Translational Research

A journey of personal experience

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PD Dr. Andreas D. Meid, MSc

2022-06-03

Outline

• Introduction

• Case studies

  1. Preclinical-to-clinical: QSP modeling
  2. Clinical-to-Real-world: G&T prediction
  3. Bedside-to-bench: Reverse translation

• Recap and next steps …

• Q&A

• Discussion

Translational research

The Definition

• Many alternative approaches in the literature
• “Translational research transforms scientific discoveries arising from laboratory, clinical, or population studies into clinical applications to reduce cancer incidence, morbidity, and mortality.”
• Three stages of translational research T1-T3 to foster the multidirectional integration of basic, patient-oriented, and population-based research

The framework

T1: Q S P
Preclinical-to-clinical translation

T1: Q S P The scope of QSP

T1: Q S P Translational pipeline

• Cellular level
• In vivo level
• Clinical level

Antibody trafficking Payload distribution

T1: Q S P Translational modeling app

T1: Q S P Clinical trial simulation

T2: G&T
Trial-to-real-world
translation

T2: G&T Generalizability & Transportability

T2: G&T Expected results

T2: G&T T-DM1 use-case

Observed survival

Prediction

T2: G&T G&T modeling app

T3: RT
Reverse
translation

T3: RT Tamoxifen real-world studies

T3: RT Tamoxifen TARGET trial

• Study design
• Endpoint
• Exposure-Response

END by group

END by endpoint

A plan for reverse translation?

Recap and next steps …

Projects at stages

• T1: QSP modeling

• T2: G&T modeling

• T3: Reverse translation

Questions ?

Discussion

Formal biosketch

• Training
  • Pharmacist and Biometrician / Biostatistician (master thesis at Merck Serono, Clinical Pharmacokinetics)
  • Doctorate in Pharmacoepidemiology (PhEpi) at Heidelberg University Hospital
  • Habilitation in Clinical Pharmacology and PhEpi at Heidelberg University
• Work experience
  • Group leader at Heidelberg Clinical Pharmacology & Pharmacoepi [1]
  • Biometric and PMx support of IITs
  • Pharmacological counselling support (model-based TDM)
  • Research focus [1,2]: Model-informed decision making with RWE and PMx

‘Quantitative Pharmacologist’ - current role

Where could this role lead professionally?