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Cell & Gene Therapy Program

Target Product Profile: Definition of the key features of your product to build your industrial development roadmap.

From Academic Research to Patients: Advancing methods to ensure a smooth transition from academic work to the first industrial and regulatory data.

Regulatory Landscape: Build the interaction plan and strategy of communication with EMA & FDA.

Nonclinical Development: Choose the right model for your evidence based strategy.

Clinical Plan: The backbone of your entire development plan.

CMC Accelerated Development: Help in achieving a scale up of your production method.

From EU to US: Suit your innovative therapy to the International regulatory Framework.

Access to Market: Identify the target population & price potential.

Dedicated Team

Post thumbnail Decebal Bora, Pharm.D., MPH

Decebal Bora, Pharm.D., MPH

Vice President Regulatory Strategy

Post thumbnail Cécile F. Rousseau, PhD

Cécile F. Rousseau, PhD

Senior Director, Nonclinical

Post thumbnail Peri Aghadiuno, MBBS, MRCOG

Peri Aghadiuno, MBBS, MRCOG

Senior Medical Director

Post thumbnail Private: Véronique Gelebart, M.Sc.

Private: Véronique Gelebart, M.Sc.

Global Head of Clinical Research

Post thumbnail Michael Day, PhD

Michael Day, PhD

Senior Director, Regulatory Science

Post thumbnail Private: Alexandra Beumer Sassi, PhD, RAC

Private: Alexandra Beumer Sassi, PhD, RAC

Senior Director, CMC

Post thumbnail Emmanuelle Sabbah-Petrover, PhD

Emmanuelle Sabbah-Petrover, PhD

Director, Complex Biologics

Lionel Mavoungou, PhD thumbnail

Lionel Mavoungou, PhD

Associate Director, Chemistry, Manufacturing and Controls (CMC) & Advanced Therapy Medicinal Product (ATMP)

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