Welcome to CView‑Consult

Supporting clinical innovation
with expertise, humanity, and purpose

At CView‑Consult, I support clinical research teams in developing innovative therapeutic solutions, driven by a deep conviction: scientific progress only matters when it truly improves patients’ lives. Passionate about science and closely connected to the realities of patient care, I bring my expertise to projects that require rigor, responsiveness, and a clear understanding of clinical challenges. My mission is simple and meaningful: to help accelerate the development of new treatment options, while ensuring quality, ethics, and safety at every step. Because behind every protocol, every dataset, and every study, there are people waiting for answers. And they are the reason I commit myself every day.

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Parcours & Légitimité

Since September 2024

Founder and Executive director of CView-Consult Gmbh

▪ OT4B (Ongoing since March 2025)

Support Phase 3 protocol writing and study set-up activities for a program in Prader Willi Syndrome.

▪ Synendos Therapeutics AG (July 2025-March 2026)

Supported the development of study protocol and start-up activities of early phase clinical trials in CNS indications (Anxiety – Tourette syndrome – Post traumatic stress disorder) with focus on early signal detection.

▪ Vico Therapeutics (February 2025 – April 2026)

▪ Protocol writing of a phase 2 clinical trial in Huntington Disease and support of clinical team on ad-hoc basis.

February 2021 to August 2024

Head of Clinical Sciences and Data Management – Azafaros B.V.

Managed and led a cross-functional team (statistics, bioanalytics, pharmacology, data management) for the lead asset Nizubaglustat from phase 1 to phase 3.

▪ Responsible for vendor management (selection, contract negotiation and budget control).

▪ Led clinical development plan discussions (with integrated biomarker strategy) and clinical study execution in EU, USA and LaTam.

▪ Responsible for protocols and study documents development for CTA submission, in multiple clinical phase studies.

From 2014 to 2020

Principal Clinical Scientist – Roche pRed Neuroscience / Product development, Personalized Health Care

Led clinical team to support the design of clinical development plan(s), with clinical phase 1 and 2 study design(s) in Multiple Sclerosis (BS-CD20, MAGLi), Alzheimer disease (Brain shuttle Gantenerumab) and Schizophrenia.

▪ Led collaboration meetings between pRED and Product Development group.

▪ Authored protocol for biomarker studies as part of biomarker strategy plan.

2013 to 2014

Clinical Scientist – Novartis Ophthalmology

Supported medical lead in the development of program-level documents and collaborated on phase 3 protocol development in diabetic retinopathy with Lucentis.

Skills

Clinical Science:

▪ Study design, protocol, ICF, CSR writing, feasibility questionnaires, data management activities, Data cleaning, interpretation and reporting.

▪ Experience with small molecules, antibodies.

Therapeutic Areas:

▪ Rare diseases (Pulmonary Hypertension, Huntington disease and Lysosomal disorders), Multiple Sclerosis, Alzheimer disease, Parkinson disease, schizophrenia and Age-Related Macular edema.

Regulatory: HA interactions

▪ (FDA, EMA and MHRA).

▪ Dossier for CTA submissions, Briefing books, Integrated safety summary, summary of clinical efficacy, ILAP documents.

Leadership & Management

▪ Cross-functional team leadership, mentoring junior scientists, managing scientific advisory Board.

Scientific Comm.

▪ Presentations at webinars, family meetings and investigator meeting, scientific publications.

Expertise & Services

Clinical Development Strategy

I help teams build thoughtful, efficient, and patient‑centered clinical development strategies. My approach combines scientific depth with practical experience across early and late phases. How I support you:

Integrated development plans

Biomarker‑driven strategies

Early signal detection

Cross‑functional scientific leadership

Protocol Design & Scientific Documentation

Strong clinical studies begin with strong scientific foundations. I design protocols and study documents that are clear, feasible, and aligned with patient needs. Deliverables include:

Protocol authoring (Phases 1–3, natural history studies)

Study rationale and design optimization

ICF, CRF, and charter development

Tailored designs for rare and CNS indications

Study Start‑Up & Clinical Execution

I work closely with clinical teams to ensure studies launch smoothly and progress with clarity and quality. Support areas:

Study start‑up coordination

Vendor selection and oversight

Scientific troubleshooting

Cross‑functional team alignment

Data Management & Data Interpretation

Reliable data is essential for meaningful insights. I help teams build strong data structures and interpret results with scientific precision. What I offer:

CRF design and database specifications

Data cleaning and review

Interpretation of clinical, biomarker, and safety data

Support for interim analyses and reporting

Regulatory Support

I assist teams in preparing clear, structured, and scientifically robust documentation for regulatory submissions and interactions. Expertise includes:

CTA/IND preparation

Briefing books and scientific responses

Support for regulatory meetings

Integrated safety and efficacy summaries

Scientific Communication

I help teams communicate their science with clarity, empathy, and impact — whether addressing investigators, regulators, or patient communities. I provide:

Scientific presentations and training

Investigator meeting content

Patient‑advocacy communication

Support for publications and posters

Grant Applications & Strategic Narratives

I support teams in articulating their science and vision in a compelling way for grants and strategic documents. Services include:

Scientific sections of grant applications

Program‑level summaries

Strategic scientific storytelling

Publications Scientifiques

article

First-in-human single-dose study of nizubaglustat, a dual inhibitor of ceramide glucosyltransferase and non-lysosomal glucosylceramidase: Safety, tolerability, pharmacokinetics, and pharmacodynamics of single ascending and multiple doses in healthy adults

Auteurs : Cecile Paquet Luzy, Emilie Doppler, Thomas M Polasek, Ruben Giorgino
Revue : Mol Genet Metab. 2024 Jan;141(1):108113.

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A First-in-Human, Randomized, Double-Blind, Placebo-Controlled, Ascending Single- and Multiple-Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of the L-ido azasugar AZ-3102 in Healthy Volunteers

Auteurs : C. Paquet Luzy, E. Doppler, R. Giorgino (Azafaros Clinical Research and Development)
Événement : WORLD Symposium and SSIEM 2022 posters

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PROspective Longitudinal Study of Neurological Disease TrajectOry in children living with Late-Infantile or Juvenile Onset of GM1 or GM2 Gangliosidosis (PRONTO study)

Auteurs : Roberto Giugliani, Benedicte Heron, Jeanine R. Jarnes, Marc C. Patterson, Maurizio Scarpa, Emilie Doppler, Cecile Paquet Luzy
Événement : WORLD Symposium and SSIEM 2022 posters

article

Miglustat in late-onset Tay-Sachs disease: a 12-month, randomized, controlled clinical study with 24 months of extended treatment

Auteurs : Barbara E. Shapiro, Gregory M. Pastores, John Gianutsos, Cécile Luzy, Edwin H Kolodny
Revue : Genet Med. 2009 Jun;11(6):425-33.

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article

Miglustat in adult and juvenile patients with Niemann-pick disease type C: Long-term data from a clinical trial

Auteurs : James E. Wraith, Darleen Vecchio, Elisabeth Jacklin, Larry Abel, Harbajan Chadha-Boreham, Cécile Luzy, Ruben Giorgino, Marc C Patterson
Revue : Mol Genet Metab. 2010 Apr;99(4):351-7.

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article

Long-Term Miglustat Therapy in Children with Niemann-Pick Disease Type C

Auteurs : Marc C. Patterson, Darleen Vecchio, Elizabeth Jacklin, Larry Abel, Harbajan Chadha-Boreham, Cecile Luzy, Ruben Giorgino, James E. Wraith
Revue : J Child Neurol. 2010 Mar;25(3):300-5.

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article

Miglustat in patients with Niemann-Pick disease Type C (NP-C): A multicenter observational retrospective cohort study

Auteurs : M. Pineda, J.E. Wraith, E. Mengel, F. Sedel, W.-L. Hwu, M. Rohrbach, B. Bembi, M. Walterfang, G.C. Korenke, T. Marquardt, C. Luzy, R. Giorgino, M.C. Patterson
Revue : Mol Genet Metab. 2009 Nov;98(3):243-9.

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article

Natural history of Niemann-Pick disease type C in a multicentre observational retrospective cohort study

Auteurs : Wraith JE, Guffon N, Rohrbach M, Hwu WL, Korenke GC, Bembi B, Luzy C, Giorgino R, Sedel F.
Revue : Mol Genet Metab. 2009 Nov;98(3):250-4.

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