« As an experienced preclinical development manager, I can help you design your preclinical development strategy according to your goals: from IND/IMPD to NDA/MAA submissions; and be at your side for the preparation of high quality regulatory documents and during the interactions with the Health Authorities »

Philippe Daull, PhD

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.

Review of Preclinical Outcomes of a Topical Cationic Emulsion of Cyclosporine A for the Treatment of Ocular Surface Diseases.

Ocul Immunol Inflamm. 2021 Aug 4:1-11. PMID: 34348575

Daull P, Baudouin C, Liang H, Feraille L, Barabino S, Garrigue JS.

Tiny dexamethasone palmitate nanoparticles for intravitreal injection: Optimization and in vivo evaluation.

Int J Pharm. 2021 May 1;600:120509. PMID: 33766637

Canioni R, Reynaud F, Leite-Nascimento T, Gueutin C, Guiblin N, Ghermani NE, Jayat C, Daull P, Garrigue JS, Fattal E, Tsapis N.

Improving Stability of Tear Film Lipid Layer via Concerted Action of Two Drug Molecules: A Biophysical View.

Int J Mol Sci. 2020 Dec 14;21(24):9490.

PMID: 33327408

Eftimov P, Olżyńska A, Melcrová A, Georgiev GA, Daull P, Garrigue JS, Cwiklik L.

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