Drug Delivery Innovation: Getting Advanced Therapies To Patients
By Fran DeGrazio, executive editor, Drug Delivery Leader
Patient needs have continually shaped innovation in drug delivery. Looking back over my 40 years in the industry, I can recall the days when drug products were routinely packaged in glass vials with aluminum seals and elastomeric stoppers without any consideration for changing the format for launch or during lifecycle management. Of course, this was before the emergence of biopharmaceuticals. Back then, small molecule, chemically derived drugs were the standard, and often the form of delivery was oral. Injections were utilized for acute care and administered almost 100 % in a hospital or clinical environment.
I recall an industry leader in biopharmaceutical development once stating that there was no need to alter their packaging or delivery methods because their drug was superior to others, making any changes in packaging or delivery unnecessary. However, times have changed. One of the key drivers in medicinal innovation since that time has been the development of large molecule, biologic treatments.
The development of biologic therapies has opened many opportunities for improved quality of life for patients. Currently, there are over 7,000 rare diseases, many of them tied to a genetic cause. In oncology alone, there are several hundred types of cancer. These are caused by genetic, environmental, infectious, and hormonal factors, among others.
Even though there has been a tremendous amount of progress made through the years in preventing disease, managing disease, and extending lifespans, we all know that there are many more opportunities for improvement. These market needs are what continue to drive next generation innovation in therapies. By extension, there is a parallel need for innovation in methods for delivering these new therapeutics to patients.
Delivering Advanced Therapies And Precision Medicines
A variety of innovations are currently under development, including advancements in formulation delivery technologies such as nanoparticles, as well as companion diagnostics that facilitate precision medicine. Additionally, antibody-drug conjugates (ADCs) are being developed to deliver chemotherapy agents directly to cancer cells and are a notable example of a combination product that brings both a drug and biologic together.
One clear benefit of these technologies is that they deliver on the promise of precision medicine that was introduced as personalized medicine in the late 1990s and early 2000s. Leveraging genetic testing, as an example, helps to not only treat but prevent illness more effectively. The hope is that, over time, these new technologies can not only deliver patient-centric solutions but help to manage healthcare costs more effectively.
We recently had the opportunity to introduce some of these innovation concepts at a Drug Delivery Leader Live online event I cohosted, “Next-Gen Drug Delivery: Rethinking Routes For New Therapies.” Our panelists, James Wabby, head of global regulatory affairs for emerging device technologies and combination products at AbbVie, and Carolyn Dorgan, director of technical services at Suttons Creek and former assistant director at CDRH within the FDA, are both experienced in the industry and focused on opportunities for innovation. Their insights underscore the need for advancements in delivery approaches.
Making Patient Centricity Central To Delivery Innovation
Since the introduction of the 21st Century Cures Act signed into law in 2016, there has been a reinforcement of patient-centered approaches in the development and review of medical products. As James Wabby said during the Live event, the intent of these innovation strategies is to “get the right product to the right patient.” In this video clip entitled, “The Future Portfolio Of Innovative Therapy Delivery,” James outlines this concept as background for detailed discussions around these new technologies.
While there appears to be widespread interest in these technologies, an audience poll we conducted during the Live event showed that over 30% of the participants are particularly focused on strategies for crossing the blood-brain barrier (BBB). This emphasis underscores the considerable, continued significance of addressing longstanding BBB challenges within industry. Directionally, it also reinforces the fact that one major trend now and in the future is “delivering specificity in getting drugs to the right locations, “as mentioned by Carolyn Dorgan in this clip entitled, “Leveraging Combination Therapies For Precision Targeting.”
Bolstering Organizational And Regulatory Readiness For Delivery Innovation
In addition to understanding the wide variety of new technologies that are in the pipeline, there are two additional challenges that should be considered, in my experience, anytime there is movement into a new area of development. One is organizational readiness, and the other is the overall regulatory strategy.
As biopharma organizations enter these new therapy delivery domains, it is critical that they update their approaches. An organization intending to have success with next generation therapeutics must strengthen various functions to deliver on that promise. This bolstering of capabilities involves establishing diverse and effective relationships with partners and suppliers, ensuring robust quality management systems, enhancing comprehension of container closure systems and their significance in the final combination product, and, importantly, addressing regulatory requirements. Lastly, executive- and management-level leaders must understand the new challenges and how to address them. Carolyn speaks to all of these considerations in the clip entitled, “Organizational Readiness For Next-Gen Therapeutics.”
Lastly, there is a need for an Integrated regulatory strategy for these new types of technologies. This concept of a regulatory strategy, however, is much more than just having a regulatory plan. Again, as I have discussed in earlier articles, the need for cross- functional cooperation is imperative. When we speak of regulatory strategy factors such as reimbursement strategy, quality systems, intellectual property, development plans, and strategic partnerships, all contribute to a comprehensive and integrated approach. I believe it is important to understand all these aspects when considering a move into new technology areas. You can hear more about these considerations in this clip of James talking about “Integrating Regulatory Strategies For Advanced Therapy Development.”
Numerous emerging technologies are poised to shape the future of precision medicine. Frankly, however, realizing their full potential requires more than technological innovation alone. Success depends on adopting a comprehensive approach to strategy and business that guides organizational evolution for long-term advancement.