Développement d'une stratégie de distribution d'un produit thérapeutique devant suivre la chaîne du froid et gestion du Time Out of Refrigeration associé.

Abstract

The business conditions of the healthcare industry have considerably shifted in the recent years. Biopharmaceutical companies are subject to rapid growth and changes as well as an increasing complexity in terms of distribution chain configuration. Beyond a strict regulatory scrutiny, the fast-paced launch of generic drug, after patent expiry, put a tremendous pressure and strengthen competition among pharmaceutical companies. Simultaneously, product quality compliance and cold chain integrity must be ensured along the entire supply chain for thermosensitive drugs due to an increased scrutiny for product protection, a stricter regulation in terms of distribution as well as a higher exposure to risks. Mithra Pharmaceuticals decided in 2014 to focus its core business more on the field of R&D. In this way, the company currently switched from a mid-sized conventional pharmaceutical company, distributing branded generic drugs and over-the-counter products, to an international and innovative biotech-pharma company. To support this R&D pillar, Mithra’s state-of-the-art technologic R&D and production platform represents a real asset for the company. Indeed, the company will now be involved in the entire process of its own products from their development until their commercialization. Mithra is currently embracing many challenges concerning the distribution of its first manufactured in-house thermosensitive generic product, the vaginal ring Myring™. In this context, the present project thesis aims at developing a suitable distribution strategy for this thermosensitive product ensuring its quality and integrity. Therefore this project thesis deals with different sub-topics. On the one hand, it deals with the implementation of an effective TOR management strategy in Mithra’s Logistics & Planning department and the enhancement of some internal standard operating procedures such as the management of production outputs in the warehouse taking into account the secondary packaging process and the management of thermosensitive inventories. On the other hand, I intend to improve the procedures of finished products expedition as well as the management of customers’ order. Nowadays, the firm has indeed not yet any experience in coordinating outgoing flows of thermosensitive products. I then worked on the shipment of Myring™ finished products from Mithra CDMO to a 3 PL. The goal was to select the best suited logistic provider for storage and associated transport of that specific product. Based on the 3 PL chosen, a shipping risk assessment was carried out for the different distribution roots under the enterprise’s responsibility and on the vaginal ring.