11th Annual MIBio Conference

18th October 2023 - Cambridge, UK

Dr Adam Walker

Principal Consultant

Badrudiin Olow

Associate Consultant

Introduction

Scendea is pleased to share our experience at the 11th annual MIBio conference, a gathering of experts in the fields of biologics formulations and drug delivery. The conference served as a platform for illuminating discussions on the stability of biopharmaceuticals.

Morning Session

The morning session commenced with a presentation delving into current dynamics of drug delivery and the potential innovations looming on the horizon. Notably, the significance of comprehending therapeutic modality requirements, aligning with customer expectations, and adapting to external ecosystem mega-trends was underscored. It was concluded that while alternative drug delivery mechanisms may have their place, injection and oral routes would continue to dominate the landscape for newly approved drugs. The requirement for a cultural shift in the industry to enable earlier focus on device and platform development was also highlighted, as externalisation of this aspect of product development, coupled with a lack of harmonisation of device regulations, is adversely impacting the development of innovative products which utilise alternative drug delivery. Overall, the outlook was for products utilising more traditional delivery routes, such as injection and oral administration, to continue to address chronic conditions in the outpatient setting. On the other hand, alternative delivery routes would likely begin to dominate centralised, more invasive in-patient/HCP-driven healthcare markets.

Following this, an enlightening talk addressed human factors considerations in formulation development. Some thought-provoking case studies, where insufficient focus on human factors engineering early in product development led to significant impact to patient health through incorrect use, were presented. Similarly, case studies where adequate consideration to human factors engineering had led to marked improvements in patient convenience were also presented. Optimal approaches to human factors engineering throughout the product lifecycle were also discussed. The key takeaway was the imperative early understanding of use scenarios and environments to mitigate human factors-related risks, with an emphasis on the fact that small changes can enhance usability.

Subsequently, an engaging presentation was delivered focussing on crystallization-driven self-assembly, highlighting the sequential addition of polymers to craft biomaterials, including 2D platelets with adhesive properties. These biomaterials potentially have utility in the development of novel and improved delivery routes for biotherapeutics.

This was complemented by an insightful presentation elucidating advanced drug delivery strategies for the oral administration of peptides and proteins, shedding light on the rationale and challenges associated with the molecular engineering of peptides for oral use. Examples provided included self-orienting micro-injectable devices, which could facilitate the oral administration and improved bioavailability of biotherapeutics and other products more typically requiring injectable administration.

Afternoon Session

The afternoon session commenced with an engaging discussion panel that peered into the future of biopharmaceutical drug delivery.

The panel's focus centred on enhancing existing biopharmaceutical drug delivery methods, emphasising improvements in device technology, formulation enhancements, and human factors considerations. Additionally, it delved into the exploration of novel and radical methods such as oral and nasal delivery. This featured Scendea’s Dr Adam Walker, who lent his expertise to articulate the regulatory challenges, opportunities and considerations associated with innovative biopharmaceutical delivery approaches.

The conference culminated with compelling presentations outlining an alternative biological strategy for the oral delivery of therapeutic peptides and an illuminating talk aimed at unravelling the mechanisms of degradation and stabilization in biologics formulation. The latter placed a significant focus on the impacts of excipients in this process.

Conclusion

The 11th annual MIBio conference was a significant forum for exploring biopharmaceutical stability and cutting-edge drug delivery methods. With informative presentations and an expert panel, the conference facilitated a deeper understanding of these aspects whilst setting the stage for the future of research and development in this field. Notably, the event highlighted the importance of traditional delivery methods while recognising the potential of alternative mechanisms. It also emphasised early considerations of human factors in formulation development and how even minor adjustments can significantly enhance usability. The conference offered a glimpse into the future and addressed potential challenges and opportunities in novel biopharmaceutical delivery.

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