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Dr. rer. nat. Jürgen Schanzer

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

Clinical Development

  • Support of clinical teams in design and planning of clinical trials (Study Population, Inclusion- & Exclusion Criteria, Objectives, Starting dose, Dose escalation & Risk Management Plan)
  • Medical and scientific advice to all stages of clinical development with an extensive experience in oncology, hematology and immunology

Translational Research

  • 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

Preclinical Development

  • 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

Project Management

  • 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

Medical Writing

  • Medical writing of IMPDs, IBs, CTD sections for BLA & MAA filings, PIPs, TPPs and briefing documents for regulatory agency meetings
  • Program development for Biological Evaluation of Medical Devices

Scientific Writing

  • 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

Medical Advisor

  • 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

Partnering ⋅ Due Diligence

  • Scientific support of advisory boards, consultant and investigator meetings
  • 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

Patent Filing

  • 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
alcahest gmbh
pharma and biotech consulting
Dr. rer. nat. Jürgen Schanzer
Senior Consultant & Medical Writer
Alcahest GmbH
Riesengebirgstr. 28
93057 Regensburg, Germany