Exploratory Day One


Registration and refreshments


Opening remarks from the chair

Ms Eleni Lagkadinou

Early Drug Development Challenges for Precision Medicine

Ms Eleni Lagkadinou, Early Clinical Leader in Experimental Medicine Oncology and Global Drug Discovery, Bayer HealthCare
Panel discussion

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

Speed networking


Morning coffee

First in Human Studies

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

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


Biomarkers in Early Development

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: kws-biotest

Afternoon refreshments


Biomarker Strategy

Biomarkers in Early Development

Safety Pharmacology


Drinks reception

last published: 24/Oct/16 09:05 GMT