Gilead_Digital Health Stanford Final_PREZENTIUM.pptx

Gilead

1. Digital Health 2.0 Strategy – Master Deck Prepared for Gilead 16 th December 2022

2. Content Section 2 : Digital Health to support patients in Oncology Clinical trials   Section 1 : Digital Health

3. Digital Health solutions have demonstrated significant value for patients – in Oncology and other TAs We believe pharma companies can distinguish themselves by the support provided beyond the drug The Digital Health opportunity Takeaway: We examined our entire pipeline and product ecosystem to identify where and how digital health efforts can most improve the quality of our patients’ lives today and tomorrow. In this quest, we’re prepared to take measured risks, learn vital lessons, and innovate faster to improve clinical trial outcomes. Digital health has the potential to accelerate research Digital tools are proven to help support enrollment, improve retention, and ultimately, bring life-changing medicines to patients faster and more efficiently.

4. Digital Health focus Core focus Support clinical trials with digital therapeutics for patients on a drug only trial Support clinical trial of DTx  applications that may be launched in a commercial setting as a companion to the drug or a standalone Lifestyle technologies for wellness and health-related purposes Evidence based technology that measures or intervenes to help patients Deliver actual therapeutic interventions to treat or prevent disease Digital Health Digital Medicine Digital Therapeutics Fitness Apps Adherence Reminders Symptom Management

5. Digital Health is proven to improve outcomes for patients, and go beyond the drug Access to patients WHOLE TREATMENT EFFECT Time Clinical effect Digital Intervention Digital Intervention Digital Intervention INDIVIDUAL EFFECT Preferences Social - phenotype Circumstance CURRENT % SHARE OF PATIENTS FUTURE + % SHARE OF PATIENTS Individual effect Additional factors, collectively have a larger impact on outcomes, opportunity for evidence-based digital interventions to address limits in care experience Whole treatment effect Tending to the whole patient enables Gilead to bridge the gap serving the whole treatment effect Clinical effect Treatment provision accounts for only ~20% of health outcomes Source: Sean R. Zion and Alia J. Crum 2018: Fig.1 on Page 4

6. Operates within the Tech and Innovation Organization (part of Clinical Operations) Gilead’s Digital Health team Part of broader team that includes… Health Equity/ Diversity Inclusion Real World Data Patient Experience Decentralized Trials Digital Health

7. Digital Health Mission Our mission is to transform clinical trials to be more human centric by identifying innovative technologies and processes that improve patient outcomes

8. Patient/Site Facing Capabilities Enterprise Foundational Enablers Cybersecurity, Privacy & Regulatory AI and Machine Learning^ Centralized Data Management Decentralized Trials Data Interoperability Big Data Enabling Ecosystem Patient Monitoring Patient and Site Engagement Patient Adherence Patient And Site Facing Capabilities And Enterprise Foundational Enablers Patient Education Patient Behavioral Mod Electronic – Clinical Outcome Assessment Digital Endpoints^ Care Reminders Medication Adherence Augmented/Virtual Reality & Gamification Mindfulness and Stress Management Recruitment Compliance Analytics and Interventions* Patient/HCP Communication * Site’s ability to analyze patient adherence compliance data and initiate direct interventions ^ Digital Endpoints cover devices and wearables

9. Digital Twin – Innovation to expedite Clinical trials using Real World data and Big data How does Digital twin function? 1 2 3 The patient enroll in a clinical trial, and visits the sites to have baseline data collected The Digital twin is created after the first visit, the patient returns to the site to have data collected throughout the trial The Digital twin’s trajectory can be compared with the actual patient’s record at the end of trial How does Digital twin benefit Clinical trials? Make trials more Patient-centric Increase Power and confidence Shorten enrollment timelines A Digital Twin is a comprehensive,  longitudinal, and computationally  generated clinical record that describes what would have happened if a specific patient had received a placebo Digital Twin have not been applied in Oncology yet Source: Unlearn

10. Chatbots have potential to use across clinical trial journey to reduce patient and site burden Screening & recruitment Finding the right patient Enrollment Enrolling right patient to the trial Monitoring Ongoing monitoring of patient conditions Medication Adherence Helping patient to stay on drugs Medical Information Providing medication & disease information to patients A Chatbot is an AI system that can hold a conversation with a person, usually over the internet Use of Chatbot in Clinical Trials Sources are in speaker notes

11. Virtual Reality (VR)/Augmented Reality (AR) creates an immersing artificial environment for users mixed with real environment VR/AR can help cancer patients with Patient Engagement & Adherence Chronic Pain Management 1,4 Solutions could help guided mindfulness to treat chronic pain in cancer patients Mental Health Support 1 ,2,3 Solutions that use VR tools to provide support related to Anxiety, Depression and other mental health conditions in cancer patients Treatment Rehabilitation 4,5,6,7 Solutions helping cancer patients in rehabilitation set-up after surgery, chemo/ immune/radiation therapy Rehabilitation include improvement in cognitive impairment, pain, physical & mental health Use of AR/VR in Clinical Trials Use case of AR/VR in clinical trials for oncology is limited. However, experience from healthcare practice would expand R&D application in future Sources are in speakers notes

12. Our Digital Health Approach 1. Work with cross-functional team to Identify Priority Disease areas within each TA 2. Understand the pain points and possibilities for stakeholders for the Priority disease areas 3. Perform/Leverage landscape analysis of solution providers for the domain 4. Pilot the solution for the disease area 5. Evaluate relevancy / usability within TA and across TAs

13. Section 2: Digital Health to support patients in Oncology Clinical trials  

14. Why adoption in digital in Oncology trials less/limited? Complexity in Digital Health Impacts to Development of complex processes and stringent regulation Impact on organization of HCP team ways of working Time demanding Specific educational program needed for implementation Tedious consultations tracking with each visit Dealing with IT team due to complexity of systems Additional clinical evidence for efficacy and safety Evaluation of digital therapeutics needed Patient Physician/ Nurse Pharma Industry/eco-system These challenges must be addressed individually to scale up Digital Health application

15. https://www.internationalcancercluster.org/uploads/9/8/5/8/98582788/kaiku_health_icss_pitch__1__1.pdf Digital Health proven to increase lifespan for Oncology patients Takeaway: Our Digital Health Team has evaluated DTx Solutions that can be used to support our oncology Clinical Trial patients and improve QoL without burdening the trial. Digital Interventions Show a Significant Potential Improving Clinical Outcomes in Oncology 5 Oncology’s unique challenges require new approaches, and old methods may not work Digital health can help modernize and simplify execution Use of digital health has increased lifespan of oncology patients by 5.2 months Evidence from literature: A randomized controlled trial with 766 metastatic cancer patients shows that a digital symptom monitoring (non-commercial research tool) during chemotherapy helps patients live longer (5.2 months longer median overall survival), improves quality of life (31% of patients), and reduces hospitalization (4%) and ER visits (7%) 2 20 80 100 60 40 1 3 4 6 7 8 Overall survival probability, % Years from enrollment Log-rank test: P=0.03, hazard ratio: 0.83 (95% Cl, 0.70-0.99; P=0.04) Source: Bash E, Deal AM, Dueck AC, Scher HI, Kris MG, Hudis C, Scharg D.Overall Survival Results of trial assessing Patient-Reported Outcomes for Symptom Monitoring During Routine Cancer Treatment. JAMA. 2017 Jul; 318(2): 197-198. Patient-reported symptom monitoring Usual care SCIENTIFIC EVIDENCE

16. Gaming and VR for pediatric cancer patients AI driven symptom and AE reporting AI analysis of CT scans to improve NSCLC diagnosis App to treat cancer-related anxiety and depression (w/MSK) Breast cancer treatment side effect reduction Edu and AE reporting via remote pt. monitoring Symptoms Mngt through analytics-driven PRO Wearable in cancer trial to monitor physical activity Patient engagement in Oncology Prescription Digital Therapeutic (PDT) for management of cancer symptoms Chatbot to provide medical information Takeaway: Our Digital Health Team has performed the landscape Analysis and will be performing prioritized experiments to accelerate the solutions to enable the clinical Study outcomes Oncology solutions on our radar Current Digital Health Landscape Patient Monitoring Patient Adherence Patient and Site Engagement Lee Health VR Gaming Sidekick BBK Worldwide Memora Health Kaiku Health and Novartis Collaborate Oleena® Huma / Bayer Moovcare Blue Note Therapeutics Attune Wefight Actigraph

17. Use of VR for mindfulness and treatment adherence Industry example Lee Health is a not-for-profit health system in Florida Lee Health also provides telehealth/virtual care services to patients requiring primary care Lee Health introduced virtual reality treatment room at Golisano Children’s Health Center The goal of the room is to create a soothing atmosphere to help make the 2-to-6-hour chemotherapy treatments more comfortable for children Patients can also use the room to watch movies, play video games or video chat with friends and family while receiving their treatment Patient and Site Engagement Patient Adherence Patient Monitoring Sources: 1. Lee Health , 2. Globenewswire Lee Health has introduced virtual reality treatment room for pediatric cancer patients undergoing chemotherapy About 1 Use Case 2

18. Digital Health Case Study for Patient Engagement Industry example Patient and Site Engagement Patient Adherence Patient Monitoring TCN centralizes the operations, data and management of patient recruitment and patient and site engagement  programs TCN has a suite of modules that provides sponsors and sites with real-time visibility into performance, from media and referral management to patient reimbursement and travel The platform provides engagement services for: Travel & reimbursement resources Study alerts Appointment & medication reminders Visit-by-visit guides Educational resources & videos Gamification About 1 Use Case 2 Cellectar Biosciences has partnered with BBK to provide patient concierge services for patients participating in clinical trials BBK’s services has been used for pivotal trial of iopofosine for Waldenstrom macroglobulinemia, a rare Oncology condition Sources: 1. BBK Worldwide 2. Cellectar Biosciences BBK – TrialCentralNet (TCN) platform provides patient recruitment and patient and site engagement services for clinical trials

19. Memora’s tool has been used in clinical trials for oncology as well as other TAs. Results for oncology are pending. Memora Health provides patient monitoring & adherence services to Oncology patients Industry example Partners/ Customers Value Proposition Providers Patient Adherence Helping patients through their care plan with automated, interactive guidance on oral therapies Patient Monitoring Real-time monitoring of symptoms and adverse events Health Plans HealthTech Automation Using automation to help care team focus on urgent and complex patient issues Patient and Site Engagement Patient Adherence Patient Monitoring

20. Adverse event report management tool Industry example Sources: 1. Sidekick Health , 2. prnewswire Patient and Site Engagement Patient Adherence Patient Monitoring Sidekick Health is a digital therapeutics company that helps people prevent and manage chronic diseases Company leverages behavioral economics, gamification , and artificial intelligence for an engaging patient experience for behavior change Sidekick's digital therapeutics platform will aim to promote behavior modifications to improve the wellbeing of breast cancer patients as well as adherence to drug treatment, for example by managing side effects Sidekick and Lilly will launch the platform initially in Germany in 2023 followed by other geographies and expansion into other Therapy areas Sidekick has partnered with Eli Lilly to provide a personalized treatment plan for patients with breast cancer in Germany About 1 Use Case 2

21. Digital Health Case Study for Patient Engagement Industry example Patient and Site Engagement Patient Adherence Patient Monitoring Improve patients’ compliance to 80-95% Provide HCPs real-time symptom information, allowing early intervention  Machine learning model to predict development of toxicities Digital symptom monitoring during chemotherapy helps patients live longer (5.2 months longer median overall survival), improves quality of life (31% of patients), and reduces hospitalization (4%) and ER visits (7%). Kaiku Health – app used in a phase III clinical trial for symptom monitoring and patient engagement  Use case  Results Symptom monitoring and QoL questionnaires for melanoma study Sponsor collaborator: BMS

22. Currently undergoing clinical trials but has received FDA authorization for use during COVID-19 pandemic Blue Note Therapeutics’ Attune App: Cognitive behavioral test to help patients with depression and anxiety management Industry example Value Proposition Effective coping skills Animated lesson modules to provide education and management of emotions associated with cancer diagnosis through treatment Support from community Connection with fellow program peers to facilitate discussion of experiences Accessibility Treatment app tailor to one need is accessible from any smart device About Prescription based Cognitive Behavioral Stress Management (CBSM) program designed for cancer patients First DTx program designed for depression and anxiety related to cancer Patient and Site Engagement Patient Adherence Patient Monitoring

23. Determined as Class II medical device falling under enforcement discretion per FDA Guidance in 2019 Oleena is first DTx approved in Oncology using algorithm-based recommendations for symptoms management Industry example Patient and Site Engagement Patient Adherence Patient Monitoring Real-time Real time and continuous access to education and advice adapted to patients needs Automated and Adaptive insights Customized platform that centralizes patient reported data and triggers appropriate alerts for timely clinical interventions Better care Timely and informed interventions to enhance quality of care, improve clinical outcomes and reduce costs About A prescription mobile app to manage symptoms and remote patient monitoring in cancer patients through real time recommendations Customizable platform for the care team with automated notifications and alerts Value Proposition

24. Moovcare is a CE mark device focusing on relapse or complication in Lung cancer patients Moovcare provides symptoms management services through analytics-driven PRO services Sources: 1. Moovcare , 2. BMS , 3. CT.gov Industry example Patient and Site Engagement Patient Adherence Patient Monitoring Mobile/web application to enter weekly PRO data to platform to analyze symptoms Platform detects anomaly and alert care team to further investigation In March 2020, BMS France has signed exclusive agreement with Sivan to deploy Moovcare web application in hospitals across France 2 Moovcare mobile application is being used in Lung cancer trial Moovcare is not FDA approved, and its role in improving clinical care is being studied through this research Moovcare automatically delivers electronic patient reported outcome (ePRO) surveys on common symptoms experienced by lung cancer patients. About 1 Use Case 3

25. Use of chatbot to provide medical information Industry example Sources: 1. Wefight , 2. CT.gov Patient and Site Engagement Patient Adherence Patient Monitoring Wefight’s Vik Chatbot helps patients to identify right clinical trials for eligible patients and helps with ongoing patient monitoring activities The chatbot has been used for multiple conditions like Breast Cancer, Atopic Dermatitis, Asthma, Mental health etc. in clinical trials and practice for v alidation of chatbot to provide correct medical information to breast cancer patients Wefight has done an observational clinical trial in France to validate Vik’s ability to provide correct medical information to breast cancer patients Endpoint : The quality of the participating patient's information about disease and treatment will be assessed using the standardized EORTC QLQ-INFO25 survey in both groups About 1 Use Case 2

26. Use of wearables in cancer trials to monitor physical activity Industry example Sources: 1. Actigraph , 2. Journal of Science and Medicine in Sport Patient and Site Engagement Patient Adherence Patient Monitoring Actigraph devices are used in a randomized control trial to measure physical activity or rigor in cancer patients To assess whether moderate-to-vigorous intensity physical activity (MVPA) change in cancer survivors was maintained 12-weeks following the Wearable Activity Technology and Action Planning (WATAAP) intervention MVPA and sedentary behavior were assessed using Actigraph at baseline, the end of the intervention (12-weeks), and at 24-weeks Distance-based interventions using ActiGraph produce increases in MVPA that endure at least 12-weeks after the intervention is completed Use case objective and methodology Use case

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28. Qure.AI algorithm does AI driven analysis of x-rays and CT scans to diagnose lung cancer Industry example Value Proposition 1 AI-driven analysis of chest X-rays & CT scans for early detection of lung cancer Helped providers with clinical workflow integration and diagnosis Offerings 1,2 qTrack A lung health management platform that enables effective disease response by providing ready access to all patient information to relevant stakeholders qCT AI for lung nodules that empowers screening programs and facilitates incidental screening for early detection of lung cancer from CT scans qXR AI for chest X-rays that helps in the detection of multiple abnormal findings on a chest X-ray in less than 1 minute Impact 2 60+ c ountries 8M+ scans to train the algorithm 10M+ lives touched 600+ care centers use the services 1 2 3 Patient and Site Engagement Patient Adherence Patient Monitoring Sources are in speaker notes AstraZeneca has partnered with Qure.AI to deploy lung cancer detection tool in emerging markets in Asia, Latin America, Middle East & Africa 3,4

29. Section 3: Digital Health to support patient in Virology and Immunology Clinical trials   OPTION 2 Note: slide 2 text replaced as option 2 Section 1: Digital Health to support patient   Section 2: Digital Health to support patient in Oncology Clinical trials   Tom

30. Significant increases in engagement in care (top) and in HIV viral load suppression (bottom) over one year of follow-up (n=77) Digital Health improves outcomes for people living with HIV For patients who can utilize an adherence and support app Retention in Care Among Participants Viral Suppression Among Participants Stigma scores are improved with increased used of the community message board.* Social support is sought and provided regularly. ** Dillingham et al, AIDS Pat Care STDs 2018, *Flickinger et al AIDS Behav 2018, ** Flickinger et al AIDS Behav. 2017, ***Flickingeret al Telemed & eHealth 2019

31. Resources for physicians to help diagnosis and treat patients Injection reminders, PRO collection Support & edu for HIV patients InSight AI algorithm to predict risk of sepsis based on vital signs myIBDCoach eLearning for adherence, symptom mngt , depression and more Longitudinal online symptom tracking Constant Care IBD disease activity monitoring and learning modules HealthPROMISE Tracks patient symptoms and integrates with EMR HIV adherence ap for oral meds Life4me Prevention information and self-monitoring Big Data in IBD Fine-tune treatment to impact cost, health and safety ViiV PROgress PROs in HIV Care to help HCP interactions MyIBDCoach Medisafe HUMIRA Complete TrueColours UC AETC Big Data in IBD Constant Care Life4me Smartpatient ViiV PROgress Virology and Immunology – selected solutions on our radar Inflammation Virology Current Digital Health Landscape Use case Medication Adherence AE and Symptom Management Monitoring and Diagnosis Patient Engagement and support Health Promise Sepsis | Dascena

32. Case Study for Virology Case study for Virology – Patient Engagement Placeholder slide for Case study for Virology – Patient Engagement Insert Text Here Insert Text Here Insert Text Here

33. Study objective Methodology Results Effects of early integrated palliative Care in Patients with Lung Cancer A study was conducted where patients with newly diagnosed incurable lung cancer were randomly assigned to receive either early integrated palliative care and Oncology care or usual care Digital modality: ePRO Primary end point: Change in quality of life (QOL) from baseline to week 12 Secondary end points: Change in QOL from baseline to week 24 Change in depression per the Patient Health Questionnaire-9, and differences in end-of-life communication Intervention patients reported lower distress from baseline to week 24   For patients with newly diagnosed incurable cancers, early integrated PC improved QOL and other salient outcomes QOL measurement: 27-item Functional Assessment of Cancer Therapy-General (FACT-G) scale, which assesses four dimensions of QOL (physical, functional, emotional, and social well-being) Higher score signify superior quality of life and vice-versa Mood and anxiety: Patient Health Questionnaire-9 (PHQ-9) Hospital Anxiety and Depression Scale (HADS) Lower score signify no distress Intervention patients reported greater improvement in QOL from baseline to week 24   Sources: 1. National Health Library

34. ICON – FIRECREST learning management system helps to increase patient understanding of trial specific aspects and commitments. It also features an option for patients to query the details on procedures to truly engage in the process. Digital Health Case Study for Patient Engagement A mid sized Pharma organization was conducting a Phase IB trial with plans to enroll 188 Non-Small Cell Lung Carcinoma patients. The study presented with challenges from the outset. Most notably screening activities were extremely slow. Consequently, the LPI target date was in danger of being missed ICON deployed localized Site Engagement Liaisons (SELs) to identify and analyze the issues that were causing this slow down in screening activities. They were able to review the issues and to support immediate actionable tactics within a three-week period Industry example There was a notable increase in performing sites by up to 71.8%. Site enrollment rates doubled which had the knock-on affect of the screening phase being completed 9 weeks ahead of schedule Sources: 1. ICON case study Patient and Site Engagement Patient Adherence Patient Monitoring Use case 1   Results

35. Recruitment acceleration with Chatbot use in Clinical trials C hatbots in clinical recruitment have an enormous advantage in converting warm leads into trial participants leading to faster recruitment Information from outreach is collected through complex web form which either takes away interest or leads to low quality leads as they don’t understand questions well Trial Coordinator contact each patient individually Pre-screening is done through phone/email Chatbots are omnichannel and can operate across multiple major platforms (FB, Slack, WordPress, etc.) all at once Chatbots can help in the optimization of the lead generation process Chatbots can capture all possible leads whether they are from mobile, desktop or tablet Separate outreach plan is creating through each mode like websites, advertisement etc. Lead generation plan is usually complex which leads to investment of time and money for creation Sources: 1 , 2 , 3 , Pre-recruitment outreach Post-recruitment outreach ~40% Trial budget allocated for patient recruitment 1 $19.5K Cost of replacing one patient lost due to non-compliace 2 $1Mn Potential average savings in Oncology Phase II trials by gaining efficiency of mere 5% in recruitment rate through Chatbot Assumption – Average cost of Phase II Oncology Trials is $50Mn Chatbots can help coordinator pre-qualify leads by asking screening questions during the conversation to filter out non-qualified leads Chatbots can provide instant responses to frequently asked questions, eliminating the phone calls and the back and forth by email $11Bn Savings in Healthcare sector through use of Chatbot in 2023 3 Use of Chatbot In traditional setting Patient and Site Engagement Patient Adherence Patient Monitoring

36. Use of chatbot to provide medication adherence & symptoms management Industry example LifeLink Systems provides personalized “conversational” services for clinical care workflow to improve patient engagements The platform provides customizable conversational services linked with patient interactions, EHR & CRM Provides services to both providers and life sciences companies Conversational tool used as intervention to monitor NSCLC patients for medication adherence and symptoms management Sponsor collaborator: University of Pennsylvania/ Pfizer University of Pennsylvania & Pfizer used LifeLink’s conversational tool as an intervention to identify effective strategies to help patients with lung cancer manage side effects and achieve optimal adherence to oral targeted therapies via text messages Algorithm monitors and manages reported symptoms High-grade symptoms are triaged directly to the patients' cancer care team Sources: 1. LifeLink Systems , 2. CT.gov Patient and Site Engagement Patient Adherence Patient Monitoring ZS About 1 Use Case 2

37. Takeda Using Chatbot To Improve Patient - Centricity And Trial Design Sponsor collaborator: Takeda Patient Engagement and support Industry example Chatbot provides integrated and continuous support for patients with chronic diseases at risk of serious events and ER visits App is integrated with a dashboard, connected to sensor and wearable options Under development - future enhancements intended to help patients better understand their prognosis and provide improved support https://www.clinicalresearchnewsonline.com/news/2021/03/29/takeda-using-chatbot-to-improve-patient-centricity-and-trial-design Patient and Site Engagement Patient Adherence Patient Monitoring Use case  Results 

38. Sleep and Activity monitoring through wearable devices Early detection of complication To reduce occurrence of serious adverse event Other Key measurements Like stress monitoring, dehydration etc. Activity Tracking Physical activity and ambulatory tracking of medically-related data Real-time measurement To support continuous informed decision Cost effective and Scalable Easy to implement with low impact on Sponsor pocket Wearables or Mobile Health comprises of devices that enable wireless communication or data transmission to accurately measure true patient experience Benefits of Wearables over current technology Clinicians have struggled to measure symptoms like pain, fatigue, low mood etc. as current existing technology fails to reflect true patient experience Patient and Site Engagement Patient Adherence Patient Monitoring

39. Huma and Bayer to build an AI-powered CT scan analysis tool to improve NSCLC diagnoses Use case  Results Monitoring and Diagnosis Check w Joe… is this applicable in several years Industry example Bayer and Huma will co-develop a ML model that can distinguish between different forms of non-small-cell lung cancer in imaging data Will initially use AI to identify the distinguishing characteristics of each form of lung cancer, and build machine learning tools around those findings The goal is to both speed up lung cancer diagnoses and make them more precise and avoid repeated cancer-characterizing tests, which are often invasive and costly Work currently ongoing Patient and Site Engagement Patient Adherence Patient Monitoring Sponsor collaborator: Bayer ZS Develop Artificial Intelligence and Machine Learning models to analyze app and wearable-collected health data in combination with EHRs to help diagnosis NSCLC Bayer is a significant investor in Huma

40. Digital Twin Application in Healthcare Source: `https://hal.archives-ouvertes.fr/hal-03549320/document https://www.unlearn.ai/post/unlearn-signs-multi-year-collaboration-with-merck-kgaa-darmstadt-germany-to-accelerate-immunology-trials-using-twintelligent-rcts-tm https://www.appliedclinicaltrialsonline.com/view/debunking-top-5-myths-about-digital-twins-in-clinical-trials https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9586248/ A personalized tool for diagnosing  breast cancer using temperature data 1 Diagnosis Using multimodal datasets to optimize treatment pathway for accurate drug recommendation in NSCLC patients 4 Treatment recommendation Faster and efficient trials by reducing control arm size, trial time for approval and label expansion 2,3 Clinical Trials

41. Digital Twin can be leveraged as an improved version of External Control Arm in clinical trials About Uses external data AI enabled algorithm process information to create digital twin to reduce arm size No Issue of confounding variables and bias, reducing false positives and high chances of regulatory acceptance Digital Twin Process Baseline data collected during patient’s 1 st visit Digital twin created Model will run algorithm Train & validate ML model basis on historical patient data External Control Arms (ECA) Uses external data Do not use AI ; help in reducing arm size by reducing control arm Data are populated with patients who were not in the original patient sample of the trial Chances of having confounding variables and bias, leading to false positives and limited regulatory acceptance Usually preferred for early-stage trials or trials where difficult to enroll patients in control arm Subset of patients from the external control population with similar propensity scores to those in the study population is selected to create an ECA Adding an ECA to a clinical allows more trial patients to take the experimental treatment