09:15
Early Drug Development Challenges for Precision Medicine
Ms Eleni Lagkadinou, Early Clinical Leader in Experimental Medicine Oncology and Global Drug Discovery, Bayer HealthCare
09:45
Dr Steinar Madsen, Medical Director, Norwegian Medicines Agency, Norway
Mr Mickael Montembault, Clinical Program Lead - Clinical Pharmacology Science & Study Operations (CPSSO), GSK
Finding The Risk / Innovation Balance In First In Human Clinical Trials: What Lessons Can We Learn From The Bial Trial?
Dr Steinar Madsen, Medical Director, Norwegian Medicines Agency, Norway
Mr Mickael Montembault, Clinical Program Lead - Clinical Pharmacology Science & Study Operations (CPSSO), GSK
First in Human Studies
11:40
- Pros and cons of moving a novel compound straight into patients rather than healthy volunteers
- Demonstrating POC and target engagement in healthy volunteer trials to guide subsequent patient trials
- Optimal study design for FIH trials accelerate early clinical development
Dr Peter Dewland, Senior Director Early Phase Research, M.A.C. Clinical Research
Accelerating Early Clinical Development – Healthy Volunteer v Clinical Patients for First-in-Human (FIH) Trials?
- Pros and cons of moving a novel compound straight into patients rather than healthy volunteers
- Demonstrating POC and target engagement in healthy volunteer trials to guide subsequent patient trials
- Optimal study design for FIH trials accelerate early clinical development
Dr Peter Dewland, Senior Director Early Phase Research, M.A.C. Clinical Research
Innovations in Biomarkers
11:40
Biomarkers in respiratory drug development: towards personalised medicine
First in Human Studies
12:00
How to design safe and efficacious clinical trials using Translational Modeling approach
Innovations in Biomarkers
12:00
Biomarker Driven Patient Selection For Early Clinical Trials
First in Human Studies
12:20
Exploratory Clinical Testing of Neuroscience Drugs
Innovations in Biomarkers
12:20
Dr Martin Lunnon, Visiting Senior Lecturer, Institute of Pharmaceutical Science, Kings College London
Meeting the Challenge of Biomarker Adoption in Clinical Trials For Rare Diseases
Dr Martin Lunnon, Visiting Senior Lecturer, Institute of Pharmaceutical Science, Kings College London
First in Human Studies
12:40
Support For CNS Drug In First In Human Studies By Translational Modelling
Innovations in Biomarkers
12:40
The Immunoscore: Toward An Integrated Immunomonitoring From the Diagnosis To the Follow Up Of Cancer Patients
Safety Pharmacology in Early Development
14:30
Using QT Assessment In Early Clinical Development To Replace The TQT Study
Biomarkers in Early Development
14:30
·Confirming translation of mechanism and predicting efficacy in early clinical trials dramatically reduces failures in discovery and reduces costs.
·With careful design and validation, complex PD biomarker programs, including functional assays, can be successfully employed in multi-centre trials
·The presentation will use examples to illustrate how immune function can be mapped in the clinic in support of drug development in inflammation and immune oncology
Session led by:
Using PD biomarkers to confirm mechanism and predict efficacy in human trials as a means of reducing the risks in development
·Confirming translation of mechanism and predicting efficacy in early clinical trials dramatically reduces failures in discovery and reduces costs.
·With careful design and validation, complex PD biomarker programs, including functional assays, can be successfully employed in multi-centre trials
·The presentation will use examples to illustrate how immune function can be mapped in the clinic in support of drug development in inflammation and immune oncology
Session led by:
Safety Pharmacology in Early Development
14:50
Developments and Challenges For Pharmacology in Early Development
Biomarkers in Early Development
14:50
High Throughput Assessment of Immune Biomarkers in Cancer
Safety Pharmacology in Early Development
15:10
ADME and Safety For Early Development and Drug Discovery
Biomarkers in Early Development
15:10
Pharmacogenetics in the evaluation of new drugs: regulatory and methodological aspects
Safety Pharmacology in Early Development
15:30
Biomarkers in Early Development
15:30
Using Biomarkers To Define, Understand and Communicate Decision Criteria In Early Clinical Development
15:50
Afternoon refreshments
Biomarkers in Early Development
16:20
Safety Pharmacology
last published: 24/Oct/16 09:05 GMT
