プロフィール詳細

プロジェクトを作成

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Dr. Philippe G.に依頼

France

Independent Consultant in R&D - Pharma/Biotech

プロフィール概要

I hold a PharmD and a PhD in Life Sciences from the University of Strasbourg (France). I have 15 years of experience in R&D, including collaborations or positions in companies / organizations of (i) different sizes (large, medium and startups), and (ii) various facilities (pharmaceutical companies, CDMOs and consultancy). My scientific interests are mainly focused on vaccine development, formulation/delivery of biologics & innovative pharmaceutical products. In this context, I have acquired a strong knowledge in a wide range of areas, particularly in Immunology, Formulation, Infectious Disease and Analytical characterization, thus allowing me to work on cross-disciplinary projects. In addition, I have also developed a solid expertise in Pharmaceutical Development: Support in early drug discovery. Identification of unmet medical needs. Technological positioning. Defining target product profile (TPP). Gap analysis. Identification, understanding & compliance of regulatory requirements. Participation in the guidance of clinical development projects for new products. Scientific and regulatory advice. CMC & non-clinical aspects: Formulation development, Analytical method & Potency assay development & validation, Optimization & Scale-up of biomanufacturing process (USP/DSP), Non-clinical pharmacology studies, Identification & management of CROs/CDMOs... Since 2019, I have been acting as an independent consultant through my company called PG Consulting and located in Strasbourg (France). By providing expertise and strategic input, I support biotech and pharmaceutical companies in the development of their product candidates, from discovery to initiation of clinical trials (Human & Animal Health).

専門分野

• ★ Biology/Life Sciences
• ★ Vaccine Development
• ★ Technical & Scientific Writing
• ☆ Analytical Chemistry
• ☆ Nanotechnology
• ☆ Biotechnology & Bioengineering
• ☆ Drug Development
• ☆ Medical Affairs
• ☆ Product Compliance
• ☆ Research
• ☆ Medical Copywriting

サービス

• Writing
• Research
• Consulting
• Product Development

Writing Clinical Trial Documentation, Technical Writing

Research Market Research, User Research, Meta-Research, Feasibility Study, Fact Checking, Gap Analysis, Gray Literature Search, Systematic Literature Review

Consulting Scientific and Technical Consulting, Regulatory Consulting

Product Development Formulation, Product Evaluation, Manufacturing, Concept Development, Prototyping

職務経験

Independent Consultant: R&D and Strategic Foresight

PG Consulting (self-employed)

1月 2019 - 現在

Project Holder : Business creation project

BoostVax Project

1月 2018 - 7月 2019

Pharmaceutical Project Coordinator

Baccinex (CDMO)

9月 2017 - 12月 2017

Biopharmaceutical and Industrial Development Project Manager

VitamFero SAS (Biotech)

11月 2014 - 7月 2017

PhD student

University of Strasbourg & Sanofi Pasteur

2月 2009 - 12月 2013

学歴

PhD in Life Sciences (Specialization in Vaccinology)

University of Strasbourg (UdS)

2月 2009 - 12月 2013

MSc in Pharmacology

University of Strasbourg (UdS, France)

9月 2005 - 9月 2008

PharmD

University of Strasbourg (UdS, France)

9月 2001 - 9月 2008

認定資格

• MSBM’s certificate (Master of Biological and Medical Sciences) in Cellular Pharmacology, Pharmacokinetics and Pharmacogenetics

  University of Strasbourg (UdS, France)

  9月 2005 - 現在