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Session: Medical Technologies Powered by Medical Affairs: Are You Ready?

 

Q: How can MA help to overcome the slow adoption of patients to use ‘digital’ and ‘devices’? I also feel that HC stakeholders are at a very different pace, which is slowing us down, since collaboration will remain key. 

Juniad Bajwa: MA should represent to their internal stakeholders the voice of the HCP community, and the voice of patients/consumers. I would argue that the health systems/payers/providers/regulators may be moving faster than traditional life science organisations (esp. post COVID19), and it is imperative that we try and understand the challenges and opportunities of today (and deliver value), before we try and design potential future value propositions.

Volker Libenberg: In addition to Junaid’s response: MA plays a key role in raising awareness and educating about the capabilities of digital devices.

Q: How can companies or even department differentiate themselves with AI? Or stand out from the crowd?  

Juniad Bajwa: Understand what AI can do – and establish mechanisms to have curated data, domain experts, access to compute power to truly leverage the power of AI. Plus have the right talent to work on the data, for new and novel insights.

Volker Libenberg: Fully agree on the need for data to be structured and curated. Medical Affairs in addition can engage in defining standards, support proficiency testing and standards to integrate data across multiple centers to improve the use of real world data for research purposes.

Q: New technologies (AI/NLP) are costly, how do you recommend Medical Affairs show a ROI for investing in this technology? Considering we operate in the pre-license and “non-promotional” space?

Volker Liebenberg: The value of Medical Affairs activities can e.g. be assessed the context of the value chain and calculate or estimate their effect on time to market or effort (staff time) for the specific use cases.

Q: Junaid/Loubna: What would you recommend to Medical Affairs Professionals who wish to move into healthcare technology space? How would you make the move from Big Pharma to Big Tech (Apple or Microsoft for example)?  

Juniad Bajwa:

• Build networks and knowledge; understand how technology is making a meaningful difference to healthcare
• Try and follow companies of interest and understand their strategy
• Understand and articulate how you, with your knowledge/ skills/ experience/ expertise, can add value to that organization
• Keep an eye out for roles, e.g. these at Microsoft, or feel free to reach out and connect with me on LinkedIn.

Volker Liebenberg: In the Pharma/Medtech space the emerging use of companion diagnostics (CDx) offers an attractive bridging opportunity between the two worlds.

Q: How can data be leveraged to help diagnose complex multi-organ diseases such as Lupus as currently patients are misdiagnosed for 5+ years on average?

Volker Liebenberg: Genomic and multi-omics data is currently emerging to complement the existing diagnostic information available to physicians. Clinical reports are generated with the use of digital software solutions, that help analyze the vast amounts of data  generated by novel technologies like genomic sequencing and generate reports, that can be read and interpreted by clinicians. Reducing the time to diagnosis is one aspect of what the technology can do.

Q: What do you see as the biggest barrier or challenge when trying to adopt these innovative technologies?

Volker Liebenberg: In the commercial space I consider the educational effort to be the biggest hurdle, i.e. the time to familiarize yourself with the solution and master it. Of course the complexity and the value of the solution matter in this context as an essential part of the dimension of the barrier.

Q: During the presentation from Prof. Bloem we heard individual treatment is crucial (listen to the patient) and will be the future. Will AI or software solutions reproduce these individual approaches, or what comes next?

Volker Liebenberg: Absolutely they will. Already today we see decision support systems helping physicians to manage complex data to personalize therapy. Technological advances and the increasing amount of digital data will continue to drive the use of more and more sophisticated systems.

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Session: Searching for a True Patient Partnership in Healthcare

 

Q: A few regions in the world lack the existence of patient advocacy groups due to cultural stigma. How can we support the initiation of such groups to enhance experience-sharing and increase awareness? 

Roger Wilson: This is an issue which troubles patient ‘umbrella’ groups (i.e. associations of associations). If you look at how patient groups form where they do exist it is usually initially within a treatment centre, developing mutual support. This then extends to other centres, goes online, gathers energy. There are a number of really important factors in encouraging their growth. First is involvement of the clinicians, attending meetings, answering questions, etc. Then comes some funding – in the past pharma has been important here but I know it is more difficult. Finally there is a willingness on the part of the hospital/healthcare system/local regulators to take them seriously. The evolution is not a simple single step, it is a process which takes time.

Rosamund Round: As an industry it is important we continue to educate and raise awareness about the importance of not only clinical research but of medical developments as a whole. In certain cultures illness is seen as a weakness, something to hide from one’s community, and this in turn means that people are not sharing their experiences or, in some cases, even getting the treatment they need to be well. This is not something that will be quickly resolved but it is important we continue to discuss research and medical options available, and break down the stigma surrounding illness and medical care. Partnering with trusted members of various communities and supporting advocacy groups in their efforts to improve the diversity of their members is also a worthwhile endeavor. In the meantime, online groups allow patients to communicate anonymously if they wish while still receiving the support they need and this is one area where we as an industry can certainly support further development.

Q: Berkely, you mentioned the importance of impact metrics; can you comment more on this? We often see the metrics being based around the Pharma objective. How can we develop metrics that work for both patients and Pharma?

Berkeley Phillips: The IMI PARADIGM project, an initiative within the large IMI public-private partnership between EFPIA member companies and the EU Commission, has just completed. One of its key outputs is an evidence based suite of metrics that reflect benefits for patients and benefits for the company. The consortium comprised patient organisations, academic centres and pharma companies and the metrics were therefore co-developed together. They are a combination of “hard metrics” such as faster recruitment of clinical trials or increased utilisation of PRO endpoints, and “softer metrics” such as enhanced trust, mutual respect, greater transparency etc. The latter are more difficult to measure but no less important. Now that PARADIGM has completed the suite of metrics will be hosted both on the PFMD website and the EUPATI website.

Q: Technological advances are great!  Who should pay for it?

Roger Wilson: Every advance has a cost. Who pays for them?  The developer carries such costs as investment, recovered when the revenue rolls.

Rosamund Round: When using technology within clinical trials it is important to ensure it is implemented to support patients and in no way increase burden or cause any out of pocket expenses. Where a study is being managed by a pharma company and/or CRO the cost should remain with those parties and not be felt by patients or sites.

Q: Are DCTs already happening a lot? 

Roger Wilson: Increasingly. We are developing an academic one in the palliative setting in sarcoma at the moment.

Rosamund Round: The effect of COVID-19 has lead to an exponential growth in the use of DCTs, though these types of trials have actually been happening for a number of years. Parexel has experience in implementing over 100 DCTs and this number continues to grow and more people become aware of the possibilities to alleviate participant burden by making trials more accessible. At Parexel. Over 50% of Ph II/III and over 80% of RWE proposals include DCT elements, so we continue to see the shift towards this way of working.

Q: Are regulators and payors really ready for decentralized clinical trials? Can you talk to GCP in these scenarios? 

Rosamund Round: The pandemic has meant that many regulators had no choice but to adjust their guidance to allow critical patient care to continue through the pandemic. Although we have seen some of these restrictions re-introduced, regulators are more accepting of DCTs as they, sites, patients and sponsors have all gained more experience. For DCTS, normal GCP rules apply and in all cases patients remain under the care of their studies principle investigator providing patient oversight to support patient safety.

Q: Berkeley: Patient engagement initiatives clearly add value but we need to build the body of evidence – how can we encourage publication of these initiatives? encourage patients to be co-authors?

Berkeley Phillips: I fully agree. One of the reasons we at Pfizer are writing a publication co-authored with patients is to demonstrate the impact for patients and industry of meaningful patient engagement and in doing so hopefully encourage others to do the same. The more people see positive success stories, the more widespread and mainstream it will become.

Q: When recruiting for a clinical trial what are the most successful tactic for patient and caregiver engagement?

Roger Wilson: You need patient involvement and engagement at an early stage, prior to protocol, to help guide you through the challenges which recruitment may present. I was asked to get involved in a trial some years ago at a relatively late stage, when the protocol was finished and they were writing patient consent information. I was horrified. I predicted that whatever we did with the consent information no patient would enter the study. They had taken a medical view of equipoise, they had not considered patient psychology and what the randomisation looked like to a patient. Actually I was wrong, one patient did enter the study, there were ten centres offering it, the study was withdrawn after 12 months at a cost.

Rosamund Round: Clear communication. It is imperative that patients and caregivers understand not only what a study will entail before they choose to join, but that they remain informed and engaged throughout the study and receive the support and information they need when returning back to ‘normal life’ after the study is completed. This communication can be delivered in numerous ways but in all cases, this ensures patients and caregivers feel like part of the study and, in turn, supports greater study compliance.

Q: To Roger: There was an interesting question raised during the keynote lecture by Professor Bas Bloem on Monday. He was asked what (in general) do patients think of pharma. I would be interested in your thoughts. 

Roger Wilson: In general I would say its on a scale from “horrible” to “wonderful” with individuals wandering up and down that scale the whole time. When costs are high and you are not researching treatments relevant to me you are “horrible”. When you have a new treatment and it works for my condition you are “wonderful” even if the local HTA is denying access to it. Away from the general to the more considered viewpoint, full of dichotomy, which is what I suspect the questioner is recognising.  I think the dominant public-facing problem pharma has is the cost of new treatments. I know all the arguments about cost of r&d but the pricing of new pharmaceuticals seems to most of us to be closely related to witchcraft – wave a wand and dream of gold. While its like that expect the public response witches got in the 17th century. The rise of venture capital, hedge funds etc as backers of biotech has not helped, or in take-overs which result in large percentage price rises. Neither it must be said has regulation helped. It seems to run a fine line all the time between complicity (for example over surrogate endpoints) and constraint (wanting even more evidence). I have pharma stocks in my pension scheme so I want them to succeed, but I don’t want high prices when it comes to treating me. I know this is not an answer you can act on but I hope it helps understand the issues in play.

Q: Are you seeing a change in the industry approach to patient involvement? How is the perception of patients / patient organizations about pharma-industry? 

Roger Wilson: Yes. When I was first involved and going to conferences sponsored by pharma there was amazement that a patient wanted to come to them, was happy to speak at them, and wanted to talk to the company. Then the lawyers and lawmakers got involved. Oh dear. We went backwards for 4 or 5 years. Now it is changing but most industry researchers are seeking instant involvement at the time of their choice, usually when they want help with an informed consent leaflet. Convincing them that is too late for patients to be effective can be hard work, We are now finding that ethics committees and funders are wanting to see involvement. That helps. But many companies still have to take practical steps to create a sustainable level of involvement which adds value through relationship-building, shared trust, and patients learning about what their researchers are actually doing. It is happening, but it is slow.

Rosamund Round: Historically, it has now always been positive and in certain communities this situation remains the same. However, the increased awareness of clinical research and the importance of vaccination have received a huge amount of press this year, which has led to somewhat improved perceptions.

Q: Great to see the concrete examples in the session- how can we build on these? and are there are examples the panel can share about proposed or future examples?

Roger Wilson: The things we are getting going in the academic research area include:  patient initiated research ideas, studies with primary outcomes based on PROs, patient-led finding decisions or with patient having last-word, involved patients managing a lay-summary from first idea to protocol, co-production of protocols, patients involved in clinics during course of study, we have even seen patients taking informed consent in Phase 1 dose escalation studies.

Rosamund Round: Regularly eliciting feedback from patients and caregivers helps to highlight to industry the greatest challenges in research participation. Maintaining open and trusted relationships will ensure that the awareness of these issues is raised and enables industry to build on work to date, using that maintain to continually improve and improve clinical research access and experiences for patients.

Q: What would be the biggest hurdles to this change to true patient partnership? 

Roger Wilson: Senior management must have a policy which says it is in the company’s strategic interest to have effective involvement.

Q: Roger, please can you comment on how to balance engaging representative patients with ‘expert’ patients – how to optimise the level of expertise without losing relevant insights? 

Roger Wilson: This is a question to which I wish I knew the answer. I could write a small book on this. We see ’superstar’ involved patients doing everything, or often carers in that role. They are rarely ‘representative’, but what does ‘representative’ actually mean. I think the best answer is to say that you should carefully define what kind of patient you want involved at any stage, just as you might when you look at post-doc experience when appointing a new researcher. If you need someone who can give strong messages at a senior management seminar, support strategic decision-making, and act as a bridge between related projects – you appoint one kind of person and it isn’t someone whose involvement experience is limited. If you want input to a study or programme which is developing a new treatment you might want a recent patient. Follow those ideas – don’t be scared of creating a profile of needs but do be prepared to modify it if recruitment becomes difficult.

Q: Involving patients earlier in development is a great principle… how do we make sure that we have a truly representative patient voice; one that understands the development process but also can represent patients effectively? 

Rosamund Round: By developing a multi-pronged approach which incorporates a number of channels for collecting data from the general public, patient advisors and advocacy groups to gather robust feedback to ensure that any approach taken is truly patient centric and representative of the patient voice. In addition, it is important to gather participant feedback during and after research studies to enable us as an industry to truly provide support that patients and caregivers want and need.

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Session: R WE Ready to Transform Patient Care?

 

Q: Do you have any advice around communicating findings from RWE? For example, any compliance concerns, being careful to distinguish from results from clinical trials. 

Lianna Ishihara: RWE should be guided by rigorous standards and methodology and there are available guidelines from ISPE, ISPOR, FDA, etc. There are benefits and caveats to using real world data and these should be acknowledged along with presenting results. Establishing data quality and being transparent about methodology are also important.

Q: The COVID-19 pandemic has seen conflicting results from the many, often small-scale RWE studies conducted on potential treatments, in contrast with the clear findings from large RCTs such as RECOVERY. Will this be a setback for the use of RWE? 

Lianna Ishihara: The COVID-19 pandemic has raised the importance of obtaining high quality real world data and using robust methodology to generate valid RWE to inform healthcare. It is true that some real world research that was not of high quality has been published in during the ongoing Covid-19 pandemic. However, the extraordinary value of real world data has also been highlighted so I do not believe it has been a major setback, but the importance of governance has to be addressed as well. This article gives some interesting commentary on the topic.

Q: To what extent do you expect patient concerns regarding the collection and processing of their personal health data to be an obstacle to the generation of useful RWE? 

Lianna Ishihara: There will need to be a balance between patient data protection and its appropriate use for research, which is transparent and demonstrates benefits to all stakeholders. As individuals take a more active role in their own healthcare including personal health data, there may be more willingness to use these data to generate useful RWE that benefits the patients themselves.

Q: Thank you panel for excellent presentations. Re: Sreeram’s use cases – do any HTA bodies currently consider data from social media listening, wearables etc, or is this still aspirational? 

Lianna Ishihara: At the moment I am not aware of examples of social media listening being use for HTA decision making, however wearables/apps and other digital health data are already being discussed by regulatory and HTA authorities. Without being able to say for which company or product, I am aware that some RCTs and RWE studies do include endpoints/measures that are collected using wearables and digital apps, however at this point these are usually not the primary endpoints.

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Session: Beyond the Field: Evolving Field Medical Engagement and Talent for The Future

Q: How do you test for digitally savvyness during recruiting? Any insights? 

Tobias Vogt: Come up with some digital cases, case studies. Does not need to be pharma related. And of course do at least one of the job interviews via remote channel

Kate Bradford: Right now this is very rudimentary but essentially it is around how well does the candidate know their digital self. Can they set the technology up effectively, conduct an interview appearing professional and articulate and deal with a situation when the technology fails. In the future I’d like to assess or hear about a candidate’s ability to manage breakout rooms, use mural, moderate an overtime virtual  adboard. Also how do they manage different types of content and ‘hand over the reins’ in a digital presentation to the HCP. I do attend visits with my team and coach then on how best to engage with HCPs and this will become more a formalized process now we know the majority of our interactions will be online

Bora Erdemli: Another way is to test digital savviness is to gauge the level of their knowledge around existing digital information resources beyond conventional channels such as social media and other public HCP portals. What information sources / channels do they frequently follow? Who are the digital opinion leaders in their field? How do they or are they planning to incorporate these insights into their next conversation with their customers?

Q: How do you factor virtual vs F2F exchange into resource planning? 

Kate Bradford: Right now I report on a monthly basis the overall split on F2F v virtual. I’m hoping that 12 months data will give me the chance to look back and see if there is a regular trend. I still think this is only 1!component of resource planning – I factor in: number of sites an MSL can manage for clin trial support, number of thought leaders, lifecycle and complexity of the product, stage of development and how close to launch we are. The method of communication is not the main driver but this shift does mean we can reach and do more potentially with less.

Bora Erdemli: There are three other components that can be taken into account: (1) The time that might be saved due to limited travel (2) The level of difficulty in establishing new relationships and gain access to key opinion leaders (3) The length of the virtual interactions vs. face to face.

Q: Will we no longer base our resource planning/new hire on territories, but other factors? 

Kate Bradford: See above. I’ve been using a flexible model for the last 18 months based around workload and business need. Still have a primary focus to keep MSLs in the eu5 but some of my team cover up to 4 countries. This has been made easier in Covid because the travel burden was quite high.

Tobias Vogt: Territories will remain important as long as we have physical F2F. But territories can be staffed more thinly as we continue to substitute F2F with virtual visits.

Bora Erdemli: As we are learning more during our recent customer interactions around their preferences, we will need to adjust our territory alignment and associated engagement planning dynamically. In addition to our periodic look at allocation of our field team’s time and effort, medical affairs leadership need to have a more agile approach to reallocating resources. But, the first step is to create base level understanding of what customer wants and build a continuous influx of information to inform resource allocation decisions.

Q: How can we upskill to enhance emotional intelligence around interactions in the virtual world? 

Kate Bradford: This can be tricky – the psychology behind zoom fatigue is real. Also a delay/lag in response and a lack of eye contact are both factors that lead to mistrust in humans. I put my team through a few virtual engagement workshops – focusing on listening skills, being comfortable with silence, how to pass the baton to the HCP, ensuring that each slide has a ‘so what’ factor – the usual pace,pitch, pause, power approach. Much mire can be done here and I like the idea of building in reward for this kind of behaviour.

Tobias Vogt: Courses to create awareness around EQ and how to establish rapport vitrually. Mentoring / buddy programs to continuously improve EQ. Specific training / exchange in management on how to drive / reward EQ in the workforce.

Q: Will the move to virtual engagement warrant a change in MSL resourcing? 

Kate Bradford: I think we will. Face pressure to do more with less eg. No travel means mire chance to do interactions and the risk of an increase in ‘call rate’. We must remember that our HCPs don’t miraculously have mire time to engage with us and their availability and appetite to engage must be factored in. The MSL role still has a huge component of preparation and follow up work which is very different from a sales rep role and therefore 6 calls a day might be ok on Tuesday but Weds is spent dealing with the workload created by this increased activity. I agree we need to think about capabilities and resilience, flexibility, growth mindset to deal with change rise to the top along with the ever present scientific expertise.

Tobias Vogt: Different skills will be needed. More mental flexibility/agility.

Q: Agree % virtual will vary dramatically per country, some want very little now. Is 60% good in terms of potential quality of virtual engagements vs F2F, for us and the HCPs? 

Kate Bradford: Ask your customers/audience! They have been through this with telemedicine in their hospitals and watched consultations in Covid flip to 90% virtual in Mar/Apr but then come back to 10% in July/sept. Might flip again with second wave. I think a 60:40 virtual/F2F split is on the cards and should not impact quality if you choose the right channel for the right stakeholder preference.

Tobias Vogt: We see approximately 50% virtual engagement target for end of 2021 across all European countries (ranging from 25% – 80%)

Q: What is one key learning on digital engagement made during the first COVID wave? 

Kate Bradford: Embrace it! It’s not as bad as you think!! Keep it real and as human as possible  – it’s ok if your doorbell rings, dog barks, children invade. It reminds the person on the other end that the technology is secondary to the personal interaction you are having.

Tobias Vogt: Content is king in virtual engagements, you need highly-relevant, fresh, non-promotional content to engage virtually.

Bora Erdemli: Put the spot light on your customer. Listen to who they are, how they feel, what they may need, and how they would like to receive it. Remember that another virtual meeting is not your only option to maintain a good “conversation/exchange”. Technology is a “glue” to keep us connected in many different ways. Be open to explore.