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About: Demet (Dee) Sag

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http://demetsag.wordpress.com
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www.linkedin.com/in/demetsag Dr. Sag has speciliazed in Molecular Genetics and Developmental Biology. Applied her strong scientific knowledge on translational research for diagnostics and targeted therapies with cutting edge technologies. She turns around failing projects to the completion by gathering resources, training others if necessary, and manage budgets to execute them on time correctly. Worked in public, private and federal working environments with stellar scientists. These interactions brought her an important perspective to solve obstacles wisely. She has experienced both in academic and industrial settings which is very unique. Warm persona with ironmade standards on work ethics, time management, work-life balance that will benefit any team. Specialties Recognized Authority *Cross-Matrix Leadership *Alliance Management *Strategic Execution *Consulting * Diverse Portfolio * Biologics *Medical Device *Drug *Gene-Cell *Regulatory, Scientific & Medical *Dynamic *Innovative *Curious *Idea to Market "My passion is to find solutions for unmet health issues. Established diverse portfolio in translational medicine from an innovation to market under global regulatory requirements with precision using functional genomics to system and signaling cascades in stem cell differentiation and development related to pathology (disease), targeted molecule, drug for biomarker selection, or discovery. Thus, my regulatory medical written reports reflect quality deliveries, after a careful data and gap analysis. When life gave me lemons, I made lemonade. Early on my career accessed to seven international grants, scholarships and fellowships to fund my doctoral thesis and set up fully funded research lab based on stem cell and functional genomics to system. Next, bridged between academia-industry. Proactive communicator to originate strategic alliances in academia, industry, federal to get the job done right less than given budget and time. My Proposed Value is integration of science and medical needs with 360-degree product-life-cycle under regulatory requirements." EDUCATION “Focus on Knowledge and Stay Curious” PhD, Molecular Genetics and Stem Cell Developmental Biology, Illinois Tech, Chicago, IL MS, Microbial Engineering and Biotechnology, Illinois Tech, Chicago, IL BS, Biology, Basic and Industrial Microbiology, Ege (Aegean) University, Bornova (Izmir), Turkey -Magna Sum Cum Laude among the 450-graduating class at Faculty of Science in six majors, finished in 3 years. Certificates and Continued Education,  Clinical Affairs certificate CITI Program, A Division of BRANY, March 2021-2024 Credential ID 41766751  Conflict of Interest, CITI Program, A Division of BRANY April 2021-2024 Credential ID 41766752  CA and R&D - Basic/Refresher, CITI Program, A Division of BRANY April 2021-2024 Credential ID 41766750  Dual Regulatory Certificate, RAPS in Drug and Medical Device Global, EU, US (November, 2020)  Life Science Industry Certificate (LSIP), BRIDGE Grant Biocom Collaborative Institute  CRA, GCP, KRGI Clinical Research and International Biopharmaceutical Association (IBPA)  Genome Structure and Function, nanotechnology, sensors, thin layer membrane, microfluidics, lab on chip for Personalized Medicine, ELBA Foundation and NATO Advanced Science Institute, Isola de Elba, ITALY (1996) SELECTED ACCOMPLISHMENTS Translational Science in Clinical Medicine: Fast-tracked translational research development in key health areas by conducting pre-clinical studies and by collaborating with medical teams to maintain quality deliverables. Achieved cost reduction, improved success rates by customized biosensor/biomarkers. Guided the planning and implementation of all operational aspects of Translational Medicine clinical trials from study concept to reporting in accordance with timelines, budget, operational and quality standards for all aspects of the management, clinical execution in multiple therapeutic areas. Boosted client revenue by 30% by presenting durable multi-use sensors in a previously untapped market, gathering customer intelligence, and identifying new product opportunities for improved technology introduction. Ensured product selectiveness for a biomarker developer client by communicating with research, product development, and marketing teams, assisting in industry testing, and presenting product innovation strategies to involved stakeholders. Accelerated customer retention by 50% for a clinical research client by identifying gaps in preclinical assays and by presenting solutions for timely project response and initiation. Expanded client research for multiple drug applications while reducing trial cost by 40% by identifying gene utilization in targeted therapies, developing and providing information resources, and reducing product failure risk. 
 • Strengthened industry exposure for a Translational Medicine program at UCSD by providing translation medicine, education and training; assisted student researchers in gene application for accurate diagnostics and targeted therapies. • Invited Expert Panel Member by Canadian Government to review of The Centre for the Development and Commercialization of Biotherapeutics (CDCB), Ottawa, Ontario, Canada (April 9-11, 2014) and 2017 for commercialization. • Diverse portfolio to streamline “clinical development” with team building and stakeholder communication Regulatory and Medical Affairs: Guided the planning and implementation of all operational aspects of Translational Medicine clinical trials (First in Human, Concept Study, Investigational, Observational, I, II, II/III, IV) from study concept to reporting in accordance with timelines, budget, operational and quality standards for all aspects of the management and clinical execution of global early phase clinical trials across multiple therapeutic areas. Established 20% increase in survival rate of cancer patients with acquired or inherited coagulopathies by creating a clinical application, developing protocols, and facilitating regulatory submissions and timely amendment Author, editor, regulatory documents on clinical research, protocols, publications, patents, grants. Clinical study reports (CSRs), Informed consent forms (ICF), Target Product Profile (TPP), labeling, Common Technical Document (CTD), Investor Brochures (IB), Post Market Surveillance, Risk Analysis and Management, Compliance, Quality, Design, GCP, Biologics, GMP. US FDA: IDE, PMA, 510 k & IND, BLA, NDA EU EMA: CTA, MAA, IMPD, EU MDR 2017/745, Clinical Evaluation Plan & Report (CEP/CER), EU IVDR 2017/746, Performance Evaluation Plan & Report (PEP & PER) Ethics, Global Strategy for Medical Devices, Global Strategy for Pharmaceuticals (P), Medical Device Definition and Lifecycle (M), Pharmaceutical Definitions and Lifecycle (MP), Role of the Regulatory Professional, Project Management for the Regulatory Professionals (PM), Risk Management (M), PMS (M), CAPA and Recalls (M), Due Diligence Product Development (MP), GCP (MP), Understanding of the Clinical Applications (MP), Effective Regulatory Communications (MP), Writing with Good Writing Practice and Statistical Applications (MP), Medical Writing for Biologics and Pharmaceuticals (CTD, NDA, MAA, BLA), Medical Writing, Investigational Applications(IND, IDE, Canadian CYA, Canadian ITA, European CTA, European IMPD), Medical Writing for Medical Devices (PMA, 510k), Global Regulatory Affairs &Intelligence, European Regulatory Affairs & Strategy, US Regulatory Affairs & Strategy. Authored, reviewer for regulatory documents, reports on clinical research and trial design, protocols, publications, articles, abstracts, and scientific posters with a matching scientific approach from sequencing, large datasets, integration of information, and statistics. Business Development with Strategic Alliance & Key Opinion Leader (KOL) Engagements: Ensured product selectiveness for a biomarker developer client by communicating with research, product development, and marketing teams, assisting in industry testing, and presenting product innovation strategies to stakeholders. Stayed vigilant in life science market and follow the trend closely to analyze the primary acquisition goals, mergers, partnerships. Evaluated the market and positioned the product value to gain easy integration and acceptance for sale. Built-up teams and reached out to KOLs to provide logistics and deliverables. Administered grants, monitored budgets, operated cost management beyond the job description up to $10 million for 1-4 years. Result: Bridged Clinical development and Operations under Regulatory requirements for product development: o Invited by Canadian Government as an Expert Panel Member for the review of The Centre for the Development and Commercialization of Biotherapeutics (CDCB), Ottawa, Ontario, Canada (April 9-11, 2014) for commercialization. o Revitalized a failing industry partner project (Bayer) while reducing clinical trial time by 70% by bridging communication gaps and creating a database for error-free sample processing to ensure quality. o Boosted client revenue by 30% by presenting durable multi-use sensors in a previously untapped market, gathering customer intelligence, and identifying new product opportunities o Expanded client research for multiple drug applications while reducing trial cost by 40% by identifying gene utilization in targeted therapies, providing information resources, and reducing product failure risk. o Accelerated customer retention by 50% for a clinical research client by identifying gaps in preclinical assays and by presenting solutions for timely project response and initiation. o Strengthened industry exposure for a Translational Medicine program at UCSD by providing translation medicine, education, training; assisted student researchers in gene application for accurate diagnostics and targeted therapies. o Large pharma EU pre-clinical submission (Nov 2021- March2022) o Translational Medicine, identify biomarkers for immunotherapy platform using single cell genomics Key Words: Single cell (immune, microbiome, stem cells, viral, bacterial, fungi), Cellular differentiation and programing, Development, Genetics, Genomics, Chromosome Walking, In Vivo, Immunology, Inflammation, Genomics Physiology, Biomarkers-Biosensors, Nanotechnology, Gene and cellular Therapy, Laser, Optics, comparative development, physiology, signaling cascades, GPCR, single/stem cell, Metabolism, Endothelial Cell Activation, Vaccines, companion diagnostics (CDx), pharmacogenetics/ pharmacogenomics (PGx), bioinformatics. Neurodegenerative: Alzheimer’s Disease; Blood Brain Barrier (BBB), Rare Diseases: Hemophilia B, Cystic Fibrosis, CFTR, Oncology, Hematology, Tumor, Blood Cancers, Cardiovascular (CVD), Thrombosis, Trauma, Stroke, Dementia, Cancer Coagulopathies, Human Vein Tissue engineering (Lentiviral), Anti-Coagulant Therapy, Gene Therapy (AAV, lipids), Diabetes, Industrial Microbiology, Biotechnology, Infection, GI Microbiome, Host-Pathogen, Sepsis, Anti-Fungal Treatment, Comorbidities, regulatory affairs, strategy, medical affairs, US FDA, EU, ISO, ICH. CAREER SUMMARY Functional Transgenomics, Founder & President, 2010-Present Assistant Professor, Bahcesehir University, Biomedical Engineering Dept. Besiktas, Istanbul, Turkiye, 2008-2010; Izmir Institute of Technology, Urla, Turkiye, 2000-2004 Principal Scientist, Duke University, Industry Large Pharma Partnership: GSK), 2010-2012, ECU, Greenville, NC (Industry Partnership: Innovative Biosensors, Inc.), 2006-2007; Research Fellow, UNC, Gene Therapy Center, Chapel Hill, NC 2004-2006, Duke University Medical Center, Department of Surgery Durham, NC, 2002-2004 Post-Doctoral Fellow, NIH NCI Advanced Technology Center, Bethesda, MD, 1999-2000 and SIU, School of Medicine, Springfield, IL, 1998-1999 Teaching Faculty (2007-2016): UNC-NC College System, Chapel Hill, Durham, Fayetteville, Boone (15 cr./sem.), 2009-2012; UC, San Diego, 2016; National & California Mesa Universities, Mira Mesa & Palomar Colleges, San Diego, CA, 2012-2016; Un of Phoenix, Ground, Raleigh, NC, 2007-2011; Taught at traditional/untraditional, national/international, urban/rural settings to 17-45 old’s majoring in medicine, nursing, science, engineering Anatomy-Physiology, Genetics, Population Genomics

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