Demet Sag, PhD, CRA, GCP, Expert, Author, Writer
Roles at http://pharmaceuticalintelligence.com
Expert, Author, Writer for the following Research Categories:
- Personalized medicine and Genomic Research
- Biological Networks, Gene Regulation and Evolution
- Biomarkers & Medical Diagnostics
- Coagulation Therapy and Internal Bleeding
- Cell Biology, Signaling & Cell Circuits
- Cardiovascular Pharmaceutical Genomics
- CANCER BIOLOGY & Innovations in Cancer Therapy
- Molecular Genetics & Pharmaceutical
- Stem Cells for Regenerative Medicine
- Nanotechnology for Drug Delivery
UPDATED on 4/22/2020
Demet (Dee) Grace Sag, PhD
857-701-3571
Demet.Sag@functionaltransgenomics.com
LinkedIn.com/in/demetsag
Clinical Trial Operations Protocol
Regulatory Affairs & Medical Writing
- 15+ years work experience Regulatory Medical Writing and Clinical Translational Medicine in academic, industry, CRO, and government settings, bridged in between key opinion leaders (KOLs)
- Developed Clinical Trial Protocols and Regulatory Submission to bring the innovation for commercialization using Translational Medicine, involves multidisciplinary interactions from RD innovation (drug, medical device, combination therapies) under regulatory requirements. Experienced in Phase 0, I, II,I/II, II/III, III, and IV clinical trials.
- Applied functional transgenomics for biomarker development and support clinical trials (dx and cdx) using the gene expression and immune responses in health (Embryonic Stem Cell-transregulation of a single cell to be a functional system) or in disease, for oncology and hematology. Comfortable to use any living system and modeling from gene discovery and mechanism identification to tissue engineering & molecular therapies using stem cells as discovery vehicles based on a thorough understanding of signal transduction cascades. Established a rich portfolio of biotechnology spanning industrial microbiology (manufacturing, microbial engineering) to translational medicine
- Immunotherapy, Immune-Modulation, ImmunoOncology, shRNA, cell modification, orchestrating immune responses
- Gene therapy, HemophiliaB, FIX, VKOR, AAV2-8, lipid, SINE-wave, electrophoresis
- Tissue Engineering, human vein, lentiviral vector carrying Thrombomodulin
- Sepsis Shock, gene expression control, vasopressin
- Cancer Vaccine, GI microbiome & cancer using synthetic genomics for Rx and Dx
- Medical Regulatory Writing, communicates science & clinical application
- EXPERTISE: Translational Medicine, FunctionalTransgenomics, Regulatory Affairs,(CER, EU MDR, IVDR, Clinical Trials, ICH E2, E3, E6, E9, IND, NDA, CTD, CSR, FDA, IB, IRB, IACUC), Product Development (Diagnostics, Pharma, Medical Device), Industrial Microbiology, Biomanufacturing
- TARGETED DISEASES: Cancer, Hematology, Cardiovascular & Coagulation, Diabetes, Metabolism, Neurodegenerative Diseases (Alzheimer’s, Parkinson), Sepsis, Immunology (B, T, DC cells), Infectious Disease.
- TECHNOLOGY: Stem Cell, Biosensor, Biodefense, Biomarker, Nanotechnology, Gene Therapy, Laser, Optics, Imaging, Tissue engineering, Trans regulation, Precision, CDx
EDUCATION
Ph.D., Molecular Genetics and Stem Cell Dev Biology, Illinois Institute of Technology, Chicago, IL
01/1995-12/1998
MS., Microbial Genetic Engineering. & Biotechnology, Illinois Institute of Technology, Chicago, IL
08/1992-12/1994
B.S., Basic and Industrial Microbiology, Aegean University, Science Faculty, Bornova, Turkey
08/1987-07/1990
– Magna Sum cum Laude in Science Faculty, in all majors, completed in 4 years in 3 years
- Dual Degree (Faculty of Science & Faculty of Literature, Teaching) Demonstrated effective management of the classroom; Used in multiple instructional methods and techniques in recognition of the different learning styles.
PROFESSIONAL WORK EXPERIENCE
PRINCIPAL (Owner), Functional TransGenomics (FTG) , LLC. (1/2010 to Present)
DIVERSE and STRONG KNOW HOW: Applied Translational Medicine, Functional Transgenomics, Gene/RNA Regulation, Industrial Microbiology that are corner stones of clinical product development in pharmaceutical, biological, medical device, RX or Dx.
- FTG consulting started when I was teaching 15 credits per semester at the UNC system simultaneously doing research at Duke Biomedical Engineering-Duke Medical Center to develop projects for friends through word of mouth in the industry. As a result I started consulting and moved to industry. Also, family factors and health played a role.
Clinical RD, Clinical Operations, and Translational Medicine: Led the planning and implementation of all operational aspects of Translational Medicine clinical trials (Phase 0, 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. Examples: on project level decision making, manage scientifically and operationally complex studies, consult, support, develop strategic commercialization plans, mentor team members for a complex patient population to manage multidisciplinary Clinical Trial. Contributed to the evaluation of clinical sites and external service, the data review. Worked closely with the medical monitor, project and study teams deliver enhanced efficiencies and quality around tactical deliverables, Investigational New Drug (IND), New Drug Application (NDA), Investigator Brochures (IB), MAA, EUA clinical trail applications, and regulatory report Submissions, protocol development, amendments and all supporting documents, PK/PD.
Medical Writing and Regulatory Affairs: Analyzed clinical data with a strong scientific evidence to deliver the message succinctly using an innovative approach for Drug/Pharmaceutical, Biologic, Medical Device, Combination. Overseen, reported clinical research /trials, and written protocols/publications with an understanding of the US Medical Testing Environment and GLP under FDA, CAP, CLIA guidelines, and clinical practices under GCP Guidelines/ICH E6. Authored and Wrote IRBs, IACUC, SOPs, new drug applications (NDAs). Led the development of Clinical Evaluation Reports (CERs), performed Clinical Risk Benefit Analysis (CRBA) in cross functional teams, Informed consent forms (ICF), ICH E2A Clinical Safety Data Management, ICH E3 Structure and Content of Clinical Study Reports (CSR), ICH E8 General Consideration for Clinical Trials, clinical research forms (CRF), ICH E9 Statistical Principles, statistical analysis plans (SAP). Worked under medical device guidelines to prepare submission documents (MEDDEV 2.7/1, ISO 13485, US FDA 510 (k), investigational device exemptions (IDE), ISO 13485. Developed Study Operations Protocols (SOPs), Work Instructions (WI), templates for monitoring plan, and other study essential documents.
CLIENTS under FUNCTIONAL TRANSGENOMICS (FTG) (2010 to Present)
Medical Writing and Regulatory Affairs:
Regulatory Affairs EU MDDR Clinical Evaluation, Boston Scientific Marlborough, MA
02/2020 to 3/2020
Tria-Urétéral stent, NEW DEVICE,-Made with Percushield™ technology designed to provide protection against the accumulation of both Mg and Ca salts during indwell. (Short term consulting)
Regulatory Affairs EU MDDR Clinical Evaluation, CynoSure, Inc. , A Hologic Company
02/2019 to 11/2019
(Director Level) – Cynosure unit is sold in Nov 2019)
- Created SOPSs, WIs, and templates per regulation. Completed the full CERs for COMPLEX Laser based innovative Medical Device including the components. Performed literature search for the state of the art, competitive market analysis with biological, technological, clinical applications. Analyzed the clinical and scientific literature, results and appraised quantitatively
- Executed due diligence of the devices to create equivalence device presentation, generated post market follow up/risk/vigilance plans. Sole responsibility of writing Clinical Evaluation Reports (CERs) MEDDEV 2/7/1 Revision 4 per EU MDDR. The Devices were complex laser technology based with multi clinical indications:
- Smartlipo® Triplex® and Delivery Systems (1064/1320/1440nm Nd:YAG laser), SmartSense™ Delivery System distributes precise energy by measuring motion and delivery of laser power. ThermaGuide Temperature sensing cannula provides temperature feedback to deliver the appropriate level of laser energy.
- Cellulaze®, (1440nm Nd:YAG laser) is a minimally invasive treatment that effectively targets cellulite. SmartSense™ Delivery System distributes precise energy by measuring motion and delivery of laser power. ThermaGuide™ Temperature sensing cannula provides temperature feedback to deliver the appropriate level of laser energy.
- PrecisionTx® (1440 Nd:YAG laser) has a cutting edge technology for high demand lower face and neck revitalization treatments. SideLaze800™ side-firing fiber for unmatched precision, ThermaGuide™ temperature sensing cannula for increased safety
- SculpSure® (1064nm Diode Laser), is the world’s first FDA-cleared laser treatment for non-invasive body and sub-mental contouring. Petite Mask software for sub-mental designed specifically for patients with a narrow jawline; Updated GUI Screen.
- PicoSure® (532/1064, 755 nm Alexandrite Laser),The world’s first picosecond aesthetic laser-optimal wavelengths for treating pigmentary conditions and overall skin revitalization, with the added capability of tattoo removal.
- Icon™ (1064 Nd:Laser, 2940nm Er:YAG laser, 1540 Nd:YAG laser, and Intense Pulse Light-IPL) with 7 hand-pieces, is the industry-leading aesthetic platform. Skintel™, the industry’s only live melanin reader. Facial vessel clearance and pigment reduction, Surgical, acne scar treatment, Stretch mark treatment, Wrinkle reduction, Leg vein clearance, hair reduction, skin resurfacing etc
- Medlite (532/1064, 585, 650nm short pulse lasers), has the Q – switched Nd:YAG technology provides safe, effective treatments for tattoo removal, skin revitalization, and pigmented lesions.
- RevLiteSI (532/1064, 585, 650nm) high-powered, treats everything from pigmented lesions to fine lines and wrinkles, and colorful tattoos. Built on the original ConBio™ Q-Switched laser technology, is a multi-wavelength system.
- Cynergy™ MPX/PhotoGenica V-Star/Vascular WorkStation (1060nm Nd:YAG and 595nm Pulse Dye Laser), World-class, dual-wavelength vascular workstation proven safe and effective, including for pediatric use. It is able to treat Facial and leg telangiectasis, Spider veins, Hemangioma, Port-wine stains, and more.
- The Elite+™ Aesthetic Workstation (755nm Alexandrite and 1064 Nd:YAG laser) to treat 12 indications for all skin types, and variable spot size using a dual-wavelength system delivering treatments for hair removal, vascular treatments, epidermal pigment, and wrinkle reduction. Utilizes pigment measuring technology.
- Vectus® Laser (1064nm diode laser) is for hair removal, consistently one of the most in-demand aesthetic treatments.
- Contributed to IDE for SmartXide/MonoLisa Touch
LEAD MEDICAL WRITER Translational Medicine & External Grant Reviewer, Grant Engine, Chapel Hill, NC
2017 to 2018
- Consulted with the C level executives to bring their innovation to commercialization through analyzing the translational process from preclinical development to clinical development. Provided support to present the benefit of the technology for health in economical terms, comparative market analysis for comparable products (due-diligence), summarized the budget, align the timelines with the project for a success, generated necessary collaborations between academia or industry KOLs, assessed the data (scientific finding, preclinical application towards first in human and concept, phase 1, phase 2) for commercialization.
- Led-Managed the federal industry grant projects and ensured that our team will deliver the wining grant for the technological innovation for commercialization with a seamless plan. (The Small Business Innovation Research (SBIR) Phase I, Phase II and combined programs, which is a highly competitive program that encourages domestic small businesses to engage in Federal Research/Research and Development (R/R&D) that has the potential for commercialization.)
- Identified shortcomings and enabled go and no go decisions when it is necessary.
- Reviewed and wrote SBIR Fast track (Phase I/II) , Phase I, and Phase II applications on innovative technologies,
- Reviewed and developed commercialization plans including budgets for personnel salaries, assay development expenses, travel, environmental support (equipment, facilities). Insured project timelines and aims match with deliverables.
Technologies (clinical trial phase) from innovation to commercialization:
- Dualogics, LLC (Phase I) has a platform, OrthoMab(™), to develop bispecific Ab with variable biophysical and immunologic properties. It is developing a novel antibody-based treatment targeting the pathogenic T cells for graft-versus-host disease (GVHD). The allogenic hematopoietic stem cell transplantation (HSCT) provides the only chance of a cure for some types of cancer to prevent up to 70% of HSCT deadly complication. RNA technology and manufacturing emphasized.
- Plakous (Phase I) has the technology to extract/preserve the cytokines, growth factors previously locked within the placental disc.
- Symberix (Fast Track-Phase I&II) plans to develop “Symbiotic Drugs” the first treatment indicated to ameliorate chemotherapy-induced diarrhea (CID) by bacterial-specific enzymatic activity in the gastrointestinal tract microbiome. Currently, CID treatments are palliative, addressing the symptoms of CID, but not its cause.
- ApolloDx (Fast Track-Phase I&II) has a comprehensive technology platform for point-of-care discrimination between acute bacterial and viral infections. Biomanufacturing, industrial microbiology and emphasizing on RNA technology was one of the key factors. The ApolloDx Rapid-BV (Bacteria-Virus) called APOLLOMER test is to prevent antibiotic misuse of antibiotics.
- ARIZ Precision Medicine (Phase I) is developing a targeted therapy for Multiple Myeloma based on siRNA technology deducing early diagnosis by specific biomarker in specific cell types though a local delivery.
- AI Tracking Solutions LLC (AITS) (Fast Track-Phase I&II) to produce a neural network tracker (NNT), which automatically determines the location of all particles in each frame of a video, and retains the identity of all particles from frame to frame. The Particle Tracking (PT) is a powerful biophysical tool for elucidating molecular interactions, transport phenomena of diverse species, and rheological properties of complex materials by combined convolutional neural networks and machine learning.
- Tarran-Eldec (Phase I) is creating a stable peptide to reduce inflammation to help Cystic Fibrosis patients by regulating the Orai-1-dependent influx of Ca2+ for an effective anti-inflammatory therapeutic to treat chronic lung disease, which is the primary cause of morbidity and mortality in CF patients. Transactivation and RNAs were also concerned.
- Panaceutics (Phase I) is going to formulate a personalized multi drug formula as a single dose gel suspension don addressing the pill burden, which will reduce adverse drug reactions (ADRs) and improve adherence.
- Mucoimmune, LLC (PhaseII) has a novel treatment for the respiratory syncytial virus (RSV) by directly delivering high concentrations of monoclonal antibody to the lung. Biomanufacturing and transcription regulation were critical
- VoltMed (Phase I), medical device company, has a technology to evaluate brain tumors. Their product is called IRE and H-FIRE(™) using the commercial IRE device NanoKnife(®) as the predicate device.
- Adeptrix, (Fast Track-Phase I&II) a proteomics company, has a proprietary Affinity Bead Assisted Mass Spectrometry (Affi- BAMSTM) technology. Their assay facilitates discovery and validation of new protein biomarkers by simultaneously measuring changes in total protein abundance, an abundance of different protein isoforms and site-specific wealth of post-translational modifications (PTMs) for 500 essential proteins and protein sites.
- CibusDx (Phase I) wants to detect infectious diseases by a small handheld device measuring disposable test strips through the electronic biosensor in long-term care facilities to food production sites, like Noratest for Nora Virus.
- Arcato Laboratories Inc. (Fast Track-Phase I&II) aims to advance the oral healthcare and to limit opiate use by Orawax and prevent opioid types of drugs.
- Magnetic Particle Imaging (MPI) (Fast Track-Phase I&II) is developing a localized inflammation imaging technique.
- Molecular Assemblies (Fast Track-Phase I&II) has the proprietary novel enzymatic approach to synthesize DNA and to replace the 30-year-old chemical method.
- Abreos Bioscience (Phase I) to develop sensitive laboratory and point-of-care tests to monitor active drug serum concentrations of the therapeutic mAb drugs that will provide pharmacokinetic info for mAb and biosimilars.
- Initos Pharmaceuticals LLC, (Fast Track-Phase I&II) aims to use Oligonucleotide Enhancing Compounds (OECs) for splice correction in Cystic Fibrosis-relevant Manufacturing of the oligos and RNA regulation were essential.
- Good Bowls (Phase I) is a low-income friendly cooperation to provide healthy nutrition at a low cost.
- Revive (Phase I) to address the sudden cardiac arrest (SCA) and developed the next generation automated external defibrillator to treat sudden cardiac arrest (SCA).
- Chromocode (Phase I and Fast Track-Phase I&II) wants to develop non-invasive parental testing (NIPT) with their ddPCR technology, novel method of “super-color” multiplexing for traditional qPCR instruments. RNA manipulation was important.
- Digenomix (Fast Track-Phase I&II) is a spin-off technology company from Fludigm. It is developing an automated Single Cell Genomics sequencing technology. This technology utilizes transactivation and regulation of RNA, to apply a qPCR technology.
PATENT REVIEWER, Turk IP Law, Miami, FL.
4/2015 to 12/2016
- Reviewed patent application and insured claims are written coherently to cover the IP.
- Analyzed prior art, search previous or similar apps.
EXPERT, AUTHOR, MEDICAL WRITER,
Leaders in Pharmaceutical Business Intelligence (LPBI) Group, Boston
1/2013 to 9/2018
- Venture works on the publication of e-books, meetings, providing intelligence to the investors to connect
- Personalized medicine and Genomic Research;
- Biomarkers & Medical Diagnostics;
- Cell Biology, Signaling;
- Cancer Biology & Innovations in Cancer Therapy;
- Stem Cells for Regenerative Medicine;
- Nanotechnology for Drug Delivery
FREELANCE WRITER, Sanguine, Inc. Los Angeles, CA
2012 to 2014
• Patient-centered information regarding available clinical trials and application to improve health
Selected Ad Hoc Editorial Boards
2010 to 2016
• Journal of Investigative Genomics (ISSN: 2373-4469JIG),
• Journal of Human Virology & Retrovirology (ISSN: 2373-6453JHVRV),
• Journal of Alzheimer’s Association (Elsevier for Alzheimer’s and Dementia)
• Journal of Nutrition
GENETICIST, VARIANT CURATOR WRITER, Pathway Genomics, Inc., San Diego, CA
2013 to 2014
- Assisted the Laboratory Director in the design of clinical testing pipelines and provided genomics variant analysis, SNP determination utilizing Sanger and NGS Interpreted and classified genetic variants identified through clinical testing as well as interfacing with Clinical Genetics Services (CGS) for pre- and post-sign out issues, including variant assessment curation. Worked on clinical developmental applications .
TECHNICAL WRITER, Philips Healthcare, San Diego, CA
2015 to 2016
• Reviewed and wrote medical device regulatory materials under the US, EU, and Japan Regulatory guidelines
• Wrote SOP (Standard Operational Protocols), WP (Work Protocols), Operational Manual.
CURATOR WRITER, Rancho Biosciences, San Diego, CA
2014 to 2015
• Curation of microbiome for synthetic biology in development of oncology vaccines
• Utilized microbiome, genomics, variant databases
• Curation of drug targets through chemical and clinical databases
Clinical Operation and Translational Medicine
DIRECTOR, CLINICAL TRANSLATIONAL MEDICINE, Empiriko Inc., Newton, MA (start-up)
6/2016 to 12/2017
Managed and led development of the Personalized Miniaturized Fingerprinting (PMF) Medical Device to combine three analysis chemical (LC, MSMS), biological(single used 3D printed biosensor), and toxicity (Biomimiks) in one to deliver the results on real time to physician electronic records and patient’s smartphone as a Point of Care Device at hospitals, offices, rural areas, homes.
- Medical Device Product & Portfolio Management: Spearheaded launch of a $300M novel point of care device, PMF, by identifying drug targets & selecting biomarkers for diagnostics. Promoted continuous precision product in collaboration with Harvard & MIT. Maintained product discreteness in a competitive industry by analyzing FDA approved emerging biomarkers & diagnostics tests, critically reviewing biosensor model applications, and ensuring prototype relevant to the existing clinical practices.
- Regulatory Medical Writing: Prepared clinical evaluation report and analysis, literature matrix, study protocols, appraised clinical studies. Bridged information gaps by integrating therapeutic interactions and genetic research findings. Provided precision medicine through development of diagnostics, analyzing targeted therapies for product / business development.
- Due Diligence: Clinical trials, Current Medical devices, Applied or Approved Tests, Regulations and FDA, Insurance, Pharmacology and Drugs, Analysis-Algorithm-Statistics techniques
- Clinical Trial, and Translational Medicine: Integrated Therapeutics, drug-drug interactions for anticoagulant, anti-platelet, lipid, arrhythmia therapies. Developed cancer panels, women health reacted cancers (Breast, Ovarian, Cervical, Endometrial / Uterine). Develop a presentation for BIO2016. Disease Panels: Type 2 Diabetes, Metabolic syndrome, Obesity, Neuropathy, Hormonal panels. 18 biomarker panels for CVD specific patient at risk for analysis. Bleeding, Atrial fib, Stroke, CVD-clinical tests, CVD – Genetics, Calcium Mechanism, Coagulation, Hemostasis, Platelets, Immune response and inflammation, Fibrinolysis, Comorbidity – Cancer, Diabetes Comorbidity, Neuropathy, Metabolic Syndrome, Endocrinology, PE-DVT, INR in/dependent..
SCIENTIFIC CONSULTANT, La Porte, and Associates, San Diego, CA
2/2015 to 9/2016
- The trial is designed to investigate the efficacy and safety of multiple dosing regimens of selepressin and to confirm the effectiveness and safety of one dosing regimen in the treatment of adult patients with septic shock requiring vasopressor. Developed vectors, applied genetic approach for transactivation and RNA regulation. Targeted Vasopressin, which is a GPCR, in Sheep model in lungs and kidneys. (Phase II/III, Phase III)
- Sepsis Project under the Selepressin Evaluation Programme for Sepsis-Induced Shock – Adaptive Clinical Trial (SEPSIS-ACT) NCT02508649 (start date July 2015, first completion Oct 3, 2017, actual study completion date Feb. 26, 2018.
DIRECTOR OF TRANSLATIONAL MEDICINE, MediStem, Inc., San Diego, CA
1/2012 to 12/2014
- Developed clinical marketing strategy materials, investigator brochures, supported regulatory application documents. Played a role in the cross-functional disease interactions to communicate with stakeholders. (Phase I, Phase II) Engaged in the development and commercialization of adult stem cell therapies from the endometrial regenerative cell (ERC), a universal donor stem cell product that promotes new blood vessel formation (angiogenesis), reduce inflammation, regulate immune system function, augment tissue repair and healing. During the process RNA technology and transactivation/gene regulation applied.
- Investigated ERCs to treat a range of diseases, including ischemic conditions, cardiovascular and neurological diseases, kidney failure, liver failure, pulmonary diseases, and orphan disease indications, as well as autoimmune diseases, such as type 1 diabetes.
- As of March 6, 2014, Medistem, Inc. operates as a subsidiary of Intrexon Corporation.
DIRECTOR OF BIOLOGY, Regen Biopharma, San Diego, CA
1/2012 to 12/2013
- Developed a strategy to utilize tryptophan catabolism pathway through Indoleamine 2, 3-dioxygenase (IDO), which is a critical homeostatic regulator and confined in immune system mechanism for the balance between tolerance and immunity, for the treatment or prevention/delay cancer but also other related diseases by stem cell-based Dendritic Cell Vaccine (DCvax) development.
- Applied translational research methodically to develop a comprehensive technology for clinical applications using not only with the three types of IDO (pro-IDO like, IDO1, and IDO2) but also tryptophan 2, 3, dehydrogenase (TDO) solely degrades L-Trp at first-rate limiting mechanism in the liver and the brain. (Phase I/II)
Business Development/Alliance Management
Independent Contractor, Business Development – Sales.
03/2020 to Present
- Serology Based Point of Care (POC) IVD, Global Sale of the EU CE certified, and FDA EUA and approved IVD test.
DIRECTOR OF TRANSLATIONAL GENOMICS, Symmetric Computing, Boston, MA
1/2014 to 12/2015
- Developed business and managed alliances.
- Analyzed next gene sequencing data, RNA technology.
DIRECTOR of MARKETING AND BUSINESS DEVELOPMENT, ClearRoadMap, Washington, DC.
1/2014 to 12/2016
- Provided marketing and business development for the mHealth information platform. integration across ten separate search interfaces (510k, DeNovo, Predicates, PMA, Supplements, Standards and Guidance, Recalls, Warning issuances, Clinical Trials.gov, CMS NCD + LCD Reimbursement), Automated Natural Language Processing (Description, Indication of Use, Predicate, Contraindications, Biocompatibility, Adverse Effects, Recall Reason, Study Inclusion Criteria, Study Outcome, Warnings, etc)
- Informed what the mHealth Checklist is and how it will provide the insights to categorize a medical device within the three primary health information technology categories: Health Administration, Health Management, and Mobile Medical Devices.
DIRECTOR OF BIOLOGY, Business Development, Biotech Vendor Services, San Diego, CA.
12/2013 to 12/2014
• Organized scientific events and symposiums with key opinion leaders free to the attendees.
- Provided a platform to life science vendors to market their services and products with a fee
GLOBAL INNOVATION LEADER, X-Labs, Zurich, Switzerland.
3/2012 to12/2004
• Introduced the liquid nanoformulation technology originated in Switzerland and manufactured in Singapore.
- Created alliances and partnerships to introduce the technology in the US market. (Phase IV)
BUSINESS DEVELOPMENT, AleraLabs, Durham, NC
5/2009 to 12/2012
• Visited clients and presented the services of AleraLabs for services for preclinical and clinical tests/analysis (PhaseI – IV)
- initiated communications, identified challenges, and provide solutions.
BUSINESS DEVELOPMENT, GC, Carbon, British Columbia, Canada
1/2010 to 12/2012
• Boosted client revenue by 30% by presenting durable multi-use sensors in a previously untapped market, gathering customer intelligence, identifying new product opportunities for improved technology introduction.
Fundamental Investigations & Technologies: Regulatory affairs, FDA, Submission, PK/PD, Biomarker and Assessment, Stem Cells, Cancer, Cardiovascular, Infectious, Coagulation, Coagulopathies, Sepsis, GPCR, Vasopressin, IDO, Immunotherapy, ImmunoOncology (IO), Women Health, Translational Medicine, Diagnostics, Biomarker, Genetics, End Organ Failure (liver-renal), Regulatory Writing, Business Development & Marketing, Clinical Trial phases I-IV, ICH, E3, E6, E9, Clinical Record Evaluation, MEDDEV 2.7/1 Rev4 (EU MDDR), ISO 13485, US FDA 510(k), Medical Device, Variant Analysis, Bioinformatics, Databases for Genome and variations, *Clinically relevant population databases (ClinVar, HGMD, ExAc, ClinVitae, EMBL, LongevityMap, GenAge, CellAGe, DrugAge, GenDr, AnAge, OmicsTools, 1000 geneProject)
Senior Principal Scientist (2007-2012)
SENIOR PRINCIPAL SCIENTIST, Duke University, Industry Large Pharma Partnership: GSK)
3/2010 to 6/2012
- Investigated non-invasive nanotechnology for early detection and providing therapy utilizing biomarkers, functional genomics, signaling, chemistry, optics, advanced imaging and Photonics Expedited diagnostics for three diseases by 20% by securing places on a consortium and by developing new targets with single-cell genomic applications in Nanomedicine for Alzheimer, cancer (brain, GI, breast), & CVD. Lead projects and advised 2 Ph.D. students (a neurosurgeon and molecular geneticist), three postdoctoral fellows (chemist, biophysicist, bioengineer), a technician, and three graduate students. Improved the scope of device to disease and stage identification by partnering with the large Pharma (GSK), and biotech company (Metabolon) investigating POC. Investigated toxicology analysis of nanomolecules using Zebrafish and mice
- Fundamental Investigations & Technologies: Nano-biotechnology, Modeling, Nanomedicine, non-invasive diagnostics/therapies, Cancer, CVD, Alzheimer Disease Staging, Dementia, In vivo Modeling, Biomarkers, Functional Genomics, Signaling, Optics, Photonics, clinically relevant and population databases
PRINCIPAL SCIENTIST, ECU, Greenville, NC (Industry Partnership: Innovative Biosensors, Inc.)
12/2006 to 12/2007
Project 1: Immuno-Biosensor (B cell) Stability, Preservation for Diagnostics and Fast Immune response within 24hour
- Led the team to increase survival of ONLY immune biosensor cells and create immediate immune response. Augmented the core technology CANARY (Cellular Analysis and Notification of Antigen Risks and Yields) for rapid detection of pathogens (bacterial and viral) (Innovative Biosensors, Inc). Stabilized and increased the life of the cells from two weeks to four weeks at room temperature and six weeks at 4C in 3 months with advanced cell preservation methods. Rejuvenated a 3-month delayed, a budget deficit project in less than 90 days by drafting weekly progress reports, analyzing essential performance metrics, and prioritizing resource allocation to save money.
Project 2. Prepared Biomarker Panels for Coagulopathies of Cancer for Core Facility
Project 3. IRB committee member
- Fundamental Investigations & Technologies: Immunology, vaccine, infectious disease, pathogen, Ca signaling, biowar, ADC, CANARY, Genetics, B lymphocytes, Receptor, Apoptosis, Biosensor, clinically relevant and population databases
Senior Scientist – Fellow (2005-2002)
RESEARCH FELLOW, University of North Carolina, Gene Therapy Center, Chapel Hill, NC
1/2005 to 12/2006
Gene Therapy for Hemophilia B, Anticoagulant Therapy with VKOR-FIX, and SINE wave Technology
- Developed a new gene delivery technology called SINE wave electroporation and gene therapy/DNA vaccine for Hemophilia B in vivo (NATURE Molecular. Therapy). (Monahan, Stafford, Huang Groups). Restored vitamin K cycle with VKOR in clinical application to improve anti-coagulant therapy by investigating the properties of the transmembrane signaling directs by VKOR enzyme & its interactions with hFIX. (Monahan & Stanford). Defined parameters match to neonatal gene therapy. Saved six months of resources for a 2-year long project. Strategically managing grant allocation, maintaining cross-department collaborations, assisting research for smooth lab functions.
- Fundamental Investigations & Technologies: Modeling, Biomarkers, Translational Medicine Research, Hemophilia B, VKOR, hFIX, IM, IV, Enzyme Kinetics, Specific Activity, animal surgery and modeling, AAV2, AAV4, SINE Wave Electroporation
RESEARCH FELLOW, Duke University Medical Center, Department of Surgery Durham, NC
2/2002 to 12/2004
Industry Partnerships, Clinical Trials Bayer, Boston Scientific, Baxter & Humacyte
Cancer, GPCR, G protein signaling: Demonstrated that secreted soluble protein stimulating stroma to develop the tumor. Utilized G protein and G Protein-Coupled Receptors (GPCRs) for drug development in prostate and breast cancers.
Cardiovascular and Coagulation Biology, Thrombosis, Medical Device:
- Bioengineered human vein with lentivirus vector to insert thrombomodulin to prevent coagulation. Assessed endothelial cell activation Cardio Pulmonary Surgery (CPS) patients, use of anticoagulant agents. Determined the endothelial cell activation pathways on Cardiopulmonary bypass (CPB). Investigated how Aprotinin inducing Endothelial Cell Activation and Coagulation through PAR mechanism. Investigated Bovine Thrombin, xenotransplant, anti-coagulant application, autoimmune response (Baxter),
- Fundamental Investigations & Technologies: Prostate and Breast Cancer, Cardiovascular, Coagulation Thrombosis, Cardiopulmonary Bypass (CPB), Anastomosis, Biomarkers, Animal modeling, Translational Medicine, Enzyme Kinetics, Endothelial Cell, Cancer, GPCR, Signaling, Regulatory Affairs, IRB, Clinical Data, Clinical Trials, clinically relevant and population databases
Post-Doctoral Fellow, NIH NCI Advanced Technology Center, Bethesda, MD
9/1999 to 12/2000
- Defined the mechanism of targeting of ReI/CREB and p300 complexes at the interleukin-2 promoter by the Anaplastic Lymphoma Kinase (ALK). Analyzed forms of the ATF4 in T-cells. Elucidated IL 2 expression during T cell activation in microarray data.
Fundamental Investigations & Technologies: T cells, Signaling, Transcriptional Control, ATF4, NFkB, CREB/ p300, IL2, Modelling, Biomarkers, Experimental Translational Medicine Research, population databases
Post-Doctoral Fellow, Southern Illinois University, School of Medicine, Springfield, IL
12/1998 to 9/1999
• Developed anti-fungal therapy method. Targeted genes for anti-fungal therapy by using molecular biology and function of chitin synthesis during chitin synthesis (FEMS Microbiology Letters 182 [2000) 349-353) in A. nidulans within six months.
ACADEMIC EXPERIENCE-FACULTY
- Teaching is a transferable skill to communicate with the stakeholders, to complete the project for smooth product development. Taught Anatomy and Physiology (heavily to premed, nurses), Genetics, Developmental Biology, Complex Disease and Nutrition, Paradigms of Health. Applied educational philosophy based on learning through inquiry of basic scientific knowledge, providing daily life examples, hands-on, critical and inclusive facilitation. Demonstrated effective management of the classroom to the diverse background of the student body at various settings in rural and urban locations across the US and internationally.
- University of California, San Diego (UCSD)
1/2016 to 8/2016
- National Un., Mira Mesa College, Palomar College, California Mesa Un., San Diego, CA
1/2012 to 8/2016
- Faculty, UNC- NC College System, Chapel Hill, Durham, Fayetteville, Boone, NC
1/2009 to 6/ 2012
- Faculty, Bahcesehir University., Besiktas, Istanbul, Biomedical Engineering
8/2008 to 12/2010
- ASSISTANT PROF. Dept. of Molecular Genetics, Izmir Institute of Technology, Turkey
10/2000 to 12/2002
CONTINUING EDUCATION AND CERTIFICATION — Power is knowledge, so keep brain gymnastics to feed the curiosity
Regulatory Affairs Certification (RAC), Medical Device & Drug, Regulatory Affairs Professionals (RAPS) ongoing
(2020)
Life Science Industry Certificate (LSIP) Biocom Collaborative Institute (Beach Bio, BayBio, IllinoisBio)
2013
Business Environment, Finance; Project, Process and Product; Business Development, Marketing & Sales
CRA, GCP, KRGI Clinical Research and International Biopharmaceutical Association (IBPA)
2010
Earned an internship. Assigned to perform specific tasks and these tasks are based upon real-life industry documentation.
Genome Structure and Function, EL.B.A. Foundation and NATO ASI, Elba, ITALY
1996
Only 65 scientists selected from 15 countries. Applied microchip on thin membrane with for personalized medicine
ACCOMPLISHMENTS AND HONORS
- Naturalized US citizen for Biodefence
- Bridge Grant, UCSD-BIOCOM Institute, San Diego CA
- European Molecular Biology Organization Scholarship, Paris, France
- NATO Advanced Science Institute (ASI) and ELBA Foundation “Genome Structure and Function” on Elba Island, ITALY
- National Merit Scholarship, Government of Turkey,
- British Council Graduate Study Scholarship
- Japanese Monbusho Scholarship
- Science Faculty, Ege University (Magna SUM CUM LAUDE, completed in 3 years among 450 graduates)
PROFESSIONAL ASSOCIATIONS
- Regulatory Affairs Professional (RAPS)
- American Clinical Research Professionals (ACRP)
- American Association for the Advancement of Science (AAAS)
- Genetics Society of America (GSA)
- Society of Developmental Biology (SDB)
- The American Society of Gene Therapy (ASGT)
- The American Society of Microbiology (ASM)
- American Association of Cancer Research (AACR)
- American Heart Association (AHA)
WORK EXPERIENCE SUMMARY
- Functional TransGenomics (2010 – Present) Many clients, contracts, consulting
- Academic Teaching and Research (1996-2016)
- Principal Scientist (2007-2012) Duke Biomedical Engineering, Durham, NC and Innovative Biosensor-ECU, Rockville, MD
- Senior Scientist (2001-2007) Duke University Medical Center – Surgery, Durham, NC – Gene Therapy, UNC, Chapel Hill
- Postdoctoral Fellow (1998-2000) SIU, Springfield Il and NIH, NCI, Bethesda
APPLIED TECHNICAL SKILLS
Engaged with early stage project teams to help optimize animal model study design during the target validation stage for translational medicine applications |
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Genomics | Genome Structure, Function, IVD, Copy Number, Repeated Sequences, Gene Dose |
Development, Stem Cell | Gene Targeting, Transcriptional, Translational and Post-Regulation gene expressions, System Biology, Synthetic Biology, preclinical R&D environment |
Molecular Biology | Transgenics, GPCR, receptors, Western-Southern-Northern Blots, SDS-PAGE, ELISA, EMSA, Flow cytometry (FACS), Immunohistochemistry (IHC), Recombinant Technology, PCRs, immunofluorescence |
Signal Transduction | GPCR, MAPKs, ERK, Jun, p36, G proteins, apoptosis (caspases, programmed death) developmental pathways (wnt, hedgehog, notch), cancer, angiogenesis (VEGF) |
Gene Delivery | AAV, lentivirus, naked plasmid, electroporation, injection (egg, embryo, neonate skull, IM, IV, IP), nanoparticles, sensors |
Cell Culture | Primary cell lines (AoSMC, HUVEC); Immortal cell lines, such as LnCap, HEK293, PC9, mammary lines, endometrium; immune cells like Jurkat, B, T , Dendritic; neuronal cell lines; muscular cell lines and tissues. |
Translational Studies with Animal Models: Provide scientific support in the design, planning, and logistics for in vivo model development, validation, and use, update |
|
Animal surgery | Heart failure model, cardiovascular coagulation porcine model, hemophilia mice and dog model, cancer models, nude mice, SCID mice, Sheep as a sepsis model, Injections, rabbit for antibody model, a collection of samples such as blood, tissue, and organs |
Model Organisms | Porcine (Pig), Canine (Dog), Feline (Cat), Ovine (Sheep), Mus musculus(mouse), Xenopus (frog), Zebrafish (a small fish), D. melanogaster (Fruit fly), C. elegans (worm), S. cerevisiae (Yeast), A. nidulans (Fungi), Microbiome (GI, dermatology, open caveats), Enterobacter, E.coli, HIV, HTLV-1, bioweapons (Anthrax, Salmonella) |
Assay Development, Validation, Biochem. | Linking, screening tests, cell differentiation, and function, gene regulation, infections, protein-antibody interaction, host-pathogen, host-tumor, circulating single cells for prenatal, and cancer, diabetics-cardiovascular-cancer patients, non-invasive technologies, PK/PD. |
Bioimaging | Optic, compound microscope, fluorescence microscope, immunofluorescence, in vivo imaging technologies, hyperspectral, point of care |
Sequencing & Screening | Next-gen sequencing (NGS), Illumina, Ion Torrent, PacBio, microarray, high throughput screening (HTS) |
Computer skills | Access, C++, SAS, Minitab, Visual Basics; Graphics, Microsoft, Sigma Plot, Adobe Photoshop, Microarray Analysis, Affymate, PAM, SAM, LACK, Bioinformatics, Gene Cluster, Greengene, Vector NTI, DNASTAR, ArrayFOX, ARRAYPro, GeneSPotter, Versim PLE. |
Translational Medicine for Clinical Applications |
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Immunology and Inflammation | Cell modifications, gene expression analysis at a transcriptional and translational level for diverse diseases and infections, developing medical devices/models, wound healing, prevention of trauma, and side effects of therapies |
Diagnostics | Biosensors, Biomarkers (DNA, RNA, peptides), microorganisms, stem cell, clinical |
Therapy | Gene Therapy, Anti-fungal, Anti-Coagulant, Immunotherapy, Vaccines |
Disease Focus | Cardiovascular (Diabetes, A-fib, Stroke, Pulmonary Hypertension, Dementia), Coagulation, Cancer (Stem Cell, T, B, DC), Infectious Disease, Microbiome-Cancer synthetic biology |
Selected Publications
Sag, D, “The Life Time Commitment: The origin of Indoleamine 2, 3 dioxygenase (IDO).” Pharmaceutical Intelligence Online Scientific Journal, (Aug. 2013).
Sag, D “The Delicate connection between IDO (Indoleamine 2, 3 dioxygenase) and Cancer Immunology” Pharmaceutical Intelligence Online Scientific Journal, (Aug. 2013).
Sag, D “Confined Indoleamine 2, 3 dioxygenase (IDO) Controls the Hemostasis of Immune Responses for Good and Bad: Pharmaceutical Intelligence Online Scientific Journal, (Jul. 2013)
Liu, F., Sag, D., Wang, J., Shollenberger, L. M, Yuan, X., Li, S., Thompson M., Monahan, P. E. Sine-wave current for more efficient and safer in vivo gene transfer, Molecular Therapy (2007) 15 10, 1842–1847. doi:10.1038/sj.mt.6300261.
Culp, W, Dodge, C. L., Miao, Y., Li, L., Sag, D., Borgia, P.T., “The chsA gene from A. nidulans is necessary for maximal conidiation” FEMS Microbiology Letters 182, 349-353 (2000).
Sag, D. Liu, F., Stafford, D.R., Samulski, R., Monahan, P. “Intravascular Double Gene Electrotransfer of VKOR and FIX in A Single Construct Increases the FIX Specific Activity.” (2013 manuscript in prep.).
Sag, D., Baig, Jaggers, J., Lawson, J. H. “The Effects of Aprotinin on Endothelial Cell Coagulant Biology”
S. Hanish, K. Baig, M. Poh, M. Murphy, D. Sag, M. Milton, J. H. Lawson. Topical bovine thrombin promotes intimal-medial hyperplasia at the venous outflow tractin a peripheral arteriovenous fistula model. J. Vasc Surg.
Sag, D., Hanish, S.I., Baig, K, Poh, M.P., Lamaire, A., Ellison, J.S., Manson, R.J., Milton, M., Lawson, J.H. “The safety of bovine thrombin in surgeries.”
Sag, D. and J. H. Lawson. “The Effects of Bovine Thrombin for specific cellular differentiation”
- I Hanish, K. Baig, M. M Poh, M. Murphy, D. Sag, L. G Milton, J. H Lawson “Topical Bovine Thrombin Promotes Intimal-Medial Hyperplasia Of the Venous Outflow Tract Of ArterioVenous”
Sag, D. “An X-chromosome screen for trans-acting transcriptional regulators of the Drosophila germline sex determination gene, ovo, reveals multiple positive-acting and negative acting loci”.
Sag, D. “ovo has two signaling mechanisms: negative and positive.”
Selected e-Books (https://pharmaceuticalintelligence.com/biomed-e-books/):
https://lnkd.in/ekWGNqA
- Genomics Orientations for Personalized Medicine (Frontiers in Genomics Research Book 1
- Cancer Biology and Genomics for Disease Diagnosis (Series C: e-Books on Cancer & Oncology Book 1)
The Magic of the Pandora’s Box: Epigenetic and Stemness with Long non-coding RNAs (lincRNA) - Cancer Therapies: Metabolic, Genomics, Interventional, Immunotherapy & Nanotechnology in Therapy Delivery (Series C. Book 2)
- Metabolic Genomics & Pharmaceutics (BioMedicine Metabolomics, Immunology, Infectious Diseases Book 1)
- Regenerative and Translational Medicine: The Therapeutic Promise for Cardiovascular Diseases Milestones in Physiology: Discoveries in Medicine, Genomics & Therapeutics (Series E: Patient-Centered Medicine Book 3)
- Cancer Therapies: Metabolic, Genomics, Interventional, Immunotherapy & Nanotechnology in Therapy Delivery (Series C.Book 2)
International Meeting Presentations:
Sag, D., and M. D. Garfinkel, An X-Chromosome Screen for trans-acting transcriptional regulators of the Drosophila germline sex determination gene, ovo, reveals multiple positive-acting and negative-acting loci” Annual Drosophila Research Conference 41 2000:394C. (Flyable ID FBrf0125899)
Sag, D., Tekin, S., and M. D. Garfinkel, “Gene-dosage sensitive trans-acting regulators of the D. melanogaster ovo germline promoter” 38th Annual Drosophila Research Conference, April 16-20, 1997, Chicago, IL. (Part of EMBO Grant application for my lab)
Sag, D., Tekin, S., Garfinkel, M. (1997). “Gene-dosage-sensitive trans-acting regulators of the D.melanogaster ovo germline promoter. A. Dross.Res. Conf. 38: 265A. http://flybase.bio.indiana.edu/reports /FBrf0092363.html\ (EMBO Grant application for my lab)
Thesis and Dissertation (Supported with Grants & Fellowships from NATO, EMBO, Turkey, US):
Sag, D. Ph.D. dissertation, title “Gene-dose trans regulation of the female germline specific D. melanogaster ovo gene” December 1998, Illinois Institute of Technology, Chicago IL.
Sag, D. Master Thesis, title, “Comparing growth of two Echerichia coli constructs containing Vitreoscilla hemoglobin gene,” December 1993, Illinois Institute of Technology, Chicago IL.
Sag, D, Japanese Ministry of Education Grant for Graduate Education; Nitrosomonas industrial microbiology application to remove radiological pollution in the soil.
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Demet Sag, PhD, CRA, GCP
Mobile: 858-729-4942
Expertise in application of Molecular and Developmental Genetics onto drug discovery, diagnostics and targeted therapies for personalized medicine based on signal transduction, primary developmental pathways, biomarkers and functional genomics.
Technical Summary
- Model Organisms Transgenics, Surgery: Animal surgery and handling, Primary and Mortal Cell Cultures Human Tissue and Organs,Wet Lab, Microbial Screening and tests, Biochemistry: Coagulation Tests, Enzyme Kinetics, Chromatography, High Throughput Screening, Molecular Biology and Bioinformatics Tools, Statistics, Imaging.
Professional Summary
Life Scientist with diverse expertise in bench, clinical and engineering for drug discovery, diagnostics and targeted therapies based on signal transduction, primary developmental pathways, biomarkers and functional genomics.
Private industry experience also includes Innovative Biosensors (CANARY technology development as a Senior Scientist), Bayer, Baxter (Cardiovascular and Coagulation Scientist at Duke Medical Center), Pathway Genomics, Medistem, Regen Biopharma as a Translational Medicine scientist (at San Diego, CA), AleraLabs (Business Development) are the few that I have done business as a consultant/contractor. Scientific Advisor for biomarker design at Bioexplore, Nodia (India) and at Vaxenta, San Diego,CA (USA) for natural cancer vaccine development.
Highlights:
- Established a rich portfolio of biotechnology tools spanning from industrial microbiology to translational medicine. Research experiences in siRNA and/or micro RNA functional studies to build sensors, biosensors, nanosensors including designing biomarkers for circulating cancer cells, detection of immune cells, monitoring immune response after therapy, pathogens and contaminants.
- Diverse expertise from bench (molecular and developmental/ stem cell biology) to clinical research (cardiovascular, cancer, coagulation, hematology, anti-coagulant, bleeding, congenital, maternal, infectious diseases) and engineering (companion diagnostics/therapies, point of care tools, nano/biosensors).
- A strong background in signal transduction pathways, specifically GPCRs and G protein mechanisms, cancer cell biology and molecule biology working with Nobel Laureates and private and academic institutions last 15+years.
- Experienced in working with many living systems (porcine, rat, mice, fruit fly, frog, worm, yeast, bacteria, and virus) from gene discovery to identify mechanisms for tissue engineering, therapies, diagnostics, drug targets using stem cells, metabolism & primary pathways as discovery vehicles based on through understanding of signal transduction, gene regulation & transgenics.
- Solid understanding of translational medicine with clinical research and writing regulatory documents, FDA applications, protocols, SOPs, 314 NDA, 312 INDs, E3, E6, ICH, pre-IDE, 510(k), PMAs IRDs, package inserts, protocols, protocol amendments, clinical study reports, journal articles, abstracts, and scientific posters.
- Administrated grants, monitored budget control and operated cost management beyond the job description up to $10 million dollars for from 1-4 years with a given trust early on. Planned, supervised, built teams around the needs of a project from ground zero. Turned around projects for success after training and mentoring team in needed areas.
SUBJECT EXPERTISE:
- GENOMICS/Biosensors/Biomarker/ Bioinformatics/Nanotechnology: Improved the core technology of the company, CANARY, by increasing survival of the only immune cell biosensors, B cells, for combat and public defense. Oversaw development of nanobiosensors for Alzheimer’s, Breast Cancer, Cardiovascular diseases. Designed markers using siRNA, RNA, modified oligos (moligos of Zebrafish).
- Immunology:Demonstrated immune response analysis, screen inflammation and design immunomodulation for immunotherapy-vaccine (DCvax). Detected cellular differentiation after surgery, cardiopulmonary bypass, xenotransplants, transgenics, transplantation, grafts, gene therapy, tissue engineering.
- Oncology and Cancer:(Breast, Ovarian, Prostate, Adult Lymphoma) Developed methods to improve survival rate, found biomarkers, redesigned immune cells, T and B cells. Analyzed inflammation restructured angiogenesis and coordinated interdisciplinary collaborations.
- Gene Therapy/ DNA Vaccine:Created proof of principle study for human Hemophilia B therapy in vivo. Developed a novel Sine Wave Alternative Electroporation gene delivery. This work led to FDA approved Hemophilia B therapy.
- Cardiovascular and Coagulation:Directed studies on endothelial cell activation, anti-coagulant properties of vein tissue during congenital heart diseases, transplants, cardiopulmonary bypass, guided vein tissue engineering and implementation of lentiviral gene delivery. Performed cellular differentiation measurements at in vitro and in vivo (pig, mice, human tissues, clinical trials) after drug, sealant, and medical device applications.
TECHNICAL SKILLS:
- Personalized Medicine, Designed biomarkers with DNA, RNA peptides, bionanosensors, Genome Structure and Function, Molecular Biology, Protein & Gene Expression, Signal Transduction, Inflammation, Western Blot, SDS-PAGE, ELISA, EMSA, Flow cytometry (FACS), Immunohistochemistry (IHC), Recombinant Technology, PCR, Assay Development and Validation, Biochemistry, Coagulation Tests, Enzyme Kinetics, High Throughput Screening (HTS), Microarray Analysis, Affymate, PAM, SAM, LACK, Bioinformatics, Gene Cluster, Greengene, Vector NTI, DNASTAR, ArrayFOX, ARRAYPro, GeneSPotter, Model Organisms, Porcine, M. musculus, D. melanogaster, A. nidulans, Xenopus, C. elegans, S. cerevisiae, Zebrafish, pathogens not only bacteria but also viruses, HIV, HTLV-1, Adeno Associated Virus (AAV), lentivirus Transgenics, Genomics, System Biology, Gene Targeting, Biodefense, Diagnostics, Therapies, Cell Cultures, AoSMC, HUVEC, LnCap, HEK293, PC9, Jurkat, Mammary, T cell and B cell, Animal surgery, Human Tissue-Organs.
- Computer Skills: Database and programming, Access, C++; Engineering math/statistical, SAS, MiniTab, Visual Basics; Graphics, Micrografx Designer, Microsoft Power Point, Microsoft Visio, Stanford Graphics, Sigma Plot, Freelance, Adobe Photoshop.
EDUCATION & CERTIFICATIONS:
- PhD, Molecular Genetics and Stem Cell Developmental Biology, Illinois Institute of Technology, Chicago, IL
o Thesis: Sag-Ozkol, D. Ph.D. dissertation, title “Gene-dose trans regulation of the female germline specific D. melanogaster ovo gene” December 1998, Illinois Institute of Technology, Chicago IL.
- MS, Microbial Engineering and Biotechnology, Illinois Institute of Technology, Chicago, IL
o Thesis: Sag, D. Master Thesis, title, “Comparing growth of two Echerichia coli constructs containing Vitreoscilla hemoglobin gene”, December 1993, Illinois Institute of Technology, Chicago IL.
- BS, Biology, Basic and Industrial Microbiology, Ege University, Bornova (Izmir), Turkey
o Magna Sum Cum Laude among 450 graduating class of Faculty of Science in six majors.
o Life Science Industry Certificate (LSIP) Biocom Collaborative Institute (BIOCOM, BayBio, IllinoisBio) 2013
o CRA, GCP, KRGI Clinical Research and International Biopharmaceutical Association (IBPA) 2010
o Genome Structure and Function, ELBA Foundation and NATO Advanced Science Institute, Elba, ITALY 1996
AWARDS & AFFILIATIONS:
- LSIP, Life Science Immersion Program, Bridge Grant, SDSU-BIOCOM Institute, San Diego CA (2013)
- European Molecular Biology Organization Scholarship, Paris, France
- NATO, Advanced Science Institute and ELBA Foundation Grant on Genome Structure and Function, Elba Island, Italy
- National Merit Scholarship, Government of Turkey, top third in nationwide exam
- British Council Graduate Study Scholarship nationwide exam and application
- Japanese Monbusho Scholarship (Grant: Fertilizing radiologically contaminated by Nitrosomanas
- Science Faculty, Ege University, entered with highest score and completed in 3 years as Magna Sum cum Laude
EXPERIENCE:
Principal (2010- current)
Functional TransGenomics Consulting, Del Mar, CA 2010 – Present
Consulted and contracted to validate gene targets, find drug targets and biomarkers for diagnostics and therapeutics; writing tasks; scientific advisory and business development and marketing.
- 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).
- Consulted and will be presenting VxP Pharmaceutical for their Transgenics products at BIO2014 in San Diego
- Partnered with FDASMART for oncology and oncology drugs sourcing globally, Europe, Asia Minor, USA.
- Consulted for Omics’s Group for organizing international meetings on regulation, genomics, pharmacogenomics, metabolomics, translational medicine and stem cells
Scientific Advisory Board Member
- Identified gene targets and validated, designed biomarkers as peptide or RNAs (Bioexplore, Noida Region, India)
- Immunomodulation and target drug candidates for natural anti-cancer vaccines (Vaxenta, San Diego, CA, USA).
Scientific Writing: Authored, writer, reviewer for regulatory documents, FDA applications, protocols, SOPs, 312-INDs, 341-NDA, ICH, pre-IDE, 510(k), E3, E6, PMAs IRDs, package inserts, protocols, protocol amendments, clinical study reports, journal articles, abstracts, and scientific posters with matching strong scientific approach from sequencing, large datasets, integration of information, bioinformatics, statistics for various clients per hour, per project and freelancer.
- Ad hoc reviewer for non-profit and Elsevier Journal (Alzheimer’s and Dementia),
- Authored and edited blogs for career.com, edited for Sanguine marketing blogs,
- Currated articles to identify biomarkers for a type of cancer (Pathway Genomics, Inc, San Diego, CA)
- Worked at developing media for the ERC that is on clinical trials now ( Medistem, Inc, San Diego, CA)
- Offered a comprehensive review article on Indolamine 2,3 deoxygenate for developing RNAi based vaccine in stem cell therapy (Regen BioPharma, San Diego, CA),
- Organized a review paper for marketing letter on international regulation on companion diagnostics for a client.
- Presented at an International Meeting in Philadelphia, PA on International Regulation a GDx, GCP. GMP Trades.
Leaders in Pharmaceutical Business Intelligence, Expert, Author, Writer 2013 to Present
The venture operates as an online Scientific Intellectual exchange – Open Access Online Scientific Journal for curation and reporting on frontiers in Biomedical, Genomics, Biological Sciences, Healthcare Economics, Pharmacology, and Pharmaceutical & Medicine.
Curated, authored, edited articles and regulation documents on the following Research Categories:
- Personalized medicine and Genomic Research;
- Biological Networks;
- Gene Regulation and Evolution;
- Biomarkers & Medical Diagnostics;
- Coagulation Therapy and Internal Bleeding;
- Cell Biology, Signaling;
- Cardiovascular Pharmaceutical Genomics;
- Cancer Biology & Innovations in Cancer Therapy; – Stem Cells for Regenerative Medicine;
- Nanotechnology for Drug Delivery
Senior Scientist Experience (2007-2012)
Duke University, Department of Biomedical Engineering 2010 – 2012
- Mentored and trained two Ph.D. students for development of point of care tools for personalized medicine by combining Nanobiotechnology, biomarkers, functional genomics, signaling, chemistry, optics, and photonics.
- Collaborated in breast cancer, Alzheimer’s and cardiovascular diseases with Duke Medical and Duke Clinical Research Centers for applying nanomedicine therapies and for developing non-invasive diagnostics tools.
- Wrote, edited, submitted scientific articles and grant proposals (Alzheimer’s disease with nanotechnology, diagnostics tool development from lung cancer: Identification of cardiovascular markers for point of care tool development by optics; Breast cancer with nanotechnology and genomics; pulmonary arterial hypertension, differentiating beta cells by imaging; insulin resistance mechanism during beta cell differentiation. Edited scientific articles, grant applications.
Bahcesehir University, Faculty of Engineering. Besiktas Istanbul 2008 – 2009
- Created multidisciplinary programs between universities and industry.
- Developed and organized a Medical Anatomy and Physiology course for multidisciplinary engineering with hands diagnostic tool development and project management under a real budget.
Innovative Biosensors, Inc., ECU, Greenville NC 2006 – 2007
- Project 1: Developed the core technology of the company called CANARY ^TM by preservation method. Result: Increased survival of biosensor cells by 25% at room temperature and 30 % at 4oC in three months at nano level sensitivity that created immediate immunity and immune response modulation against biological weapons.
- Contributed public health and biodefense with development of only available immune cells as biosensor for Molecular Diagnostics tool development. This method applicable to translational medicine for complex disease prevention.
- Spearheaded the project and leverage expertise in the field of cellular and molecular biology worked on the cells for improving the stability of signal transduction, cell proliferation and preservation. Led 5 people for RD and reported the results to CEO and VP of R&D.
- Project 2: Developed a screening mechanism to identify and improve survival rate of cancer patients with acquired or inherited coagulapathies. Result: Established an inter-departmental project among oncology, radiation oncology, surgery, pathology and molecular biology departments to increase survival rate of cancer patients.
- Wrote SOPs, IRDs, INDs, IRBs, IACUC, pre-IDE, clinical documents for patients. Wrote grant proposals on prevention of coagulapathies to increase survival rate of patients and biosensors.
Research Fellow Experience (1998-2006)
University of North Carolina, Gene Therapy Center Chapel Hill, NC 2005 – 2006
- Project 1: Delivered a new direction of research, the original project was straightforward assays of blood coagulation protein/protein-protein interactions and blood clotting function. Directed and coordinated development of Hemophilia B gene therapy, which is an X chromosome linked congenital disorder among four departments at UNC, School of Medicine, Bioengineering, Pharmacology and Biology. Result: Created a novel gene delivery method, Sine Wave Alternative Electrotransfer. Established a DNA vaccine expressing hFIX (Nature Mol. Thr. 2007. Worked with an excellent multidisciplinary team. **This proof of concept study led into an FDA approved drug for Hemophilia B.
- Project 2: Originated new anti-coagulant therapy by investigating properties of the transmembrane signaling directed by the VKOR enzyme and its interactions with hFIX. Result: Improvement if naked DNA is used not with AAV.
- Project 3: Participated prevention of immune response during and after viral gene therapy. Implemented and described parameters matched to neonatal gene therapy. Result: Seemed advantageous but require safer delivery.
- Planned and applied a comparative cohort studies based on age, gender, genetic background of mice for delivery mechanisms (intramuscular or intra vascular) and types of viral vector (AAV2, AAV4, AAV6).
- Published scientific paper for a proof of concept study, organized data, wrote/edited IACUC application, IRBs.
Duke University Medical Center and Clinical Research Center, Department of Surgery Durham, NC 2002 -2004
Determined drug development targets through gene regulation, GPCR (G protein activated receptors), PAR, MAPKs, thrombomodulin, tissue factor, DNA binding protein and coagulation factors. Analyzed cell differentiation and proliferation for pre-clinical and clinical studies for surgery, trauma, heart attack, cardiopulmonary bypass, topical bovine thrombin, aprotinin, anti-coagulant therapies, medical device, human vein tissue engineering, and endothelial cell activation. Turned around projects from private industry/companies towards on time completion
- Project 1: Found a secreted soluble protein from endothelial cells inducing tumor development in stroma in vitro and in vivo in three months. Result: Proved that only co-culture injection onto nude mice cause tumor development. Screened angiogenesis in tumor development for prostate cancer tumor development.
- Project 2: Examined transcriptional regulation of genes leading to cell proliferation in both in vitro (cell culture) and in vivo systems (porcine vasculature) with proliferative rates and phenotypes mapped. Result: Suggested responsible inflammatory and activation pathway genes through specialized responses of G protein coupled receptors receptor called PARs during cell differentiation responses.
- Project 3: Demonstrated the effects of topical bovine thrombin (Baxter) at vascular anastomic sites of arteriovenous PTFE bypass and the effects of aprotinin on endothelial cell coagulation biology (Bayer). Result: Improved health of patient decreased healthcare cost and increased the lifetime of grafts controlling bleeding and endothelial cell activation in human vasculatures.
- Investigated systematic evaluation for the proliferative stimulation of vascular endothelial cells by thrombin through G protein expression and downstream kinase activation. Measured expressions of PAR (specific GPCR), MAPKs, hFII, hFV, hFVII, hFVIII, hFIX, hFX, IL6, IL10, IL2, tPA, TF, complements, nuclear proteins on porcine, primary cells.
- Prevented endothelial cell activation and immune responses after clinical interventions such as graft transplants, CPBP, trauma, surgery, medical device and drug interventions to keep hemostasis.
- Project 4: Prepared IRBs, INDs, IACUC, NDA, reports, labeling samples, generated clinical documents, brochures and presentations for medical device, grafts and drugs. Result: Applied GCP methods, approved.
Teaching Experience (Professor and Adjunct Professor), 1990-Present
Transferable skill to Business Development and Marketing to expand and increase effectiveness by training and communications among key opinion leaders, customers, patients, sales force and marketing teams.
Hold dual degrees in Science Education from Faculty of Literature & Biology from Faculty of Science at Ege University
Taught: Anatomy And Physiology, Microbiology, Genetics, Population Genetics, Biochemistry, Developmental, and Cell & Molecular Biology at Historically Black Colleges Liberal Arts Colleges or Junior Colleges, traditional universities.
- National University, San Diego, CA ( Anatomy and Physiology, Bio201) 2014-present
- U. of North Carolina & NC System (Anatomy & Physiology; Biology, Genetics, Population Genetics) 2009-12
- U. of Phoenix, Raleigh, (Complex Diseases, Human Nutrition, Paradigms of Health, Alternative Med) (2007-11)
- Columbia Coll., Upward Bound, Chicago, IL, (Biology, Physics, Chemistry, Algebra) Tutor-Consult (1993-95)
- Illinois Institute of Technology, (Genetics, Biology, Chemistry)TA (1993-98)
Izmir Institute of Technology, Molecular Genetics Department, Izmir, Turkey 2000 – 2002
- Developed courses such as molecular biology, genetics, developmental biology biochemistry, and
- Created programs around molecular biology, genetics and genomics at the new establishing department.
PUBLICATIONS & PRESENTATIONS:
Peer reviewed Published Articles:
- Sag, D., “The Life Time Commitment: The origin of Indolamine 2, 3 dioxygenase (IDO).” Pharmaceutical Intelligence Online Scientific Journal, (Aug. 2013).
- Sag, D., “The Delicate connection between IDO (Indolamine 2, 3 dioxygenase) and Cancer Immunology.” Pharmaceutical Intelligence Online Scientific Journal, (Aug. 2013).
- Sag, D., “Confined Indolamine 2, 3 dioxygenase (IDO) Controls the Hemostasis of Immune Responses for Good and Bad.” Pharmaceutical Intelligence Online Scientific Journal, (Jul. 2013)
- Liu, F., Sag, D., Wang, J., Shollenberger, L.M., Yuan, X., Li, S., Thompson M., Monahan, P. E. “Sine-wave current for more efficient and safer in vivo gene transfer, Sag-Ozkal, D Molecular Therapy (2007) 15 10, 1842–1847.doi:10.1038/sj.mt.6300261.
- Culp W., Dodge, C. L., Miao, Y., Li, L., Sag-Ozkal, D., Borgia, P.T., “The chsA gene from A. nidulans is necessary for maximal conidiation” FEMS Microbiology Letters 182, 349-353 (2000).
- Sag, D., Liu, F., Stafford, D.R., Samulski, R., Monahan, P. “Intravascular Double Gene Electrotransfer of VKOR and FIX in a single construct increases the FIX specific activity.” (2013 manuscript in prep.).
- Sag, D., Baig, Jaggers, J., Lawson, J.H. “The Effects of Aprotinin on Endothelial Cell Coagulant Biology”
- Hanish, S., Baig, K., Poh, M., Murphy, M., Sag, D., Milton, M., Lawson, J.H., “Topical bovine thrombin promotes intimal-medial hyperplasia at the venous outflow tractin a peripheral arteriovenous fistula model.” J Vasc Surg.
- Sag, D., Hanish, S.I., Baig, K, Poh, M.P., Lamaire, A., Ellison, J.S., Manson, R.J., Milton, M., Lawson, J.H. “The safety of bovine thrombin in surgeries.”
- Sag, D., and Lawson, J.H. “In vitro model for The Effects of Bovine Thrombin for specific cellular differentiation.”
- Hanish, S.I., Baig, K., Poh, Murphy, M., Sag, D., Milton, L.G., Lawson, J.H. “Topical Bovine Thrombin Promotes Intimal-Medial Hyperplasia Of the Venous Outflow Tract Of Arterio-Venous”
- Sag, D., “An X-chromosome screen for trans-acting transcriptional regulators of the Drosophila germline sex determination gene, ovo, reveals multiple positive-acting and negative acting loci”.
- Sag, D., “ovo has two signaling mechanisms: negative and positive.”
E-Books, Amazon.com and Kindle Platform
- Metabolomics (Editor and contributing author, e-book for Jan 2015) by Leaders in Pharmaceutical Business Intelligence
- Genomics Volume I (2014) (contributing author) by Leaders in Pharmaceutical Business Intelligence
- Cancer and Genomics – Volume One (for Dec. 2014) (Editor and contributing author) by Leaders in Pharmaceutical Business Intelligence
- Cancer and Immunotherapy – Volume Two (for Dec. 2015) (Editor and contributing author) by Leaders in Pharmaceutical Business Intelligence
International Meeting Presentations:
- Sag-Ozkol, D., and M. D. Garfinkel, An X-Chromosome Screen for trans-acting transcriptional regulators of the Drosophila germline sex determination gene, ovo, reveals multiple positive-acting and negative-acting loci” Annual Drosophila Research Conference 41 2000:394C. (Flybase ID FBrf0125899)
- Sag, D., Tekin, S., and M. D. Garfinkel, “Gene-dosage sensitive trans-acting regulators of the D. melanogaster ovo germline promoter” 38th Annual Drosophila Research Conference, April 16-20, 1997, Chicago, IL.
- Sag-Ozkol, D., Tekin, S., Garfinkel, M. (1997). “Gene-dosage-sensitive trans-acting regulators of the D.melanogaster ovo germline promoter. A. Dross. Res. Conf. 38: 265A. http://flybase.bio.indiana.edu/reports /FBrf0092363.html
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