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Richard Barker, former Director General of ABPI, proposes a new agenda on how to restore public confidence in the value behind science.
Our R&D model is broken, comes the cry from the lab. Getting approval now requires unaffordably large trials, say the developers. Proving value has become a fourth hurdle, add the market access executives. Existing marketing and sales investments now look like the wrong people using the wrong tools to do the wrong things to the wrong target audiences, complain business managers. Meanwhile the patients ask: What does all this mean for the medicines we need? All this is very bad news for the old order, but could actually be good news for real innovators.
We need to rethink the whole concept of pharmaceutical innovation, around four "Grand Challenges:"
» 1. Where will tomorrow's discovery research be done—academia, medical charities, SMEs, traditional pharma companies, or creative combinations of all four?
» 2. How can we escape from today's burdensome development and regulatory paradigms?
» 3. How will future innovations be marketed, in an era of payer-driven value assessment?
» 4. Will pharma companies take full advantage of new technologies to both drive and track patient access, optimum use, and desired outcomes?
The answers to these questions will determine whether the industry enters a new, but very different, era of prosperity—or continues its current decline.
If you know where to look, there are optimistic signs of new life and new thinking in all four of these areas.
Companies are experimenting very actively with new discovery models, embedding researchers in academic groups, spinning out product portfolios with venture capitalists, and co-developing products with research charities and academics. I believe these are just the first 'straws in the wind;' we will see further changes in where products are sourced, as the NIH and major academic medical centers invest in discovery themselves, driven by the need for outside sources of revenue.
Many companies now spend half of their research budgets outside, and some are asking how much further might the trend need to go? A lot depends on whether the major companies can create small company dynamism inside their own walls. This is a very different leadership task from managing a massive global network.
In development, we have many consortia exploring the tools needed to reshape the process for the new era of more focused, stratified medicine. Tools already under study include validated biomarkers, ways to incorporate value measurement in clinical trials, models for progressive authorization, new clinical data informatics tools, and real-world data collection.
Marketing and sales—or, as I relabeled it when I was ABPI Director General—"establishing value and access," is in the throes of major change. Sales forces are being scaled back, key account management is taking hold, and health economic value arguments are becoming more important than classic brand positioning and promotion.
Turning to the use of rapid advances in IT to drive the uptake of biopharma innovation is only in its earliest stages. Of course, person-to-person communications will always have a role, with governments, value agencies, health systems managers, and individual prescribers. But industry must embrace the new tools of mobile health and social networking. Otherwise these channels will be dominated by those whose interests are very different, and not obviously pro-innovation: powerful PBMs, new e-health entrants, anti-industry activists, and budget-conscious health system managers.
So early experiments with interactive websites, Twitter feeds, mobile patient education videos, and medication alerts to mobile phones are all welcome. But they need to be assessed very carefully from two quite different viewpoints: their effectiveness in getting 'the right medicine to the right patient at the right time' and their reputational impact. If we do not bear both in mind we will simply repeat the saga of DTC advertising.
So, profound change is already under way at all stages of industry's value chain. What are the barriers in our four Grand Challenge areas?
In discovery, so much has been invested in 'industrializing' research in big internal labs that it is hard to reorient to place multiple bets with multiple outsiders, and to invest the creativity and time to make the new relationships work.
Despite the many consortia and think-tank proposals, practical examples of progress on streamlining development are few and far between, as both companies and regulators are afflicted by risk aversion. Progress here must be measured by promising real product pilots, and these are still rare.
Marketing and sales organizations are still dominated by those who 'rose through the ranks' with very few imports from other industries to bring fresh perspectives and expertise in pricing for value, engaging customers in real time, and managing relationships for win-win outcomes.
In this area, a new mindset is as critical as new skills. In today's world—let alone tomorrow's—the major developed economies struggle to meet their health budget demands. Payers and health managers must take truly radical action to engage patients, reshape care, and realign incentives if the healthcare funding gap is not to widen further. The industry must be an ally—not a bystander—in that struggle.
In this economically pressured environment, digital tools to prompt good health behaviors, educate patients, issue medication reminders and track outcomes have huge potential. But it is still hard, in many pharma companies, to find a convincing digital strategy—and sometimes even harder to find who is supposed to be developing it.
So I believe 'innovating innovation' is still mainly on the drawing board.
The UK, where I spent the last seven years heading the ABPI, is—as Pharm Exec's Editor-in-Chief says—a place that likes to talk a lot about innovation. We have had, in recent years, the Cooksey Review, the Office of Life Sciences, the Life Sciences Supercluster, and most recently the Academy of Medical Sciences report on reviving UK clinical research. And those are simply the ones you may have heard of.
But issuing reports about innovation and achieving fast patient access to affordable innovation are two very different things. The latter needs a new set of relationships between industry, academic researchers, HTA agencies, and the health service. Such relationships must have at their heart a shared desire for innovation to reach the patients most likely to benefit, at prices recognized as value-adding by the National Health Service and the health systems of the world.
This unfinished business and the four Grand Challenges have led us to set up a new, independent Centre for Accelerating Medical Innovations, based in the UK, at Oxford University, but also with a European and global remit. We'll be building on the work of the Athenaeum Group, a European forum founded four years ago and involving the heads of major regulators, companies, clinical centers, and patient organizations. The Centre will study and evaluate the new innovation models and new technologies that companies and the public sector are pioneering. It will also stress the "missing disciplines" that can perhaps unlock the problem of faster, more affordable innovations.
Take the traditional development paradigm, for example. Changing this will require greater patient engagement, statistical innovations, ethical rebalancing, new IP approaches, legal and policy reevaluation—all necessary for eventual public and political acceptance of urgently needed change. We need everyone in the policy arena to realize the problem they are tackling is no longer how to safeguard huge populations from indiscriminate promotion and prescribing of mass-market drugs. The key question now is how targeted medicines that are designed around defined populations can be brought to the right patients swiftly and at an affordable price. Quite a different problem, with a different solution.
For too long the industry wore its R&D productivity challenge as a badge of honor: 10 to 12 years and $1.5 billion and rising per new medicine. Pharma now realizes that an innovation model with these features is unsustainable in a post-blockbuster era; many investors came to that conclusion some time ago. Industry must work, along with regulators, academic scientists, and—most importantly—patients, to devise new, more sustainable innovation models.
It goes without saying that shifts at the scale I've described will change the face of Big Pharma, the most important of which is taking seriously the shift from being in the product business to being in the outcomes business.
Innovating innovation itself is indeed the new challenge. But it can only be achieved in partnership with our stakeholders, most of whom know they need us to be successful. As do we all—as patients, of the present and the future.
Richard Barker is Director, Centre for Accelerating Medical Innovations. He can be reached at firstname.lastname@example.org