Oncology Central

ATMP and biosimilars: challenges and how to overcome them

As part of our spotlight on biosimilars, we recently spoke with Gopalan Narayanan from Voisin Consulting Life Sciences (UK) about whether there are sufficient resources available to clinicians looking to adopt biosimilar’s, regulatory challenges during ATMP development and the potential of both of these products to transform the treatment of complex diseases.

Could you tell us about your career to date and your current role at Voisin Consulting Life Sciences (VCLS)?

I am a physician by training, having further qualified as an internist and as pharmaceutical physician. After working for pharmaceutical and biotech companies, I worked more than 11 years at the Biologicals Unit at UK MHRA, including as an Expert medical assessor and Head of the unit. I was also a member of the Committee for Advanced Therapies (EMA/CAT), Scientific Advice working Party (CHMP/SAWP), Gene Therapy Working Party and Biosimilar Working Party (CHMP/BMWP)

I am currently VP of Disruptive Biologics at VCLS, a life science consulting company who has global agencies experience and boutique approach, offering strategic and operational advices on health product development to biotech, pharmaceutical and medtech manufacturers.. My role involves providing advice and guidance on the global development and regulatory strategy for ATMPs and complex disruptive biologics.

Firstly, what is an ATMP?

ATMP stands for Advanced Therapy Medicinal Products, the terminology used to cover cell and gene therapies in the EU. The specific regulation that applies to ATMPs is Regulation (EC) No. 1394/2007.

Could you tell us about the main challenges of ATMP development? (Chemistry Manufacturing and Control and clinical challenges)

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