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

tel. +49 (0)178 480 32 05
email schanzer@alcahestpharma.com