Cell & Gene Therapy Program

Director, Complex Biologics

As Director at Voisin Consulting Life Sciences, Emmanuelle manages projects involving cellular and gene-based medicinal products; from early stages of development to late clinical development phases and up to the preparation of MAA/BLA, both in Europe & the US. She provides strategical and regulatory input. Emmanuelle has particular expertise in GMO requirements for ATMPs in Europe.

Emmanuelle has been working for 12 years in the biotech industry; first as an R&D project manager, then as head of regulatory affairs. Her Ph.D. in science added to R&D experience allows her understanding of the constraints & the challenges that developers faced daily.

She has significant experience in agency meetings and has performed 20+ scientific advice (national, supranational), as well as classification requests and PRIME applications. Emmanuelle also led orphan drug designation requests (ODD); both in the EU and US, pediatric investigation plan (PIP), and FDA (type B & C) meetings.

Before joining VCLS, she headed for 6 years the regulatory affairs department of a French biotech company. Her major achievement was granting authorization for the First-In-Human clinical trial of lentiviral vectors for therapeutic immunization (worldwide premiere). She was responsible for clinical trial applications and in charge (author/review) of core documents (Protocol, IB, IMPD, patients’ documents), and GMO specific documents. Emmanuelle started her career as a project manager in oncology for 5 years at MabLife (formerly MAT Biopharma) and worked for 2 years at St Bartholomew’s Hospital, London (UK) where she led the development of a radiolabelled monoclonal antibody intended for diagnosis and treatment of pancreatic cancer.

Emmanuelle is an active member of the ATMP group at the France Biotech Association and Alliance for Regenerative Medicines (ARM).

She holds a Ph.D. in Structural and Molecular Pharmacology from the University Paris 5.

Emmanuelle is based in our Boulogne office in France.

Vice President Regulatory Strategy

Decebal Bora is a highly experienced regulatory science professional with more than 20 years in the field of health product development. As VP Regulatory Strategy at Voisin Consulting Life Sciences (VCLS), Decebal is leading all regulatory activities of the firm (regulatory science, CMC & quality, regulatory non-clinical, regulatory clinical and, publishing) on strategic and operational standpoints.

Before joining VCLS, Decebal worked for several international biopharmaceutical companies including, Biogen Inc., F.Hoffmann-La Roche Ltd, Baxter World Trade and, innovative SMEs in the field of ATMPs (eg. ActoGeniX N.V, Promethera Biosciences), NCEs (PTC Therapeutics) and biotech (Morphosys AG).

During his tenures, he has been involved in pre-registration, launch and life cycle management activities in the field of drug development with on-going interactions with the FDA, EMA, and national agencies for both GMO and gene therapies. He is instrumental in strategizing and implementing the development of innovative and complex health products.

Dr. Bora holds a Pharm.D. degree from the Catholic University of Louvain (Belgium) and a master’s degree in public health from the Jean Monnet Faculty in Sceaux (France). Decebal is active in various trade associations where he is representing VCLS.

Decebal is based in our Paris (France) office.

Director, Nonclinical

With 10+ years in nonclinical and translational research and histotechnology, Dr. Cécile F. Rousseau has considerable expertise in medical devices, engineered cellular therapies, and companion diagnostics.

Upon completing a Ph.D. program in Medical and Biological Engineering at the University Claude Bernard – Lyon 1 in 2002, Cécile proceeded with postdoctoral research in tissue engineering (including but not limited to cartilage, soft organs), toxicology and pharmacology at the Laboratory of Cartilage Biology and Engineering and at the Laboratory of Molecular Assembly of Biological Interest, both located at the Institute for the Biology and Chemistry of Proteins.

In 2006, Cécile joined the pharmaceutical industry where she gained experience from both sides CRO/Client relationship. First, as Senior scientist manager of the Preclinical and Characterization group for Organogenesis Switzerland GmbH in Zug, Switzerland / Lyon, France, then for Organogenesis Inc., in Canton, MA – USA, and later as Principal Scientist for Leica Biosystems – Companion Diagnostics R&D in Danvers, MA – USA.

At Organogenesis, Cécile developed and implemented with her group new analytical tools to characterize specimens generated from in vitro and in vivo nonclinical and translational research studies using molecular biology and histo-technologies. Cécile’s responsibilities included but were not limited to management, design, and execution of nonclinical studies related to process validation, engineering runs, material analysis and to assess medical devices for oral and burn application, early-stages engineered cellular therapies for soft tissue regeneration; management of non-GLP and GLP studies with external CROs to conduct safety and efficacy studies in rodent and swine models.

She supported Clinical/Medical Affairs groups through nonclinical studies that support pre-market approval for new products, existing indications for approved products (e.g. mode-of-action studies), and new indications for approved products (e.g. proof-of-concept studies). Cécile partnered with the Oral Regeneration business unit by providing scientific information and imaging support to complete product monograph (Gintuit™).

In 2014, Cécile became responsible for the development and implementation of IHC and ISH in vitro diagnostic (IVD) strategies to enable and support the development and implementation of companion diagnostics for manual and automated staining platforms at Leica Biosystems – Companion Diagnostics R&D in collaboration with pharmaceutical company partners. As Principal Scientist, Cécile prepared design control plans and development protocols and ran design review. She devised and managed milestone-driven plans for product development, optimization, and verification of new class II/III diagnostic medical devices. She authored and reviewed R&D relevant portions of clinical study protocols. Cécile also performed histopathology analysis on various cancer indications, developed scoring guidelines for new IHC and ISH assays in collaboration with pathologists, and provided analytical scoring training on new IHC and ISH assays to pathologists during site initiation visits to support clinical studies.

At VCLS, the main projects in which Cécile is involved concern the nonclinical and clinical areas, including but not limited to medical devices, cellular therapy, gene therapy, and in vitro diagnostics.

Senior Director Regulatory Science

As Senior Director Regulatory Science at VCLS, Michael (Mike) is responsible for providing both regulatory strategy and CMC consulting services to clients for global product development ranging from small molecule drugs to biologics and advanced therapies.

Mike has over 20 years of experience in the pharmaceutical/biopharmaceutical industry and consulting services, having worked on the review, preparation, and maintenance of numerous regulatory documents and submissions, including INDs, ANDAs, BLAs, and NDAs.

Prior to joining VCLS, Mike was the Managing Director of CMC/Global Regulatory Affairs at Cardinal Health Regulatory Sciences. Whilst there, he was responsible for providing comprehensive regulatory and CMC global strategy to clients at various stages of their product development. This covered advising on drug formulation, as well as device and combination product development. He was also responsible for providing leadership and the development of regulatory/scientific staff.

Over this time, Mike has led and attended a large number of meetings and interactions with the FDA, including information requests, pre-IND, end-of-phase 2, pre-NDA, and Type C/Scientific advice. This has involved close collaboration with a number of FDA divisions including the Division of Oncology Products, the Division of Neurology Products, the Office of Tissues and Advanced Therapeutics, the Office of Generic Drugs, and the Office of Combination Products.

He has a thorough comprehension of modern techniques of analytical chemistry including the development and validation of methods, installation, operation, and performance qualifications of instrumentation. Additionally, Mike has significant experience in performing cGMP compliance audits.

Mike received his PhD in Pharmaceutical Sciences and Chemistry from the University of Missouri-Kansas City. He also currently serves as adjunct faculty for the University of Missouri-Kansas City, School of Pharmacy and is the Vice-President of the Pharmaceutical Technical Exchange Association.

Mike is based in VCLS offices in Cambridge, MA, USA.

Senior Director, CMC

As a Director, Chemistry, Manufacturing, and Controls (CMC) at VCLS, Alexandra (Alex) is responsible for providing CMC and regulatory consulting services to clients to help them take their products from early clinical phases to marketing authorization, particularly for biological, cell and gene therapy products. 

Alex has over 17 years of experience in the pharmaceutical/biopharmaceutical industry and consulting services. She brings significant expertise in analytical method development, quality control, formulation development, product manufacturing scale-up, stability, and CMC matrix team leadership. Alex has worked with a variety of dosage forms and molecules, with particular emphasis on large protein parenteral products. 

Prior to joining VCLS, Alex was a Regulatory Affairs CMC Consultant at Cardinal Health Regulatory Sciences. She was responsible for providing regulatory strategy and assisting clients on regulatory submissions. She was responsible for a range of products including biopharmaceuticals, gene therapy, cell therapy, combination products, and medical devices. 

Prior to joining Cardinal Health, Alex was a CMC Regulatory Executive at GlaxoSmithKline, where she developed CMC strategy and coordinated regulatory submissions for Marketing Authorization in the US, EU, Japan, and emerging markets. Previously to her regulatory role, Alex authored several CMC sections for Clinical Trial Applications for biopharmaceutical compounds.  Prior to GSK, she held several positions at a generic pharmaceutical company in Brazil. 

Alex received her PhD in Pharmaceutical Sciences from the University of Pittsburgh, School of Pharmacy. Her dissertation work was with pre-clinical and formulation development of biopharmaceutical microbicides. She received her Pharmacy degree from the University of Sao Paulo, Brazil.  She completed her post-doctoral studies at Magee-Women’s Research Institute. Alex is also US RAC certified and is a member of the Regulatory Affairs Professional Society (RAPS), the Association of Women in Bio, and the Alliance for Regenerative Medicine. 

Alex is based in VCLS offices in Cambridge, MA.