Day Two: Thursday 20 May 2010
last modified: 10 May '10
MORNING PLENARY
09.00
Coffee break
09.10
Opening remarks from the chair
CBE, Professor of Pharmacology, Oxford University
09.15
Keynote presentation: Fostering creativity in scientific research
Baroness Greenfield is Director of the Royal Institution of Great Britain (the first woman to hold
that position) and Professor of Pharmacology at the University of Oxford, where she leads a multi-disciplinary team investigating neurodegenerative disorders. In addition she is Director of the Oxford Centre for the Science of the Mind, exploring the physical basis of consciousness.
Her books include “The Human Brain: A Guided Tour” (1997), “The Private Life of the Brain” (2000), and “Tomorrow’s People: How 21st Century Technology Is Changing the Way We Think and Feel” (2003) and “‘ID’ - The Quest for Identity in the 21st Century” published in May 2008 by Hodder Publishing. She has spun off four companies from her research, made a diverse contribution to print and broadcast media, and led a Government report on “Women In Science”.
She has received 29 Honorary Degrees, Honorary Fellowship of the Royal College of Physicians (2000), a non-political Life Peerage (2001) as well as the Ordre National de la Legion d’Honneur (2003). In 2006 she was installed as Chancellor of Heriot-Watt University and voted `Honorary Australian of the Year’.
In 2007 she was made a Fellow of the Royal Society of Edinburgh. Susan Greenfield is an outstanding keynote speaker on creativity and leadership. human behaviour, and science and the future.
CBE, Professor of Pharmacology, Oxford University
09.45
The role of the clinical pharmacologist in meeting new challenges facing drug discovery and development
• CP role in identifying the best targets
• CP role in identifying the best candidates
• CP role in identifying risks in exploratory development
Senior Director, Group head - Research Clinical Pharmacology, Pfizer Global R&D
10.15
Keynote presentation: The role of experimental medicine in development
• Experimental medicine / clinical pharmacology can play an integrated role in many parts of the R&D stages
• Experimental medicine’s role is about building clinical confidence in basic molecule properties
• In full development the experimental medicine support is to generate clinical data to ensure “regulatory readiness”
• Experimental medicine has also important bridging functions in diverse areas
Associate Vice President, Experimental Medicine & Bioanalysis, Ferring Pharmaceuticals
10.45
Morning coffee
11.15
Keynote presentaiton: Will public-private partnerships rescue pharma’s floundering R&D model? First lessons from the Innovative Medicines Initiative
• Open innovation as a new model for pharmaceutical development
• Personalised medicine: opportunities and challenges for health stakeholders
• New approaches to drug safety: an urgent need
• Is the European Union back at the forefront of biomedical research?
Executive Director, Innovative Medicines Initiative
11.45
Translational medicine - bridging bench to bedside
- Translational medicine approaches to de-risking assets early in development
- The value of translational medicine in building confidence around critical areas of differentiation
- Approaches to optimising early development study design to maximise value
Dr Magnus Sjogren,
Head Translational Medicine, ECREM, Schering-Plough Research Institute
12.15
Panel session: New paradigms in early clinical development
• How can new technologies enhance early development?
• What impact will the need for faster proof of concept have on phase I trials design?
• Volunteers and patients – making the right choice
13.00
Lunch
AFTERNOON PLENARY: REGULATORY REVIEW
14.00
Review of new ICH guidelines and impact on phase I clinical trials
• Understanding the ICH’s new areas of non-clinical data required for phase I applications
• ICH S9 non-clinical evaluation for anti-cancer pharmaceuticals
• ICH S6 guidance on non-clinical safety evaluation of biotechnology derived pharmaceuticals
• ICH M3 guidance on non-clinical safety studies
• How much easier will the guidelines make it to register phase I clinical trials?
Principal Scientific Officer, MHRA
14.30
Panel session: European regulatory review: approaches to FIH studies
• Starting dose selection
• Dose escalation
• Maximal dose
• Exploratory clinical trials as first in human study
• Relevant guidance
• Reasons to request supplementary information
Dr Chantal Bélorgey,
Head of Division on Evaluation of Special Status Medicinal Products and Clinical trials, Afssaps
Senior Preclinical Assessor, Pre-authorisation, Coordinator Early Phase Development, Federal Agency for Medicines and Health Products
Dr Steffan Steffen,
Medical Assessor, BfArM
15.30
Afternoon coffee
16.00
Predictive value of animal models
• Issues surrounding animal models in predicting safety and efficacy
• What should one look for to maximise the value of animal models?
• Post hoc use of animal models to address future concerns
Director of Toxicology, Takeda Global R&D
16.30
Clinical translational approaches in early development
• Strategies to bridge the translational gap in neuropsychiatry
• Development of new therapies for multiple sclerosis and depression
• Imaging and other exploratory studies for target investigation and validation in neuropsychiatry
Translational Sciences / Preclinical Safety, Roche
17.00
Value of biomarkers in the oncology therapeutic area in Proof-of-Concept clinical evaluations
• Bridging basic pharmacology to clinical medicine by characterising the drug candidate to enable decisions affecting further development
• Achieving early decision making in phase I studies
Dr Chetan Lathia,
Director Global Clincal Pharmacology, Bayer Corp
17.30
Closing remarks from the chair
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last modified: 10 May '10
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