Lynn Dressler’s background spans translational research in breast cancer, health policy and bioethics. Her training and experience in the policy arena, coupled with the ethical issues associated with human genetic and genomic research, serve as a bridge between scientific discovery and practical implementation. Overall, her interests are to address the policy and ethical issues faced in integrating pharmacogenomics into clinical practice and integrating research ethics into the scientific process.  

As a translational researcher in breast cancer, she has worked at the interface between the laboratory and practice, evaluating promising new tumor markers to predict prognosis and response to therapy. Her laboratory at UNC Lineberger Cancer Center performed the clinical research study that demonstrated clinical validity and directly lead  to the FDA approval of the HER2 FISH assay (Abbott Pathvysion kit™). This test is now used throughout the U.S. and Europe to predict response to immunotherapy (trastuzamab; (Herceptin™) and doxorubicin in breast cancer patients. The HER2 story is one of the leading examples illustrating how the pharmacogenetics of somatic tissue can help direct individualized therapy.

Dressler is Principal Investigator on one of five projects of the NIH/NHGRI designated Center of Excellence in Ethical, Legal, Social Implications (ELSI) Research (CEER) at UNC, one of eight such sites in the United States. Her study is a multi-case study policy analysis of the large, early NIH Genetic Research efforts (SNP/HAPMAP and Environment-Genetics Polymorphisms) which have now generated data that are being used by secondary investigators. This study will examine lessons learned in these early experiences and how they can be applied to policy development needs of future genomic studies. Dressler also serves as the co-director of the Research Ethics Consultation Core, a service to help investigators, administrators, IRBs, etc. think through the challenging ELSI issues inherent in many of today’s research.

Dressler is completing the last year of a U10 award (of which she is PI), a laboratory study evaluating RNA and protein expression that may predict response to oral capecitabine and standard chemotherapy in elder breast cancer patients.

“We have the opportunity to not only help usher in a new era and standard of care in the practice of medicine, but also develop a programmatic model for effective, equitable and responsible integration of genomic information into medical practice,” she says.

Teaching:
Dressler participates in a variety of guest lectures related to the ethical, legal, social, and policy issues involved in performing genomic and genetic research and translating research into practice, especially in the context of pharmacogenomics.
 

Affiliations:

National:

• Invited Member, CDC Evaluation of Genomic Assays for Prevention and Practice (EGAPP) Stakeholder’s Group.
• American Association for Cancer Reseracher (AACR)-National Cancer Institute (NCI)-Food and Drug Administration (FDA) Cancer Biomarkers Collaborative. Member, Biospecimen and Clinical Assay Working Groups
• Chair, Regulatory and Ethics Subcommittee. National Cancer Institute (NCI)  Clinical Trials Group     Banking Committee (GBC).
• Co-Chair, Biospecimen and Correlative Science Advisory Committee of the  Cancer and Leukemia Group B (CALGB), an NCI-sponsored cooperative oncology clinical trials group;
• NIH/NHGRI Inter CEER Policy Working Group: National Human Genome Research Institute Trans Centers of Excellence in Ethical, Legal, Social Research.
• Cadre Member: Ethics, Breast, Health Services Research, Cancer Control and Health Outcomes Committees of the Cancer and Leukemia Group B
• Member: American Society of Bioethics and Humanities; American Society of Clinical Oncology

Within UNC-Chapel Hill:

• Office of Human Research Ethics. IRB Committee Member.
• UNC Vice Chancellor’s ad hoc Committee on Tissue Banks and DNA Repositories.

Select Publications

Ten select publications out of a total of 78 publications. No patents.

1. Hayes DF, Thor AD, Dressler LG, Weaver D, Edgerton S, Cowan D, Broadwater G, Goldstein LJ, Martino S, Ingle JN, Henderson IC, Norton L, Winer EP, Hudis CA, Ellsi MJ, Berry D. HER2  and Benefit from Paclitaxel Chemotherapy for Node Positive Breast Cancer. New England Journal of Medicine. 357 (15):1496-1506., 2007.
2. Dressler LG. Control and Use of Banked Human Specimens in Research. Biospecimen “Ownership” Counterpoint.  Journal of Cancer Epidemiology, Prevention and Biomarkers. 16(2). 190-191. January, 2007.
3. Dressler LG and Juengst E. Thresholds and Boundaries in the Disclosure of Individual Genetic Research Results.  American Journal of Bioethics. Nov-Dec; 6(6):18-20. 2006.
4. Carey L,  Perou C, Livasy C, Dressler L, Conway-Dorsey K, Karaca G, Cowan D, Torester M, Tse C, Edmiston S, Deming S, Geradts J, Cheang M, Nielson T, Moorman P, Earp HS, and R Millikan. The Poor Basal-like Breast Cancer Subtype is Over-represented in Young African-American Women   JAMA 2006; 295:2492-2502.
5. Dressler LG, Berry DA, Broadwater G, et al. HER2 by Fluorescent in Situ Hybridization (FISH) Compared to Immunohistochemistry Shows Similar Prediction for Outcome Following Dose-Intense Adjuvant Doxorubicin Therapy in Breast Cancer: The CALGB Experience.  J. Clinical Oncology. 2005. July 01. 23:4287-4297.
6. Dressler, Lynn. Human Specimens, Cancer Research and Drug Development:  How Science Policy can Promote Progress and Protect Research Participants. Invited Background Paper.  National Cancer Advisory Board of the Institutes of Medicine (IOM).  March, 2005. Available at: http://www.iom.edu/Object.File/Master/26/207/IOM_fnl.pdf
7. Dressler LG and Thor A. HER2 testing. Laboratory, Technical and Clinical Issues. Int’l J of Breast Disease. 11:77-87. 2000.
8. Dressler LG, Geradts J, Burroughs M, Cowan D, Millikan RC and Newman B.  Policy guidelines for the utilization of formalin- fixed, paraffin-embedded tissue sections. The UNC SPORE experience. Breast Cancer Research and Treatment. 58(1). 31-39. 1999.
9. Dressler LG.  Genetic Testing for the BRCA1 Gene and the Need for Protection from Discrimination: an Evolving Legislative and Social Issue. Int. J of Breast Disease. 10(1,2): 127-135. 1998.
10. Dressler LG, Eudey L, Gray R, Tormey D, Gilchrist K, McGuire WL, Clark G, Osborne CKO, Mansour E, Abeloff M.  Prognostic potential of DNA flow cytometry measurements in node negative breast cancer patients: Preliminary analysis of an intergroup study (INT0076).  Journal of the National Cancer Institute 167-172, 1992.

Select Presentations

Invited talks, 2007 (from a total of 70):

• October, 2007: American Society of Human Genetics (ASHG) Annual Meeting. ASHG Social Policy Panel: DNA as a Unique Identifier: Privacy, Trust, and the Future of Genomic     Biorepositories. Dressler LG:“Research Regulators’ Concerns with Access and Use of Open-Source Genetic Research Data.”
• October 3, 2007: NCI. Custodianship and Ownership Issuses in Biospecimen Research Symposium Workshop. “Ownership, Control and Human Specimen Research. Considerations for Biobanking     and Oversight.” Washington DC. 
• September 5, 2007: “Biobanking and Disclosure of Research Results: Addressing the tension between professional boundaries and moral intuition.” Organizational meeting of co-authors of upcoming book: Mapping the Language of Research Biobanks and Health Registries: From traditional to research biobanks. Edited by UNESCO President.
• August, 8, 2007. AACR-FDA-NCI Cancer Biomarkers Collaborative. “Ethical, Legal and Policy Issues of Use of Human Specimens in Cancer Research.”
• May 18, 2007:  University of North Carolina, Institute for Pharmacogenomics and Individualized Therapy, Chapel Hill. 2nd Annual Drug Research Symposium. “ESLI as a facilitative science in pharmacogenomic studies.”
• February 24-28, 2007: 17th Annual National Interdisciplinary Breast Center Conference. “Ethical, Legal and Social Issues in Breast Cancer Genetic Research in the New Millenium of Genomic Medicine.” Las Vegas, NV.
• February 21, 2007: Centers of Excellence in ELSI Research (CEER) Annual Meeting. Washington DC. Disclosure of Genetic Research Results-An Overview of the NRSA F32 Training Grant.