Drug Development 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. 

Global Head of Clinical Research

As Global Head of Clinical Research Business Unit, Véronique is responsible for leading the team in the drive to provide clients with the highest level of support in developing and conducting their clinical trials in a full service mode. 

Véronique has more than 30 years experience in clinical research, working both in large Pharma and small biotech. This means she is well placed for understanding the challenges clients face both on a strategic and day to day operations making her adept at finding commercial and scientific and operational solutions.   

Prior to joining VCLS, Véronique worked as Global Head of Clinical Development Operations at AB Science and was the Global Head of Trial and Data Management for Oncology & Rare Disease at Sanofi.  

Her expertise spans many areas including Clinical Methodology, Clinical Project Management, Biometry, Interventional Studies, Risk Based Monitoring. She was also exposed to several therapeutic areas such as, Oncology, Rare Diseases, Infectious Disease, and Cardiology. 

Véronique gained her Master’s Degree in Statistics at the Université de Bretagne Occidentale. 

Véronique is based in our Boulogne office in Paris.  

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.