Selda Samakoglu, Md, Phd Email & Phone Number

San Carlos, California, Us

I am leading a clinical program to advance our TIL cell therapies combined with checkpoint inhibitors and validate the significant potential for TIL as a treatment option in earlier stages of the disease in metastatic melanoma, head and neck, and non-small cell lung cancers.

Woburn, Ma, Us

I am executing a broad, aggressive clinic development plan of our Immulytic™ platform (RP1, RP2, and RP3 oncolytic viruses) at Replimune in combination with checkpoint inhibitors to treat a wide range of solid tumors, including immunologically cold tumor types.

Melbourne, Victoria, Au

Leads strategy for the overall global (US/EU) clinical development taking into consideration the medical, scientific, regulatory, and commercial issues for plasma protein therapeutics in hemoglobinopathies.Leads multi-disciplinary, multi-regional, matrix clinical development team (US/EU) for plasma protein drug, hemopexin (CSL889), identifying contingencies, potential risks and strategies to address future obstaclesOversee the development strategy, clinical development plan, and clinical protocols. Recommends scope, complexity, and size, which influence the budget of all aspects of a program. Provides continual critical evaluation of the development strategy to maintain a state-of-the-art development plan that is competitive and consistent with the latest regulatory requirements• Synopsis / Protocol Development, Study Execution, & Study Interpretation • Trial of Medical Monitoring • External Interactions • Due Diligence, Business Development, and Alliance Projects • Leadership, Task Force Participation, Upper Management Accountability

Lawrence Township, Nj, Us

The disease strategy leader in providing strategic compound leadership and decision making within the areas of translational and clinical research, analysis, and application of approaches to curing hematological malignancies treated with Nivolumab (anti PD1), Elotuzumab (anti-SLAMF7), Ulocuplumab (anti CXCR4) and Ipilimumab (CTLA-4).

Sunnyvale, Ca, Us

 Portfolio oversight, managerial responsibility, and cross-functional liaison Overseeing translational medicine strategy of up to 12 clinical development programs for ibrutinib and its combinations including confirmation of molecular MoA (target engagement, PD measurement, and modulation of tumor immunity), identification/implementation/execution of predictive biomarker strategies, the proposal of evidence-based combination therapies, as well as expansion of clinical indications. Lead team to chart actionable biomarker landscapes associated with clinical responses, lines of treatments, disease etiologies, or stages to guide the rapid development of pipeline molecules as a single agent or in combination. Inform next wave therapeutic opportunities through interrogating disease biology

Ingelheim Am Rhein, Rhineland-Palatinate, De

 Led the development of clinical and translational medicine strategy for IAP Activator, BET, and mTOR inhibitors from first in man studies through proof of concept. Contributed the design of clinical pharmacology studies and ensure a robust system of execution, analysis, interpretation, and reporting of clinical PK and PD, safety, efficacy data and ensure the quality of regulatory submission efforts. Formulated short term and long term strategy and milestones for early clinical development programs. Negotiated, established, and managed key collaborations. Served as a principal representative at internal and external meetings

Foster City, Ca, Us

 Global clinical biomarker leads in oncology, inflammation and immunology and responsible for the formulation of methodology studies, proof of mechanism studies, proof of concept studies, medical device studies, clinical development plans, trial design, protocols, amendments, biomarker study budgets, conducting data review, analysis, and interpretation.

Us

 Led a group of scientist and oversight of a GLP lab to develop pharmacodynamics biomarker assays using genetics, genomics, proteomics, molecular pathology, and imaging technologies

Us

Led preclinical pharmacology team assigned for demonstrating the mechanism of action, PK, PD, efficacy and, safety relationships of monoclonal antibodies using xenograft mouse models of cancer as well as orthotopic and metastatic models. Provided leadership to establish a PDX tumor and serum biomarker database consisting of information for RTK gene copy number, mutation status, gene, and protein expression in tumor tissue, serum, and plasma concentration. Established and led the novel target discovery and mechanism of action group with 5 direct reports who can employ biophysical, biochemical, molecular and cell biology tools to select and characterize novel target genes and lead therapeutic candidates by functional criteria uniquely defined for each R&D project at ImClone and Eli LillyLed development of lenti- or adenovirus vector driven RNAi technologies for target identification, target validation, and biomarker identificationIsolation of Double Minutes (DM) from chemo-resistant patient tumor tissue, which created a proof of concept as source of multi-drug resistance genes and disease-specific activated oncogenes. Implemented as part of ImClone’s research program to identify novel target gene and resistance biomarkers. Demonstrated the proportional increased of drug resistant stem cell-like tumor cells in NSCLC and CRC tumors previously treated with chemotherapy or Necitumumab. Led ImClone’s first research group to study molecular profiling of drug resistant stem cell-like tumor cells to discover drug resistance biomarkers Developed a novel system by Flp-mediated homologous recombination, integrating a promoter-reporter construct to an open chromosomal location to overcome reporter-gene silencing. Utilized this system to coordinate small molecule library screening for MCM2 (repressors of minichromosome maintenance complex component) and CD13 promoter as drug targets.

Charted research that investigated a genetic strategy for single or combinatorial analysis of microRNA function in mammalian hematopoietic stem cells. Characterize and improve the delivery of oligonucleotide drugs (anti-miRs and microRNA mimics) across hematological malignancies

Pioneered a genetic strategy for the treatment of sickle cell anemia by co-regulating globin transgene expression and RNA interference. Guided research on globin gene transfer for the treatment of beta-thalassemia and sickle cell anemia as well as analysis of clinically relevant mutations occurring lymphoid cells harboring gamma-retrovirus-encoded hsytk suicide genes.Recognized as a key inventor on a patent for tissue-specific and regulated RNAi expression vector technologies from drawing board to pre-clinical in vivo efficacy studies. (Composition and methods for delivery of interfering RNA. Attorney Docket No 51590.63357P)

Analyzed mechanisms causing sustained reversion of beta-thalassemia in mice by doxycycline-controlled erythropoietin delivery from muscles.

Discovered that betaMinor-globin messenger RNA accumulation in reticulocytes governs improved erythropiesis in beta thalassemic mice after erythropoietin complementary DNA electrotransfer in muscles.SELECTED PUBLICATIONS Samakoglu S, et al. Importance of the Hsa-miR-29b/DNMT3b/Tumor Suppressor Gene Axis in the Benefits of EGFR Antibody + Cisplatin/Gemcitabine Combination Therapy in NSCLC Models. Cancer Genomics and Proteomics 2012, 9:2, 754-68 Prewett M, et al. Estimating Preclinical Efficacy Targets Utilizing Cetuximab Efficacy in KRAS Mutant and Wild-type Colorectal Cancer Models. Anticancer Res. 2011 Jun;31(6):2149-60. Duignan IJ, et al. Pleiotropic stromal effects of vascular endothelial growth factor receptor 2 antibody therapy in renal cell carcinoma models. Neoplasia. 2011 Jan;13(1):49-59.Samakoglu S, et al. A genetic strategy to treat sickle cell anemia by coregulating globin transgene expression and RNA interference. Nature Biotechnology, 2006, 24(1): 89-94.Samakoglu S, et al. Progress toward the genetic treatment of the beta thalassemias. Annals New York Academy of Science, 2005, 1054: 78-91,Samakoglu S., et al. Mechanisms leading to sustained reversion of beta thalassemia in mice by doxycycline controlled Epo delivery from muscles. Molecular Therapy, 6(6), 793-803, 2002.Samakoglu S.,et al. Beta-minor globin mRNA accumulation in reticulocytes governs improved erythropoiesis in beta-thalassemic mice after erythropoietin cDNA electro-transfer in muscles. Blood, 2001, 15 April, Vol: 97, no;8, 2213-2220.Samakoglu S., et al. Improvement of erythropoiesis beta thalassemic mice after intramuscular electrotransfer of the mouse erythropoietin cDNA. Molecular Therapy, 2000, vol: 1 (5), 299.Samakoglu S., et al. Nucleotide changes in the gamma-globin promoter and the (AT)xN12(AT)y polymorphic sequence of beta LCRHS-2 region associated with altered levels of HbF. Human Genetics, 1999, vol: 7, 345-356.

Md, Medicine / Oncology

Ph.D, Molecular Biology And Medical Biology