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

2020JUNESTRATEGY 25thONLINE MEETING

TRACK 5 VIRTUAL TRIALS

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

TRACK 2 PATIENT RECRUITMENT & CENTRICITY

TRACK 1RISK BASED MONITORING

2019 ATENDEES

TRACK 4 EMERGING BIOPHARMA

TRACK 3 OUTSOURCING

TRACK 8 STORAGE & DISTRIBUTION

TRACK 7 CLINICAL DATA & IRT

TRACK 11 ADVERSE EVENTS / CASE PROCESING

TRACK 10 SIGNAL DETECTION

TRACK 6 A.I. & MACHINE LEARNING

INVESTMENTS & VENTURE CAPITAL 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.

TRACK 9 DIRECT-TO-PATIENT

TRACK 12 REAL WORLD EVIDENCE

AGENDACLINICAL OPERATIONS

AGENDACLIN. TRIAL SUPPLY & PHARM. VIGILANCE

SPONSORS

CLINICALOPERATIONS

PHARMACOVIGILANCE

CLINICALTRIALSUPPLYCHAINCLINICALOPERATIONS CLINICALTRIALSUPPLYCHAIN

PHARMACOVIGILANCE

http://

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SPONSORSCLINICALOPERATIONS PHARMACOVIGILANCECLINICALTRIALSUPPLYCHAINCLINICALOPERATIONS CLINICALTRIALSUPPLYCHAIN PHARMACOVIGILANCE

IQVIA 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.

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.

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.

VISIT WEBSITE

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PRO-PARTNERS

VISIT WEBSITE

VISIT WEBSITE

LEAD

CO-HOSTVISIT WEBSITE

VISIT WEBSITE

VISIT WEBSITE VISIT WEBSITE VISIT WEBSITE

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.

VISIT WEBSITE

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AGENDA p.1

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

TRACK & ROOM RISK BASED MONITORING PATIENT RECRUITMENT & CENTRICITY OUTSOURCING EMERGING BIOPHARMA VIRTUAL TRIALS

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

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

Strategies for developing patient centric studies & effectively working with patient advocates

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

Jack Fernandes - CEORegencia Biosciences

Jessica Raiz - Sr. Director, Clinical Research Timber Pharmaceuticals

Abhit Singh - Chief Regulatory Officer Intrommune Therapeutics

Andrea Small-Howard - CSOGB Sciences

08:00 - 09:00

15:50 - 16:50

11:00 - 12:00

14:30 - 15:30

10:00 - 11:00

15:30 - 15:50

09:00 - 10:00

12:00 - 14:00

14:00 - 14:30

ROUNDTABLE TOPIC CONFIRMED FOR SPONSOR

ROUNDTABLE TOPIC CONFIRMED FOR SPONSOR

ROUNDTABLE TOPIC CONFIRMED FOR SPONSOR

ROUNDTABLE TOPIC CONFIRMED FOR SPONSOR

ROUNDTABLE TOPIC CONFIRMED FOR SPONSOR

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

Strategies to guarantee privacy of recruited patients whilst ensuring the truthfulness of collected data for uncompromisable study results

Running global, multi-country hy-brid and virtual clinical trials - the future of clinical trials?

What steps need to be taken at the end of the virtual trial to ensure there is full documentation of the chain of custody for all patients?

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ROUNDTABLE TOPIC CONFIRMED FOR SPONSOR

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.

Oliver Steinbach - VP R&D

A.I & MACHINE LEARNING

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

Tamika Jackson - CEO

( *TIME - E.T. )

KEYNOTE PRESENTATION KEYNOTE PRESENTATION

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

13:00 - 14:00

14:00 - 15:00

15:00 - 16:00 1 - 1 MEETING *10:20-10:40 E.T. 1 - 1 MEETING *10:40-11:00 E.T.

16:00 - 17:00

17:00 - 19:00 1 - 1 MEETING *12:00-12:20 E.T. 1 - 1 MEETING *12:20-12:40 E.T. 1 - 1 MEETING *12:40-13:00 E.T. 1 - 1 MEETING *13:00-13:20 E.T. 1 - 1 MEETING *13:20-13:40 E.T. 1 - 1 MEETING *13:40-14:00 E.T.

19:00 - 19:30

19:30 - 20:30

20:30 - 20:50

20:50 - 21:50

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

Tamika Jackson - CEO

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

ROUNDTABLE TOPIC CONFIRMED FOR SPONSOR

ROUNDTABLE TOPIC CONFIRMED FOR SPONSOR

ROUNDTABLE TOPIC CONFIRMED FOR SPONSOR

ROUNDTABLE TOPIC CONFIRMED FOR SPONSOR

ROUNDTABLE TOPIC CONFIRMED FOR SPONSOR

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

How the explosive growth of Bio-logics has changed the Cold-Chain Clinical Supplie Chain landscape

Centralized or Decentralised Warehous-ing: 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

Mohammed Ahmad - Director & HeadTakeda Pharmaceuticals

Ashraf Yousef - Sr. Med. Director Shire

Catherynne Cruz - Scheckner Ionis Pharmaceuticals

AGENDA p.212

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STORAGE AND DISTRIBUTION DIRECT-TO-PATIENT SIGNAL DETECTION ADVERSE EVENTS / CASE PROCESSING

REAL WORLD EVIDENCE

PHARMACOVIGILANCECLINICALTRIALSUPPLYCHAINCLINICALTRIALSUPPLYCHAIN PHARMACOVIGILANCE

Considerations regarding regional reg-ulations for the distribution of medica-tion at both the recipients & dispatch-ers locations

Strategies to successfully implement DtP and chososing the right DtP model

Determining whether a clinical trial is appropriate for DtP model

ROUNDTABLE TOPIC CONFIRMED FOR SPONSOR

How RWE can allow for more informed and reliable strategic decisions earlier when it comes to patient safety

Challenges with use of RWD to generate acceptable RWE

Using RWD in optimization of trial design, assisting in site and investigator selection, expediting trial duration and generation of new trial designs.

CLINICAL DATA & IRT

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

Joanne McCaigue - DirectorPosieda Therapeutics

William Haddock - VP SafetyOvid Therapeutics

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

Melissa Peirsel - Manager of IRT Services

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.

Rich Nelson - Senior Manager Logistics

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

KEYNOTE PRESENTATION KEYNOTE PRESENTATION

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

1 - 1 MEETING *12:00-12:20 E.T. 1 - 1 MEETING *12:20-12:40 E.T. 1 - 1 MEETING *12:40-13:00 E.T. 1 - 1 MEETING *13:00-13:20 E.T. 1 - 1 MEETING *13:20-13:40 E.T. 1 - 1 MEETING *13:40-14:00 E.T.

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

Tamika Jackson - CEO

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

Tamika Jackson - CEO

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CLINICALOPERATIONS PHARMACOVIGILANCECLINICALTRIALSUPPLYCHAINCLINICALOPERATIONS CLINICALTRIALSUPPLYCHAIN PHARMACOVIGILANCE

INVESTMENTS & VENTURE CAPITAL

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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.

Daniel Haders II, Ph.D. Managing Director

Healthcare Tech Nex Cubed

Key considerations when approaching investors - investor insights.

ROUNDTABLE TOPIC

TIME SLOT (*E.T.)

9:00 - 10:00

SPEAKER TBC TBC TBC

SPEAKER TBC TBC TBC

SPEAKER TBC TBC TBC

TOPIC TBCSPONSOR ROUNDTABLE TOPIC

11:00 - 12:00

ROUNDTABLE TOPIC

15:50 - 16:50

ROUNDTABLE TOPIC

14:30 - 15:30

Current key therapeutic areas which investors are focusing on and why?

TIME SLOT (*E.T.)

TIME SLOT (*E.T.)TIME SLOT (*E.T.)

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

LEARN MORE ABOUT OUR SPEAKERS

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CLINICALOPERATIONS PHARMACOVIGILANCECLINICALTRIALSUPPLYCHAINCLINICALOPERATIONS CLINICALTRIALSUPPLYCHAIN PHARMACOVIGILANCE

TRACK 1 RISK BASED MONITORING

SPEAKER TBC TBC TBC

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

ROUNDTABLE TOPIC

GO TO MENU NEXT PAGE

TIME SLOT (*E.T.)

SPEAKER TBC TBC TBC

SPEAKER TBC TBC

IQVIA

SPEAKER TBC TBC TBC

PREVIOUS PAGE

9:00 - 10:00

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

SPONSOR ROUNDTABLE TOPIC

TIME SLOT (*E.T.)11:00 - 12:00

ROUNDTABLE TOPIC

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

ROUNDTABLE TOPIC

TIME SLOT (*E.T.)14:30 - 15:30

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

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

LEARN MORE ABOUT OUR SPEAKERS

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

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CLINICALOPERATIONS PHARMACOVIGILANCECLINICALTRIALSUPPLYCHAINCLINICALOPERATIONS CLINICALTRIALSUPPLYCHAIN PHARMACOVIGILANCE

TRACK 2PATIENT RECRUITMENTPATIENTE CENTRICITY

Abhit Singh TBC Chief Regulatory Officer

Intrommune Therapeutics

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

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Jessica Raiz Senior Director,

Clinical Research Timber Pharmaceuticals

Strategies for developing patient centric studies & effectively working with patient advocates

SPEAKER TBC TBC

IQVIA

How does patient- focused strategy improve business outcomes?

Patient recruitment using field-based advocacy.

Jack Fernandes CEO

Regenica Biosciences

PREVIOUS PAGE

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

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CLINICALOPERATIONS PHARMACOVIGILANCECLINICALTRIALSUPPLYCHAINCLINICALOPERATIONS CLINICALTRIALSUPPLYCHAIN PHARMACOVIGILANCE

TRACK 3OUTSOURCING

SPEAKER TBC TBC TBC

How are the CROs addressing the demand for specialized services?

GO TO MENU NEXT PAGE

SPEAKER TBC TBC TBC

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

SPEAKER TBC TBC TBC

Challenges in feasibility assessments, budgeting and overall planning for increasingly complex Phase I/II patient trials with adaptive designs

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

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

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CLINICALOPERATIONS PHARMACOVIGILANCECLINICALTRIALSUPPLYCHAINCLINICALOPERATIONS CLINICALTRIALSUPPLYCHAIN PHARMACOVIGILANCE

TRACK 4EMERGING BIOPHARMA

SPEAKER TBC TBC TBC

How a shared-risked partnership model can im-prove the success rates of getting to IND and be-yond?

GO TO MENU NEXT PAGE

SPEAKER TBC TBC TBC

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

SPEAKER TBC TBC TBC

The challenges aligned with clinical trial planning through to trial design implementation and how an integrated CRO with therapeutically focused expertise can help?

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 Relationhips, Boutique, Local Reach vs Financial Stability, Cross Therapuetic Ex-pertise and Global Resources?

Andrea Small-Howard CSO

GB Sciences

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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

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CLINICALOPERATIONS PHARMACOVIGILANCECLINICALTRIALSUPPLYCHAINCLINICALOPERATIONS CLINICALTRIALSUPPLYCHAIN PHARMACOVIGILANCE

TRACK 5VIRTUAL TRIALS

Speaker TBC TBC TBC

Strategies to guarantee privacy of recruited patients whilst ensuring the truthfulness of collected data for uncompromisable study results

GO TO MENU NEXT PAGE

Speaker TBC TBC TBC

Running global, multi-country hybrid and virtual clinical trials - the future of clinical trials?

Speaker TBC TBC

IQVIA

Methods to guarentee the same quality standards as normal trials despite the small number of clinicians interfacing with patients

What steps need to be taken at the end of the vir-tual trial to ensure there is full documentation of the chain of custody for all patients?

Speaker TBC TBC TBC

PREVIOUS PAGE

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

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CLINICALOPERATIONS PHARMACOVIGILANCECLINICALTRIALSUPPLYCHAINCLINICALOPERATIONS CLINICALTRIALSUPPLYCHAIN PHARMACOVIGILANCE

TRACK 6A.I & MACHINE LEARNING

SPEAKER TBC TBC TBC

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

GO TO MENU NEXT PAGE

Oliver Steinbach VP R&D

Imagion Biosystems

Enhancing patient safety with Artificial Intelligence

SPEAKER TBC TBC TBC

How matching Electronic Health Records to RWD can improve outcomes

Enabling PVO in predictive science with the application of Artificial Intelligence

SPEAKER TBC TBC TBC

PREVIOUS PAGE

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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CLINICALOPERATIONS PHARMACOVIGILANCECLINICALTRIALSUPPLYCHAINCLINICALOPERATIONS CLINICALTRIALSUPPLYCHAIN PHARMACOVIGILANCE

TRACK 7CLINICAL 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.

GO TO MENU NEXT PAGE

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 decisions

Speaker TBC TBC TBC

PREVIOUS PAGE

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

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CLINICALOPERATIONS PHARMACOVIGILANCECLINICALTRIALSUPPLYCHAINCLINICALOPERATIONS CLINICALTRIALSUPPLYCHAIN PHARMACOVIGILANCE

TRACK 8STORAGE AND DISTRIBUTION

SPEAKER TBC TBC TBC

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

GO TO MENU NEXT PAGE

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 ef-ficiency and skyrocketed cost of clinical supply chain.

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

Catherynne Cruz-SchecknerDirector Clinical Supplies

Ionis Pharmaceuticals

PREVIOUS PAGE

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

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CLINICALOPERATIONS PHARMACOVIGILANCECLINICALTRIALSUPPLYCHAINCLINICALOPERATIONS CLINICALTRIALSUPPLYCHAIN PHARMACOVIGILANCE

TRACK 9DIRECT-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

PREVIOUS PAGE

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

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CLINICALOPERATIONS PHARMACOVIGILANCECLINICALTRIALSUPPLYCHAINCLINICALOPERATIONS CLINICALTRIALSUPPLYCHAIN PHARMACOVIGILANCE

TRACK 10SIGNAL DETECTION

SPEAKER TBC TBC TBC

Signal Management: meeting the needs of all stakeholders

William HaddockVP Safety

Ovid Therapeutics

Identifying the latest development & innovation approach for effective signal management

SPEAKER TBC TBC TBC

Why the need to address validation, analysis prioritisation, assessment is crucial to managing signals?

Applying signal detection proficiency in the sentinel system

SPEAKER TBC TBC TBC

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

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CLINICALOPERATIONS PHARMACOVIGILANCECLINICALTRIALSUPPLYCHAINCLINICALOPERATIONS CLINICALTRIALSUPPLYCHAIN PHARMACOVIGILANCE

TRACK 11ADVERSE EVENTSCASE PROCESSING

SPEAKER TBC TBC TBC

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

GO TO MENU NEXT PAGE

SPEAKER TBC TBC TBC

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

SPEAKER TBC TBC

IQVIA

Enabling a faster response by improving adverse event terminology reducing possible ambiguities?

PV: Maintaining compliance through advanced drug safety surveillance.

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

Shire

PREVIOUS PAGE

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

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CLINICALOPERATIONS PHARMACOVIGILANCECLINICALTRIALSUPPLYCHAINCLINICALOPERATIONS CLINICALTRIALSUPPLYCHAIN PHARMACOVIGILANCE

TRACK 12REAL WORLD EVIDENCE

SPEAKER TBC TBC TBC

How RWE can allow for more informed and reliable strategic decisions earlier when it comes to patient safety

GO TO MENU NEXT PAGE

SPEAKER TBC TBC TBC

Challenges with use of RWD to generate acceptable RWE

SPEAKER TBC TBC TBC

Strategies to best deploy innovative collection and analytic technologies to maximize RWE effectiveness

Using RWD in optimization of trial design, assisting in site and investigator selection, expediting trial duration and generation of new trial designs.

SPEAKER TBC TBC TBC

PREVIOUS PAGE

ROUNDTABLE TOPIC

TIME SLOT (*E.T.)

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PROVENTAI N T E R N A T I O N A L17

CLINICALOPERATIONS PHARMACOVIGILANCECLINICALTRIALSUPPLYCHAINCLINICALOPERATIONS CLINICALTRIALSUPPLYCHAIN PHARMACOVIGILANCE

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

1818 PROVENTAI N T E R N A T I O N A L

CLINICALOPERATIONS PHARMACOVIGILANCECLINICALTRIALSUPPLYCHAINCLINICALOPERATIONS CLINICALTRIALSUPPLYCHAIN PHARMACOVIGILANCE

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

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

CLINICALOPERATIONS PHARMACOVIGILANCECLINICALTRIALSUPPLYCHAINCLINICALOPERATIONS CLINICALTRIALSUPPLYCHAIN PHARMACOVIGILANCE

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

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2019 ATTENDEES p.3