Reuters Events | Pharma

Thought leadership and innovation for the Pharmaceutical Industry

A new decade is here. And despite the incredible science, pharma is ill-equipped.

By Paul Simms on Jan 14, 2020

“I drained the last of my cocktail, gazing up at the ceiling. It was one of those moments that curls the hairs on your neck. At once, the grand scale of this labyrinth of cathedrals became clear, the desert wind blowing through the clever hieroglyphics carved into every available surface. I turned my head back down to ground level just in time to see the man draw back his fist in anger, and then.

And then.

With a piercing shriek, he lunged straight at my jaw –”

Do you ever wake from a dream, marvelling at the inventiveness and detail of your subconscious mind? That disorienting moment where you lie blinking in darkness, for a second believing it really did happen. Suddenly you admire your own creative abilities in conjure up such a rich and immersive world.

It felt so real.

It’s time to summon that subconscious creativity more readily. In the 2020s, such storytelling skills will be vital in finding and communicating a purpose. This skill will separate the winners from the losers.

 

The 2010s: scaling incredible science

This past week, I asked twenty pharma and patient friends what they felt was, personally, their biggest moment of the 2010s – and their likely biggest of the next decade.

For the decade just passed, the undoubted top choice was the ability to personalise medicine, with nearly two-thirds of respondents citing gene editing as the most impactful development.

Simon Davies (Exec Director, Teen Cancer America) shared the moving story of Emily, the first young leukaemia patient to receive and recover miraculously from CAR-T therapy. Christine von Raesfeld, a patient, spoke of her own experience, suffering permanent damage from drug toxicity and told to find help elsewhere, until the chance to take part in a precision medicine DNA-led approach to predict and prevent disease called Stanford Humanwide “transformed my life.” Julie Gerberding (EVP, Merck) and Jake LaPorte (Co-Founder, Novartis BIOME) both chose CRISPR-Cas9 and its new derivatives, in particular, as the technologies that reversed the genesis of a disease and upturned the scientific playing field. Carole Scrafton, another patient, pinpoints the Human Genome Project and its subsequent insights into rare disease as the real catalyst.

Colin Sims (EVP, Kyowa Kirin) was keen to emphasise that the approval of the first CAR-T, Kymriah, also marked a new milestone: the first time pharma had protected IP over the method rather than the entity itself (you can’t patent someone’s cells…). It was, he says, a “massive shift for the premise of how the industry has run since its inception and the start of commercially viable, scalable, truly personalised therapies” and a first positive step after the early pioneer gene therapies, Glybera and Provenge, failed in the market. I agree.

The related potential of RNA therapies made the cut for Ester Banque (SVP, BMS) and Mads Dalsgaard (SVP, Lundbeck) who pointed out how anti-sense olinucleotides (ASOs) in particular can be particularly influential on RNA. Mads also lauds personalised treatments in directed monoclonal antibody therapies and our ability to select patients, with ongoing hopes for Alzheimer’s.

There was, too, a strong claim for immuno-oncology as our greatest development from Philippe Barillon (VP Insights/Analytics, Takeda) and Bruno Villetelle (SVP, Novartis) after many decades of intense research: an “incredible convergence of technical and scientific methods to co-opt the immune system” all the way from PD1 inhibitors to entire cells in the aforementioned CAR-T therapies.

Our ability to understand and manipulate cell behaviour has been key. Milind Kamkolar (CDO, Cellarity) states that this new approach “has propelled life sciences to acknowledge that reductionist ways of studying health and disease is requiring scientists to suspend current practices and be more encompassing of what really happens biologically,” whilst Carly Harrison (Chief Research & Innovation Officer, LupusChat) talks about how the application of stem cells “was (and still is in some circles) controversial, but has already a undeniable major impact in reversing serious disability.”

Such advanced, curative therapies are not the only breakthroughs. Alistair Grenfell (President EMEA, IQVIA) points out that generally, the decade was about “breaking the paradigm that pharmaceuticals are either small molecules or biologics – right from 2010, prescriptions became digital with the BlueStar healthcare app for Type 2 diabetes; the first cell therapy followed in 2011, the first gene therapy a year later” and that fundamentally, the nature of delivering healthcare has changed forever.

Michelle Longmire (CEO, Medable) made a strong case for the HPV vaccine and its acknowledged role in cutting cervical, rectal, laryngeal, and esophageal cancer by huge margins in recent years, while Klaus Dugi (CMO/EVP Ferring) believes the work put into microbiome research will shortly yield its first new therapies.

There were less positive developments. The 2010s were “the years when pharma became “affected by fake news, leading to the rise of the antivaxx movement, bringing back diseases that were considered eliminated and even becoming one of the WHO’s top-10 threats” according to Olivier Gryson, (Global Head of Digital, Abbott) “upturning a world where we’ve relied on the strongest level of evidence and which is now influenced by irrational factors”. Meanwhile, we are “losing the infection race” according to Heléna Bargiel, (Head of Commercial Excellence, LEO) with no viable strategy in place for overcoming superbugs.

 

The 2020s: all systems go

So the last decade was defined by incredible prowess in R&D. But when it came to what people felt would be the most impactful event of the next decade, interestingly, it was far less about the therapy or the science. Instead, it was all about changing the system – not just so that we can get therapy to patients, but so we can enable more personalised discovery and development from data.

But there is a problem. We have not prepared well. The system isn’t going to improve unless the levels of trust within our industry make a dramatic improvement, and our progress here has been abominable.

Yes, there is a general belief that technology will transform us. The adoption of cloud computing to potentially analyze data at scale will be a game-changer. An explosion of data and investment in digital platforms will make years of unstructured data useable.

Betul Susamis Unaran (Chief Strategy & Digital Officer, Zur Rose Group) extols the many potential virtues. “Data and digital puts people at the centre, empowers them to track, manage and improve their treatments, makes them more informed, independent and… demanding. Whilst we started later than other industries, the impact of data and digital will be biggest in life sciences. We will move from experimentation to real integration – and empowerment of humankind.”

Agreeing, Mads write that the 2020s “are not just about personalising treatments but are about a much more integrated way of understanding, assessing and delivering. AI, RWD, and ubiquitous smart devices will allow technology to truly make its way into the drug discovery/development value chain, with precise targets/MoAs and fully remotely executed clinical trials speeding up cycles between bench and bedside.”

“The new processing power from quantum computing will enable new capital to focus on applying AI to drug discovery and development, leading to more meaningful outcomes.” according to Jake. And Carole agrees that AI is “the only way to provide enough personal data for individualised medicines for the increasing numbers of patients with multiple conditions.”

Philip goes further. “We’ll become transgenic humans. We’ll soon be able to edit genes in an entire organism and go beyond fixing defect genes. This opens the door to enhancement therapies such as enhanced metabolism, strengthened immune systems, etc.” And Bruno goes further still. “The greatest convergence in the history of medicine, let’s call it healthcare’s singularity, is ahead of us. This super-converged world will require us to challenge long-standing arrangements and assumptions so that we can free up the resources and energy needed to fully leverage potential.”

Big words. Yet, as Milind – also the former CDO at Sanofi – points out, we have a more pressing, fundamental problem right out of the gate. “Sadly, we have failed to address the basics in data interoperability, standards, etc to realise these dreams.”

Colin explains that the desired ‘digitisation system provider’ – the automated, algorithm-driven delivery of healthcare – could come alive in the 2020s and transform both trials and treatment for the 2030s as devices improve. But such transformation is dependent on our ability to find ways to improve the appallingly low levels of interoperability we currently experience, often through deliberate design.

Interoperability will only come with new business models that incentivise sharing, and improved levels of trust that lubricate such sharing. As Carole writes, “For AI to work, patients need to believe in this. And right now, they don’t.”

 

Can you trust pharma?

I’m tired of the ‘trust conversation’ that has persisted for many years in pharma, especially since it was stoked by Ben Goldacre in September 2012, not because it’s unimportant but because we continue to speak in obsequious terms. Our kneejerk reaction has been one-dimensional: after all this time, we still talk only about transparency as a solution.

Transparency is a component of trust; it’s even the core of Jennifer Miller’s Good Pharma Scorecard. But it is only one component, and there are other aspects of trust that surround and precede it. Trust is usually established long before the need for transparency, as you’ll appreciate if you feel you shouldn’t need to read your partner’s text messages to trust them. In fact, transparency is only a requirement when trust has failed, when you’ve ended up in life’s courtroom and need to show evidence.

Yet, trust is not as difficult as we think. We do it every day with our families and friends.

To become a trusted, three-dimensional human, it helps to have a purpose, or a Why, in the much-quoted words of Simon Sinek. Only then can we buy into what you are doing.

“Purposeful organizations will be the decade’s winners,” says Colin, “and we need to focus at least as much on this as we do on ‘digital’ and all the other things that currently suck oxygen out of the room.” He’s right: for all the decade-long discussion of patient centricity, we still haven’t managed to effectively communicate our purpose. And we certainly haven’t found an industry argument as clear as those given by climate warriors like Al Gore or Greta Thunberg.

Laura McKeaveney (Global Head, Patient Advocacy, Novartis) believes pharma’s predicament is this serious. “If we think of healthcare as being in a similar crisis to climate change, how do we create a similar movement (with all the actors around the same table not talking about pricing, but talking about access and equitable treatment for all)? I fear that humanity is not able to make the strategic choices in this world of commercialism.”

The fear is that we will create a world where healthcare becomes a luxury. “We are the generation that has benefited from unimaginable developments in science, and with treatments in abundance for diseases that once killed us. The question is, how many can get access? How do we know if we have saved more lives than those that we have lost?”

Ester continues: “the new pathways to cures are a reality, but healthcare systems are not ready to afford them. How do we get the key stakeholders involved: payors, governments, pharma industry, etc, to work together to find sustainable ways to make new ‘science fiction’ innovation available to every needy patient?”

Peter Guenter (CEO, Almirall) explains that “the consolidation of omnipotent PBMs that de facto have [increased prices and hence] blocked the uptake of innovation in the US for any new product, except breakthrough first-in-class products for severe diseases, significantly hampering access for the US patient.”

Simon worries that “the American health system could implode by 2025 if there is no solution found to the rising costs in a model that sets the stakeholders against each other rather than enabling collaborative solutions. I hope and pray for a disruptor to appear.”

These questions, and many more ethical dilemmas, need to be answered. We need to tackle them with pro-actively and pre-emptively; a narrative which clearly defines what we are striving for. It is a narrative that will need to explain an honest path towards both sustainable profits and positive societal impact. Otherwise, the reality is, only new players in healthcare like Amazon and Apple will have the ability to aggregate the insights and processes required to make a difference. Florent Edouard (SVP, Grunenthal) suggests we’re already out of time: “it is inevitable that healthcare will be fully privatized in the hands of big tech. They will gain trust and public support, blasting through data privacy concerns, by making their solutions available for the two-thirds of humanity who still do not have access to decent healthcare but do have access to a mobile phone.”

 

A new narrative

It’s time to bring our subconscious storytelling ability to life. Alistair offers some starting threads. “Consider the power of combining genomics data with anonymous electronic health records to advance treatment access to patients who are undiagnosed but likely suffering from treatable rare diseases, and the exciting impact this could have.” He continues, “then think of the global rebalancing of innovation’s origin and commercial success: the US contributes over 60% of the first five years’ global sales value, a heavy dependence on a single market that makes life sciences hugely vulnerable to political decisions in one country, and focuses innovation on a minority of the world’s population.” Look around, and there are hundreds of problems to solve, the foundation of any compelling narrative.

Here are four of my own suggestions for the 2020s.

 

Paul’s phenomenal plotlines

1. Pharma becomes healthcare

Cell and gene therapies, as discussed, are here to stay. What’s also true is that such complex treatments rely on new equipment, staff and supply chains - and these will soon overwhelm hospitals, even beyond the cost of treatment.

To deliver the promised outcomes (especially given the proliferation of payment-by-results agreements), drugmakers must provide the services needed to administer treatments in addition to the treatment itself. This will require companies to develop new skill sets fast, most likely initially through establishing new types of partnership. There is a story of how our declining city centres and malls, once propped up by bricks-and-mortar retail, could become the new hives of sophisticated healthcare activity away from the home. A visionary narrative will be required to bring the ecosystem – especially patients – together.

 

2. The innovation gap is killing us

Science improves, year-on-year, exponentially. What’s now possible in medicine has never been so exciting. Meanwhile, the rate of science that actually reaches patients moves far more slowly. If you were to plot these two lines on a graph, the widening ‘innovation gap’ between the two represents the people we could have cured, but didn’t. The number of lives we had the ability to save, but didn’t.

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Naturally, we are a safety-first industry, so we cannot expect cutting edge science and technology to find its way to a population seamlessly and immediately. But we are also guilty of assembling a huge variety of artificial means, whether deliberately or by accident, that prevent access to the most needy. It is a failure of spectacular proportions when humanity fails to transfer innovation for purely bureaucratic reasons. We're standing on the shore and failing to throw the rubber ring to a drowning child.

There is an available narrative in finding the way, whatever it takes, to get solutions to patients, realign the numerous stakeholders and close the innovation. Most pharma currently currently neglect distribution to low-income countries, outsourcing efforts to companies like Clinigen. This can change.

 

3. Patients have the power

We welcome the rise of the super-patient, soon to be equipped with the tools to diagnose and understand which treatments work for the individual – and modify/manufacture them locally. Just as permanent body enhancements like tattoos have emerged from their associations with a criminal underground (and now feature on more than two-fifths of us), we are no longer afraid to upgrade ourselves. Biohacking and transhumanism will emerge from the preserve of an experimental minority, and it will become the responsibility of every conscientious adult to enhance their physical selves, just as we enhance our mental selves at school. And pharma, rather than attempting to suppress this Napster-like DIY community as it emerges, instead will become the Spotify, the iTunes, the institution that embraces, codifies and enables a safe, legal new industry to develop.

 

4. Prevention is bigger than cure

Today, pharma focusses on the sick. This is a small, presumably declining (if we're doing our job) market. Compared to the well, and even the wealthy well, it’s a minor fraction of the available customer base.

Curing people might seem more urgent – and attract higher prices per patient. But with the right narrative and convenient solutions, there is no reason why we cannot devote more wealth to treatments which prevent sickness or enhance our everyday wellbeing. If De Beers can make expensive diamond rings a pre-requisite for marriage, the collective communicators in the pharmaceutical industry should be capable of raising the importance of self-care.

Already our disposable incomes are dedicated to gym memberships, vitamins and intruder-sensitive doorbells. Against current dogma, our consciousness is already devoted to the fear of becoming fat, sick or poor. We only have to shift it sideways.