MICROBIOME: Navigating regulatory and CMC technical development roadmap

Thursday, April 27th 2017, 17:00 CET | 11:00 EDT
Voisin Consulting Life Science - 3, rue des Longs Prés 92100 Boulogne

Presenters: Tim Adetona, Director, Drugs, Nutritionals & Nutraceuticals, and Richard Dennett, Director, CMC & Quality

Date:          April 27, 2017

Duration:    45 Minutes

Time:          17:00 CET / 11:00 EDT / 08:00 PDT

Advances in genomic and big data analysis trends has significantly increased the interest of academia in the symbiotic relationship between the human body and its microbiome. In particular, relationship with immune system, disease etiology and outcome is being better articulated and continues to gain the attention of companies and investors. The regulatory terrain, however, is not yet sufficiently defined neither is the associated CMC technical aspects clearly elaborated. The webinar focusses on some of the CMC & Regulatory challenges for Microbiome development and offer solutions from early phase of product development.

Key learning objectives:

  • Understanding the regulatory terrain for related products in key global markets

  • Key development activities towards first-in-human evaluation

  • Tips on CMC Technical & Regulatory challenges to overcome

Keywords: Microbiome; Gut microbiota; Gut bacteria; GIT; Autologous, Allogenic Faecal Microbiota Transfer (FMT); Probiotics, Prebiotics, Synbiotics; Regulatory positioning; EFSA Health Claims; cGMP; Quality Target Product Profile (QTPP); Critical Quality Attributes (CQAs)

Tim Adetona, Director, Drugs, Nutritionals & Nutraceuticals and Richard Dennett, Director, CMC & Quality at VCLS, will share their experience in the regulation of microbiome related health products as a guide for product developers. The webinar will discuss the Regulatory positioning and CMC Technical challenges as well as the product development and evaluation activities of importance.

About the presenters:

Tim Adetona is the Director, Regulatory Science, Drugs, Nutritionals & Nutraceuticals at VCLS. He is responsible for various life-science products regulatory authorizations including drugs, biologics and innovative nutritional products in Europe, Switzerland, US and emerging markets.

Richard Dennett is the Director, CMC & Quality at VCLS. He is responsible for the management of projects involving the development of Chemistry Manufacturing and Control (CMC); having broad expertise in product/process development (multiple product classes), cGMP manufacture, Quality by Design, Technology Transfer and Validation.

About VCLS:

VCLS supports life science companies and engages in communication with regulators and payers to develop, register and launch innovative health products in global markets.