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The Journey of Biopharmaceutical Innovation

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Royal College Of Physicians

11 Saint Andrews Place

London

NW1 4LE

United Kingdom

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The birth of the modern biological pharmaceuticals industry could be considered to date back to 1976, with the foundation of Genentech. FDA approval of the first biotech product, human insulin produced in genetically modified bacteria, followed in 1982. This challenged, and continues to challenge, so many of the scientific assumptions and principles that had been established to demonstrate quality, safety and efficacy of chemical products. As legislation and clinical practice adapt to these cutting edge treatments, the complexity and impact of biological products have increased in scope, evolving from replacing endogenous proteins to the latest gene-based therapies, several of which gained regulatory approvals in 2017. We have come so far in the industry and we have so much further to travel. ERA has been part of this innovative scientific journey for the past 25 years. In celebration we have assembled a select group of speakers to share their experiences from the Past and Present, and their insights into what the Future may hold:

  • Dr Rolf Bass, apl. Professor for Pharmacology und Toxicology - Charité, Universitätsmedizin Berlin

  • Koichi Nishikawa, Vice President, Overseas Business, Chugai Pharmaceutical Co., Ltd

  • Hideki Fujiwara, Senior Manager, Clinical Operation Department, Chugai Pharmaceutical Co., Ltd

  • Sue Charles, Managing Partner, Life Sciences, Instinctif Partners

  • Dr Peter French, General Manager and Director, AusDiagnostics

  • Baroness Susan Greenfield, CEO, Neuro-Bio Ltd

ERA Consulting is in a unique position having commenced operation as an independent consultancy in 1993, just 11 years after the approval of the first biotech product. Over the last 25 years the ERA Consulting team have been at the forefront of biopharmaceutical development and regulatory strategy and innovation, supporting companies with over 500 products ranging from biosimilars to cell and gene therapies.


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Royal College Of Physicians

11 Saint Andrews Place

London

NW1 4LE

United Kingdom

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