bioaustin | texas medical device alliance | austin health...

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BioAustin | Texas Medical Device Alliance | Austin Health Tech

NEWSLETTER SEPTEMBER 2019

CONTENTS

LIFE SCIENCE INDUSTRY NEWS 2 U.S.News:InOurNeckoftheWoods…European&WorldNews:AcrossthePond… INDUSTRY RESOURCES & FUNDING OPPORTUNITIES 3 SPOTLIGHT 4 Mainstream Medical Devices – Local Sterile Contract Packaging Austin Technology Council (ATC) WOMEN IN LIFE SCIENCE & WOMEN’S HEALTH 5 UPCOMING EVENTS 6 CAREER CORNER 10 TEXAS LIFE SCIENCE ORGANIZATIONS 12 VOLUNTEER OPPORTUNITIES 13 Join the BioAustin/TMDA/AHT Newsletter Team!

Fallinstepwithallthenews,meetings,webinars,seminars,andnetworkingeventsthatyou’llfindinthisSeptembernewsletter!

OnbehalfoftheBoardofDirectorsofTexasMedicalDeviceAlliance,BioAustin&AustinHealthTech,WEWELCOMEVOLUNTEERSTOJOINTHEMONTHLYNEWSLETTERTEAM(detailspage13)

Asalways,ifyouhavenews,jobpostings,orotherresourcestoshare,pleasereachoutto

ElisaMaldonado-Holmertz([email protected])

BioAustin | Texas Medical Device Alliance | Austin Health Tech NEWSLETTER • September 2019

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LIFE SCIENCE INDUSTRY NEWS

In Our Neck of the Woods

Austin Skyline Poised to Change with Innovative Project Plans The University of Texas at Austin plans to start construction on a 17-story office tower on theBrackenridgetract,directlyeastofWaterlooPark.ThecurrentlydefunctBrackenridgeHospitalwillberenovatedandredeveloped inorder to includenewbuildingsandparks.Thiswill revive thisMedicalDistrictandexpandonUT’sDellMedicalSchool,DellSetonMedicalCenter,WallerCreekanditschainofparksaswellastheTexasStateCapitolComplex,whichisundergoingitsowntransformation.https://tinyurl.com/y3quywubA Feud Brews Between Rivals in the Pharmacy Business The latest chapter in the battle between Amazon and the incumbents it’s trying to disrupt in thepharmacybusinessisplayingoutintheformofacomplicatedspatbetweenintermediaries.Ononesideis Surescripts, the electronic prescribing company owned by Cigna’s pharmacy benefit managerExpressScripts and a coalition of other firms that compete against Amazon’s digital pharmacy unitPillPack.On the other side is ReMyHealth, a startup that until thisweekwas a Surescripts vendor.SurescriptshasaccusedReMyofimproperlyaccessingitscustomers’medicationhistorydatainordertoturn that information over to PillPack — and the tensions escalated this week, when SurescriptsterminateditscontractwithReMyandreferredthemattertotheFBI.https://tinyurl.com/y62on5fe PhRMA’s top lobbyist left his post at the end of August RodgerCurrie,thenation’stoplobbyistforthedrugindustrytradegroupPhRMAsince2016plannedtoleave theorganizationat theendofAugust.According toa2017 tax filing,heearneda salaryof> $1millionplus>$250K inother compensation.Rodgerhas served formore than 10 consecutive years aslobbyistbutisleavingto“pursuenewopportunities.”https://tinyurl.com/yxth6h5rLack of Training Compromises Trial Results Clinicaltrialsserveasameasurementsystemtoelucidateinvestigationsontopicsofresearch.However,since these data rely on patients and clinical trial staff, it can be difficult to accurately quantifyqualitative results. Therefore, this industry would have to shift focus on training everyone involved,from the investigators all the way down to the patients. “Lack of training, particularly for patients,createsvariabilitydetrimentaltotrialfindings,”saysNathanielKatz,founderandchiefscienceofficerofWCGAnalgesicSolutions.https://tinyurl.com/y3wlt655Cancer Insight Helps Clients Obtain $31 Million in CPRIT Funding Thus Far in 2019 CancerInsightisacutting-edgeclinicalContractResearchOrganization(CRO)thatdesignsandexecutesimmuno–oncologyclinicaltrials.Formoreinformationvisitwww.cancerinsight.com

Across the Pond…. Planning Application Filed for EU's First Waste-to-Jet Fuel Plant AltaltoImmingham,asubsidiaryofVelocys,hassubmittedplanstobuildthefirstfacilityinEuropethatwillproducesustainableaviationandroadfuelthroughtheconversionofcommercialsolidwasteandhouseholdwaste.AltaltohaspartneredwithShellandBritishAirwaystocreatethefacility,whichwillbeconstructedintheUK.https://tinyurl.com/y4cdlbpf


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Japanese Scientists Develop Biotech Rain-Resistant Wheat Variety Researchers from Japan's National Agriculture and Food Research Organization and OkayamaUniversity developed biotech wheat variety resistant to rain using CRISPR/Cas9 genome editingtechnology. The process took them only a year to create, whilewheat species typically take about adecadetodevelopusingtraditionalbreedingtechnology.https://tinyurl.com/y54mjlwu

INDUSTRY RESOURCES & FUNDING OPPORTUNITIES

Fulbright Research Grants to France - Deadline: September 16, 2019 OpentoalllevelsofscholarswithaPh.D.interestedinconductingresearchintheselectedregionsofFrance: Grand Est (Strasbourg, Nancy), Nouvelle-Aquitaine (Bordeaux, Limoges) or Hauts-de-France(Lille,Amiens).Up to2800€permonthanda 1200€ travel allowance.Available from3 to 12months.Howtoapply:TheAmericanapplicantdirectlysubmitsanapplicationtotheInstituteofInternationalEducation(IIE)onceheorshehasobtainedthesupportofaFrenchhostinstitution.ApplicantsmustapplythroughIIE’swebsiteathttps://www.cies.org/program/fulbright-us-scholar-program#qt-programForfurtherinformation:-IIE’sawardannouncementandapplication:https://awards.cies.org/content/hauts-de-france-regional-award-1-FulbrightCommissiongrantpage:http://fulbright-france.org/en/fulbright-grantsus-citizens/us-scholar-program/regional-programs/hauts-france Greenlight Guru:Ultimate Guide to Agile Design and Development for Medical Devices Medicaldevicedevelopmentandproduct launchesputa layerofoverheadonthedevelopmenteffortthatlimitsinnovationandspeed,buttheseproductdevelopmentprocessescanbeveryinnovativeanddynamic,whilestillfollowingalltheregulatoryrequirementsandbestpracticesforbringingamedicaldevicetomarketthatissafe,effectiveandimprovesthelivesofpatients.TheAgileMethodforMedicalDeviceDesign is an iterative process that includes all products and product features that are tested,verified and validated, and allows for tweaks, requirement changes, risk updates and complianceupdatesasneeded.Adetailedguidecanbefoundhere:https://tinyurl.com/y2ff4ja4Regulatory Alert: transparency reporting changes, requirements & deadlines Manyjurisdictionshavecurrentorpendinglegislationthatimpacthowcompaniesmarketproductsandinteractwithhealthcareprofessionals.Manufacturersneedtobeawareoftheseinordertoavoidfinesandtomaintaincompliance.Somestateshaveactivelyenforcedtheir laws,e.g.,Vermontsettledwithtwenty-fivedruganddevicemakersforfailingtoreportandforallegedgiftbanviolations.Finesrangeby jurisdictionbut are ashigh as $10,000per violation.Requirements vary and include gift bans andlimitations, payment and marketing disclosures, manufacturer and/or sales staff registration, andcompliance attestations—made under penalty of perjury. Outlined international requirements,including a calendar listing reporting deadlines can be found here:https://gardner.law/news/regulatory-alert/ Greenlight Guru:Why the FDA Pre-Submission is an Underutilized Tool FDA'sPre-SubmissionprogramoffersmedicaldevicecompaniesauniqueopportunitytocommunicateearlyonwithFDA,puttingtheballinthecourtofthedevicemakertodeterminethemeetingagendaandmakethecaseforwhytheirdeviceshouldbeapprovedformarket.Inthisweek'sblog,you'lllearnhow to successfullynavigate thePre-Subprocess to improveyourchancesof a successful submissionandsavealotoftimeandmoneyinthelongrun.https://tinyurl.com/yygsmh4d


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MDD vs. MDR tool is out now! ThisMDDvsMDRGap-Assessment/Comparisontoolsupportsyoutoevaluateallyourgaps inyourCompany.(FullversionincludesthecompleteMDR+Corrigenda,March2019)IfyouarealreadyhavingtheMDDinplaceandyouwouldliketocompareittotheMDR,mightbethistoolishelpfulforyou.This tool includes the completeMDR (Chapter l toX andAnnex l toXVll +Corrigenda fromMarch2019)withacomparisontabletotheMDD.https://tinyurl.com/y46eku8j17 Free Resources for Product Developers to Accelerate Bringing a Device to Market Bringingamedicaldevicefromconcepttomanufactureandlaunchisacomplexprocess.Afreecontenttoolkitformedicaldeviceproductdevelopmentisavailabletodownload,whichwillincludetemplates& checklists, eBooks for Ultimate Guides, and case studies. Download this free content toolkit toimproveyourproductdevelopmenteffortswithbringingsafer,moreeffectivemedicaldevicestomarketfasterandwithlessrisk.https://tinyurl.com/yx9xodxn NAMSA White Paper: Medical Device Biological Evaluation Reports - Relevance to the Revised ISO 10993-Part 1:2018 To evaluate the safety of medical devices, a risk management approach is advocated in multipleregulatory documents, andin 2018, significant changes were made in Annex A of the updated ISO10993-Part 1 Standard to support this approach.New endpoints for biological evaluationnow includephysical and/or chemical information, material-mediated pyrogenicity, subacute systemic toxicitychronic toxicity, and carcinogenicity. The updated Standard also mandates that information beprovided onmost device physical properties,materials of construction,manufacturing and finishingprocesses that are relevant to thebiological safetyof apatient.NAMSA invites you toaccess awhitepaper,“MedicalDeviceBiologicalEvaluationReports:RelevancetotheRevisedISO10993-Part1:2018,”tolearnhowthenewstandardemphasizestheimportanceofmaterialcharacterizationinformationinbiologicalevaluationreports.(Authors:ElaineDaniel,PhD,DABT;PrincipalToxicologist,NAMSAandDuaneMancini,M.Sc.;MROStrategyAdvisor,NAMSA).https://tinyurl.com/y66yoad9 Do Not Fear the FDA Meeting As medicines have become increasingly unique and complex, a more collaborative approach tointeracting with the FDA has been undertaken by industry sponsors in recent years, displacing thedated“makethemask”approach.Tryingtoforcethequality,pre-clinicalorclinicalsquarepegintotheroundholecanhavedevastatingconsequencesontiming,cost,andoutcomeofdevelopmentprograms.Meetings with FDA are designed to discuss development programs during critical points in theregulatory process; helping to ensure the peg is being placedwhere it needs to be. In 2017, the FDAreleasedtheirrevisedGuidanceforIndustryonformalmeetingsoutliningtheproceduresforrequesting,preparing,scheduling,conductinganddocumentingformalmeetings.https://tinyurl.com/y67fyh7g

Have an opportunity? Reach out to share it.

SPOTLIGHT

Mainstream Medical Devices – Local Sterile Contract Packaging

Tryingtogetintoqueuewithlargepackagingvendorscanputastoptomanyprojectlaunches.Beingflexibleandnimble,MainstreamMedicalcanebbandflowwithyourrequirements,andadjusttomeet


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yourspecificneeds.Weareexperiencedmanufacturing,packaging,anddeviceprofessionalsthathavebeen in the medical device community for decades and saw a need for a regional sterile contract-packaging vendor. Preparations are underway now to support start-up to mid-sized companies’prototype, beta launch, and full launchpackaging requirements. Please considerus and letusquoteyour upcoming projects. You can learn more atmainstreammedicaldevices.comor contact [email protected].

Austin Technology Council (ATC)

Since1992,AustinTechnologyCouncilhasbeentheinformedopinionleaderandunifyingvoiceoftechnologyinAustinandCentralTexas.Asourregion’slargesttechindustryorganization,weempowerourmemberswiththeinsights,resourcesandconnectionstheyneedtosucceedandthrive,andworkcollaborativelywithourpartnerstofosterinnovationandgrowth.We'relookingforwardtoseeingfamiliarandnewfacesattheATCSeptemberevents!Wehaveanexcitingarrayoftopicswithexpertspeakersandfacilitatorsthatcanhelpyougrowyourcompany,staycompetitive,andfosterapositiveworkplaceenvironment.Registerforoneoralloftheeventsbelow.Remember,membercompanyemployeesenjoyfreeordiscountedeventsaswellassponsorshipopportunitiestoelevateyourcompany'svisibility.Ifyou'reinterestedinjoiningATCorsponsoringanupcomingevent,contactBrandonLamberson. LearnmoreaboutTheAustinTechnologyCouncilclickhere Want a Spotlight? Reach out to share it.

WOMEN IN SCIENCE & WOMEN’S HEALTH Lone Women in Boardroom Are Likeliest to Be Stretched for Time Companies thatholdout too longonadding their first femaleboardmemberaremore likely topickonewho’salreadyadirectorelsewhere,meaningshe’llhavelesstimetodevotetothefirm,aBloombergIntelligencestudyfound.https://tinyurl.com/y46vg9q9 Join Association for Women in Science (AWIS) Aleadershipposition,theChiefDevelopmentOfficerisresponsibleforidentifyinganddevelopingnewmarketopportunitiesandrevenuestreamstosupportorganizationalstabilityandgrowth.ReadAWIS'blogaboutworkplacesengagingindiversity,equityandinclusionworkonMassbio.Also,staycurrentwiththelatestAWISKirstenR.LorentzenAwardslikethisyear’swinnerAlexandraDetweiler.AlexandraisaphysicsandastrophysicsundergradattheIllinoisInstituteofTechnologyandenrolledintheco-terminalhealthphysicsmaster’sdegreeprogram.https://www.awis.org/join/?_zs=5b6be1&_zl=j8N56One health care startup at a time, this venture capitalist wants to harness the investing power of women It’s no secret thatwomen are underrepresented among the investorswho buoy health-tech startups.STAT’sMeganThielkinghasanewpieceoutonanefforttochangethat.It’sledbyTrishCostello,theSilicon Valley venture capitalist behind the investing platform Portfolia, which is rallying female


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investors to back startups, including those working on technology for women’s health, aging, andlongevity.https://tinyurl.com/y6cdqrls

UPCOMING EVENTS

Capital City Innovation has compiled partner and community events. Check out their Calendar! https://www.capitalcityinnovation.org/events?view=calendar&month=09-2019

September 5, Houston, TX Mass Challenge Texas Finale TheMassChallengeAwardsCeremoniesarethegrandfinaleofeachglobalMassChallengeacceleratorprogram.Weare inviting top influencers from theTexas innovation community to come together tocelebrateentrepreneurshipandstartupinnovationinHoustonandbeyond.Thetopstartupsfromourcohortwill be recognizedby community leaders to a room full of potential investors and customers,MassChallenge mentors, VIP community leaders, and their loved ones. This event is the flagshipexperienceoftheglobalMassChallengeacceleratorprogramandisthefirstMassChallengeShowcase+FinalefortheHoustonprogram.https://tinyurl.com/yyr6slb7 September 11, Webinar (Free) Achieving Proof-of-Concept Success Starts in Candidate Selection Building a robust understanding of your API characteristics matched against your developmentprogramgoals supports the efficient transitionof drugproducts fromcandidate selection through toproof-of-concept. Utilizing a data-driven approach during candidate selection is key when trying todevelop dosage forms and achieve proof-of-concept success. By applying key strategies in earlydevelopment such as salt and polymorph screening to select the right API form, pre-formulationcharacterization to understand theAPI, development and assessment of preclinical formulations andscreening of technologies for dealingwith poorly solublemolecules, you are able to gain a completeunderstandingofyourmoleculepriortothefirst-in-human(FIH)clinicalstudyaboutprotectionsandethicaloversightofimportantresearch.https://tinyurl.com/y68apqqw September 16, Austin, TX (Free) Health Care Startup Boot Camp - Learning @ Texas Health CoLab/WSGR Join the third installment of the Health Innovation Roundtable, an event designed to bring thehealthcareinnovationcommunitytogethertomeet,learnandnetworkacrosstheexistinggroupsinthecity. The Texas Health CoLab at DellMedical School invites you to join us for a free boot camp incollaboration with Wilson Sonsini Goodrich & Rosati. The boot camp will empower you with thenecessary information to create and develop your startup, covering topics such as business plans,fundraising, intellectual property strategies, valuations and term sheets, andpreparing and executingyourinvestorpitch.Breakfastandlunchareprovided,andanetworkingreceptionwillfollow.https://tinyurl.com/y3zdbqp5 September 17, Free Webinar CMO/CDMO Facilities Gain Value with Single Use Containment Containmentiscriticaltoassurepersonnelarenotexposedtotheeffectsofthedrugsandtomitigateissueswithcrosscontamination.9amcentral.Registerathttps://tinyurl.com/y3pwu3sx September 19, Austin, TX The Mechanics of Term Sheets - Texas Health CoLab's Monthly Learning Series


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Duringthisdiscussion,wewillexplorethemechanicsoftermsheets,coveringthebasicsandsomekeyissuessuchaslearningthedifferencebetweenpre-moneyandpost-moneyvaluation,optionpools,

• Whatisaliquidationpreference,andwhydoesitmatter?• Thecumulativedividendtrap• Therealitiesofvaluationsforstartups• Anti-dilutionpreferences(whatcouldgowrong)?

Joinusforhappyhour!SponsoredbySchwegmanLundberg&Woessnerhttps://tinyurl.com/y3ekpdwq September 19, Austin, TX TiE Austin September Networking Event JoinTiEAustinoverdrinksandappetizerstoNetworkandDiscuss"Entrepreneur’sGuidetoNavigatingState&LocalGovernment"WewillbejoinedbyAaronGregganattorneyasourguestspeaker,aswellasseveralsuccessfulAustinEntrepreneurs.https://tinyurl.com/y4u2wldv September 19, Webinar (Free) Privacy & Health Research in a Data-Driven World- 2019 OHRP EXPLORATORY WORKSHOP Watch the live webcast of OHRP’s ExploratoryWorkshop, "Privacy and Health Research in a Data-DrivenWorld," on Thursday, September 19, 2019 from 8:15am-4:15pm EDT. Viewing is free, and noregistrationisrequired.ThiseventqualifiesforCIPaccreditation.VideooftherecordedwebcastwillbeavailableonOHRP’swebsiteaftertheevent.TheWorkshopwillexploreissuesaroundconceptionsofprivacy, ways to protect data confidentiality, and how IRBs and other review bodies can learnmoreaboutprotectionsandethicaloversightofimportantresearch.https://tinyurl.com/y52h6hf7 September 19, Webinar (Free) Cold Chain Validation Best Practices Including Immunotherapy AStep-by-StepColdChainValidationGuideCoveringAgencyResponsesonLatestClassofTherapiesWith more than 35 international cold chain regulatory compliance guidance documents, globalstandards are becomingmore comprehensive and increasingly complex. New therapies, acceleratingcosts, sustainable technologies, and emerging markets demand validated cold chain networks thatconsistently produce low-cost and high-quality outcomes for patients with a minimal variationdeliveringvaluetoyoursupplychain.Buildyourreputationofreliabilitywiththeregulators. https://tinyurl.com/yxtuvjwo September 21-24, Philadelphia, PA RAPS Regulatory Convergence 2019 Join theonly conference focused exclusively on regulatory for thehealthcareproducts industry. Findnewwaystoexamineandsolveregulatorychallenges,networkwiththebestregulatoryprofessionalsintheworld,andgetthelatest,mostup-to-dateindustryknowledge.https://www.raps.org/convergence-2019/homeSeptember 24, Austin, TX MedtoMarket Monthly Mixer Join us as we network with our member companies, physicians, investors, and lots of industryprofessionalsandassociations.Lightsnacksandbeveragesprovided.ParkingisFREEandample.Don'tmissout!https://www.eventbrite.com/e/medtomarket-monthly-mixer-september-tickets-70954148769September 24, Temple, TX Lunch & Learn Webinar - Beyond The Technology: 7 Steps To Develop High Performing Science And Technology Companies That Succeed


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Next month's webinar will feature Dr. Joanne Mitchell, a leading business coach for science andtechnologyprofessionals.Shewillwalkus throughsevenstrategies todevelopa leadership teamthatcanperformatahigherlevel.RegisternowusingthelinkbeloworemailTamiA@templebioscience.orghttps://register.gotowebinar.com/register/2171538065030933250September 27, Arlington, TX iC3TM Life Science Summit iC3TMLifeScienceSummitservesasa forumfor leaderstodiscussstrategic issues,exhibitthebroadspectrumofNorthTexas life scienceproducts and services, and tonetworkwith eachother so as togrowbusinessthroughcollaborativeefforts.Attendeesrangefromthestartupcommunitythroughlargemultinationalsrepresentingindustrysectorssuchasbiotech,pharma,healthcarecompanies,academicresearchinstitutions,innovators,andleaders.https://bionorthtx.org/ic3-summit-2019/ October 2, Austin, TX (Free) Health Tech Companies Confronting the Opioid Crisis TheHealthcareDeviceandDataMeetup®groupwillhostanexcitingeveningthatexploreshowhealthtechcompaniesareconfrontingtheopioidcrisis.Threecompanieswillengageinadynamicmoderateddiscussion(noslidepresentations)interactingwithaselectpanelofproviders,administrators,investors,and technologists to share insights and gain valuable feedback. The goal is a facilitated exchange ofideas and recommendations that will help these companies refine their solutions and benefit ourcommunityatlarge.THEDISRUPTERS(CompanyPresenters):

• DanielPowell-CEO,SparkBiomedical• KaseyClaborn,PhD-CEO,HealthEco,Inc;Asst.Professor,DellMedicalSchool• YashSabharwal-CEO,NanoMedicalSystems

THETHOUGHTLEADERS(Panelists):• CarlosTirado,MD,MPH-CMO,CARMAhealthManagement• JayWilliams-CTO,QuantumMaterialsCorp• EmmaCartmell,AngelInvestor,CartmellInvestingandAdvising• HalKatz-ChairoftheBoard,IntegralCare;PartnerHuschBlackwellLLP

Formoreinformationonhowtoregister,visit,https://www.meetup.com/healthcare-device-and-data/ October 3-4, San Antonio, TX Southwest Research Institute ISO 9001 Internal Auditor Training LearnthefundamentalsandapplicationsofISO9001InternalAuditing.Thistwo-dayinternalauditingcourse covers the recently revised ISO 9001:2015 Quality Management System (QMS) Standard,requirements and auditing techniques. For more information, please contactCarissa Plumley athttps://tinyurl.com/y22texoz October 6-8, Cleveland, OH Equity in STEM Community Convening Advancing equity in STEM requires an intentional focus on creating authentic, sustainable, andinclusive environments while simultaneously cultivating a community that collaborates, shares andimplementspromisingpracticesand tools showntoeffectchange.TheARCNetwork’s2019Equity inSTEM Community Convening serves as a meeting space for researchers, practitioners, and changeagentsdedicatedtocreatingequitableSTEMworkplaces.Attendeeswillhaveanopportunity tosharenewresearchfindingsandexchangeresources;brainstormstrategiesandcollaborateinnovelways;anddemonstrate effective programs and interventions for greater collective impact.Through this sharedpurpose we will have the interactive capacity to finally see#EquityinSTEM.https://tinyurl.com/yymlnlmn


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October 8, Webinar (Free) Bioscience and Biotechnology Career Fair Information for Employers JointhisNSFInternationalwebinarinwhichexpert,Dr.KiviaPontesdeOliveira,describesRegulation(EU) 2017/745 with a special focus on the collection, generation and evaluation of clinical data formedical devices. This includes a short introduction and general requirements on regulation and thedefinitionofclinicaldata.Shewillalsodiscusspotential routes toperformaclinicalevaluationalongwithhowtoindicate,identifyandgenerateclinicaldata.AttheendofthiswebinarDr.Kiviawillrecapstrategicstepsonhowyoucanstartpreparingtobecomecompliantnow.https://tinyurl.com/y3h7fu2r October 13-14, Austin, TX Southwest Research Institute ISO 9001 Internal Auditor Training LearnthefundamentalsandapplicationsofISO9001InternalAuditing.Thistwo-dayinternalauditingcourse covers the recently revised ISO 9001:2015 Quality Management System (QMS) Standard,requirements and auditing techniques. For more information, please contactCarissa Plumley athttps://tinyurl.com/y22texoz October 17, Austin, TX (Free) Clinical Research and CRO Experiences and Expectations (TMDA Quarterly Meeting) Moderator:BobDavis,COOLumosPharmaPanelists: JoeSkraba,CEOEntvantageDiagnostics;AdamBerman,CEOAlleviantMedical;DennisW.King, CEO Statking CRO. 2-4pm at the Norris Conference Center. Get Your Free Ticket!https://tinyurl.com/y2vkq33g October 23, Austin, TX (Free) Bioscience and Biotechnology Career Fair Information for Employers This career fair offers a great opportunity to network with students of theCockrell School ofEngineeringandtheCollegeofNaturalSciences.Youwillmeetmorethan300studentswithexperienceand interest inthebiomedical,biotechnologyand lifesciences industries.Theevent isacollaborativeeffort betweenEngineering Career Assistance Center,Natural Sciences Career Center,BiomedicalEngineering Society-Student ChapterandNatural Sciences Council. For further questions, contactLillianWang,BioscienceandBiotechnologyCareerFairCoordinator,atoffice:512-471-9084https://tinyurl.com/y2hdn486 November 7, Houston, TX Medtech Industry Forum – German Manufacturing Solutions SavetheDate!IncooperationwiththeVDMAWorkingGroupMedicalTechnologyinGermanyandtheGACCMidwest,theGermanAmericanChamberofCommerceinAtlantaisorganizingatrademissionto the US in the field of production technology for the medical industry. Join us for a businessconferenceinHoustontomeetthedelegationparticipantsandexploreGermanproductiontechnologysolutionsforthemedicalindustryanddiscovercutting-edgetechnologiesandinnovationsinboththeGerman and USMedtech industries. This event is free to attend, but prior registration is required.Contact:CatherineMalone,GACCSouth,[email protected]:https://tinyurl.com/y6h47ast February 19-20, Tampa, FL


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2020 Life Science Women’s Conference- Save the date! The Life ScienceWomen's Conference is an unparalleled opportunity for women to accelerate theircareersinthelifesciencefieldthroughmentoring,networking,andeducation.Mentorship,networking,andeducationarefundamentalstoclimbinganycareerladderandthetoolsacquiredatthiseventarespecifically structured forwomenseekingadvancement.Thespeaker’sprogram isdesigned togreatlycontributetoeducationalandprofessionaldevelopment.Ourlineupofpresenterswillincludesomeofthe best and brightest in their distinct field of expertise. These powerfulwomenwill be focusing onwomen's enlightenment, career development, leadership role, networking, mentorship, andempowerment.https://lifesciconf.com/

CAREER CORNER

Quantitative Radiology Solutions QuantitativeRadiologySolutions,LLCissearchingforaCEOtobringitsnovelautomatedanatomyrecognitionsoftwaretomarketandcontinuetobuildvalueintothecompany.www.quantitativeradiologysolutions.com Jaden Group China A Chinese based company soliciting for individual or company that will represent our company in the USA. Part time job. To learn more about our company, kindly visit our website. http://www.jadenfactoring.com BENEFITS: •$6,500 monthly salary payable at 28th day of every month. •5% commission on each payment collected on behalf of our company Note: All transactions are legal and no cash transactions involved. All expenses regarding representing our company will be shouldered by us and you are not expected to contribute a dollar at any point. If you are interested to represent us, get back to us so we can provide our job description. Forward your reply to [email protected], [email protected] and [email protected] Abbott jobs.abbott/us/en/search-results?keywords=austin Aeglea Biotherapeutics aegleabio.com/biotechonology-careers/#career-opportunities

VP Operations, Paradromics Paradromics is looking for a Vice President of Operations. The candidate will be responsible for Quality Assurance, FDA Regulatory Compliance, Manufacturing, Project Management, Facilities, and Logistics. Emphasis will be placed upon medical device manufacturing experience, with a preference for manufacturing of implantable electronic devices. Contact Chelsea Coleman [email protected] International Biopharmaceutical Company Sr. Director/Director, Regulatory Affairs Candidate must be willing to relocate to Fairmont, CA or be willing to move to Shanghai, China. (Relocation assistance will be provided) This position will be responsible to develop a strong working relationship with the internal team and external resources to quickly integrate resources and move the regulatory work forward aligned with regulatory authorities’ requirements. This is an amazing opportunity and a great time to join their growing team, so please let me know if you’re interested: Trevor Pandya, Recruiter at Sterling Life Sciences, a Division of Sterling-Hoffman Executive Search; [email protected] Medical Device Search Group https://www.medicaldevicesearchgroup.com/open-positions Contact Andrew Brown


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ALKU – Texas https://www.alku.com/advancedsearch.aspx?search=1 Contact Logan Blake, Regulatory & Scientific Recruiter at [email protected] Contact Michelle Cloutier, Regulatory & Scientific Recruiter, 978.296.6934, [email protected] Alleviant Medical, Inc. We're hiring! If you are an experienced Manufacturing Engineer (Austin, TX) looking for a new opportunity, visit: http://bit.ly/2YzcSTW Asuragen asuragen.com/careers/ FDA Quality and Regulatory Consultants (FDAQRC) fdaqrc.com/careers/ IntegReview https://integreview.com/careers Life Sciences & Technology Black Diamond Networks https://www.blackdiamondnet.com/jobs Contact Alex Magoon |Recruiter T. 978.289.9741, [email protected] Luminex luminexcorp.com/about-luminex/careers/open-positions/

T. (786)372-4343 E. [email protected] Molecular Templates mtem.com/careers/ Paratus Diagnostics paratusdiagnostics.com/careers Interested candidates should apply directly to Paratus CEO Dr. John C. Carrano at [email protected] QA Consulting, Inc. https://qaconsultinginc.com/careers/ Contact: Mallori Groh; [email protected] Skills Alliance https://www.skillsalliance.com/jobs/ Contact [email protected] Syneos Health syneoshealth.com/careers Theradiag http://www.theradiag.com/en/?s=career Subject line: “Sales manager / Therapeutic Drug Monitoring”[email protected]

Project Manager (Boston, MA) Daytoday,managingprojectsbetweenourclientandtheirCRO.6-monthminimumcommitmentandwill requiresomeinternational travel. Idealcandidatesare fluent inMandarinChinese.Please letmeknow if interested and I can sendalongmore information - or if youknow someonewhomaybe agood fit for this position, we do offer a generous referral bonus! Contact Zoe Burbridge,PharmaceuticalAccountManageratALKU,Phone:978.806.0125Email:[email protected] Quality Auditor (Germany) StartDate:September,Duration:2-dayauditofvendor,Title:QualityAuditor(medicaldevice)


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Description: The client is looking for a strong quality auditor with significant medical deviceexperiencethatcanperformaqualificationauditforavendorlocatedinGermany.Theauditwillberelated toapotential vendor thatwouldhelpwith thedevelopmentof amedicaldeviceproduct, soneedstheauditortohaveastrongunderstandingofqualitysystemsformedicaldeviceincludingpart820,ISO13485:2016,etc.TheauditwouldneedtobeperformedinSeptemberandtheclientisworkingwithschedulingtheweek/daysthatwouldwork,sotheauditorwouldneedtohaveatleastoneweekin September free to perform audit. Contact AlexMagoon, Recruiter – Life Sciences & Technology,Phone:978.289.9741Email:[email protected] Know of more career opportunities? Please let us know!

TEXAS LIFE SCIENCE ORGANIZATIONS

ATX Women in MedTech [email protected] Austin Health Tech Meetup https://www.meetup.com/Austin-Health-Tech/ Austin Technology Incubator (ATI) https://ati.utexas.edu BioAustin LinkedIn Group https://www.linkedin.com/groups/6535301/profile BioHouston http://biohouston.org/ BioMed San Antonio http://www.biomedsa.org BioNorth https://bionorthtx.org/ Capital City Innovation https://www.capitalcityinnovation.org/ Health Technology Forum Meetup https://www.meetup.com/HealthTechnologyForum-Austin/ Health Wildcatters, Dallas www.healthwildcatters.com

Temple Health & Bioscience District http://www.templebioscience.com/ Texas Biomedical Research Institute, San Antonio https://www.txbiomed.org/ TX Health Catalyst, Austin https://dellmed.utexas.edu/thc Texas Medical Device Alliance (TMDA) LinkedIn Group https://www.linkedin.com/groups/6952028 The Health Cell, San Antonio http://thehealthcell.org TMCX/TMCX+, Houston http://www.tmc.edu/innovation/innovation-programs/tmcx-plus/ Top Austin-Area Medical Device Companies https://tinyurl.com/ya9v2s5u Velocity Texas, San Antonio https://velocitytx.org/ Women in Bio-Texas (WIB-TX, Austin & Houston) https://www.womeninbio.org/page/


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VOLUNTEER OPPORTUNITIES

Capital City Innovation/BioAustin/TMDA/AHT/TX Health Catalyst/Capital Factory/ Health Tech Austin WearemappingtheAustin’slandscapeinhealthcare/lifesciences/biotech/medtech.Anyoneinterestedinvolunteeringtocollect/compilethisinformationasateam?Ifyouare,[email protected]. ATX Women in MedTech Lookingforvolunteerstosupportcommunityoutreach,eventmanagement,PR,[email protected]. BioAustin Weare seekingvolunteers tomaintainourwebsite. If interested,please reachout toScottCollins [email protected]

THANKS TO OUR TMDA SPONSORS!

Withwarmregards,DanaAbramovitz,ElisaMaldonado-Holmertz,VictoriaO’DellandTamikoOgurion behalf of BioAustin, Texas Medical Device Alliance (TMDA), Capital City Innovation (CCI) andAustinHealthTech(AHT)

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