Understanding risk in pharmaceutical supply chains

The ReMediES (Reconfiguring Medicines End-to-end Supply) project - involving 22 industrial partners comprising global pharmaceutical companies, major contract manufacturing organisations, equipment manufacturers, and logistics specialists – examined future pharmaceutical supply chains supported by novel technology. These technology interventions spanned the end-to-end pharmaceutical supply chain: R&D, Primary Manufacturing, Secondary Manufacturing, and Distribution to patients. The ReMediES project delivered outputs that are captured in Badman and Srai (2018) – see academic references at the end of this document. This briefing sets out the key outputs emerging from the strand of activity linked specifically to the management of pharmaceutical supply risk

Digitalisation of Development and Supply Networks: Sequential and Platform-Driven Innovations

We draw from an eight-year dataset of 98 organisational entities involved in pre-competitive innovation networks across the UK pharmaceutical sector. These data map into three networks that are representative of: (i) a product development-led sequential pathway that begins with digitalised product development, followed by digitalisation of supply networks, (ii) a supply network-led sequential pathway that starts with digitalised supply networks, followed by digitalisation of product development, and (iii) a parallel — platform-driven — pathway that enables simultaneous digitalisation of development, production, and supply networks. We draw upon extant literature to assess these network structures along three dimensions — strategic intent, the integrative roles of nodes with high centrality, and innovation performance. We conduct within-case and cross-case analyses to postulate 10 research propositions that compare and contrast modalities for sequential and platform-based digitalisation involving collaborative innovation networks. With sequential development, our propositions are congruent with conventional pathways for mitigating innovation risks through modular moves. On the other hand, we posit that platform-based design rules, rather than modular moves, mitigate the risks for parallel development pathways, and lead to novel development and delivery mechanisms

Exploring Implications of Continuous Manufacturing within the Pharmaceutical Sector through Industrial Landscape Mapping and Cross-Sector Analysis

On-going new technology development in Continuous Manufacturing (CM) has enabled potential for significant step changes within the Pharmaceutical sector e.g. shifting from ‘batch’ to ‘continuous’ processing has implications for (a) product variety, consistency and functionality (b) energy and resource efficiency (c) inventory and customization options and (d) overall industry structure. However, current adoption rates of CM remain in the range of 5%. This research looks to explore and address the operations and supply chain management challenges associated with CM, specifically through learning from other industrial systems. Research question(s): Emerging research questions include (a) what are the architectural differences between current (batch) and future (continuous) manufacturing operations and (b) associated implications for up-stream and down-stream supply chain configurations, structures, processes and systems. Methods: An Industrial landscape mapping methodology was developed (integrating value chain analysis with supply network configuration mapping) that is applicable to a broader industrial systems context. The pharmaceutical sector was mapped to provide the basis for (a) exploring alternative product-process supply network options and value chain implications of a shift to CM and (b) cross-sector analysis involving six previous case studies (i.e. six industrial systems that have exhibited different types of disruptive innovation). Key findings: This research provides a basis for understanding (a) current and future supply network configurations (b) critical interconnections between industry actors and (c) the overall industry structure. Preliminary cross-case analysis suggests several generic aspects to supply networks, including the blurring of industry boundaries, and the critical requirement to manage uncertainty in selective elements of the value chain

Combining field data analysis and simulation to evaluate an alternative Just-In-Time clinical trial supply strategy

This paper combines recurrence analysis of field data from clinical trial supply chain (CTSC) with a proof-of-concept inventory profile simulation to evaluate an alternative packing capability that supports just-in-time (JIT) manufacturing and distribution of investigational medicinal products (IMP). Assumptions for JIT packing supply capabilities and expedite quality release were taken from a detailed design prototype recently commissioned by a leading pharmaceutical consortium. The suggested technological intervention is assessed in its ability to reduce finished good inventory while adequately responding to the dynamics of uncertain patient recruitment and required service levels. The proposed combination of field data analysis and simulation enables practitioners to consider the possibilities for a more economically viable adaptive clinical trial supply based on JIT technologies and near real-time product utilisation information across multiple locations

Continuous manufacturing and product-process archetypes: implications for supply network design in Pharma

Continuous Manufacturing has enabled the potential for significant step changes within the Pharmaceutical industry. However, adoption rates remain in the range of 5%. This research examines the challenges and implications of the shift from ‘batch’ to ‘continuous’ processing in terms of e.g. product variety and supply network design

Emerging product-process archetypes in oncology: informing the sustainable provision of next-generation medicines

The emergence of more targeted molecular therapies has contributed to accelerated growth within the oncology market. Projected to become the leading therapeutic area by 2017, forecast spends are expected to be in the range of $74-84 billion. Coupled with its many specificities around pricing, insurance implications, and ethics, we argue that the oncology segment may best inform future pharmaceutical value network design characteristics - in supporting the sustainable manufacture and supply of next-generation medicines. Through exploration of future state scenarios and opportunities areas, driven by the adoption of emerging process and digital technologies, a base framework is extended to enable a systematic assessment of a series of candidates representative of the wider oncology market. These include niche, low volume drugs on-patent with high QALYs (quality-adjusted life years), through to higher volume generics with a history of supply shortages. A series of emerging product-process ‘archetypes’ in oncology are proposed – classified as ‘New Niche’, ‘Old Niche’ and ‘Established Generics’ – with associated models for reconfiguration, based on the clustering of potential supply benefits. A key application of this systems approach is the potential of informing economies of drug ‘repurposing’, through its extension from commercial to drug discovery, development and clinical trial contexts, and in matching emerging process capabilities to future adaptive supply requirements – for the sustainable provision of next-generation medicines