Impressum

Dr.med. Christian Andreas Emmendörffer

Senior Regulatory Affairs Professional With Strong Background In Quality Assurance, Operations, And Life Science

Senior Regulatory Affairs professional with strong background in Quality Assurance, Medical Devices and Regenerative Medicine (Advanced Therapy Medicinal Products). Medical Doctor with significant expertise in Immunology, Immunotoxicology, In vitro Toxicology and Inflammatory Diseases/ Oncology.

More than 20 years of international experience in regulatory affairs and quality assurance including cell therapeutics and medical devices/ combination products. More than 15 years of experience in Applied Research and Contract research. More than 10 year hands-on experience and profound entrepreneurial background in business development of biotech/medtech start-ups. Direct leadership experience in international internal and external teams. Possess recognized experience in medical device development, materials, cell therapeutics, cell- based systems and approval of clinical trials including first in man studies. Ability to integrate strategic and global big picture thinking with operational and project management skills.

Core Competencies

• Regulatory Affairs for both medical devices and cellular therapeutics
• Regulatory Compliance (FDA/EMA/Swissmedic/PEI/BfArM)
• Implementation and maintenance of QA systems (ISO 13485 and cGMP)
• Fachtechnisch verantwortliche Person (FvP) *Qualified Person (EU)
• Supplier Qualification
• NCR, CAPA and Change Management
• Product and Business Development
• Translation of Research into Business
• Client Relationships
• KOL Management
• Negotiations
• Reimbursement
• Immunology including clinical immunology
• Immunotherapy

Professional Experience

Phalcon Consulting, Niederrohrdorf, Switzerland  *August 2015 – present, CEO and founder

• Regulatory affairs (Medical Devices, Pharma)
• Biocompatibility and Clinical Evaluation (Medical Devices)
• Technical File / Consultation Dossier for CE mark
• Product range: orthopedic, cardiovascular, neurology (class IIb/ class III), combination products
• Implementation and maintenance of Quality Assurance systems (GMP, ISO 13485)
• Risk management
• GDP compliance (Pharma, Medical Devices)
• Contract Qualified Person, FvP.
• Preparation of audits by regulatory bodies
• Pre-inspection audits
• GAP analysis
• Training of staff
• Interim management
• Accredited CTI coach (Swiss government) for Medtech / Life Science
• Coaching and financing for Life Science companies especially start-ups
• Co-Editor TüV Media: CE-Routenplaner, 2016

Xeltis AG/BV, Zürich and Eindhoven, Switzerland/Netherlands  *2011 – August 2015
A European medical device start-up focused on development of class III medical devices of cardiovascular surgery (pulmonic valved conduit and large diameter vascular implants), both combination product and medical device only.

Vice President (VP) of Regulatory Affairs and Quality Assurance, FvP

• Submissions to Notified Body, competent authorities (FDA, SwissMedic, PEI, BfArM)
• Interaction with Ethical Committees
• Implementation of approval strategy for EU (CE-Mark) and FDA (HUD, HDE and EFS)
• Manage technology shift from tissue engineering to class III medical devices
• Design and implementation of ISO 13485 compliant QA system (incl. NCR, CAPA, Change Management)
• Biological risk assessment, BSEP for FDA submission
• Risk management file and risk assessment for class III medical device (cardiovascular)
• Supplier qualification
• Clean production area for commercial production
• Design and lead of preclinical development program according to ISO 10993 series
• Interaction with Ethical committees and regulatory agencies for First in Man (tissue engineered vascular graft (combination product) and class III medical device)
• Evaluation of reimbursement strategies/ market access.

V-Care Biomedical Group, Zug/Leipzig/London, Switzerland/Germany/ UK  *2009 – 2012
Start-up company in the field of regenerative medicine for veterinary medicine.

CEO and Founder

• Implementation of a GMP compliant production including CAPA and PMS
• Development/production/sales and marketing of bone-marrow or adipose tissue derived mesenchymal stem cells
• Sales and marketing of kits for production of platelet enriched plasma (PRP therapy),
• Sales and marketing of wound care products including collagen based wound dressings
• Design clinical trial for approval of a cellular therapeutic in veterinary medicine
• Interaction with regulatory agencies to achieve jurisdictional classification of mesenchymal stem cells in veterinary medicine (Germany, Switzerland and UK)
• Approval for marketing (UK, Switzerland)
• Business development and financing

Phalcon Consulting, Burgdorf/Leipzig, Germany  *2008 – 2012, CEO and founder

• Interim management
• Coaching and financing for Life Science companies especially start-ups
• Contract Qualified Person, FvP.
• Implementation and maintenance of Quality Assurance systems
• Training of staff
• Preparation of audits by regulatory bodies – pre-inspection audits
• GAP analysis

Agenolab GmbH & Co KG, Stuttgart, Germany  *2008 -2010
Biotech start-up offering service in microbiology and environmental hygiene for pharmaceutical industry, technology transfer of production of autologous keratinocyte transplants according to cGMP.

COO, Interims management

• Revision of the QA system from ISO 9001 compliance to cGMP according to the EU-GMP guideline (incl. NCR, CAPA, Change Management)
• Preparation of audits by regulatory bodies to obtain certificates for microbiological services and whole trade license for autologous keratinocyte transplants

Euroderm GmbH, Leipzig, Germany  *2002 – 2008
Production, marketing and sales of autologous epidermal transplants and epidermal test system for in vitro toxicology

CEO and co-founder

• Maintenance of a cGMP compliant QA system
• Procurement licences for clinical sites according to the German Drug Act (AMG)
• Product release (QP, FvP)
• CAPA and NCR management
• Supplier qualification and audits
• PMS
• Management buy-out (Modex Therapeutics) and successful financing (Series A to C) of a biotech start-up in the field of regenerative medicine
• Head of operations and qualified person for autologous epidermal transplants (EPIDEXTM)
• Approval of reimbursement by health insurance companies in Germany and in Switzerland

Modex Therapeutics SA, Lausanne, Switzerland  *2001 – 2002
Production of autologous epidermal transplants

Operations Manager of the production site/ subsidiary in Leipzig, Germany

• Maintenance of a cGMP compliant QA system (NCR, CAPA, Change Management)
• Successful inspections by regulatory authorities (Swissmedic, RP LD Leipzig)
• Management of operations at the subsidiary
• Scale up of production process from five to 50 transplants per months
• Manage technology transfer to the clean room at the Lausanne site
• Head of production of both sites
• Process optimization and support COO in cost reduction program
• Successful negotiations on management buy-out to start euroderm GmbH.

ZYOBIOTECH GmbH, Hannover, Germany  *1999 – 2001
Production, marketing and sales of autologous bone-marrow stem cells and dendritic cells of cancer immunotherapy

Medical Director, Head of Quality Control

• Implementation and maintenance of quality control measures for cGMP compliant QA system (NCR, CAPA, Change Management)
• Production of hematopoietic stem cells (bone marrow and peripheral blood) and dendritic cells of immunotherapy of melanomas, renal and pancreatic cancer
• Manage inspections by regulatory authorities
• Implementation of QA systems at clinical sites

Fraunhofer Institute for Inhalation Toxicology and Experimental Medicine (ITEM), Hannover, Germany  *1985 – 2000
Applied research for pharmaceutical, chemical and automotive industry

Post doc to provisionary head of the Department of Immunobiology

• Implementation of a cGMP compliant production site for cell based medicinal products
• Implementation of GLP compliant work environment
• Management of audits by regulatory bodies (GLP, GMP)
• Applied and basic research in the field of immunology/ immunotoxicology focusing on chronic inflammation, autoimmune diseases, transplant medicine
• Lung immunotoxicology including lung transplantation and infectious diseases of the lung (e.g. CMV and RSV infection)
• Successful application for several research grants (200 K EUR to 2 Mio EUR)
• Author of several peer reviewed articles
• Active participation in national and international immunotoxilogical working groups (e.g. WHO IPCS)
• Several presentations and head of sessions at international scientific congresses.

Achievements

• Co-Editor and author TüV Media: CE-Routenplaner, 2016
• Approval of FIM study of vascular implant for EC-TCPC correction, Moscow, Russia  *2013
• Approval of FIM study of right atrial patch, Moscow, Russia  *2013
• Implementation of a ISO 13485 compliant QA system and production facility, Eindhoven, Netherlands  *2013
• Approval of FIM study for tissue engineered vascular graft for EC-TCPC correction, Paul-Ehrlich Institut, Langen, Germany  *2012
• Establishment and management of a GMP-facility at Fraunhofer-ITEM including manufacturing licence  *1998

Education / Training

• GDP compliance manager – Concept Heidelberg
• Certified RA Manager – MedicalMountains, Tuttlingen, Germany
• Qualified Person (EU) and FvP (CH)
• Assistant Professor in Immunology (PD Dr. med) – Medical School Hannover, Germany
• MD Degree – Medical School Hannover, Germany
• Post Doc in Immunology / Immunotoxicology – Fraunhofer-ITEM, Hannover, Germany
• Languages – German (native), English (fluently), French (elementary proficiency), Italian (elementary proficiency)

Professional Memberships

• Regulatory Affairs Professionals Society (RAPS)
• The Organisation of Professionals in Regulatory Affairs (TOPRA)
• Advanced Medical Technology Association (AdvaMed)
• Deutsche Gesellschaft für Regulatory Affairs (DGRA)
• Mitteleuropäische Gesellschaft für Regulatory Affairs (MEGRA)
• Medical Mountains, Tuttlingen
• Forum PharmaMedtech, Nürnberg
• Deutsche Gesellschaft für Pharmazeutische Medizin (DG PharmMed)
• Drug Information Association (DIA)
• European QP Association
• Active participation in ASTM and DIN working groups