Kathleen Basmadjian | Senior Director, Global Regulatory Policy & Intelligence, Global Regulatory Affairs
Janssen

Kathleen Basmadjian, Senior Director, Global Regulatory Policy & Intelligence, Global Regulatory Affairs, Janssen

Kathleen Basmadjian, PhD
Janssen Research & Development, LLC. 
Kathleen concentrates on coalescing cross-sector and global regulatory policy as a Senior Director in the Janssen R&D Global Regulatory Policy and Intelligence team within the pharmaceutical sector of Johnson & Johnson.  Recent areas of concentration include Combination Products, Digital Health, and Microbiome.
Dr. Basmadjian has worked in Regulatory Affairs in both the public (US FDA and NIH) and the private (pharmaceutical MNCs) sectors for 30 years. Prior to a formal move into the policy role, Kathy headed several global and regional therapeutic areas within regulatory affairs in her 15 years with J&J, most recently in the previous Centocor Biotech unit.  A large percentage of her regulatory career was spent in the small molecule drug arena, at Novartis, the National Institute on Drug Abuse and the US FDA.
Kathleen conducted her doctoral research on malaria at the National Institute of Allergy and Infectious Diseases, receiving her degree from Catholic University of America, while working at the FDA.

Appearances:



Microbiome World Congress USA Day 2 2017 @ 09:20

Plenary Panel: Regulations in response to the Microbiome

Plenary
  • How do you work with regulators in development of Microbiome treatments?
  • How do you prevent Wild West scenarios where many companies are promoting their product and operating without oversight?
  • From FMT, Prebiotics to Probiotics, from food supplements to traditional treatments- what protocols must be established for such a wide variety of products?
  • What standards are necessary and what does solid translational evidence look like in judging the efficacy of microbial treatments?

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