PARIS--(BUSINESS WIRE)--Voisin Consulting Life Sciences (VCLS) announces the appointment of Dr. Gopalan Narayanan as Vice-President, Disruptive Biologics. Dr. Narayanan brings over 18 years of experience as a pharmaceutical physician, and has internationally recognized expertise in the development of innovative biotherapies, primarily through his previous role as a regulator. He was at the UK Medicines and Healthcare products Regulatory Agency (MHRA) for nearly 12 years as an expert medical assessor, and 4 years heading the Biologicals Unit.
“The appointment of Dr. Narayanan further enhances VCLS’s ability to support biotechnology companies throughout ATMP research and development, and lead scientific interactions with regulators and payers. Narayanan’s considerable experience strengthens our capabilities to provide clients with a global perspective, at the forefront of scientific innovation,” commented Dr. Emmanuelle M. Voisin, Founder and CEO, VCLS.
As a member of the Committee for Advanced Therapies of the European Medicines Agency (EMA/CAT) and representing EMA/CAT in the Scientific Advice Working Party (CHMP/SAWP), Dr. Narayanan has extensive experience in the regulatory aspects of ATMPs and other complex biologics. He was a leading Rapporteur for marketing authorization applications (MAAs), as well as a leading coordinator for Scientific Advice procedures. With a focus on advanced therapies and other biologics, he also has extensive experience in the provision of advice from UK MHRA, as well as an in-depth understanding of the functioning of the UK and European regulatory agencies.
“ATMPs present unique scientific and regulatory challenges requiring tailored solutions to fulfill their promise. I am delighted to be part of an organization which is leading this very exciting future direction of medicine,” said Dr. Gopalan Narayanan.
The Future of ATMPs
ATMPs are medicinal products based on genes (gene therapy), cells (cell therapy) and tissues (tissue-engineered therapy). These advanced therapies herald revolutionary treatments for a number of pathologies, with a particular focus on rare diseases, neurodegenerative disorders such as Alzheimer's, or oncology indications. They have huge potential for patients, with a promise of more personalized treatments and regenerative medicine.1
For twenty years, VCLS has been providing expert guidance to help ATMP developers find a regulatory path for their scientific breakthrough innovations. Over 40,000 clinical studies have been conducted with ATMPs2,3, however only eight ATMPs have been approved in the EU since 2009 when the Committee for Advanced Therapies was established.4 This gives an understanding of the challenging scientific and regulatory complexity of these advanced therapies, the potential of which has yet to be realized.
As part of VCLS’s commitment to help more ATMPs reach patients, the firm frequently presents its opinions, methodological approaches to ATMP development, or view on environment changes. The next webinar on ATMP development is on the 16th March 2017.
VCLS is also participating in a series of international conferences, such as the European Section of the Alliance for Regenerative Medicine (ARM) on 23rd March 2017 in Barcelona.
About Voisin Consulting Life Sciences
Voisin Consulting Life Sciences is a global product development consultancy, which guides Biotechnology, Pharmaceutical and Medtech manufacturers throughout product development and commercialization. From discovery to patients, VCLS assists innovators to design product development strategies that optimize clinical development in order to drive commercial success, through an understanding of both regulators and payers.
VCLS’s team of health product specialists seamlessly supplement innovative life sciences companies’ resources with strategic advice and cross-functional operational capabilities. The firm offers integrated solutions to development planning, manufacturing, quality and controls, nonclinical and clinical testing, safety monitoring, and interactions with regulators and payers. With offices in Cambridge, Somerville and San Francisco (MA, CA & NJ, USA), London (UK), Paris and Rennes (France), Lausanne (Switzerland) and Bangalore (India), VCLS serves a broad range of developers and investors.
For more information, visit www.voisinconsulting.com.
References
1. https://ec.europa.eu/health/human-use/advanced-therapies_en
2. https://clinicaltrials.gov/ct2/results/map?term=cell+therapy
3. https://clinicaltrials.gov/ct2/results?term=gene+therapy&Search=Search
4. http://www.ema.europa.eu/docs/en_GB/document_library/Minutes/2017/02/WC500220811.pdf
