Profile Details

Create Project

★★★★★

☆☆☆☆☆

USD 120 /hr

★★★★★

☆☆☆☆☆

Hire Dr. Christophe M.

France

USD 120 /hr

Global Healthcare Market Access & Innovation Planning Lead. . Turns complex challenges into therapeutic and diagnostic

Profile Summary

Health Access Consulting expert in global & European landscapes Advanced therapeutic and diagnostic innovative companies seeking solutions to market access and regulatory issues for therapeutic and diagnostic innovations seek my solutions since 20 years and 250+ clinical strategy projects completed I provide solutions for pricing, market access, early innovation reimbursement, expert liaison based on validated clinical data. A personal quote: Answering patient’s needs at correct time, accurate clinical data on the expected pathway, make institutions happy I provide Personalized Medicine expertise to P&MA departments on the path to clinical development strategy excellence, en route to EU-APAC market access My expertise and management acumen enabled teams sales rise from €1.5 to €3.5 million from 2022 to 2023 fiscal year in Personalized Medicine Landscapes. Patient and Client centric, passionate about personalized medicine concept, you'll find public communications about some of my projects on my Linkedin page https://www.linkedin.com/in/christophe-michel-pma

Subject Matter Expertise

• ★ Medical Devices
• ★ Medical Device Development
• ★ ISO 13485
• ☆ Biostatistics
• ☆ Molecular Biology
• ☆ Biomarkers
• ☆ Genetics
• ☆ Microarrays
• ☆ Omics
• ☆ Transcriptomics
• ☆ Proteomics
• ☆ Genomics
• ☆ PCR
• ☆ Next Generation Sequencing (NGS)
• ☆ DNA Sequencing
• ☆ Gene Expression Analysis
• ☆ Genome Sequencing
• ☆ Exome Sequencing
• ☆ ChIP-Seq
• ☆ Kinases
• ☆ Neuroscience
• ☆ Behavioral Neuroscience
• ☆ Cognitive Neuroscience
• ☆ Neuropharmacology
• ☆ Molecular Neuroscience
• ☆ Statistics
• ☆ Health Data Analysis
• ☆ Health Policy
• ☆ R
• ☆ Drug Discovery
• ☆ Drug Design
• ☆ Drug Development
• ☆ Small Molecule Drug Development
• ☆ Biologic & Biosimilar Development
• ☆ Pharmacogenomics
• ☆ Pharmaceutical Regulatory Affairs
• ☆ Bioavailability
• ☆ Post-Market Surveillance
• ☆ Medical Device Marketing
• ☆ Medical Device Safety Testing
• ☆ Medical Device Validation
• ☆ Medical Device Design
• ☆ Medical Implants
• ☆ Wearable Technology
• ☆ Medical Device Regulatory Consulting
• ☆ European Medical Device Regulation (MDR)
• ☆ ISO 14971
• ☆ EU In vitro Diagnostic Regulation (IVDR) Compliance
• ☆ In vitro Diagnostics
• ☆ In vitro Diagnostic Design
• ☆ Point-of-Care Devices
• ☆ Biomarker Analysis
• ☆ Clinical Trials
• ☆ Clinical Trial Design
• ☆ Patient Recruitment
• ☆ Clinical Data Management
• ☆ Clinical Trials Data Analysis
• ☆ Medical Imaging/Radiology
• ☆ Interventional Radiology
• ☆ Public Health
• ☆ Global Health
• ☆ Disease Control And Prevention
• ☆ Quality of Life Assessment
• ☆ Health Technology Assessment
• ☆ E-Health & Telemedicine
• ☆ Healthcare Administration & Management
• ☆ Medical Affairs
• ☆ Healthcare Quality Improvement
• ☆ Magnetic Resonance Imaging (MRI)
• ☆ Endoscopy
• ☆ Positron Emission Tomography (PET)
• ☆ Ultrasound
• ☆ Regulatory Affairs
• ☆ Immunotherapy
• ☆ Gene Therapy
• ☆ Pharmaceutical Technology
• ☆ Medical Equipment & Supplies
• ☆ Healthcare Reimbursement
• ☆ Product Evaluation
• ☆ Shelf-Life Testing
• ☆ Hypothesis
• ☆ Peer Review
• ☆ Research Methodology
• ☆ Survey Design & Methodology
• ☆ Meta-Research
• ☆ Feasibility Studies
• ☆ Technology Scouting
• ☆ Fact Checking
• ☆ Literature Search
• ☆ Gap Analysis
• ☆ Scientific Animation & Illustration
• ☆ Medical Illustration
• ☆ Continuing Medical Education (CME) Training
• ☆ Skills Training
• ☆ Regulatory Writing
• ☆ Clinical Trial Documentation
• ☆ Clinical Trial Protocol Writing
• ☆ Clinical Study Reports
• ☆ Medical Writing
• ☆ Medical Content Writing
• ☆ Research Summaries & Abstracts
• ☆ Technical & Scientific Writing
• ☆ SOP & Protocol Writing
• ☆ White Papers
• ☆ Case Studies
• ☆ Science Communication
• ☆ Literature Review
• ☆ Systematic Literature Review
• ☆ Copywriting
• ☆ Emails & Newsletters
• ☆ Marketing Copy
• ☆ Social Media Copy
• ☆ Web Copy
• ☆ Blog Posts
• ☆ Public Relations Writing
• ☆ Scientific Proofreading & Editing
• ☆ Proofreading & Editing
• ☆ Language Translation
• ☆ Course Content Writing
• ☆ Business Strategy
• ☆ International Business
• ☆ Public-Private Partnership
• ☆ Data-Driven Decision Making
• ☆ Customer Service
• ☆ Entrepreneurship
• ☆ Health Economics
• ☆ Medical Law
• ☆ European Law
• ☆ Marketing Strategy
• ☆ Market Research
• ☆ Qualitative Market Research
• ☆ Quantitative Market Research
• ☆ Business Intelligence
• ☆ Innovation Management
• ☆ Project Management
• ☆ Risk Management
• ☆ Management Consulting

Services

• Writing
• Research
• Consulting
• Data & AI
• Product Development

Writing Medical Writing, Technical Writing

Research Market Research, Feasibility Study, Technology Scouting, Gap Analysis, Scientific and Technical Research

Consulting Business Strategy Consulting, Go-to-Market Strategy Consulting, Digital Strategy Consulting, Healthcare Consulting, Operations Consulting, Scientific and Technical Consulting, Regulatory Consulting

Data & AI Image Analysis

Product Development Product Evaluation, Product Validation, Quality Assurance & Control (QA/QC), Product Compliance

Work Experience

Global Market Access & Innovation Planning Lead.

n816 Life

June 2015 - Present

Director of Market Access for Medical Devices

Alira Health

March 2021 - March 2024

Director of CA-RA-QA surgical robotics

Robocath

June 2020 - August 2020

Senior Consultant, Medical Device Evaluation

Guerbet Group

February 2019 - May 2020

Senior Consultant in Clinical Evaluation and Regulatory Affairs

Real Staffing

July 2016 - January 2019

Clinical Evaluation Project Lead

Haute Autorité de Santé

June 2012 - May 2015

Education

DIU-FIEC

Université de la Méditerranée (Aix Marseille II) - France

September 2011 - May 2012

PhD

Université Henri Poincaré (Nancy I) - France

January 1993 - November 1998

Certifications

• Certification details not provided.