Dr. Juergen Schanzer

Dr. Jürgen Schanzer is a translational expert with more than 17 years of experience and a proven track record in preclinical and clinical development of biopharmaceuticals.

Jürgen provides scientific, regulatory and strategic support based on his extensive experience in the technical development of antibodies including design, affinity maturation, expression, protein purification and analytics. In addition, he has experience in the development of cell and gene therapy products. He was closely involved in cellular assay development, in vivo toxicity, pharmacokinetics, dose-response studies and in vivo models. Jürgen has a strong background in oncology, hematology, immunology and virology and supported all stages of drug development from preclinical to phase 1, 2 and 3 trials.

As biologist by training, Jürgen holds a PhD in biochemistry from the Eberhard Karls University in Tübingen. During his PhD, Jürgen was employed at Micromet AG (now Amgen) and investigated tumor immunotherapy by IL-2 and GM-CSF antibody cytokine fusion proteins.

After his PhD, he joined Roche Diagnostics GmbH as Laboratory Head and Project Leader in the preclinical development of antibodies, bispecific antibodies, antibody drug conjugates and antibody like scaffold fusion proteins. As Principal Scientist he was responsible for the development of biopharmaceuticals within multidisciplinary project teams from early target assessment until identification of a lead candidate for evaluation in phase 1 clinical studies. In 2018, Jürgen joined Morphosys AG as Lab Head Pharmacology and Immuno-Oncology Program Leader in the development of MOR210 (anti-C5aR Mab) enabling a phase 1 trial in collaboration with I-Mab Biopharma. At Morphosys, he was also supporting the preclinical and clinical development of tafasitamab (MOR208) in phase 2 & 3 trials in relapsed refractory DLBCL.

During his career as medical writer, he prepared several CTD sections for BLA filings, IBs, TPPs and briefing documents for regulatory agency meetings. Currently, he is finalizing the European Medical Writers Association (EMWA) Professional Development Programme (EPDP), which provides a high-quality training for medical writers.

Jürgen has a track record of scientific writing with 15 publications in peer reviewed journals, posters at conferences and more than 16 patents. Furthermore, he is speaker at numerous international conferences in the development of novel antibody therapeutics.

Professional Experience

2020 – present

Senior Consultant

Alcahest GmbH

  • Scientific, regulatory and strategic support for all stages of non-clinical and clinical development of biopharmaceuticals
  • Medical writing of IMPDs, IBs, PIPs, and briefing documents for regulatory authority meetings

2021 – present

Director Translational Medicine

Riboscience LLC, USA Remote

  • Development and execution of PD assessment and biomarker strategies for the immunomodulator RBS2418/pembrolizumab phase 1 trial (NCT05270213)
  • Selection and management of CROs for fit-for-purpose biomarker assay implementation, quality control and analysis of flow cytometry, ctDNA, CTCs, IHC, IF, DNA/RNA Seq and proteomic data
  • Review and presentation of biomarker data to management to predict and measure treatment response and immunomodulatory properties of RBS2418
  • Medical Writing of CTPs, Study Protocol amendments, study reports and scientific publications & conference posters

2018 – 2020

Lab Leader & Senior Scientist Preclinical Pharmacology

Morphosys AG, München

  • Scientific Support of Clinical Development of tafasitamab (anti-CD19 Mab) in phase 2 & 3 clinical trials in relapsed refractory DLBCL and CLL in combination with bendamustine (B-MIND), lenalidomide (L-MIND), venetoclax & idelalisib (COSMOS)
  • Immuno-Oncology program leader preclinical development of MOR210 (anti-C5aR Mab) enabling a phase 1 trial in China in collaboration with I-Mab Biopharma (preclinical development plan, project transfer & monthly data evaluation)
  • Management of laboratory (2 Scientists & 4 Technicians) and preclinical activities & external collaborations with CROs
  • Medical Writing (Study reports, briefing packages for FDA meetings, TPP, annual IB updates & sections of CTD for BLA filings)
  • Evaluation of partnering & due diligence of external clinical development candidates

2012 – 2017

Principal Scientist – Discovery Oncology

Roche Diagnostics GmbH, Penzberg

  • Project leader preclinical and clinical development of antibodies, ADCs & Scaffolds: Coordination of preclinical and clinical development plans, timelines & resources, milestones and budget including cell culture models, in vivo toxicity, pharmacokinetics, dose-response studies, efficacy, histology analysis within a matrix structure, presentation to management
  • Coordination of preclinical projects enabling phase I trials with CROs and external biotechnology companies e.g. Molecular Partners (Switzerland)
  • Lab Group Leader: Molecular Biology, Protein purification & In Vitro cellular assays
  • Evaluation of partnering of external clinical development candidates
  • Scientific writing of SOPs, reports, project proposals, publications & patents
  • Medical writing e.g. Investigator’s Brochure for IND filing of RG7787
  • Speaker at International Conferences in preclinical and clinical drug development

2007 – 2012

Senior Scientist – Large Molecule Research & Protein Engineering

Roche Diagnostics GmbH, Penzberg

  • Project leader of technical development of bispecific antibodies: Coordination of preclinical and clinical development plans, timelines & resources, milestones including cell line development, material supply, DSP, protein purification & analytics, MS analytics, Biacore & stability analysis within a matrix structure
  • Design & development of novel therapeutic proteins (bi- & multispecific antibodies) and platform technologies (e.g. Cross Mab)

2001 – 2005

PhD Biochemistry in Cancer Immunotherapy

Micromet AG, München

  • Molecular biology - Cell culture & cell line development - Protein purification & analysis - FACS – In vitro cellular assays - PBMC isolation from human blood including isolation of CD4+ & CD8+ T cells, NK cells & macrophages - In Vivo analysis - Scientific writing

1997 – 2000

Research Associate

Metabasis Therapeutics Inc., San Diego USA

  • Research and development of protein-based assays in the discovery of small molecule drugs in the areas of virology, diabetes and inflammation

Education

2001 – 2005

PhD Biochemistry in Cancer Immunotherapy

Eberhard Karls Universität Tübingen

  • PhD Thesis: A human cytokine/single-chain antibody fusion protein for simultaneous delivery of GM-CSF and IL-2 to Ep-CAM overexpressing tumor cells

1990 – 1996

Diplom Biologie (equivalent Master of Science Biology)

Technische Universität München

  • Major: Microbiology
  • Minors: Immunology, Genetics, Clinical Chemistry