ONLINE CLINICAL TRIAL SUPPLY CHAIN STRATEGY …...ONLINE CLINICAL TRIAL SUPPLY CHAIN STRATEGY...

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ONLINE CLINICAL TRIAL SUPPLY CHAINSTRATEGY MEETING 2020

18th November 2020, Wednesday 1:00pm - 6:00pm UK | 8:00am - 1:00pm NY

UK: +44 (0)207 096 1222US: +44 (0)20 3314 0100 [email protected] www.proventainternational.com Connect with us

SPONSORS

AGENDA

KEYNOTE PRESENTATION

TRACK 1: IRT

TRACK 2: Storage and Distribution

TRACK 3: Packaging & Labeling

TRACK 4: Global Networks

TRACK 5: Direct-To-Patient

TRACK 6: Technology & I.O.T

2019 ATTENDEES

CONTRIBUTORS TO THE AGENDADr Luisa Freitas dos SantosVP Global Clinical Supply ChainGSK

Peter Schuepbach VP, Technical OperationsDalCor Pharmaceuticals

Danny RaymakersHead of Integrated Supply Chain LogisticsJohnson and Johnson

Rodney EricksonDeputy Head of IRTBoehringer Ingelheim

Wilhelm ScigallaVP, Head of Technical & Pharmaceutical OperationsOculis

Arul JosephSenior Director, Pharmaceutical Development and Clinical Supply ChainAvanir Pharmaceuticals

Richard HsiaSenior Director, CTM ManagementSunovion Pharmaceuticals

Trevor KnottDirector, Clinical Trials SupplyEisai

OUR UNIQUE ONLINE MEETING FORMATRoundtable 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.

Innovative SolutionsWhatever your challenge may be, let our official event partners find the solution. Gain access to our carefully selected solution providers and find your next strategic partner that will help take your business to the next level.

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.

OUR VISION

OUR MISSION

To be a platform for creating life-saving therapies and to facilitate the creation of a completely patient centric pharmaceutical industry.

By encouraging key leaders and their companies to put the patient at the very heart beat of every innovation. Sharing valuable insights and strategies to assist in the discovery, development and commercialisation of life saving therapies.

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UK: +44 (0)207 096 1222US: +44 (0)20 3314 0100 [email protected] www.proventainternational.com

THOUGHT LEADERSanaClis 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.

SPONSORSOUR

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CO-HOST SPONSORS

CPI connects academia, businesses and funders to de-risk innovation. The Medicines Manufacturing Innovation Centre was established by a collaboration between CPI, the University of Strathclyde, UK Research and Innovation, Scottish Enterprise and founding industry partners, AstraZeneca and GSK.The consortium aims to develop the medicines manufacturing processes of the future, enabling a more agile, responsive medicines supply chain through improved manufacturing processes. It will enable new and disruptive technologies to be proven at scale in a GMP environment. This will allow the rapid adoption of next-generation processes that reduce risk, cut costs and save time, enabling a healthier society and a robust UK economy.

N-SIDE, an innovative software consulting company, has been an active player in clinical trial supply chain management for almost 20 years. Using cloud-based cutting-edge technologies, their solutions optimize the entire clinical trial supply chain management process from planning and production through to protocol design and delivery of supplies. The N-SIDE Suite for Clinical Trials enables the pharmaceutical and biotech industry to future-proof their clinical trial supply chain management while minimizing costs, drug waste and ensuring proactive risk management.

Pharmaceutical companies — and other organizations looking to make significant cost and quality improvements in their cold chains — are switching to Pelican BioThermal for single-use and reusable temperature-controlled packaging. Our innovative, patented technologies and consultative services ensure product quality, mitigate excursion rates, reduce packaging costs and drive TCO across your entire supply chain. Our global network of consultative cold chain experts provides our customers with consistent packaging and logistics experiences wherever they do business. While our full line of single-use and reusable packaging solutions — from parcel to pallet shippers — are competitively priced, the real economic value we bring to our customers focuses on TCO.

Suvoda is an innovative SaaS company, focused on transforming clinical trials using the power of technology. Suvoda’s Interactive Response Technology (IRT) system solves complex patient randomization and clinical trial supply chain challenges, so that customers have peace of mind to focus on their patients. Suvoda IRT sets clinical trials up for success by offering a variety of configurable and customizable features, powerful reporting, and advanced functionality, built to support complex and innovative study designs. Headquartered in Conshohocken, PA, Suvoda has offices and staff around the world, offering exceptional customer and advisory services to biopharmaceutical companies and clinical research organizations of all sizes. Learn more at www.suvoda.com.

PRO-PARTNERS




https://www.sanaclis.eu/

https://www.uk-cpi.com/

https://www.n-side.com/

https://pelicanbiothermal.com/

https://www.suvoda.com/en-us/

https://www.myoderm.com/

https://www.cryopdp.com

http://www.appliedmaterials.com/

https://www.ecrscorp.com/

https://www.s-clinica.com/

https://www.yprime.com/

https://www.cavu-group.com/

https://www.tagntrac.com/

https://www.dryce-pharma.com/


AGENDAPART 1



TRACK & ROOM01 - IRT 02 - STORAGE AND

DISTRIBUTION 03 - PACKAGING & LABELING 04 - GLOBAL NETWORKS 05 - DIRECT-TO-PATIENT 06 - TECHNOLOGY & I.O.TTIME (UK) TIME (NY)

1:00pm - 1:30pm UK

8:00am - 8:30am NY

KEYNOTE PRESENTATION Clinical supply chain challenges and learnings from a global pandemic

Dr Luisa Freitas dos Santos — VP Global Clinical Supply Chain, GSK

1:30pm - 1:45pm UK

8:30am - 8:45am NY BREAK

1:45pm - 2:45pm UK

8:45am - 9:45am NY

IWRS & IRT Wilhelm Scigalla — VP, Head of Technical & Pharmaceutical Operations, Oculis

Addressing the need for smarter and more advanced storage and distribution facilities as part of the supply chain Peter Schuepbach — VP, Technical Operations, DalCor Pharmaceuticals

Streamlining the packaging labelling Trevor Knott — Director, Clinical Trials Supply, Eisai

How global networks responded to the Covid pandemic challenges – key learnings for building resilience in the future Dr Luisa Freitas dos Santos — VP Global Clinical Supply Chain, GSK

Direct to Patient IMP shipments for Virtual Trials Danny Raymakers — Head of Integrated Supply Chain Logistics, Johnson and Johnson

Disruptive Technologies Implementation in Drug Development is Required and NOT an Option Frank Leu — Chief Executive Officer, Novapeutics

2:45pm - 3:00pm UK

9:45am - 10:00am NY BREAK

3:00pm - 4:00pm UK

10:00am - 11:00am NY

Dr. Marius Oprean — Director Corporate Development,

SanaClis

Dr. Dave Berry —

Grand Challenge Lead - MMI, CPI

Paul Terry —

Director of Sales EMEA, Peli BioThermal

Marcel Besier —

Director Services Delivery Europe, Suvoda

Sebastien Coppe —

Life Sciences Director, N-SIDE

4:00pm - 5:00pm UK

11:00am - 12:00pm NY BREAK

5:00pm - 6:00pm UK

12:00pm - 1:00pm NY

Hot-Button Topics in IRT Rodney Erickson — Deputy Head of IRT, Boehringer Ingelheim

Assuring Distribution & Storage within the Clinical Trials Supply Chain in times of COVID-19: Lessons learned Yvonne Ziegler — Professor & Director, Pharma Supply Chain Management, Frankfurt University

Smart packaging for patient adherenceArul Joseph — Senior Director, Pharmaceutical Development and Clinical Supply Chain, Avanir Pharmaceuticals

How to develop a Monitoring Plan to incorporate a risk-based approach? Jonathan Rabinowitz — Professor, Bar Ilan University

The reality of Direct-to-Patient Richard Hsia — Senior Director, CTM Management, Sunovion Pharmaceuticals

Using clinical supply analytics to make faster, better decisions in order to meet the agility demands of today’s clinical trials Scott Sutton — Senior Director, Supply Chain, Constellation Pharmaceuticals

END







Dr Luisa Freitas dos Santos

VP Global Clinical Supply Chain

GSK

Clinical supply chain challenges and learnings from a global pandemic

1:00pm - 1:30pm UK 8:00am - 8:30am NY


• Impact of C-19 pandemic across global clinical supply chains• Immediate response and trigger of bcp in multiple nodes globally – specific examples provided• Mechanisms utilised to ensure continuity of supply to investigators and patients• Acceleration of deployment of digital solution in the context of the global pandemic• Learnings for the future




TRACK 1IRT



Rodney EricksonDeputy Head of IRT

Boehringer Ingelheim

Hot-Button Topics in IRT

5:00pm - 6:00pm UK 12:00pm - 1:00pm NY

• Direct to patient shipments• Audit trail reports for inspections• Increasing complexity of clinical studies

Wilhelm ScigallaVP, Head of Technical &

Pharmaceutical OperationsOculis

1:45pm - 2:45pm UK 8:45am - 9:45am NY

IWRS & IRT • Why IRT?• When IRT?




TRACK 2Storage and Distribution



Peter SchuepbachVP, Technical Operations

DalCor Pharmaceuticals

Yvonne Ziegler Professor & Director, Pharma Supply Chain Management Frankfurt University

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

1:45pm - 2:45pm UK

5:00pm - 6:00pm UK

Dr. Marius OpreanDirector Corporate Development

SanaClis

What does the future hold in terms of cost effective storage and distribution in Clinical Trials Supply after Covid-19 & Brexit in such challenging times

SPONSOR

Assuring Distribution & Storage within the Clinical Trials Supply Chain in times of COVID-19: Lessons learned

8:45am - 9:45am NY 3:00pm - 4:00pm UK

10:00am - 11:00am NY

12:00pm - 1:00pm NY

• Getting clinical supply to patients in time of COVID.• Storage & Distribution challenges in different geographical regions.• Controlled storage and distribution conditions. What is really required and necessary.• Clinical storage and distribution cost. Why is it so different to commercial products?

• Flexible Storage & Logistic - Hub Model for Clinical Trials Supply• Smarter Distribution: would QP services be a burden in the foreseeable future• Pressure on sourcing Comparators during challenging times: Strategic Sourcing approach

• What have been the challenges of the Clinical Trials Supply Chain with regards to distribution & storage during the COVID-19 pandemic?• Which digital tools are available to support compliance?• Which are the lessons learned?




TRACK 3Packaging & Labeling



3:00pm - 4:00pm UK

Dr. Dave BerryGrand Challenge Lead - MMI

CPI

Achieving effective late stage trial customisation through novel-automation and digitised quality

SPONSOR

Trevor Knott Director, Clinical Trials Supply

Eisai

Streamlining the packaging labelling

1:45pm - 2:45pm UK

• Use of booklet labels vs single panel labels• Central packaging vs regional packaging• Comparators – central vs regional vs sites provide own

8:45am - 9:45am NY

Arul JosephSenior Director,

Pharmaceutical Development and Clinical Supply Chain

Avanir Pharmaceuticals

Smart packaging for patient adherence

5:00pm - 6:00pm UK 12:00pm - 1:00pm NY

10:00am - 11:00am NY

• Why is smart packaging needed for patient adherence?• Types of smart packaging• How to choose the best packaging option?

• Effectively leverage digitisation to assure quality and meet bespoke patient demands. • Novel multi-product automation to deliver speed and flexibility.• Late stage customisation to drive waste reduction.• How you can access this collaboration project.




TRACK 4Global Networks



Dr Luisa Freitas dos Santos

VP Global Clinical Supply Chain

GSK

How global networks responded to the Covid pandemic challenges – key learnings for building resilience in the future

1:45pm - 2:45pm UK

3:00pm - 4:00pm UK

Paul TerryDirector of Sales EMEA

Peli BioThermal

Covid 19 – The challenge of temperature controlled pharmaceutical shipments for clinical trials and bulk distribution

SPONSOR

• Understanding regulatory rational for RBM• How to see the potential of multitasking existing systems for RBM• Examples of using existing systems creatively as RBM tools

• How are the new considerations informing risk mitigation and redesign of global networks/footprints?• Are new medicines such as the mRNA-based vaccines going to require new global networks or impact current ones, in what way and what preparation should be done?• How will current global networks respond to the ‘new normal’?

8:45am - 9:45am NY

10:00am - 11:00am NY

Jonathan Rabinowitz

ProfessorBar Ilan University

5:00pm - 6:00pm UK

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

12:00pm - 1:00pm NY




TRACK 5Direct-To-Patient



Danny RaymakersHead of Integrated

Supply Chain LogisticsJohnson and Johnson

Richard Hsia Senior Director, CTM ManagementSunovion Pharmaceuticals

Direct to Patient IMP shipments for Virtual Trials

1:45pm - 2:45pm UK

3:00pm - 4:00pm UK

5:00pm - 6:00pm UK

Marcel BesierDirector Services Delivery Europe

Suvoda

Can Direct-to-Patient Enable More Complex Trials?

SPONSOR

The reality of Direct-to-Patient• What is working and what is not• DtP relation to Decentralized Trial

• Moving from a COVID-19 pandemic site to patient model to a planned protocol approach• Benefits of different Direct-to-Patient models (depot/ pharmacy to patient vs. site to patient)• Considerations for turning a traditional study into a Direct-to-Patient study within the context of a Virtual Trial

• Are sponsors planning to leverage more decentralized models in the future• Operational readiness in order to support DtP and increasingly complex trials • How eClinical innovations enable more patient-centric and inclusive trials • What new expectations sponsors need to set for patients

8:45am - 9:45am NY

10:00am - 11:00am NY

12:00pm - 1:00pm NY




TRACK 6Technology & I.O.T



Frank LeuChief Executive Officer

Novapeutics

Scott Sutton Senior Director,

Supply Chain Constellation

Pharmaceuticals

Disruptive Technologies Implementation in Drug Development is Required and NOT an Option

1:45pm - 2:45pm UK

5:00pm - 6:00pm UK

Sebastien CoppeLife Sciences Director

N-SIDE

Trial design: how to get clinical supplies a seat at the table?

Using clinical supply analytics to make faster, better decisions in order to meet the agility demands of today’s clinical trials• What information is needed to make informed decisions and from where can that information be sourced?• How does the speed and agility of decisions differ between manual and automated data collection and reporting?• What is the impact of connecting different systems (e.g. IRT, EDC) for data reporting?• What is your ideal data analytics environment for making rapid clinical supply decisions?

8:45am - 9:45am NY

3:00pm - 4:00pm UK

SPONSOR

10:00am - 11:00am NY

12:00pm - 1:00pm NY

• How to bring strategic added value to clinical decision makers?• How to maximize the chance to have supply-friendly protocols with a reduced risk and drug waste ?• Leverage successful business cases, align your processes & structure and implement a data-driven culture.

• Enhance supply forecasting and product tracking / authentication using new technologies in drug development, such as in the supply chain management.• The risk of all stakeholders being ‘risk adverse’ in adopting disruptive technologies and processes.• Blockchain, AI, deep data Mining, internet of things, and decentralized trials as the emerging healthcare technologies and processes.



UK: +44 (0)207 096 1222US: +44 (0)20 3314 0100 [email protected] www.proventainternational.com 11

2019 ATTENDEES

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Acceleron Pharma Director, CDMO OperationsAchillion Pharmaceuticals Senior Director of Pharmaceutical SciencesAkebia Therapeutics Director, CMC & Operations ManagementAkebia Therapeutics Senior Director, Regulatory CMCAldeyra Therapeutics Senior Director, CMC & Supply ChainAlkermes Associate Director, Clinical Supply ChainAlnylam Director, Clinical Supply ChainAMAG Pharmaceuticals Director, Strategic Procurement Amicus Therapeutics Associate Director, IRT & Global Clinical Supply

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Executive Vice President, Technical Operations

Bill & Melinda Gates Medical Research Institute

Clinical Supply Leader

Biogen Associate Direct, Clinical Drug SupplyBiogen Associate Director Clinical Drug Supply Biogen Associate Director, Product Protection Program LeadBiogen Clinical Drug Supply- Operations Capabilities

Management-IRT SpecialistBiogen Lead, Clinical Supply CapabilitiesBiogen R&D Global Strategic SourcingBiogen Senior Director, Product and Supply Chain SecurityBiogen Senior Manager, Clinical Drug SupplyBiogen Senior Supervisor, Product and Supply Chain Security Biogen Associate Director Strategic Operations and TechBluebird Bio Director of Supply Chain Boehringer Ingelheim IRT ExpertBoehringer Ingelheim IRT SpecialistBoston Scientfic Clinical Supply Chain Lead

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Senior Director, Product Development

Curis Associate Director, CMC Deciphera Pharmaceutical Head of Clinical Supply Operations Dicerna Pharmaceuticals Inc

Associate Director, Supply Chain

Eli Lilly Sr Director, CT Material Production and Materials Management

Entasis Therapeutics Associater Director, Supply Chain Entasis Therapeutics Clinical Project Leader Flexion Therapeutics Clinical Supply ChainForma Therapeutics RDIS Head, Senior Director Gelesis CTO Immunogen Supply Chain Lead Incyte Senior Director, IMSCIronwood Pharmaceuticals Lead, Clinical SupplyJohnson & Johnson Sr Manager – Clinical Supply Chain Lead Mersana Therapeutics Director, Supply ChainNeon Therapeutics Associate Director Supply OperationsNovapeutics Chief Executive OfficerNovartis Director of Supply ChainPfizer Clinical Research Sourcing Strategist

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Pfizer Clinical Research Sourcing StrategistPfizer External Vendor Packaging SchedulerPfizer Global Clinical Supply FellowPfizer Lead, IRT Data StewardPfizer Senior Manager - IVRS Global Operations TeamPieris Pharmaceuticals Senior Director of Clinical Operations Pieris Pharmaceuticals Senior Director, Supply Chain OperationsProteostasis Therapeutics Associate Director - Clinical Drug Supply and IRTPTC Therapeutics, Inc. Clinical Supplies & Desginated RepresentativeRegeneron Pharmaceuticals, Inc.

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Head of Pharmaceutical Sciences Systems, Americas

TARIS Biomedical Senior Director, Product Development and Technical Operations

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Head of Global Supply Chain

Ultragenyx Associate Director, Global Supply Chain



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