Mitigating Raw Materials Risk for Supply Chain Continuity by Tom Dinka.pdfVIP

Mitigating Raw Material Risk for Supply Chain Continuity Tom Dinka Doe Ingalls of North Carolina, LLC April 23, 2009 What’s driving the focus on risk mitigation? • Globalization of the supply chain • Adverse events: e.g. heparin • Biopharmaceutical industry is maturing – Lean manufacturing practices – Process optimization – Scalability considered earlier – Companies want to save $$ • Competing demands for raw material resources • FDA has increased interest in risk mitigation Slide from Deborah M. Autor, Director CDER Office of Compliance, DCAT Mar09 Slide from Richard Friedmand, Director CDER Division Manufacturing Product Quality, DCAT Mar09 To mitigate effectively, we need to understand total supply chain risk Crude oil (or other basic Industrial chemical factory source) cGMP repackager cGMP distributor Biotech manufacturing Systematic vs. Specific Risk Systematic Risks: affect the majority of your raw materials. Based on market conditions. Specific Risks: affect a segment of raw materials Key systematic risks today: Chemical market • Biotech industry is a small percentage of overall chemical market demand • Specialty producers still upgrading facilities to meet quality standards • Chemical industry consolidating • Chemical industry is a mature industry • Transparency to original source is major challenge • Many materials still do not have compendia • China is a net importer of many chemicals (isopropyl, benzene, acetone, methanol) Key systematic risks today: regulatory • Limited oversight from foreign drug regulators