Phillips-Medisize explains how to improve R&D productivity through intelligent drug delivery
Brain Waves
Phillips-Medisize and its Medicom Innovation Partner subsidiary show how strategic development of drug delivery devices boosts the pharmaceutical industry’s R&D productivity, shortening development lead times for intelligent connected drug delivery devices in line with increasingly rapid technology advances. It also means enhanced value for patients and all other stakeholders.
Healthcare costs consume a steadily increasing share of national economies, rising in the USA from around 5% of gross domestic product in 1960 to almost 18% in 2014. As a result, the entire healthcare delivery system is under pricing pressure, with pharmaceutical companies under particularly close scrutiny, even though prescription medicine only accounts for around 10% of overall health expenditure. Increasingly, the industry is beginning to focus on delivering positive outcomes for patients, justifying the costs of therapy compared to the existing standard.
Costs continue to rise as pharmaceutical companies develop better products, often a biologic drug. Biologics are targeted at more complex diseases (i.e autoimmune disorders) and are significantly more expensive to develop. That hasn’t pleased patients or their medical insurers, who enjoy the benefits of progress, but don’t like facing higher costs. Shareholders would also prefer greater value from investments in pharmaceutical companies, in terms of dividend yields and long-term growth in share values.
Integration Lead Times
Biopharmaceutical pricing pressure spurs demand for innovation
Medicom’s executive VP Kevin Deane and Phillips‑Medisize’s CTO Bill Welch believe that strategic development of drug delivery devices plays an important role in meeting price pressure by providing higher value solutions.
Welch and Deane illustrate the urgent need for corrective action by referring to a Deloitte report: The return on R&D expenditure, (R&D productivity) among 12 leading pharma companies with products in late stage development has dropped from an average of 10.1% in 2010 to 3.7% in 2016.
This is in part due to few new drugs reaching so-called ‘blockbuster’ status with sales exceeding one billion USD, but also due to treatments becoming more complex, and therefore more expensive to develop. Further, biopharmaceutical companies increasingly compete to develop targeting what are often still unfulfilled treatment needs, potentially dividing the available market. And pressure on R&D returns is even higher when payment is made only according to measurable outcomes.
While all this has being going on, the way in which drugs are delivered to patients these days is increasingly made by complex delivery devices, as opposed to traditional tablets or capsules. Such simpler means accounted for nine out the top ten drugs delivered in 2005. But eight out of the top ten in 2015 involved delivery by injection. This shift involved a ten-fold increase in the value of drugs delivered by injection, while the overall value of the top ten drugs had increased by just 53%.
Pointing to the increasing number of devices being connected online to reach 20 to 50 billion USD by 2020, Welch and Deane say that: “The healthcare industry, and specifically drug delivery, will inevitably be caught up in this societal change too”.
Maximum value
Welch and Deane note that pharmaceutical company R&D departments can improve productivity by adopting a dual-track strategy. Ideally, this strategy should focus on both R&D efficiency, meaning development of more affordable drugs through less costly R&D, and R&D effectiveness, so that patients benefit from the greater value of more innovative drugs, along with higher quality information.
Welch and Deane say pharmaceutical companies have, to date, focussed more on R&D efficiency, less on R&D effectiveness for greater value. They cite consultants Deloitte as having established that pharmaceutical companies tend to become market leaders when they integrate value-adding strategies early in the R&D value chain, with these no longer being sole commercial or R&D function remits, but of both functions together.
This results in better end-to-end decisions addressing all stakeholder needs, from payers through providers to patients. Leading companies take this approach along with a focus on development of high levels of expertise in particular therapy areas, as well as targeting populations for maximum value creation.
Drug delivery devices play an increasing key role here with many of the new drugs being introduced ensuring more effective treatment and potentially also reducing treatment documentation.
Patient perception of a drug, and the pharmaceutical company providing it, depend very much on the delivery device, Welch and Deane maintain, as this can contribute towards better support of patients, care providers and other key care system stakeholders. Medicom, for example, is proud of the approach it takes to identify how specific delivery devices can support patients and obtain improved care results.
Welch and Deane say maximum value is achieved by firstly researching the market to find opportunities arising from unmet therapy needs, along with assessing the competitive position. This enables drug delivery device manufacturers to approach the market with differentiated rather than lower value “me too” solutions that simply replicate what others are already doing.
Only then can plans be drawn up for launch and further development of identified high value therapy solutions in the market. These plans should also allow for assessment of possible risks, constraints and uncertainties - on the regulatory side, in the supply chain and in treatment opportunities.
Allowance should also be made for assessment, for both the device manufacturer and users, of newer technologies for incorporation into the devices in the short or long term, including online “connected health” communication possibilities. Dealing with life cycle management becomes increasingly more important in a dynamic environment in which the pace of technological evolution increases, making some solutions less attractive in value, or even obsolete, as time passes.
The process of strategy development should be completed within 2-3 months and evaluates existing feasible solutions as building blocks, supported by stakeholder interviews, user research and workshops with clients. Rapid prototyped delivery devices can be a useful tool to support device development, as well as in identification of further opportunities.
Phillips-Medisize starts each development path with a strategy stage, consisting of consideration of market differentiation, market execution and constraints-to-execution phases. The product development stage starts in the last of these three phases. The manufacturing stage and its associated manufacturing design and development phase begin early during the product development stage, immediately allowing full-scale production.
The company states that this approach achieves shorter lead times than standard lead-time approaches, because of the inclusion of the strategy stage. A key element in shorter lead time to production is that all development team members are involved in the entire project, saving a considerable amount of time that would otherwise be consumed in transferring knowledge from one team member to another. Time is also saved by handling device development in parallel with development of technology platforms that provide technology needed for devices in development.
According to Welch and Deane, pharmaceutical companies can help themselves and better understand patient needs by considering drug delivery device strategies already at an early stage of commercial considerations in drug development, thereby gaining a better view of the potential value that can be added to care programs.
Although most pharmaceutical companies recognise the growing importance of the role played by drug delivery devices, all of them need to understand that R&D effectiveness is becoming equally, if not more, important than R&D efficiency. It also means that early planning of specific drug delivery devices for individual types of therapy “will often hold the key to unlocking greater value”.
Unlocking greater value in this way is the means by which performance of medicines developed for each specific type of therapy can be improved, Welch and Deane maintain. As this creates better understanding of how the therapy works, there is a direct benefit for patients and the support they obtain from the various stakeholders. And as this understanding grows, so does also the potential for spin-offs into more differentiated products.
Integration of drug and device development with manufacturing is the key holistic approach and the driver towards obtaining significant improvements in R&D productivity, Welch and Deane conclude.
Intelligent multiple sclerosis solution
Medicom provides an injection delivery device designed to treat multiple sclerosis as an example of a product developed with the company’s drug delivery strategy approach for maximum added value. It is a solution that has at its core the prevention of severe MS relapses as “a clear health economics driver”. It achieves this by improving “event-driven” patient interaction and information-sharing with healthcare professionals (HPCs) on specific MS therapy needs, to an extent that “off-the-shelf devices are simply not able to deliver”.
Among product features are visual and audible indicators, reducing the burden on patients to remember when to treat themselves, as well as to ensure full dose administration by reducing the risk of premature needle retraction. Patients can adjust needle injection speed and depth for optimal comfort. Ergonomic design in terms of the injection button position and use of a low-force safety release enables single-hand use and easy access to various injection sites.
The needle is automatically inserted and retracted gently and smoothly by a motor, and as the needle is always hidden. These aspects lead to less anxiety during treatment. And finally, Bluetooth or USB connection to the MS drug delivery device provides an interface for automatic updates via a smart device app.