8:30 Registration & Coffee
9:00 Chairman's Opening Remarks
Prof Mike Smith, Co-Director, CoMIR
9:10 APPLICATIONS OF IMAGING TO CLINICAL DRUG DEVELOPMENT
Dr Colin Miller, Vice President, Business Development, BioImaging Technologies
The path taken from preclinical studies into the clinical evaluation of drug candidates using imaging modalities What is the value added in early phase trials of drug candidates Application of imaging in clinical evaluation Benefits of imaging in early phases The issues surrounding imaging data in trial management 9:40 THE USE OF IMAGING TO ACCELERATE CLINICAL TRIALS
Dr Peter Steiger, Chief Executive Officer & President, Synarc
How to choose the best technology to achieve your clinical trial goals Does the expense of the technology justify the savings to be made in real time? Development and validation of new imaging end points and surrogate markers Where is the technology going to take the drug development process: what is the next step? 10:20 .
11:00 Morning Coffee
11:20 THE VALUE OF IMAGE DATA
Dr Sanjay Santi, Associate Professor of Radiology, Harvard Medical School
New developments in Oncologic Radiology
-Multislice CT
-PET
-Perfusion imaging
Trends in data analysis and management
-Tumor volumes
-Electronic image management
Critical success factors
-Up-to-date imaging protocols
-Early radiologist involvement
12:00 SURROGATE ENDPOINTS IN MEDICAL IMAGE DATA
Dr John Waterton, Director, Imaging, Discovery Enabling Science Technology & Information, AstraZeneca
Better choice of drug targets in discovery Earlier go/no decisions on compounds Determine the right dose Shorten time to market 12:40 Networking Lunch
14:00 MEDICAL IMAGE ASSESSMENT
Dr Donald Rosen, Chief Technology Officer & Co-Founder, RadPharm
Pitfalls in oncology imaging in clinical trials What are the differences between RECIST (Response Criteria in Solid Tumours) and WHO (World Health Organisation) standards for tumour evaluation by imaging State of the art imaging technology 14:40 RADIOTRACER DEVELOPMENT
Dr David Dutka, Senior Research Fellow, PET Imaging Centre, Hammersmith Hospital, London, UK
The ability of PET to obtain information on drug distribution and binding in the living human The individual challenges presented by PET chemistry
-short half-life
-the need for specific radioactives
The design or choice of radioligands for imaging particular target cardiac receptors Possible future applications of PET 15:20 Afternoon Tea
15:40 MYCOCARDIAL PERFUSION IMAGING
Dr Luiz Belardinelli, Vice President, Drug Research and Pharmacological Sciences, CV Therapeutics
Pharmacology of adenosine receptors Rationale of adenosine (Adenoscan) in mycocardial and perfusiin imaging studies Features of the ideal pharmacological agent for mycocardial perfusion imaging Pharmacological principles applied to the development of CVT-3146 Pharmacological characterisation of CVT-3146 16:20 THE REGULATORY BOTTLENECKS
Dr Jim Sumner, President, WorldCare
What are the regulatory requirements unique to medical imaging in clinical trials How to design your imaging trial to survive an audit: what to expect from the FDA What does the FDA guidance document mean to industry? How to work within the “rules” to speed up your clinical trial programs 17:00 Chairman’s Closing Remarks and Close of Day One
17:10 Networking drinks reception
8:30 Re-registration and Coffee
9:00 Chairman’s Opening Remarks
Dr Sandra Chica, Associate Medical Director, Perceptive Informatics
9:10 QUANTITATIVE IMAGING
Dr Venkatesan Thangaraj, Chief Technology Officer, Enmed
Clinical benefits of developing imaging technology to diagnose disease Implementing quantitative imaging protocols Cross platform protocol validation whilst maintaining quality assurance Data analysis and archival 9:40 INTEGRATION OF COMPUTER MODELING AND MEDICAL IMAGING TECHNOLOGIES
Dr David Steinman, Senior Scientist, The John P. Robarts Research Institute
Techniques currently being used to elucidate the biophysical factors involved in atherosclerosis development Determine whether local blood flow patterns can be used to better predict the risk of stroke and optimize bypass grafting surgical techniques The implications of including medical imaging in trial design for drug development The increasing need for digitalisation of images and centralised laboratory analysis 10:20 ADVANCES IN CLINICAL TRIAL DESIGN TO YIELD EFFECTIVE THERAPIES TO TREAT CARDIOVASCULAR DISEASES
Dr Claudio Marelli, Clinical Research Director, Nycomed Amersham
Overview of imaging in cardiology
-Current status and future perspectives
Integrating cardiac imaging techniques into the drug discovery process Value of cardiac imaging in clinical trials
-preclinical development
-clinical trials
11:00 Morning Coffee
11:20 SPEEDING UP DRUG DEVELOPMENT
Dr Ian Wilding, Chief Executive Officer, Pharmaceutical Profiles
Using scintigraphic imaging to visualize product performance in the gastrointestinal tract and lungs Candidate drug selection using human absorption studies Bridging the gap between in vitro and full clinical development using human imaging studies Targeting drug delivery through product visualization 12:00 IMAGING IN NEUROLOGY
Speaker to be confirmed, ,
12:40 Lunch
14:00 MRI MONITORING OF FEMALE SEXUAL RESPONSE
Dr Ken Maravilla, Principal Investigator, University of Washington
Rationale for using MRI to assess response Early studies to evalute feasibility of MRI MRI response versus other methods Studies for evaluating reproducibility of MRI method Possible future role of MRI for clinical trial evaluations of new drug therapies for female sexual response 14:40 3D ULTRASOUND
Dr Leonard Avecilla, Director, Education Services, BioImaging Technologies
What is 3D ultrasound and how will it impact on the clinical trial sector? The new modalities being developed in non traditional imaging areas The therapeutic areas that make use of 3D imaging technologies Cost effectiveness of using ultrasound techniques as a diagnostic tool 15:20 Afternoon Tea
15:40 THE PARTNERSHIP ISSUES
Prof Mike Smith, Co-Director, CoMIR
Overview of the NHS and University policy on R&D IPR issues with public sector organisation Available knowledge base to support drug development Potential resource base in terms of equipment and expertise Existing trial facilities and clinical networks to support clinical trials 16:20 EXPLORING THE LOGISTICAL ASPECTS OF IMAGE ASSESSMENTS
Dr David La Point, Executive Director of Business Development and Strategic Planning, Intelligent Imaging
What is the role and responsibility of a core laboratory, regulatory personnel, CRO and sponsor? The need to have immediate clinical information from the imaging modality in order to properly care for the patient but not compromise the study (i.e. bias from ‘preliminary’ reads) The feasibility of maintaining blinded personnel performing image acquisition but still insure complete image acquisition which provides adequate data 17:00 Chairman's Closing Remarks and Close of Conference
