Drug Delivery Innovation: If You Build It, Will Anyone Care?
By Fran DeGrazio, executive editor, Drug Delivery Leader
Innovation. We hear the term thrown around quite a bit in the biopharma industry. But what does it really mean and how do we make it happen? It’s often considered to be having new ideas on products or technologies. The reality is that it is much more than that because, if one does not consider innovation from a broad perspective, the ultimate goal of helping a patient will never occur. If you cannot get a product to the person that needs it, it is not a success no matter how great the idea was.
Innovation in drug and biopharma delivery is essential to address new modalities, deliver drugs precisely, improve patient experience, and incorporate sustainability, to mention some major drivers.
I was fortunate enough to recently have moderated a discussion with a team of experts on the subject of innovation at a recent Drug Delivery Leader Live online event, “Innovations In Drug Delivery: Opportunities For Enhancing Familiar, Mature Approaches.” Our experienced speakers consisted of James Wabby, Head of Global Regulatory Affairs - Emerging Device Technologies and Combination Products, AbbVie; Carolyn Dorgan, Director, Technical Services, Sutton’s Creek; and Courtney Evans, Principal Consultant, Suttons Creek.
As I reviewed my thoughts about the discussion, I identified four key takeaways that provide a framework for our discussions of innovation as we go forward.
Technology Advancement Always Leads Regulatory Advancement
When a new technology is being introduced, whether from a medicinal perspective or a device delivery perspective, there is a unique opportunity to work with the regulatory agencies to build collaboration and establish precedents for the future. For an illustration, you can hear about the history and current state of injectable drug delivery technologies in this event segment featuring Carolyn Dorgan and James Wabby. Courtney Evans provides the regulatory perspective during the following short video clip.
So, do not consider the lack of regulatory or industry standards in some areas to be a barrier to innovation. Instead, see it as an opportunity to help inform policy and define the future path. Ultimately, regulatory innovation must occur to successfully bring a new technology to market.
Innovation Is Iterative
The often iterative nature of innovation means that the next concept developed does not need to be a huge leap. As a matter of fact, based on my industry experience, people often state they want significant innovations, but the reality is that most organizations, as well as the personnel within them and the patients they are addressing, want something they are already comfortable with. This preference results in changes that are usually small in nature.
We can find some potential validation of this tendency by referring to one of the survey questions asked of the audience at the Live event. The question was as follows: Regarding its evolution or advancement, which drug/therapy delivery type or route are you most interested in
The highest response was 33% of attendees stating that advances in autoinjectors were of most interest. Given that other options included newer technologies such as oral robotic pill delivery or nanotechnology combination therapies, the stronger interest in a much longer standing technology may indicate some preference for iterations of the better known.
In an earlier part of my career, in various R&D and technical roles supplying packaging and delivery systems, I often told customers, “You always say you want new innovation from your suppliers, but you never want to change anything.” This reluctance is a real problem in such a conservative industry and one that must be considered when evaluating market risks.
Typically, industry R&D and technical personnel are interested in new concepts and technologies. They want to see efforts to bring innovations to the market. The industry is typically conservative and risk-averse, due to the unknown risks of new innovations. For an innovation to be adopted, it must outperform existing standards. A deep understanding of both technical aspects and human factors, including acceptance and payor considerations, is crucial for success. You can also hear a bit more perspective on resistance versus acceptance in the clip entitled “Patient Adoption of On-Body Delivery Systems.”
Integrated Product Development Is Critical
Thirdly, as I have mentioned in previous blogs relating to combination products, the aspect of developing an integrated approach is critical in delivering successful innovations. This is especially true when it comes to the development of a comprehensive regulatory strategy.
When one speaks of integration of combination products, the most obvious aspect is combining the drug or biologic with the delivery device. But again, think more broadly: it really encompasses external partners and various third parties that you will be leveraging along with the potential of combining other aspects such as a platform device or digital capabilities. All of these aspects must be part of an integrated strategy and execution plan. I recommend you take a few minutes to watch this illustrative event segment with James Wabby and Carolyn Dorgan.
Innovation Success Requires Patient And Payor Adoption
Lastly, patient and payor considerations are significant in the final success of an innovative product. Being “first in a space” can be a good thing, but it can also bring challenges and risks that were not considered historically. Here we can show some contrast by watching a clip of Carolyn Dorgan speaking about creative innovation success with Nalaxone versus the challenges presented with market penetration of the Smartronix product, an on-body injection combination product, which was recently discontinued. James and I discuss that contrasting example here.
Frankly, especially when discussing products for self-administration or to be used by those that are not trained clinicians, the word is simplicity. To really gain an understanding of the comprehensive event dialogue, I suggest watching the full recording here. Much of the material is presented in case study format, which is great for elucidation.
Since most of our discussions during the event covered current and historical combination products, we are looking forward to bringing a focus to truly next-generation combination products in additional coverage and events.