What the event will discuss:

• A regulatory update – what are the impacts and expectations?
• Utilising exploratory trials to make go/no go decisions at early developmental stages
• The application of biomarkers and maximising efficiency of phase I through effective implementation
• Facilitating the transition from preclinical studies to phase I trials through comprehensive data analysis
• Patient-based phase I trials – assessing the suitability and practicalities
• An overview of trial design methodologies and the value of interim analysis

Benefits of attending

• Hear strategic guidance on developing and implementing your clinical trial submissions to ensure you are in line with national and international regulators
• Facilitate your go/no-go decision and reduce time and financial constraints through effective use of exploratory trials
• Find out about methodologies for making accurate predictions and effectively translating data from pre-clinical models to First in Man (FIM) in order to save you time and money
• Ensure optimum dosages in FIM studies as a result of enhancing assessments of animal data, toxicity and PK/PD data
• Hear case studies from pharma and biotech companies on how to identify and validate biomarkers during early development to obtain Proof of Concept and facilitate decision making
• Identify practical improvements to your trial design and examine the use of adaptive trials and interim analysis
• Find out the latest developments in patient based phase I trials across your therapeutic area and improve your patient network to ensure effective communication with CROs and physicians to ensure optimum patient recruitment

Who you will meet:

Heads and managers of