Pierre-Michaël Coly
Project Manager @ Leads To Development
About
As a Project Manager, I leverage my experience in preclinical drug development to support operational planning, regulatory strategy, and scientific communication. My role bridges the gap between Biotechs, Regulatory Authorities, and service providers, ensuring the seamless execution of projects. Key contributions include: * The operational management of CMC and nonclinical activities for various product types (biologics, peptides, small molecules) * drafting expert reports, regulatory documents (IMPD, IB, IND), and development plans critical to the lifecycle of medicinal products. Previously, I collaborated on cutting-edge research at Inserm, where I managed projects exploring extracellular vesicles and their role in tumor progression and cardiovascular diseases. My expertise lies in operational project management, interfacing with stakeholders, and converting complex scientific challenges into viable therapeutic solutions. Driven by a passion for innovation, I aim to facilitate impactful advancements in the biopharmaceutical industry.
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France
Biotechnology
Cross-Cultural Communication Skills, Stakeholder Relations, Teamwork, Project Team Management, Collaborative Problem Solving, Biopharmaceuticals, Budgeting, Drug Development, Academic Research, Biotechnology, Communication, Cell Biology, Molecular Biology, Cell Culture, Neuroscience, Flow Cytometry, qPCR, Immunohistochemistry, Confocal Microscopy, Western Blotting
Experience

Project Manager
Ville de Paris, Île-de-France, France
I am involved in multiple projects covering both operational and regulatory aspects for various types of products and indications. My role involves: • Providing scientific support • Operational planning • Operational project management • Interfacing between clients, regulatory authorities and service providers • Writing expert reports, development plans and regulatory documents (e.g., IBs, IMPDs, INDs…)

Scientist, Senior Postdoctoral Researcher
Paris, France
• Management of research projects focused on imaging extracellular vesicles (and other nanocarriers) in zebrafish preclinical models. Coordination of collaborations with stakeholders of the academic and industrial sectors. • Development of optogenetic tools intended to control the production of extracellular vesicles. Application of these tools to the study of the role of extracellular vesicles in tumor progression.

Postdoctoral Research Scientist
Inserm - Paris Centre de Recherche Cardiovasculaire de Paris - Hôpital Européen George Pompidou
Paris, France
Managed research projects focused on extracellular vesicles and vascular physiopathology, with the goal of developing extracellular vesicles as drug delivery vehicles and diagnostic biomarkers. Worked on models of atherosclerosis and autophagy deficiency, with a personal fellowship obtained from the Lefoulon-Delalande Foundation •Supervised a team composed of grad students, research engineers, and a PhD candidate • Established and optimized in-vitro (engineered cell lines) and in-vivo (atherosclerosis mouse model) protocols for extracellular vesicle isolation and characterization including immunophenotyping approaches • Identified new potential targets implicated in the propagation of endothelial inflammation, resulting in oral and written communications

PhD Candidate
Rouen , France
Mission: Elucidate the molecular mechanisms of glioblastoma cell migration associated with therapeutic resistance Skills developed: Theoretical and cellular and molecular biology expertise. Scientific and technological watch. Development and implementation of innovative experimental protocols. Budget management. Writing of scientific articles. Promotion of results through posters and oral communications during national and international conferences. Organization of a regional congress. Establishment of scientific collaborations. Supervision of a team of engineers and grad students

Research Assistant
Rouen , France
INSERM U982, Laboratory: "Neuronal and Neuroendocrine Differentiation and Communication" Mission: Study the signaling pathways activated by membrane receptors (GCPRs) in the context of tumor invasion Activity: Bibliographic watch. Development and implementation of experimental protocols.
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