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

Andrea Small-Howard Chief Security Officer GB Sciences

Anthony Zuccarello Director, Dev. Supply Chain CMC Rocket Pharmaceuticals

Atif Abbas Vice President, Oncology Clinical Dev.Spring Bank Pharmaceuticals

Dale Dhanoa CEO INVENT Pharmaceuticals

Kevin Ryan VP & Chief Compliance Officer ACADIA

Mohammed Ahmad Medical Director Head of Medical Clinical QualityTakeda Pharmaceuticals

Ben Exter VP & Head of Pharmacovigilance Unum Therapeutics

Jack Fernandes CEO Regenica Biosciences

Abhit Singh Chief Regulatory OfficerIntrommune Therapeutics

Atul Deshpande Chief Strategy Officer & Head US OperationsHarbour Biomed

SPONSORS

HOTEL & TRAVEL

SAN DIEGO

2020

OUR UNIQUE MEETING FORMAT

Roundtable Discussions These 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 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 out of the office 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 suggests a suitable time and place, all you need to do is grab the coffee.

Strategic NetworkingStrategic networking opportunities form a key benefit of the meeting. Our proven format for building and strengthening alliances is underscored by a host of networking programmes, from a buffet breakfast through to evening drinks, make lasting connections that benefit you.

CONTRIBUTORS TO THE AGENDA

STRATEGY MEETING WEST COAST

11thMAY

AGENDA

TRACK 2 PATIENT RECRUITMENT & CENTRICITY

TRACK 1RISK BASED MONITORING

2019 ATENDEES

TRACK 4 EMERGING BIOPHARMA

TRACK 3 OUTSOURCING

TRACK 6 STORAGE & DISTRIBUTION

TRACK 5 CLINICAL DATA & IRT

TRACK 8 ADVERSE EVENTS / CASE PROCESING

TRACK 7 SIGNAL DETECTION

TRACK 9 A.I. & MACHINE LEARNING

TRACK 10 INVESTMENTS & VENTURE CAPITAL

CLINICALOPERATIONS PHARMACOVIGILANCECLINICALTRIALSUPPLYCHAINCLINICALOPERATIONS CLINICALTRIALSUPPLYCHAIN PHARMACOVIGILANCE

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1 - 1 MEETING *10:20-10:40 1 - 1 MEETING *10:40-11:00

Ketty Belizaire - Senior DirectorMylan

Andrea Small-Howard - CSOGB Sciences

ROUNDTABLE TOPIC CONFIRMED FOR SPONSOR






How to develop a Monitoring Plan to incorporate a risk-based approach

Exploring how RBM data can be used to drive study quality

Develop a monitoring plan which focuses on mitigating risks at both the program and study levels decision-making

AFTERNOON COFFEE BREAK

DRINKS & CANAPE RECEPTION

Implementation of innovative approaches to achieve Proof-of-Concept results in record time in Early Phase Clinical Trials?

Strategies to successfully match and recruit eligible patients to clinical trials

Patient recruitment using field-based advocacy

How are the CROs addressing the demand for specialized services?

The impact of future technology on the design and execution of Phase I/II trials. New technologies, Remote Clinical trials. Newtechnologies & Remote Clinical trials.

Turning ‘High Value Study’ Feasibility into successful trial execution

How a shared-risked partnership model can improve the success rates of getting to IND and beyond

Emerging biopharma growth by partnering with VC, Pharma companies and CDMO/CRO

Does one size fit all when you are an EBP? The pros and cons in working with a Small CRO vs a Large CRO

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

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

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

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

Identifying the latest development & innovation approach for effective signal management

Signal Management: meeting the needs of all stakeholders

Applying signal detection proficiency in the Sentinel System

How improving performance while reducing complexity can enable real-time signal detection for pro-active monitoring

Discovering solutions for drug counterfeiting issues & analyzing viable measures to combat & protect consumers

PV: Maintaining compliance through advanced drug safety surveillance

The A.I Paradigm Shift -Is It Just a Hype

Enhancing patient safety with A.I.

Enabling PVO in predictive science with the application of A.I.

TRACK & ROOM

8:00 - 8:30 a.m.

RISK BASED MONITORING

4:30 - 5:30 p.m.

8:30 - 9:00 a.m.

6:00 - 7:00 p.m.

9:00 - 10:00 a.m.

10:00 - 11:00 a.m.

11:00 - 12:00 a.m.

12:00 - 1:00 p.m.

2:30 - 3:00 p.m.

3:00 - 4:00 p.m.

4:00 - 4:10 p.m.

4:10 - 4:30 p.m.

REGISTRATION & BREAKFAST NETWORKING

PATIENT RECRUITMENT & CENTRICITY OUTSOURCING EMERGING BIOPHARMA CLINICAL DATA & IRT STORAGE & DISTRIBUTION SIGNAL DETECTION ADVERSE EVENTS CASE PROCESSING

A.I. & MACHINE LEARNING

01 02 03 04 05 06 07 08 09

AGENDA AT A GLANCE

NETWORKING BREAK1 - 1 MEETING *10:00-10:20 NETWORKING BREAK

3 COURSE NETWORKING LUNCH

1 - 1 MEETING *20min 1 - 1 MEETING *20minNETWORKING BREAK1 - 1 MEETING *20min NETWORKING BREAK

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1 - 1 MEETING *12:00-12:20 1 - 1 MEETING *12:20-12:40 1 - 1 MEETING *12:40-13:00

1 - 1 MEETING *13:30-13:50 1 - 1 MEETING *13:50-14:10 1 - 1 MEETING *14:10-14:30

AFTERNOON COFFEE BREAKAFTERNOON COFFEE BREAK

REGISTRATION & BREAKFAST NETWORKING

DRINKS & CANAPE RECEPTIONDRINKS & CANAPE RECEPTION

Kevin Ryan - VP & CCO ACADIA

Abhit Singh - Chief Regulatory OfficerIntrommune Therapeutics

Atif Abbas - Vice PresidentSpring Bank Pharmaceuticals

Dale Dhanoa - CEOINVENT Pharmaceuticals

Anthony Zuccarello - DirectorRocket Pharmaceuticals

Reddy Tummala - Vice PresidentKaryopharm Therapeutics

Mohammed Ahmad - Director & HeadTakeda Pharmaceuticals

Atul Deshpande - CSO & HeadHarbour Biomed

Gabriel Lazarin - Vice PresidentDeepcell

Melissa Morandi - Vice PresidentAegerion Pharmaceuticals

Melissa Peirsel - Manager IRT Services

Gajanan Bhat - VP Clinical ScienceSpectrum Pharmaceuticals

Benjamin Exter - VP & HeadUnum Therapeutics

Melissa Rossi - Senior DirectorModerna Inc

Jack Fernandes - CEORegencia Biosciences

Renu Weerasinghe - Global LeadTakeda

Oliver Steinbach - VP R&DImagion Biosystems

Ashraf Yousef - Sr. Med. Director Shire

Kevin Buckley - Sr. VP HUYA Bioscience Int.

3 COURSE NETWORKING LUNCH

5:30 - 6:00 p.m. INVESTOR’S PANEL INVESTOR’S PANEL THE INVESTOR PANEL

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

Tamika Jackson - CEO

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Joanne McCaigue - DirectorPosieda Therapeutics

Catherynne Cruz - Scheckner Ionis Pharmaceuticals

WELCOME SPEECH & INVESTOR’S PANEL DISCUSSION

1:00 - 1:30 p.m. KEYNOTE PRESENTATION KEYNOTE PRESENTATIONKEYNOTE PRESENTATION

1:30 - 2:30 p.m.





Karen Giraudo - Assoc. Director BioMarin

1



TRACK 1 RISK BASED MONITORING

Kevin Ryan VP and Cheif Compliance

ACADIA

How to develop a Monitoring Plan to incorporate a risk-based approach.

ROUNDTABLE TOPIC

GO TO MENU NEXT PAGE

TIME SLOT9:00 - 10:00 a.m.

SPEAKER TBC TBC TBC

Exploring how RBM data can be used to drive study quality.

ROUNDTABLE TOPIC

TIME SLOT3:00 - 4:00 p.m.

SPEAKER TBC TBC

IQVIA

Optimizing and adopting use of RBM data for predictive analytics and clinical ops decision-making.

TIME SLOT11:00 - 12:00 a.m.

Develop a monitoring plan which focuses on mitigating risks at both the program and study levels

ROUNDTABLE TOPIC


SPEAKER TBC TBC TBC

2

+ INFO ABOUT OUR SPEAKERS

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SPONSOR ROUNDTABLE TOPIC

http://proventainternational.com/events/clinical/usa-west/clinical-west/



TRACK 2PATIENT RECRUITMENTPATIENTE CENTRICITY

Abhit Singh Chief Regulatory Officer

Intrommune Therapeutics

Implementation of innovative approaches to achieve Proof-of-Concept results in record time in Early Phase Clinical Trials?

ROUNDTABLE TOPIC


TIME SLOT9:00 - 10:00 a.m.

Gabriel Lazarin VP Clinical & Business Dev.

Deepcell

Strategies to successfully match and recruit eligible patients to clinical trials.

ROUNDTABLE TOPIC


SPEAKER TBC TBC

IQVIA

How does patient- focused strategy improve business outcomes?

TIME SLOT11:00 - 12:00 a.m.

Patient recruitment using field-based advocacy.

ROUNDTABLE TOPIC


Jack Fernandes CEO

Regenica Biosciences

3


PREVIOUS PAGE





TRACK 3PATIENT RECRUITMENTPATIENTE CENTRICITY

Atif Abbas Vice President

Spring Bank Pharmaceuticals

How are the CROs addressing the demand for specialized services?

ROUNDTABLE TOPIC


TIME SLOT9:00 - 10:00 a.m.

Melissa Morandi VP President Global QualityAegerion Pharmaceuticals

Clinical Trial of the future: what is the impact of future technology on the design and exe-cution of Phase I/II trials? New technologies, Remote Clinical trials, etc.

ROUNDTABLE TOPIC


SPEAKER TBC TBC TBC

Challenges in feasibility assessments, budg-eting and overall planning for increasinglycomplex Phase I/II patient trials with adaptive designs

TIME SLOT11:00 - 12:00 a.m.

“Turning ‘High Value Study’ Feasibility into successful trial execution”

ROUNDTABLE TOPIC


Ketty Belizaire Senior Director

Mylan

4


PREVIOUS PAGE





TRACK 4EMERGING BIOPHARMA

Dale Dhanoa CEO

Invent Pharmaceutical

How a shared-risked partnership model can improve the success rates of getting to IND and beyond?

ROUNDTABLE TOPIC


TIME SLOT9:00 - 10:00 a.m.

Gajanan Bhat VP Clinical Science/Biostatics

Spectrum Pharmaceuticals

Emerging biopharma growth by partnering with VC, Pharma companies and CDMO/CRO - TBC

ROUNDTABLE TOPIC


SPEAKER TBC TBC

SANACLIS

The challenges aligned with clinical trial planning through to trial design implemen-tation and how an integrated CRO with ther-apeutically focused expertise can help?

TIME SLOT11:00 - 12:00 a.m.

Does one size fit all when you are an EBP? The decision to work with a Small vs Large CRO - The pros and cons in working with a Small CRO vs a Large CRO? Closer Relation-hips, Boutique, Local Reach vs Financial Sta-bility, Cross Therapuetic Expertise and Glob-al Resources?

ROUNDTABLE TOPIC


Andrea Small-Howard CSO

GB Sciences

5


PREVIOUS PAGE





TRACK 5CLINICAL DATA & IRT

Anthony Zuccarello Director Dev. Supply Chain

Rocket Pharmaceuticals

How IRT integrations can support global multilingual studies, streamlining delivery and eliminating multi vendor coordination to improve clinical trials.

ROUNDTABLE TOPIC


TIME SLOT9:00 - 10:00 a.m.

Joanne McCaigue Director, DM & Programming

Statistical & Data Sciences Posieda Therapeutics

How to better leverage the power of multi-ple disparate systems and access real-time data to make better informed decisions.

ROUNDTABLE TOPIC


Melissa Peirsel SCSUS Manager IRT Services

Sharp Clinical Services

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

TIME SLOT11:00 - 12:00 a.m.

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

ROUNDTABLE TOPIC


Speaker TBC TBC TBC

6


PREVIOUS PAGE





TRACK 6STORAGE AND DISTRIBUTION

SPEAKER TBC TBC TBC

The need for smarter and more advanced storage and distribution facilities as part of the supply chain.

ROUNDTABLE TOPIC


TIME SLOT9:00 - 10:00 a.m.

Karen Giraudo Associate Director Technical

Ops and Supply ChainBioMarin

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

ROUNDTABLE TOPIC


SPEAKER TBC TBC TBC

Rapid growth of complex protocols impedes efficiency and skyrocketed cost of clinical supply chain.

TIME SLOT11:00 - 12:00 a.m.

Centralized or Decentralised Warehousing: What are the pros and cons for each solu-tion?

ROUNDTABLE TOPIC


Catherynne Cruz-SchecknerDirector Clinical Supplies Ionis Pharmaceuticals

7


PREVIOUS PAGE





TRACK 7SIGNAL DETECTION

Reddy Tummala VP Pharmacovigilance

Karyopharm Therapeutics

Signal Management: meeting the needs of all stakeholders

ROUNDTABLE TOPIC


TIME SLOT9:00 - 10:00 a.m.

Benjamin Exter VP & Head of Pharmacovigilance

Unum Therapeutics

Identifying the latest development & innovation approach for effective signal management

ROUNDTABLE TOPIC


SPEAKER TBC TBC TBC

Why the need to address validation, analysis prioritisation, assessment is crucial to man-aging signals?

TIME SLOT11:00 - 12:00 a.m.

Applying signal detection proficiency in the sentinel system

ROUNDTABLE TOPIC


Renu Weerasinghe Global Safety Lead

Takeda

8


PREVIOUS PAGE





TRACK 8ADVERSE EVENTSCASE PROCESSING

Mohammed Ahmad Medical Director, Head of

Medical Review Takeda Pharmaceuticals

How improving performance while reduc-ing complexity can enable real-time signal detection for pro-active monitoring?

ROUNDTABLE TOPIC


TIME SLOT9:00 - 10:00 a.m.

Melissa Rossi Sr. Director Pharmacovigilance

Mederan Inc.

Discovering solution for drug counterfeiting issues & analyzing viable measures to com-bat & protect consumers.

ROUNDTABLE TOPIC


SPEAKER TBC TBC

IQVIA

Enabling a faster response by improving ad-verse event terminology reducing possible ambiguities?

TIME SLOT11:00 - 12:00 a.m.

PV: Maintaining compliance through advanced drug safety surveillance.

ROUNDTABLE TOPIC


Ashraf Yousef Sr. Medical Director, Immunology & Devices, Global Safety Lead

Mylan

9


PREVIOUS PAGE





TRACK 9A.I & MACHINE LEARNING

Atul Deshpande Chief Strategy Officer & Head US Operations

Harbour Biomed

The A.I Paradigm Shift - Is It Just a Hype?

ROUNDTABLE TOPIC


TIME SLOT9:00 - 10:00 a.m.

Oliver Steinbach VP R&D

Imagion Biosystems

Enhancing patient safety with Artificial Intelligence

ROUNDTABLE TOPIC


SPEAKER TBC TBC

IQVIA

How matching Electronic Health Records to RWD can improve outcomes

TIME SLOT11:00 - 12:00 a.m.

Enabling PVO in predictive science with the application of Artificial Intelligence

ROUNDTABLE TOPIC


Kevin Buckley Sr. VP, Intellectual Property

HUYA Bioscience Int.

10


PREVIOUS PAGE





TRACK 10 INVESTMENTS & VENTURE

CAPITAL

GO TO MENU NEXT PAGEPREVIOUS PAGE

Introducing The New ‘Investment & Venture Capital’ Track - Proventa International’s latest evolutionary step in developing our signature Strategy Meetings. Now not only providing essential operational strategy solutions but also aiding in equally important fund raising and investment seeking strategy.

11

Daniel Haders II, Ph.D. Managing Director

Healthcare Tech Nex Cubed

Key considerations when approaching in-vestors - investor insights.

ROUNDTABLE TOPIC

TIME SLOT9:00 - 10:00 a.m.

SPEAKER TBC TBC TBC

An investor perspective on building a strong portfolio to best showcase your company.

ROUNDTABLE TOPIC


SPEAKER TBC TBC TBC

TOPIC TBC


TIME SLOT11:00 - 12:00 a.m.

Current key therapeutic areas which inves-tors are focusing on and why?

ROUNDTABLE TOPIC


SPEAKER TBC TBC TBC


CLINICALOPERATIONS PHARMACOVIGILANCECLINICALTRIALSUPPLYCHAINCLINICALOPERATIONS CLINICALTRIALSUPPLYCHAIN PHARMACOVIGILANCE SPONSORSIQVIA is a leading integrated information and technology-enabled healthcare service provider, dedicated to helping its clients improve their clinical, scientific and commercial results. QuintilesIMS’s approximately 50,000 employees conduct operations in more than 100 countries. Companies seeking to improve real-world patient outcomes and enhance clinical trial outsourcing through treatment innovations, care provision and access can leverage QuintilesIMS’s broad range of healthcare information, technology and service solutions to drive new insights and approaches. QuintilesIMS solutions span clinical to commercial, bringing clients a unique opportunity to realize the full potential of innovations and advance healthcare outcomes.

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 yourtrial. We have a global dept network that covers every region of the world as well as Qualified Person (QP) services for European distribution.

SanaClis was founded in 2000 by seasoned industry experts all of whom have had executive level positions in leading pharma companies and large global CROs and is one of the very few full-service CROs for clinical trials mainly in Central and Eastern Europe (CEE) offering a comprehensive range of services including: regulatory, clinical monitoring, IMP & CTS management, customs clearance & brokerage, site contracting & payments, project management, quality management, training, central laboratory Russia - including bioequivalence studies, data management, statistics and medical writing. Its facilities, depots and processes meet the most stringent international standards and local requirements. Moreover, SanaClis developed its own software solution to track warehouse operations in real time internally and externally for clients.

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CrO Biosciences is an information management consulting firm that provides clients with Inspection Readi-ness, 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 opera-tions 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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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


2019 ATTENDEES p.1

14



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


2019 ATTENDEES p.2

15



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

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clinic ......services for european distribution. sanaclis was founded in 2000 by seasoned industry...

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