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Using Advanced Imaging Biomarkers to understand if your drug works. Dr. Olga Kubassova, Founder and CEO of Image Analysis 15/05/2013. Clinical Trials Today. Time Pressure . Competition
Dr. Olga Kubassova,
Founder and CEO of Image Analysis
Baminnercept (BG9924), Biogen, an agent in development for rheumatoid arthritis (RA) and lupus, which targets lymphotoxin-beta, a component on the surface of cells that signals the inflammatory process to begin.
Denosumab (AMG 162), Amgen, which targets RANK ligand, a protein involved in the development of bony erosions in Rheumatoid Arthritis and bone loss in osteoporosis.
Ofatumumab (HuMax-CD20), GSK an infused biologic designed to reduce the number of B cells, which may decrease disease activity in Rheumatoid Arthritis
Belimumab (Benlysta), Human Genome Sciences/GSK, which inhibits the activity of B-lymphocyte stimulator (BLys), a protein that causes B cells to grow in number and perhaps produce antibodies. Belimumab is in development for lupus as well as RA.
Canakinumab (Ilaris), Novartis, which targets the proinflammatory cytokine interleukin-1 beta (IL-1β). Approved for a rare autoimmune disorder called cryopyrin-associated periodic syndrome (CAPS), canakinumab is currently in clinical trials for Rheumatoid Arthritis and Juvenile Arthritis.
Fostamatinib disodium, AZ, an agent that works by blocking the effects of a protein called sykkinase, which helps B-cells to mature. Fostamatinib disodium is in clinical trials for Rheumatoid Arthritis.
Masitinib, AB Science, which inhibits the activity of mast cells, which become activated and contribute to joint inflammation in RA. Masitinib is taken orally and has been in clinical trials for RA.
……Lexicon Genetics, Pfizer,Galapagos, Vertex, Morphosys, Lilly, Rigel/AstraZeneca, Takeda, Abbvie….
However, application of insensitive or qualitative metrics to quantify MRI will not make the full use of the information provided by MRI
Cancer Centre, NY, USA
Dr. Mikael Boesen, MD
Prof. Peter Taylor,
Kennedy School of Rheumatology,
Nikolay Tzaribachev, MD
IA team and Independent Clinical Advisory Board have worked in close collaboration with clinical specialists and radiologists specialising in MSK, Oncology, Neurology and Cardiology focusing on quantification of inflammation and perfusion.
Olga is a CEO of IA, which she founded in 2007 after completing her PhD on ‘Development of Algorithms for Dynamic MRI Data Analysis’ UK. Olga co-authored of over 40 papers, 5 book chapters and books. Olga and the Clinical Board oversee each clinical trial design to ensure
the most effective use of imaging
Dr. Olga Kubassova
Validation: over 40 papers
Used: world-wide, over 25 installations in clinics and support of major clinical trials
Regulatory: Class Iia, CE, ISO13485, CRF21-11 (pending), FDA510K (pending)
Radiological Assessment of the Rheumatoid Arthritis knee with DEMRIS, Dynamika: imaging remission on Day 2
Radiological Assessment of the Rheumatoid Arthritis knee with RAMRIS: Synovitis:
Baseline: 1; Day 1: 1; Day 2: 1, Day 7: 1: no response to treatment
Boesen, M; Kubassova, O et al, Arthritis 2011
Fully Automated Detection of tumor in DCE-MRI of breast using Dynamika’s pixel-by-pixel iMAPs approach:
- In colours, active inflamed tissues, redder colours show less activity, bright, yellow colours - more
iMAPs with Dynamika, Image Analysis
TONSET – Contrast Absorption Time highlights the initial time point where contrast was absorbed into tissues
TWASHOUT – Time of Washout highlights the start point where contrast diffuses out of tissues
GD – Contrast Uptake Pattern highlights regions where contrast was absorbed, retained and was quick to diffuse out of tissues over time.
IRE- Initial Rate of Enhancement highlights the how quickly contrast was absorbed
IRW – Initial Rate of Washout highlights how quickly contrast diffuses out of tissues
ME – Maximum Enhancement highlights tissues that retain contrast where red indicates low or no inflammatory activity and white/yellow high activity.
Automated mapping of inflammatory activity with Dynamika’s parametric maps
Nail bed inflammation in PsA
Prostate Cancer Imaging Data Analysis
@OlgaKubassova or @ImageAnalysisUK