The manufacturer of ABC1, a recombinant DNA-derived coagulation Factor IX concentrate for hemophilia B, is focused on expanding the product's indications to include routine prophylaxis for diverse populations and special subgroups. The product, provided as a lyophilized powder in single-dose vials, necessitates a unique production process involving highly stringent purification steps. This effort is geared toward enhancing the product's utility in preventing and reducing bleeding episodes in various patient populations beyond its current specified uses for on-demand control, perioperative management, and routine prophylaxis in individuals with hemophilia B, excluding immune tolerance induction.

The manufacturer of ABC1, amidst preparing for a new dosage regimen for an expanded indication, faces multiple critical challenges. First, to support clinical data for 3200 patients over six months, they aim to supply 48,000 investigational vials to registered clinical sites before the given timeline. Secondly, a raw material supply issue prompts the quest for a new Tier-1 supplier, potentially affecting the product's formulation and manufacturing process. This challenge is amplified by the discovery that a batch supplied by the potential new raw material provider to another manufacturer is under investigation for potential contamination, raising public health concerns. Concurrently, the manufacturer plans to upscale the commercial production of the existing product, partnering with a contract manufacturer outside the US, with a validated cGMP plan intending to commence production in the next six months.

The manufacturing team of ABC1 is confronted with a critical decision: whether to allocate raw materials to reformulate and supply investigational drug batches to clinical sites or prioritize meeting the market's supply and demand. With materials sufficient for only 40,000 vials, the cost of $167.50 per vial in production, and a selling price of $945 in the US and EU (reduced to $499 for foreign markets), they face a dilemma. While demand in the US and EU might not exhaust current inventory, potentially resulting in reduced future orders, foreign markets show higher demand and growth potential. The intricacy lies in balancing the need for investigational drug supply for new indications against the market's demand dynamics, profitability, and future sales orders, considering the contrasting market demands and pricing variations.

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.

• 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 as 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