1:22 Deliverables

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Apr 3, 2024

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Eric: Drug Development Process 1- Hybrid/Virtual & decentralized recruitment (eRecruitment, remote monitoring solutions) Strengths:  Patients like convenient and patient- centric accommodations: Being sent medications directly to their homes, engaging with research professionals through telehealth services, receiving care from visiting nurses, collecting lab samples at home, and use of mobile applications. For patients, the more flexible the clinical trial, the happier they are  Limiting the number of required site visits lowers travel time, as more than 70% of the American population lives more than two hours away from a research site. By limiting travel time and the number of site visits, patients with inflexible work schedules can now participate. This will also help with a trial’s recruitment goals as 85% of clinical trials fail to meet their recruitment goals and can add almost 11 months of delays for late-stage trials, driving up operational costs and delaying time to market  A study by the Tufts Center for the Study of Drug Development said that decentralized phase 2 studies are completed one to three months faster than traditional trials. The t ime savings yield “a net benefit that is up to five times greater than the upfront investment required,” the study said. Decentralized phase 3 trials also finish more quickly than site-based equivalents. “Similar time savings yields a net benefit that is up to 14 times greater than the upfront investment required," the researchers wrote. Weaknesses:  Finding and keeping patients in clinical trials is difficult, and recruitment is not becoming any easier with the trend toward increasingly complex trials  In person trials are complex as is, so decentralized trials can be more complex or at least at the beginning when everyone is getting familiarized Opportunities:  Accelerate patient recruitment by Threats:  Patient attitude — some patients may

making it easier to find potential participants in areas where travel is difficult for them. More patients would be able and willing to take part if participation is easier, reducing the recruitment burden on CROs and sponsors. Example would be social media advertisement  Studies by Tufts and JAMA in recent years calculate the average cost to bring a drug to market to more than a billion dollars. Opportunity to counteract some of these rising research costs and allow manufacturers to invest in a broader range of life-changing therapies  The study suggests decentralized trials have faster recruitment and higher retention rates than traditional studies. Plus, the decentralized versions need fewer review boards, which lowers regulatory costs and provides increased flexibility for protocol changes. be more comfortable being seen in person, especially where they’re unsure about using technology. This applies for the elderly, or people participating in a trial for the first time  In the 2021 Florence State of the Industry Survey, 68% of research sites, sponsors, and CROs said they worried about the cost of new technology. The unclear ROI on the new technology was a major concern about investing in technology. Technology will usually require a large upfront investment. But you can make that investment more satisfying to your organization’s leaders by talking to software vendors about the ROI their other customers have seen. Good investment?: Yes, I do think that decentralized trials would be a fantastic investment. With the removal of the geographic boundary imposed by site locations, decentralized trials expand access to a larger and more diverse patient population, who were not previously candidates for clinical research solely due to their location. Broadened trial access allows CROs to reach a bigger number and perhaps a more diverse pool of patients . The removal of a geographic boundary also changes the type of advertising and outreach needed to reach patients. Decentralized trials enable the redirection of recruiting efforts from traditional, local advertising to partnering with specific online patient advocacy groups to find qualified candidates. While it’s important to be aware of these challenges, the benefits decentralized trials offer for patient recruitment and retention arguably outweigh potential risks which – with the right partners, vendors, and approach – can be mitigated. Market metrics: A WCG survey showed that 94% of research sites have adopted at least one decentralized method , and 88% of sites have already hosted hybrid trials that combine remote technology and in-person site visits. In a recent survey by PPD , Thermo Fisher Scientific’s clinical research business: more than half (55%) of the 150 biotech and biopharma leaders surveyed noted that a top “pain point” they face is “challenges with patient recruitment in clinical trials.” Decentralization is part of the solution to this, providing a way to recruit participants. Respondents expected their clinical trials to be more decentralized in the future: the

respondents already running decentralized trials say an additional 24% will be decentralized by 2024, and those that have not yet started expect 27% to be decentralized by 2024. 2- Patient recruitment organizations (PRO) Strengths:  40% of the total cost of clinical trials is from recruitment and almost half of all research sites fail to meet recruitment goals, so PROs will be in much demand to help research sites enroll enough patients and keep them retained for the duration of the trial  Effective recruitment strategies will likely become increasingly important as therapies become more personalized and clinical trials need to draw smaller pools of patients Weaknesses:  Not guaranteed to get the necessary number of patients for a trial, if that happens then money is lost and the trial is delayed Opportunities:  Patient recruitment is very niche and so pharmaceutical companies may want to leverage a PRO for their specific expertise and to execute their patient recruitment strategy. PROs understand research sites and can optimize their marketing strategies to the specific trial.  There’s a concern that people of different ages, races, and ethnicities may react in different ways to drugs. PROs play a major role in these diversity and inclusion recruitment initiatives. They help with appropriate research site selection. Threats:  Lack of eligible patients for a specific trial  Dropout of patients which will increase cost of recruitment and delay trial Market metrics: Approximately 30% of patients drop out of clinical trials, resulting in heavy financial costs. On average, it costs $6,533 to recruit one patient to a clinical study , and the cost

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of replacing patients is even higher. The average cost to recruit a new patient if one is lost due to non-compliance is $19,533. Delays in product launch are estimated to result in an average loss of $8 million per day in opportunity costs for a drug. Good investment?: I think PROs can be a great investment as CROs will need much help recruiting patients especially with the development pf decentralized trials which could make people hesitate to enroll because they are unfamiliar with the technology. With more complex drugs being developed, there will be more need for certain people who can fit the criteria for those complex drugs and therefore will need PROs to find and recruit those people. Around 37% of research sites fail to meet enrollment goals, so PROs will have a lot of demand. There are some threats as many people might not be comfortable participating in a decentralized trial especially if it’s for a more complex drug, resulting in the trial not meeting recruitment goals, therefore will incur a hefty loss. However, as people become more familiarized with the technology, there will be more willing to join. 3- Trial logistics (non-recruitment) Strengths:  Samples must be maintained to preserve stability. If the sample is received outside of stability for any reason, it is rejected and produces no data toward the clinical trial objectives. In addition, patients need to redraw blood which can lead to dissatisfaction and potentially cause them to drop out of the trial. Weaknesses:  High cost of drug development and clinical trials will impede the growth of clinical trial logistics market  Increasing cost in patient management and scarcity of skilled professionals to execute services on time will likely limit the growth of the market Opportunities:  Growing cases of chronic diseases such as cardiovascular infections, malignant growth, obesity, and diabetes are leading to the increasing drug development & clinical drug trials, driving the logistics market  Increasing demand of clinical trials in emerging countries will increase demand of logistics to figure out multinational transportation of products Threats:  Increase in drug costs. Shipping costs for local labs are generally low, although you are unable to negotiate volume pricing. Global lab shipping costs v aries by the location, it can be moderate to high but is dependent of multiple factors and trade-offs  Site support for global labs can be limited due to language barriers and time zones  Significant risk in putting clinical packages into a global network without previously ensuring that the network in question is reliable and

offers not only appropriate handling but also alternatives. This vetting process is a critical component to the success of international clinical trials run through the central laboratory  Many events affect transportation and can easily become major bottlenecks when it comes to moving patient samples around the world. Strikes, extreme weather, natural disasters, political unrest can easily affect the ability of a laboratory to receive samples in a timely manner and test and report specimens within stability Market metrics: The logistics & distribution segment accounted for the largest share of 25.3% in 2022. The services segment is segmented into logistics & distribution, storage & retention, packaging, labeling, and blinding, manufacturing, comparator sourcing, and others. This is due to the rise in the global biologics pipeline, highly regulated structure of the market, and an increase in the usage of temperature-sensitive drugs are driving the market growth. Good investment?: Trial logistics seems attractive, but comes with many risks. There will be more demand for trial logistics as there is a rise in drug research. The increase in focus for companies to reduce costs will certainly help the logistics market. However, there are many things in the world that can go wrong and result in a complete disaster in the transportation of product. For me the rewards do not outweigh the risks and because of that concern I would not invest in the trial logistics segment.

4- Biometrics & biostatistics/bioinformatics (monthly review of clinical trials patients data, PK/PD) Strengths:  Statistical consultancy influences a sponsor’s clinical trial in several ways. The service offers independent, external statistical advice, and can cover all areas from optimizing study design, procedures and strategies, to the analysis of study data and informed interpretation of results. It is therefore recommended that statistical consultancy advice is sought from the inception of a clinical trial  Statistical consultant aims to help resolve any challenges and increase the chances of a successful outcome  Biometrics are a reliable method of identification that cannot be stolen or forgotten like passwords Weaknesses:  There are hundreds of government- certified EHR products but no national technical standards for capturing biometric images, encrypting biometric data in storage or transmission, or comparing and matching biometrics—all of which are necessary to facilitate the exchange of biometric information between different systems, known as interoperability Opportunities:  Adding biometrics to patients’ EHRs and using them alongside other demographic data (such as name, address, birthdate) could improve matching rates for several reasons. Fingerprints, faces, palms, irises, and other features are unique to individuals. These features change little, if at all, and are inseparable from the patient.  Allow for multiple collection methods such as a scanner on your phone or on-site  Collecting and storing clinical data in one place, or with one company, allows for a more efficient process. Integrating data handling activities across clinical data management, biostatistics and medical writing services allows for effective planning and communications across functions Threats:  Medical organizations need to be careful about data security issues. If sensitive information is exposed, the consequences can be severe. If someone’s password got hacked, the person can easily replace it. But if biometrics data got exposed, you cannot change someone’s eyeballs or fingerprints. You will likely need to replace the identification system or exclude the victim  It is often costly to acquire biometrics identification technology  Physical damage can render the body part involved in biometrics unusable

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 Voice biometrics can help businesses cut costs, increase efficiency and boost customer experience. By reducing the need for passwords and PINs, voice biometrics can help enterprises save time and money. And by providing a more secure authentication process, voice biometrics can help businesses reduce fraud and keep customer data safe. Market metrics: The global biometrics market size reached US$ 33.2 Billion in 2022. Looking forward, IMARC Group expects the market to reach US$ 87.4 Billion by 2028, exhibiting a growth rate (CAGR) of 17.36% during 2023-2028. Good investment?: Yes, this segment would be a good investment as there are tons of strengths and opportunities. Even though there are risks, they aren’t major and don’t have high chances of happening. Biometrics systems are gaining immense popularity across the globe as they are easy to use and implement, as well as provide a cost-effective solution for ensuring high-end security and assurance. Apart from this, biometrics technologies are extensively used in both governmental and private organizations, and institutional setups for door access, employee identification and marking attendance. They are also installed in high- security areas to safeguard the facility and reduce the risk of intrusion by identifying unknown people through automated biometrics recognition Kundana: Medical Device CRO Industry Overview SWOT Analysis: Hybrid/Virtual & Decentralized Recruitment (eRecruitment, remote monitoring solutions) Strengths Weaknesses  These platforms can reach more individuals than centralized trial options since it reduces in-person site  Specific devices are more adaptable for virtual recruitment features. For example, class I and II participants

visitations. This allows for more diverse study populations.  Data is collected and assessed through a “real-life” lens, determining appropriate candidates for specific devices.  Hybrid/virtual & decentralized recruitment features can be segmented into different stages (e.g., I, II, and II) with different classifications. They can also include all of them (the outreach calls can help solidify this). o For initial recruitment processes, eRecruitment platforms are standard; however, once participants have been selected, there is room for technological recruitment specialization. For example, if a sponsor is outsourcing recruitment for stage I (i.e., pilot) studies for crutches, individual conferencing solutions would be feasibl e can leverage virtual tools for device installations, while class III participants need to visit a central site for implantation.  Additional resources would need to be employed for individuals without internet access or smart technology devices (i.e., smartphones), which increases costs. Additionally, further training would be required for some medical devices.  Oversight is difficult when there are decentralized sites.  Options addressing decentralized recruitment for class III devices are starting to be conceptualized (one emerging space is the hybridization of post-implantation consultations; however, more research needs to be conducted for virtual implantation consultations)  Compromisation of PII and deviation from protocol. o Since many services in this stage are digitized, there is a higher risk of cyber breaches. Additionally, some participants might misuse the medical devices and unintentionally (or intentionally) input faulty information. This is where oversight is problematic . Opportunities Threats Market Metrics: Overall, virtual/hybrid & decentralized clinical trial recruitment is expected to reach a market size of $5B by 2027. Is it a Good Investment? The virtual/hybrid and decentralized clinical trial segment seems to be a good investment. This space is rapidly growing, and more patients want an option to participate in decentralized sites.

Two out of three device classifications (i.e., class I and some of class II) are suited for this type of recruitment and can be consulted through digital solutions. However, the only drawback is class III device accessibility. Most devices here have to be implanted or shown on-site, which can be a detractor for some individuals looking to participate. There are some emerging solutions to this inefficiency, but they will need some time to develop and implement. From a search fund perspective, getting ahead of this curve could prove fruitful and ultimately provide a non- negotiable service for testing class III devices. Since this research is in its initial stages, it would be best to acquire companies specializing in this research and other hybrid/virtual operations, so the established procedures can provide a revenue base to fund the class III research. Patient Recruitment Organizations (PRO) Strengths Weaknesses  Services are fragmented across the industry. This can include an emphasis on media planning, which is responsible for selecting the right combination of media channels to deliver and pique individuals’ interest in trial participation, copywriting and advertising, mining patient information data from electronic health records, etc.  Current feeds of patient information and administrative protocol are dispersed across different systems (e.g., Excel). This creates administrative fatigue, leading to 40- 50% of patients being lost in the screening stage.  AI, cloud, and machine learning capabilities can help reduce costs associated with patient recruitment and better select cohorts for testing. For example, AI programs can detect individuals on social media open to participating in a class III trial for a new pacemaker due to their posts about arrhythmia (essentially, AI and machine learning can “understand” the individual’s experience and use that information to create targeted marketing opportunities).  If a patient were to drop out, replacing them would cost an additional fee. This means PROs must be precise, which is difficult because recruitment is based on behavioral phenomena. However, as Adnan mentioned in Thursday’s meeting, if we can find a PRO that provides exceptional service, this would be a high-worth investment to acquire. Opportunities Threats Market Metrics: This sector is expected to reach $1.6B by 2030 at a CAGR of 8.0% Is it a Good Investment?

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The services offered by PROs are crucial to the success of medical device clinical trials, thus making it a good investment. Most trials experience recruitment problems and are left with high participant turnover rates. Therefore, demand for these organizations is growing. Companies can pick between an advertising/marketing track and a patient-data-driven track, which can be customizable to trial duration and device classification. Emerging technologies, such as AI and machine learning, are starting to optimize these systems with social media and better select patients, which can reduce trial costs and improve efficiency. Trial Logistics (Non-recruitment) Strengths Weaknesses  There are various offerings within this segment, such as product tracking/storage (e.g., ocean and air temperature-controlled transportation), technical support, and materials for clinical sites. These options can be tailored to different stages.  There are high costs associated with this segment. On average, logistics assisting stage I, II, III, and IV studies cost around $522M.  Leveraging machine learning and AI capabilities, such as predictive analysis, can help determine the required materials for operations. This algorithm consumes large amounts of data to learn an organization and its buying patterns, which are then used to make product decisions. This can be customized to the medical device’s clinical stage (I, II, III, IV) and related ancillary material to prevent shortages and supply chain strains.  Supply chain issues are becoming more frequent. For example, the growing trend of hyper-personalization within the medical device industry is slowing down different logistic processes. Opportunities Threats Market Metrics: This market is expected to reach a market size of $29B in 2026 at a CAGR of 9% Is it a Good Investment? The trial logistics segment is a good investment because it offers many different capabilities. These services can be personalized to different device classifications and practices and ultimately optimize them to be more proactive. Algorithms, such as predictive analysis, can prevent supply chain clogs and order essential products before it depletes. This helps reduce double-inventory orders and additional costs born out of human error, which medical device companies want.

Biometrics & Biostatistics/Bioinformatics (monthly review of clinical trials patients’ data, PK/PD) Strengths Weaknesses  There are different services offered in this segment since it is very broad. Examples include statistical analysis planning (SAP), shells development, and independent data monitoring, which can be tailored to invasive and noninvasive devices (this depends on class)  Adaptive design and interim analysis services have helped optimize medical device trials, which has reduced associated costs and required resources  Large amounts of data can be wasted or deemed too complex by existing analytical tools.  Since data comes from many different sources (e.g., BMDs), effectively mining it for information can be costly.  Enhanced AI, cloud computing, and biotechnologies can help provide new ways of obtaining information.  This includes various biometric monitoring devices (BMD), such as skin patches and sensors, to determine how patients react to the medical device at hand.  There is an increased risk of cyber- attacks and PII compromisation, also seen with digital/virtual patient recruitment platforms.  Biometric and biostatistics innovations are occurring rapidly, which could make some services obsolete (one example of this is having a feedback system built directly into the medical device, which would render some BMDs unnecessary) Opportunities Threats Market Metrics: This segment is projected to reach a market size of $868M by 2027 at a CAGR of 15% Is it a Good Investment? The biometrics and biostatistics segment seems like a good investment. This information is vital to clinical trials and can provide different metrics to determine if a device is functional. At the moment, AI technologies, such as interim analysis, have been leveraged to optimize data; this has reduced trial costs, which makes it appealing to companies. While there is a risk for PII compromisation and cyber attacks, many biometric CROs have implemented programs to secure data. In terms of innovation, BMDs can provide a new way of determining how patients react to devices, which helps researchers collect real-time information. This is at the forefront of data collection in the medical device industry, which is something to keep an eye on when looking at companies.

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1:22 Deliverables

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