PROVENTAI N T E R N A T I O N A L

2020JUNESTRATEGY 25thONLINE MEETING

Andrea Small-Howard Chief Security Officer GB Sciences

Jack FernandesCEO Regenica Biosciences

Oliver Steinbach VP R&DImagion Biosystems

Catherynne Cruz-SchecknerDirector Clinical Supplies Ionis Pharmaceuticals

Joanne McCaigueDirector, DM and Programming / Statistical and Data SciencesPosieda Therapeutics

Ashraf YousefSenior Medical Director, Immunology and Devices, Global Safety LeadShire

William HaddockVP SafetyOvid Therapeutics

Jessica Raiz Senior Director, Clinical ResearchTimber Pharmaceuticals

Ben Exter VP & Head of Pharmacovigilance Unum Therapeutics

Abhit Singh Chief Regulatory OfficerIntrommune Therapeutics

OUR UNIQUE ONLINE MEETING FORMAT CONTRIBUTORS TO THE AGENDA

Roundtable DiscussionsThese interactive and informal discussion groups are the hallmark of the meeting. The brightest minds in the industry are brought together in 60-minute sessions that enable participants from all over the world to share ideas, challenges and lessons learned.

Personalised AgendaEach delegate receives a personalised agenda with the roundtable discussions that you choose. You only attend sessions and meetings that fit your challenges and interests, ensuring your time spent on the online platform is focused and well-utilised.

One-to-one MeetingsThe most effective and time efficient way to assess potential partners at a strategic level. Gain access to our exclusive networking app to identify the people that you need to meet. The app will allow for instant anddirect messaging to organise online meetings during the dedicated time to most benefit you.

Strategic NetworkingStrategic networking opportunities form a key benefit of the meeting. Our new online format for building and strengthening alliances to make lasting connections that benefit you.

2019 ATTENDEES

TRACK 2 STORAGE & DISTRIBUTION

TRACK 1CLINICAL DATA & IRT

TRACK 3 DIRECT-TO-PATIENT

AGENDACLINICAL TRIAL SUPPLY CHAIN

SPONSORS

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SPONSORS

CrO Biosciences is an information management consulting firm that provides clients with Inspection Readiness, regulatory submission planning and management. We have the expertise necessary to acquire agency approval for regulatory applications in biotechnology, pharmaceutical, and medical device organizations. CrO is a global, woman-owned, operated and controlled company; which consists of regulatory and clinical operations professionals with over 60 years of combined experience. Why settle for working with another company when you can work with the best in the business? Our unique methodologies are up to date with the current rules, regulations, guidances, technologies, and latest industry trends keeping us ahead of the curve every time.

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PCI is an integrated full service provider and a trusted partner to leading companies in the global healthcare industry. Using its knowledge of pharmaceutical development,clinical manufacturing and packaging solutions, PCI provides unparalleled expertise and a seamlessly integrated drug development service delivering speed-to-market and commercial success for its client’s products. From molecule to market, its innovative, leading-edge technology and continued investment in their people and facilities enables PCI to address global drug development needs at each stage of the product lifecycle. From its dedicated Clinical Trial Centers of Excellence, the Clinical Services team offers a truly global service balanced with a localized focus. PCI’s clinical trial services include, Pharmaceutical Development including Highly Potent Molecules, Clinical Trial Manufacture including Highly Potent Molecules, Clinical Packaging and Packaging Design, Primary Packaging, Secondary Packaging, Specialty Product Packaging, Clinical Supplies Management, Clinical Planning and Support, Project Management, IVRS-IWRS, Qualified Persons (QPs), Support Services, Data Access.VISIT WEBSITE

LEAD

CO-HOST

IQVIA (NYSE:IQV) is a leading global provider of advanced analytics, technology solutions and contract research services to the life sciences industry. Powered by the IQVIA CORE™, IQVIA delivers unique and actionable insights at the intersection of large-scale analytics, transformative technology and extensive domain expertise, as well as execution capabilities. Formed through the merger of IMS Health and Quintiles, IQVIA has approximately 67,000 employees worldwide. Learn more at www.iqvia.com.

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Sharp Clinical’s IRT platform manages patient interactions and drug supplies during clinical trials and perform a range of functions for sponsors, drug depots and investigative sites. Our solution includes simple to complex randomization schemes, a warehouse returns system and a supply forecaster which will predict patient enrolment and clinical supply consumption. Sharp Clinical also offers a full complement of clinical trial services, including analytical, formulation development, clinical manufacturing and packaging, storage and distribution. Our creative packaging design capabilities help to save time, costs and ensure on-time deliveries for your trial. We have a global dept network that covers every region of the world as well as Qualified Person (QP) services for European distribution.

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Oracle Health Sciences helps you get therapies to market faster and detect risks earlier. Oracle offers a complete set of clinical and safety solutions that support critical processes throughout the clinical development lifecycle—from study design and startup to conduct, close-out, and post-marketing.

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At Proventa Talent, we always look ahead to ensure that the service we deliver to you is second to none, both now and in the future. Proventa Talent based around our three key principles of commitment, intelligence and partnership ensures an unparalleled recruitment solution in the industry. We work with the leading talent in the field to offer a service of high quality, efficiency and transparency. In addition to this, our relationship with many organisations across the Life Sciences sector means that we are constantly developing our recruitment services to offer market-leading solutions including Contingency, Executive Search, Contract and fully integrated Recruitment Process Outsourcing to suit your short, medium and long term needs.VISIT WEBSITE

CSM, a Clinigen company, has been providing innovative clinical trial supplies and biological sample management services since 1997. With two facilities in Post-Brexit EU and three in the US, CSM is committed to ensuring clinical trials are a success, regardless of size or scope, from Phase I to Phase IV projects. With employees over 5 sites in the US and Post-Brexit EU and a proprietary ERP system, CSM is agile by design. CSM innovates to make clinical trials more (cost-) efficient and reliable with specialized service solutions like Investigator Initiated Study service, On-Demand packaging and labeling, Direct-to-Patient shipping and QP services.

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PRO-PARTNERS

VISIT WEBSITEVISIT WEBSITE VISIT WEBSITE VISIT WEBSITE VISIT WEBSITE VISIT WEBSITE VISIT WEBSITE VISIT WEBSITE

PROVENTAI N T E R N A T I O N A L

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AGENDA

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1 - 1 MEETING *5:30-5:50 p.m.

TRACK & ROOM( *TIME - E.T. )

TRACK & ROOM( *TIME - G.M.T. )

15:50 - 16:50

14:30 - 15:30

15:30 - 15:50

14:00 - 14:3019:00 - 19:30

19:30 - 20:30

20:30 - 20:50

20:50 - 21:50

1 - 1 MEETING *15:30-15:50 E.T.

1 - 1 MEETING *10:10-10:30 E.T.

08:00 - 09:00

11:00 - 12:00

10:00 - 11:00

09:00 - 10:00

12:00 - 14:00

13:00 - 14:00

14:00 - 15:00

15:00 - 16:00

16:00 - 17:00

17:00 - 19:00

1 - 1 MEETING *10:20-10:40 E.T. 1 - 1 MEETING *10:40-11:00 E.T.

How eConsent can improve sponsor and CRO oversight and ensure enrollment are

meeting timelines

How IRT integrations can support global multilingual studies, streamlining delivery and eliminating multi vendor coordination

to improve clinical trials

How to better leverage the power of multiple disparate systems and access real-time data to make better informed

decisions

01

CLINICAL DATA & IRT

Joanne McCaigue - DirectorPosieda Therapeutics

Catherynne Cruz - Scheckner Ionis Pharmaceuticals

Melissa Peirsel - Manager of IRT Services Rich Nelson - Senior Manager Logistics

1 - 1 MEETING *13:00-13:20 E.T.

03

DIRECT-TO-PATIENT

ROUNDTABLE TOPIC CONFIRMED FOR SPONSOR

Strategies to successfully implement DtP and chososing the right DtP model

Considerations regarding regional regulations for the distribution of medication

at both the recipients & dispatchers locations

Determining whether a clinical trial is appropriate for DtP model

1 - 1 MEETING *13:40-14:00 E.T.

The need for smarter and more advanced storage and distribution facilities as part

of the supply chain

How the explosive growth of Biologics has changed the Cold-Chain Clinical Supplie Chain

landscape

Centralized or Decentralised Warehousing: The pros and cons for each solution

02

STORAGE AND DISTRIBUTION

KEYNOTE PRESENTATION

1 - 1 MEETING *13:20-13:40 E.T.

The Ten Most Important Risk Factors to Address in order to Maintain “Real Time” Inspection-Ready TMFs

Tamika Jackson - CEO

PROVENTAI N T E R N A T I O N A L

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TRACK 1CLINICAL DATA & IRT

SPEAKER TBC TBC TBC

How IRT integrations can support global multilingual studies, streamlining delivery and eliminating multi vendor coordination

to improve clinical trials.

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Joanne McCaigue Director, DM & Programming

Statistical & Data Sciences Posieda Therapeutics

How to better leverage the power of multiple disparate systems and access real-time data to make better informed

decisions.

Melissa PeirselManager of IRT Services

SHARP

How to effectively pick and utilize IRT to better support your supply design.

How to better leverage the power of multiple disparate systems and access real-time data to make better informed

decisionsSpeaker TBC

TBC TBC

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ROUNDTABLE TOPIC

TIME SLOT (*E.T.)

SPONSOR ROUNDTABLE TOPIC

TIME SLOT (*E.T.)

ROUNDTABLE TOPIC

TIME SLOT (*E.T.)

ROUNDTABLE TOPIC

TIME SLOT (*E.T.)15:50 - 16:5014:30 - 15:30

LEARN MORE ABOUT OUR SPEAKERS

11:00 - 12:009:00 - 10:00

PROVENTAI N T E R N A T I O N A L

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TRACK 2STORAGE AND DISTRIBUTION

SPEAKER TBC TBC TBC

The need for smarter and more advanced storage and distribution facilities as part

of the supply chain.

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SPEAKER TBC TBC TBC

How the explosive growth of Biologics has changed the Cold-Chain Clinical Supplies

Chain landscape?

Rich NelsonSenior Manager of

Global Logistics PCI Pharma Services

Rapid growth of complex protocols impedes efficiency and skyrocketed cost of clinical

supply chain.

Centralized or Decentralised Warehousing: What are the pros and cons for each

solution?Catherynne Cruz-Scheckner

Director Clinical Supplies Ionis Pharmaceuticals

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ROUNDTABLE TOPIC

TIME SLOT (*E.T.)

SPONSOR ROUNDTABLE TOPIC

TIME SLOT (*E.T.)

ROUNDTABLE TOPIC

TIME SLOT (*E.T.)

ROUNDTABLE TOPIC

TIME SLOT (*E.T.)15:50 - 16:5014:30 - 15:30

LEARN MORE ABOUT OUR SPEAKERS

11:00 - 12:009:00 - 10:00

PROVENTAI N T E R N A T I O N A L

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TRACK 3DIRECT-TO-PATIENT

SPEAKER TBC TBC TBC

Strategies to successfully implement DtP and choosing the right DtP model

GO TO MENU NEXT PAGE

SPEAKER TBC TBC TBC

Considerations regarding regional regulations for the distribution of

medication at both the recipients & dispatchers locations

SPEAKER TBC TBC TBC

Methods to ensure that the CTM/IMP is delivered to patient in good quality

Determining whether a clinical trial is appropriate for DtP model

SPEAKER TBC TBC TBC

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ROUNDTABLE TOPIC

TIME SLOT (*E.T.)

SPONSOR ROUNDTABLE TOPIC

TIME SLOT (*E.T.)

ROUNDTABLE TOPIC

TIME SLOT (*E.T.)

ROUNDTABLE TOPIC

TIME SLOT (*E.T.)15:50 - 16:5014:30 - 15:30

LEARN MORE ABOUT OUR SPEAKERS

11:00 - 12:009:00 - 10:00

PROVENTAI N T E R N A T I O N A L6

COMPANY

AbbVieAbbVieAcceleron PharmaAcelRxAcerta PharmaAcerta PharmaAcerta PharmaAcerta PharmaAchaogen, Inc.Achillion PharmaceuticalsAduro BiotechAdverumAdverumAkebia TherapeuticsAkebia TherapeuticsAkebia TherapeuticsAldeyra TherapeuticsAlectorAlectorAlkermesAllogene TherappeuticsAlnylam Amarantus Bioscience, Inc.AmgenAmgenAmicus Therapeutics Amylyx PharmaceuticalsAnaptysBioAnnexon BiosciencesAntiva BiosciecesArena PharmaceuticalsAstellas PharmaAstexAstex PharmaceuticalsAstex PharmaceuticalsAstex PharmaceuticalsAstex PharmaceuticalsAstex PharmaceuticalsAtara BiotherapeuticsAudentes TherapeuticsBaxterBeigeneBeigeneBeigeneBeigeneBeigene

JOB TITLE

Director Clinical Data ManagementDirectorDirector, CDMO OperationsDirector-QualityChief Operating OfficerSenior Director, Medical Safety Operations and ExcellenceHead of Medical Safety ScienceMedical Safety DirectorAssociate Director Clinical OperationsSenior Director of Pharmaceutical SciencesDirector Clinical ScienceExecutive Director, Clinical OperationsAssociate DirectorSenior Director, Regulatory CMCDirector, CMC & Operations ManagementSenior Vice President, Chief Development OfficerSenior Director, CMC & Supply ChainVice President, Head of Development OperationsChief Development OfficerAssociate Director, Clinical Supply ChainHead, Clinical Systems & ProgrammingDirector, Clinical Supply ChainChief Scientific OfficerDirector, Observational ResearchSenior Global Trial ManagerAssociate Director, IRT & Global Clinical Supply StrategyGlobal Head of Supply ChainVP Clinical DevelopmentSenior Director, Global Clinical OperationsChief Medical OfficerVice President, Safety and PharmacovigilanceGlobal Head, Real World EvidenceExecutive DirectorSenior Director Clinical OperationsClinical Trial ManagerDirector, Clinical OperationsClinical Trial LeadAssociate Director, Drug SafetyVice President, Drug Safety and PharmacovigilanceSenior Director, Clinical OperationsVice President, Global Patient SafetySenior Director Clinical Business OperationsSenior Manager Clinical Business OperationsSenior Investigator Assoc. Director Safety ScienceSr. Director, PVDS

BeigeneBeigeneBellicum PharmaceuticalsBellicum PharmaceuticalsBill & Melinda Gates Medical Research InstituteBiogenBiogenBiogenBiogenBiogenBiogenBiogenBiogenBiogenBiogen BioMarinBioMarinBiomarinBioMarin PharmaceuticalBioMarin PharmaceuticalBioMarin PharmaceuticalBiomarin Pharmaceuticals Blackthorn TherapeuticsBlackthorn TherapeuticsBluebird Bio Boehringer IngelheimBoehringer IngelheimBoston Scientfic Bristol Meyers SquibbBristol-Myers SquibbBristol-Myers SquibbCalithera BiosciencesCelgeneCelgeneCelgeneCelgeneCelgeneCelgeneClovis OncologyCollegium Pharmaceutical, Inc.Corcept TherapeuticCorcept TherapeuticCorvus PharmaceuticalsCSL BehringCuris Cymabay

Vice President Global Head, Quality & ComplianceHead of Supply Chain OperationsDirector, Safety OperationsExecutive Vice President, Technical OperationsClinical Supply LeaderLead, Clinical Supply CapabilitiesAssociate Director Clinical Drug Supply Senior Manager, Clinical Drug SupplyClinical Drug Supply- Operations Capabilities Management- IRT SpecialistSenior Director, Product and Supply Chain SecurityAssociate Director, Product Protection Program LeadSr. Supervisor, Product and Supply Chain Security R&D Global Strategic SourcingAssociate Direct, Clinical Drug SupplyAssoc Director Strategic Operations and TechMedical DirectorSenior Medical DirectorDirector PVRMVice President, Pharmacovigilance, Medical Writing, Development Sciences QualityAssociate Director, GVP ComplianceMedical DirectorExecutive Director, Head of Data ManagementDirector, Clinical OperationsSenior Director, Biostatistics & Data ManagementDirector of Supply Chain IRT ExpertIRT SpecialistClinical Supply Chain Lead Associate Director Clinical Operations US RegionGlobal Supply Chain Network Planner Co-opHead of Devens Biologics SupplyDirector, Clinical BiomarkersStrategic Program ManagerDirector, Clinical Supply Chain ExcellenceDirector, Strategic Operations Clinical Supply ChainSenior Strategic PlannerSenior Manager, Investigational Material Supply ChainSenior Director, Strategic Program Management, IMSCSenior Director, Clinical OperationsSenior Director, Product DevelopmentQA DirectorQA Associate DirectorDirector Drug SafetyExecutive Director, Pharmacovigilance Operations, Global Clinical Safety & PharmacovigilanceAssociate Director, CMC Medical Director

COMPANY JOB TITLE

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2019 ATTENDEES p.1

77 PROVENTAI N T E R N A T I O N A L

COMPANY

CymabayCytokineticsDeciphera PharmaceuticalDenali Therapeutics IncDermiraDermiraDicerna Pharmaceuticals IncAMAG PharmaceuticalsEli Lilly Entasis Therapeutics Entasis Therapeutics ERX PharmaceuticalsEureka Inc.Eureka Inc.ExelixisFibroGenFibroGenFibroGenFibroGenFibroGenFibroGenFibroGenFlexion TherapeuticsForma Therapeutics Gelesis GenentechGenentechGenentechGenentechGenentechGenentechGenentechGenentechGenentechGenentechGenentechGenentech Inc.Genentech/RocheGeronGigaGenGileadGileadGileadGileadGilead SciencesGilead Sciences

JOB TITLE

Clinical ScientistDirector, Clinical OperationsHead of Clinical Supply Operations Senior Director, Reg and CQAVP Clinical OperationsSVP Project ManagementAssociate Director, Supply ChainAMAG PharmaceuticalsSenior Director, CT Material Production & Materials Manag.Associater Director, Supply Chain Clinical Project Leader Chief Medical OfficerDirector, Clinical OperationsDirector Director, Clinical OperationsExecutive Director, Clinical Quality AssuranceSenior Director, Clinical ComplianceAssoc Director, Drug Safety and PharmacovigilanceSVP, Clinical Development, Drug Safety & PhVSenior Director, Clinical ComplianceDirectorSeniorr Manager, Drug Safety ComplianceClinical Supply ChainRDIS Head, Senior Director CTO Country Study SpecialistGlobal Business LeadPV LeaderPrincipal Pharmacovgilance Process LeadGlobal Head, Core Safety ScienceAssociate Group Director, SafetyAssociate Group Medical DirectorMedical Director Safety ScienceGroup Medical Director – Oncology Safety ScienceSenior Group Medical Director & Group Head, Safety SciencePrincipal Safety ScientistGroup DirectorSenior Group Medical Director, Safety ScienceVice President Pharmacovigilance and Drug SafetyDirector of ImmunologyAssociate Director Quality AssuranceR&D Systems AnalystSafety SpecialistDirector, ITAssociate Director, Clinical Operations Director, Clinical Operations

Gilead SciencesGilead SciencesGilead SciencesGlobal Blood TherapeuticsGlobal Solutions For Infectious DiseaseIdeaya BiosciencesIdeaya BiosciencesIDEAYA BiosciencesImmunogen IncyteInovio PharmaceuticalsIonis PharmaceuticalsIovance BiotherapeuticsIovance Biotherapeutics IncIronwood Pharmaceuticals Janssen BiopharmaJazz PharmaceuticalsJazz PharmaceuticalsJohnson & Johnson Kite PharmaMedeor TherapeuticsMenlo TherapeuticsMersana TherapeuticsMyokardiaMyoKardiaMyoKardiaMyoKardiaMyoKardiaMyoKardiaMyokardiaMyokardiaMyovant SciencesNektar TherapeuticsNektar TherapeuticsNektar TherapeuticsNeon TherapeuticsNovapeuticsNovartisPersona BiomePfizerPfizerPfizerPfizerPfizerPharmacyclicsPharmacyclics

Director, Clinical Operations – Early PhaseAssociate DirectorGlobal Clinical Trial ManagerSenior Director, PharmacovigilanceDirector, Clinical OperationsClinical Program DirectorHead of Clinical OperationsSenior DirectorSupply Chain Lead Senior Director, IMSCSenior Vice President, Global QualityVice President & Head of SafetyDirector Clinical, GVP & GLP QualityDirector, Drug SafetyLead, Clinical SupplyClinical Research ManagerSenior Director, Pharmacovigilance and SafetyVice President, Pharmacovigilance & Medical AffairsSenior Manager, Clinical Supply Chain Lead Senior Director, Pharmacovigilance & EpidemiologyDirector, Clinical OperationsVice President, Clinical OperationsDirector, Supply ChainAssociate Director, Clinical OutsourcingSenior Director, Outsourcing and ProcurementAssociate Director, Clinical OpreationsVice President, PharmacovigilanceConsultant PV LeadExecutive Director, Clinical ScienceMedical DirectorSenior Director, Clinical QAGCP Quality ConsultantSenior Director, Clinical Data ManagementClinical Trial ManagerAssociate Director, Clinical OperationsAssociate Director Supply OperationsChief Executive OfficerDirector of Supply ChainChief Executive OfficerExternal Vendor Packaging SchedulerGlobal Clinical Supply FellowClinical Research Sourcing StrategistSenior Manager, IVRS Global Operations TeamLead, IRT Data StewardSr. Director, Section Head, Drug Safety & Pharmacovigilance Ops.Associate Medical Director

COMPANY JOB TITLE

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2019 ATTENDEES p.2

8 PROVENTAI N T E R N A T I O N A L

COMPANY

PharmacyclicsPharmacyclicsPharmacyclicsPharmacyclics LLC., an AbbVie CompanyPharmacyclics, An AbbVie CompanyPieris Pharmaceuticals Pieris Pharmaceuticals Portola Inc.Portola Inc.Portola Inc.Proteostasis TherapeuticsPTC Therapeutics, Inc.Quark PharmaceuticalsQuark PharmaceuticalsQuark PharmaceuticalsQuark PharmaceuticalsQuark PharmaceuticalsRegeneron Pharmaceuticals, Inc.RocheRubius TherapeuticsSamumed Sangamo TherapeuticsSangamo TherapeuticsSanofiSanofiSanofiSantenSanten INCSarepta TherapeuticsSeres Therapeutics

JOB TITLE

Senior Director, Clinical QAHead of Clinical ScienceAssociate DirectorAssociate Director, DSPV Case ManagementAssociate Director, Clinical OperationsSenior Director, Clinical Operations Senior Director, Supply Chain OperationsExecutive Director, Clinical OperationsProcurement Process LeadProcurement ManagerAssociate Director, Clinical Drug Supply and IRTClinical Supplies & Desginated RepresentativeDirector, Clinical OperationsSenior Director Clinical OperationsClinical Program ManagerHead of PharmacovigilanceLead, Drug AssociateDirector, Supply Chain OperationsSafety ScienceSenior Director of Supply ChainAssociate Director, Clinical OperationsAssociate Director Clinical OperationsAssociate Director, Clinical ScienceProject Excellence and Innovation Head, Clinical Supply Chain Clinical Supply Chain Project LeaderClinical Supply Chain Project LeaderAssociate Director, Clinical ProgramDirector, Global PharmacovigilanceAssociate Director, Global Supply Chain & LogisticsSupply Chain Lead

ShireShire Sunovion Sunovion Symic BioSymic BioTakedaTakedaTakedaTakedaTakedaTakeda Takeda Pharmaceutical Company Ltd.TARIS BiomedicalTetraphase PharmaceuticalsTheravanceTheravanceTitan PharmaceuticalsTricida IncUltragenyxUnity BiotechnologyUnity BiotechnologyUniversity of San FranciscoZogenixZogenixZogenix

Clinical & Medical Category LeadHead of Clinical Supply Chain Senior Director, Clinical Trial Materials ManagementAssociate Director Strategic SourcingSenior Director, TranslationSenior Director, Quality AssuranceDirector, Supply ChainGlobal Category Manager ProcurementHead of Global Direct Materials ProcurementDirector, Clinical Supply Strategy Vice President Medical Safety, Global Head Signal and Risk Management Lead, Clinical QAHead of Pharmaceutical Sciences Systems, AmericasSenior Director, Product Development and Technical OperationsHead of Global Supply ChainVice President BiometricsDirector, Clinical Data ManagementDirector, REMS Program & Drug Safety ComplianceHead of Drug Safety & PharmacovigilanceAssociate Director, Global Supply ChainSr. Clinical Program Manager, Clinical OperationsDirector Clinical OperationsResearch Fellow UCSFDirector, Clinical Process Improvement & InnovationHead of Clinical OperationsAssociate Director, Clinical Science Liaison Clinical Development

COMPANY JOB TITLE

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2019 ATTENDEES p.3