WebinarS
We are hosting a series of webinars presented by imaging specialists covering a variety of topics related to imaging aspects of clinical studies. All webinar sessions are free to attend and places will be offered on a first come first serve basis.
If you would like to attend one of the sessions or suggest a topic: email webinar@ixico.com
UPCOMING
Advanced MRI Biomarkers for use in Clinical Trials of Neurodegeneration
The 30 minute presentation will cover:
* Recap: the traditional uses of MRI (volumetric and safety)
* Potential of novel MRI methods
- More sophisticated volumetric methods
- Diffusion
- Functional MRI
* Challenge of using the ADNI-2 approach in therapeutic trials.
* What we need to know...
The speaker for this session is Prof. Derek Hill, CEO of IXICO, a world renowned expert and professor of Medical Imaging Science.
After the presentation, there will be 20 minutes for questions and answers.
Date: 21st March 2012
PREVIOUS
The use of Hippocampal Volume as a Biomarker for Enrichment of Prodromal Alzheimer's Disease Trials
The last year has seen a growing consensus that biomarkers need to be part of the diagnostic criteria for prodromal AD. It has also seen the EMA give qualification opinions on CSF, low hippocampal volume and amyloid PET for selecting subjects for prodromal AD studies. The selection of appropriate biomarkers for prodromal AD studies and the potential implication on labelling and clinical use of new medicines is an area of active debate. This webinar will focus on the low hippocampal volume biomarker, how this fits into a wider biomarker strategy, and the challenge of operationalizing a biomarker strategy in AD drug development programmes.
The 30 minute presentation will cover:
* Hippocampal volume: single timepoint vs. longitudinal measurements
* Baseline hippocampal volume as a proximity marker for conversion to AD
* Concordance of low hippocampal volume with amlyoidal pathology
* Strengths and weaknesses of the ADNI cohort for validating this biomarker
* Approaches to selecting a cut-point
* CAMD interaction with EMA and FDA qualifying low hippocampal volume
* Pros and cons
The speaker for this session is Prof. Derek Hill, CEO of IXICO, a world renowned expert and professor of Medical Imaging Science.
After the presentation, there will be 20 minutes for questions and answers.
Date: 31st January 2012
MR & Amyloid PET Imaging to Select Subjects, and Assess Safety and Efficacy in AD Studies
Imaging is becoming increasingly key in clinical trials of new Alzheimer's Disease therapies. This is both because imaging has a valuable role to play in selecting patients for studies focused on pre-dementia or prodromal AD, and because regulators are requiring Sponsors to exclude subjects with more than a certain number of micro-bleeds, and to regularly monitor brain scans for possible side-effects of the therapies.
The 30 minute presentation will cover:
* The role of MRI and Amyloid PET in identifying suitable subjects for studies
* Challenges of using MRI to assess safety in global studies
* Choice of efficacy endpoints: lessons from ADNI-1 and other studies
* The impact of ADNI-2 on the use of innovative MRI-endpoints for early phase studies
* The biomarker qualification paradox
The speaker for this session is Prof. Derek Hill, CEO of IXICO, a world renowned expert and professor of Medical Imaging Science.
After the presentation, there will be 20 minutes for questions and answers.
Date: 2nd March 2011
Operational Considerations in Imaging-Based AD Trials from Site Qualification to Image Analysis
Operational excellence is fundamental to the success of a clinical trial. End to end operational considerations will be discussed. This 40 minute presentation session will cover:
* Differences between Clinical and Quantitative MRI
* Imaging Protocol Development: ADNI implementation and site-specific sequences
* Site Qualification: the underlying scientific rationale, topics surrounding phantom selection, data transfer and timelines
* Image QC: data QC vs. endpoint QC, artefacts, their frequency and impact on analysis
* Safety and Eligibility: turnaround times, local vs. central reads, radiologist qualifications
* Image Analysis: current and newer methods
The speaker for this session is David Cash, PhD, Director of Medical Imaging, IXICO.
After the presentation, there will be 20 minutes for questions and answers.
Date: 27th October 2010
Using Magnetic Resonance Imaging to Assess Safety, Efficacy and Eligibility of New Alzheimer's Disease Therapies
During the last two decades, neuroimaging methods have been widely used to study the natural history of Alzheimer's Disease. They have also been used as a means of assessing safety and efficacy of novel treatments as well as helping define eligibility criteria of recruited subjects in clinical trials.
MRI endpoints widely used in AD trials will be discussed, along with their level of maturity. This 30minute presentation session will cover:
* Potential of MRI to assist with enrichment of the study population
* Challenges in using MRI to assess safety
* Choice of efficacy endpoints: lessons from ADNI and other studies
* Some dos and don'ts
The speaker for this session is Prof. Derek Hill, CEO of IXICO, a world renowned expert and professor of Medical Imaging Science.
Date: 18th February 2010