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Voisin Consulting, Inc. Names Mark A. De Rosch, PhD, to Lead U.S. Operations



10/9/2013 9:48:36 AM

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Cambridge, Mass., USA, and Paris, France - October 9, 2013 - Voisin Consulting Life Sciences, a leading drug development consultancy, announced the appointment of Mark A. De Rosch, PhD, as vice president of Regulatory Drugs/Biologics and head of US Operations. Dr. De Rosch is responsible for providing strategic counsel to pharmaceutical and biotech companies with product and drug pipeline development globally. He also is leading Voisin's US-based regulatory team.

Mark A. De Rosch, PhD

"Mark is a great fit, as he has sound product expertise, broad regulatory experience, and a successful track record in designing and executing global regulatory strategies," said Emmanuelle M. Voisin, PhD, Voisin Consulting Life Sciences founder and CEO.

"Mark's track record and expertise strengthens our capabilities to provide clients with a global regulatory perspective, from strategic to tactical operations in moving drugs and biologics from research to development and through commercialization. Mark's success in working with FDA from the pre-IND stage through product approval and his experience in building strong regulatory teams is a tremendous asset for our clients who wish to develop their products synergistically in the US and Europe. I am excited about the contributions that he will make in his senior management role," Dr. Voisin said.

Dr. De Rosch's expertise lies in development of regulatory strategies for drugs and biologics, especially including orphan and pediatric diseases, which are two of Voisin Consulting Life Sciences' core strengths. Dr. De Rosch brings more than 20 years experience at leading pharmaceutical and biotech companies, such as Vertex Pharmaceuticals, where he was deeply involved in the regulatory approval of Kalydeco® and was involved in regulatory activities for development of Incivek®. He has proven expertise from pre-IND through NDA and post-marketing in the US and EU, as well as other markets including Canada and Australia. Dr. De Rosch has deep experience in several therapeutic areas, including hematology, respiratory, auto-immune/rheumatology, oncology, pain, renal, and medical imaging/radiopharmaceuticals.

"I am delighted to join Voisin Consulting Life Sciences, with whom I have worked with for many years as a client. I am pleased to become part of an enthusiastic group, at the cutting-edge of science, regulation and marketing. I look forward to contributing to the growth opportunity for the organization in assisting pharmaceutical and biotech clients in navigating FDA regulations. From our US office located in Kendall Square in Cambridge, Mass., our FDA expertise will add appreciable value to both US- and non-US-based clients," said Dr. De Rosch.

About Voisin Consulting Life Sciences

Voisin Consulting Life Sciences is a product development consultancy, which provides biotech, pharma and medtech companies with combined strategic and operational capabilities for interacting with regulators and payers. With a presence in the US, France, Switzerland, the UK, Singapore and India, the firm specializes in drugs, biologics, cell, gene and tissue-engineering therapies, medical devices/IVD/theranostics, combination products, borderline products and bioactives/food supplement. Voisin Consulting Life Sciences also has an active regulatory publishing group and supports electronic submissions through both the FDA and EMA gateways. The firm also has extensive experience in assisting companies with scientific advice meetings with regulatory agencies such as FDA, EMA, and EU National Agencies. For more information, visit www.voisinconsulting.com.

Media Contacts:

David Connolly

dconnolly@lavoiegroup.com

617-374-8800, ext. 104

Or Samantha Stenbeck

sstenbeck@lavoiegroup.com

617-374-8800, ext. 102

US Corporate Contact:

Mark De Rosch, PhD

vccambridge@voisinconsulting.com

+1 617 492 1537

Cambridge, Mass.

European Corporate Contact:

Emmanuelle M. Voisin, PhD

+33 (0)1 41 31 83 00

vcparis@voisinconsulting.com

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