For 35 years, I’ve watched new technology in drug delivery methods emerge from nearly every seat in the house, from R&D to project management to business development.
Over the course of those years and job titles, this industry has remained steady in its approach of small, incremental changes. While progress can often feel like it is moving at a glacial pace, patient safety demands it, along with product integrity and the confidence of commercial supply.
Of course, glaciers have been known to dramatically reshape a landscape over time. When I look back over nearly four decades, the transformation carved out by constantly emerging technology is mind-boggling.
Today, we are on the verge of a seismic shift in one drug delivery method in particular: inhalation. Currently, an alarming number of patients suffering from asthma and COPD don’t get the proper dose of their medication due to the simple fact that they are improperly using their inhalers. One research report puts that number at up to 94 percent.
Technology could change that in a dramatic fashion. The 3M Intelligent Control Inhaler, currently in development, for example, is being designed with features to remind patients to take their medication, instruct them on proper inhalation technique, and detect whether or not they received the right dose.
The inhaler could also connect to their mobile devices and could be used to collect and monitor health data. This could be used to reinforce positive aspects of inhaler technique including usability and adherence.
The improved delivery of drugs to the lungs in the right dose and at the right time has the potential to be game-changing. By increasing adherence and usability we may be able to improve the lives of patients by reducing complications related to their asthma or COPD, and drive down costs related to those complications for providers and payers.
Other advancements include finding more effective and efficient ways to go to clinical trial to reduce the cost of development, and allowing pharma to invest even more resources into R&D. Also, there is the added benefit of reducing development cycle time, allowing life-changing medicines to be brought to the patient that much sooner.
When it comes to drug delivery methods in general, two main factors are the driving forces behind emerging technology: patient empowerment and the emergence of generics.
During the first 20 years of my career, the patient wasn’t a high consideration during the research and development process. That has changed profoundly. Now, we are very cognizant about the end-user and enhancing their lives.
From a philosophical standpoint, it is simply an honest and good starting point. We truly want the device to address the patient’s needs and do what we say it is going to do.
From a business standpoint, it just makes sense. If a product is effective and user-friendly, providers will prescribe it and patients will use it. Technology makes it easier to address issues at the start of development, with the goal of ensuring better results in the long term.
The rise of generics has driven the need for new drug delivery technology—the 505B2 route if you will. When two companies are selling what is essentially the same drug, the method in which the drug is delivered to the patient becomes a critical factor in standing out from the competition. One can assume providers and patients will prefer and ultimately purchase the product that gets the drug where it needs to be in the most effective way.
There are many challenges standing in the way of emerging technologies in the drug delivery industry. The biggest challenges are the risks, and paying for it. We have an especially challenging situation since most of the payer-quantified value comes from the molecule delivered, rather than the technology that delivers it.
The question becomes: “How do we get these technologies from the development lab to the pharmacy counter?” We are missing the innovative business models that help turn technologies into sustainable businesses and currently the onus is on the developer to fulfill the regulatory, quality, and development requirements.
A new mindset is required with a more “up-front” approach, rather than “add it on” at the end to get the license to sell.
The other big challenge when it comes to emerging technology is getting patients and their healthcare providers to embrace it. Whenever new technology is introduced, growing pains are inevitable. Learning how to use a new device takes time. It is a short-term investment for long-term gains, but, in their busy day-to-day lives, patients and providers may not always see it that way.
Indeed, organizations need to be accepting that uptake, particularly in inhalation, may be slow to begin with, or not as aggressive as some plans may have suggested, despite potential health economic benefits.
The financial challenges are impacting and changing the research and development process in a very big way. At 3M, we pride ourselves on dedicating time to creating new and innovative ideas. However, we now must be more strategic than ever in how we do that. We can no longer invent for the sake of invention.
In order to work within an evolving financial framework, we now start the process of identifying a problem and then going in search of an innovative solution. This approach has led to a more focused number of new inventions, but the inventions that do happen are much sturdier and more applicable.
Organizations need to build an environment whereby marketing, sales, and R&D personnel can discuss openly and fuel the creative process.
In my opinion, the next 35 years promise to be more exciting than the previous 35. We are going to get much more training, feedback, and monitoring through digital delivery devices, and this will only accelerate new and improved technology developments further.
And as we figure out new and improved funding mechanisms, the possibilities will grow even faster. We all just need to be willing to embrace the changes on the way. Trying to stop technology is like trying to stop a glacier. If you don’t get behind it, you’d better get out of the way.
 Lavorini et al., 2008. Respir. Med. 102(4):593-604.
About the Author
Richard Beesley is the head of Global Inhalation and International Business Development at 3M Drug Delivery Systems.