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Business & Profession Health Economics and Policy, Professional Development, Business and Innovation, Education and Training

Something Ends, Something Begins

Beware anyone claiming something is dead: they have probably agreed to write an article for an industry publication and find themselves in need of a punchy title. They are also possibly wrong, or at the very least premature in their assessment, and may have an interest in what comes next. Some of that is definitely true here; however, I will leave you, as medical professionals, to assess the vital signs of the traditional Medical Advisory Board and inform the next of kin if necessary.

In a recent article, we talked about the high-stakes guessing game at the heart of innovation. The Medical Advisory Board (MAB) may hold a unique place in this guessing game, as both a big part of the problem, and an even bigger part of the solution.

Unlike a company’s Board, which is a relatively fixed group of individuals, appointed by the shareholders to provide advice, guidance, and oversight to the company’s executive management team, a MAB is a group of medical professionals convened on a discrete basis, to provide expertise and advice on a specific topic. This could be general advice on the clinical environment or the landscape within a specific therapeutic area, or it could be focused on reviewing specific clinical data or the potential of products that have either been approved or are in development.

The temporary nature of MABs means that they are expensive. Like, really eye-wateringly expensive. According to the brilliant Marcia de Souza Lima, arranging a single meeting of a traditional MAB frequently requires a budget of at least US$150,000, depending on duration, location, and number of participants – and can cost much more if you factor in the time that the Medical Affairs team will invest in the process.

Likewise, the sensitive nature of commercial entities interacting with doctors means that the process is complicated. Like, really, really, mind-numbingly complicated. For very good reasons, big healthcare businesses can’t just phone leading doctors up for a chat about their new product idea. Although the case against healthcare companies can often be overstated, there have been enough examples of malfeasance that there is no longer any “benefit of the doubt.” A mixture of internal compliance policies, external regulations, and the hyper-vigilant (and endlessly litigious) competitors have created the need for a paper trail that is long and winding.

If challenged, a company needs to be able to explain why these particular healthcare professionals have been selected, demonstrate via independent sources that the fair market rate is being used when remunerating them both directly and indirectly (a three-week, all-expenses-paid stay at a ski resort or a beach hotel, anyone?), and maintain a record of every aspect of the interaction. The underlying requirement is that the healthcare company can demonstrate that they are paying for the doctors’ time and advice when there is a real need, and are in no way inducing them to take any commercially beneficial action or public position.

My favorite example of the compliance rabbit hole is the two paragraphs that the Association of British Pharmaceutical Industry code devotes to the subject of appropriate pens for meetings (1). On the surface, this seems like the height of bureaucratic overreach, but a moment’s reflection with a cynical mind will lead you to the idea that a pharma company may have previously distributed personalized Mont Blanc pens – or something similarly expensive – to doctors in the hope of securing a more favorable relationship.

The cost and complexity of engaging with doctors means that established healthcare businesses can only justify MABs in the areas where they have validated or very promising products, so that they can offset these expenses against future revenue. For early-stage innovator businesses, engaging doctors through a MAB will be almost impossible to justify, particularly when funding is increasingly hard to find. Of course, this is assuming that an early-stage innovator even has enough knowledge of the clinical landscape to identify the doctors who can provide a valuable perspective or help validate product development decisions – there are whole Medical Affairs departments within large healthcare companies tasked with maintaining this knowledge and relationships.

POV: Marcia de Souza Lima, medical affairs expert, Alexandria, Virginia, USA
 

Science is paramount in drug development. The impact of new innovative technologies on patients’ lived experiences is the litmus test. Medical and scientific experts are the guiding lights linking these two ends. They are supported by the resources, know-how, and drug development machinery from industry. All the groups in this continuum are interconnected, interdependent, and need to understand and engage with each other.

After 10 years practicing as an ophthalmologist clinician and surgeon, this is the philosophy, together with a strong moral and ethical compass, that has led me throughout my career as a clinical development and medical affairs professional in the pharmaceutical and biotech industry.

However, drug development is a highly regulated process – necessarily so to protect the safety of patients – so knowledge does not flow effortlessly along this continuum. Setting up a MAB takes time, money, careful planning, and specialist knowledge. In many companies, the request for a MAB is part of the yearly financial planning process, which starts mid-year, meaning that it can easily be between 12 and 18 months in the making. Although regulations vary by country, it is often preceded by a needs assessment to ensure that seeking scientific and medical advice is necessary and does not lead to undue influence, particularly if the drug is at the commercial stage. Participant selection, qualifications, questions, and all materials need to be approved by compliance professionals. Contract signing and scheduling limitations mean that even the most agile companies need to have a lead time of at least four months for a MAB. Conducting a MAB is frequently fraught with risk; an ill-informed comment, a lack of fruitful exchange or even a well-intentioned desire to help by keeping negative comments at bay, could send the program development into a tailspin. It’s a high stakes process, and it limits the type and frequency of feedback.

Nevertheless, successful product development is absolutely not possible without advice from experts. This advice needs to be appropriate for the stage of development, entail a variety of expertise, and be obtained as often as needed: all of this while being compliant with the necessary regulations.

It is worth pausing for a moment here to think about what this all means. So… innovation is hard. Being an entrepreneur and breaking into a specialist market is hard. Life is unfair! Should we break out the violins and play a sad song for the frustrated aspirations of future healthcare tycoons? Possibly, but the flip side of this is the rising costs of healthcare, the inequities of care in the current system, and an aging population with health needs that are straining the current clinical workforce to breaking point. It is the doctors, and ultimately the patients, who lose out.

If we want to significantly address any of these systemic challenges, then the next 20 years of care cannot look like the last 20 years. Innovation is an essential external factor that will allow ophthalmologists to provide better care, to more patients, within the same amount of time. But it is not just the velocity of the innovation process, but also the type of innovation that needs to change.

Although there is substantial unmet need that can be addressed by traditional drug development and the evolution of traditional medical devices, the approval and market access path for these products is well established, and they will continue to arrive at the fastest rate that current science, technology, and market forces will allow (although a bit more competition always helps push things along). Necessary and fundamental change is also likely to come in secondary areas of innovation, like medical records. Currently, ophthalmologists are forced to work with disconnected digital experiences in their professional lives that they would never accept in their personal lives when booking a holiday or checking their bank balance. More usable and interconnected systems for accessing and managing patient data will create more time and focus when dealing with patients.

At this point we haven’t even yet scratched the surface of the opportunity presented by smartphones – supercomputers in the pockets of (almost) every patient across the globe, all equipped with cameras, screens, and processors that are refreshed faster (and therefore are often better) than anything in traditional medical products. The next generation of innovation may include applications that will monitor eye health outside of the clinical setting, allowing preventative interventions, better eye health outcomes, and completely new commercial models for care. The COVID-19 pandemic has driven new behaviors that continue to pave the ways for an explosion of digital health and telemedicine applications.

These kinds of innovations will have product refresh life cycles that are measured in weeks and months, not years and decades. With algorithms to train, clinical data sets to test, and new features added regularly, the companies behind these innovative technologies will need a much more dynamic and agile way to engage ophthalmologists for inputs, testing, validation, and feedback. They will not only need to engage with ophthalmologists more often, they will also need to engage a much greater number of ophthalmologists from more diverse backgrounds, at different stages in their clinical careers, if they are going to develop products that work across all areas of clinical practice. This requires not just a different mechanic, but a different model, very different to the traditional KOL approach taken by established industry players.

There is a whole separate conversation to have about the knowledge flowing in the other direction. Ophthalmologists themselves have a long track-record of kick-starting innovation, by identifying a need and partnering with outside experts and industry-experienced professionals to develop and patent novel technologies. The same systems that could support a more dynamic relationship between the innovator and the ophthalmologist, could also function as a catalyst for innovation coming out of clinical practice.

POV: Radhika Rampat, Consultant Ophthalmic Surgeon & Associate Academic Director, Refractive Surgery Alliance Fellowship Network based in London, UK
 

From the viewpoint of a young ophthalmologist with research interest in digital healthcare and innovation – I have seen a palpable shift in the way we perceive eye care in the last few years.

Being in leadership positions throughout training and beyond, I often found myself trying to be the architect of change – sometimes I hit the jackpot and other times just a brick wall. My motivation for advisory work stems from these very experiences in training and practice over the last 10 years. I have become weary of seeing band-aids being placed on problems, which really require definitive solutions with longevity.

An evolved system would empower an open collaborative environment where there was no guessing game and effective, informed decisions could be made with a unique overview of the problem.

I have a vision for sustainable and efficient eye care delivery supported by seamlessly connected and evolving digital solutions – and I can feel that the tide is finally turning.

So, returning to the tagline of the article, advice from ophthalmologists, as an essential input for innovation, has never been more needed, but the traditional MAB might not be the only (or best) format to support the innovation needs of the industry (including manufacturers and clinicians). Perhaps the Medical Advisory Board isn’t dead, but is just in need of some innovation of its own to keep up with the changing needs of the industry to be aligned, agile, and ready to deal with the challenges and opportunities to come.

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  1. Prescription Medicines Code of Practice Authority (2021). Available at: https://bit.ly/3wFFFWW.
About the Author
Duncan Welling

Director of Choir Consulting Ltd, Digital Innovation Advisor at MedHealth Captial, Consulting Partner at Ogilvy Consulting Uk, Digital Strategy and Transformation Advisor at Teva Pharmaceuticals. His new venture is Overture.Health. He is based in London, UK.

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