ISPEP is a community interest company, an organisation that was founded in July 2024 in response to the urgent need to support patient engagement professionals and ensure standardised approaches and frameworks for patient engagement practices that are competently created, delivered and measured. ISPEP grew swiftly in response to this pressing need.  At the time of writing ISPEP comprises more than 1,000 patient engagement professionals from almost 400 different organisations. These are pharma and biotech companies, clinical research organisations, patient advocacy groups, umbrella patient organisations, global health organisations, regulatory bodies and solutions providers.


Collectively, this provides a highly diverse and competent network of PEPs with depth, breadth and crucially, vast patient engagement specific experience to peer-review and develop patient engagement practices that demonstrably improve patient outcomes by placing the patient at the centre of every healthcare conversation and healthcare process.


ISPEP members are integrated into all parts of the discovery, research and development of medicines; PEPs are supported with the skills to ensure that internal and external stakeholders are aligned at all stages of the R&D and lifecycle of a product and that the most impactful evidence and data sets are continuously generated, consolidated and communicated for comprehensive commitment to PFDD.


The ISPEP community comprises leaders from senior positions in pharma companies, CROs and PAGs who have R&D, Clinical Operations, Patient Affairs, Patient Access and Patient Advocacy subject area expertise. We have collectively overseen company acquisitions, created clinical outcome assessment strategies, co-designed, recruited and delivered multiple clinical trials and collaborated with hundreds of patient experts for patient activation, behavioural change and advocacy initiatives leading to policy change on local, international and global scales. In addition to these broad programmes of patient engagement. ISPEP members are proficient in tactical projects such as creation of a new PRO or running awareness campaigns for health days. Our collective community expertise is broad, strategic and business focused to ensure an ROI can be documented from every patient engagement activity and event.


The leaders, the drivers, the future of patient engagement will be managed by members and partnerships from and with ISPEP. The decades ahead are dynamic.


Because ISPEPpers are 'all in'.

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