Christof KREUTZ

En résumé

Entreprises

• Swissmedic - Reviewer for Authorization Applications

  2012 - maintenant Domain of anti-infectives: Review of clinical study reports, periodic safety update reports, Summary of Product Characteristics, and Company Core Data Sheets for new molecules, changes of indications, or changes of Summary of Product Characteristics. First decision about acceptance or rejection of the application and presentation of this decision to internal and external expert committees to find the final decision. Responsible to ask questions to sponsors or to give them advices when additional trials or analyses were required for the market authorization. Advisory function for sponsors in drug development. Permanent contact with healthcare professionals and the press in regulatory questions.
  
  Operational Highlights
  Facilitate the work of the expert committees by presenting them a clear and concise evaluation report.
  Excellent matrix communication between all departments of the authority thus reducing the requirement of questions to the sponsors

• Bionorica - Consultant

  2011 - 2011 Domains of gynaecology and respiratory tract diseases: Writing of synopses and protocols, all strategic and operational management for study planning, initiation and execution involving bid defense, budget, administrative affairs, planning and supervision of manufacturing as well as contracts with CROs and investigation centers. Orchestrate contact with key opinion leaders. Coordinate CROs and different internal departments (pharmacovigilance, regulatory affairs, preclinical and clinical research, manufacturing). Provide medical input for approval of international drug instructions and for periodic drug safety reports. Lead search for investigation centers in Russia. Manage team of 5.
  
  Operational Highlights
  Reduced working time for subcontractors through accurate planning and rapid and excellent line and network management, thus saving money.
  Initiated logistics and facilitated all conditions necessary for successful launch of study, including writing/approving necessary documents, securing contracts with CROs, and establishing good communications with all stakeholders. Ensured that feasibility of studies was guaranteed.

• Sanofi-Aventis - Clinical Project Leader

  Paris 2010 - 2010 Domain of anticoagulation: Directed team of 10 in analysis of clinical cases involving anticoagulation (particularly those involving deaths and hemorrhages). Orchestrated contact, communication, and coordination of CROs and Sanofi-Aventis project leaders on international level, as well as collaboration between different internal departments. Translated information from project leaders to create medical expertise about special clinical cases. Presented findings to committees of opinion leaders, with aim to definitively classify reason of death or hemorrhage as major or minor (with results of study being added to patient information distributed with drug). Ensured that pharmacovigiliance department was promptly informed of results, as well as statistical CRO, in order to provide maximum accuracy for registration of adverse events and minimize errors in database.
  
  Operational Highlights
  Chartered high level of accuracy for study, which led to development of superior medical expertise, making it possible that at maximum only 1 out of 100 patients was rejected by key opinion leader committee. Not only did this improve pace of study, but it decreased study costs by reducing need for group meetings.
  Orchestrated critical communications with study centers in Philippines that had been formerly chronically delayed, employing excellent line management and communication practices.

• Pierre Fabre - Expert for Clinical Drug Development

  Castres 2008 - 2009 Led team of 10 in preparation of 2 international clinical studies in therapeutic area of infectious diseases (including immune system strengthening and vaccines). Orchestrated contact, communication, and organization of meetings with cosponsors and international opinion leaders, as well as coordination of responsible internal departments for elaborating development projects. Prepared, wrote, and reviewed clinical study documents. Coordinated contact with CROs, evaluating services and costs, as well as coordinating multiple CROs in different countries.
  
  Operational Highlights
  Chartered successful creation of synopsis and protocol via competency as specialist for microbiology and epidemiology of infectious diseases, combined with expert project management skills and strong drive to meet targets and goals.
  Spearheaded development of culture of cooperation amongst employees affected by various politics of company by promoting open communication policy that gained their loyalty and motivated entire team.

• NEGMA - International Clinical Project Leader

  2004 - 2008 Domains of oncology, gastroenterology, metabolic diseases, ophthalmology: Led strategic planning of drug and medical device development, focussing primarily on gastroenterology and oncology, with aim to move to next phase of development or market authorization. Managed team of 10 staff members. Directed coordination of responsible internal departments for elaborating drug development projects. Orchestrated contact and communication with international opinion leaders and CROs. Facilitated presentations of developing drugs on scientific congresses and satellite symposiums. Planned, organized, and prepared clinical aspects of drug development. Assisted in audits of CROs, as well as facilitating any necessary training of CRO members before study initiation. Supervised and coordinated services of various CROs in international multicentre studies. Wrote and reviewed clinical study protocols, statistical analysis plans, and clinical study reports. Published study results.
  
  Operational Highlights
  Chartered greater efficacy in communications, orchestrating travel authorizations, especially throughout the United States, when necessary to improve accuracy and shorten time frame for studies.
  Orchestrated communications between various internal departments that weren’t effectively cooperating, including preclinical, information, pharmocovigilance, regulatory, pharmaceutical, and marketing.

• ITEC PHARMACOLOGY AND CRIS (CROs) - International Clinical Project Leader

  1998 - 2003 Domains of metabolic diseases, endocrinology, cardiovascular diseases, infectious diseases, neurology: Directed operational management of clinical studies. Managed teams from 5 to 10 people, depending on size of study. Wrote/reviewed study protocols, then organized study logistics, including budget, number of people required, duration of study, necessary materials, and scheduling of meetings. Analyzed all documents of pharmaceutical dossier, including toxicology and pharmacology. Orchestrated meetings between key opinion leaders and ITEC Pharmacology and/or CRIS. Supervised investigators’ meetings, presenting results from meetings to sponsors. Submitted studies to ethics committees, FDA, and BfArM. Conducted final analysis and exploitation of study results. Collaborated with monitors and statisticians, writing/reviewing clinical study reports and journal publications of study results.
  
  Operational Highlights
  Expanded breadth of projects by directly contacting all potential investigators and by new approaches to boost recruitments of healthy volunteers in order to identify new opportunities that general manager could sell to sponsors.
  Saved critical studies in multiple instances through consistent generation of new ideas, solid leadership of participating staff, strategic coordination, and thorough communication with all stakeholders.

Formations

• University Of Saarland (Homburg)

  Homburg 1991 - 1997 Specialist Degree for Microbiology and Epidemiology of Infectious Diseases

• University Of Saarland (Homburg)

  Homburg 1984 - 1990 Doctor of Medicine

Réseau

• Alexandre DAUTIN

• Damien GOY *

• Delphine LASSALLE

• Fatine BENJELLOUN

• Ludovic JUBE

• Maud REGNIER

• Melissa ESTEBAN

• Svet KRISTOF MSC CCRA