The title10 Most Efficient Drug Delivery Solution Providers in 2023 of your publication

Harnessing Technology for Beer Health

Medicaon Management in the Digital Age

Medicaon Compliance

Overcoming Barriers to Adherence

Jeffrey Hackman Chairman and CEO Comera Life Sciences

Ca Life Sciences

Transforming IV to SQ Biologic Therapies to Improve Patients’ Quality of Life

Good Nutrion can be the Savior of Your Life

Note E d t o r ’ s

Drug Delivery Revolutionizing for Better Health

Intheever-evolvinghealthcarelandscape,drugdelivery

solutionprovidersarevitalinadvancingmedical treatmentsandpatientoutcomes.Theseinnovative companiesspecializeindevelopingtechnologiesand systemsthatensurethesafe,efficientandtargeteddelivery oftherapeuticdrugs.Withtheirexpertise,theybridgethe gapbetweenpharmaceuticalsandpatients,revolutionizing thewaymedicinesareadministered.

Oneofthekeychallengesinhealthcarehasalwaysbeen optimizingdrugdeliverytomaximizethebenefitsof medicationswhileminimizingsideeffects.Drugdelivery solutionprovidersaddressthischallengethrougharangeof cutting-edgetechnologies.Theseprovidersareatthe forefrontofinnovation,fromadvanceddrugdelivery devicessuchasauto-injectors,inhalersandtransdermal patches,tonovelformulationsandcontrolled-release systems.

Thesignificanceofdrugdeliverysolutionproviders becomesparticularlyevidentwhenconsideringthegrowing fieldofpersonalizedmedicine.Tailoringtreatmentsto individualpatients'needsrequiresprecisedrugdelivery mechanisms.Theseprovidersdevelopcustomizedsolutions thatcandelivermedicationsattherighttime,intheright dosage,andtothespecificsiteofactionwithinthebody. Thislevelofprecisionisinstrumentalinimproving therapeuticoutcomesandreducingadverseeffects.

Furthermore,drugdeliverysolutionproviderscontributeto theaccessibilityandconvenienceofmedications.For patientswithchronicdiseases,self-administrationof medicationsisoftenapartoftheirdailyroutine.These providersdevelopuser-friendlydevicesandtechnologies thatempowerpatientstomanagetheirtreatments effectivelyathome,promotingindependenceand improvingtheirqualityoflife.

Inadditiontotheirimpactonpatients,drugdelivery solutionprovidersalsocollaboratecloselywith pharmaceuticalcompaniesandhealthcareprofessionals.By workingintandem,theyoptimizedrugformulations, enhancedrugstability,andensurecompliancewith regulatorystandards.Thiscollaborativeeffortstreamlines thedrugdevelopmentprocess,expeditingtheavailabilityof newandimprovedtherapies.

InsightsCare'slatestedition,10MostEfficientDrug DeliverySolutionProvidersin2023,navigatesyoutothe rapidlychanginghealthcarelandscape.Theroleofdrug deliverysolutionprovidersisincreasinglypivotalfortheir relentlesspursuitofinnovationandcommitmenttopatientcentriccare.Byharnessingthepoweroftechnology,these providersempowerpatients,advancemedicaltreatments andultimately,shapethefutureofhealthcaredelivery

Hope you have an exciting read!

-PoojaShah

Chidiebere Moses Ogbodo Visualiser David King Art & Design Head Mrunalinee Deshmukh

Business Development Manager

Emily Jones

Managing Editor Pooja Shah

Executive Editor

Saloni Agarwal

Co-designer Paul Belin Art & Picture Editor Deepanjali Jena

Marketing Manager Bill Thompson

Business Development Executives

Anna Smith, Jack Miller

Technical Head Jacob Smile Assistant Technical Head Prashanth Hiremath

Digital Marketing Manager

Alina Sege

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Sales Executives Mike, Carl, John

Technical Consultants David, Robert

SME-SMO Executives Gemson

Circulation Manager Tanaji Fartade

Description Featuring Person Company Name

ADOCIA adocia.com

Comera Life Sciences comeralifesciences.com

Crossject crossject.com

ICONOVO AB iconovo.se

Matrivax Research and Development Corporation matrivax.com

PolyPid polypid.com

Topas Therapeutics GmbH

Gérard Soula CEO

Jeffrey Hackman Chairman & CEO

Patrick Alexandre Founder & President of its Executive Board

Johan Wäborg CEO

Adocia is a clinical-stage biotech company specialized in the development of best-in-class medicine relying on innovative formulations of already-approved therapeutic proteins.

Comera Life Sciences is committed to transforming the formulation of biotherapeutics for the ultimate benefit of patients

Crossject is revolutionizing the administration of well-established, clinically-proven treatments and bringing unprecedented advantages to patients with its innovative, needle-free autoinjector ZENEO®.

ICONOVO AB is developing proprietary inhalation products for licensing.

Enda Moran CEO

Dikla Czaczkes Akselbrad CEO

Matrivax Research and Development Corporation is applying breakthrough science to develop life-saving vaccines for people in need around the globe.

PolyPid is a global clinical-stage biopharmaceutical company focused on developing, manufacturing and commercializing novel, locally administered therapies to improve surgical outcomes.

TransCode Therapeutics, Inc. transcodetherapeutics.com

Xylome xylome.com

Ziccum AB ziccum.com

Klaus Martin CEO

Michael Dudley Co-Founder and CEO

Dr. Thomas Kelleher CEO

Dr. Thomas Jeffries President & Founder

Ann Gidner CEO

Topas Therapeutics GmbH is a clinical-stage biotechnology company with a mission to deliver novel, disease-modifying treatments for autoimmune and inflammatory diseases.

TransCode Therapeutics, Inc., an RNA oncology company, has developed a modular, iron oxide nanoparticle–based nanocarrier system for the delivery of RNA therapeutics to tumors.

Xylome is a synthetic biology company with a deep understanding and proprietary genomic tools for the manipulation of non-conventional yeasts.

Ziccum AB's ambient drying technology

LaminarPace opens up unique thermostable formulation possibilities for next-generation biomolecules - from vaccines to protein therapeutics.

Jeffrey Hackman

Chairman and CEO

Comera Life Sciences

Transforming IV to SQ Biologic Therapies to Improve Patients’ Quality of Life

In contrast to IV delivery, SQ delivery involves a single brief injecon through a smaller syringe designed to cause less pain and discomfort. According to the majority of physicians that Comera has surveyed, SQ dosing is strongly preferred over IV, if available.

BBiologictherapieshavegainedalotofattentionin

thelasttwodecadesfortheirroleintreating diseasesforwhichnotreatmentspreviously existed.Formanypatients,however,intravenous(IV) deliveryiscurrentlytheonlyoptionfortakingthese lifesavingmedicinesbutthisofteninvolvestheuseofIV needlestoadministerliquidmedicationsintotheveinsof patients.Infusionsareperformedinanin-patientsettingof eitherahospitaloraninfusioncenter.Thatprocesscomes attheexpenseoftimeandcomfortasthetreatmentcantake multiplehourstoadministerandcanbeapainful experience.

Thisprocessnaturallyraisesquestionssuchas,“Howare thesetreatmentsimpactingthequalityofpatients’lives?” IVdeliveryofbiologicscanbetime-consumingandalso painfulandcostly.Thismakesitchallengingforeveryone involved.

ComeraLifeSciencesisalifesciencescompanythat leveragesthepowerofhighprecisionscienceand engineeringtosupportpatientsingainingbacktheir freedom.Throughitsinvestigationalself-injectable innovativesubcutaneous(SQ)biologics,patientsmayhave accesstoanalternativetherapeuticdeliveryoptioninthe futurethatcanpotentiallyaidinimprovingtheirqualityof life.

IncontrasttoIVdelivery,SQdeliveryinvolvesasingle briefinjectionthroughasmallersyringedesignedtocause lesspainanddiscomfort.Itenablesself-administrationat home,sparingpatientsfromtravelingtofrequent appointmentsandreducinghealthcarecostsforsupplies, storageandstaffing.Moreover,anSQinjectionhaslower healthcaredeliverycostsandcanbeadministeredwithinthe comfortofpatients’homes.Accordingtothemajorityof physiciansthatComerahassurveyed,SQdosingisstrongly preferredoverIV,ifavailable.

JeffHackman,theChairmanandCEOofComeraLife Sciences,isleadingthecompanyasitadvancesapromising clinicalpipelineaimedtoimprovepatientexperience, potentiallyincreasepatientadherenceandreducethe overallcostofcareduringtheircourseoftreatment.

Let’s learn more about the innovative work Comera is doing to advance SQ therapeutics and how it has the potential to improve patients’lives.

ABriefonComeraLifeSciences

ComeraLifeSciencesaimstogivepatientsthefreedomto self-administerlife-savingproductsathome,amissionthat isimportanttoJeffonapersonallevel.Hiswife,who passedawayfrombreastcancer,hadtoendurevarious intravenous(IV)therapeuticsduringherten-yeartreatment journey.

MillionsofpatientsneedingIVdrugsmustspendhoursata hospitalorinfusioncenterwithalargeneedleintheirarm. It’spainful,time-consumingandcostly.Intendingtochange thisrealityforpeoplelikehiswife,Jeffjoinedthe successfulteamatComeraastheCEOin2021.

JourneytoInception

Thecompanywasfoundedin2014asReFormBiologics andrecentlyrebrandedasComeraLifeSciencesto reflectthevisionofbringingaboutacompassionatenew erainmedicine.Comeraisbuiltonthebeliefthattrue medicaladvancesareinspiredbycompassion.Itsteamof innovatorsseesitselfinpatientsandtheirfamiliesandis workingtomakemeaningfulchangestohowpeopletake medicines.

Fromtheoutset,Comera’sgoalhasbeentodevelopnovel excipients—substancesaddedtoabiologicdrugtoaidin manufacturing,deliveryandstability—thatcantransform biologicsfromIVinfusionstosubcutaneous(SQ)injections thatcanbeeasierforpatientstouse.SinceJeffjoined Comera,thecompanyhasexpandeditsfocustogobeyond formulationscience,anditisnowreimaginingtheimpact thatitssciencecouldhaveonhealthcareandthepatient experience.

JeffandtheteamatComera,together,areworkingwith industrypartnerstoacceleratethedevelopmentofSQ formulationsofmonoclonalantibodies(mABs)thatcan substantiallyimpactmillionsofpatientswhilealso developingtheirpipelineofcandidates.Thisambitious missionledthemtotakethecompanypublicinMay2022.

Comera’sfocusistohelppatientswhodependonIV biologicsfortreatingsignificantdiseases.That’swhythe companyhassetouttomaximizethetruepotentialoflifechangingbiologicsbyempoweringpatientstoadminister theirownmedicineviaasingle,simpleinjectionwherever theyfeelmostcomfortable.

Comera is working to transform IV biologics into SQ versions that can be administered by syringe in a single dose, potenally increasing paent compliance and quality of life.

TheSQore™TechnologyApproachtoTransform Medicines

Comeraisnottheonlyonestudyingexcipienttechnology, butitsteamisoneofthefirsttopursuethissciencefor antibodyreformulationandpotentialpatientcareathome. Foundationaltothecompany’sapproachisitsSQore™ technology,aproprietaryexcipientformulationplatform thataimstotransformmedicinesfromIVtoSQform.

AlongstandingchallengetodevelopingviableSQbiologics isviscosity AlowervolumeofmedicineinanSQ formulationrequiresincreasingthedrugconcentration, oftentotheextentthatbiologicalmoleculesaggregateor sticktogethersothattheycannolongerbedelivered throughasyringe.Todate,fewcompanieshavebeenable todevelopeffectiveexcipientstoreducetheviscosityof antibodiesforSQdelivery.However,theSQoreplatform potentiallysolvesthisdilemmathroughproprietary techniquesusingexcipientstodecreasetheviscosityofIV drugssothattheycanbedeliveredsubcutaneouslywhile maintainingtheirstabilityandefficacy

Unlikeotherexcipientapproachesthathavebeen unsuccessfullyappliedfordecades,SQoretechnologydoes notalterthestructureorformofantibodiesinsolution, reducingdrugproductdevelopmentuncertainty,timeand expense.ComeraisworkingtotransformIVbiologicsinto SQversionsthatcanbeadministeredbysyringeinasingle dose,potentiallyincreasingpatientcomplianceandquality oflife.

UniqueProductsandSQSolutionsatComera

Thebiologicsmarketisestimatedtogrowto$422billionin 2025,andpatientsworldwiderelyonIVdrugsforvarious conditions.Infact,sevenofthetoptenglobalmedicinesare biologicsandmostareadministeredintravenously,so there’sanopportunitytoimprovehowthesepatients receivetheirmedicinessignificantly.

Comerahasover200excipientsthatitisusingto reformulatemarketedIVbiologicsforSQadministration.It hasanumberofnovelandproprietaryexcipients,andits leadexcipientiscaffeine.InitsSEQURUS-1and SEQURUS-2preclinicalstudies,Comera’steamhas demonstratedthatacaffeineexcipientcanreducethe viscosityofthemABipilimumabwithoutaffectingits bioactivity.

The biologics market is esmated to grow to $422 billion in 2025, and paents worldwide rely on IV drugs for various condions. In fact, seven of the top ten global medicines are biologics, and most are administered intravenously, so there’s an opportunity to improve how these paents receive their medicines significantly.

Thecompanyalsohasapipelineofthreewhollyowned candidates:CLS-001,anSQformulationofthemAB vedolizumabinpreclinicaldevelopmentforinflammatory bowelsyndrome;CLS-002,aSQformulationofan unannouncedmABinpreclinicaldevelopmentforimmunooncology;andCLS-003,acandidateintheresearchstage foranunannouncedindication.CLS-001andCLS-002are currentlyinIND-enablingstudies,withfilingsanticipated in2024.

SQdelivery,whenavailable,isgenerallypreferredby patientsandhealthcareprovidersandcanresultinreduced drugdelivery-relatedhealthcarecostsandresourceuse.

AdvancementofTherapeuticPipeline

Inadditiontoitsinternalpipeline,Comeraisadvancinga pipelineoftherapeuticreformulationsthroughpartnerships. Comerahasthreeongoingpartnershipswithother companiestodevelopSQdrugformulationsusingits innovativeproprietarySQoreformulationplatform.

ComerahasaresearchcollaborationwithRegeneron,a leadingU.S.biotechnologycompany,withhigh-priority assetsindevelopment.Recently,Comeraextendedand broadenedthiscollaboration,whichincludesarightto negotiatealicenseafterfurthertechnicalevaluationis complete.Asecondpartnershipiswithanundisclosedtop 10globalpharmaceuticalcompanyforadrugthatis commercializedglobally,andgrantsComeratheoptionsto licenseafterfurthertechnicalevaluationiscomplete.

Throughitscollaborationswithpharmaceuticaland biotechnologycompanies,ComeraisleveragingtheSQore

platformtoenhancebothcommercialbiologicsandthosein theearlydevelopmentstages.Itsproprietaryplatform supportsothersintheindustrytoaddressformulation challengesandmakebiologicsmoreeasilyadministered subcutaneously.Alltheseinitiativesaimtobringthis importanttherapeuticmodalityclosertothepatientswho needit.

WrappingUp

Lookingahead,Comerawillcontinueitstwo-pronged approachofgrowththroughitsinternalpipelineand partnerships,complementedbyasizablepatentportfolio protectingitstechnology

Representingamassivelygrowingmarket,biologicsareat thevanguardofcutting-edgebiomedicaltechnologyand drivingthenextgenerationoftreatmentsforpatients.For thisreason,thecompanywillcontinuetofocusonhighvaluecollaborationswithnear-termmilestonepotential. Comeracurrentlyhasthreeongoingpartnershipsallof whichincludeoptionstolicenseafterthetechnical evaluationoftheassetiscomplete.

ThegoalwillbetogetanSQ-basedbiologicintoclinical trials.Comera’steamisheadedinthatdirectionwithINDenablingstudiesongoingin2023.Theirapproachto reformulatingknownbiologicsdemonstratesthepotential forafasterdevelopmenttimelineandlowerdevelopment costs.

Represenng a massively growing market, biologics are at the vanguard of cung-edge biomedical technology and driving the next generaon of treatments for paents.

Crossject

Saving Lives in Emergency Situations through Needle-free Injectables

Thedrugdeliveryindustryisoftenonaconstant

lookoutforinnovativewaystoimprovehowdrugs aredeliveredtopatientswhoaresufferingfroma specificillness.Syringesorneedlesareoneofthefirst preferredresourceswhenthedrugisrequiredtobe delivereddirectlyintothepatient'sbody,passingthrough theskin.Thisistrueinthecaseofmedical emergencies—wherequickactionisrequiredtowardoff theriskofseverities,along-termconsequence,orto manageasituationofstressorcrisis.

However,inemergencieslikeanepilepticseizure, anaphylacticshock,orsufferinganoverdose—where patientsarethevictims—doneedlesandsyringesguarantee tobeanimmediatetherapeuticsolution?

Crossjectisaleadingcompanythatisrevolutionizingthe administrationofwell-establishedtreatmentsinemergency situationsbydevelopinginnovativelife-savingsolutions. ®ZENEO isitsinjectiveapproachwhichprovidesan alternativetousingneedlesandsyringes.Patientsnolonger havetofearneedlesasthisproductisaneedle-freeselfadministrationinnovationdesignedtosupportpatientsin emergenciesandlife-threateningsituations.

InaninterviewwithInsightsCare—PatrickAlexandre, theFounderofCrossjectandPresidentofitsExecutive ® Board—shareshowhiscompany'sinnovation,ZENEO ,is dedicatedtofulfillingthemissionofsavingthelivesof patientsacrosstheworld.

Below are the highlights of the interview: Kindlybriefusaboutthecompany.Whatledtoits inception?

CrossjectisaFrenchspecialitypharmaceuticalcompany basedinDijonandspunofffromFournierLabs.The

companyhasbeenlistedonEuronextGrowthinParissince 2014.ItreceivesfundingfromtheUnitedStatesBARDA (BiomedicalAdvancedResearchandDevelopment Authority)undercontractn°75A50122C00031andfrom Bpifrance(FrenchGovernmentinvestmentbank).

Crossjectisdevelopingandwillsooncommercializea portfoliooftreatmentsforemergencies,includingepileptic seizures,adrenalinsufficiency,anaphylacticshock,and opioidoverdose,allbasedonitsuniqueneedle-freeauto® injectionplatform,ZENEO .

®ZENEO findsitsoriginsinthecombinationand miniaturizationofcutting-edgetechnologiesusedinthe automotive,pharmaceuticalandaerospacesectors.Our technologyreliesonaspecificallyformed,siliconized, depyrogenated,pharmaceuticalglasstube(unique techniqueworldwide)thatcansupportupto1,200barsof pressure,inconjunctionwithapolycarbonatenozzlewith submillimeterconduitthatdirectstheinjectionthruclothing andintotheskin/muscleinapreciseminutestreamtothe desireddepthofinjection.

Thisuniquedeliverysystemiscoupledtoastate-of-the-art energymaterial-basedgasgeneratorwithanactuator culminatinginasimple-to-use,safeandefficientinjection system.

Shedsomelightonyourjourneyastheguidinglightof thecompany.Howdoesyourpresenceplayan importantroleinthegrowthofthecompany?

Withitspatented,needle-freeauto-injectionsystem, Crossjectaimstobecometheworldleaderinselfadministeredemergencytreatments.

In1997,Ibegandirectingtheconceptualizationand developmentofneedlelessinjectiontechnologyat

®ZENEO needle-free auto-injector is a device that has been designed with patients for patients. It enables a very easy injection in only two steps, "Open and push" onto the injection site. With this device, Crossject brings to the patient and caregivers the molecules that they would have received in the hospital before arrival. It is a unique technology for the needle-free injection of medicines.

The prefilled, single-use device propels the treatment through the skin in less than a tenth of a second. ZENEO® is factory-set as a function of the viscosity of the medicine, its dosage, and injection route (subcutaneous or intramuscular).

Its reliance has been reflected in the last Human Factors study conducted by Crossject in 2022, which showed a 99.6% success rate on the use scenario assessed.

Patrick Alexandre Founder and President of its Executive Board Crossject

About ZENEO®, a Needle Free Auto-Injector

LaboratoiresFournier,nowAbbvie.In2001,Ibuiltupon ® thatacquiredexpertisetolaunchCrossjectandZENEO , whichhasnowproventobeaworld-premieretechnology toinjectadrugwithoutaneedle,eventhroughclothing.

IgraduatedfromSupélec,atopengineeringschoolin France,andwasanR&Dmanagerinthesteelindustryfor 10yearsbeforejoiningthepharmaceuticalindustry,whereI workedfor15years.

Canyouelaborateuponthecorevalues,missionand visiononwhichthecompanyisbuilt?

Dare

Fromthesolidfoundationofitsunmatchedtechnology, Crossjectaimstobecometheworld'sleading pharmaceuticallaboratoryforemergencyneedle-freeautoinjectables.

Persevere

Crossject'sincomparabletechnologyisthefruitofnoless than20yearsofR&D.ThankstoitscontinuousR&D effortsdatingbackto1997,Crossjecthascreatedahighperformanceauto-injectionsystemprotectedby400patents ® worldwideuntil2036.ZENEO istheworld'sfirstclinically provenprefilledneedle-freeauto-injectorcapableof deliveringtreatmentsintramuscularlyorsubcutaneously

Innovate

Crossjectdevelopedaneedle-freeinjectiontechnology, uniqueworldwide,capableofdeliveringtreatmentsinless thanatenthofasecond.Toalwaysmoveforward, Crossjecthasunitedavanguardteamofspecialistsfroma rangeofindustriesandthusgatheredtheexpertiseitneeds toempowereachstepofitsevolution.

Tosavelivessimply

Thepurposeoftherevolutionary,needle-freeauto-injection ® systemZENEO isnothinglessthantosavelivesin emergencies.

Briefusonthescientificprocessofdrugdeliverytothe company'stargetpopulation.

ZENEO®usesminiaturizedautomotiveindustry technologyfromairbagsandpre-tensioningseatbelt systemstodeliverdrugproductsintothemusclewithout theuseofaneedle.

Assoonasthedeviceispressedagainsttheskin,thespringloadedstrikerisreleased.Ithitsagasgeneratorlocatedat

thetopofthedevice,andhighpressureisreleasedbythe expansionofpowders(slowandfast).Thishighpressure pushesdowntheliquidintoacanalwithadiameterof 0.4mm,andathinjetofpharmaceuticalproducthitsthe skinat200m/sandreachesthemuscle.

Dependingonthevolumeorviscosityofadrug,thedevice pressureprofilecanbemodifiedtoreachthetargeted injectiondepth.

Howdoesyourcompanyofferpersonalizedtreatmentto thepatient'sconcerns?

®ZENEO addressmanyissuesthatpatientsarefacingwith currentsolutions.Oneofthebiggestfearsregarding injectabledrugsistheneedle.Crossjectgoesbeyondthe needleandchangestheinjectionparadigmformanypeople, as20%ofusfeartheneedle,and10%arecompletely needlephobic.

®ZENEO hasbeendevelopedtobeveryeasytousetomake surethatevennaïveuserscaninjectadrugquicklyand th safelyinlessthan1/10 asecond;itisparticularly interestingforanemergencysituationsuchasepileptic seizurewhereitisratherchallengingforanon-professional caregivertogiveanIntramuscularinjectionofMidazolam withaneedle-basedsolutiononaconvulsingpatient.

WhatdiagnostictoolsdoesCrossjectfindtobeessential inconductingitsoperations?

Understandingpatientneeds,thedifferentscenarios,and theenvironmenthasbeenatthecentreofCrossjectneedle-

freedrug/devicecombinationsproducts.Thecompanyhas designeditsuniquesolutionwithandforthepatientand testeditthroughnumerousHumanFactorsstudiesthat assessedthatthedevicewasusedproperlyandsafelyin differentuseenvironments.

WhatendeavoursisCrossjectcurrentlypursuingto improveitsmeasuresforpatients?

Crossjectisconstantlydiscussingwithhealthauthorities andpatientstoensureitsdevicemeetscrucialmedical requirements.Thecompanyhasbeendevelopingaportfolio ofsevendrugs,mostlyforemergencyusetobringto patientsortheirentouragesolutionsthatcanbesafelyused outsidethehospital.

Whatadvicewouldyouliketogivetobudding entrepreneursandenthusiastswhodesiretoventure intodrugdelivery?

Maintainyourenthusiasm,expandyourknowledgebase, andpushforperfectioninarapid,sustainablemethodology Failoften,failquickly,learnfromyourfailuresandmove ontowardssuccess!

Howdoyouenvisionscalingyourorganization's servicesandoperationsin2023andbeyond?

Throughourpartnershipswithinternationalpharmaceutical companiesandgovernmentagencies,weintendtobecome theworld'sforemostsupplierofrapid,safe,easy-to-use needle-freeauto-injectorsforpersonalemergencyuse.

Crossject

developed a needle-free injection technology

®ZENEO , unique worldwide, is capable of delivering treatments in less than a tenth of a second. With this patented, needle-free auto-injection system, the company aims to become the world leader in self-administered emergency treatments, saving patients' lives worldwide.

2022hasbeenanimportantyearforCrossjectasithas signedanagreementwithBARDAforthelate-stage development,regulatoryapprovalandprocurementofits leadcompoundZENEOMidazolam.Thisprogramhasalso shownpositiveoutcomesthroughabioequivalencestudy Thisstudydemonstratedbioequivalenceinanintra® muscularinjectionwithZENEO Midazolamcomparedto aninjectionofmidazolamwithasyringeand30-mm needle.Italsodemonstratedthatclothinghadzeroimpact ® concerninginjectionwithZENEO

2023willbeacrucialyearforCrossjectasitwillfileits firstmarketingauthorization,adrug-devicecombination, ZENEO®Midazolam,aswellaspursueother developmentssuchasZENEOHydrocortisoneforwhich thecompanyhassignedalicensingagreementwithETON pharmaceuticals.

Whataresomeofthetestimonialsorrecognitionthat accuratelyhighlightyourorganization'spositioninthe market?

Manypatientadvocacygroupswithintheepilepsy,food allergyandadrenalcrisisworldhaveexpressedserious desiresforarapid,safe,easy-to-useemergencyauto® ® injector.ZENEO ,Midazolam,ZENEO Epinephrineand ®ZENEO Hydrocortisonebringthisdesiretorealityfor thesepatientsandtheircaregivers.

Digital

Everyindustry,includinghealthcareandmedicine,in themodernageincorporatesdigitaltoolsand varioustechnologiestoenhanceoperations.When itcomestoimplementingdigitalization,technologyisnota driver,butitiscriticaltomaketheprocesshappen.

AccordingtoAnitaGoel,MD,PhD, the next generation of healthcare will be decentralized, mobilized, and personalized. Instead of the past's blunt instruments, we will give patients more precise medications and therapies

Themostvitalpartofhealthcareismedicine;withoutit, therapeuticprocesseswillbehampered.Astelemedicine, virtualreality(VR),roboticsandArtificialIntelligence(AI) arechangingthehealthcarelandscape,takingthehelpof thesetools,themanagementofmedicinecanbedone appropriately.Medicationmanagementisastrategythat involvesmanagingmedicinestocks,prescriptions,and administrationtopatients.Ingeneral,theprocessconsists ofthebrownbagmethod,andwithitshelpofit,patients andcaregiversareengagedincreatingalistofcomplete, accuratemedicine.Itisalsoknownasthe'Medication ManagementPathway'.

Let’s understand in detail the key role of digitalization in managing medication!

WhyisdigitalizationinMedicationManagement important?

Adherencetopersonalizedmedicineandmanagementisthe bestsolutionforthesuboptimaluseofmedicines.Hospitals andsmallclinicsprimarilyfacemedicationmanagement issuesandadverseoutcomesduetoprescribingerrors, medicationcontradictions,overandunder-prescriptions, patients'responses,etc.,aspatientsarevulnerablebetween theprocessofgettingprimarycareandaspecialistopinion. Hence,itistheresponsibilityofhospitalsandhealthcare systemstoundertaketheobligationofmedication management.

Additionally,oldsystemsweremanualandnon-digitalized. Also,thevisibilityofmedicinestockwaslowandmedical datawasvague,aswellasthelackofdigitalizationmade thesystemspronetoerrors.TheOECDgrouphastopay millionsforsucherrorstostabilizethehealthcaresystem. Moreover,thewholeprocessissuspectedofhavingnonadherencetomedicinemanagement.Thereisalways mismanagementincatchingthestatisticsofactualpill intake,misunderstanding,patients'biasedresponses,etc.

Oneoftheimportantdrawbacksoftraditionalmethodsof handlingmedicinemanagementispatientsarenotexposed toappropriatetools.Asaresult,theycannotfacilitatethe managementoftheirmedicines.Moreover,dailyhospital staysarebecomingshort,andtherapies/counsellingarealso provided;however,patientsoftendonotrememberthe instructionsprovidedduringtheirmedicalvisitsdueto multiplehealthproblems.Insuchascenario,fastdigital methodsmustbeappliedforbetterandsmoothmedication management.

DigitalizedHealthcare

Duetotheinceptionofdigitalmethods,thehealthcare sectorhasbeenmodified.Forexample,telehealth, electronic,mobile,telemedicine,etc,havebecomepopular andrecognizedaspowerfultoolsthatmaketheprocesses easy Accordingtoareviewin2017,fourprimarydigital strategiesthatenabledmedicationadherenceinpatientsare interactivevoicerecordingsystems,ShortMessageService (SMS),telemonitoring,andweb-basedsoftware.

Interactive voice recording systems:Whilehandling medicines,problemssuchasmedicationsideeffects,costs, andforgettingabouttheintakeofmedicinescanhamperthe decisionandhealthofpatients.Inthiscase,interactive voicerecordingsystemsremindindividualstotakeorrefill theirmedications.Thesystemprovidespersonalizedand medication-specificremindersandcommunicationwith voicerecognition.

Short Message Service (SMS): Formedicineadherence, SMSservicesareusedoften.Astudyshowsthattext messageinterventionshaveimprovedtheadherenceratein patients.Italsoshowsthatthosepatientswererecovering fromchronicphysicalandmentaldiseasessuchasHIV, asthma,diabetes,schizophrenia,etc.

Telemonitoring:Remotepatientmonitoringduringand afterthepandemichasbecomeanorm,spreading awarenessamongpatientstotaketheirmedication schedulesseriously.Healthcareprofessionalshelppatients withanyhelpwithoutinterruptingtheircomfortathome andpatientshavingdifficultiesreachingthemedicalcare centres.Forexample,wearablesensorsusedinthismethod canhelpprofessionalstracktheirpatients'healthconditions fromadistance.

Web-based Software:Thissoftwaresolutionimproves medicalmanagement,especiallyafterhospitaldischarge.It includedpillidentification,patient-friendlyreminder leaflets,interactioncheckers,adherencemonitoring checkers,weeklymedicationschedules,anddailypill reminders.

ElectronicMedicationManagement(EMM)

WiththehelpofEMM,errorsinprescribingmedicinesand dispensingthemcanbeavoided.Thesesystemsenhancethe accuracyandlegibilityofmedicalinformationforclearand transparentprocessesforpatients,hospitalsand professionals.Ratherthansearchingforinformationandbig filesofpatientsinpaperformat,cliniciansandprofessionals candirectlyaccessitthroughdigitalservices.

Thesystemisdevelopedtodigitallymanagemedical prescriptions,reviews,dispensing,medications, administration,etc.,intheirelectronicfiles.Moreover, EMMprotectspatients'dataandprovidesthemwithsafety. EMMadoptsthetechnologyandsecurityprotocolsthat enablesafemode.Also,if,inanycase,anyelectronic devicehavinganEMMsystemgetslost,adminscanwipe thedataelectronically

In conclusion, digitalizationinMedicationManagementis vitalforenhancinghealthcareoperations.Byadopting digitaltoolsandtechnologies,hospitalsandhealthcare systemscanaddressmedicationmanagementissues, improvepatientadherenceandminimizeerrors.Digital strategieslikeinteractivevoicerecordingsystems,SMS interventions,telemonitoringandweb-basedsoftware enablepersonalizedandeffectivemedicationmanagement, leadingtobetterpatientoutcomes.ElectronicMedication Managementfurtherenhancesaccuracy,accessibility,and datasecurityinhealthcareprocesses.

-SaloniAgarwal

Dikla Czaczkes Akselbrad CEO PolyPid Ltd.

Surgical Site Infections, the most common hospital-acquired infections in the US, can result in additional seven to eleven days of hospitalization and cost the US healthcare system as much as $10 Bn each year. Our main product, D-PLEX is designed to release antibiotics 100 over a period of thirty days to prevent post-surgical wound infections or SSIs.

PolyPid Ltd

Eliminating Surgical Site Infections (SSIs) through Controlled Delivery of Medications

Post-surgicalcomplicationshinderthepatient'sreturn

totheirpreoperativehealthstatus.Healthcare acquiredinfections,inparticularsurgicalsite infections(SSI),unfortunatelyremainamongstthemost commonpotentiallypreventablecomplications.Thosewho developinfectionsnotonlyfacearisktotheirhealthbut mayalsohavetodelayotherimporttreatment(i.e., oncologiccare).Fromahealthcaresystemperspective, surgicalsiteinfectionsriskincreasedhospitalstays, escalatedexpenses,andhigherreadmissionratesandthus, infectionshavebecomeaclinicalandeconomicburdenfor patientsandhospitals.

OnewaytoreducethethreatposedbySSIistoimprovethe prophylacticmeasurestakenperioperatively,suchastimely andcontrolledadministrationofmedicationsatthesurgical incisionsite.PolyPidLtd,aglobalclinical-stage biopharmaceuticalcompanytargetsthiscoreaspect.Its productcandidatesallowsurgeonstodelivermedications locallytothebodyfordaysandmonths,inacontrolledand continuousmanner.

InaninterviewwithDiklaCzaczkesAkselbrad,PolyPid's CEO,shehighlightsthecoreproductsdevelopedatthe companytoimprovepatientoutcomesinlocalizedmedical conditionssuchasinfection,pain,inflammationandcancer

Below are the highlights of the interview

Kindlybriefusaboutthecompany.Whatledtoits inception?

PolyPidisanIsrael-based,publiccompany,tradedon NASDAQ.OurPLEX(Polymer-LipidEncapsulation matriX)platformwasdevelopedbyourfounder,Dr.Noam Emanuel,inresponsetoaclearneedfromphysicians, specificallydentistswhowerelookingforasolutionthat cantreatsevereguminfectionsoveraprolongedperiod. Overtheyears,PolyPidhasdemonstratedthecapabilitiesof itsPLEXplatformtoencapsulateandlocallydeliverseveral typesofActivePharmaceuticalIngredients(API),including antibodies,proteins,peptidesandsmallmolecules. PolyPid'sproprietaryPLEXtechnologypairswithAPIs,

enablingprecisedeliveryofdrugsatoptimalreleaserates overdurationsrangingfromseveraldaystomonths.

PolyPid'sleadproductcandidateD-PLEX isinPhase3 100 clinicaltrialstopreventabdominalsurgicalsiteinfections. Inaddition,wearecurrentlyinthepreclinicalstagestotest theefficacyofOncoPLEXforthetreatmentofsolidtumors, beginningwithglioblastoma.

Shedsomelightonyourjourneyastheguidinglightof thecompany.Howdoesyourpresenceplayan importantroleinthegrowthofthecompany?

IjoinedPolyPidin2014,andinmypositionasChief FinancialOfficer,Isuccessfullyraisedover$200million forthecompany.Iledthecompanythroughitsinitialpublic offeringinJune2020,rightinthemidstofthechaosofthe earlydaysoftheCovid-19pandemic. AspartofPolyPid's executivemanagementteam,Ihelpedthecompany maintainhighpatientrecruitmentnumbers,recruitingclose to1,000patientsacross60centers,despitethepatient recruitmentdeclinethatmostpharmaceuticalcompanies facedduringthepandemic.

ThispastJuly,IassumedtheroleofChiefExecutive Officerofthecompany.OneofmyfirstactionsasCEOwas toguidethecompanythroughanexclusivelicensing agreementwithAdvanzPharmaforthecommercialization ofthecompany'sleadproductcandidate,D-PLEX ,forthe 100 preventionofsurgicalsiteinfections.Thisdeal,whichwas signedevenbeforetheresultsofthecompany'sPhase3 clinicaltrialwerereleased,includedupfrontandmilestone payments,aswellasroyaltiesonnetsales.Itisnowmy roletoexpandthebreadthofPolyPid'spipelinewhile transitioningthecompanyfromaclinicalstagecompanyto acommercial-focusedone.

Canyouelaborateuponthecorevalues,missionand visiononwhichthecompanyisbuilt?

Whilethestandardsofcarehaveadvanced,physicians' abilitytooptimizesurgicalcareremainslimited.From surgicalinfectionpreventiontoeffectivelocaldeliveryof medications,PolyPidisonamissiontoimprovesurgical outcomes,armingsurgeonswithitsproprietarylocaldrug

deliveryplatformthatintegrateswithexistinghospital/and operatingroomprotocols.

Withcontrolledandcontinuouslocaldeliveryofmedication usingPolyPid'sPLEXtechnology,physicianscan incorporatethissolutionintovarioussurgicalprocedures–distributingmedicationdirectlyatthesurgerysitewith optimalreleaseratestomaximizethesuccessofthe procedure.

PolyPid'sPLEXplatformcircumventsabigchallenge manufacturersencounterwhendevelopingnewdrugs,how todeliverdrugstotheirtargetinhighenoughconcentration tobeeffectivewithoutanyriskofsignificantsystemicdrug exposure,dramaticallyincreasingthesafetymarginofa givenmedication.Whetherbyenhancingthedeliveryof alreadyapproveddrugsorbycreatingnewapproachesto innovativemolecules,webelieveourPLEXplatformcan improveefficacy,reducesystemicsideeffects,andgenerate betterpatientoutcomes.

Whatarethecoreproductsandservicesthatyour companyhastooffer?Inwhatwaydotheyservethe targetpopulation?Howarethesedifferentfromother formsofcarethatpatientsreceiveordonotreceivein general?

PolyPidhasdevelopeditsownproprietarydrugdelivery platformthatcanencapsulatealmostanyAPIanddeliverit locallyoveraprolonged,pre-determinedperiod.Ourmain product,DPLEX isdesignedtoreleaseantibioticsover 100 thirtydaystopreventpost-surgicalwoundinfectionsor SSIs.SSIs,themostcommonhospital-acquiredinfections intheUS,canresultinanadditionalseventoelevendays ofhospitalizationandcosttheUShealthcaresystemas muchas$10Bneachyear

DPLEX hasshowninalargephasethreetrialareduction 100 of54%ininfectionsincomplex,largeincisioncolorectal surgeries(>20cm),comparedtothecurrentstandardof care.Oursecondproduct,OncoPLEX,currentlyinpreclinicalstudies,combinesourPLEXplatformwith approvedchemotherapytoserveaslocalintra-tumoral adjuvanttreatmentforsolidtumors.OncoPLEXprovidesa high,localconcentrationofchemotherapydirectlytothe tumorresectionbedforaperiodofupto3weeks,limiting theriskoftypicalsideeffectsoftraditionalsystemic chemotherapydelivery

Whatadvicewouldyouliketogivetobudding entrepreneursandenthusiastswhodesiretoventure intotheprocessofdrugdelivery?

Iwouldadviseyoungentrepreneurstopreparefora marathon.Drugdevelopmentingeneralanddrug

developmentbasedonnoveldrugdeliveryplatformsisa longjourney,ithasupsanddowns,highsandlows,and therearesurprisesateverycorner,onthescienceside, talent,andfinancing.Aleaderinthisareashouldremain focusedontheendgoalwhileadjustingtothechanging circumstances.

Howdoyouenvisionscalingyourorganization's servicesandoperationsin2023andbeyond?

Wehaverecentlycompleteda977-patientphasethreetrial, thelargestclinicaltrialinthepreventionofinfectionin colorectalsurgeryinoveradecade.Ournextstepwillbeto discusswiththeFDAthepathforapprovalofthedrug.

Oncewehaveaclearpathforapproval,wewillscaleup ourmanufacturingcapabilitiesandstartdeveloping commercialcapabilitiestobeabletobringtheproductas fastaspossible,post-approval,tothehandsofsurgeons.A bigpartofthisscale-upwillbedoneincollaborationwith partners.WealreadyhaveacommercialpartnerforDPLEX inEuropeandareinadvanceddiscussionswith 100 otherpotentialpartnersforotherterritories,suchasIndia, ChinaandLatinAmerica.

Intermsofpipeline,ourcurrentfocusisonpairingPLEX withchemotherapy.Weareconstantlyevaluatingourfuture programtoidentifynewareaswherewecanaddvalueon ourownorwithotherbiotechcompaniespairingPLEX withnovelantibodies.Wehaveshowninthepastthatthe PLEXplatformworkswellwithsmallmoleculesaswellas largemolecules,peptides,andsiRNA.

ThePLEXplatformisidealwhenlocaladministrationis preferredtosystemicadministrationtoavoidtoxicitywhile addressinglocalizeddiseaseandtheassociateddifficulties ofachievingsustainabletherapeuticdruglevelsatthesite. Wearelookingtocollaboratewithcompaniesinterestedin thelife-cyclemanagementofalreadyapprovedmolecules andfornewinnovativeoneswhereeffectivelocaldisease eradicationisthemajorclinicalgoal.

Whataresomeofthetestimonialsorrecognitionthat accuratelyhighlightyourorganization'spositioninthe market.

WeareproudforourcompanytohaveachievedCorporate LiveWireGlobalAwardsWinner2022/2023-BioPharmaceuticalCompanyoftheYear.

Barriers Overcoming to Adherence

Aroutinemightbeboring;however,itsavestime, anditisimportantforpatientswhoaresuffering fromchronicdiseaseslikediabetes,HIV,blood pressure,etc.Suchpatientscanalsoenjoyagoodqualityof lifeiftheymaintainaregularintakeoftheirmedicines. Poorclinicaloutcomesaregenerallynotcauseddueto treatmentandmedicalissuesbutbecauseofirregularityin theintakeofmedicine.

Thoughpatientsreallycareabouttheirhealth,thestateof ignorance,'Medicationnon-adherencestatearisesduetoa varietyofreasons,includingaffordabilityissues,less knowledgeandunderstandingoftheimportanceoftaking medicines,andmostimportantly,hazardoussideeffectsof thesemedicines,especiallyinchronicdiseases.

Let's understand in detail the compliance to follow in overcoming barriers!

MedicationAdherence:Types

TheWorldHealthOrganizationdefinesmedication adherenceas"The degree to which the person's behavior

corresponds with the agreed recommendations from a health care provider."Ingeneral,healthcareprofessionals usetermssuchasadherenceandcompliance simultaneously.However,inpractice,thesetermsdifferina smallcontext.Complianceimplieshowthepatientis obedienttothephysician'sprescriptionsandauthority Adherencebelievesinacombinationofthephysician's adviceandthepatient'slifestyle.

Ifanythingfromprescribingmedicinetothe completionoftreatmentgoeswrong,thenoneof theprimaryreasonsmustbenon-adherenceto medicines.Amongseveralreasons,twomain reasonsareindisputableanddegreeofoverlap.In thefirstone,clinicalprofessionalsprovide prescriptions,butthemedicinenevergetsinitiated.Thisis alsoknownas'non-fulfillmentadherence'.Thesecondtype involvesaconditionwhereinpatientsstoptakingmedicines afterstartingandcontinuingthemforawhilewithout consultingtheirdoctors.Thisisalsoknownas'nonpersistence'behaviour.

ReasonsbehindMedicationNon-adherence

Whydoesnon-adherencetomedicinecontinuetobean issueformostpatients?Patientsalwayswanttogetbetterin notimeandstill,theyfailtofollowtheroutine.Someofthe reasonsarementionedbelow:

Ÿ InadequateEducation:Patientsareunawareofthe advantagesoftherapyorthepotentialnegativeeffectsof non-adherence.Forthatreason,theymayrefusetotake theirmedicines.Also,theymighthaveconcernsabout negativeeffectsorgraduallyloseinterest.

Ÿ ComplexityinMedicines:Simplyput,patientsmay finditdifficulttorecallwhattheirdoctortoldthem. Theymightrequiremoreassistancetorememberthe scheduleandwhichmedicineshouldbetakenatwhat time.

Ÿ FinanceProblems:Sometimes,moneybecomesthe biggestbarrierinthejourneyofcuringpatients.Patients whocan'taffordamedicationmaystoptakingit. Medicinescanbehighlyexpensiveandhencepatients areindenialoftakingthemforalongtime.

Ÿ LogisticsProblems:Patientsmayfinditchallengingto stayonscheduleduetoissueswithtransportation.They mightnotpickthemedicinesupiffrequenttripstothe pharmacyarenecessary,particularlyifthepatienthas severaldrugsthatarerenewedonvariousschedules. Moreover,ifthepatientisnotcapableofreachingdrug storesduetohealthconditions,theirmedicalsupplyis likelytobedelayed.

Howcanweimprovemedicationadherencewith medicalcompliance?

Withbettercommunicationandautomatedoutreachvia mobiles,manyoftherecognisedobstaclestomedication adherencecanberemoved.Textmessaginghasbeenfound tobeausefulstrategyforencouragingadherence.In practice,carryingoutmedicalcomplianceisverycrucialas variousaspectsaffecttheprocess.Forsuccessful medicationadherence,the100percentinvolvementof

patients,cliniciansandhealthcaresystemsplaysavitalrole. Inordertocarryoutiteffectively,theremustbeavarietyof waysanddifferentadherenceapproachesinconjunction usedforpatients.Ablendofnumerousmethodsis recommendedinsteadofsuggestingasinglemethod.

Someofthemethodsarementionedbelow:

Ÿ ProperEducationandCommunicationwithPatients: Byprovidingpatientswithtimelyinformationand detailedinstructions,healthcareprofessionalscanhelp themovercomeobstaclestomedicationadherence.They shouldbeinformedaboutprescribedmedication,the benefitsoffollowingtheircareplan,andresourcesto minimisesideeffects.Helppatientstomergetheir medicationandcareplanintotheirdailyroutine.

Ÿ Motivationisnecessary:Patientsmustbeencouraged tofollowtheirtreatmentplanandremindedofits importanceinadditiontoreceivingeducationaboutthe same.Thisensurespatients'adherencetotheir prescriptions.Moreover,ifapatientachievesany milestoneinhisjourneyofmedicationadherence,this shouldbeacknowledgedandappreciatedtimely.

Ÿ IdentifyandaddressBarriers:Toincreasemedication adherence,patientparticipationindecision-makingis veryessential.Tochoosethebesttreatmenttechnique, healthcareprofessionalsmustfirstdiscoverthe underlyingcausesofpatientnon-adherence.Moreover, applyingtechnologyanddigitalmeanstothetreatment canbenefitthepatients.Patientsmustbekeptontrack byproactivelyrespondingtoqueries,offering encouragement,anddisseminatinginformation,etc.

Inconclusion,

Inconclusion,wemightanswerthecommonquestion amongpatients—whyamInotgettingcured?Togetcured andcomebacktonormallife,patientsmustknowthe importanceofmedicationadherenceanditsbenefits.Not impossiblewithgoodcommunication,digitalwaysto reminders,andmedicalhelpthiscanbeachieved.

-SaloniAgarwal

Ann Gidner CEO Ziccum

Ziccum

Expanding the Potentials for Next-Gen Vaccines and Biologics

Biologicsareoftencomposedoflivingorganisms andmolecularweightsthatmakethemvulnerable tochangeintheenvironment.Traditionally,inthe healthcaresector,thesebiologicsaredeliveredinliquid form.However,theirliquidformulationsposechemicaland physicalstabilityconcernsastheycanbenegatively affectedbymoisture,temperature,oxygen,orprolonged storage.

Inrecentyears,drug-deliveryoperatorshavebeenlooking toeliminatethisformulationgap.Thus,theyareslowly optingforalternativebiologicsthatareratherformulatedas adrypowderandfreeze-driedproductsthataremore promisingwithregardtotheirstabilityandlongershelflife.

Toaddressthemarket'sneeds,Ziccumisdeveloping LaminarPaceTM,auniqueambientdryingmethodfor pharmaceuticalsandvaccines.Unlikeotherpharmaceutical dryingsystems,itusesthescienceofmasstransferrather thanheattransfertotheactiveingredient,thusenabling thermostabledrypowderpharmaceuticals.

InaninterviewwithInsightsCare,AnnGidner,theCEO, talksaboutZiccum'sinnovativetechnologythatenablesit tostandoutinthedrugdeliverymarket.

Below are the highlights of the interview.

Kindlybriefusaboutthecompany.Whatledtoits inception?

ZiccumwasestablishedinApril2017asaspinoutfromits parentcompany,InhalationSciencesAB(ISAB).Itwasset uptodevelopandcommercializeISAB'slaminardrying system,LaminarPace.

LaminarPacewasoriginallyinventedbyPerGerde(Assoc. ProfofInhalationToxicologyattheInstituteof

EnvironmentalMedicineinKarolinskaInstitutet, Stockholm)togeneratesmallamountsofmicronized particlepowderforaerosolization,includingbiologics.As therewas(andremains)asignificantunmetneedfora systemthatcandrybiologicswithnoheatdamage,the potentialofLaminarPaceambientdryingwasimmediately clear

Shedsomelightonyourjourneyastheguidinglightof thecompany.Howdoesyourpresenceplayan importantroleinthegrowthofthecompany?

IbecamethenewCEOofZiccumonMay9thandhitthe groundrunningwithanambitiousraftofnewstrategies. TheseincludedanewBusinessModel,targetingkey vaccineplatforms,streamliningthecompany'sproject pipelineandstrengtheningitsfocusonindustrialpartnering.

Ihavedecadesofseniorstrategicpharmaexperienceandan extensiveinternationalandnationalnetwork.Ialsohave significantexperienceinbuildingupandturningaroundlife sciencestartupsanddesigningandimplementingnew businessmodelstoachievesteep,sustainable growth—whichisofparticularvaluetoZiccum.

Duringmyrole,I'veledZiccumfirmlytowardanactionbasedapproach,restructuringthecompanyandfirmly targetingpharmaandbiopharmacompanies(thecompany's earlierfocuswasonNGOsandIGOs.)SincethetimeI startedworkingthere,wehaveenlargedourbusiness developmentpipelineverysignificantly,withawiderange ofnewdialoguesestablished.Wehavealsoclosed2022, receivingfundingforanadvanced,cutting-edgeproject developingdigital3DModellingandaDigitalTwinof LaminarPace.Thiswillbeveryvaluableinhelpingpartners implementthetechnologyseamlesslyintotheirvaccineand biopharmamanufacturinglines.

Canyouelaborateuponthecorevalues,mission,and visiononwhichthecompanyisbuilt?

Ziccum'svisionistoenablenewbiologicaltreatmentsfor patientneedsglobally.Ouruniquecontributiontowardsthis isbymakingdrugformulation,biopharmaceutical processing,producttransportandpatientadministration moreefficient–withouruniqueambienttechnologyfor dryingnext-generationvaccinesandbiotherapeutics.

LaminarPacecandrydelicatebiomolecules,withnoheat stressordegradation,fromnebulizeddropletsintodry,fastdissolvingparticlesthatarethermostableandalsowellsuitedtoinhaledandnoveladministrationroutes.

Wearepassionateaboutdrivingforwardinnovationin biopharmaceuticalformulation.Theinnovationwe'reseeing aroundnewbiologicsandvaccinestodayisfantastic–from cancervaccinestopersonalizedvaccinestomRNA.We wanttomatchthatinnovationindevelopmentwith innovationinformulationtoo.Andthereisabigneedfor this.

Taketheyear,2022.Theworld'sthreebest-sellingdrugs wereallBiologics.FromPfizer'smRNACovid-19vaccine toAbbVie'smonoclonalantibodytreatmentforrheumatoid arthritistoMerck'shumanizedantibodycancer immunotherapy.They'reallinspiring,ingenioustherapies derivedfromliving,protein-basedbiologicalmaterials–andtheyhavealltransformedthetreatmentlandscapeof theirindications.

Buttheyallrequirerefrigerationorultra-coldfreezingtobe storedandtransported.Oneofthem,forexample,canonly bestoredandtransportedatanultra-lowtemperature(ULT) of-60ºCto-86ºCwhichisabigchallengeifyouarea

healthcareproviderinaLowtoMiddle-Incomecountrythat doesnothavethatkindofinfrastructure.

So,weseeagreatopportunityhereforambientdryingto helpformulateanewgenerationofthermostable biopharmaceuticalsthatcouldalsobeadministeredusinga rangeofdifferentroutesbeyondonlyinjectables.

Weemphasizesustainabilitytoo.Webelievethat thermostablevaccinesandbiologicscanhelpreducethe impactoftheglobalcoldchainforthosetherapies—helping reducethecurrentlylargecarbonfootprintoftoday's pharmaceuticalmanufacturingandsupplychains.

Whatarethecoreproductsandservicesthatyour companyhastooffer?Inwhatwaydotheyservethe targetpopulation?

OurcoreproductisLaminarPace,ouruniqueambient dryingmethodforbiopharmaceuticalsandvaccinesbased onmasstransfer,notheattransfer.Thetechnologyis offeredbylicensingtovaccineandbiologicsdevelopers andmanufacturersintheglobalpharmaceuticalindustry Byreducingdryingstresstotheactiveingredient, LaminarPaceuniquelyenablesparticle-engineered, thermostabledrypowderbiopharmaceuticalswhichcanbe easilyhandledandtransportedandalsoarehighlysuitable fornoveladministrationroutes.Thetechnologyhasbeen successfullyappliedtomRNA,peptides,proteins, antibodies,lipids,andenzymesaswellasexcipientsand adjuvants,andiswellsuitedforindustrialapplication.

LaminarPacedriesnext-generationvaccinesandbiologics asthermostable,particle-engineeredpowdersthatrequire nocoldchainandarehighlysuitedfornoveladministration routes.

Take the year, 2022. The world's three bestselling drugs were all Biologics. From Pfizer's mRNA Covid-19 vaccine to AbbVie's monoclonal antibody treatment for rheumatoid arthritis to Merck's humanized antibody cancer immunotherapy. They're all inspiring, ingenious therapies derived from living, protein-based biological materials – and they have all transformed the treatment landscape of their indications.

But they all require refrigeration or ultra-cold freezing to be stored and transported, which is a big challenge if you are a healthcare provider in a Low to Middle-Income country that does not have that kind of infrastructure.

So we see a great opportunity here for ambient drying to help formulate a new generation of thermostable biopharmaceuticals that could also be administered using a range of different routes beyond only injectables.

Howdoesyourcompanyofferpersonalizedtreatmentto thepatient'sconcerns?

LaminarPaceoffersvaccineandbiologicsdevelopersto deliveruniquecapabilitiesandcompetitiveadvantagesin formulatingtheircompoundsfornoveladministration routes.WearecurrentlyevaluatingLaminarPacedryingfor personalizedcancertreatments.Thetechnologyisapplied notprimarilyforthermostabilitypurposesbutforvery convenient,gentleandconvenientdryingofindividual doses.

Howdoyouenvisionscalingyourorganization's servicesandoperationsin2023andbeyond?

Wearecurrentlycarryingoutanadvanced3DDigital modelling/DigitalTwinprojectthatisoptimizing LaminarPaceforintegrationintothepharmaceutical manufacturingprocess.(ThisisinpartnershipwiththeICP InstituteofComputationalPhysicsteamattheZurich UniversityofAppliedSciences'SchoolofEngineering (ZHAW).TheprojectisacceleratingLaminarPace's industrialdevelopmentandscaleoutasauniqueunitof pharmaceuticalproduction.

Unlikeotherlegacymethodsfordryingpharmaceuticals (spraydryingandfreeze-drying,forexample),LaminarPace operatesbymasstransferratherthanheattransfer, eliminatingextremetemperaturesandheatstress.Both vaccinesandbiologicsarevulnerabletodegradationfrom heatstress.RetainingAPIactivityatthetemperaturesused intoday'slegacydryingtechnologiesremainsachallenge fordrugdevelopersandformulationspecialists. LaminarPacemeetsthatneed.

Itisalsoahigh-yield,low-wastedryingtechnology The increasingcostofbiopharmaceuticalrawmaterialsoffers importantbenefits.Withspraydrying,forexample,a typicalprocessyieldisaround40%to70%(leaving60%to 30%waste).LaminarPacedryingdeliversacomparatively highprocessyieldofaround80%,meaningtypically,only 20%oftherawmaterialsarewastedinthedryingprocess.

3DmodellingwillbeusedtooptimizeLaminarPacedesign, exploringoptimalcapacityloadsandincreasingthe repeatabilityofoutcomes.Itwillbeavaluableenablerof techtransferandintegrationintoexistingpharmaceutical productionchains.Acloud-enabledDigitalTwin,the ultimatestageoftheproject,willenablereal-time modellingandoptimization.

Whataresomeofthetestimonialsorrecognitionthat accuratelyhighlightyourorganization'spositioninthe market?

WerecentlyreceivedfundingfromtheEurostarsfunding bodytowardsour3DDigitalTwinproject.International competitionforfundingwasintense.Itisanimportant validationofourbusinessplanandtechnology(andthe impactitcouldhaveinvaccineandbiologics manufacture)—thatourproposalwaschosenamongso manycompetitors.