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Vice President, Disruptive Biologics

Gopalan Narayanan, M.D.

Dr Narayanan provides leadership within the area of complex and disruptive biologics such as Cell and Gene therapies, called Advanced Therapies Medicinal Products (ATMPs) in Europe, including guidance on product development and regulatory strategy. In addition, he participates in the global effort of rationalising the development process, by enabling innovative regulatory mechanisms through which Advanced Therapies and other disruptive biologics can be developed and brought to patients faster and more efficiently.

He has over 20 years of experience as a Pharmaceutical Physician. He has substantial experience, understanding and expertise in the development of innovative products, primarily through his previous role as an expert regulator. He was at the UK MHRA for nearly 12 years as an expert medical assessor, and 4 years as Manager of the Biologicals Unit.

Dr Narayanan was also a member of the Committee for Advanced Therapies (EMA/CAT 2009 – 2013), Scientific Advice Working Party (CHMP/SAWP 2009 – 2013) representing EMA/CAT, Biosimilar Working Party (EMA/BMWP) and Gene Therapy Working Party (CAT/GTWP).

He was a leading rapporteur and coordinator in the EU for centralized marketing authorisation applications and scientific advice respectively for advanced therapies and other biologics. He was the Rapporteur for Glybera, the first Gene Therapy to be approved in ICH region.  He also has extensive experience in the assessment of MAAs and provision of advice at UK MHRA. He has in in-depth understanding of the functioning of the UK and European regulatory agencies.

During his time as manager of Biotech Unit at MHRA, Narayanan managed 20+ staff, of highly trained and experienced professionals. This unit is one of the busiest units in Europe for provision of scientific advice and assessment of marketing authorisation applications. He has been rapporteur for several guidelines and has several publications in the area of biological medicinal products, particularly gene and cell therapies. He also presented regularly at international conferences such as DIA, BIO, and Phacilitate etc.

Narayanan qualified as a physician, and has dual specialist postgraduate qualification in general internal medicine and pharmaceutical medicine. He is currently on the Scientific Editorial Board of Human Gene Therapy Clinical Development journal and Review Editor of Regulatory Science section of Frontiers in Medicine, and is based in the UK.

Resources by Gopalan Narayanan, M.D.

Gopalan Narayanan
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