Drug Delivery Partnership

This year’s conference, in an unusually chilly Florida, saw the world’s largest pharma and medical device companies represented in an intimate and cooperative environment. The key theme was the nature of partnerships to improve healthcare outcomes – whether within internal teams, between pharma and CROs/CMOs or between companies as diverse as GSK and Apple.

Patient focus and patient well-being (in the widest sense) was appropriately paramount in providing the motivation for partnerships. This translated into the design world language of UX and Human Factors Engineering, both exploratory and formative. Such techniques were not only being applied to discover and explore the finer points of patient convenience, image and lifestyle, but also to tackle the significant challenge in needing to demonstrate successful patient outcomes. Pharma companies are equipped with drugs that have succeeded in passing 3 phases of clinical trials and yet according to AstraZeneca these might be taken correctly by patients only 50% of the time and at worst only 30%. Human Factors presentations from Sanofi and Clara Health helped to shed some light on the shortfalls of compliance and adherence, whether from inappropriate devices, or human forgetfulness, use error, denial, stigma, discomfort or avoidance of pain.

The benefit of small patient sample size, and yet deep understanding, was described by Sanofi, who further qualified the need to ensure representation of all groups, including those with comorbidities and the young and elderly. It was recognised these latter groups have unique characteristics to determine and are not just smaller and older versions of adults.

Delegates observed that human factors, design, technology and digital connectedness can address some of these issues and that drug development cycles of up to 15 years provide ample time within which to address delivery solutions. Sanofi shared its term drug ‘deliverability’ to emphasize the earlier thinking needed about total delivery solutions and not just molecules. Others observed the potential write-offs in terms of developing devices too early, especially when only 1 in 10,000 potential drugs becomes licensed.

Image credit: PDD

Many talks discussed the potential benefits, and potential pitfalls, of digital and connected technologies. Sanofi remarked that an integrated healthcare programme now includes as many engineers, designers and human factors specialists as drug scientists and that the programme manager’s role included IT.

Several speakers involved in integrated solutions commented that the fast, agile and adaptive nature of app development was diametrically opposed to the conventional and assured waterfall model of drug development programmes but that now these streams now needed to be concurrent.

The benefits that mobile consumer devices could help bring to both patients and pharma companies was evident, as were the thorny issues of their required validation and constant support throughout use.  Many solutions have steered clear of the download to devices (e.g. control via an app) and focused on patient condition and treatment management and the upload of data (e.g. review via an app).

Several speakers recognised the personalisation of care to be a longer-term goal made possible by biometric sensing and connected healthcare technologies. Artificial Intelligence (AI) could determine individual treatments based on direct and indirect physiological measures, enhanced by personal and contextual factors. In the nearer term, data from connected healthcare might help Pharma companies to understand the patient factors leading to the compliance and adherence issues.

Others saw the benefit that connected healthcare might bring within the R&D phase of programmes, to help provide less invasive research methods for Pharma companies to better understand patients up-front. Might this offer some diagnosis of the causes of poor compliance and adherence, rather than provide the big data of symptoms, which doesn’t necessarily provide the insight needed for effective action?

The advantages offered by connected technologies might also affect the nature of devices themselves. Phillips Medisize observed that the cost viability of disposable electronics is marginal (not to mention the almost indefensible sustainability) and yet the disposable device market is currently around 20 times the size of the reusable market. The equivalent electronics cost budget for a reusable device lasting 3 years could be 150 times greater than for a weekly disposable and this might encourage a shift towards reusable devices. Several companies such as Hasselmeier and Teva referred to their reusable clip-on connected modules. If the recent consumer reaction to single-use plastics extends from food and household products to their healthcare products this will be a further significant driver towards reusable devices or modules.

Since the conference was held in the US, it was no surprise that ‘the agency’ (FDA) was mentioned frequently in the context of broader healthcare objectives and connected technology. One delegate mentioned the FDA’s declared intention to monitor social media reviews of medical devices – both positive and negative. This was seen as a shift in FDA mind-set towards greater recognition of benefit alongside risk; the change in its terminology from ‘risk-benefit’ to ‘benefit-risk’ being regarded as more significant than might first appear.

Many exhibitors showcased new drug delivery devices and technologies. On-body devices, ranging from electronic and controlled (BD and Sorrel Medical) to elastomeric (Enable Injections) were in evidence. These devices suit the newer, large molecule biologics which a study by BD shows might also be deliverable safely and in larger drug volumes. New needle-safe solutions continue to be developed including a needleless auto-injection product from Portal Instruments and needleless retraction systems from Credence. There were GUI-based auto-injection platforms from Elcam as well as single-use platforms, tested to six sigma levels of quality, from BD.

Image credit: PDD

During the event there were expert panels involving the conference delegates. These discussed that a pharma industry creating fewer blockbuster drugs now needed diverse capabilities in science, human understanding and technology to improve healthcare and that partnerships with other organisations were an effective way to achieve this. The nature of partnerships was discussed and Noble, recognising the benefits, also referred to new and detailed challenges- even a 4-way CDA could be problematic. The nature of intellectual property ownership was also raised in regard to the much-lauded co-creation method. The potential benefits of partnership were recognised as was the corresponding need to avoid procurement short-termism to safeguard longer-term value. A concluding panel agreed that the essential ingredients for worthwhile company partnerships remained at the personal level and included trusting partners to deliver, enjoying the working relationship and having a frank and friendly openness to overcome the inevitable obstacles and friction that would arise.