INTEGRATING IOT AND SMART PHARMA TECHNOLOGY TO · Describing why data integration is critical to IoT success and the fundamental IoT challenges Creating a well-defined strategy for

INTEGRATING IOT AND SMART PHARMA TECHNOLOGY TO OPTIMIZE DECISION MAKING AND ENHANCE PATIENT EXPERIENCE

13 - 14 OCTOBER 2020 - BOSTON, MASSACHUSETTS

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

KEY THEMES

Fundamentals of IoT: Knowing where to start and what to do

Creating and developing a digital and IoT transformation roadmap

Building the business case, gaining buy in and securing the funding for new technologies

Identifying and selecting technology and vendors that can solve unique business problems

Initiating pilot projects, implementation and scaling IoT and tech 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

Sandeep Menon, Senior Vice President

and Head Early Clinical Development,

Pfizer

Satish Maram, Director Integration

Services and Data Enablement,

AstraZeneca

Kyle Holen, Head, Development

Design Center, AbbVie

Cornelia Thieme, Director Global Manufacturing

Science, Biogen

Robert Boland, Executive Director,

Head of Digital Delivery & Data, Quality and Business Services,

CSL Behring

Prasenjeet Sarkar, Sr. Director

Manufacturing and PD IT,

Kite Pharma

Marissa Dockendorf, Principal Scientist,

Merck

Eileen Cortes, Director – QA Global

Validation, Biomarin

CUTTING-EDGE INSIGHT DELIVERED BY INDUSTRY LEADERS, INCLUDING:

The summit is created and designed by:

IoT & SMART PHARMASUMMIT 2020

Platinum Sponsor:

Sponsors:

Sandeep Menon, Senior Vice President and Head Early

Clinical Development, Pfizer

Satish Maram, Director Integration Services and Data

Enablement, AstraZeneca

Kyle Holen, Head, Development Design Center,

AbbVie

Cornelia Thieme, Director Global Manufacturing Science,

Biogen

Siddharth Bohra, Chief Business Officer - Tech, Media,

Consumer & Life Sciences, Larsen & Toubro Infotech (LTI)

Rita Kelley, Managing Director, Innoplexus USA

Sharin Roth, Director,

Otsuka Pharmaceutical Development & Commercialization, Inc.

Heidi Evenson, VP, Technology Program Management,

Vertex Pharmaceuticals

Robert Boland, Executive Director, Head of Digital Delivery &

Data, Quality and Business Services, CSL Behring

Prasenjeet Sarkar, Sr Director of Manufacturing and PD IT,

Kite Pharma

Daniel Velez, Corp QA Specialist,

Amgen

Marissa Dockendorf, Principal Scientist,

Merck

Mike Benecky, Sr Director, Global Regulatory Affairs,

GSK

Kimberly Crimin, Head, Advanced Analytics,

AbbVie

Nishtha Jain, Digital Technology and Product Consultant,

GSK

Brenden Alexander, Manager, NA Engineering and Strategic

Projects, Sanofi

Rasmus Hogreffe, Head of Virtual Clinical Trials,

LEO Innovation Lab

Manish Saxena, Consulting VP – Pharma & Medical Device

Transformation, Predana LLC

Luiz Barberini, Operations Manager - External Manufacturing Latin America,

Bayer SA - Brasil

Eileen Cortes, Director – QA Global Validation,

Biomarin

Dr. Gunjan Bhardwaj, Founder and CEO,

Innoplexus

Featured presenters, moderators and panelists:


Dear Pharma specialist,

The evolving and strict regulatory landscape within the pharma sector has led to many organizations remaining cautious when adopting emerging technology.

However, recent years has seen falling R&D productivity, cost increases, compliance and non-adherence challenges, patents expiring and stakeholder expectations evolving which is driving the pharma sector to focus their energy on IoT (Internet of Things) and other emerging smart technologies.

The pharmaceutical industry is in fact, perfectly positioned to leverage IoT technologies across manufacturing plants, supply chains, delivery routes, clinical trials, R&D and many other areas.

Whilst some early adopters have already started exploring IoT to enable end-to-end digital integration across the supply chain, many are still wondering where to start and what to do.

Our IoT & Smart Pharma Summit will focus on:

Fundamentals of IoT: Knowing where to start and what to do IoT for manufacturing & supply chain optimization IoT for clinical trials R&D IoT and the future of smart labs

Ensure you secure your place at the conference to network and discuss with your peers and competitors who may have already solved some of your common challenges.

I will look forward to meeting you in Boston in October.

Many thanks

Mark GilesManaging DirectorIoT & Smart Pharma Summit 2020

IoT Pharma Summit 2020 is designed for C Suite, VP’s, Presidents, Heads, Directors, Team Leaders and Senior Scientists from:

IoT Digital Strategy & Transformation Analytics, AI & Machine Learning Digital Innovation and Emerging Technology Manufacturing Plant Supply Chain Clinical Trials Research & Development Smart Labs Data Management, Data Governance & Data Science Patient Centricity Cloud Regulation Business Development Commercial Affairs

Our sponsors, technology & solution providers include:

IoT Hardware, Sensors and Device Components Data - Storage/Platforms/Collection/Security/Integrity Machine intelligence/AI/Machine Learning IoT Platforms and Infrastructure IoT Applications Cloud Computing Mobile Devices Integrators Augmented Reality & Wearables Cyber Security Clinical Trials Manufacturing


Mini Symposium: Monday, 12 October 2020 (12:30 – 17:00)

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 toaddress these during the course of the day.

13.30 SESSION 1

13:30 The Potential of Artificial Intelligence / Machine Learning in Life SciencesPresented 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, andadvisor for a prominent online innovation management journal and was a member of the scientific advisory board of a US based not for profit instituteresearching in complexity sciences in the healthcare industry.

14:15 Q&A, Discussion

14:30 Refreshment break

Artificial Intelligence in Life Sciences: Cost-Benefit of Implementation and Avoiding Common Pitfalls

PROGRAM AND AGENDA

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.

“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.


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 doPresented 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 morethan 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 immunotherapypipeline in cancer 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 cancers, regardless of biology, gaining approval in 22 indications. She has alsosuccessfully launched five products globally which have achieved over USD 1B in sales. Through these efforts, she has excelled in bringing new drugs to market andsignificantly 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.


DAY ONE: TUESDAY 13 OCTOBER 202007:30 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

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? 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, GSKBrenden Alexander, Manager, NA Engineering and Strategic Projects, SanofiMike Benecky, Sr Director, Global Regulatory Affairs, GSKManish Saxena, Consulting VP – Pharma & Medical Device Transformation, Predana LLCPrasenjeet Sarkar, Sr Director of Manufacturing and PD IT, Kite PharmaSharin Roth, Director, Otsuka Pharmaceutical Development & Commercialization, Inc.

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DAY ONE: TUESDAY 13 OCTOBER 202009:40 Spotlight Presentation Proudly Hosted by Innoplexus

10:10 MORNING COFFEE BREAK AND NETWORKING

10:40 Consumer & patient experience: Leveraging IoT, Wearables and Sensors for the greater good How can IoT help make a connected experience for a customer or patient? Managing the tsunami of data that IoT creates Leveraging machine learning and artificial intelligence to predict what’s happening with consumers and patients

Robert Boland, Executive Director, Head of Digital Delivery & Data, Quality and Business Services, CSL Behring

11:30 Organizational assessment and analysis to uncover unique problems and identify potential use cases for IoT Critical requirements of Leadership, Board of Directors and Investors: Ensuring leaders responsible for developing the digital strategy pathway understand IoT in context

rather than a separate piece of the puzzle Creating cross functional teams and collaboration that bridges the strategic drivers into operational effectiveness Matching needs assessment with actual IoT applications that can be tracked throughout development and deployment stages

Cornelia Thieme, Director, Global Manufacturing Science, Biogen

11:40 Spotlight Presentation Proudly Hosted by Larsen & Toubro Infotech (LTI)Siddharth Bohra, Chief Business Officer - Tech, Media, Consumer & Life Sciences, Larsen & Toubro Infotech (LTI)

12:10 LUNCH BREAK AND NETWORKING

13:10 IoT Journey from POC to Pilot Overview of the pharmaceutical product in development and project timelines Business case: Identifying current challenges and how IoT solutions can drive value Build vs. buy: Evaluating internal capabilities to develop solutions vs. vendors Vendor selection: Assessing customized solutions vs. off the shelf products Proof of concept: Validating quality, scalability, ease of use and overall fit Pilot: Taking a staged approach to roll-out

13:40 Spotlight Presentation Proudly Hosted by Dassault Systèmes


DAY ONE: TUESDAY 13 OCTOBER 202014:10 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 andservices 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 TechnologySandeep 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


08:00 REGISTRATION, COFFEE AND NETWORKING09:00 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 to optimize clinical trials and improve patient outcomes Rasmus Hogreffe, Head of Virtual Clinical Trials, LEO Innovation Lab

Automating the factory floor Manish Saxena, Consulting VP – Pharma & Medical Device Transformation, Predana LLC

09:45 Regulatory considerations for IoT and medical app development within clinical trials Mike Benecky, Sr Director, Global Regulatory Affairs, GSK

Advancing the IoT Agenda: Relationship management and building trust with external partners and suppliersLuiz 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 Nishtha Jain, Digital Technology and Product Consultant, GSK

Security and risk management: Developing a data privacy, security, and vulnerability management process Daniel Velez, Corp QA Specialist, Amgen

11:25 ROUNDTABLE 1:Scalability: From pilot to full-scale rollout

ROUNDTABLE 2:Use of AI in early clinical development and drug discovery

ROUNDTABLE 3:IoT for predictive and preventative maintenance: Asset intelligence, condition monitoring and remote maintenance Prasenjeet Sarkar, Sr Director of Manufacturing and PD IT, Kite Pharma

ROUNDTABLE 4:Roundtable Discussion: Data IntegrityDaniel Velez, Corp QA Specialist, Amgen

12:00 ROUNDTABLE 5:IoT for surveillance: Monitoring equipment, instrumentation, methods and environmental variables

ROUNDTABLE 6:Enabling the Smart Lab to thrive through IoT

ROUNDTABLE 7:Leveraging IoT and Technology to optimize external manufacturingLuiz Barberini, Head of External Manufacturing - Latin America, Bayer AG

ROUNDTABLE 8:Multi-site monitoring to improve operational efficiency and reduce site downtime

13:00 LUNCH BREAK AND NETWORKING14:00 IoT and technology in CAR-T

Manish Saxena, Consulting VP – Pharma & Medical Device Transformation, Predana LL

Plant optimization: Implementing IoT technologies into manufacturing & supply chain to enhance productivity and drive down costs

14:35 Advanced analytics for the monitoring of clinical trials Kimberly Crimin, Head, Advanced Analytics, AbbVie

Data & analytics and compliance: Maximizing operational intelligence, gaining deeper business insights and optimizing decisions Eileen Cortes, Director – QA Global Validation, Biomarin

15:10 AFTERNOON COFFEE AND NETWORKING BREAK15:40 Optimizing patient centricity in clinical trials through IoT and mobile applications

Marissa Dockendorf, Principal Scientist, MerckImplementing IoT enabled devices to create smart supply chain: From shipment, transit to delivery

16:15 CLOSING REMARKS FROM THE CONFERENCE CHAIR AND CLOSE OF THE CONFERENCE

DAY TWO: WEDNESDAY 14 OCTOBER 2020


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:

Invitation only ensuring IoT, Smart Pharma and Technology is their number one priority

Strict qualification criteria which guarantees seniority, budget, investment plans and technology requirement

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


Sponsors

Platinum Sponsor:

Sponsors: 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 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

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 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/


12 – 14 OCTOBER 2020 | BOSTON, MASSACHUSETTS

Phone: +44 (0)113 2647 914

Email: [email protected]

Web: www.futurepharmaiot.com

Post: copy this form once filled in and send to: Richard Jones, AMG World, Aldgate Tower, 2 Leman Street, Aldgate, London, E1 8FA

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IoT & SMART PHARMASUMMIT 2020

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Documents

INTEGRATING IOT AND SMART PHARMA TECHNOLOGY TO · Describing why data integration is critical to IoT success and the fundamental IoT challenges Creating a well-defined strategy for