In April 2021, we invited Dr Rene Holm to share his knowledge of how and why innovative drug delivery systems are created and evaluated. Dr Holm is author or co-author of more than 200 original articles in peer-reviewed journals and patents in biopharmaceutics, pre-formulation, formulation, and physical pharmacy and is an honorary professor in physical chemistry at the Department of Science and Environment, University of Roskilde, Denmark. The following article provides a condensed overview of the topics presented at Formulation and Development Europe: Online, be sure to subscribe to our newsletter to receive updates on our latest conferences and webinars.
Drivers For Innovative Drug Delivery Systems
It is not a given that big pharma companies are always searching for novel delivery devices. It is much less expensive if new therapeutics can be delivered through existing, proven devices. Three main drivers cause companies to search out new methods of administration.
Discovery of a New Compound with Special Properties
It is possible to discover a new compound, for example, a first in class compound against a specific disease, which has unique properties that require the use of a novel form of delivery device. If the compound is strategically viable, pharmaceutical businesses may test several different forms of delivery devices. This is done with the goal of improving efficacy and ease of use. The increasing discovery and usage of biologics and synthetics have been a critical influence on delivery devices over the last few years.
Patient Centricity & Need
Companies are constantly striving to meet patients’ needs and make new delivery devices that are easier to administer and less intrusive. One example is long-acting injectables in the treatments of schizophrenic patients. Patients initially had to take tablets every day, which is easy to forget for multiple reasons. Now we have a delivery system, which is injected as little as four times a year. This helps the patients deal with their disease burdens, and not least – they also hereby receive at more effective disease treatment.
Engagement In New Modalities and Disease Areas
Innovative drug delivery systems do not always have to be a novel form of delivery for the industry; instead, companies may engage in new modalities and disease areas with no prior experience due to market trends or expansion opportunities. Janssens’ transition into tackling eye diseases required investment into new delivery devices. As for new modalities, oligonucleotides are rapidly gaining popularity which is likely to require new delivery systems.
How Are Innovative Drug Delivery Systems Tested? Evaluating their effectiveness and convincing the market
The next stage is testing potential delivery systems, evaluating their effectiveness and convincing the market and regulatory boards of their usefulness. Testing is essential and needs to be completed before companies can even consider fully implementing delivery systems into development. As with any innovation, there is no guarantee of passing the evaluation stage. The development approach and evaluation process must consider costs.
Delivery Platform Approach: Targeting Multiple Therapeutic Possibilities
A platform-based approach provides pharmaceutical and biotech others with accelerated development timeframes and reduced risk; however, this comes with caveats. Developing a device platform requires ensuring that it can be used in the maximum possible range of possible therapeutic areas and patient populations. While this is desirable, it comes with challenges due to the need for flexibility for different volumes and dosing frequencies as therapeutic classes and indications may vary. An excellent platform for cancer treatment may be utterly incompatible with an autoimmune drug owing to drug product characteristics, patient desires, treatment routine, and many other factors. This can cause also lead to compatible drugs being delivered with lower efficacy than a bespoke solution.
Strong Internal Business Case: Going it alone
If it is strategically viable, for instance, due to the discovery of a new compound or an industry competition, companies may decide to invest in creating a specialized novel device. This requires more financial input and risk, so it is usually only done for compounds or trends with very high potential returns.
Companies will often collaborate with Contract Researching Organizations (CROs) and Contract Manufacturing Organizations to reduce risk. Their specialized nature and experience reduce the cost of investment and speed of research, manufacturing, and regulatory approval. CROs and CMOs have grown rapidly in recent years, and their success has led to a shift in procedure. Before the prevalence of such companies, many pharmaceutical organizations were much more risk-averse. In many cases companies avoided anything that was not almost guaranteed to succeed.
Regardless of the approach taken, many new potential devices never make it to market. It is common to realise during the discovery staged that the device is unfeasible. Devices may be unrealistic from an engineering perspective, unviable due to costs or market demand or simply undesirable to potential patients due to side effects, administration method or industry competition.
The path towards innovative novel delivery paths is expensive and time-consuming. Ensuring that existing and new therapeutics can be administered and simplified is vital. It is essential to bolster the research and advancement of innovative technologies and drug delivery systems within the pharmaceutical industry to ensure the sector can keep up with any improvements in formulation and discovery of new modalities.