How Can Institutions Foster OMICS Research While Protecting Patients?

Transcription

1 IOM Workshop on the Review of Omics-Based Tests for Predicting Patient Outcomes in Clinical Trials How Can Institutions Foster OMICS Research While Protecting Patients? E. Albert Reece, MD, PhD, MBA Vice President for Medical Affairs, University of Maryland John Z. and Akiko K. Bowers Distinguished Professor and Dean, March 30, F Street Conference Center 20 F Street NW Washington, DC 20001

2 What is OMICS Research?

3 The Clinical Application of OMICS Research Is Inherently Multi-disciplinary It requires collaborations between: Basic science researchers Healthcare clinicians Research and clinical leadership Technology managers Institutional resources and support

4 What Are The Institutional Challenges in Conducting OMICS Research? Addressing specific questions about OMIC changes and their biological significance Providing tools for quickly screening millions of compounds to determine which will alter the identified targets Enabling critical decisions about which specific interventions to pursue and which to discontinue before reaching the clinic Refining and producing high-quality therapies for those targets and testing their efficacy and toxicity before entering the clinic Designing clinical trials that emphasize matching patients based on their OMIC characteristics and likely response to therapy Fostering research while also protecting patient privacy Source: The Power of Research, the Promise of Hope. National Cancer Institute

5 Institutions Must Become More OMICS Literate and Supportive TO DO SO, INSTITUTIONS MUST: Become aware of emerging scientific opportunities and the potential contributions that OMICS research can make to improving health and preventing and curing disease Provide opportunities for basic scientists and clinical investigators to interact on a regular basis Embrace and promote the campus core values including a commitment to open communication, fairness, trust, respect, integrity, diversity, and teamwork

6 Institutions Must Ramp Up OMICS Training TO MEET THE TECHNICAL NEEDS OF OMICS RESEARCH, INSTITUTIONS MUST: Embrace the education of medical and graduate students as well postdoctoral and resident trainees in the basics of omics research and clinical applications. Support and encourage the active participation of faculty in teaching medical and graduate school courses related to biochemistry, molecular biology, genetics, genomics, and other areas of special expertise. Work cooperatively with other departments to obtain Training Grants, P01-type grants, and participate in building other large-scale institutional grant programs.

7 OMICS-Based Research at Penn State Hershey Harold L. Paz, MD, MS Senior Vice President for Health Affairs, Penn State University Dean, Penn State College of Medicine CEO, Penn State Milton S. Hershey Medical Center and Health System

8 Growth of OMICS Research Increase in Genetics and Genomics Research at Penn State Hershey % of Full Review Studies % 3.8% 4.5% 6.2% 4.6% % of full review studies that included "genetics" or "genomics" in study title 6.3%

9 Institutional Responsibilities in Omics-Based Research Institutional Review Board (IRB) Clinical Laboratory Improvement Amendments (CLIA) Health Insurance Portability and Accountability Act (HIPAA) Intellectual Property

10 Front-Door Consent Goal: Universal, front-door consent from patients to collect samples for possible future genetic studies Challenge: Logistics of implementation Informed consent Staff time and training Harmonizing consent with actual sample flow Sample collection and storage Clinical workflow Processing and storage (including off-site backup) Data management De-identified health registry Ethical issues

11 Case study: Genome-wide association study NIH grant to do genome-wide association studies (GWAS) on reproductive health Problem: Consent forms changed over time and did not always include consent for genetic studies and public disclosure IRB decision: Approved use of samples from patients whose consent forms had included consent for genetic studies PI had to re-consent any patient whose original consent form did not include genetic testing Ethical / Privacy Issues NIH now requires GWAS to be put on dbgap Even de-identified genetic information may pose privacy issues

12 OMICS RESEARCH AT UNIVERSITY OF MARYLAND SCHOOL OF MEDICINE

13 Highlights/Milestones in Genetics/OMICS Research at UM School of Medicine (UMSOM) UMSOM establishes Biopolymer Core, which makes synthetic DNA and peptides USOM researchers discover differential expression of human calcitonin gene between thyroid and lung cancer cell lines UMSOM researchers discover changes in expression of the erbb2 gene contribute to the proliferation of a breast cancer cell line UMSOM researchers elucidate the association between polymorphisms in the paraoxonase gene and the risk of coronary artery disease UMSOM researchers discover that polymorphisms in the dihydropyrimidinase-related protein 2 (DRP-2) gene significantly increase an individual s susceptibility to developing schizophrenia Biopolymer Core expands to become Biopolymer/ Genomics Core Facilty 2007 UMSOM Establishes the UM Institute for Genome Sciences UMSOM names a Director of Genetics and Genomic Medicine UMSOM establishes a Translational Genomics Core to facilitate use of OMICS data in clinical decision making

14 Examples of Initiatives to Facilitate OMICS Research We have created a number of Institutional Cores to facilitate OMICS research and to accelerate the translation of such findings into clinical practice, including: A Biopolymer/Genomics Core Facility to enable and foster institutional science by providing the expertise, state-of-the-art resources, and the training necessary to promote cutting edge genomic research. Proteomics Core Facility to promote the understanding and use of the study of Proteomics strategies by placing the most modern gel electrophoresis, Mass Spectrometry, and protein analysis tools into the hands of researchers. A Translational Genomics Core Facility to aid clinicians participating in early phase drug development clinical trials, as well as basic scientists with an interest in assessing the clinical relevance of their research data.

15 The UM Institute for Genome Sciences (UM-IGS) UM-IGS uses the powerful tools of genomics and bioinformatics to: Understand genome function in health and disease, Study molecular and cellular networks in a variety of model systems, Generate data and bioinformatics resources of value to the international scientific community. UM-IGS specialty areas include: High-throughput sequencing Microbial genomics, Infectious diseases, Cancer genomics, Human genetic variation, Bioinformatics, Metagenomics UM-IGS Director Claire Fraser-Liggett, Ph.D. IGS has more than 100 full-time faculty and staff and $100 million in funding

16 Examples of Current OMICS-Based Research at the Alan R Shuldiner, MD Associate Dean & Director of Personalized Medicine; Genetics and Genomic Medicine Studies the molecular basis and genetics of type 2 diabetes, obesity, and insulin resistance. Genome-wide scans have identified genes involved in glucose transport, obesity, and response to platelet therapy. Edward A Sausville, MD, PhD Associate Director for Clinical Research, University of Maryland Cancer Center Studies the genetics of cancer, Looking for new drug targets. Currently, overseeing a clinical trial of a new drug for treating advanced melanoma based on a patient s genetic profile. Stephen B Liggett, MD Director, Lab for Cardiopulmonary Genomics Studies of genetic variants in heart and lung disease patients and their response to treatment in order to develop geneticallybased personalized medicine. Currently studying genetics of individual response to betaadrenergic receptor blocker therapy

17 UMSOM s Human Research Protection Office (HRPO) The HRPO is the coordinating office for the Human Research Protections Program. It provides: Support for the Institutional Review Board (IRB), which provides oversight activities for more than 1,000 clinical research protocols. Education and training for more than 2000 investigators and staff involved in research involving human subjects. Susan Buskirk, MS Assistant Dean and Executive Director HRPO Investigator toolkits, which are resources for investigators to use when designing, writing, and organizing their research protocols. The HRPO has also established the Research Subject Advocate and Safety Program, a confidential hotline to discuss problems, express concerns, ask questions, obtain information, or offer input regarding clinical trials. The hotline is for: Former, current, or prospective clinical trial participants, Designated patient representatives Members of the community

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