A global approach for a more sustainable and cost-effective supply chain
Faced with the many challenges of the supply chain, one of the major difficulties lies in the compartmentalized organization of most large laboratories. Each one manages the stage for which it is responsible, without necessarily taking into account the constraints of others, or sharing its own upstream or downstream challenges. The frequent use of subcontractors is not conducive to better collaboration either, as the interests of the subcontractors don’t always coincide with those of the lab.
Furthermore, the stakes involved in clinical trials have grown enormously in recent years. In the past, the low cost of production did not require us to include an economic rationale, but this is no longer the case with biomanufacturing, which is much more expensive (see the ‘Issues exacerbated by biomedicines’ box at the end of this section).
The ethical issues raised by drug shortages, as well as environmental, geopolitical and regulatory concerns, are also quite new. We are, therefore, moving from a situation where the sole concern was to secure the trial, and which could easily be resolved by accumulating intermediate stocks, to a complex situation where numerous parameters must be taken into account.
To meet this challenge, it is essential to have a global vision of the supply chain - from the manufacture of active ingredients to the administration of drugs to patients. Such a vision makes it possible to put in place a strategic and global management structure to coordinate the measures taken at each stage, a level of planning that is often lacking today.
Chemistry, manufacturing, and controls (CMC): breaking down the barriers
Since the same product can be used in various clinical trials (for different types of cancer, for example), having a global vision makes it possible to synchronize these studies to consolidate production, with significant economies of scale as a result. Breaking down information silos also makes it possible to manage the production plan in an agile manner throughout the study, according to the study’s exact needs - taking into account, for example, the number of doses taken by patients. This could initially be forecast, then adjusted precisely to the requirements of the patients recruited for the studies, doctors' prescriptions, or even expiration dates.
Packaging: standardize & consolidate
Rather than creating and producing bespoke packaging for each study (as is commonly done), we will seek to standardize the kits, boxes and labels - allowing us to share them between different studies while ensuring that the kits for each study remain clearly identifiable to avoid any confusion in hospital pharmacies. This makes it possible to reduce costs, timeframes and environmental impacts. Green approaches also make it possible to design eco-responsible packaging, which is more economical in materials and more easily reusable and/or recyclable.
To minimize the environmental footprint of leaflets (instructions with one page per language), we can replace traditional paper with an e-labeling system, using a QR code affixed to the treatment box. This solution can also reduce packaging operation times, as it is no longer necessary to order specific instructions for each study.
Protocol and forecast calculation of clinical needs: anticipate and plan
When developing the study, medical and scientific aspects naturally take precedence, but anticipating the operational and logistical constraints of this stage will considerably facilitate its planning and implementation. This requires us to involve all stakeholders, each offering their specific expertise to help us implement the most suitable approach. For example, adjusting the arrangements for making treatments available in hospitals, as defined in the protocol, will make it possible to cover patients' needs without wasting too many resources or generating too many shipments by plane and/or lorry.
Distribution: prepare and execute
Subsequently, we will monitor the recruitment of patients in order to estimate their final number as early as possible, and thus estimate the required resources. In particular, we will be able to optimize the distribution of stocks in different countries for sustainability and responsiveness. Beyond medications, logistical preparation and execution must also concern all the equipment and medical devices used in the study. Here again, we can integrate sustainable approaches for reuse and recycling (eg. insulated containers).
Optimizing the drug supply chain for clinical trials, therefore, requires us to approach each stage with precise knowledge of its challenges, using fluid, transparent communication to fully understand these challenges. This overall vision makes it possible to rationalize the choice and management of subcontractors, and to contractualize their objectives in line with the interests of the lab. Above all, it makes it possible to drastically cut waste – we commonly see reductions of 30% to 40%. Helping to remove obstacles and bottlenecks is also a powerful lever for acceleration; for certain clients, we have managed to halve the time taken to start studies, a decisive gain in such a competitive environment.
Issues exacerbated by biomedicines
Biomedicines and live biological products are derived from biological sources (cells, bacteria, etc.). In addition to synthetic drugs, these medicines make it possible to diversify treatments and meet previously unmet medical needs, eg. vaccines and immunotherapy, or gene, cellular and tissue therapies. For labs, biomedicines represent a colossal challenge, equal to their immense therapeutic promise. On the other hand, bioproduction operations exacerbate challenges throughout the clinical trial supply chain: the products are expensive to manufacture, delicate to transport and difficult to store (often requiring very low temperatures). It is, therefore, very important to optimize the entire supply chain - in order to minimize waste, achieve economies of scale and, ultimately, promote the development and economic viability of these new therapies.
