Medical Wrter

TUAN A. ELSTROM

*** ****** ****** **. **** ** MOUNT PLEASANT SC 20464

CELL: 847-***-**** ***********@*****.***

QUALIFICATIONS SUMMARY

TOP-PERFORMING TECHNOLOGIST

R&D - REGULATORY COMPLIANCE - MEDICAL AFFAIRS - NEW BUSINESS DEVELOPMENT & MARKETING PROVEN RECORD OF SUCCESS IN DELIVERING VALUES TO COMMERCIAL ORGANIZATIONS AND EARLY STAGE VENTURES. A HIGHLY CREATIVE PROFESSIONAL WITH EXCEPTIONAL ORAL AND WRITTEN COMMUNICATION SKILLS AND A TALENT FOR PRESENTING COMPLEX SCIENTIFIC CONCEPTS AND PROCESSES IN A LANGUAGE THAT’S EASILY UNDERSTOOD BY BUSINESS EXECUTIVES, KEY DECISION-MAKERS, AND PEOPLE OF DIFFERING BACKGROUNDS AND EDUCATIONAL LEVELS. EXPERTISE

o BUSINESS DEVELOPMENT & MARKETING

SCIENTIFIC ADVICE, EXECUTIVE LEADERSHIP, AND DECISION-MAKING

INNOVATIVE SOLUTIONS TO COMPLEX R&D PROBLEMS AND STRATEGIES FOR VALUE CREATION

TRANSLATION RESEARCH PROJECT MANAGEMENT (PRE-CLINICAL, PHASE I-II, PMR, MED DEVICE)

ADVANCING MEDICAL TECHNOLOGY AND THERAPEUTICS INTO CLINICAL TRIALS

DESIGN OF CLINICAL TRIALS AND EXECUTION STRATEGIES

DEVELOPMENT OF R&D BUDGETS AND TIMELINES (PRE-CLINICAL TO NDA SUBMISSION)

INVESTOR PRESENTATIONS, BUSINESS PLANS, FINANCIAL MODELING

GRANT (NIH, SBIR/STTR, STATE) SUBMISSION PROCESS AND STRATEGIES

IP STRATEGY, DEVELOPMENT (INVENTING), AND PORTFOLIO MANAGEMENT

PARTNERSHIP, LICENSING, TECHNOLOGY TRANSFER, AND TRANSLATIONAL SCIENCE STRATEGIES

SCIENTIFIC/TECHNICAL/CLINICAL/IP DUE DILIGENCE OF LICENSING & INVESTMENT OPPORTUNITIES

COMMERCIAL OPPORTUNITIES ASSESSMENTS OF THERAPEUTICS AND MEDICAL DEVICE

PRODUCT POSITIONING & MARKETING OF MED DEVICE AND THERAPEUTICS

RELATIONS MANAGEMENT (CROS, API & DRUG PRODUCT MANUFACTURERS, ANALYTICAL LABS) o MEDICAL COMMUNICATIONS

CLINICAL TRIAL DOCUMENTS (PROTOCOL, CONSENT FORMS, IB, CRF, FINAL REPORT, ETC.)

CONTENTS FOR REGULATORY DOCUMENTS (ORPHAN DRUG DESIGNATION, PEDIATRIC STUDY PROTOCOL, FDA COMMUNICATIONS)

GRANTS (NIH, SBIR/STTR, STATE)

WRITING EVIDENCE-BASED PEER-REVIEWED SCIENTIFIC PUBLICATIONS

INTERPRETATION/EXPLANATION OF SCIENTIFIC AND CLINICAL DATA TO PHYSICIANS AND LAYPERSON

SCIENTIFIC & MEDICAL RELATIONS (I.E. SCIENTIFIC MESSAGING, SPEAKER/KOL PRESENTATIONS, MEDICAL INFO REQUESTS, ABSTRACTS, POSTERS, CONFERENCES)

INPUT/REVIEW OF MARKETING/PROMOTION MATERIALS FOR COMPLIANCE WITH REGULATIONS

LITERATURE SEARCHES AND INCORPORATION OF ACTIONABLE INFO INTO MEDICAL COMMUNICATIONS

REVIEW OF PHARMACOVIGILANCE AND PRODUCT COMPLAINTS REPORTS

DRAFTING PROVISIONAL PATENT APPLICATIONS AND INVENTION DISCLOSURES PROFESSIONAL EXPERIENCE HISTORY

CIPHER PHARMACEUTICALS US, LLC – CHARLESTON, SC

SCIENTIFIC ADVISOR 2015 TO MAY 2017

INNOCUTIS HOLDINGS, LLC – CHARLESTON, SC

DIRECTOR OF CLINICAL RESEARCH 2014 - 2015

FIRSTSTRING RESEARCH, INC. – MOUNT PLEASANT, SC

VP BUSINESS DEVELOPMENT & OPERATIONS 2009 - 2014

APTEUS, INC. – LAKE BLUFF, IL

PRINCIPAL / FOUNDER 2003-2009

SONTRA MEDICAL CORPORATION /ECHO THERAPEUTICS (NASDAQ:SONT/ECTE) - FRANKLIN, MA DIRECTOR OF BUSINESS DEVELOPMENT AND MARKETING 2002-2003 SONTRA MEDICAL, INC. - CAMBRIDGE, MA

DIRECTOR OF BUSINESS DEVELOPMENT & CLINICAL PROGRAM MANAGER 1998-2002 ABBOTT LABORATORIES - ABBOTT PARK, IL

ASSOCIATE INSTRUMENT SCIENTIST 1992-1998

PROFESSIONAL EXPERIENCE DETAILS

CIPHER PHARMACEUTICALS US, LLC – CHARLESTON, SC

THE US OPERATION OF CIPHER PHARMACEUTICALS (MISSISSAUGA, ON) SPECIALIZING IN THE COMMERCIALIZATION OF THERAPIES FOR DERMATOLOGICAL CONDITIONS INCLUDING HERPES LABIALIS (SITAVIG), DERMATITIS (BIONECT), AND NAIL DYSTROPHY (NUVAIL)

SCIENTIFIC ADVISOR 2015 TO MAY 2017

REPORTED TO THE PRESIDENT & GENERAL MANAGER, US WITH RESPONSIBILITIES OF PROVIDING TECHNICAL AND SCIENTIFIC CONTRIBUTIONS TO THE FUNCTIONS OF GLOBAL MEDICAL AND CLINICAL AFFAIRS DEPT. BUSINESS DEVELOPMENT AND MARKETING CONTRIBUTIONS

PROVIDED SCIENTIFIC ADVICE AND EXECUTIVE LEADERSHIP AND DECISION-MAKING WITHIN MULTIPLE AREAS:

DELIVERED SCIENTIFIC/TECHNICAL/CLINICAL/IP/COMPETITION DUE DILIGENCE SUPPORT TO THE CORPORATE BUSINESS DEVELOPMENT TEAM IN THE EVALUATION OF LICENSING OPPORTUNITIES

REPRESENTED MEDICAL AFFAIRS ON THE PROMOTIONAL REVIEW COMMITTEE TO REVIEW AND APPROVE MARKETING/PROMOTIONAL MATERIALS FOR ACCURATE AND COMPLETE INFORMATION IN COMPLIANCE WITH REGULATORY REQUIREMENTS

CONTRIBUTED TO R&D AND COMMERCIAL ASSESSMENT PLANS BY SOURCING/DRAFTING ITEMIZED BUDGET ESTIMATES FOR EARLY AND CLINICAL STAGE ASSETS IDENTIFYING REQUIRED PRECLINICAL/CLINICAL STUDIES, NUMBER OF SUBJECTS, STUDY PROTOCOLS, TIMELINES, CMC COSTS, MILESTONES, AND NDA SUBMISSIONS.

DRAFTED AN ITEMIZED BUDGET ESTIMATE FOR THE R&D OF A TATTOO REMOVAL CREAM

PROVIDED SCIENTIFIC/CLINICAL INPUTS TO THE TARGET PRODUCT PROFILE FOR THE COMMERCIAL ASSESSMENT OF DERMADEXIN FOR TREATING SEBORRHEIC DERMATITIS

COMMERCIAL/CLINICAL/SCIENTIFIC ASSESSMENTS OF ASF-1096 (SALBUTAMOL) CREAM FOR TREATING A VARIETY OF DERMATOSES CULMINATING IN A DECISION TO PURSUE A SPECIFIC INDICATION RELATING TO INFLAMMATORY MYOPATHY

ASSISTED THE VP OF ALLIANCE & STRATEGIC PORTFOLIO MANAGEMENT:

MANAGED A LICENSED PRE-CLINICAL ASSET WITH THE GOAL OF ADVANCING IT TOWARDS IND-FILING FOR THE TREATMENT OF MELANOMA

REVIEWED AND ASSISTED WITH DECISION-MAKING OF IP PORTFOLIOS RELATING TO IN-LICENSED PRODUCTS

SOURCED, ANALYZED, AND SIZED COMMERCIAL MARKETS USING INTERNET RESOURCES, EPIDEMIOLOGY DATA, SECONDARY MARKET RESEARCH, AND CLINICAL LITERATURES IN SUPPORT OF MARKETING AND MARKET ACCESS/PAYERS INITIATIVES

SOURCED A UNIVERSITY SPIN-OUT PRECLINICAL ASSET FOR DERMATOLOGY APPLICATIONS

CO-INVENTOR FOR THE USE OF ASF-1096 IN THE TREATMENT OF INFLAMMATORY MYOPATHIES- DRAFTED/FILED A PROVISIONAL PATENT APPLICATION

IN-LINE PRODUCT SUPPORT ACHIEVEMENTS

AUTHORED MULTIPLE SUPPORT DOCUMENTS FOR CLINICAL AND BUSINESS RELATED ISSUES:

GENERATED AND DISSEMINATED SCIENTIFIC AND CLINICAL INFORMATION TO MARKETING AND MSL AS A KEY FUNCTION OF MEDICAL AFFAIRS

DRAFTED MANUSCRIPTS FOR SUBMISSIONS TO PEER-REVIEWED JOURNALS FOR THE CLINICAL USES OF CURRENT PRODUCTS

ADVISED THE MEDICAL DIRECTOR (MD) WITH SCIENTIFIC MESSAGE DEVELOPMENT

ESTABLISHED A SCIENTIFIC RATIONALE FOR THE KEY PRODUCT DIFFERENTIATION FACTOR OF DELAYED RECURRENCE OF HERPES EPISODES OBSERVED WITH THE USE OF SITAVIG

CONTRIBUTED TO THE SCIENTIFIC UNDERSTANDING OF THE IMPORTANCE OF NAIL BARRIER FUNCTION AND ITS ROLE IN DISEASED NAILS AND CONDITIONS IN SUPPORT OF NUVAIL KEY OPINION LEADERS (KOLS), ADVISORY BOARDS, STUDIES, AND PUBLICATIONS

PARTNERED WITH THE MEDICAL DIRECTOR TO IDENTIFY OPPORTUNITIES FOR LEVERAGING RELATIONSHIPS WITH KOLS AND PHYSICIANS TO PRESENT AND PUBLISH CLINICAL EXPERIENCES WITH SITAVIG, NUVAIL, AND BIONECT

ASSISTED THE MEDICAL DIRECTOR AND SCIENTIFIC & MEDICAL RELATIONS (MSL) IN PREPARING PRESENTATIONS FOR PODCASTS, KOLS, PORTFOLIO COMMITTEE MEETINGS, ADVISORY BOARD SPEAKERS, POSTERS, AND CONFERENCES

PREPARED WITH THE MEDICAL DIRECTOR A SPEAKER SLIDE DECK FOR THE NAIL MASTERS INAUGURAL ADVISORY BOARD MEETING (PRESENTED BY DR. JAMES Q. DEL ROSSO – 2017 AAD)

PREPARED SCIENTIFIC/CLINICAL INFO AND SLIDE DECK FOR A MEETING OF KOLS IN THE CLINICAL ASSESSMENT OF POTENTIAL INDICATIONS OF USE FOR ASF-1096 CREAM

DESIGNED AND IMPLEMENTED STUDIES RELATED TO SCIENTIFIC, MARKETING AND OTHER BUSINESS ISSUES:

DESIGNED STUDY DEMONSTRATING THE POTENTIAL OF DUAL THERAPY FOR NUVAIL WITH TOPICAL ANTIFUNGAL AGENTS USING IN VITRO RELEASE TESTING (IVRT) AND RESULTS WERE PUBLISHED IN A PEER-REVIEWED JOURNAL (ADIGUN ET AL., 2016, CO-AUTHOR)

DESIGNED A STUDY TO ASSESS THE EFFECT OF NUVAIL ON THE ABILITY OF CLINICAL FUNGAL ISOLATES TO PENETRATE HUMAN NAIL

CO-AUTHORED AND SUBMITTED A MANUSCRIPT OF A CASE STUDY REPORT FOR BIONECT

INITIATED THE DRAFT OF A MANUSCRIPT ON THE IMPORTANCE OF BARRIER FUNCTION IN THE HUMAN NAIL AS IN-LINE PRODUCT SUPPORT FOR NUVAIL (CO-AUTHOR W/ DRS. JAMES Q. DEL ROSSO, DO FAOCD AND DANIEL B. WARD, JR. MD FAAD)

REVIEWED/APPROVED VENDOR PROPOSALS & PRE-CLINICAL/CLINICAL STUDY REPORTS CLINICAL AND REGULATORY CONTRIBUTIONS

THROUGH CLOSE CONTACT WITH REGULATORY, RESOLVED EMERGENT AND ONGOING ISSUES:

ADVISED REGULATORY ON US FDA & HEALTH CANADA NDS SUBMISSIONS INCLUDING LABELING, CLINICAL STUDY PROTOCOLS, IND AMENDMENTS, ANNUAL REPORTS, AND WAIVERS RELATING TO POST- MARKETING REQUIREMENTS

PROVIDED SCIENTIFIC INPUT FOR AN APPLICATION TO RELEASE A PEDIATRIC POST MARKETING REQUIREMENT (FDA AMENDED)

MANAGED A WIDE VARIETY OF SCIENTIFIC/CLINICAL STUDIES AND DRAFTED AND SUBMITTED NUMEROUS ASSESSMENTS AND OTHER SCIENTIFIC AND BUSINESS DOCUMENTS:

AN APPLICATION REQUESTING ORPHAN DESIGNATION FOR A CLINICAL STAGE ASSET

A PMR PEDIATRIC STUDY PROJECT

A FINAL PEDIATRIC STUDY PROTOCOL SUBMITTED TO THE FDA FOR REVIEW

STATISTICAL ANALYSIS PLAN FOR A PEDIATRIC STUDY PROTOCOL

COMPREHENSIVE TECHNICAL/CLINICAL ASSESSMENT OF THE FUNCTIONS OF THE COMPONENTS OF A TOPICAL PRODUCT IN PREPARATION FOR A REQUEST FOR DETERMINATION FROM THE FDA WITH A GOAL OF SUBMITTING A 510(K) APPLICATION

PROOF-OF-CONCEPT STUDY PROTOCOL AND INVESTIGATOR BROCHURE FOR THE EVALUATION OF A CLINICAL STAGE ASSET IN THE TREATMENT OF A SPECIFIC INFLAMMATORY MYOPATHY PHARMACOVIGILANCE

ADDRESSED PRODUCT COMPLAINTS/INFORMATION REQUESTS/ADVERSE EVENTS

DRAFTED CORRESPONDENTS FOR MEDICAL INFORMATION REQUESTS FROM PHYSICIANS

CLOSED OUT PV WEEKLY AND MONTHLY COMPLIANCE LOG FOR MEDICAL AFFAIRS

GATE-KEEPER OF PRODUCTS CLINICAL STUDIES DATA AND INFORMATION TO SUPPORT PV MATTERS

PROVIDED SCIENTIFIC/TECHNICAL SUPPORT REPRESENTING CIPHER IN THE COMPLETION OF A DOSE ESCALATION STUDY & A THOROUGH QT STUDY/JOINT PMR FOR TRAMADOL

PROVIDED SCIENTIFIC/TECHNICAL SUPPORT REPRESENTING CIPHER IN A CONSORTIUM OF CANADIAN MANUFACTURERS TO CONDUCT STUDIES TO SATISFY HEATH CANADA’S CANADIAN TRAMADOL ABUSE SURVEILLANCE PROGRAM INITIATIVE

INNOCUTIS HOLDINGS, LLC – CHARLESTON, SC

A SMALL SPECIALTY PHARMA COMPANY COMMERCIALIZING PRODUCTS FOR TREATING DERMATOLOGICAL CONDITIONS INCLUDING HERPES LABIALIS, DERMATITIS, AND NAIL DYSTROPHY DIRECTOR OF CLINICAL RESEARCH/CONSULTANT FEB 2014- APRIL 2015 REPORTED TO THE CHIEF OPERATING OFFICER WITH RESPONSIBILITIES FOR THE MANAGEMENT OF A POST-MARKETING REQUIREMENT (PMR) PEDIATRIC STUDY

ESTABLISHED A PROCESS AND SUBMITTED FOUR NIH GRANTS (R44, R21, R34, U44)

CO-INVESTIGATOR/PRIMARY AUTHOR OF A DIRECT TO PHASE 2 SBIR (R44) GRANT APPLICATION THAT WAS SELECTED FOR PROBABLE FUNDING (IMPACT SCORE:15) OF $1.38 MILLION

SUBMITTED RFPS, VETTED, AND NEGOTIATED PRICING FOR A PMR PEDIATRIC STUDY

ASSISTED IN THE TECHNICAL/SCIENTIFIC DUE DILIGENCE OF PRODUCT LICENSING OPPORTUNITIES FIRSTSTRING RESEARCH, INC. – MOUNT PLEASANT, SC

CLINICAL STAGE BIOTECHNOLOGY COMPANY DEVELOPING A PIPELINE OF DRUGS (CONNEXIN SYNTHETIC PEPTIDES) FOR SCAR PREVENTION, INFLAMMATION REDUCTION, WOUND HEALING, AND COMPLEX TISSUE REGENERATION. VP BUSINESS DEVELOPMENT & OPERATIONS MAR 2009-OCT 2013 REPORTED TO PRESIDENT & CEO. CONTRIBUTED TO THE WRITING OF BUSINESS PLANS, FINANCIAL MODELS, AND CAPITAL RAISING. SOURCED PARTNERSHIP/LICENSING OPPORTUNITIES.

CONTRIBUTED TO THE ADVANCEMENT OF CLINICAL PROGRAMS BEYOND PHASE II

DRAFTED A POST PHASE II PRE-IND FDA BRIEFING PACKAGE

DRAFTED A PHASE III CLINICAL STUDY PROTOCOL FOR A CHRONIC WOUND INDICATION

MADE SIGNIFICANT CONTRIBUTIONS TO GRANTS WRITING/SUBMISSIONS AND IP ENGINEERING

THE COMPANY RECEIVED EIGHT (8) SOUTH CAROLINA EPSCOR/IDEA PHASE 0 AWARDS AS WELL AS A SCRA TECHNOLOGY VENTURES MATCHING GRANT

THE COMPANY RECEIVED SIX (6) PHASE I/PHASE II SBIR AWARDS

DRAFTED FOUR (4) PROVISIONAL PATENT APPLICATIONS FOR ADDITIONAL THERAPEUTIC INDICATIONS BEYOND THE ORIGINAL TECHNOLOGY PLATFORM’S IP

APTEUS, INC. – LAKE BLUFF, IL

A BUSINESS DEVELOPMENT CONSULTING FIRM TARGETING EARLY STAGE TECHNOLOGY VENTURES AND OFFERING SERVICES IN MANAGEMENT, MARKETS ASSESSMENT, BUSNESS MODEL DEVELOPMENT, FINANCIAL MODELING, TECHNOLOGY DUE DILIGENCE, INTELLECTUAL PROPERTY (IP) MANAGEMENT, IP ENGINEERING, IP DUE DILIGENCE, IP LICENSING, AND EXECUTION OF VALUE -CREATION STRATEGIES. INVENTED, DRAFTED, AND FILED PROVISIONAL PATENTS OF INVENTIONS THAT INCLUDE VOICE RECOGNITION, SOFTWARE, BUSINESS METHODS, MEDICAL DEVICE, DIAGNOSTIC ASSAYS, DRUG DELIVERY, AND GENERAL BIOTECHNOLOGIES PRINCIPAL / FOUNDER 2003-2009

VALUE –ADDED SERVICES & ACCOMPLISHMENTS FOR CLIENTS INCLUDED:

ADVISED THE BERGQUIST COMPANY IN THE DEPLOYMENT OF A CORPORATE VENTURE INVESTMENT IN HANDYLAB, INC THAT WAS ACQUIRED BY BECTON DICKINSON FOR $275 MILLION (2009)

T2 BIOSYSTEMS (NASDAQ: TTOO - FLAGSHIP VENTURES PORTFOLIO CO.) (AUG ‘06- AUG ‘07)

WORKED CLOSELY WITH FOUNDING CEO ON MARKETS/TECHNOLOGY ASSESSMENTS AND IP STRATEGY

ASSISTED IN THE IDENTIFICATION AND RECRUITMENT OF AN INTERIM CHIEF SCIENCE OFFICER

COMPLETED AN ASSESSMENT OF BIOSENSORS TECHNOLOGY AND DIAGNOSTIC PRODUCTS

CO-INVENTOR ON SEVEN PROVISIONAL PATENT APPLICATIONS FOR CLINICAL DIAGNOSTICS

IP STRATEGY MANAGEMENT FOR A PORTFOLIO CO. OF PURETECH VENTURES, BOSTON, MA (2008 –2009)

IP ENGINEERING OF PROVISIONALS RELATING TO STEM CELL TECHNOLOGY, COMPOUNDS, NON-INVASIVE DIAGNOSTIC MODALITIES, TRANSDERMAL DRUG DELIVERY, AND BUSINESS METHODS

IP DUE DILIGENCE / LICENSING ASSESSMENT OF PATENTS RELATING TO DERMATOLOGICAL DISORDERS

MARKETS ASSESSMENT, TRANSLATIONAL MEDICINE, AND IP STRATEGIES/PATENT MAPPING FOR DRUGGABLE PEPTIDES (PAIN, OBESITY, ALZHEIMER’S, GI, IMID, CNS, DIABETES, CVD) AT A SERIES-A VENTURE FUNDED

(QUAKER BIOVENTURES, AMGEN VENTURES, INTERSOUTH) BIOTECHNOLOGY COMPANY (AUG’07-APR’08)

CONSUMMATED AN IP LICENSING & ROYALTY AGREEMENT FOR THE COMMERCIALIZATION OF AN OPTICAL DISTAL TARGETING PRODUCT FOR LONG BONE FRACTURE REDUCTION (2007) SONTRA MEDICAL CORPORATION /ECHO THERAPEUTICS (NASDAQ:SONT /ECTE) - FRANKLIN, MA A DEVELOPMENT STAGE COMPANY COMMERCIALIZING A NON-INVASIVE CONTINUOUS GLUCOSE MONITOR AND A TRANSDERMAL DRUG DELIVERY SYSTEM FOR BIOPHARMACEUTICALS USING SONOPHORESIS DIRECTOR OF BUSINESS DEVELOPMENT AND MARKETING MAY 2002-MAY 2003

DEFINED THE COMPANY’S STRATEGIC OBJECTIVES, BUSINESS PLANS, AND FINANCIAL MODELS FOR IMPLEMENTATION IN THE AREAS OF CLINICAL STUDIES, PRODUCT DEVELOPMENT, REGULATORY STRATEGY, AND MARKETING OF THE SONOPREP® DEVICE AND ITS APPLICATIONS IN GLUCOSE MONITORING AND TRANSDERMAL DELIVERY OF TOPICAL ANESTHETICS

NURTURED KEY RELATIONSHIPS WITH R&D, BUSINESS DEVELOPMENT, AND MANAGEMENT EXECUTIVES OF A MAJOR MED/DIAGNOSTICS CO THROUGH TERM SHEET NEGOTIATION AND DUE DILIGENCE SESSIONS LEADING TO A SUBSTANTIAL COMMITMENT FOR A TECHNOLOGY LICENSING AND EXCLUSIVE MARKETING AGREEMENT

CO-INVENTOR ON MULTIPLE US PATENT APPLICATIONS INCLUDING ONE ISSUED PATENT RELATING TO THE SONOPREP DEVICE THAT WAS 510(K) CLEARED WITH INDICATIONS FOR APPLICATIONS IN ELECTRO PHYSIOLOGY AND TOPICAL ANESTHETICS DELIVERY

SONTRA MEDICAL, INC. - CAMBRIDGE, MA

A VENTURE CAPITAL-BACKED STARTUP CO-FOUNDED BY PROF. ROBERT LANGER OF MIT TO DEVELOP AND COMMERCIALIZE BIOMEDICAL PRODUCTS WITH TECHNOLOGY LICENSED FROM MIT DIRECTOR OF BUSINESS DEVELOPMENT & CLINICAL PROGRAM MANAGER 1998-2002

ASSISTED THE CHAIRMAN/FOUNDER WITH MAJOR BUSINESS DEVELOPMENT RELATED INITIATIVES COMPRISING MERGER NEGOTIATIONS, RAISING VENTURE CAPITAL, EXECUTIVE RECRUITING, STRATEGIC PARTNERSHIP OPPORTUNITIES, FINANCIAL MODELING, AND MANAGEMENT OF CLINICAL PROGRAMS FOR NON-INVASIVE GLUCOSE MONITORING AND TRANSDERMAL DRUG DELIVERY.

KEY CONTRIBUTIONS INCLUDED CONSUMMATION OF A REVERSE MERGER, INVESTOR ROAD-SHOWS, A SERIES- B FINANCING, INTERIM-CEO RECRUITMENT, ESTABLISHING SEVERAL RESEARCH AND LICENSING AGREEMENTS

(HUMAN CLINICAL TRIALS OF NON-INVASIVE GLUCOSE SENSING, GLUCOSE SENSING TECHNOLOGIES, TRANSDERMAL DELIVERY OF INSULIN), AND MANAGEMENT OF THREE SUCCESSFUL HUMAN CLINICAL STUDIES

CONTRIBUTED TO THE DEVELOPMENT OF A BREAK-THROUGH FEEDBACK APPROACH FOR NON-INVASIVE ULTRASOUND-MEDIATED SKIN PERMEATION (SONOPREP

®)

ABBOTT LABORATORIES - ABBOTT PARK, IL

ASSOCIATE INSTRUMENT SCIENTIST 1992-1998

PERFORMED RESEARCH, TECHNOLOGY DUE DILIGENCE, COMPETITIVE INTELLIGENCE, AND MARKET ASSESSMENTS RELATING TO THE NEXT GENERATION (NON-INVASIVE/MINIMALLY INVASIVE) DIABETES PRODUCTS AND ADVANCED DIAGNOSTIC DETECTION TECHNOLOGIES FOR SELF-PERFORMING IMMUNO- ASSAYS/CLINICAL CHEMISTRY/ AND MOLECULAR DIAGNOSTICS ANALYZERS

MADE SIGNIFICANT CONTRIBUTIONS TO THE DEVELOPMENT OF THE SOF-TACT GLUCOSE METER THROUGH CONCEPT EVALUATION, CLINICAL TESTING OF THE PRINCIPLE COMPONENTS, AND OBTAINING CUSTOMER REQUIREMENTS FOR PRODUCT FEATURES

CONTRIBUTED TO THE ESTABLISHMENT OF A CORPORATE VENTURE PROCESS LEADING TO INVESTMENTS IN COMPANIES WITH EMERGING TECHNOLOGIES, COMMERCIALIZATION OF THE STATE-OF-THE-ART GLUCOSE METER (SOF-TACT), AND THE PROLIFERATION OF PATENT MAPPING THROUGHOUT THE DIAGNOSTICS DIVISION

RECIPIENT OF THE CHAIRMAN’S AWARD AND CO-AUTHORED 9 US ISSUED PATENTS EDUCATION

MASSACHUSETTS INSTITUTE OF TECHNOLOGY - CAMBRIDGE, MA BACHELOR OF SCIENCE IN AERO-ASTRONAUTICS (AVIONICS) ENGINEERING – CLASS OF 1992

SUMMER INTERN AND CONSULTANT TO ABBOTT LABORATORIES

MEMBER OF THE VARSITY SOCCER TEAM & THE BETA THETA PI FRATERNITY Professional Development: Dermatology Product Development Course: Current Issues for Topical Products

(Apr 2016) - Sponsored by Dow Development Laboratories, LLC. INTELLECTUAL PROPERTY

INVENTOR/CO-INVENTOR OF 13 ISSUED PATENTS AND SEVERAL PENDING APPLICATIONS IN THE FIELD OF MEDICAL DIAGNOSTICS, DRUG DELIVERY, AND THERAPEUTICS.

ISSUED:

8,870,810: METHOD AND APPARATUS FOR ENHANCEMENT OF TRANSDERMAL TRANSPORT 8,287,483: METHOD AND APPARATUS FOR ENHANCEMENT OF TRANSDERMAL TRANSPORT 7,066,884: SYSTEM, METHOD, AND DEVICE FOR NON-INVASIVE BODY FLUID SAMPLING AND ANALYSIS 6,887,239: PREPARATION FOR TRANSMISSION AND RECEPTION OF ELECTRICAL SIGNALS 6,294,342: MAGNETICALLY ASSISTED BINDING ASSAYS UTILIZING A MAGNETICALLY RESPONSIVE REAGENT 6,032,059: DEVICE FOR THE DETECTION OF ANALYTE AND ADMINISTRATION OF A THERAPEUTIC SUBSTANCE 6,014,577: DEVICE FOR THE DETECTION OF ANALYTE AND ADMINISTRATION OF A THERAPEUTIC SUBSTANCE 6,009,343: ENHANCED TRANSDERMAL TRANSPORT OF FLUID USING VACUUM 5,998,224: MAGNETICALLY ASSISTED BINDING ASSAYS UTILIZING A MAGNETICALLY RESPONSIVE REAGENT 5,913,833: METHOD AND APPARATUS FOR OBTAINING BIOLOGICAL FLUIDS 5,895,362: TRANSDERMAL TRANSPORT USING ULTRASONIC STANDING WAVES 5,807,274: PUMP FOR USE IN NON-INVASIVE OR MINIMALLY INVASIVE DETECTION OF ANALYTES 5,725,480: NON-INVASIVE CALIBRATION AND CATEGORIZATION OF INDIVIDUALS FOR SUBSEQUENT NON-INVASIVE DETECTION OF BIOLOGICAL COMPOUNDS

PENDING: PROVISIONAL PATENT APPLICATION - “TREATMENT OF INFLAMMATORY MYOPATHIES” PUBLISHED - 201******** “MAGNETIC NANOSENSOR COMPOSITIONS AND BIOANALYTICAL ASSAYS THEREFOR” – FILED 10-8-2015 (ASSIGNEE: T2 BIOSYSTEMS, INC.) PUBLICATIONS

ADIGUN CG, VLAHOVIC TC, MCCLELLAN MB, THAKKER KD, KLEIN RR, ELSTROM TA, WARD DB. EFINACONAZOLE 10% AND TAVABOROLE 5% PENETRATE ACROSS POLY-UREAURETHANE 16%: RESULTS OF IN VITRO RELEASE TESTING AND CLINICAL IMPLICATIONS OF ONYCHODYSTROPHY IN ONYCHOMYCOSIS. J DRUGS DERMATOL. 2016 SEP 1;15(9):1116-20.

CHAPTER 33: TRANSLATIONAL STRATEGIES FOR THE DEVELOPMENT OF A WOUND HEALING TECHNOLOGY (IDEA) FROM BENCH TO BEDSIDE. GAUTAM S. GHATNEKAR AND TUAN A. ELSTROM. WOUND REGENERATION AND REPAIR, METHODS AND PROTOCOLS ROBERT G. GOURDIE, TEREANCE A. MYERS EDITORS. HUMANA PRESS. 2013. NOVEL WOUND HEALING POWDER FORMULATION FOR THE TREATMENT OF VENOUS LEG ULCERS THE JOURNAL OF THE AMERICAN COLLEGE OF CERTIFIED WOUND SPECIALISTS, VOLUME 3, ISSUE 2, PAGES 33-41 ANGELA V. GHATNEKAR, TUAN ELSTROM, GAUTAM S. GHATNEKAR, TERESA KELECHI. CUNNINGHAM DD, HENNING TP, SHAIN EB, YOUNG DF, ELSTROM TA, TAYLOR EJ, SCHRODER SM, GATCOMB PM, TAMBORLANE WV. VACUUM-ASSISTED LANCING OF THE FOREARM: AN EFFECTIVE AND LESS PAINFUL APPROACH TO BLOOD GLUCOSE MONITORING. DIABETES TECHNOL THER. 2000 WINTER;2(4):541-8. SUBMITTED FOR PEER-REVIEW:

MARIO TAGLIAGAMBE, MD, TUAN A. ELSTROM, BS, DANIEL B. WARD, JR., MD FAAD. “HYALURONIC ACID SODIUM SALT, 0.2% GEL IN THE TREATMENT OF RECALCITRANT DISTAL LEG ULCERS”

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