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The summit is created and designed by:

IoT & SMART PHARMA SUMMIT 2020

13 - 14 OCTOBER 2020 - , MASSACHUSETTS INTEGRATING IOT AND SMART

PHARMA TECHNOLOGY TO KEY THEMES  Fundamentals of IoT: Knowing where to start and what to do OPTIMIZE DECISION MAKING  Creating and developing a digital and IoT transformation roadmap  Building the business case, gaining buy in and securing the funding for new technologies AND ENHANCE PATIENT  Identifying and selecting technology and vendors that can solve unique business problems  Initiating pilot projects, implementation and scaling IoT and tech EXPERIENCE through the entire organization  IoT for Manufacturing & supply chain optimization  IoT and smart pharma technology for clinical trials  R&D IoT and the Future of smart labs

CUTTING-EDGE INSIGHT DELIVERED BY INDUSTRY LEADERS, INCLUDING:

Sandeep Menon, Satish Maram, Kyle Holen, Cornelia Thieme, Robert Boland, Prasenjeet Sarkar, Marissa Dockendorf, Eileen Cortes, Senior Vice President Director Integration Head, Development Director Global Executive Director, Sr. Director Principal Scientist, Director – QA Global and Head Early Services and Design Center, Manufacturing Head of Digital Delivery Manufacturing and Merck Validation, Clinical Development, Data Enablement, AbbVie Science, & Data, Quality and PD IT, Biomarin AstraZeneca Business Services, Kite Pharma CSL Behring

Platinum Sponsors:    Sponsor: www.futurepharmaiot.com | +44 (0) 113 2647 914 | [email protected] Featured presenters, moderators and panelists:

Sandeep Menon, Sharin Roth, Marissa Dockendorf, Rasmus Hogreffe, Senior Vice President and Head Early Director, Principal Scientist, Head of Virtual Clinical Trials, Clinical Development, Otsuka Pharmaceutical Development & Merck LEO Innovation Lab Pfizer Commercialization, Inc.

Mike Benecky, Manish Saxena, Satish Maram, Heidi Evenson, Sr Director, Global Regulatory Affairs, Consulting VP – Pharma & Medical Device Director Integration Services and Data VP, Technology Program Management, GSK Transformation, Enablement, Vertex Pharmaceuticals Predana LLC AstraZeneca

Kimberly Crimin, Robert Boland, Head, Advanced Analytics, Luiz Barberini, Kyle Holen, Executive Director, Head of Digital Delivery & AbbVie Operations Manager - External Head, Development Design Center, Data, Quality and Business Services, Manufacturing Latin America, AbbVie CSL Behring Bayer SA - Brasil

Nishtha Jain, Digital Technology and Product Consultant, Cornelia Thieme, Prasenjeet Sarkar, GSK Eileen Cortes, Director Global Manufacturing Science, Sr Director of Manufacturing and PD IT, Director – QA Global Validation, Biogen Kite Pharma Biomarin

Brenden Alexander, Siddharth Bohra, Daniel Velez, Manager, NA Engineering and Strategic Dr. Gunjan Bhardwaj, Chief Business Officer - Tech, Media, Corp QA Specialist, Projects, Founder and CEO, Consumer & Life Sciences, Sanofi Innoplexus Larsen & Toubro Infotech (LTI)

Rita Kelley, Managing Director, Innoplexus USA

 www.futurepharmaiot.com |  +44 (0) 113 2647 914 |  [email protected] Dear Pharma specialist, IoT Pharma Summit 2020 is designed for C Suite, VP’s, Presidents, Heads, Directors, Team Leaders and The evolving and strict regulatory landscape within the pharma sector has led to many Senior Scientists from: organizations remaining cautious when adopting emerging technology. T IoT However, recent years has seen falling R&D productivity, cost increases, compliance and T Digital Strategy & Transformation non-adherence challenges, patents expiring and stakeholder expectations evolving which T Analytics, AI & Machine Learning is driving the pharma sector to focus their energy on IoT (Internet of Things) and other T Digital Innovation and Emerging Technology emerging smart technologies. T Manufacturing T Plant The pharmaceutical industry is in fact, perfectly positioned to leverage IoT technologies T Supply Chain across manufacturing plants, supply chains, delivery routes, clinical trials, R&D and many T Clinical Trials other areas. T Research & Development Whilst some early adopters have already started exploring IoT to enable end-to-end digital T Smart Labs T Data Management, Data Governance & Data Science integration across the supply chain, many are still wondering where to start and what to do. T Patient Centricity Our IoT & Smart Pharma Summit will focus on: T Cloud T Regulation T Fundamentals of IoT: Knowing where to start and what to do T Business Development T IoT for manufacturing & supply chain optimization T Commercial Affairs T IoT for clinical trials T R&D IoT and the future of smart labs Our sponsors, technology & solution providers include: Ensure you secure your place at the conference to network and discuss with your peers T IoT Hardware, Sensors and Device Components and competitors who may have already solved some of your common challenges. T Data - Storage/Platforms/Collection/Security/Integrity I will look forward to meeting you in Boston in October. T Machine intelligence/AI/Machine Learning T IoT Platforms and Infrastructure Many thanks T IoT Applications T Cloud Computing Mark Giles T Mobile Devices Managing Director T IoT & Smart Pharma Summit 2020 Integrators T Augmented Reality & Wearables T Cyber Security T Clinical Trials T Manufacturing

 www.futurepharmaiot.com |  +44 (0) 113 2647 914 |  [email protected] Mini Symposium: Monday, 12 October 2020 (12:30 – 17:00) Artificial Intelligence in Life Sciences: Cost-Benefit of Implementation and Avoiding Common Pitfalls

Overview: Recent developments have confirmed that Artificial Intelligence (AI) and Machine Learning (ML) has the potential to reshape the life sciences sector. Whether the ultimate driver is cost efficiency, optimizing clinical trial design and execution, or potentially accelerating speed to market, AI technology can enable a true competitive edge by potentially achieving all three. By attending this symposium, Innoplexus will demystify AI & ML, explore its potential, alleviate concerns and set realistic expectations about what this powerful technology can do. PROGRAM AND AGENDA 12:30 Registration, snacks, coffee, light meet & greet 13:00 Introductions & Icebreaker: This session is designed to get to know one another and share AI-related insights, concerns and challenges. The information will be documented, and we will aim to address these during the course of the day. 13.30 SESSION 1 13:30 The Potential of Artificial Intelligence / Machine Learning in Life Sciences Presented by Gunjan Bhardwaj, CEO & Founder, Innoplexus About Gunjan: Gunjan Bhardwaj is the Founder and CEO of the Innoplexus group. He was earlier with the Boston Consulting Group and before that the leader of the global business performance think-tank of Ernst & Young and a manager in the German practice with a solution focus on strategy and innovation. He has led projects in strategy, analytics, and technology for various clients in different parts of the world. Gunjan was also a partner, senior-editor, and advisor for a prominent online innovation management journal and was a member of the scientific advisory board of a US based not for profit institute researching in complexity sciences in the healthcare industry. 14:15 Q&A, Discussion 14:30 Refreshment break

“THE DRUG VALUE CHAIN IS CHANGING. THE COMBINATION OF AI AND BLOCKCHAIN TECHNOLOGIES IS FUNDAMENTALLY ALTERING THE WAY THE LIFE SCIENCES ECOSYSTEM OPERATES, CREATING NEW PATHWAYS FOR THE DISCOVERY OF LIFESAVING DRUGS. AT THE SAME TIME, AI IS NOT A TOOL DESIGNED TO REPLACE JOBS. IT AUTOMATES TIME-CONSUMING, RESOURCE HEAVY, LOW-LEVEL COGNITIVE TASKS. THIS THEN FREES UP TIME AND CAPACITY TO ALLOCATE TO HIGH-LEVEL, COGNITIVE TASKS, THEREBY CREATING GREATER VALUE AND RETURN ON INVESTMENT.” GUNJAN BHARDWAJ, INNOPLEXUS, CEO & FOUNDER, 2019.

 www.futurepharmaiot.com |  +44 (0) 113 2647 914 |  [email protected] Mini Symposium: Monday, 12 October 2020 (12:30 – 17:00)

14:40 SESSION 2 14:40 How Innoplexus’ platforms can help at various stages of drug lifecycle and setting realistic expectations about what AI can do Presented by Rita Kelley, Managing Director, US Operations, Innoplexus About Rita: Rita Kelley is the Managing Director of Innoplexus USA and Senior Vice President of Corporate Development & Marketing at Innoplexus. She has more than 30 years of experience in driving successful commercialization from R&D to the business organization. Prior to joining Innoplexus, Rita served as Vice President of Medical and Commercial Strategy at BioNTech SE, where she helped build and significantly grow the novel mRNA immunotherapy pipeline in and rare diseases.

Rita also has held senior executive global positions at Pfizer, Novartis, and Merck, where she led the global effort that successfully achieved the historic, first in class, best in class approval of Keytruda® for treating MSI-H , regardless of biology, gaining approval in 22 indications. She has also successfully launched five products globally which have achieved over USD 1B in sales. Through these efforts, she has excelled in bringing new drugs to market and significantly increased business revenues through the identification of new pathways across multiple indications. 15:25 Q&A, Discussion 15.40 Refreshment break 15:50 SESSION 3 INTERACTIVE WORKSHOP: Barriers to implementing Artificial Intelligence / Machine Learning initiatives at your organization & identifying possible ssolutions How will the interactive session work?  Within this session, you will form working groups and complete a case study assignment. This will allow you to share your challenges and objectives with your peers and work collaboratively to solve the problems. You will share your outcomes with fellow attendees, all of which will be memorialized.  Key focus areas include:  1. What are your/colleagues concerns regarding AI initiatives rolling out at your organization? What can be done to overcome these?  2. What other implementation barriers need to be overcome; who & how many decision-makers are involved in implementation?  3. In which areas of drug discovery & development do you think that AI solutions can most assist you? Facilitated by George Tsiolis, Head of Global Marketing, Innoplexus 4.45 Wrap up

Post Event: Innoplexus will also create an AI Symposium Outcomes Report that will be sent out to all attendees within 2-3 weeks after the event.

 www.futurepharmaiot.com |  +44 (0) 113 2647 914 |  [email protected] DAY ONE: TUESDAY 13 OCTOBER 2020

07:30 REGISTRATION, COFFEE AND NETWORKING 08:00 Welcome address from the conference chair: 08:10 Navigating the complexities associated with IoT implementation and data integration  Describing why data integration is critical to IoT success and the fundamental IoT challenges  Creating a well-defined strategy for IoT data integration  Taking an API-centric approach for inter-device communication  Starting small and frequently re-assessing: Limiting the scope, scale and complexity of initial IoT projects Satish Maram, Director Integration Services and Data Enablement, AstraZeneca KEYNOTE PRESENTATION KEYNOTE

08:40 PANEL DISCUSSION: The Future of Pharma: Challenges and Opportunities Associated with IoT and Emerging Technologies  How is the digital landscape continuing to change the pharmaceutical industry?  Where do you see the biggest opportunities and interesting IoT use cases in the pharma sector within the next 2 – 3 years?  What do you see as being the biggest challenges and risks associated with IoT adoption in the pharma sector?  What is holding the sector back and what do you believe will help accelerate the benefits of IoT?  How will the regulatory landscape, policies and procedures continue to impact IoT?

PANEL DISCUSSION PANEL  How important is it for companies to take an agile approach to strategy, digitilize their core business, create disruptive products and services as well as capture value from data?  How do you see advanced analytics, AI & ML changing the sector?  What piece of advice would you give to any business leader that is considering or embarking on an IoT project? Panellists: Nishtha Jain, Digital Technology and Product Consultant, GSK Brenden Alexander, Manager, NA Engineering and Strategic Projects, Sanofi Mike Benecky, Sr Director, Global Regulatory Affairs, GSK Manish Saxena, Consulting VP – Pharma & Medical Device Transformation, Predana LLC Prasenjeet Sarkar, Sr Director of Manufacturing and PD IT, Kite Pharma Sharin Roth, Director, Otsuka Pharmaceutical Development & Commercialization, Inc.

 www.futurepharmaiot.com |  +44 (0) 113 2647 914 |  [email protected] KEYNOTE PRESENTATION DAY TUESDAY ONE: 13 OCTOBER 2020 13:40 13:10 12:10 11:40 11:30 10:40 10:10 09:40 Robert Boland,Executive Director, HeadofDigitalDelivery&Data,QualityandBusinessServices, Spotlight PresentationProudly HostedbyDassaultSystèmes IoT JourneyfromPOCtoPilot LUNCH BREAKANDNETWORKING Siddharth Bohra,ChiefBusinessOfficer- Tech,Media,Consumer&LifeSciences,Larsen &Toubro Infotech(LTI) Spotlight PresentationProudlyHostedbyLarsen & Toubro Infotech(LTI) Cornelia Thieme, Director, GlobalManufacturingScience, Biogen Organizational assessmentandanalysistouncoveruniqueproblemsidentifypotentialusecasesfor IoT             Consumer &patientexperience:Leveraging IoT, Wearables andSensorsforthegreatergood MORNING COFFEEBREAKANDNETWORKING Spotlight PresentationProudlyHostedbyInnoplexus

Creating crossfunctionalteamsandcollaborationthatbridgesthestrategicdriversintooperationaleffectiveness rather thanaseparatepieceofthepuzzle Critical requirementsofLeadership, BoardofDirectorsandInvestors:Ensuringleadersresponsiblefordevelopingthe digitalstrategypathwayunderstandIoT incontext Leveraging machinelearningandartificialintelligencetopredictwhat’s happeningwithconsumersandpatients Managing thetsunamiofdatathatIoT creates How canIoT helpmake aconnectedexperienceforcustomerorpatient? Pilot: Taking astagedapproachtoroll-out Proof ofconcept:Validating quality, scalability, easeofuseandoverallfit Vendor selection:Assessingcustomized solutionsvs.offtheshelfproducts Build vs.buy:Evaluatinginternalcapabilitiestodevelop solutionsvs.vendors Business case:Identifyingcurrentchallengesandhow IoT solutionscandrivevalue Overview ofthepharmaceuticalproductindevelopment andprojecttimelines Matching needsassessmentwithactualIoT applicationsthatcanbetracked throughoutdevelopmentanddeploymentstages  www.futurepharmaiot.com |  +44(0) 1132647 914 CSLBehring |  [email protected] DAY ONE: TUESDAY 13 OCTOBER 2020

14:10 Technology Demonstrations: Quick Fire Technology and Product Demonstrations This session provides an additional opportunity to meet with our product and solution providers in the exhibition hall to learn more about the products, technology and services that have been developed to solve some of your unique challenges. The technology demonstrations will last approximately 8 minutes on four cycles with the opportunity to ask questions immediately afterwards over the refreshment break 14:50 AFTERNOON COFFEE BREAK AND NETWORKING 15:20 Modern Approaches to Clinical Trials through IoT and Smart Technology Sandeep Menon, Senior Vice President and Head Early Clinical Development, Pfizer

15:50 Advanced Analytics and AI in Pharma: Strategy, Implementation and Management  The role and impact of advanced analytics and AI in pharma  Overcoming the huge challenges associated with the application of Advance Analytics in complex environments  The importance of leadership and change management qualities to drive strategic initiatives across the organisation: Supporting investment and encouraging experimentation  Proof of Concept experimentation and fast course correction  Identifying the highest priority use cases that will solve unique problems  Building an analytics roadmap and integrating AI and machine learning into your data strategy Kyle Holen, Head, Development Design Center, AbbVie

16:20 Agile approach for transforming IT delivery: Debunking agile myths for Biopharma  Understanding why Agile Methodologies are not widespread across the Biopharma sector  The value of Agile Methodologies: Increasing business value and productivity whilst reducing costs  Practical steps you can take in your own organization to begin the transformation to an Agile mindset and adopt Agile methodologies across your enterprise and teams Heidi Evenson, VP, Technology Program Management, Vertex Pharmaceuticals

17:00 Closing remarks from the conference chair and end of day one 17:15 NETWORKING DRINKS RECEPTION

 www.futurepharmaiot.com |  +44 (0) 113 2647 914 |  [email protected] DAY TWO: WEDNESDAY 14 OCTOBER 2020

08:00 REGISTRATION, COFFEE AND NETWORKING 09:00 WELCOME ADDRESS FROM THE CONFERENCE CHAIR - Mark Giles, Managing Director, AMG World Track 1: IoT & Smart Pharma for Clinical Trials and R&D Track 2: IoT for Manufacturing & Supply Chain Optimization 09:10 Virtualising Clinical Trials through IoT: Leveraging remote and digital innovations Automating the factory floor to optimize clinical trials and improve patient outcomes Manish Saxena, Consulting VP – Pharma & Medical Device Transformation, Rasmus Hogreffe, Head of Virtual Clinical Trials, LEO Innovation Lab Predana LLC 09:45 Regulatory considerations for IoT and medical app development within Advancing the IoT Agenda: Relationship management and building trust with clinical trials external partners and suppliers Mike Benecky, Sr Director, Global Regulatory Affairs, GSK Luiz Barberini, Head of External Manufacturing - Latin America, Bayer AG 10:20 MORNING COFFEE BREAK AND NETWORKING 10:50 AI and IOT: Preparing for the future of disruptive innovation and emerging tech Security and risk management: Developing a data privacy, security, and Nishtha Jain, Digital Technology and Product Consultant, GSK vulnerability management process Daniel Velez, Corp QA Specialist, Amgen 11:25 ROUNDTABLE 1: ROUNDTABLE 2: ROUNDTABLE 3: ROUNDTABLE 4: Scalability: From pilot to full-scale rollout Use of AI in early clinical development IoT for predictive and preventative Roundtable Discussion: Data Integrity and drug discovery maintenance: Asset intelligence, condition Daniel Velez, Corp QA Specialist, Amgen monitoring and remote maintenance Prasenjeet Sarkar, Sr Director of Manufacturing and PD IT, Kite Pharma 12:00 ROUNDTABLE 5: ROUNDTABLE 6: ROUNDTABLE 7: ROUNDTABLE 8: IoT for surveillance: Monitoring Enabling the Smart Lab to thrive through Leveraging IoT and Technology to Multi-site monitoring to improve equipment, instrumentation, methods IoT optimize external manufacturing operational efficiency and reduce site and environmental variables Luiz Barberini, Head of External downtime Manufacturing - Latin America, Bayer AG 13:00 LUNCH BREAK AND NETWORKING 14:00 IoT and technology in CAR-T Plant optimization: Implementing IoT technologies into manufacturing & supply Manish Saxena, Consulting VP – Pharma & Medical Device Transformation, chain to enhance productivity and drive down costs Predana LL 14:35 Advanced analytics for the monitoring of clinical trials Data & analytics and compliance: Maximizing operational intelligence, gaining Kimberly Crimin, Head, Advanced Analytics, AbbVie deeper business insights and optimizing decisions Eileen Cortes, Director – QA Global Validation, Biomarin 15:10 AFTERNOON COFFEE AND NETWORKING BREAK 15:40 Optimizing patient centricity in clinical trials through IoT and mobile applications Implementing IoT enabled devices to create smart supply chain: From shipment, Marissa Dockendorf, Principal Scientist, Merck transit to delivery 16:15 CLOSING REMARKS FROM THE CONFERENCE CHAIR AND CLOSE OF THE CONFERENCE

 www.futurepharmaiot.com |  +44 (0) 113 2647 914 |  [email protected] Sponsorship

How can you get involved as a sponsor?

The IoT & Pharma technology vendor landscape is vast. New entrants are innovating rapidly. It is therefore a prerequisite that solution providers acquire a granular understanding of the industry’s needs in order to develop those bespoke solutions that are critical to winning new business. Our focus ensures we deliver qualified delegates only:

T Invitation only ensuring IoT, Smart Pharma and Technology is their number one priority T Strict qualification criteria which guarantees seniority, budget, investment plans and technology requirement T Paying attendees only ensuring they are truly invested in the topic

Position your organization as an industry expert among the most prominent & influential pharmaceutical companies thereby establishing yourselves as the natural partner for all their IOT &Smart Pharma projects. We would welcome the opportunity to discuss various options in more detail, for more information please contact

Simon Wright CEO AMG World

[email protected]  +44 7734 666 249

 www.futurepharmaiot.com |  +44 (0) 113 2647 914 |  [email protected] Sponsors

Innoplexus’ goal is to be the leading provider of Artificial Intelligence solutions to pharma, biotech and CRO organizations and partner with them to accelerate drug development, clinical trial optimization, provide data- driven insights in real time to facilitate improved strategic decision-making and refine processes. We will partner Platinum Sponsor: with you and walk you every step of the way to potentially accelerate your drug’s time to market. Our proprietary Artificial Intelligence, Blockchain and Machine Learning Services include:

- Identifying optimal targets based on efficacy, safety, clinical & commercial requirements - Narrowing target selection by using in-silico validation - Validating targets based on published scientific data - Lead Identification - Pipeline Prioritization by identifying & validating potential uses of target, pathway, disease & drug candidates - Prospectively analyzing clinical trial design to predict probability of technical and regulatory success - Retrospectively analyzing clinical trial failures to identify cause - Identifying & prioritizing clinical trial sites based on a multitude of parameters - Identifying top or emerging Key Opinion Leaders for clinical trial involvement - Centralizing clinical, medical, commercial, & regulatory information in a single dashboard - Identifying biomarkers to enable patient segmentation and improve response to drug - Providing real-time regulatory insights & changes in clinical guidelines - Data as a Service [DaaS] https://www.innoplexus.com/

Bigfinite is a solutions provider that transforms manufacturing operations with the use of advanced analytics, artificial intelligence, and pharma 4.0 technologies focused on optimizing pharmaceutical and biotech companies. The Bigfinite analytics platform seamlessly integrates unlimited sources of structured and Sponsors: unstructured data to deliver actionable insights across all manufacturing sites. Bigfinite offers an intuitive way to gain meaningful operational intelligence with data by enabling real-time visibility and predictive insights in a GxP compliant manner with end-to-end data integrity. Founded in 2014, the company is based in San Francisco, California and also has a European office in Barcelona, Spain.https://www.bigfinite.com/

LTI leverages its rich heritage in engineering and manufacturing to accelerate innovation for our clients across supply chain management, shop-floor-to-top floor integration, labs, serialization and traceability, and analytics. The LTI CLAP (Connected Labs and Plants) solution will provide an unified view of Men, Machines and Materials for greater transparency, real-time insights, decisions at the edge, improved productivity, reduced downtime and better user experience. LTI delivers business outcomes by leveraging digital solutions for 400+ clients across 32 countries. LTI has annual revenues of ~$1.5B, and is a part of the 20B+ Engineering and Manufacturing conglomerate L&T. LTI has successfully transformed the parent L&T group’s operations by identifying and deploying several high-ROI use cases for IIOT. www.lntinfotech.com

Armis is the leading agentless, enterprise-class device security platform, designed to protect organizations from cyberthreats created by the onslaught of unmanaged and IoT devices. Fortune 1000 companies trust our unique out-of-band sensing technology to discover and analyze all managed, unmanaged, un-agentable and IoT devices – from traditional devices like laptops and smartphones to new smart devices like smart TVs, webcams, printers, HVAC systems, industrial control systems and PLCs, medical devices and more. Armis provides unparalleled device discovery and intelligence, real-time continuous device behavior analysis and threat detection to identify and stop threats or secure suspicious or malicious devices

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