Refining Processes for the Co-Development of Genome-Based Therapeutics and Companion Diagnostic Tests Workshop Summary (2014) / Chapter Skim
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Appendix B: Speaker Biographical Sketches
Appendix B: Speaker Biographical Sketches
Pages 63-74
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From page 63... ...
Buller was a director in the Oncology Medicine Development Centre at GlaxoSmithKline (GSK) , focusing on development and implementation of clinical strategies around the company's portfolio of oncology drug candidates.
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From page 64... ...
He is the author of more than 140 publications and has received numerous awards and honors, including multiple year listings in the Guide to America's Top Physicians prepared by the Consumer Research Council of America. His major laboratory research interest over the years has been the molecular genetics of ovarian cancer.
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From page 65... ...
He played a key role in coordinating NHGRI's activities related to family health history and was the planning chair for the NIH Consensus Development Program's 2009 State of the Science Conference "Family History and Improving Health." He also participated in efforts to help insure the appropriate representation of family health history and genomic data in electronic health records. Additionally, as chief of the Genomic Healthcare Branch in the Office of the Director, he oversaw efforts to advance genomics education for health professional disciplines including nurses, physician assistants, physicians, and pharmacists.
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From page 66... ...
He has been a member of the Secretary of Veterans Affairs Advisory Council on Genomic Medicine and the National Advisory Council for Human Genome Research at NIH. He is currently an international expert panel member for Genome Canada; a member of the board of external experts for the National Heart, Lung and Blood Institute; a member of the IOM Roundtable on Translating Genomic-Based Research for Health; and a member of the external scientific panel for the Pharmacogenomics Research Network.
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From page 67... ...
Dr. Koch is responsible for all Roche Molecular Diagnostics research and early development activities, including research efforts associated with biomarker discovery and validation, the development of new diagnostic platform technologies such as next-generation sequencing, and continuing improvements in the performance of existing real time polymerase chain reaction (PCR)
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From page 68... ...
His group successfully conducted clinical trials to launch the first molecular test for assessing axillary nodal status in women diagnosed with breast cancer. Prior to this position, in 2001 he was appointed general manager of the cellular diagnostics group at Veridex.
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From page 69... ...
His academic interests are primarily focused on investigating the role of molecular genetic testing in the analysis of tissue specimens, specifically on the methods and clinical settings in which molecular testing provides inde
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Pratt, Ph.D., is a medical and clinical molecular geneticist board certified by the American College of Medical Genetics. She is currently chief director, molecular genetics, for Quest Diagnostics.
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Pamela L Swatkowski, B.S., is director of regulatory affairs at Abbott Molecular, where she is responsible for strategic regulatory programs including companion diagnostics regulatory and business development support, product lifecycle management, and global product registration filings for the molecular diagnostics product line.
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From page 72... ...
She is the author of more than 90 peer-reviewed articles. In her focus at the forefront of consumer participation in genetics research, services, and policy, she serves in a leadership role on many of the major international and national organizations, including the IOM Health Sciences Policy Board, the National Coalition for Health Professional Education in Genetics board, and the International Rare Disease Research Consortium Interim Executive Committee, and she is a member of the IOM Roundtable on Translating Genomic-Based Research for Health.
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From page 73... ...
Mr. Thompson also serves as co-chair of the food and drug law committee in the American Bar Association and of the medical device committee of the Food and Drug Law Institute (FDLI)
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