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Zero To Hero: Helping A Pharma Company Start Up Global Operations To Deliver A Potentially Life-Saving Antiviral

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Executive Summary

A pharmaceutical startup company received U.S. Food and Drug Administration approval for a promising antiviral. But before it could get a signed contract, it needed to guarantee quick delivery of large quantities of the drug. Deloitte helped the company in its efforts to ramp up global manufacturing and distribution from scratch in record time, with minimal investment. They were able to get the drug to market five times faster than usual - in five rather than 25 months - to help save lives of patients with severe symptoms. This bio tech startup company with fewer than 100 employees had a promising new drug that showed signs of being effective. But it had no existing manufacturing or supply chain capabilities. One of the key challenges was to secure global production and supply chain capacity without a clear idea of the total market size or even which markets would place orders. This uncertainty made it hard to know how much to invest and complicated the process of vendor selection and negotiation. The model needed to work for both near-term orders and the full-scale commercial launch. Deloitte helped the company in its efforts to draw up a plan including production schedules and vendor solicitation. The plan considered everything from technical specifications to due diligence on technical capabilities for all dimensions - raw materials, Active Pharmaceutical Ingredient (API), synthesis, formulation, fill and finish and packaging. It also covered a variety of distribution scenarios.

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