Dr. rer. nat. Jürgen Schanzer

Senior Consultant Clinical & Preclinical Development
Clinical Development
Medical Advisor
Medical Writing
Preclinical Development
Translational Research
Scientific Writing
Project Management
Partnering
Due Diligence
Patent Filing

Clinical Development

Medical Advisor

Medical Writing

  • Support of clinical teams in study design and coordination of local and international clinical studies
  • Medical and scientific advice to all stages of clinical development with an extensive experience in oncology, hematology and immunology
  • Feasibility studies, patient analysis, identification of key opinion leaders and selection of study centers
  • Assistance of clinical teams in interaction with CROs and collaborators
  • Preparation of presentations, status reports and regulatory submission documents
  • Identification and development of collaborative relationships with current and future key opinion leaders (KOLs), key centers and local collaborative groups in the focus disease area
  • Implementation of scientific product information, medical education materials and research concepts
  • Organization of symposia in various disease areas, scientific support of speakers and medical presentations to regional healthcare audiences
  • Support of all scientific communication activities in close collaboration with marketing, market access and field sales
  • Medical writing of clinical study documents e.g. Investigator Brochure, Trial protocol, Trial amendments, Patient information sheet and consent form, Case report forms and others

Preclinical Development

Translational Research

Scientific Writing

  • Advice and coordination of preclinical projects enabling phase I trials for biologics
  • Preparation of preclinical and clinical development plans
  • Planning of timelines, resources & milestones
  • Support of preclinical development teams in the review, analysis, interpretation and presentation of study results
  • Contribution to the design and execution of clinical studies in collaboration with clinical operations and medical affairs
  • Transition of research stage projects to clinical development
  • Identification of clinical indications with high unmet medical need
  • Development of biomarker strategies
  • Planning and coordination of cell culture models, in vivo toxicity, pharmacokinetics, dose-response studies, in vivo efficacy models & histology analysis
  • Scientific writing of manuscripts and publications for submission in peer reviewed journals
  • Preparation and/or delivery of presentations at conferences for preclinical and clinical drug development

Project Management

Partnering ⋅ Due Diligence

Patent Filing

  • Project Management in all areas of clinical & preclinical development of novel therapeutics with special expertise in the areas of oncology, immunology, hematology, virology, diabetes & inflammation
  • Scientific support for advisory boards, consultant meetings, and investigator meetings including preparation and/or delivery of presentations
  • Scientific input in the preparation of presentations for partnering of clinical development candidates including due diligence meetings
  • Support of innovation and business development by reviewing novel targets and technologies
  • Advice on how to protect inventions in the fields of pharmaceuticals, life sciences, biology & biotechnology e. g. pharmaceutical active ingredients (small molecules or biologics), pharmaceutical formulations (galenics), therapeutic or diagnostic methods
  • Support in filing of patents in collaboration with experienced patent attorneys