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Monday, 10/09/2017 2:59:23 PM

Monday, October 09, 2017 2:59:23 PM

Post# of 461951
Why would a panel with these credentials agree to present at the premiere Alzeheimer's scientific conference (CTAD) if they had crap to talk about? Illogical!

LB18 - Clinical Pharmacokinetics and Pharmacodynamics Characterization of ANAVEX™2-73 for Designing a Phase 2/3 Study in Mild-to-Moderate Alzheimer’s Disease

Mohammad Afshar, MD, PhD(1) - Ariana founder and CEO

Frédéric Parmentier, PhD(1),
Use of network-based cross-species methods for rule/pattern discovery and target/compound prioritisation in neurodegenerative disease

Abstract: One of the major goal in the field of neurodegenerative disease (ND) research and drug discovery is the prioritisation of candidate neuroprotective targets. Over the past years, several models of ND pathogenesis have been generated in yeast, invertebrates and mammals. These models have emphasized multiple disease mechanisms and they have been widely used in genomic screens to search for genes dysregulated by ND-associated protein expression and for modifiers of protein aggregation/toxicity (Willingham et al., 2003;Giorgini and Muchowski, 2006;Bilen and Bonini, 2007). This is notably the case for Huntington’s disease, a dominantly-inherited ND (Zuccato et al., 2010) that is now recognized as a ‘model neurodegenerative disease’ to best understand the mechanisms of more complex NDs such as ALS or Alzeihmer’s disease (Nollen et al., 2004;Kuhn et al., 2007). The goal of my project will be to analyze large datasets for HD and other NDs by using cross-species data integration procedures and target prediction methods which are based on the use of bionetworks. The expected results are conceptual advances in the field of disease modeling and gain of knowledge emphasizing top-priority targets for neuroprotection, which is anticipated to provide unprecedented guidance to target validation and neuroprotective drug profiling/discovery in HD/ND.

Ene I Ette, PhD(2),
President and CEO Anoixis

Dr. Ette has over 26 years of broad experience in academia, drug evaluation and regulation, and the pharmaceutical industry. He has a Ph.D. in Clinical Pharmacology, an MBA, an M.S. in pharmacology, a B.S. in pharmacology, and a B.S. in pharmacy. A prolific author of several original articles in peer-reviewed journals, book chapters, numerous conference presentations and proceedings, Dr. Ette is on the editorial board of many clinical pharmacology / pharmacy journals as well as a referee for many biomedical journals. He is primary the editor of the classic pharmacometrics reference text, Pharmacometrics: the Science of Quantitative Pharmacology. He is also an invited speaker at many international clinical pharmacology/ pharmacy, pharmaceutical science, and statistical meetings.

Dr. Ette is a fellow of the American Colleges of Clinical Pharmacology and Clinical Pharmacy. He is the 2006 recipient of the American College of Clinical Pharmacy’s Therapeutic Frontier Lecture Award for distinguished scientists. He was a consultant to FDA from 1998 to 2001. In 1999 he was the recipient of the American College of Clinical Pharmacy’s prestigious Russell Miller Award for outstanding contributions to the clinical pharmacy literature; and in 1996 the recipient of Excellence in Review Science Award in CDER (FDA). At the FDA he was the major author of the Guidance for Industry: Population Pharmacokinetics.

He is an adjunct professor of applied pharmaceutical sciences at the University of Rhode Island’s College of Pharmacy and the University of the Pacific’s Thomas J. Long School of Pharmacy and Allied Health Sciences. Before now, he was the Senior Director/Head, Clinical Pharmacology, Vertex Pharmaceuticals, Cambridge, MA. where he introduced and championed efforts in the integration of knowledge-based (pharmacometric modeling and simulation) principles into drug development. Before taking up appointment at Vertex he was a leading pharmocometrician in the Office of Clinical Pharmacology, Center for Drug Evaluation and Research (CDER) at the Food and Drug Administration (FDA). He has broad experience academia, drug evaluation and regulation, and the pharmaceutical industry. Moreover, he has broad experience in the evaluation and development of drugs. He is a holder of patents.

Need no further introduction:
Emmanuel O Fadiran, PhD3, Christopher U Missling, PhD3;

(1)Ariana Pharma, Paris, France,
Ariana offers comprehensive and FDA-tested clinical and biomarker data analysis services that guarantee you get the most out of your data

We deliver actionable information that improves disease diagnosis management, advances clinical development, and minimizes risk.

Using our KEM® (Knowledge, Extraction, Management) technology, Ariana

– improves the process of identification and validation of biomarker signatures
– increases the power of multi-parametric diagnostic tools
– identifies best patient responder sub-groups and populations at risk of AEs, and improves clinical trial success rates.
Our technology uncovers hidden signals and complex relationships that conventional statistical analyses miss. It’s a unique approach that is both complementary to and supported by statistical analyses, guaranteeing robust, reproducible results. We can easily analyze complex combinations of data including clinical, imaging, metabolic, biochemical and NGS/omics.

(2)Anoixis Corp., Natick, MA,
Pharmacometric Services
Anoixis Corporation helps our partner companies achieve breakthroughs in their drug development process by applying our expertise in pharmacometrics to provide pharmacometrically-guided strategic development plans, innovative study designs, and data analysis. We provide innovative and informative study design and analysis like no other.

Population Modeling
Trial Simulation
Study Design & Analysis
Consulting Services
Workshops

(3)Anavex Life Sciences Corp., New York, NY
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