Joint Fellowship Training Program Fellows Bedri Karakas, Ph.D. Phone:   301-796-0241 E-Mail:   bedri.karakas@fda.hhs.gov Professional Background Dr. Karakas received his Ph.D. from the University of Georgia, Athens with studies in plant molecular genetics, dissecting metabolic pathways via the antisense posttranscriptional silencing mechanism, gene transfer, and molecular stress tolerance. He was a Post-Doctoral Research Fellow in a Breast Cancer Therapeutics Laboratory at Johns Hopkins University, Baltimore, Maryland and began the NCI-FDA Oncology Product Research/Review Fellowship program in October 2006. Research Interests Dr. Karakas is pursuing research in breast cancer biology including identification of drug targets for targeted therapy via somatic cell gene knock out/knock in techniques and has studied the TGF-beta growth promotion pathway. He has researched drug resistance in modified cell lines and the sequencing of breast cancer tumors and breast cancer cell lines for mutational/functional analysis in the PIK3CA oncogene. Dr. Karakas was involved with studies of the RNAi gene knockdown versus gene knock out for identification of gene function in cancer initiation and progression. He is pursuing research into targeted therapies, oncogenomics, genomic biomarker identification and validation, and the development of early cancer diagnostics using DNA mutation biomarkers. Fellowship Experiences "This fellowship provided me with the opportunity to see both sides of the story in the oncology product development process. I have participated in core courses and workshops on drug, biologics, and medical device review and regulations (e.g., New Reviewers Workshop, Introduction to Drug Regulation and Review, IND Regulations, Topics in Clinical Trials). I have attended numerous meetings related to the IVD approval process and shadowed FDA reviewers. I am an active member of FDA's Clinical Genomics Group. On the research side, I have been working on validation of a DNA mutant biomarker in early diagnosis of cancers in plasma by magnetic bead and emulsion PCR technology. "Most of all, the NCI-FDA fellowship gave me the opportunity to be in an environment where there is a continuing discussion by both researchers and the reviewers about development of safe and effective products. I feel that I have acquired a new skill set that has adequately prepared me for a future career in drug development and the regulatory drug/device approval process." Career Goals "The NCI-FDA fellowship experience will complement my previous diverse training and, most importantly, allow me to achieve my goal of bringing the most promising new diagnostics and therapeutics for use in the diagnosis/treatment of human cancers. I am seeking new opportunities for a regulatory and/or research position."

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