Dinesh Mistry

Executive Strategist/Global Regulatory Affairs

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• More than 19 years of experience in implementing European and US regulatory strategies
• Extensive experience in neuroscience/pain therapy areas, biologicals (monoclonal antibodies), biosimilars, oncology, inflammation, immunology and respiratory therapeutic areas.
• Extensive experience interacting with EMA, MHRA and FDA at all stages of development.
• Led successful orphan designation applications in EU/US and scientific advice meetings for various rare diseases at EMA, MHRA and FDA over the last few years.
• Regulatory experience in both development and marketed products.
• Global regulatory lead for early (up to proof of concept) pain portfolio at Pfizer.