David Orbach Email & Phone Number

New York, Ny, Us

Switzerland 🇨🇭 , Ch

Roche Tissue Diagnostics.Ventana Medical Systems.• Support “Companion Diagnostics” - oncology biomarker immunohistochemistry (IHC) assay co-development with global pharmaceutical partner(s) including “digital pathology”. • Also help with Clinical Chemistry and Clinical Quality areas 10% of time.• Work with ~7 global pharmaceutical partners, on ~10 tumor biomarkers, spanning ~15 indications via cross-matrixed teams.• Interface with Regulatory Affairs, Assay Development, Clinical Development, Risk Management, Clinical Operations, Clinical Study Manager, Medical Writing, Pathology, Digital Pathology, Business, Manufacturing Operations, Biostatistics, Legal, Project Manager, Project Leaders, IT, etc.• Proofread and approve version-controlled documents (milestone deliverables) before review by FDA & global health authorities.• Maintain Design History File (DHF) in a state of audit readiness; ensure inspection readiness; ensure traceability & completeness.• Support and/or approve technology assessments, design reviews, milestone reviews and/or help colleagues and partner(s).• Helped transition to a new modular Quality Management System (QMS) by presenting plan, steps to implement, guiding teams, managing expectations, training, supporting, coaching, mentoring.• Comply with 21 CFR 820, ISO 13485:2016 (QMS) Quality Management Systems, ISO 14971:2019 (Risk), ISO 20916 (Clinical), Regulation (EU) 2017/746 (IVDR) (Europe), ICH/GDP, GCP, GMP, (GxP), CAP/CLIA, Standard Operating Procedures (SOP), CLSI, etc.• Also review and approve Diagnostic Protocols, Investigator Brochures, Validation Plans and Reports, Summary of Analytical Performance, Performance Evaluation Plan, Clinical Performance Report.• Use SAFe Agile, ServiceNow, SharePoint, Confluence, Jira, Kiteworks, Trello, Veeva, Smartsheet, Monday, Wiki, etc.• Aware of audits (TUV, MDSAP, and pharma partner), and help with FDA pre-sub meetings & responses to FDA feedback and root cause investigations.

Lake Success, Ny, Us

Helped with the initial wave of COVID EHR efforts in the largest private hospital system in NYS. Captured business needs from stakeholders amidst changing regulations, mapped clinical workflow, and documented software improvement requirements.Helped to predict, prioritize, and design EHR changes to meet clinical and business needs in a highly-dynamic environment.Liaised with software developers, beta tested new builds, helped train users, improved health outcomes for Medicaid “Health-Homes” patients.{6-month contract via Starpoint/YOH recruiter}

Focused on creating in-vitro diagnostic device to quantify cyanide to help emergency responders treat victims of house-fire smoke inhalation, industrial spills, and military and homeland security incidents.Participated in pre-seed workshop, eLab, and NSF I-Corps NYCRIN program:Spoke to customers to discover true end-users, customers, purchasers, influencers, saboteurs, identify product-market fit, customer segmentation, value propositions, key resources, key partners, etc.Won $30,000 in grant funding from NYSTAR/CCMR/JumpStart, NIH-CTSC, & eLab to develop organic polymer to sensitively and specifically bind and quantify cyanide levels in blood using nanofabricated organic field-effect transistors (OFETs). Gained cleanroom experience at the Cornell Nanoscale Facility (CNF), liaised with IRB, IACUC animal care and use committee, Environmental Health and Safety, Office of Sponsored Programs to ensure all pieces were present before proceeding.Read FDA 21 CFR Part 820 while still focusing on product development and learned about 510(k) and PMA pathways, IDE, de novo, pre-submission inquiry meeting, quality management systems, etc. [Keywords: customer segmentation, value proposition, minimal viable product (MVP), sales channels, marketing, business plan, business model canvas, voice-of-the-customer (VOC), client-facing, stakeholder analysis, point of care, POC, proof of concept.]Also helped students and other startups around Cornell and remotely via InnoCentive platform:1) Health Hackathon Mentor/Advisor at Cornell University and Weill Cornell Medicine (e.g., a 3D printed prosthetic hand and wrist device with proximity and force sensing and LED array indicator).2) NASA Innocentive Challenge: Designed a Compact Aerobic and Resistive Exercise System for Astronauts on long space flights and ventures >3 months.

New York, Ny, Us

* Aggregated and analyzed data for 500+ patients with pelvic congestion syndrome (a.k.a. pelvic venous hypertension), nutcracker phenomena, lymphedema, lipedema, hernia, etc.* Streamlined clinical data collection mechanisms and digitized surveys.* Recommended IRB oversight for several novel clinical studies involving venous angiography, fluoroscopy, embolization, balloon angioplasty, venous stenting, intravascular ultrasound (IVUS), laser ablation, sclerotherapy, mesh removal, liposuction, etc.* Collaborated with colleagues in four surgical sites around NYC/NJ.[Keywords: interventional, endovascular, endovenous, chronic venous obstruction, Gelfoam, coil, WALLSTENT, renal vein, IVC, greater saphenous vein, uterus, bladder, varicose veins.]

Los Angeles, Ca, Us

* Helped team win $4 million in Series A funding round from Khosla Ventures.* Worked collaboratively at the junction of clinical trials, oncology, and novel drug-delivery device research and development at the Max Planck Institutes for Intelligent Systems in Stuttgart, Germany.* Reviewed literature and recommended clinical treatment endpoints for a novel therapeutic delivery system for three oncology indications.* Evaluated contract research organizations (CROs), designed international animal trials, and selected optimal animal models and solid tumors for evaluation.* Experimented with animals ex-vivo using ultrasound imaging, tracking, and external magnetic targeting/maneuvering/guidance system and planned in-vivo animal test protocols to investigate the efficacy, safety, and toxicology with CRO in Germany.* Innovated technical solutions to novel problems, captured images, analyzed data, and wrote reports to benefit interdisciplinary teams.[Keywords: In vivo imaging system (IVIS), IACUC animal care and use committee, rabbits, rats, animal trials, pre-clinical, clinical trial design, histology, ultrasound, high-intensity focused ultrasound (HIFU), fibroids, solid tumors, brain cancer, liver cancer, literature summarization.](Company emerged from stealth mode on 3/3/2021)

Ithaca, Ny, Us

Directed and marketed the MEng Program in Biological and Environmental Engineering.Taught “Professional Development and Industry Survival Skills”. Mentored graduate students in design projects.Started medical device company based on Cornell-owned technology.Developed polymer-based sensors to solve emergency problems (cyanide toxicity)Collaborated with industry, faculty, and hospitals to develop projects and gained laboratory funding.Recruited, oriented, and advised students toward successful careers.Tutored and counseled students in need.

Rosemont, Il, Us

* Helped build a concept-based database to streamline and facilitate patient care and research via controlled vocabulary and easier population of structured data fields ("Semantic interoperability").* Served as subject matter expert for procedures involving surgery, radiology, microbiology, pathology, and laboratory domains. Used clinical terminology to optimize EMRs for 3500+ hospitals using SNOMED CT, medical terminology, etc.* Increased processing efficiency 20-fold using engineering and medical backgrounds.* Training in "Health Informatics" via online courses ever since.[Keywords: HL7, ICD9, ICD10, migrating, ontology, EHR, EMR, IMO, data abstraction, accuracy, procedures, orthopedic surgery, gynecological procedures, interventional radiology, blood bank, biobank, antibiotic susceptibility testing (AST), clinical, research.]

New York, Ny, Us

* Developed and taught four additional biology and bioengineering courses: -Pharmacology -Microbiology/Immunology -Pathogen Reduction Engineering. -Special Topics in Bioengineering -Genetic Engineering/Synthetic Biology.* Pre-Medical Advisor:Taught, advised, mentored, and wrote letters of recommendation resulting in 34 of 35 students getting accepted into medical school, with 9 students getting into MSTP or combined MD/PhD programs.* Co-managed the Center for Biomedical Engineering.* Co-instructed award winning multi-centered student teams with Columbia University and GenSpace. (IGEM gold medal 2011 and bronze medal in 2012.)* Gained over $5000 in grants from private donors for research.

New York, Ny, Us

* Developed and taught biology and bioengineering courses with labs (Cell & Molecular Biology, Anatomy & Physiology) * Served as Pre-Medical Advisor:* Mentored students in several research projects (Cardiac cell sheet tissue engineering education modules, redesign urinary catheters etc.)* Helped bring in $1,000,000 in grant funding via a presentation to the Board of Trustees* Promoted to a 3-year position for excellence in teaching, mentoring, research, innovation, and budgeting.

New York, New York, Us

* Designed and conducted a quality improvement study to analyze the process of patient care and patient throughput.* Directly evaluated emergency room, lab, pharmacy, CT Suite, transporters, radiology, admitting, nurses, doctors, and consult services to verify automated time stamps and sought staff input.* Engaged staff to identify root causes of delays and compiled ideas.* Automated the data extraction and collection process collaboration with the IT department and quality assurance division. Used Cerner, PACS, Excel, STATA, ACCESS.* Analyzed big data sets to identify bottlenecks in the process of care.* Recommended changes to hospital administration to streamline workflow and patient satisfaction.* Funded by NYS-DOH Empire State Clinical Research Investigator Program ("ECRIP") training grant.

Stony Brook, Ny, Us

* Diagnosed, treated, and managed the care of patients with mental, neurological, medical, and surgical issues.* Collaborated with 100 different colleagues from different service teams (e.g., cardiology, neurology, obstetrics, endocrine, oncology, nephrology, etc.) to ensure best care for my patients.* Passed all USMLE’s.* Merit award winner.* Worked 80 hours per week as a physician supervised by a different attending each month.Used Cerner, PowerChart, PACS, VA hospital system. Also familiar with Aprima, STATA, Excel, Access, PowerPoint.

Livermore, Ca, Us

* Assisted development of a rapid, sensitive, specific pathogen detection system with multiplex capability for detecting food-borne illness pathogens, select agents (bioweapons), and point-of-care biomarkers for diagnosis.* Gained public trust security clearance.

Bethesda, Md, Us

* Used advanced analytical equipment to help elucidate the causes and treatments for seizures and epilepsy. * Used combined Gas Chromatography - Mass Spectroscopy to measure neurosteroid concentrations in blood samples of animals with decreased seizure thresholds just before their menstrual cycles.

Newark, Delaware, Us

* Designed and developed an assay to measure permeability / protein transport across walls of ePTFE (GoreTex) vascular grafts.* Tested various parameters & samples; * Wrote a computer program to analyze results; * Optimized novel graft designs;* Presented finding to colleagues and published an internal report.

Certificate (Graduate Level), Clinical Epidemiology & Health Service Research ("Summer Intensive Program" Of 9 Graduate Courses)

Md With Highest Honors, Medical Doctor

Ms, Biomedical Engineering

Bs, Biological/Biosystems Engineering