Brennan Miles, Managaing Consultant - Drug Delivery at Team Consulting writes:
Members of the team began their medical device career 20 years ago on the development of novel inhaler technologies, and have kept the interest in respiratory drug delivery ever since.
Despite being virtual, DDL 2021 managed to put together a motivating mix of live speakers, on-demand presentations and papers. Here are my top four take-aways from the conference, including trends to watch out for in 2022.
1. Digitalisation and AI
Connectivity in drug delivery devices has been popular for some time now. We already know that adherence to medication, taken routinely and compliantly with correct device preparation, is a big factor in successful delivery of drugs to the lungs. Device developers are continuing to tackle these aspects with the introduction of digital connectivity and sensing modules. When paired with a device and companion app, these technologies support the user in achieving compliance. They also offer on-the-go monitoring of device usage, which provides very useful data for healthcare providers.
The DDL lecture this year presented by Dr Sabine Häussermann and Professor David Price explored beyond the upfront user benefits of connectivity and discussed the role that Artificial Intelligence (AI) and machine learning have in supporting effective respiratory healthcare outcomes. AI algorithms can make sense of vast quantities of data with an efficiency that far exceeds human cognitive ability. There are already great examples of using AI for the diagnosis of respiratory diseases, for example with the interpretation of spirometry measurements. Here data driven AI analysis can be proven to be 85% accurate, versus human ability to generally only achieve 45% accuracy when interpreting data sets.
Dr Häussermann was clear to point out that “the key to good AI is good data” and “garbage in equals garbage out”. There is a clear emphasis on device sensing and connectivity technologies to ensure that they generate the high-quality input data that is needed to support AI systems. She also noted that for healthcare deployment the most effective use of AI is through a “combination of both the machine and the human”. AI saves valuable time on the laborious number crunching tasks, however, humans add something which the algorithm cannot, which is common sense and empathy with the patient.
AI is the natural progression for digitisation of healthcare. However, as these systems develop, we must be mindful of cybersecurity risks and a regulatory landscape that is currently struggling to keep up with the rapid pace of development. We’ve already discussed some of these cybersecurity risks which you can read here.
2. Nasal Delivery
Another exciting area is intranasal drug delivery. Notably by Dr Julie Suman (of Next Breath) in her lecture titled ‘Targeted Nasal Drug Delivery – for Nose, Body and Brain’, but also in a number of on-demand presentations by Kindeva, Nanopharm and Hovione. Nasal drug delivery was once the ‘poor cousin’ of the respiratory market, but interest is now growing. It offers significant opportunities for delivery of not only systemic drugs, but also for vaccines and delivery to the central nervous system (CNS) via the olfactory nerves.
CNS drug delivery via parenteral administration has always been challenging. However, the appeal for intranasal delivery is that olfactory neurons that occupy the upper nasal region offer a direct connection to the CNS, bypassing the blood brain barrier. This opens the door for many therapies such as emergency use medications like Naloxone, for opioid overdose and other opportunities that could use this route such as future treatments for Alzheimer’s and Multiple Sclerosis. Dr Suman was clear to point out the specific device and administration challenges with current nasal delivery devices. For instance, depth of nozzle insertion into the nasal cavity can change deposition by up to 30%, and some existing devices can be very sensitive to the administration angle.
As a device developer the team naturally feel that these delivery and usability challenges can be addressed through good user centred design. By creating innovative solutions that are vigorously tested, we can ensure that future nasal devices are safe, effective and easy to use.
3. COVID-19 treatments
Understandably, over the past two years there has been significant review of SARS-Cov-2 and various treatments and vaccines at almost all drug conferences. COVID-19 is of course caused by a respiratory virus, spread by droplets and aerosols, therefore inhaled treatments are clearly right on topic. Professor Peter Barnes of the National Heart and Lung Institute at Imperial College London presented how inhaled therapies can assist treatment in the early infection and pulmonary phase of the disease. The main drivers for an effective inhaled therapy are rapid drug availability and high safety margins to reduce disease progression and transmission.
What was interesting to find out was that asthma and Chronic Obstructive Pulmonary Disease (COPD) patients have been surprisingly underrepresented in COVID-19 hospitalisations. There is a theory that Inhaled corticosteroids (ICS), typically taken by these patient groups, may be somewhat protective against the virus. Studies into this area have indicated some promising outcomes, including potentially less severe disease progression and quicker time to recover in certain user groups with ICS treatments.
This is a disease that we are all going to have to learn to live with. Effective respiratory treatments will continue to have an important role to play for COVID-19, something we understand well having developed our own emergency ventilator at the beginning of the pandemic.
Alongside the development of such treatments, inhaled antivirals should also continue to be explored for a more sustainable, longer-term solution to limiting and preventing severe interventions.
4. Influence of the tobacco industry on the respiratory industry
This has been a highly divisive topic for obvious reasons. The controversial acquisition of the UK Vectura Group by Phillip Morris (makers of cigarette brand Marlboro) made national and international headlines this year. Vectura receives an income from several inhalers licensed for the treatment of asthma an COPD and many prominent respiratory groups have expressed concern about this takeover, including the British Thoracic Society, the COPD Foundation and Royal Pharmaceutical Society. The DDL conference itself took steps in 2021 to remove any sponsorship from Vectura as a direct result of the recent takeover.
Concerning ethical concerns with the tobacco industry aligning itself with the healthcare industry, Presenter Dr. Toby Capstick said that “the attempt by the industry to present itself as promoting healthcare while simultaneously profiting massively from cigarettes is obscene”, a view echoed by other prominent healthcare voices. The counter argument is that tobacco companies want to diversify and move away from a pure cigarette market and invest in less harmful products including nicotine replacement products and smoking cessation devices where there is potential for the two industries to work together on new, regulated product innovation.
However the most strongly aggrieved parties in this argument are both the patients suffering from smoking related diseases and those in the respiratory sector who have spent years combating the harmful side effects of tobacco. Despite the ‘conflict-of-interest’ argument the tobacco industry is already making inroads into the pharma industry. This has already been seen in the development of COVID vaccines with Medicago and GSK, where Medicago is a Canadian biopharmaceutical company already part owned by Phillip Morris Investments. It will be interesting to see how this situation evolves.
Sustainability
Sustainability at DDL this year was less talked about, but it has been an area that has been heavily covered at other drug delivery conferences throughout 2021. The team have presented on device sustainability topics at three events this year and are expecting it to remain a very prominent topic for 2022.
While the focus in respiratory has been on the development of more patient-centric devices to improve the known issue of poor patient adherence, inevitably there is also an environmental cost. The trade-off for improved usability has been that devices have become increasingly complex, using more components, more exotic materials, and new intricate manufacturing methods. This in turn means increased energy is needed for their production and there is an increase in the amount of environmental waste when they reach the end of life.
Previously the industry and regulatory position have been that the health benefits to the patient, of correctly and safely receiving medication, outweighs the environmental impact of the device. But this way of thinking is fast becoming outdated, especially as society in general is becoming more aware of the damaging impact that single use, predominantly plastic products have on the environment. There is now a real drive to ensure that complex device technology is targeted only where it really adds value, and that it is balanced against the increased carbon footprint that is consequently generated. Tools such as Life Cycle Assessment are becoming more widespread in the medical device industry, although the actual real-world use is difficult to determine because few studies have been published. Expect to hear more about sustainability initiatives as device and pharmaceutical companies continue to develop and evolve their future eco-design strategies.
It is clear following DDL that there are some key topics to acknowledge and look out for in 2022. Sign up to our newsletter to keep up with our latest insights.