Carlo Incerti, speaking at World Orphan Drug Congress 2011

Carlo Incerti,
SVP Global Medical Affairs
Genzyme

Dr. Incerti serves as Officer of Genzyme Corporation, where he oversees Global Medical Affairs , which includes Medical Operations, Global Regulatory Affairs and Compliance, Corporate Quality Systems, Global Patient Safety and Risk Management, Evidence Value Development/Health Economics and Outcomes Research and Global Policy.
The mission of the Global Medical Affairs Group is to facilitate and enable patient access for Genzyme’s products through an integrated global strategy. GMA functional area operates as a continuum to enhance the value proposition of Genzyme’s products, thus ensuring a successful “product journey” from the development stage through the administration of therapy.

Dr Incerti is a Board Certified Endocrinologist, who started his career in the medical profession as a staff member and then as Associate Professor at the Department of Endocrinology of Modena University Hospital in Italy. He joined Genzyme in 1992 as Medical Director Europe and then was promoted to Senior Vice President Biomedical and Regulatory Affairs Europe. In this tenure he successfully led the European Clinical and Regulatory Affairs group in gaining a Marketing Authorisation Approval in Europe for all of the Genzyme products developed so far. In 2003 he assumed the responsibility for the whole EU R&D group as Head Research & Development Europe, which then included also Latin America. Dr Incerti has also served as Chairman of the Board of Directors of Genzyme Srl in Italy and of Genzyme Europe BV in The Netherlands.

He is currently member of the Board of EBE (European Biotechnology Enterprises), member of the Board of EFPIA (European Federation of Pharmaceutical Industries and Associations) and Vice Chairman of the Governing Board of IMI (Innovative Medicine Initiative), a Joint Undertaking between the EU Commission and EFPIA, which oversees the management of EU research funds for a total of 7 Billion Euro.

Appearing:

World Orphan Drug Congress Day 1 Tuesday 29th November 2011

2.15pm

Strategies for ensuring reimbursement and improving patient access

How do you compile compelling data for approval when patient populations are small?
How to identify and overcome hurdles to achieve rapid market access per member state?
Obtaining substantial clinical data to ensure a successful market introduction
How can post-marketing approval studies confirm efficacy and guarantee reimbursement?
Will orphan drug development shift to require evidence based data to ensure efficacy?

Carlo Incerti,

SVP Global Medical Affairs,
Genzyme

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