Medicinal products
Experimental strategy, sudy design & project management
Extensive experience of medicinal product development; especially in ophthalmology, & for all the segments of the eye. My services include:
- Design of the experimental strategy according to your goals (IND/IMPD submission, or MAA/NDA submission)
- Selection of the appropriate CROs & set up of the experimental protocols (efficacy studies (in vitro, ex vivo & in vivo), Pharmacokinetics & bioanalytical methods, regulatory toxicology studies according to the Good Laboratory Practices (GPL)
- Oversee & manage of the tests with respect of the deadlines
- Data analysis and report writing
- Troubleshooting
- & more according to your needs
Medical devices
Experimental strategy, study design & project management
Extensive experience of medical device development; especially in ophthalmology & within the field of artificial tears. My services include:
- Definition of the experimental strategy & preclinical biocompatibility study package based on a thorough risk analysis & in compliance with the Medical Device Regulation (MDR)
- Set up experimental protocols (in vitro, ex vivo & in vivo testing) according to the Norms &/or the Good Laboratory Practices (GLP)
- Oversee & manage of the tests with respect of the deadlines
- Data analysis and report writing
- Troubleshooting
- & more according to your needs
Regulatory documents preparation
My scientific expertise & my knowledge of the regulatory pathways for medicinal products & medical devices allow me to bring you the know-how useful for the preparation and writing of your scientific rationales and regulatory documents.
Medicinal products
- Preparation of the nonclincal modules of the CTD (2.4, 2.6 & module 4)
- Preparation of IND/IMPD & Investigator Brochures for clinical trials
- Interaction with Regulatory Agencies, (FDA, EMA, ANSM, …) within the frame of pre-IND, Scientific Advice & MAA/NDA procedures
Medical devices
- Preparation of the Biological Evaluation Report (for the technical dossier) according to MDR
- Risk analysis & management
- Regulatory reponses to Notified Bodies & Health Authorities
- On site audits
& more according to your needs
Scientific writing
Research articles & synthetic reviews
Author of several reviews & research articles, I can help you create high quality scientific and technical content to increase your visibility within the scientific community:
- Original research articles & reviews (peer-reviewed journals)
- Literature reviews (bibliographic reports)
- Critical analysis of articles
- Data analysis
- & more according to your needs
Experience & expertise
- Expert scientist in cell biology (PhD Sherbrooke Univeristy, Qc, Canada) & biochemistry/biophysics (MSc Biochemistry/Biophysics (Magistère of Chemistry/ Biology, University of Strasbourg, France)
- Extensive experience as a preclinical development Manager and Expert for medicinal products (peptide, new chemical entities) & medical devices (eye drop, cream)
- Researcher and Lead Scientist within North-American and French startup & biotech
- Project management & Translational research within an international pharmaceutical group
Scientific contributions
Antiviral response in vernal keratoconjunctivitis may be protective against COVID-19.
Allergy. 2021 Aug 14. PMID: 34390598
Leonardi A, Rosani U, Cavarzeran F, Daull P, Garrigue JS, Brun P.
Interactions of Meibum and Tears with Mucomimetic Polymers: A Hint towards the Interplay between the Layers of the Tear Film.
Int J Mol Sci. 2021 Mar 9;22(5):2747. PMID: 33803116
Eftimov P, Yokoi N, Melo AM, Daull P, Georgiev GA.
Ocular surface response of two preservative-free cylcosporine A emulsion eye drops in a mouse model of dry eye.
Curr Eye Res. 2021 Aug;46(8):1096-1104. PMID: 33588656
Daull P, Nagano T, Gros E, Feraille L, Barabino S, Garrigue JS.