The 10 Most Innovative Women Leaders In Life Science - 2023 April2023

Elements of Progress

Understanding the Core Aspects of Innovations in the Life Science Niche Industry Insights

Gradual Rise of Women in the Stem Field

Editorial Note

The

Representation of ETERNAL EXCELLENCE

Womenaremakingsignificantcontributionsto

thefieldoflifesciences,drivinginnovations andadvancingknowledgeinnumerousareas. Thefieldoflifescienceisconstantlyevolving,andittakes strongleaderstodriveinnovationandbringbreakthroughs tothemarket.In2023,weareproudtorecognizethe10 mostinnovativewomenleadersinlifesciencewhoare changingthegameandpushingboundariesintheir respectivefields.

Womenarebeinginstrumentalinadvancingcancer research,developingnewtreatmentsandtherapies,and improvingpatientoutcomes.Thesewomenaredriving innovationinareassuchasbiotechnology,pharmaceuticals, genomics,andmore.

Hirecharacter. Trainskill.

Womenscientistsareleadingthewayinthedevelopmentof personalizedmedicine,whichtailors’medicaltreatmentsto patientsbasedontheirgeneticmakeup,lifestyle,andother factors.Theyareleadingteamsandcompaniesthatare bringinglife-changingsolutionstopatientsaroundthe world.

Womenareplayingasignificantroleinthefieldof genomics,makingbreakthroughsinunderstandingthe humangenomeanddevelopingnewgenetherapies.They

arealsodrivinginnovationsinbiotechnology,developing newapproachestodrugdevelopment,tissueengineering, andregenerativemedicine.Womenscientistsaredriving innovationsinneuroscience,developingnewtechniquesfor brainimagingandexploringtheconnectionsbetweenthe brainandbehavior

Theircontributionstothefieldoflifesciencearepavingthe wayforahealthierandmoresustainablefuture.Weare honoredtorecognizetheseexceptionalwomenand celebratetheirachievementsinthelatesteditionofInsights Success,entitled“The10MostInnovativeWomen LeadersInLifeScience-2023.”

Theirstoriesserveasaninspirationtothenextgeneration ofwomenleadersinlifescience,remindingusaboutthe importanceofdiversity,inclusivityandequityindriving innovationandcreatingabetterfutureforall.

Flip through the pages and have a delightful reading experience.

Cover Story

Editor-in-Chief

Merry D'Souza

DeputyEditor Executive Editor Assistant Editors

Visualizer

David King

Senior Sales Manager

Marketing Manager

John Matthew

Technical Head

Technical Specialist

Ankita Pandharpure

Art & Design Director Associate Designer Sihanee M., Rouniyar A. Peter Collins

Business Development Manager

Sales Executives

David, Martin

Business Development Executives

Steve, Joe Jacob Smile Prachi M.

Digital Marketing Manager

Dominique T.

SME-SMO Executive Sagar L.

Circulation Manager

Research Analyst

Frank Adams

Database Management Technology Consultant

Robert Brown Stella Andrew David Stokes

sales@insightssuccess.com

April, 2023

Abhishek Joshi

Revati Badkas

Jenny Fernandes

Anish Miller

FeaturedPerson

AllysonBower-Willner

Sr.DirectorofMarketing

Brief CompanyName

MölnlyckeHealthCare molnlycke.us

Innovara innovara.com

Merck merckgroup.com

Lykins

ColleenJ.Payne

Founder,CEO,Director ofOperations

DoloresJ.Schendel ChiefScientificOfficer

Dr.GiulianaVallanti

Sr.Directorof Marketing

EvelinaVågesjö CEOandCo-founder

JenniferS.Buell

PresidentandChief ExecutiveOfficer

PamelaContag CEO

KarunaTherapeutics karunatx.com

MCIDiagnosticCenter mcidiagnostics.com

MedigeneAG medigene.com

AGCBiologics agcbio.com

LytixBiopharma lytixbiopharma.com

MiNKTherapeutics minktherapeutics.com

BioEclipseTherapeutics bioeclipse.com

AllysonBower-Willnerinfluencesthelandscapebyleading teams,productlaunches,andmarketdevelopment.

BarriBlauveltisCEOofInnovara,aglobalpharmaceuticalbusiness andmanagementdevelopmentfirm.

UnderBelénleadership,Merckhasdefineditsstrategic ambitiontobecometheglobal21stcenturyscienceand technologypioneerandsetitsgoalof€25billioninGroup salesby2025.

WithCharmaine'sguidanceKarunaTherapeuticsisaclinicalstagebiopharmaceuticalcompanydriventocreateanddeliver transformativemedicinesforpeoplelivingwithpsychiatricand neurologicalconditions

ColleenisaserialEntrepreneur,NuclearMedicine Technologist,MotivationalSpeaker,andesteemedAuthor.She isthefounderandPresidentofMCIDiagnosticCenterandshe isblazingtrailsandmakinghistoryalongtheway

ProfSchendelwasDirectoroftheInstituteofMolecular ImmunologyoftheGermanResearchCenterfor EnvironmentalHealthattheHelmholtzCenterinMunich.

Dr.Giulianaisanexpertinthedevelopmentand industrializationofT-andhematopoieticcelltransduction processeswithlentiviralandretroviralvectors.

Evelinahasdevelopedmethodstosteerimmunecellfunctions anddelineatedanewmechanismofactionduringtissue regeneration.

JenniferS.Buell bringsmorethan25yearsof biopharmaceuticalexperience,leadingteamstoadvance discoverycandidatesthroughtoclinicaldevelopmentto commercialization.

Pamelaisdedicatedtosolvingunmethealthcareand environmentalneedsthroughthediscoveryandfosteringof scienceandtechnology

BarriBlauvelt CEO

BelénGarijo ChairoftheExecutive BoardandCEO

Charmaine

ChiefCommercial Officer(CCO)

Allyson Bower-Willner Allyson Bower-Willner Perspectives of Disruption

in Healthcare Industry

Implementinghervastmarketingexperiencein

healthcare,understandingthebreadthanddepth, includingmedicaldevices,pharmaceuticals,biologics, precisionmedicine,andinvitrodiagnostics,Allyson Bower-Willnerinfluencesthelandscapewithleading teams,productlaunches,andmarketdevelopment.

AstheSr.DirectorofMarketingatMölnlyckeHealth Care,shehelpstopromotetheorganizationalgoalsof providinghigh-performingsolutionsthatdelivermorevalue tocustomers.

WecaughtupwithAllysontolearnmoreabouthowher professionaljourneyhasshapedhercurrentposition,having facedseveralchallengesandleadinghertroughthem.

Below are the highlights of the interview:

Brieflydescribeyourprofessionaljourneyupuntilnow.

IwouldsaythethemeformycareerwithinMedical Deviceshasbeen“breadth.”

Myconcentrationingraduateschool,Operations Management,certainlydidnotdefinemycareer.Itesteda fewdifferentfunctions–Operations,R&D, Regulatory/Clinical,QA,Reimbursement,Business Development,andevenSalesbeforelandinginMarketing–byfarmyfavorite.I’vealsoworkedinvariousmedical devicespecialties–GI,Cardiovascular,Interventional Radiology,VascularSurgery,GeneralSurgery,Urology& Gynecology,andWoundCare.I’veworkedindependently asaheadofmyowncompany,atFortune100companies, andeverythinginbetween.Ifindthatpullingthebestfrom eachofthemhasmademestrongerasamarketerand, particularly,amuchbetterstrategist.Ithinkmyexposureto multiplefunctions,variousspecialties&inmanydifferent sizedcompaniesgivesmeabroaderperspective,makingit easierformetosolvemarketingproblems.

Whatalsocannotbeunderstatedismynetwork,which includespeoplefromsomanyfunctions,specialtiesand

typesofcompanies.Iamgratefulforthisnetworkevery singleday

Whatchallengesdidyoufacealongtheway?

Alongtheway,I’vemetsomeincrediblyenlightenedand sensitivemen,andI’vecomeacrossafewwhosawmeas anoutsider–andthosewerethehardesttimesforme.The inequalitythatremainsinpocketsinourindustryis puzzlingtome,andIseethe(oftensubtle)injustices happeninbusinessoften.Inthisindustry,I’vealways workedamongmen.Myundergraduateschoolhadaratio of1womanforevery7men.WhileIwasworkingin consultingintheMedicalDeviceindustry,Ihadmyfirst babyshowerandworkandtheattendeesincludedonlyme and17men.Andso,whileI’vebeenabletoworkthrough genderissueswithsomesuccess,Idoseethemcontinuing andI’vededicatedalotoftimetothemovertheyears.

Iparticipatedin“LeanIn”networks,joinedmycompany’s businessresourcegroupsforwomen,leveragedmentors, andmentoredyoungerwomen.I’vetookonaleadership positiontolaunch&co-leadmycompany'sProfessional Women’sAlliance.IalsoleadtheSoutheasternLife Sciences&SoutheasternLifeScienceWomen@SLSgroup tosupportwomeninthefield.Ialsoraised3childrenalong theway,andsoIfullyunderstandthechallengeswomen faceontheparentingfront.

Women’sissuesremaininourindustry,andI’mstill committedtodomyparttoensuregenderdoesn’tcome intoplaywithregardtoprofessionalopportunity&reward.

Whatsignificantimpacthaveyoubroughttothelife scienceindustry?

MyworkwiththeSoutheasternLifeSciences& SoutheasternLifeSciencewomen’sgroup(Medtech Women@SEMDA&Women@SLS)hashadthemost impactonthebroaderLifeSciencecommunityandis amongthemostrewardinginmycareer.Ourmissionwas toenhanceopportunitiesforwomenintheMedTechand

“

My work with the Southeastern Life Sciences & Southeastern Life Science group has had the most impact on a broad community, and is among the most rewarding in my career.

Allyson Bower-Willner, Sr. Director of Marketing Mölnlycke Health Care

lifescienceindustries.We’veheldmanyforums,including webinarsandconferences,tohelpexpandthenetworksand providenewskillstowomenintheindustry Asmembersof SEMDA/SLS,we’vekeptwomen’stopicsfrontandcenter, oftensponsoringkeynetworkingeventsandkeynote sessionsenjoyedbyallmembers,womenandmenalike.

TellusaboutMölnlyckeHealthCareanditsfoundation pillar.

ThecompanyIworkwithnow,MölnlyckeHealthCare, promotesspecifichigh-performancebehaviorsthatare promotedandreinforcedeveryday–includingthingslike entrepreneurship,teamperformance,taking ownership/responsibility&customer-centricity These corporatevaluescomplementmyownandallowmeto authenticallyworktowardcreative,innovativesolutions withoutfearoffailure.Atthesametime,ourProfessional Women’sAllianceallowsmeanoutlettosimultaneously ensurewomen’svoicesareuplifted&nurturedaspartof ourorganization’sfabric.

HowdoesMölnlyckeHealthCarepromoteworkforce flexibility,andwhatisyourroleinit?

AspartofourProfessionalWomen’sAlliance,we’ve supportedprogramsthathelpreinforceworkplace flexibility.Mölnlyckechallengesthestatusquo-our companyhasmovedfromafull-timeoffice-basedmodelto a2-dayperweekmodel,withflexibleworkschedulesbeing supportedbothinfrastructurally&culturally.Theflexibility helpsallofusbalanceourlivesandminimizeinefficiencies duetounnecessarytravel.Ithelpsusretainpeople.When peoplefacechallengingtimes,givingthemtheflexibility theyneedincreasestheirloyaltytoourcompany

Whatisyourtakeontechnology’simportance,andhow areyouleveragingit?

Thereisnoturningback–technologyisadvancingrapidly, challenginganycompanytokeepup.We’reconstantly assessingnewtechnologiestohelpussupportourcorporate culture&workflexiblybutalsotoaugmentourclinical offering.Fromremoteworkingtosocialnetworking&AI, itisinfiltratingeveryaspectofourwork.Myphilosophyis thatifwegetleftbehindontechnology,wewillbeleft behindintheindustry.

Whatwillbethenextsignificantchangeinthelife scienceindustry,andhowareyoupreparingforit?

Thismayseemwayoutthere,butchangesarecomingfor front-lineproblem-solvingviaAI&machineautomation. Asanindustry,wemustembracethesimplestoftheseas quicklyaspossibletoprepareourselvesforthosebroader changes.Wemustembracetechnologytominimizespeedto-executionatafractionofthecost.

AnexampleistheuseofAItoolssuchasOpenAI.In marketingforexample,“copy”(originaldocumentation) developmentisoftenagatingitem&assignedtolowerlevelmarketers.ButAIcancreatethatfirstdraftina fractionofthetimeahumancanaccomplishthesametask. AIcanhelpusdevelop&finalizemarketingcopyand materialsfasterandlessexpensively.Frommyperspective, itwillbenotimeatallbeforeAIisdoingsimilarworkin almosteveryotherfunctioninourindustry.Ireallydon’t thinkwecanevenimaginehowmuchofanimpact technologieslikeAI&machinelearningwillhaveonour lives,evenjust2-3yearsfromnow

Whatareyourgoalsintheupcomingfuture?

Mynextprofessionalgoalistoleadmydepartmentin minimizationofbothtimesandcosttoexecuteeven stronger,broader,andmorecompellingpositioning, messaging,andpromotion.Achievingthisgoalwillhelpus providemorecost-effectiveaccesstolife-changingmedical devicesforourcustomers.Thisisparticularlyimportant hereintheUStocontinuetoleadtheworldinhealthcare. Thecost-effectivenessofourmedicalsolutionshastotakea morefront-and-centerpositionacrosstheboardfor suppliersandprovidersalike.

Whatadvicewouldyouliketogivethenextgeneration ofaspiringbusinessleaders?

Aformerbossofminesaidthekeytoasuccessfulstart-up istosolveabigproblem,andthat’salwaysstuckwithme. I’dloveournewergenerationtobringyourtechnical expertiseandhelpussolvesomebigproblemslike reducingcostwhileimprovingcare!Idon’thavethe technicalskillsyou’vegrownupwith,andyoucanuse thoseskillstohelpusspringboardtheindustrytoanew efficiencystandard.Therearemillionsofpeoplerighthere intheUSwithproblemsyoucansolve,andifyousolveit foroneperson,chancesaregoodthatthereareotherswho canusethatsolutiontoo!

Gradual Rise of Women STEM Field in the

Overtheyears,wehaveseenagradualriseof

womenintheSTEMfield.Whilethereisstilla longwaytogo,progressisundeniable.Hereare someofthefactorsthathavecontributedtotheincreasing participationofwomeninSTEM:

Education:Therehasbeenasignificantincreaseinthe numberofwomenpursuinghighereducationinSTEM fields.Manyuniversitieshavemadeanefforttorecruitand retainfemalestudentsinSTEMprograms.

Rolemodels:ThevisibilityofsuccessfulwomeninSTEM fieldshasencouragedyounggirlstoconsidercareersin theseareas.WomeninSTEMhavebecomemorevisiblein

themediaandinpopularculture,makingiteasierforyoung girlstoimaginethemselvespursuingthesecareers. Mentoring:Theimportanceofmentorshipcannotbe overstated.ManysuccessfulwomeninSTEMfieldshave takenituponthemselvestomentoryoungerwomenand providethemwithguidanceandsupport.

Advocacy:Organizationsandgroupshaveformedto advocateforwomeninSTEM.Thesegroupsworkto increaseawarenessandunderstandingofthechallenges womenfaceinthesefieldsandprovideresourcesand supporttoovercomethesechallenges.

Corporateinitiatives:Manycorporationshaverecognized thebenefitsofhavingadiverseworkforceandhavetaken stepstoincreasethenumberofwomeninSTEMfields. Thisincludescreatingprogramstorecruitandretain women,offeringmentorshipandnetworkingopportunities, andprovidingprofessionaldevelopmentopportunities.

VanquishingaGenderGap

ProponentsofclosingthisgendergapintheSTEMfield pointsoutthatthisgapnotonlyreflectsunfairconditions andpoortreatmentofwomeninthisfield.Furthermore,it alsoreducesthequalityofworkandinnovationsbeing extractedfromthesefields.

Itisasubjectofrecommendationandfactsthatindicate scientificprogressreliesonuniquesolutionsthatare emergingfromdifferentperspectives.Closingthegender gapmakeSTEMfieldsmorediverse,also,redefinesthe assuranceofproblem-solvingapproacheswithavarietyof differentperspectives.

Althoughthebroadgendergapthatexistsacrossthe STEMfieldsbecomesatopicofdiscussion,thereisa greatdealofvarietyamongdifferentSTEMsubfields whenitcomestotheexactscaleandnatureofthisgap.

Somesubfieldshavenogapatallandfavourwomen ingraduation,andjobplacement.Insubjectslike socialscience,thereisagreaternumberofwomen ifcomparedtomen,anditremainsstrongly favourabletowardswomen.

EnablingInnovations

Itisafactofassurancethatwomenwould benefitfromthecreationofmore inclusiveatmospheresinSTEMfields, thesefieldsasawholecanbecome moreengaging.

Afieldlikescienceworksand functionsatitsbestwhenitconsiders

awiderangeofdiverseperspectives.Byexcludingwomen, suchfieldsnotonlyexcludeawiderangeofextremely talentedfutureleadersbutalsofreshperspectivesthatcould beusedtocreateinnovativeapproachestoresolve problems.

Engagingwomeninstemfieldshasimprovedthequalityof workbeingexecutedinthosefieldsandithasopenedup distinguishedcareeropportunitiesforwomen.

Ingeneral,researchhasdisplayedthat,‘diverseworkplaces arehappierinnatureandmoreproductive,’indicatingthat STEMorganizationscoulddobetterforthemselvesby beingmoreinclusive.

BreakingtheStereotypes

Theideaofthegenderequalityparadoxisnotwithoutits problems.Criticspointoutthatcountrieswithpoor representationinSTEMfieldshavealonghistoryof excludingwomenfromscienceandmathematics,whichhas beendeeplyembeddedintotheculturethatsurrounds younggirlsastheyaregrowingup.

Theyalsopointoutthatthereisnogapinabilitysince researchersfoundthatgirlsperformedaswellorbetterthan boysonSTEMtestsinmostcountries.

TruesolutionstothegendergapinSTEMfieldsworkon multiplelevels.Exclusionbeginsinchildhood,whenyoung girlshavebeenpushedawayfromcreativefieldslike science,andmathematics,andareencouragedtoadopt morecare-orientedwork.

Thisscenarioisdrasticallychangingasparentsare encouragingandremindingtheirchildrenthattheycan growuptodoanythingthattheywant.Parentsarealso providingawiderangeofopportunitiesforchildrento exploretheirinterests,includingthoserelatedtoSTEM, suchascodingcampsandsciencefairs.

Ineducation,scholarshipsandgrantsarestrivinghardto bringwomenintoSTEMdepartments.However,these departmentsmustdoeverythingintheirpowertoprevent discriminationandsexismagainstfemalestudentsto improvepreservationrates.

Intheworkplace,employeesmustidentifyandaddressthe discriminationintheirhiringpracticessotheycangenerate adiverseworkplacethatenhancesproductivityamongtheir employees.

Outsideofschoolandtheworkplace,broadersocietal changesarealsocalledfor Womenareoftenharderhitbya couple’sdecisiontoraiseafamily,forcingthemtotake

moretimeoffofworkduringcriticalperiodsintheir careers,suchasearlyonatanewjoborevenduringtheir doctoralstudies.

Despitethesesituations,womenaremakingnoteworthy progressnotonlyinSTEMfields,butalsointheir profession,andarebreakingthestereotypes.

VanquishingaGenderGap

ProponentsofclosingthisgendergapintheSTEMfield pointsoutthatthisgapnotonlyreflectsunfairconditions andpoortreatmentofwomeninthisfield.Furthermore,it alsoreducesthequalityofworkandinnovationsbeing extractedfromthesefields.

Itisasubjectofrecommendationandfactsthatindicate scientificprogressreliesonuniquesolutionsthatare emergingfromdifferentperspectives.Closingthegender gapmakeSTEMfieldsmorediverse,also,redefinesthe assuranceofproblem-solvingapproacheswithavarietyof differentperspectives.

AlthoughthebroadgendergapthatexistsacrosstheSTEM fieldsbecomesatopicofdiscussion,thereisagreatdealof varietyamongdifferentSTEMsubfieldswhenitcomesto theexactscaleandnatureofthisgap.

Somesubfieldshavenogapatallandfavourwomenin graduation,andjobplacement.Insubjectslikesocial science,thereisagreaternumberofwomenifcomparedto men,anditremainsstronglyfavourabletowardswomen.

EnablingInnovations

Itisafactofassurancethatwomenwouldbenefitfromthe creationofmoreinclusiveatmospheresinSTEMfields, thesefieldsasawholecanbecomemoreengaging.

Afieldlikescienceworksandfunctionsatitsbestwhenit considersawiderangeofdiverseperspectives.By excludingwomen,suchfieldsnotonlyexcludeawide rangeofextremelytalentedfutureleadersbutalsofresh perspectivesthatcouldbeusedtocreateinnovative approachestoresolveproblems.

Engagingwomeninstemfieldshasimprovedthequalityof workbeingexecutedinthosefieldsandithasopenedup distinguishedcareeropportunitiesforwomen.

Ingeneral,researchhasdisplayedthat,‘diverseworkplaces arehappierinnatureandmoreproductive,’indicatingthat STEMorganizationscoulddobetterforthemselvesby beingmoreinclusive.

BreakingtheStereotypes

Theideaofthegenderequalityparadoxisnotwithoutits problems.Criticspointoutthatcountrieswithpoor representationinSTEMfieldshavealonghistoryof excludingwomenfromscienceandmathematics,whichhas beendeeplyembeddedintotheculturethatsurrounds younggirlsastheyaregrowingup.

Theyalsopointoutthatthereisnogapinabilitysince researchersfoundthatgirlsperformedaswellorbetterthan boysonSTEMtestsinmostcountries.Truesolutionstothe gendergapinSTEMfieldsworkonmultiplelevels. Exclusionbeginsinchildhood,whenyounggirlshavebeen pushedawayfromcreativefieldslikescience,and mathematics,andareencouragedtoadoptmorecareorientedwork.

Thisscenarioisdrasticallychangingasparentsare encouragingandremindingtheirchildrenthattheycan growuptodoanythingthattheywant.Parentsarealso providingawiderangeofopportunitiesforchildrento exploretheirinterests,includingthoserelatedtoSTEM, suchascodingcampsandsciencefairs.Ineducation, scholarshipsandgrantsarestrivinghardtobringwomen intoSTEMdepartments.However,thesedepartmentsmust doeverythingintheirpowertopreventdiscriminationand sexismagainstfemalestudentstoimprovepreservation rates.

Intheworkplace,employeesmustidentifyandaddress discriminationintheirhiringpracticessotheycangenerate adiverseworkplacethatenhancesproductivityamongtheir employees.

Outsideofschoolandtheworkplace,broadersocietal changesarealsocalledfor Womenareoftenharderhitbya couple’sdecisiontoraiseafamily,forcingthemtotake moretimeoffofworkduringcriticalperiodsintheir careers,suchasearlyonatanewjoborevenduringtheir doctoralstudies.Despitethesesituations,womenare makingnoteworthyprogressnotonlyinSTEMfields,but alsointheirprofession,andarebreakingthestereotypes.

Whileprogresshasbeenmade,thereisstillalotofworkto bedone.WomeninSTEMcontinuetofacechallenges, includingbiasanddiscrimination,lackofaccesstofunding andresources,andwork-lifebalanceissues.However,the increasingvisibilityofwomeninSTEM,combinedwiththe effortsofadvocates,mentors,andorganizations,offershope thatwewillcontinuetoseeariseinthenumberofwomen pursuingandsucceedinginSTEMcareers.

Dr.GiulianaVallanti Creating Innovations

Makingtheuncurablecurableistheaimofthe cellandgenetherapysub-fieldofthe pharmaceuticalindustry.Itisthenextfrontierof healthcarethatwillrevolutionizetreatments,potentially cureincurablediseases,andtransformpatientlives completely.

Oneofthetrailblazersofthisstill-developingdisciplineis Dr.GiulianaVallanti,HeadofDevelopmentandGlobal HeadofR&DforCellandGeneTherapyatAGC Biologics.

Dr.Giulianaisanexpertinthedevelopmentand industrializationofT-andhematopoieticcelltransduction processeswithlentiviralandretroviralvectors.Shehas workedonthedevelopmentofGMPprocessesforlargescalevectorproductionandpurificationforlentivirus, retrovirusandAAV.Sheisdesigningprocessesthathelp scaleandcommercializecellandgenetherapies,making themavailabletothegeneralpopulation.

AGCBiologicsoffersdeepindustryexpertiseand customizableservicesandstrivestoprovideinnovative solutionstoitscustomers,helpingthemreachtheirgoals andacceleratetheirprojectsatourcGMP-compliant facilitiesintheUS,Europe,andJapan.Italsohelps facilitateapprovalandmanagespendingduringtheproduct lifecycle.

Inanexclusiveinterviewwith Insights Success,Dr. GiulianaVallantisharesdevelopmentsinthefieldofCell andGeneTherapyandherchallengesinpioneeringlifechangingwork.

Below are the highlights of the interview: Brieflydescribeyourprofessionaljourneyupuntilnow.

MycurrentroleistheHeadofDevelopmentandGlobal HeadofCellandGeneTherapyR&DatAGCBiologics,a leadingglobalContractDevelopmentandManufacturing

for Curing Lives

Organization(CDMO).IamabiologistwithaPh.D.inCell andGeneandhaveworkedinthisamazingfieldsincethe beginningofmycareer

Mymainresponsibilityistodevelopprocessesand analyticaltestingforviralvectorproductionandgenetically modifiedcells.Myteamdevelopsmanufacturingprocesses forourcustomers,aswellasnewplatformsand technologiesaimedatimprovingcellandgenetherapy productioninthefuture.

Whatchallengesdidyoufacealongtheway?

Themainchallengeisthatthefieldisstillveryyoungand immature,sostandardsandbestpracticesarefinite. However,thisisalsothemostinterestingpartofmyjob. Weareconstantlysearchingfornewsolutionsand techniquestoensureweproduceahigh-quality,safe,and functionalproduct.Thebeautyofcellandgenetherapiesis theircurativenaturetoverydevastatingdiseases.Butsince thetherapyismadeupofthepatient’sowncells,findinga waytogenetically“fix”themremainsasignificant challenge,andmyjobentailsjustthat–achievingawayto doit.

ThecoreteamatourAGCBiologicsMilansitehasbeen workingthroughthesechallengesformorethan20years, sowhilethisindustryisyoung,myteammateshaveabroad depthofexpertiseinthisspace.Thesitewasthefirst approvedinEuropeforGMPmanufacturingofcelland geneproducts,andwehavedevelopedthreecommercial productsforpatientsinneed.

Whatsignificantimpacthaveyoubroughttothelife scienceindustry?

Cellandgeneisoftenconsideredasthenewfrontierof personalizedmedicine,andIamveryproudtobepartof thisfield.MyteamandIworkhardeverydaytoensure thesetreatmentstranslatefromtheresearcher’sbenchtothe patient’sbedside.Thankstowhatwedo,incollaboration

Dr.GiulianaVallanti, HeadofDevelopmentand GlobalHeadofR&DforCell andGeneTherapy AGCBiologics

withourcustomersandpartners,wehavesavedmorethan 150infantsaffectedbydevastatinglethalrarediseaseswho arenowlivinganormallife(ex:immunodeficiencies, lysosomalstoragediseases,hemoglobindisorders).As pioneersinthisfield,theteamatourAGCBiologicsMilan sitehelpedbringtomarketthefirsttwoex-vivogene therapiesapprovedworldwide.

TellusaboutAGCBiologicsanditsfoundationpillar.

AGCBiologicsisaglobalCDMOproviding pharmaceuticaldevelopmentandmanufacturingservices forprotein-basedbiologicsandcellandgenetherapies.We specializeinthefollowingmodalitiesandsubstances, mammalianandmicrobial-basedtherapeuticproteins, recombinantDNA,plasmidDNA(pDNA),Messenger RNA(mRNA),viralvectors,andgeneticallyengineered cells.

My team and I work hard every day to ensure CGT treatments translate from the researcher’s bench to the patient’s bedside. Thanks to what we do, we have saved more than 150 infants affected by devastating lethal rare diseases who are now living a normal life.

Ourmissionistoworksidebysidewithourcustomersin ordertoimprovepatient’slivesbybringingnew biopharmaceuticalstomarket.AGCbiologicsvaluesare Innovation&OperationalExcellence,Diversity, Environment,andIntegrity

HowdoesAGCBiologicspromoteworkforceflexibility, andwhatisyourroleinit?

Ourteamsarecommittedtohighqualityandexecution standards.Everypersonknowsthatbymeetingour customers’needs,wemeettheneedsofpatients,improving –andoftensaving–lives.Ourcustomersentrustuswith thisenormousresponsibility,andwecouldnotmakeit happenwithoutourpeople.Byputtingourpeoplefirst,we helpourteamsdeliverforourcustomersandtheirpatients.

AGCBiologicspromotesahealthywork-lifebalance becausewebelievethatbysupportingouremployees’wellbeing,theycometoworkfocused,efficient,andproductive. Withmostofouractivitiescarriedoutinlabswithvery sophisticatedequipment,weareoftenrequiredtoworkonsite.Still,wehaveastructurethatallowsforsomeremote andhybridworkingacrosstheentireorganization.

Whatisyourtakeontechnology’simportance,andhow areyouleveragingit?

Technologiesevolveveryrapidlyand,particularlyinthe CellandGenefield,weneednotonlytoremainuptodate onnewones,butwealsostrivetodesignanddefinenew flows“outoftheblue”byadaptingtechnologiesdesigned forotherscopesandapplications.However,whenpossible, wedotrytoleveragepracticalsolutionsandpracticesfrom otherfieldsratherthanreinventingthewheeleverytime.

Whatwillbethenextsignificantchangeinthelife scienceindustry,andhowareyoupreparingforit?

Undoubtedly,afterclassicalchemistryfollowedby biotechnology,cellandgenetherapyisthefutureof medicine.Thefieldisstillinitsembryonicphase,and everythingwedoremainsverymanual.Thechallengeisto movethisfieldintoarealindustrywithlarge-scale, automated,andreliablesystemsandtechnologythatwill makethesetherapiesmoreaffordable,robust,andsafe.To

continueleadingtheway,aswehavedoneforthelast25 years,weareinvestingsignificantlyintechnicalinnovation, capacity,andscalability. Whatareyourgoalsintheupcomingfuture?

MygoalistodoasmuchasIcantoworktowardsmaking CellandGeneTherapymoreaccessibletoawider population.Bydevelopingnewerandbetterprocesses, thesetherapiesaremanufacturedsafely,timely,and affordably,thusensuringtheirsustainability.Personally,I’m veryhappytocontinuemyroleasamentortoyoung scientistswhoworkwithmebytransferringmypassionfor thesubjectandtechnicalskillsthatareafundamental requirementinthisfield.

Whatadvicewouldyouliketogivethenextgeneration ofaspiringbusinessleaders?

Mymainsuggestionistofollowyourpassionsandinvest timeandenergyineducationandlearningatthebeginning ofyourcareer.Beopen-minded.Youcanlearnfrommany ofthosearoundyou,notonlyfromyourmanager.Moveout ofyourcomfortzoneasmuchaspossible,eventhoughit maybechallengingatfirst–thisistheonlywaytogrow Chooseajobthatbringsasmiletoyourfacewhenyou wakeupinthemorning.Thismakesahugedifference!

Understanding the Core Aspects of Innovations in the Life Science Niche

Thelifesciencesectorhasexperiencedmany

advancementsinrecentyears,whichhaveledtothe developmentofnewtreatmentsandtherapiesfora varietyofdiseases.Innovationinthelifescienceindustry referstothedevelopmentofnewproducts,technologies, andprocessesthatimprovehealthcareoutcomesand enhancethequalityoflife.Thefollowingaresomeofthe coreaspectsofinnovationinthelifescienceniche:

ComprehensiveResearchandDevelopment:Research anddevelopmentarecrucialtothelifescienceindustry. CompaniesinvestsignificantresourcesinR&Dtodevelop newdrugs,therapies,andmedicaldevicesthatcanimprove healthoutcomesforpatients.R&Dinvolvestheuseof advancedtechnologiesandscientificmethodologiesto identifynewtreatmentsandcuresfordiseases.

Collaboration:Collaborationbetweenacademia,industry, andgovernmentisessentialforinnovationinthelife scienceniche.Collaborativeeffortscanhelptofacilitatethe exchangeofknowledgeandexpertise,leadingtothe developmentofnewproductsandtherapies.

RegulatoryEnvironment:Theregulatoryenvironment playsacriticalroleinthelifescienceindustry.Regulations areinplacetoensurethatnewproductsandtherapiesare safeandeffectiveforpatients.Theregulatoryprocesscan becomplex,andcompaniesmustnavigatetheregulatory landscapecarefullytobringnewproductstomarket.

Investment:Investmentisnecessaryforinnovationinthe lifescienceniche.Companiesneedfundingtosupport R&Defforts,clinicaltrials,andthecommercializationof newproducts.Investorsalsoplayacrucialroleinproviding

thecapitalnecessarytobringnewtherapiesandproductsto market.

DigitalTechnologies:Digitaltechnologiessuchasartificial intelligence,machinelearning,andbigdataanalyticsare transformingthelifescienceindustry Thesetechnologies arehelpingcompaniestoidentifynewdrugtargets, optimizeclinicaltrials,andpersonalizetreatmentoptions forpatients.

Artificialintelligenceisplayinganincreasinglyimportant roleinthelifescienceindustry AItechnologiescananalyze vastamountsofdatatoidentifynewdrugtargets,optimize clinicaltrials,andpersonalizetreatmentoptionsfor patients.

TheuseofArtificialIntelligenceandMachineLearningin thelifescienceshasimproveddrugdiscoveryand developmentbyanalyzinglargedatasetsandidentifying potentialdrugcandidates.

PersonalizedMedicine:Personalizedmedicineisan emergingtrendinthelifesciencenichethatfocuseson developingtreatmentsthataretailoredtoindividual patients'geneticandmolecularprofiles.Personalized medicinecanimprovetreatmentoutcomesbyidentifying patientswhoaremorelikelytorespondtospecific therapies.Precisionmedicineisanapproachtopatientcare thatconsidersanindividual'sgeneticmakeup,lifestyle,and environmentwhendeterminingthemosteffective treatment.Thisapproachhasledtothedevelopmentof targetedtherapiesforcancerandotherdiseases.

GeneTherapy:Genetherapyisapromisingareaof medicalresearchthataimstotreatorcuregeneticdisorders byintroducingnew,healthygenesintothepatient'scells. Therehavebeenseveralrecentinnovationsingenetherapy thathaveadvancedthefieldandholdgreatpromiseforthe future.

Genetherapyinvolvestheintroductionofgeneticmaterial intoapatient'scellstotreatorpreventdisease.Gene therapyhasthepotentialtoprovidelong-lastingoreven permanentcuresforgeneticdiseases.CellandGene Editing:Cellandgeneeditingtechnologies,suchas CRISPR-Cas9,arerevolutionizingthelifescienceindustry byenablingprecisemodificationstoDNAsequences.Cell andgeneeditingtechnologieshavethepotentialtotreata widerangeofdiseasesanddisorders,includingcancer, geneticdiseases,andviralinfections.

GeneeditingtechnologiessuchasCRISPR-Cas9have revolutionizedthewayscientistscanstudyandmanipulate genes.Thesetechnologieshavethepotentialtocuregenetic diseases,preventinheriteddisorders,andevencreatenew treatmentsforcancerandotherdiseases.

DigitalHealth:Digitalhealthtechnologies,suchas wearabledevices,mobilehealthapps,andtelemedicine,are transformingthewayhealthcareisdeliveredandmanaged. Digitalhealthtechnologiescanimprovepatientoutcomes, reducecosts,andincreaseaccesstocare.

CollaborativeResearch:Collaborativeresearchis becomingmoreprevalentinthelifescienceindustryas companiesseektoshareknowledgeandexpertiseto acceleratethedevelopmentofnewtherapiesandproducts.

Insummary,innovationinthelifesciencenicheisdriven byresearchanddevelopment,collaboration,theregulatory environment,investment,anddigitaltechnologies. Companiesthatcaneffectivelyleveragethesecoreaspects ofinnovationarewell-positionedtodevelopnewproducts andtherapiesthatcanimprovehealthcareoutcomesand enhancethequalityoflifeforpatients.

Evelina Vågesjö

Bringing Local-Acng Immunotherapies to Paents

Womenhavebeensignificantlycontributingto medicinethroughouthistory,andwehave benefitedfrommanyamazingdiscoveriesmade byfemalescientists.FamousexamplesincludeRosalind Franklin'scrucialworkonunderstandingthemolecular structuresofDNAandMarieCurie'sdiscoveryofradium, whichcontributedtothedevelopmentofthex-ray.What aboutthewomenwhoarecurrentlyreshapingthelife sciencesindustry,though?

EvelinaVågesjöistheCo-founderofIlyaPharmawitha Ph.D.inphysiology,anMBAwithafocusonfinance,anda MnA.Shedevelopedmethodstosteerimmunecell functionsanddelineatedanewmechanismofactionduring tissueregenerationandhasoverseentheprojectfromits conceptionthroughclinicalproofofconceptandcompany growthEvelinaisalsoaboardmemberofLytix Biopharma(LYTIX).

Fascinatedbytheworkingsofthehumanbody,Evelina, bornandraisedinSmåland,Sweden,beganresearchinga waytosteerimmunecellbehaviourlocallyasaprojectfor herdoctoralthesisstudiesatUppsalaUniversity.

Evelinaalsoholdstwobusinessdegrees,andI'minterested inlifesciencestrategyandfinancewithagoalofenhancing health. "I got the chance to study immunophysiology, and I was able to study in real-time how bodily functions work," she says. "I was able to observe how immune cells regulate blood flow in injured tissue."

Havingmanagedherprojectfromaninitialideatoclinical proofofconceptandthescalingofthecompany,today,at age35,Evelinahasbeenrecognisednumeroustimesforher achievements.Forexample,shehasbeenselectedforthe SpringboardEnterprises’HealthInnovationHubinthelife sciences,andshewasoneoftherecipientsoftheMIT InnovationsUnder35awardin2019.

Below are highlights of the interview that shed light on Evelina Vågesjö’s journey, which began as a project for her doctoral thesis and grew into a clinical-stage biopharmaceutical company:

Brieflydescribeyourprofessionaljourneyupuntilnow.

About10yearsago,Iwasveryinterestedinsinglemutation diseasesoftheskin,whichwereoptimalforthe developmentofthefirstgenetherapies.Thefieldwasinits earlystagesbackthen.Alwaysfascinatedbythehuman bodyandcuriousaboutwhattheimmunesystemand immunecellsdoduringhomeostasis,injury,anddiseasein thecirculationandinthetissue.Iseemtobecollecting degrees,notintentionallythough,withaMastersin Biomedicine,aPhDinPhysiology,andaBScin ManagementAccounting,allthreefromUppsala University,andanMBAinFinanceandM&Afrom EdinburghBusinessSchoolatHeriot-WattUniversity

In2016,Ico-foundedIlyaPharmaABbasedonmy researchandassociatedintellectualproperty Thecompany nowdevelopslocal-actingimmunotherapiesfromitsown platforminsyntheticbiology.The3clinicalprogrammes todayengage40peoplefrom6countriesand>30 subcontractors.Idevelopedtheinitialproofofconceptand havemanagedtheprojectsinceitstarted;nowIleadthe scalingupphaseasrequiredwiththeclinicaldevelopments, especiallyfinancing,intellectualpropertydevelopmentand management,businessdevelopments,andcommunications withindustrystakeholdersandbigpharma.Haveraised>25 MUSDtotheprojectssofarandledthestrategic acquisitionofoneofourvendors,NordicBioanalysisAB, in2021.

Since2021,IhaveservedontheBoardofDirectorsfor LytixBiopharma,afantasticclinical-stageimmunooncologycompanysolvingtheproblemoftreating

Evelina Vågesjö Co-founder Ilya Pharma

Evelina has developed methods to steer immune cell funcons and delineated a new mechanism of acon during ssue regeneraon.

heterogeneoustumours,withbothpartnered-andfully ownedassetsinphase2developmentsinmultiplecancer indications.

Whatchallengesdidyoufacealongtheway?

Mixedmessagesandslowprocesses!Havelearnedto navigatecomplexandversatileenvironmentswhilepaving theway,developinginnovativeandbest-in-class pharmaceuticalassets,andkeepingstakeholders,investors, andshareholdersengaged.

Whatsignificantimpacthaveyoubroughttothelife scienceindustry?

Well,IthinkIhaveshownourteamandthelifescience industrythatpharmaceuticaldevelopmentofnew modalitiescanbebothswift,cost-efficient,andfun!

TellusaboutIlyaPharmaanditsfoundationpillar.

Themainobjectivesformygraduatestudieswereto developmoleculartollstosteerimmunecellbehaviour locally in vivo indifferentmodels.Whilstmanyofthe immuneactiveproteinsarewelldescribed,includingtheir functions,therearefewviableoptionstoutilisethese therapeutically.Forimmunecells,thespatialdistributionof localgradients in vivo isvitalforhowtoimpacttheir functionsintissue.

Toenabletargetingoftheseknownpathways,wedecided tomakealibraryoflacticacidbacteriathatcanbe geneticallyengineeredtoexpresshumanimmuneactive

proteins,forexamplechemokines,whichhaveahalf-lifeof secondsintissueandarethusnotsuitedfordevelopmentas biologicsorasgenetherapy

So,whatwemanufactureislacticacidbacteria;theseare activatedonsiteinthebodyandthenstarttoproducethe humantherapeuticprotein,oneofitsmostimportant USPs—almostforfree!

TheILP100,emilimogenesigulactibac,isourlead candidate,itisanon-humanstrainofa Limosciliobacillus reuteri (meaningitdoesnotstickto-orcolonizeinhumans) thatexpressesthechemokineCXCL12alsoknownasSDF1a.WearedevelopingILP100inatopicalformulation treatingsurgicalwoundsinobeseanddiabeticpatients,who havedelayedhealingandincreasedcomplications,andin anoralformulationtotreatcolitisincancerpatients,where 30-40%ofcancerpatientsoncheckpointinhibitortreatment needtodiscontinuethetreatmentduetoseverecolitis.

Wearestartingwiththesetwodrugcandidates,forward thereareawiderangeofpossibilitiesusingtheILPplatformandwemayexploremedicalindicationsinlung andwomen’shealthlimitingfibrosis.

HowdoesIlyaPharmapromoteworkforceflexibility, andwhatisyourroleinit?

AtIlyaPharma,theteamsworkfromsixcountries,andwe havemultiplevendorsglobally Wedohaveanoffice, whichismainlytooffertheteamaplacetomeetupator havequietfocusedtimewhenneeded.Ithinktheteam appreciatestheflexibilityandisgoodtoeachotherinthis

regard.Manyareparentsandadapttheirworkloadtofit withtheirfamily;thisworkswell,andwehavesolvedthis bymakingsmallinterchangeableexpertteamsinsteadof relyingononepersonhavingtheexpertiseonly.

Comingfromacademia,workinginglobalteams,being GenYandScandinavian-flexibilityissomethingIhave alwaystakenforgrantedandappreciated.Ihavebeen surroundedbypeopleandcollaboratorsthatworkatodd hoursfromremotelocationsbutalsoalwaysmakeitwork foradeadline,whateverthatmaybe.

Whatisyourtakeontechnology'simportance,andhow areyouleveragingit?

Itisimportanttoalwaysexplorenewoptionsand improvements,especiallywhenitcomestogeneratingand understandingdatafromthedifferentpartsofthe developmentprocess.Pharmaceuticaldevelopmentand healthcareare,however,quitetraditional,anditisnotthe first-placenewtechnologiesarebeingtestedandvalidated, asthebarmaybelowerforthefirstproofofconcept elsewhere.Wehavealsoexperiencedthatsmaller companieswithgreatnewtechnologies,forexamplein imaging,arehesitanttotakethestepofvalidation.So,we usenewtechnologiesforourclinicaltrialsinanticipationof leveragingthedatagoingforward,especiallyimagingand potentiallynewbiomarkers.

Whatwillbethenext significantchangeinthe lifescienceindustry,and howareyoupreparingfor it?

Havingthebest understandingofthe therapeuticsspace,Isee moreandmorenew modalitiesinearly developmentaswellasnew andinnovativetakeson immunotherapiesforawide rangeofunmetneeds beyondcancer.Ithinkthe regulators,withtheFDA havingadaptedthemostto meettheseprojects,are ready,butthatthe pharmaceuticalindustry, especiallybigpharma,may bewisetostayconnectedandbereadyfortheeverchanging,fasterpaceofproductdevelopmentthatmaynot fittraditionalsilosandindications—thereisstillavast unmetmedicalneedtobeaddressed.

Whatareyourgoalsintheupcomingfuture?

Iam,ofcourse,focusedondeliveringtheclinicaland commercialmilestonesforIlyaPharma’sassets.Having identifiedgapsinthemarketforcell-andgenetherapy productdevelopmentinfrastructureandservices,especially forlatestageclinicalandcommercialapplications,itwould begreattobeabletoleveragetheCMCknow-howwehave gatheredandmaybetapintoorbuildouttheinfrastructure forusandforothers,facilitatingthePoCinpatientsofdrug candidatesfornewmodalities.

Whatadvicewouldyouliketogivethenextgeneration ofaspiringbusinessleaders?

Thisismyfirstdownturnintheeconomyasabusiness leaderandCEO.Navigatingclinicaldevelopmentsduring thepandemicwaschallenginghoweverchanging macroeconomicconditionsduringlongdevelopment projectsinLifeSciencerequiresthatYoutohavemultiple doorsopenandbemoreagileandopentoexplore opportunitieswhereYouinitiallymaybedidnotexpectto findthem!