ABC1 is a recombinant DNA-derived Factor IX concentrate designed for individuals with hemophilia B, catering to the control and prevention of bleeding episodes on demand, perioperative management of bleeding, and routine prophylaxis. The product is available in lyophilized powder form in single-dose vials, paired with sterile water for reconstitution. Stored in light-protective packaging, it is to be stored at temperatures between 225C (36 to 77F) without freezing. The manufacturer is striving to expand its indications to include routine prophylaxis for reducing bleeding episode frequency across diverse populations, leveraging a new dosage form and potentially encompassing special population subgroups. The production process involves highly stringent purification steps to ensure the product's safety and efficacy. The manufacturer is encountering several product-related challenges. To support a new indication requiring adjusted dosages, the clinical team proposed supplying the product as an investigational product to registered clinical sites six months prior to September 1, necessitating the provision of 48,000 I.V. vials for 3,200 patients' clinical data collection within a 6-month period. Additionally, due to a raw material supply issue, the manufacturer is seeking to replace the raw material with a new Tier-1 supplier, which could impact the product's in-process materials and formulation. There are concerns regarding the potential contamination of this raw material, as a batch supplied by the new supplier to another manufacturer is under investigation for possible public health risks. Simultaneously, the manufacturer is planning to scale up the commercial production of the currently marketed product and establish a validated cGMP plan with an external contract manufacturer outside the US, aiming to commence production within the next six months.

The manufacturing team faces a critical decision as they have the materials to produce 40,000 I.V. vials while needing 48,000 vials to support the investigational drug batches for a new indication. The dilemma lies in whether to prioritize reformulating the investigational drug supply to clinical sites or meeting the existing market demand. Each vial of the ABC product costs $167.50 to produce but is sold at $945 per vial in the US and EU markets, while the foreign markets will see a reduced price of $499 per vial due to currency fluctuations. Production, taking 36 hours per vial, includes additional purification steps before packaging. While the US and EU markets may not fully utilize the available inventory, leading to potentially reduced future orders, the foreign markets show higher demand, suggesting greater potential for orders. This situation necessitates a choice between catering to the immediate market demand or allocating resources toward investigational drug supply, impacting future market orders and profitability.

Strategy for Supply Chain and Business Decision:

Based upon this case scenario create a strategy for the manufacturer taking into consideration both tasks: 1) supply to clinical sites; 2) supply to US and foreign markets. Add to this assessment the impact of raw materials supplies (as described earlier). Then present a logical pathway to a resolution. Take an approach of presenting a business decision pitch with the best suitable option, as the manufacturer's supply chain and risk management (RM) team to the executive management.

• Estimate the time, and raw materials, and calculate how much it will take to create the
• Evaluate if there is any option for introducing any contract manufacturing work that could add up or scale up If so, how should the manufacturer strategize meeting the demand? Note: This would add as a third option (apart from the two options, i.e. strategic pathways)
• Develop the RPN calculation for the raw material supplier change (i.e., B). Assess and create a product severity, occurrence, and detection
• Create an assessment of new raw material suppliers and implementation into quality Include additional review that may be needed due to their recent history of ingredient contamination issues with the potential to cause public health concerns, for another manufacturer.
• Apply general risk management process and develop a cause-and-effect assessment, as applicable for all options (two options and additional if added for contract manufacturing).
• Calculate and present the decision path for both options and how the limited supply of raw materials and estimate of potential 40,000 V., production meets the best strategy for the two options and market demands of 48,000 I.V. How should the deficit of 8,000 I.V. be justified?
• Provide a comparative of both options strategies and the decision path to the best and final