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Thought leadership and innovation for the Pharmaceutical Industry

Pharmaceutical companies and regulators are in need of increasing amounts of input from patients throughout the entire product development lifecycle, from identifying what questions to ask in the earliest stages of research through clinical development to approval. 

 

This usually means partnering with patient organisations and advocacy groups but pharma’s ambitions here frequently come up against a problem. Very often, both industry and patient organisations are not set up to participate in these processes – with industry lacking systematic processes and patient advocates the required training and resources.. 

 

Since many patient organisations are both volunteer-run and chronically underfunded, they often lack the capacity to resource meaningful engagement on the professional level required by industry. 

 

An obvious way forward for pharma is expanding the work it does with such groups to develop their ability to participate in pharmaceutical and medical research, and by helping expand their technical skills or administrative resources. 

 

But if it is to scale such patient engagement optimally, pharma must first understand the challenges involved. Not least among these is a very basic need to bring individuals up to speed on the nature of the industry and its complexities, says Susan Schaeffer, President & CEO of The Patients’ Academy for Research Advocacy, a US, non-profit, patient education start-up.  

 

“Very few people who don't work in the pharmaceutical or medical product industry have any idea how these products actually get discovered and developed,” says Schaeffer. “When you look at it from the outside as a lay person, it's really overwhelming. It's complicated, highly technical and scientific. For the average person, that's intimidating. For a patient who, on top of everything else in a normal life, is also managing a health condition, it's a lot.”

 

A lack of representation

This means countless patients who could become strong advocates discount themselves as they don’t feel qualified, says Schaeffer. “There aren't that many patients who are up to speed and able, willing and prepared to participate.”

 

This has massive ramifications for the entire production pipeline, not least because it contributes to the consistent lack of representation, from trial participant populations through to patient advocacy. 

 

Encouraging and empowering patients to share their voice, then, has a clear imperative and there are a number of ways of doing this, some better than others. 

 

Many organisations provide in-house programmes to educate patients in their disease areas on how to engage in research, while others engage umbrella organisations to run masterclasses and workshops.  

 

But the danger is that these processes are originated without the input of patients, leading to major inefficiencies, says patient advocate and social entrepreneur Jan Geissler, who is the Founder and CEO of think tank Patvocates and the former Director of the European Patients' Academy (EUPATI). 

 

Building by listening 

His diagnosis of rare cancer, chronic myeloid leukaemia (CML), aged 28 led him into the field of patient advocacy and makes him uniquely placed to understand the needs of patients and to see a lack of understanding from some pharma companies. 

 

It might be that pharma engages an agency or some other third-party to engage with patients in training but without consulting the patients about unmet need in terms of training and engagement needs. “It's quite often all about us – without us,” says Geissler. 

 

A recent example has been the response to the COVID-19 pandemic, he says, where some pharmacos have not always helped resource the most pressing needs of the patient advocacy community.  

 

“Companies want to help and they set up something like a knowledge exchange platform, but the patient organisations mostly suffer from not having the tools, the right equipment or workforce for running virtual meetings, trainings and workshops to tackle the diverse challenges emerging from COVID-19.”

 

A better approach for pharma would be to build its understanding of patient groups by listening to them, says Schaeffer. “Pharmas absolutely should have patient days where they make it a listening session and find out from those patient groups and individuals what they think and what they need.” 

 

A multi-sponsor approach

The danger of bias or a lack of neutrality is another risk to anticipate as pharma helps build groups’ capabilities, adds Geissler “I don’t think that training can neutrally be done by industry in any way. The preferred option is if it's run by the community, with support by multiple funders.”

 

Training and masterclasses done by the patient advocacy community is the right approach, says Mihaela Militaru, Senior Director, EU Patient Insights and Advocacy, Oncology & Endocrinology at Merck. Formerly a patient advocate with the European Cancer Patient Coalition (ECPC), she has been on both sides of the fence.

 

“When I was a patient advocate myself, I attended the European School of Oncology Masterclass on Patient Advocacy, and I learned tremendously there,” she says. “I trust in the development of these programmes by the patient advocates themselves, because they know best what they need.” 

 

(The ESO Masterclasses have since been handed over to WECAN, the Workgroup of European Cancer Patient Advocacy Networks, which has been running a very successful four-day Masterclass in 2019 and is currently preparing the next one, coordinated by Geissler.)

 

Avoiding conflicts of interest

At Merck this has involved granting requests to support masterclasses organised by umbrella organisations like Lung Cancer Europe, Digestive Cancers Europe, ENGAGe, WECAN 2019 Masterclass. In addition, in 2017 and 2018 Militaru’s team supported a series of training courses delivered by Geissler together with the European Patients' Forum (EPF) to help increase the digital competencies of patient advocacy groups.

 

The degree to which pharma should remain directly involved in training depends on the subject matter, adds Geissler. Certain topics, such as HTA and market access, will always be contentious. “Even if industry provided external speakers, it would always have a notion of driving a specific reimbursement and access agenda,” he says. “You could do training around medicines, R&D or these earlier phases, when it’s not really about market access.” 

 

Similarly, when training falls outside of the therapeutic arena altogether, such as looking at digital skillsets or administrative organisation, there is more potential for pharma to take a direct role. 

 

The European Patients’ Academy (EUPATI) as a patient-led public private partnership was born out of a desire to overcome such conflict-of-interest challenges. “It seems to me that having a third-party organisation that could be funded by industry and whose programmes industry could participate in at arm’s length, while having no control over the content and the delivery, could be a way to address this,” says Schaeffer. 

 

“The idea of EUPATI is to develop and provide programmes to patients and care partners so that they can come into the process feeling empowered and prepared. The core of the programme is a universal R&D 101-type of training.”

 

A gold standard 

Some of the most successful existing training programmes are being run by larger networks, including EUPATI and the Workgroup of European Cancer Patient Advocacy Networks (WECAN), which encompasses 24 disease specific umbrellas on the pan-European level and seeks to increase the number of well-trained patient advocates and experts. Splitting training into different levels, WECAN trains beginners as well as more experienced advocates. 

 

“One thing that is really emerging are advocate development programmes,” says Geissler. “Those are smaller group training programmes run by disease-specific umbrella patient organisations, which usually run for a year, where the selected group of advocates are trained with monthly meetings and face-to-face meetings at medical conferences.” 

 

Such programmes seek to build powerful advocates and future leaders.  

 

Based on the different WECAN training programmes, the WECAN Academy Knowledge Base offers online instruction relating to advocacy tools and skills, healthcare systems, policy and access, and research and data. 

 

Meanwhile the WECAN Academy Masterclass and SmartStart represent two capacity-building programmes. “We have developed quite a good capability in running trainings,” says Geissler, who is one of WECAN’s founders. 

 

A COVID-19 cashflow crisis

“What we're lacking is funding, so I think it would be much better for the community if companies started to fund or increased funding, rather than trying to do their own [training]. We need to build long-term capacity to deliver these things within in our community.”

 

This points to an important challenge for organisations like the ones Geissler is deeply involved with – one of sustainable funding. “As non-profit organisations, we're not allowed to put money into reserves and then just live off the reserves,” he says. “Now in COVID times, some charities have lost sixty per cent of their budget because they cannot fundraise and run events. They can do nothing other than cancelling most of their activities, which is really a disservice for patients.”  

 

Where pharma can help, he says, is to commit to multi-year support to a couple of chosen programmes, which enables non-profits to plan ahead, rather than be reliant on year-to-year grant applications. 

 

The bottom line is that if pharma wants to nurture a strong patient ecosystem with which it can engage fruitfully at scale, it must help fund it. “The reality is that patient organisations are always in need of funds, even the best funded ones, and industry is going to have to be a source of it,” says Schaeffer. 

 

“While everyone asks patient organisations to get public funding for these activities, it is almost impossible to get it, given barely any public funding programme invests into the training activities of the patient community” adds Geissler.