Biotech Program

Senior Director, Nonclinical & Early Clinical Development

As Director, Nonclinical, and Early Clinical Development, Carlo is responsible for leading projects for which strategic considerations are particularly challenging. Since joining VCLS, he has worked on approximately 700 major life-science projects, including gap analyses, project development plans, investigator brochures, CTD Modules (2.4, 2.6), and packages for scientific advice and investigational new drug meetings with the EMA and FDA, respectively.

He brings to the role more than 25 years of experience in the drug development process, having worked with new chemical entities, well-established products, combination products, biologics, biosimilars and gene therapy medicinal products across a range of therapeutic areas, including oncology, autoimmune disorders, CNS disorders, ophthalmology, respiratory disease, inflammation, muscular dystrophies, dermatology, vaccines, pain, stroke, and (cardio)vascular disorders.

Prior to joining VCLS, Carlo headed-up Clinical Development at Med Discovery, a Swiss biopharmaceutical company dedicated to the discovery and development of highly specific treatments for urogenital cancers. Whilst there, Carlo had specific responsibility for evaluating and selecting clinical CROs and vendors, writing development plans, and major clinical documents as well as organizing scientific and clinical advisory boards with key opinion leaders in oncology.

Carlo started his career in Geneva working for the American CRO Battelle as a research scientist. He subsequently moved to OM Pharma, a Swiss pharmaceutical company now part of the Vifor Pharma, where he was initially employed as a pharmacologist, before being promoted to Head of nonclinical development and phase I and II studies. During this time, Carlo gained significant experience in immunotherapy, vaccine development, immunology, autoimmune diseases (such as rheumatoid arthritis, lupus, and multiple sclerosis) and oncology.

Carlo is based in the VCLS Swiss offices in Lausanne, Switzerland.

Senior Director, Regulatory Science, Drugs & Biologics

As Senior Director, Regulatory Science, Mark is responsible for assisting clients to define the regulatory strategies for the global development and registration of drugs, biologics & cell and gene therapy products, especially those for life-threatening diseases. 

Mark has a proven history of building and maintaining good relationships with FDA personnel to facilitate the development and commercialization of new products (Orphan Products, PDUFA meetings, CBER, and CDER Review Divisions including OTAT).  He has managed post-approval submissions of all types, including advertising and promotional materials, drug product listings, CMC, and labeling supplements. 

He has also worked on several types of EMA mechanisms and submission types, including ODD, MAA, Scientific Advice, Pediatric. 

Mark has been engaged in regulatory affairs for more than 20 years and has experience with the preparation and submission of applications such as CTA, IMPD, INDs, NDAs,  BLAs, MAAs, ODDs, and post-approval submissions of all types.  Mark’s professional industry experience encompasses the oncology area, hemostasis, AIDS, neuropharmacological disorders, colony-stimulating factor, and ophthalmology therapeutic areas.  He has worked predominantly with recombinant proteins, small molecules, and cellular therapy products in all phases of development (pre IND – Phase 3). 

Mark served as the regulatory team leader and was responsible for coordination, preparation, review, publication, submission, and approval of several new NDAs and BLAs, as well as numerous INDs.  

Mark has a Bachelor of Science degree in Biology with a minor in Chemistry from Northeastern Illinois University in Chicago, IL. 

Mark is based in the Seattle, Washington area and regularly commutes to VCLS offices in Cambridge, MA. 

Director, CMC & Quality

Valerie Arnaudinaud-Lignier is responsible for the management of projects involving the development of Chemistry Manufacturing and Controls (CMC). She provides scientific, technical, and regulatory expertise and is involved in reviewing and preparing regulatory pharmaceutical documents: CMC sections of IMPD/IND, Briefing Packages for Scientific Advice, CMC Variations, CTD module 3, and Quality Overall Summary of MAA/NDA.

With a strong industrial experience in Quality Control, Analytical Development, and Quality Assurance (GMP), Valérie contributes actively in the elaboration of product development plans and participates in the preparation of supportive documents such as stability and method validation reports, process optimisation/development reports. In addition, Valérie is able to manage subcontractors (C(D)MOs) and technology transfer. Thanks to her significant experience in the Pharmaceutical Industry, she can provide assistance and expertise for Quality Assurance aspects of projects such as verification of manufacturing licenses and GMP certificates, review of quality contracts and batch records, and audits of manufacturers. In addition, Valérie acts as a Qualified Person (Responsible Person) in Switzerland for the release of the drug products into the market. As such, she contributes to establishing, maintaining, and supervising the quality management system and maintains good knowledge of Swissmedic procedures and Swiss regulations including Good Manufacturing and Good Distribution Practices (GMP/GDP).

Valerie brings 12 years of experience in the Pharmaceutical Industry including 8 years at Théramex (a subsidiary of Merck KGaA then TEVA group), Monaco, and 4 years at Grimberg, a global French-based Company. She was in charge of the Quality Control (IMPs and marketed products) and Analytical Development of products in therapeutic areas such as gynecology, gastroenterology, otorhinolaryngology, and supplementation in mineral and vitamins. In addition, Valérie was responsible for maintaining and improving the Quality Management System in strong interaction with the Quality Assurance department as well as reviewing Quality and Service Agreements. In her function, she also prepared and attended Health Authority Inspections. In this role, Valérie gained experience in the chemistry of small molecules, analytical method development and validation, specification set-up as well as stability testing. She was involved in the pharmaceutical development, life-cycle management, and dossier authoring of many dosage forms such as solid (tablet, capsule), semi-solid (cream, gel), liquid (suspension, solution) and flexible (transdermal patch) forms.

Valerie earned an MSc in Physics and Chemistry and a Ph.D. in Pharmaceutical Sciences from the University of Bordeaux (France) in the field of polyphenol chemistry.

Valérie is based in Lausanne office.

Senior Director, Regulatory Science

As a Director, Regulatory Science, Lise manages projects from early stages of development to late clinical development phases and up to preparation of MAA/BLA/NDA, both in Europe & the US. She works in close collaboration with international life sciences companies to help in the preparation, coordination and submission of centralised Marketing Authorisation Applications (MAAs), as well as New Drug Applications (NDAs), and Biologics License Applications (BLA), of innovative drugs and biologics. This includes strategic input and regulatory writing services of CTD Modules, managing the team of experts involved, as well as coordinating the preparation of written and oral answers as part of the assessment procedures. Lise is also involved in European scientific advice procedures including the authoring of Briefing documents, in orphan drug designation (ODD) applications, as well as in the preparation of Paediatric Investigation Plans (PIP). She also provides recommendations on the feasibility of these applications and on the strategy to develop to meet Agencies’ expectations.

Lise has more than 10 years of experience, having worked in academia, the pharmaceutical industry, and consultancy, where she gained an in-depth knowledge of various therapeutic areas (including oncology, neurology, ophthalmology, metabolic diseases and ENT).

Lise started her career as a medical and regulatory writer for a French pharmaceutical company where she was responsible for authoring a wide spectrum of regulatory documents. She also gained experience of the centralized procedure and in responding to regulatory agency questions.

Then, as a principal regulatory scientific and medical writer, Lise led a team of medical writers, working in close collaboration with cross-functional internal and external teams and experts, and acting as a key liaison person for regulatory activities.

More recently, Lise moved into the provision of consultancy services to support international drug development programmes. In this role she was responsible for authoring and reviewing non-clinical and clinical modules of the CTD; the assessment, utilisation and positioning of available data; writing of meeting requests, briefing packages and responses to questions from agencies; as well as ODD requests and PIPs.

Lise graduated in 2005 with a chemical engineering degree from both the European Engineering School in Chemistry, Polymers & Materials, ECPM in Strasbourg (France), and from the University of Stuttgart (Germany). She was awarded her PhD in biochemistry from the Biochemistry Institute of the University of Stuttgart and conducted post-doctoral research at the Pasteur Institute in Paris.

In addition to French, her mother tongue, Lise speaks English and German, and has a basic knowledge of Spanish.

Lise is based in our Boulogne office in France.

Medical Director

As a Medical Director, Zoran is responsible for providing input and critical review of the clinical sections of a variety of documents for regulatory submissions. He plays a key role in designing clinical development programmes and in identifying Scientific Advice questions for regulators and joint regulator-HTA bodies. Zoran also provides expertise in responding to the issues raised by regulators during the assessment of applications and participates in the preparations for client presentations and for oral explanations.

Zoran brings to this role extensive experience across various therapeutic areas of medicine and disease prevention such as neurology and psychiatry, rare diseases, oncology and vaccines. He has worked in all phases of clinical development, including running clinical trial sites.

Prior to joining VCLS, Zoran spent over 10 years at the MHRA working as a Senior Medical Assessor and as the Biologicals and Biotechnology Unit Manager. From his work as a regulator, Zoran has gained expertise in the assessment of medical aspects of Marketing Authorisation Applications, Orphan Drug Designations and early access pathways (including project ORBIS and ILAP). His experience also covers contribution to EMA and MHRA scientific guidelines and procedures (such as for Advanced Therapies, Biosimilars and MHRA Post-Brexit regulatory pathways) and authoring papers for expert advisory groups.

He made regular presentations to the Committee for Medicinal Products for Human Use (CHMP) and Co-ordination Group for Mutual Recognition and Decentralised Procedures (CMDh). He held observer positions at Central Nervous System Working Party (CNSWP) and Scientific Advice Working party (SAWP) contributing to development of EMA guidelines for industry (e.g. for investigation of Alzheimer’s disease, schizophrenia and depression). Zoran also held the position of principal assessor for the Clinical Trials, Biologicals and Vaccines Expert Working Group (CTBVEAG) of the CHM.

Zoran qualified as a Medical Doctor from the University of Tuzla (Bosnia and Herzegovina) and he is Fellow of Faculty of Pharmaceutical Medicine of Royal College of Physicians (UK), Member of Royal College of Psychiatrists (UK) and International Fellow of American Psychiatric Association (US). He holds Master of Science degrees in Pharmacology, Translational Medicine and Information Systems Design and diplomas in Pharmaceutical Medicine and in Chronopharmacology.

Director, Market Access

As a Director in the Market Access team, Gabrielle is responsible for conducting market access analyses and providing recommendations and input to client development plans, early access challenges, and due diligence activities.

Since joining VCLS, Gabrielle has worked closely with clients across a wide range of health technologies, including orphan drugs, advanced therapies, repurposed drugs, and has developed an expertise in ultra-rare diseases, cystic fibrosis, retinitis pigmentosa, hematopoietic cell transplantation, and antibiotic resistance.

She brings 20-years of experience from having worked in different business cultures in a variety of global market access positions in both pharmaceutical and biotech companies. This includes more than 6 years of working in the field of rare diseases.

Gabrielle started her market access career in 1999 at Lundbeck. As a global pricing and reimbursement manager, she was responsible for Lundbeck’s mood disorder portfolio (Cipramil, Cipralex) and worked on neurology assets (desmoteplase, Azilect, Ebixa, Circadin). In this role, she contributed to a number of value dossiers and was responsible for formulating the defense of Cripalex price, leveraging price differentiation, benchmark analyses, and expertise gained in European policies and pricing rules. She was also responsible for evaluating pricing and reimbursement potential in life-cycle management and for business development opportunities.

Gabrielle subsequently joined Ipsen in 2012 as global market access and pricing director for rare diseases, for a joint venture in hemophilia with the US-based start-up Inspiration Biopharmaceutical Inc. She developed European market access strategy plans for Ixinity and Obizur (for hemophilia B and acquired Factor VIII deficiency respectively) and presented them to buyers when assets were sold.

She also successfully developed and lead pricing and reimbursement strategies for Somatuline antitumor indication (neuroendocrine tumors) and for the orphan drug Xermelo (carcinoid syndrome diarrhea).

During this time, Gabrielle successfully negotiated double-digit price increases in Europe and Turkey for Increlex and Somatuline. She also contributed to various life-cycle management, business development opportunities, and publications in acromegaly, neuroendocrine tumors, Cushing syndrome, short-stature, Huntington’s disease, multiple sclerosis, dermatology, urology, and rare cancers.

Gabrielle holds Bachelor of Arts in Psychology, in Business Information from the University of Rouen, a Masters in Competitive Intelligence from the University of Marne-la-Vallée, as well as HEOR training from the CNAM in Paris and a European Market Access University Diploma (EMAUD) from Lyon.

She has been a lecturer at EMAUD since 2012.

Gabrielle speaks English and French and 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.

Senior 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 Medical Director

As a Senior Medical Director at VCLS, Peri is responsible for providing input to, and critical review of, the clinical sections of a variety of documents, including client clinical development plans, ODD, PIP, and PRIME briefing documents. She also plays a key role in identifying questions to be raised with Regulators as part of the requests to EMA, National Agencies and Joint EMA-HTA bodies for scientific advice, and in critically reviewing the advice received. Peri also contributes to responses to issues raised (by CHMP/National regulators) and when required actively participates in the rehearsal of client presentations for oral explanations, from a clinical regulatory perspective. 

Peri brings to this role extensive expertise across various therapeutic areas including women’s health, genito-urinary medicine, infectious diseases (anti-bacterial, antiretrovirals, antimalarials, antifungal, and anti-hepatitis medicines), hematology (hemophilia, ITP), cystic fibrosis and other pulmonary related diseases, chronic graft versus host disease, inborn errors of metabolism, gastroenterology, nutrition, pain, and non-prescription products, as well as various drug-device combinations products. 

Prior to joining VCLS, Peri spent almost 10 years at the MHRA as a Senior Medical Assessor, where she gained significant expertise in the assessment of medical aspects of EU medicinal product marketing authorization applications.  She also has experience in assessing ‘prescription-only-medication POM’ switches to ‘pharmacy (P)’.  

During her time at the MHRA, she led interactions with companies and provided scientific and regulatory advice to companies before and after the submission of their applications. Peri also provided clinical support to the devices division. This involved evaluating device trial applications and amendments, providing clinical advice on devices, and providing clinical input on regulatory aspects of devices.  

While working at the MHRA, she made several presentations to the Committee for Medicinal Products for Human Use (CHMP), Co-ordination Group for Mutual Recognition and Decentralised Procedures (CMDh), Scientific Advice Working party (SAWP) and Infectious Disease Working Party (IDWP).  

Prior to joining the MHRA, Peri worked for more than seven years for the NHS, specializing in Obstetrics and Gynaecology.  

Peri qualified as a Medical Doctor from the University of Ibadan in Nigeria and she is a member of the Royal College of Obstetrics and Gynaecology. Peri recently completed a Diploma in Pharmaceutical Medicine at Kings College London.  

Peri is based in the VCLS office in Camberley, UK. 

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.

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.