Presentation for HL7 RCRIM and Clinical Genomics SIG HL7 Working Group Meeting San Diego, CA 21Jan2004.

Slides:

Advertisements

Similar presentations

1 HL7 Jan 2007 Working Group MeetingsPharmacogenomics Update RCRIM TC Philip M. Pochon Covance Enterprise Architecture.

Advertisements

HL7 Clinical Genomics SIG Jan 22, 2004 Usha Reddy, PhD IBM Life Sciences.

Presentation to RCRIM San Antonio, TX January 15, 2008 Meredith Nahm, M.S. CV/TB Global Data Standards Efforts Therapeutic Area Data Standards: Cardiovascular.

1 HL7 Jan 2010 Working Group MeetingsCTLAB Pharmacogenomics Update JOINT RCRIM and CG Session CTLAB Message Pharmacogenomics Results Overview.

Clinical Genomics Sub-team Sub-team is one of three that evolved out of the DIA Pharmacogenomics Standards Workshop. Workshop was product of collaborative.

Lecture 2 Strachan and Read Chapter 13

Applications of genome sequencing projects 1) Molecular Medicine 2) Energy sources and environmental applications 3) Risk assessment 4) Bioarchaeology,

applications of genome sequencing projects

E5 Experiences in Japan Examples with unfavorable outcome How can we improve? Masuhiro Kato, PhD Chair, EFPIA Japan Technical Subcommittee (AstraZeneca.

CZ5225 Methods in Computational Biology Lecture 9: Pharmacogenetics and individual variation of drug response CZ5225 Methods in Computational Biology.

1. 2 Key Applications of Genetic and Genomic Testing (slide 1 of 2) Diagnosis of Disease: Whereby genetic or genomic tests are used to screen a patient.

Optimization of Preclinical Animal Models Steven Perrin, PhD CEO, CSO ALS Therapy Development Institute.

1 Pharmaceutical Challenges for the Semantic Web.

Presentation Title February 23, 2011 Establishing Clinical-grade Assays for Support of Drug Trials May 3, 2012 Patrick Hurban Expression Analysis.

Personalized Medicine: Using a patient’s genomic information (as well as other physiological parameters) to improve the safety and efficacy of pharmacological.

Combating major diseases Gender aspects in research Gender aspects in research have a particular relevance to this theme as risk factors, biological mechanisms,

1 Single Nucleotide Polymorphisms (SNP) Gary Jones SPE, Technology Center 1600 (703)

6/28/00TPED1 Resistance Testing: What is it? What does it mean? How does drug resistance emerge? Overview of methods Advantages and disadvantages Current.

The Pursuit of Better Medicines through Genetic Research Terri Arledge, DVM US Department Head Drug Development Genetics.

Genomics Commercialization Glen Schuler Managing Director, Industry Liaison Office University of Saskatchewan.

I.1 ii.2 iii.3 iv.4 1+1=. i.1 ii.2 iii.3 iv.4 1+1=

Pharmacogenomics in Drug Development FDA Science Board April 9, 2003 Brian B. Spear, Ph.D. Director, Pharmacogenomics Abbott Laboratories.

I.1 ii.2 iii.3 iv.4 1+1=. i.1 ii.2 iii.3 iv.4 1+1=

Drug Discovery Process

Biomedical research methods. What are biomedical research methods? An integrated approach using chemical, mathematical and computer simulations, in vitro.

Pharmacogenomics and personalized medicines Jean-Marie Boeynaems

Pharmacogenomics: Implications for CNS Drug Development in the 21st Century Challenges for Development & Approval – Patient & Funding Agency Perspective.

Stages of drug development

September 30, 2005 Lan-Yang Ch’ang, Ph.D. Institute of Biomedical Sciences Academia Sinica Scientific Impacts to the Biotech.

Yesterday, today, and tomorrow

Lecture 27- Genomics, Medicine and Pharmaconomics Copyright © 2010 Pearson Education Inc.

The Need for Organ Site Specific Cancer Research John T Isaacs Chemical Therapeutic Program Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.

CS 790 – Bioinformatics Introduction and overview.

The Human Genome Project: prospects for cardiology Claude L’Enfant MD Director, National Heart, Lung, and Blood Institute National Institutes of Health,

Business Value of SW in Drug Discovery Eric Neumann, W3C HCLSIG co-chair Teranode Corporation F2F Cambridge MA.

Investigational Drugs in the hospital. + What is Investigational Drug? Investigational or experimental drugs are new drugs that have not yet been approved.

Heinrich & Corless Laboratories GIST Research Updates: May 2011.

Conservation of genomic segments (haplotypes): The “HapMap” n In populations, it appears the the linear order of alleles (“haplotype”) is conserved in.

Pharmacogenetics & Pharmacogenomics Personalized Medicine.

CLINICAL TRIALS IN NEW DRUG DEVELOPMENT Michael A Ross,M.D. President CPL Inc.

Personalized Medicine Dr. M. Jawad Hassan. Personalized Medicine Human Genome and SNPs What is personalized medicine? Pharmacogenetics Case study – warfarin.

The FDA: Basic Facts It takes 12 to 15 years to develop a single drug Only 1 in 10,000 potential medications makes it completely through the process Only.

Mosby items and derived items © 2007, 2005, 2002 by Mosby, Inc., an affiliate of Elsevier Inc. CHAPTER 50 Gene Therapy and Pharmacogenomics.

Lecture 6. Functional Genomics: DNA microarrays and re-sequencing individual genomes by hybridization.

FDA’s Public Workshop: Innovative Systems for Delivery of Drugs and Biologics: Scientific, Clinical, and Regulatory Challenges Paul Goldfarb, MD, FACS.

FDA Office of Orphan Products Development

Drug Resistance Reports

D4FF55A0-6B6F BF422A9BA9 Present by: Xiao Chen On December 7, 2015.

Kathleen Giacomini, Mark J. Ratain, Michiaki Kubo, Naoyuki Kamatani, and Yusuke Nakamura NIH Pharmacogenomics Research Network III & RIKEN Center for Genomic.

 Treats a population of < 200,000 in the US  Same review and development standards as for a non- orphan product  Numbers of patients in clinical trials.

Consumer Advocate Perspective Clinical Trials Registration Sharon F. Terry, JAM Sharon F. Terry, JAM President and CEO, Genetic Alliance, Inc. Founding.

독성학 박 대 훈 한약재산업학과

Expression Analysis of α4 integrin and related genetic polymorphisms in HIV acquisition and disease progression OF infected individuals Livia R. GóeS 1,

Drug Development Process Stages involved in Regulating Drugs

Single Nucleotide Polymorphisms (SNPs

Drug Discovery &Development

Pharmacogenetics and New Drug Discovery

Development of an interactive pipeline for Genome wide association analysis Falola Damilare & Adigun Taiwo – Covenant University Bioinformatics research.

Figure 1 Inclusion criteria, exclusion criteria, and criteria for virologic failure. CDC, Centers for Disease Control and Prevention; ddC, zalcitabine;

Genetic Testing for the Clinician

Broadening Eligibility Criteria to Make Clinical Trials More Representative Joint Recommendations of the American Society of Clinical Oncology and Friends.

STDMIG-PGx Implementation in Clinical Trials Using Legacy PGx DB

Biotechnology Objectives: At the end of this lecture we will be able to identify and describe the uses of biotechnology in society.

The Lifecycle of Pharmaceutical products

Clinical Trials in STS Shreyaskumar Patel, M.D.

Pharmacogenomics Genes and Drugs.

Drug Design and Drug Discovery

New developments in laboratory monitoring of HIV-1 infection

Current efforts and trends in the treatment of NASH

Presentation transcript:

Presentation for HL7 RCRIM and Clinical Genomics SIG HL7 Working Group Meeting San Diego, CA 21Jan2004

Clinical Trials Pre-Clinical (Animals) Phase I (Healthy Patients) Phase II (Small real patients) Phase III (Large real patients) Phase IV (Post Marketing)

Genetic Testing for Clinical Trials Inclusion / Exclusion Criteria Drug Metabolism Data Disease Predisposition & Progression Gene Therapy & Efficacy Viral Resistance Genotyping Other Genetic Technology for Clinical Trial Testing (eg. PCR)

Types of Clinical Genetic Testing Viral Genetics Viral Load Testing (HIV PCR Viral Load) Viral Sequence Testing (Genotype, Phenotype & Resistance Testing) Human Genetics Microarray Testing Sequencing Testing SNP Testing

Lab Subcommittee: Completed Steps Model Prototypes Viral Resistance Genotyping Human Tissue Transplant Rejection Markers Human Drug Metabolism Markers Fit Standard Use Cases to Model Revise model Add Known Variant Use Cases E.g. Reinterpretation of a Viral Sequence

Lab Subcommittee: In Progress Isolate and Standardize Common Elements Sequence, Codon, SNP, etc. Refine model with Standard Elements Fit Real Data to Model

Future Lab Model Extensions Additional Pharmacogenomics Processes Microarray Data Scientific Extensions Addition of nonSNP Genomic data (e.g. Introns) Interpretation of multiple HIV Strains

Next Steps Define Relation to New HL7-I3C- CDISC-FDA Effort Flow from Preclinical to Lab to Operational to Analysis and Submissions Models Common Large Models with Subsetted Implementations Refinement of Common Data Structures Sequence, Codon, SNP, etc.