CMC012- Taking Medicines Back to The Future – A Discussion with Hedley Rees

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SUMMARY:
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Hedley Rees is a Managing Consultant at PharmaFlow Limited, a UK based consultancy specializing in operations and supply chain management within the life science sector. Throughout his career, Hedley realized that there was and continues to be something seriously wrong with how medicine has come to market. As such, he has been a passionate advocate of modernization in the pharma and biotech industries. Hedley is also the author of Taming the Big Pharma Monster By Speaking Truth to Power and Supply Chain Management in the Drug Industry. In this episode, Hedley, Ed, Meranda and Brian discuss value chain, quality by design (QBD) and ongoing issues in the pharmaceutical industry.

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TAKEAWAYS:
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00:59 – Hedley Rees joins the show to share his background in the pharmaceutical industry, his thoughts on Big Pharma and issues he’s observed with medicine coming to market
09:43 – Hedley speaks to the importance of designing supply chains strategically and why your supply chain is actually your value chain
17:51 – Hedley discusses outsourcing in the pharmaceutical industry
24:07 – Hedley provides his thoughts on Quality by Design (QBD), including changes that must be made to the process
39:22 – Hedley shares some of his upcoming projects
42:27 – Ed, Brian and Meranda thank Hedley for joining the show
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ABOUT CMC Live
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FDA CMC regulations and guidance simplified through examination, real life experiences and risk-based advice. This podcast hopes to educate sponsors and individuals on agency related regulatory CMC matters. We will focus on the critical CMC issues and build programs that enhance drug development. CMC topics will include Regulatory Starting Materials, API and Drug Product Process, Formulation Development, Supply Chains, Analytical Controls. Advocating and interpreting CMC Strategy, directing CMC Operations and Quality Assurance oversight in conjunction with developing CMC submission content that represents the best interests of emerging biotech. NOT INTENDED TO BE PRESCRIPTIVE ADVICE BUT RATHER INTERPRETATION THAT IS RIGHT FOR YOU. Since 2007 we have provided our partners with innovative strategies and exceptional advice intended to enhance program development, product approval, and marketing presence.