The Power Players CRO Leaders Redefining the Industry in 2024

1. June | Issue 01 | 2024 The Power Players: CRO Leaders Rede?ning Industry 2024 Personalized Medicine A New Opportunity for Contract Research Organiza?ons the Cancer Research The Growing Demand for Contract Research Services in Chris Perkin CEO Altasciences Chris Perkin Shaping the Future of CRO Excellence

2. Digital health is moving from a curiosity to an accepted clinical tool.

4. Editor’s The Pillars of Discovery Note

5. I n healthcare, we often focus on the end result - the medicines that heal us, the treatments that save lives. But have you ever paused to consider the complicated web of innovation, dedication, and leadership that brings these miraculous solutions to fruition? hearts that beat for a healthier world. These leaders are not just managing companies; they’re nurturing ecosystems of discovery, fostering collaborations that transcend borders and disciplines. In a world where medical advancements are more crucial than ever, these CRO leaders stand as beacons of hope and harbingers of change. Their work touches lives in ways we may never fully comprehend yet benefit from every day. This latest issue of Insights Care pulls back the curtain on a crucial yet often overlooked aspect of healthcare: the world of Contract Research Organizations (CROs) and the visionaries at their leading edge. These are the individuals who direct the complex symphony of drug development, from initial concept to final product. So, as you delve into this edition, remember: behind every pill, every treatment, and every medical breakthrough, there’s a story of leadership, innovation, and dedication. In our feature, ‘The Power Players: CRO Leaders Redefining the Industry in 2024,’ we shine a spotlight on the innovators who are reshaping the field of pharmaceutical research. Their stories are not just tales of professional success; they are narratives of passion, perseverance, and a relentless commitment to improving human health. Wishing you an enlightening and thought-provoking read. As you turn these pages, you’ll discover the faces behind the breakthroughs, the minds that drive innovation, and the Natalie May Natalie May - Natalie May

6. CONTENTS Tiago Silva 22 Revolu?onizing Clinical Research with Quality and Innova?on Nikita Liu 30 The Impact of RTLS on Workplace Safety and Security The Background Process The Role of Imaging in Preclinical Research 18 The Brain Unveiled Advancements in Neuroscience and Cogni?ve Research 26 34 Personalized Medicine A New Opportunity for Contract Research Organiza?ons Cancer Research The Growing Demand for Contract Research Services 38

7. 08 Chris Perkin Shaping the Future of CRO Excellence

8. Editor-in-Chief Chidiebere Moses Ogbodo Managing Editor Pearl Shaw Executive Editor Natalie May Visualiser David King Art & Design Head Samuel Martinez Co-designer Paul Belin Art & Picture Editor Grace Brown Business Development Manager Emily Jones Marketing Manager Bill Thompson Business Development Executives Anna Smith, Jack Miller Sales Executives Mike, Carl, Kelly Technical Consultants David, Robert Assistant Technical Head Joseph Taylor Technical Head Jacob Smile Digital Marketing Manager Assistant Digital Marketing Manager SME-SMO Executive Gemson Alina Sege Daniel Jones Research Analyst Eric Smith Circulation Manager James Carter sales@insightscare.com June, 2024 Contact Us: Insights Success Media and Technology Pvt. Ltd. Survey No.133/134, Brand Square, Office No. 512, Kunjir Chowk, Pimple Saudagar, Pune, Maharashtra 411027. Phone - India: 7410033802, 8956487823 Email: info@insightscare.com For Subscription: www.insightscare.com Insights Success Media Tech LLC 555 Metro Place North, Suite 100, Dublin, OH 43017, United States Phone - +1614-602-4132 Email: info@insightscare.com For Subscription: www.insightscare.com https://twitter.com/Insightscare Follow us on : www.facebook.com/InsightsCare/ We are also available on : Copyright © 2024 Insights Success Media and Technology Pvt. Ltd., All rights reserved. The content and images used in this magazine should not be reproduced or transmitted in any form or by any means, electronic, mechanical, photocopying, recording or otherwise, without prior permission from Insights success. Reprint rights remain solely with Insights Success Media and Technology Pvt. Ltd. Insights Care is powered by Insights Success Media and Technology Pvt. Ltd.

9. THE POWER PLAYERS: CRO LEADERS REDEFINING THE INDUSTRY IN 2024 Featuring Person Company Brief Anca is a seasoned entrepreneur and strategist in clinical research, known for her innovative leadership and development of Clinical Maestro™, enhancing clinical trial efficiency. Anca Copaescu CEO Strategikon Pharma strategikonpharma.com Bing is a pharmaceutical scientist and executive known for his leadership in drug development, with extensive experience in clinical pharmacology and regulatory submissions. Amador Bioscience amadorbioscience.com Bing Wang CEO Chris is a visionary leader revolutionizing early-phase drug development through innovative solutions and a commitment to transforming industry standards. Altasciences altasciences.com Chris Perkin CEO David is an accomplished statistician and leader, with extensive experience in biostatistics and data management. Quanticate quanticate.com David Underwood CEO and Chairman Clinergy Health Research clinergyhealth.com Tiago possesses over 20 years of clinical development experience to innovate and enhance healthcare solutions globally. Tiago Silva Managing Director

10. Chris Perkin Shaping the Future of CRO Excellence ‘ We've integrated preclinical research, clinical research, bioanalysis, manufacturing, and all required research support services, including regulatory guidance—crea?ng an alterna?ve paradigm to outsourcing early-phase drug development. ‘ ‘ ‘

11. Cover Story Chris Perkin CEO Altasciences

12. ‘ ‘ ‘ ‘ At Altasciences, our projects with clients are not just transac?ons—they're partnerships.

13. The Power Players: CRO Leaders Redefining the Industry in 2024 rug development is a constantly changing field, adapting to meet the evolving needs of the healthcare D D landscape. In facing these changes, leaders play a crucial role by turning challenges into opportunities through innovative strategies. One such influential leader is Chris Perkin impressive five-decade-long career makes him an exceptional leader poised to continue redefining the drug development industry in 2024. , whose Chris' story at Altasciences began as a mission to address issues in the traditional drug development outsourcing model. Currently serving as the CEO, he guides Altasciences all-in-one solution for early-phase drug development, streamlining the process. His vision challenges industry norms, offering a paradigm- shifting alternative to how the industry manages the various drug development steps. in providing an Under Chris' leadership, Altasciences has become a symbol of forward-thinking and innovation in research. His commitment to creative solutions not only shapes the company, but also leaves a lasting impact on the field. In a recent interview with Insights Care, Chris shared insights into his career journey and unveiled his vision for the future of the contract research organization (CRO) industry. With a focus on improving patient outcomes, Chris remains devoted to introducing more novel solutions through his leadership at Altasciences. The following insights will offer a sneak peek into the future of drug development, guided by Chris' commitment to excellence, innovation, and a redefined approach to the field. Briefly describe your professional background and experience in the pharmaceutical industry. What inspired you to pursue a career in this field? I have loved biology for as long as I can remember; for my 10 birthday, I received a microscope, and on my 13 birthday, I was given my own laboratory (actually a small garden shed). th th

15. I was not academic enough for medicine or veterinary science—much to my disappointment—so I became a technician working on smallpox vaccine production (it was still a problem back then), snake antivenins, and rabies vaccines. That led me to university and my first CRO position as a Study Director. The combination of science and biology, as well as being part of the development of new drugs and ensuring the safety of everyday chemicals and products, were engaging and satisfying—they became my sense of purpose. investors, staff, and our potential client base; planning and implementing the changes and growth needed; building the teams; and remaining top of mind for clients in what has been an often challenging and changing market. We overcame most of our challenges by building a strong foundation internally at Altasciences, through frequent, honest, and open communications with all staff; being open to criticism and new ideas; recognizing and celebrating our achievements as a team and implementing new processes and proprietary software. Integration has become the driving force behind our growth and has been part of our DNA since day one—it cannot be effectively back-engineered. That sense of purpose has driven me for the last 50 years, and still does. It has enabled me to learn a lot, meet many brilliant scientists, and be a part of hundreds of new drugs getting to patients. It has also given me a career path from Study Director to Director of Toxicology, to General Manager, to Senior Vice President, and finally, creating and leading a CRO/CDMO, now known as Altasciences; which has become a significant and growing alternative in an industry marked by consolidation. None of this was even imaginable when I was titrating the smallpox vaccine in cell culture plates in 1969, but with hindsight it makes so much sense. Can you provide an overview of Altasciences and the role it plays in early-stage drug development? Altasciences is a CRO/CDMO that offers biotech and biopharmaceutical companies of all sizes a seamless experience for their early-phase drug development. Our services move a drug from discovery to lead candidate selection, to clinical proof of concept, and beyond—all within one CRO/CDMO. We've integrated preclinical research, clinical research, bioanalysis, manufacturing, and all required research support services, including regulatory guidance—to create an alternative paradigm to outsourcing early-phase drug development. We've eliminated the communication gaps between various development stages, sites, and departments—with complementary program management, centralized scheduling and finance, and proprietary communication tools. Somewhat early in my career, I noticed inefficiencies in the traditional drug development outsourcing model. I began questioning why all the pieces needed for drug development, particularly early-phase drug development, had to be separate—contracting different CROs and CDMOs for different services and phases. It never made sense to me. The idea of a single CRO/CDMO that could move a drug through all the early stages of development had been talked about for years, but nothing had really been done to make it happen. I was inspired to transform this outsourcing paradigm, and that's exactly what I set out to do with Altasciences. What are the core values upon which Altasciences is built, and what is the mission of the organization? Our mission is to provide clients with simple, integrated, outsourcing solutions with a focus on customer service, that removes the need for multiple providers during the early stages of drug development. Whether for one study or an entire program, we are committed to helping our clients reach critical decision-making milestones sooner by improving speed and ease from lead candidate selection to clinical proof of concept, with the goal of getting better drugs to the people who need them, faster. As a partner, we continuously look for ways to build our relationships through communication and range of capabilities, offering scientific guidance and creating an environment that What are some of the biggest challenges you have faced as CEO of Altasciences, and how have you overcome them? The biggest challenge was in the early days of transitioning our small clinical/bioanalytical CRO into a CRO focused on innovator drugs, and then into what is now a full-service, integrated early drug development CRO/CDMO. Of course, during that process, obtaining buy-in on this unique one- stop concept was also a challenge. A lot of effort had to be put into articulating the vision, simply and effectively, to

16. Altasciences' Proactive Drug Development solution

17. provides value for our clients, respect for our study participants, care for our research animals, and development for our employees. By simplifying and integrating the outsourcing experience, we can accelerate our clients' drug development by up to 40%. We call this Proactive Drug Development—and that's what makes Altasciences a different kind of CRO/CDMO. At Altasciences, our projects with clients are not just transactions—they're partnerships. We are here to help them bring their drugs to market; their goals are our goals. We believe in communication, transparency, dependability, honesty, and good science. What do you think are the biggest trends and challenges facing the CRO industry in 2024, and how is Altasciences positioned to address them? The greatest challenges that we see, and will continue to see, in early drug development are drug formulation (and sometimes availability), regulatory affairs, and unexpected findings in both preclinical and clinical evaluations. In building Altasciences, we were mindful that a full-service CRO/CDMO should be able to help the client in resolving these potential hurdles. Our integrated approach enables our scientists and managers to offer solutions to our clients which single-capability CROs are unable to do. We can safely expedite additional work. With our centralized scheduling tool, we keep the client informed of impacts on their overall timelines regularly and suggest ways to mitigate those effects. In turn, this ability provides a practical demonstration of how partnering with a full- service integrated CRO/CDMO can identify and resolve problems quickly and efficiently, no matter which aspect of early development is affected. What are some of the key leadership lessons you have learned throughout your career, and how have they influenced your leadership style at Altasciences? Throughout my career, I've learned, and witnessed, the power of collaboration and teamwork. As someone who appreciates change and innovation, I like to remain open to all ideas, make time for others, and listen—really listen. This yields the best results. And this became even more evident to me in building Altasciences—bringing together the team and listening to feedback, as well as exchanging experience and expertise, to reach our common goal of transforming the outsourcing paradigm. I am also someone who prefers to focus on solutions, rather than problems, and I like to offer my guidance to our teams to enable them to find the solutions and meet their objectives. How did Altasciences adapt to the changing needs of its clients during the COVID-19 pandemic, and what lessons have you learned from this experience? listen. ‘ At our core, Altasciences is about collaboration and teamwork, and my leadership style is much the same. What sets Altasciences apart from other CROs, and how does the company differentiate itself in the market? Unprecedented events call for extraordinary responses. Nothing could have prepared us for the changes that ‘ Our unique selling point is that we unite and integrate all the steps of early-phase drug development under one organization—we treat drug development as a continuum, not a series of separate steps to be handled by different CRO and CDMO partners. This means that scientific and operational teams from across phases work together—as one big team—on a sponsor's project, leveraging data from each other to plan a client's roadmap and anticipate and proactively address potential roadblocks. By eliminating communication gaps between various development stages and departments, we ensure smooth and rapid transitions from milestone to milestone. As someone who appreciates change and innova?on, I like to remain open to all ideas, make ?me for others, and listen—really ‘ ‘ We offer sponsors multiple points of entry for partnering with us and the ability to partner with us for multiple stages of their journey.

18. ‘ ‘ What are some of the key initiatives and projects that Altasciences is currently working on, and how do they align with the company's long-term strategy? Our integrated approach enables our scien?sts and managers to offer solu?ons to our clients which single-capability CROs are unable to do. ‘ ‘ Over the last five years, Altasciences has continued to increase capacity and expand our comprehensive service offering through both acquisitions and organic growth. Our growth is based on client feedback; what clients want and need from us. As for the future, we will continue to grow our relationships with clients. By which I mean, partnering with them for more services and even more end-to-end programs. This is where clients can experience the greatest benefits of partnering with a single CRO/CDMO like Altasciences. And this is what we will continue to refine in 2024. COVID-19 would bring to our industry. Many here at Altasciences are accustomed to working in complex situations. Our success has always been in our adaptability, our flexibility, and our ability to deliver and come together despite any challenges that arise. Throughout the pandemic, we never shut down. We continuously reviewed business continuity plans to ensure that site staff, patients, and research animals were safe, while ensuring our clients' studies continued as planned. Altasciences' Canadian clinic remained operational throughout the pandemic, ensuring continuity in study conduct for clients, and in employment for staff. What advice would you give to other CRO leaders who are looking to redefine the industry and drive innovation in drug development? Our industry is slow to change, which is understandable since we are in an extremely regimented and regulated line of work. This does not mean that change is impossible. To others, I would say, don't be afraid to challenge the status quo. Listen to your team and clients. Perseverance, a good plan, and a foundation of teamwork will attract others to buy into your vision. We learned a few lessons during this time, but one that stood out was that there is no such thing as too much communication. Whether it's with clients or employees, we become more transparent and communicative than ever—in fact, being at a distance forced us all to become better communicators and more adaptable in the ways we communicate. During this time, we implemented weekly emails and videos to internal staff, regular business updates to clients, and email updates to participants. We later replaced the weekly videos to staff with monthly vlogs from different members of the leadership team—myself included—to continue with COVID and business updates. We also implemented virtual town halls and conducted employee surveys. We've maintained the vlogs and virtual town halls, in addition to a monthly blog I write myself for all employees (which I've been doing for 13 years now!). What motivates you to continue leading Altasciences, and how do you envision its growth in 2024 and beyond? Bringing great scientific minds together to help drug sponsors truly change the lives of people around the world is what continues to inspire and motivate me. The impact is immeasurable. Along the way, it has provided a unique opportunity to learn about science, business, and management, which, in turn, has helped us build a different kind of CRO/CDMO. There is still so much work to do when it comes to bringing about significant change in the way we—as a global health community—develop new drugs and treatments so that it's faster, more streamlined, and allows for better and quicker access to potentially life-changing therapies.

19. ALTASCIENCES

20. 18 www.insightscare.com June 2024

21. The Background Process The Role of Imaging Preclinical Research in P trials. In this context, imaging techniques have become indispensable tools for researchers, offering non-invasive insights into biological processes at the molecular, cellular, and organ levels. This article explores the significance of imaging in preclinical research and its impact on advancing our understanding of diseases and the development of innovative treatments. detection is essential for developing targeted therapies and improving treatment outcomes. reclinical research plays a pivotal role in the development of new drugs, therapies, and medical technologies before they advance to human clinical Monitoring Treatment Efficacy Assessing the effectiveness of potential treatments is a critical aspect of preclinical research. Imaging modalities enable researchers to monitor the response of experimental drugs or interventions in real-time, providing valuable data on treatment efficacy. This dynamic feedback is essential for making informed decisions about the progression of a particular therapeutic approach. Visualization of Biological Processes Molecular Imaging for Biomarker Research One of the primary contributions of imaging in preclinical research is its ability to visualize biological processes in living organisms. Techniques such as magnetic resonance imaging (MRI), positron emission tomography (PET), and single-photon emission computed tomography (SPECT) allow researchers to observe and quantify changes in anatomy, physiology, and metabolism over time. This capability is crucial for understanding disease progression and evaluating the efficacy of potential interventions. Molecular imaging techniques, such as fluorescence imaging and bioluminescence imaging, enable researchers to track specific molecules or biological markers within living organisms. This is instrumental in biomarker discovery and validation, facilitating the identification of novel targets for therapeutic interventions. Advancements in Preclinical Models Early Disease Detection and Diagnosis The development of more sophisticated preclinical models, including genetically modified animals and patient-derived xenografts, has increased the demand for advanced imaging technologies. These models replicate human disease conditions more closely, and imaging helps researchers gain Imaging plays a key role in early disease detection and diagnosis during preclinical studies. By employing imaging modalities, researchers can identify subtle changes in tissues or organs that may precede visible symptoms. Early 19 www.insightscare.com June 2024

22. deeper insights into the behavior of diseases and the effects of potential treatments. optical imaging can provide complementary data, offering a more comprehensive understanding of biological phenomena. Multi-modal approaches enable researchers to cross-validate findings and obtain a more holistic view of the studied processes. Improving Translation to Clinical Trials Successful translation of preclinical findings to human clinical trials is a major challenge in drug development. Imaging studies provide crucial bridging data, allowing researchers to better understand the pharmacokinetics, pharmacodynamics, and safety profiles of experimental drugs. This knowledge is essential for designing more effective and safer clinical trials. Imaging in Gene and Cell Therapy Research The rise of gene and cell therapies has opened new frontiers in medicine, and imaging plays a pivotal role in advancing these fields. Non-invasive imaging techniques allow researchers to track the distribution, engraftment, and therapeutic effects of genetically modified cells. This is particularly important for assessing the safety and efficacy of these innovative therapeutic approaches before they progress to clinical trials. Preclinical Imaging in Neuroscience Challenges and Future Directions While imaging has revolutionized preclinical research, challenges such as standardization of imaging protocols, data interpretation, and cost constraints still exist. The future of imaging in preclinical research lies in the integration of multiple imaging modalities, the development of novel contrast agents, and the application of artificial intelligence for more accurate and efficient data analysis. Neuroimaging techniques, including functional MRI, diffusion tensor imaging (DTI), and molecular imaging, are indispensable in neuroscience research. They enable the investigation of brain structure, connectivity, and function in preclinical models. These studies contribute to our understanding of neurological disorders and the development of potential treatments for conditions such as Alzheimer’s disease, Parkinson’s disease, and psychiatric disorders. Functional Imaging and Dynamic Studies Beyond anatomical details, functional imaging techniques offer researchers the ability to study physiological processes in real-time. Functional magnetic resonance imaging (fMRI), for example, enables the observation of changes in blood flow and oxygenation, providing insights into brain activity. This dynamic perspective is crucial for understanding the mechanisms underlying various diseases and evaluating the impact of interventions on physiological functions. Quantitative Imaging for Biomarker Validation Quantitative imaging plays a crucial role in preclinical research by providing precise and reproducible measurements. This is particularly important in biomarker validation, where accurate quantification of imaging data helps establish the reliability and relevance of potential biomarkers. Robust quantitative imaging methods contribute to the identification of reliable indicators for disease progression and treatment response. In Vivo Imaging of Cellular and Molecular Processes Advancements in imaging technologies have allowed researchers to delve into the intricacies of cellular and molecular processes within living organisms. Techniques such as intravital microscopy and molecular imaging probes permit the visualization of cellular behaviors, interactions, and responses to external stimuli. This level of detail is invaluable for deciphering the molecular underpinnings of diseases and developing targeted therapeutic strategies. Multi-Modal Imaging Approaches Combining multiple imaging modalities enhances the depth and breadth of information obtained from preclinical studies. For instance, a combination of MRI, PET, and 20 www.insightscare.com June 2024

24. The Power Players: CRO Leaders Redefining the Industry in 2024 Tiago Silva Revolu?onizing Clinical Research with Quality and Innova?on I healthcare industry, the need for efficient, high-quality clinical research solutions has never been more critical. This philosophy addresses a significant gap in the market, where traditional models often fall short in balancing cost, speed and quality. nnovative approaches with rigorous quality standards are essential for delivering value in clinical development. In today's fast-paced and growing than 100 strategic drug development projects for large pharmaceutical companies and small Biotech's, helping patients having access to value adding medicines and health innovation across Europe, ASIA, and North/South America. As the Managing Director of Clinergy Health Research, can you explain the mission and vision of the company? Our mission "Helping innovation reach patients faster" says it all about our purpose of acting as a catalyst towards health innovation and I have learned over the years that this can only be achieved by taking a different and unique approach towards service provision. Tiago Silva, the Managing Director of CLINERGY Health Research, embodies this transformative approach. With over 20 years of experience in clinical development, Tiago has initiated more than 100 strategic drug development projects across the globe. CLINERGY Health Research was founded out of a desire to revolutionize the clinical research outsourcing industry by focusing on high- quality deliverables and innovative methodologies that larger CROs often struggle to provide. The company is dedicated to accelerating health innovation, ensuring that patients gain access to valuable medicines more quickly. Clinergy was born out of a personal frustration with the way the clinical/regulatory outsourcing market has been evolving over the years. During my time within the pharma industry, I have had the chance to contract CROs all over the globe and, more often than not, I would get sub-optimal results and expectations would be rarely met or exceeded. It was clear that the business and management models behind large CROs were not working in terms of cost vs benefit and, on the other hand, smaller and cheaper CROs would frequently not deliver high quality. Let's dive into our conversation with Tiago Silva to explore how Clinergy Health Research is redefining the CRO industry, overcoming industry challenges, and staying at the forefront of innovation and technology! At Clinergy, we have a very different approach to how we manage the company, making sure that 1) we do not stretch our resources, 2) we focus on services we know large CROs fail to deliver value frequently and 3) we select the right clients and projects that we believe will get high deliverables from our work. Also, we focus on indicators other than revenue and profit as key drivers as a way to achieve our mission and long-term excellence. Can you please share with our readers a brief overview of your professional background? I am a Pharm D. Even though I started my career in Pharmaceutical QA and Process Validation, I started working in clinical research early on. For the past 20 years I have been working in clinical development, delivering more 22 www.insightscare.com June 2024

25. “ Our mission "Helping innova?on reach pa?ents faster" says it all about our purpose of ac?ng as a catalyst towards health innova?on. Tiago Silva “ Managing Director CLINERGY Health Research 23 www.insightscare.com June 2024

26. Can you share with us some of the unique challenges you have faced in clinical development and management and how you have overcome them? Can you share with us a significant milestone or achievement that you are particularly proud of during your tenure as Managing Director of Clinergy Health Research? I believe some of the biggest challenges in clinical development these days are related to making sure the whole clinical operations chain (research sites, sub- contractors, CROs) hold high standards during times of high pressure for higher and higher financial returns. Over the years we have been particularly focused on developing very effect oversight capabilities so that our partners and sub-contractors have the same view we have towards high excellence and quality, and this has been making a difference on the way we deliver our services. I would say that keeping our purpose and unique business management mindset alive over the years has been a major achievement. Driving the company's direction and processes based on client´s satisfaction and high-quality output rather than on revenue and profitability (which often means squeezing workforce and reducing quality deliverables) is no easy task, but it is an obvious choice when your view is on the long run. What advice do you have for aspiring professionals looking to make a career in clinical development and management? As a leader in the healthcare industry, how do you ensure that Clinergy Health Research stays at the forefront of innovation and technology? Differentiate yourself by using all the amazing tools available to anyone these days to deliver better knowledge/services within your company. Do not wait for our company to push you. There is so much information available everywhere but only a few professionals really go the extra mile to extend their knowledge and connect the dots. Every new or existing client that partner with us receives much more value for every dollar invested compared to our competitors and that is related to the way our culture shapes efficiencies within our processes and tools which we have running in the background of our operations, so that our staff can focus on providing high knowledge/experienced- based value rather than spending time on low-value inefficient activities. That allows us to provide much quicker and assertive site feasibility services, or risk- based/central monitoring services that being major cost and time efficiencies to our clients. Where do you see Clinergy Health Research in the next 5 years and what role do you see yourself playing in that vision? We will continue to provide high quality output to small and medium-sized companies who need a truly trusted partner which sees their clients' projects as their own. As we move towards a more complex and precision-based medicine, the implementation of AI and other technology-based solutions will certainly take us to an even higher level in terms of adding value to our clients, helping us achieve our mission. How do you approach risk management and quality control in clinical trials, and what role does it play in the success of the company? I believe one of the biggest challenges in the recent history of clinical development is related to the lack of speed many pharma companies and CROs have to truly embed a risk- based approach within their working culture. There are a lot of opportunities to accelerate clinical development being lost now due to the mental barriers associated with changing the status quo. My role has been focused on making sure all our processes, tools and services are planned and conducted with such an approach in mind and the result is a way more efficient service delivery standard to our clients. Risk-based Quality Assurance is at the heart of what we do, from site/study feasibility to start-up and conduct of clinical trials to clinical/regulatory consultancy. 24 www.insightscare.com June 2024

28. The Brain Unveiled Advancements in Neuroscience and Cognitive Research N reshaping our understanding of cognition. This article delves into some of the groundbreaking developments that have propelled these fields forward, shedding light on new discoveries, technologies, and their potential implications. euroscience and cognitive research have undergone unprecedented advancements in recent years, unraveling the mysteries of the human brain and Neuroimaging Techniques: The advent of advanced neuroimaging techniques has revolutionized neuroscience, allowing researchers to study the brain's structure and function with unprecedented detail. Functional Magnetic Resonance Imaging (fMRI), Positron Emission Tomography (PET), and magnetoencephalography (MEG) are just a few examples of cutting-edge technologies that provide insights into brain activity, connectivity, and mapping. These tools enable researchers to investigate neural networks, observe changes in real-time, and correlate brain activity with specific cognitive functions. As a result, our understanding of conditions such as Alzheimer's disease, schizophrenia, and depression has deepened, potentially paving the way for more targeted interventions. computers, enabling individuals to control external devices or prosthetics through their thoughts. This technology holds immense promise for patients with paralysis or motor disorders, providing them with a means to regain mobility and independence. Additionally, BCIs are being explored in enhancing cognitive abilities, with implications for fields such as education and neurorehabilitation. Brain-Computer Interfaces (BCIs): Advancements in neuroscience have also led to the development of Brain-Computer Interfaces (BCIs), blurring the lines between the brain and external devices. BCIs allow direct communication between the brain and 26 www.insightscare.com June 2024

29. 27 www.insightscare.com June 2024

30. Optogenetics: applications in various industries, including healthcare, finance, and autonomous vehicles. Optogenetics is a groundbreaking technique that involves using light to control neurons genetically modified to respond to specific wavelengths. This method allows researchers to manipulate neural activity with remarkable precision, offering insights into the causal relationships between brain function and behavior. Epigenetics and Cognitive Epigenomics: The field of epigenetics, which explores changes in gene expression that do not involve alterations to the underlying DNA sequence, has made significant contributions to our understanding of cognitive processes. Cognitive epigenomics investigates how environmental factors and experiences can influence gene expression in the brain, impacting cognitive function and behavior. Optogenetics has contributed significantly to our understanding of neural circuits, paving the way for potential therapeutic interventions in conditions like Parkinson's disease, addiction, and mood disorders. The ability to modulate specific neural pathways with light has opened new avenues for targeted treatments and refined research methodologies. Research in this area has revealed the dynamic interplay between genes, environment, and cognition, offering insights into the molecular mechanisms underlying learning, memory, and neurological disorders. The emerging field of cognitive epigenomics holds promise for uncovering new therapeutic targets and personalized interventions for conditions such as autism, schizophrenia, and neurodegenerative diseases. Cognitive Enhancements and Neuroplasticity: Research in neuroscience has uncovered the remarkable plasticity of the human brain, challenging the traditional view that the brain's structure and function are fixed in adulthood. Studies on neuroplasticity have implications for cognitive enhancement, suggesting that the brain can adapt and reorganize itself in response to experiences, training, and environmental stimuli. Decoding Neural Patterns and Mind Reading: Advancements in neurotechnology have allowed researchers to decode neural patterns and, to some extent, read people's thoughts. Brain decoding techniques use machine learning algorithms to interpret brain activity patterns associated with specific thoughts or mental states. This technology has potential applications in areas like communication for individuals with severe motor disabilities and the development of brain-computer interfaces that can interpret a person's intentions. This understanding has fueled the development of cognitive training programs, neurofeedback, and other interventions aimed at optimizing cognitive function. As researchers continue to unravel the mechanisms underlying neuroplasticity, the potential for harnessing these processes for therapeutic purposes becomes increasingly apparent. Neural Network Modeling and Artificial Intelligence: While still in its early stages, the ability to decode neural patterns has implications for understanding the neural basis of consciousness, perception, and cognition. Ethical considerations surrounding privacy and consent in mind- reading technologies are being actively discussed as these capabilities continue to evolve. Advancements in neuroscience have inspired the development of artificial neural networks, a cornerstone of artificial intelligence (AI). These computational models are designed to simulate the structure and functioning of the human brain, allowing machine learning algorithms to recognize patterns, make predictions, and perform complex tasks. The landscape of neuroscience and cognitive research continues to evolve rapidly, propelled by technological advancements, interdisciplinary collaborations, and a deepening understanding of the brain's complexity. As researchers delve into these frontiers, the potential for transformative applications in healthcare, artificial intelligence, and our comprehension of human cognition becomes increasingly apparent. The synergy between neuroscience and AI has led to breakthroughs in areas such as natural language processing, image recognition, and decision-making algorithms. Insights gained from the study of neural networks in the human brain have contributed to the design of more efficient and sophisticated AI systems with potential 28 www.insightscare.com June 2024

32. The Impact of RTLS on Workplace Saf ety and Security N workplace safety and security. owadays, people in the workplace are experiencing significant changes than ever before, it remains a considerable issue to ensure example, if an employee enters a restricted area without proper authorization or approaches dangerous machinery too closely, an alert can be triggered to remind them of safety protocols or even automatically shut down equipment to prevent accidents. Workplace safety and security refers to measures taken to protect staff and assets from physical threats, and digital assets, such as confidential information from digital threats. In addition to enhancing physical safety measures, RTLS contributes significantly to improving overall workplace security. By implementing geofencing techniques with RTLS technology, organizations can establish virtual boundaries that trigger alerts whenever an individual enters or exits these designated zones without proper authorization. This proactive approach helps deter potential security breaches and ensures that sensitive areas remain secure. In addition to physical security measures, RTLS also contributes to enhancing occupational health and safety practices within workplaces. The technology enables organizations to track employee movements throughout their workday, identifying potential hazards or ergonomic issues that may lead to accidents or injuries. With this information, employers can implement preventive measures promptly and create safer working environments for their staff. Moreover, by analyzing data collected from RTLS systems over time, organizations gain valuable insights into patterns related to workplace safety incidents. These insights allow them to identify recurring risks or trends that require attention and take appropriate corrective actions accordingly. Such proactive risk management strategies help reduce accidents. In late 2023, the International Labour Organization (ILO) estimated that nearly three million workers die every year from work-related accidents and diseases. Non-fatal work injuries are also assessed to have been sustained by 395 million workers worldwide. estimated While enterprises and organizations invest more in workplace safety and security as high technology advances, it is challenging to maintain workplace safety in a few specific industries, both for workers and for expensive instruments. Knowing precisely where workers, equipment, and assets are at all times is critical to safeguarding the well-being of employees and assets in each of these verticals. With real-time location systems (RTLS), this information can be collected and used to improve the monitoring and working conditions in each area. What are the significant impacts? 1. Ensures Safety 2. Reduces Loss RTLS plays a crucial role in preventing accidents and injuries within the workplace. Organizations can proactively address safety concerns before they escalate into serious incidents by monitoring employee movements and identifying potential hazards or unsafe behaviours. For Integrated with RTLS technology, access control systems enable organizations to monitor entry points effectively and restrict unauthorized access. This ensures that only authorized personnel are granted access to sensitive areas 30 www.insightscare.com June 2024

33. About the Author Nikita Liu, the overseas PR manager of Blueiot (Beijing) Technology Co., Ltd., is now responsible for content marketing and digital marketing. Blueiot is a world-leading RTLS (Real-time Location System) provider committed to developing high-precision locating products and solutions for indoor applications. Nikita Liu Nikita Liu 31 www.insightscare.com June 2024

34. such as server rooms or research laboratories where valuable assets are stored, which can achieve anti-lost of valuable assets. Moreover, by tracking assets using RTLS tags attached to equipment or inventory items, organizations can minimize thefts and losses while optimizing resource allocation. The ability to locate misplaced items quickly saves time and reduces operational costs associated with replacing lost assets. estimation can be achieved within a proximity range. BLE- based RTLS has gained popularity in retail environments for personalized marketing campaigns and customer analytics. Ultra-Wideband (UWB) technology offers high-precision localization capabilities suitable for demanding applications like industrial automation or healthcare settings where centimeter-level accuracy is required. UWB-enabled tags emit short-duration pulses at very low power levels, which allow precise distance measurement between tags and anchors installed throughout the environment. Personnel location information can also help enterprises to optimize resources and control costs. By analyzing the activities of employees in different areas, enterprises can reasonably plan the layout of office space, equipment configuration and material supply so as to avoid resource waste and excessive investment. In addition, it is relatively easy to integrate and deploy people's location information using RTLS technology. Modern RTLS systems usually use wireless sensor networks or Bluetooth technology for data collection and transmission, which is relatively easy to install and flexible to adjust. At the same time, the relevant software platforms are gradually improved and popularized so enterprises can quickly access and use these systems to monitor and manage personnel location information. What types of technologies are available? Only some of the technologies can be applied effectively in RTLS, especially in indoor scenarios. RTLS is a technology that tracks and monitors assets or people in real-time. It utilizes various technologies to provide accurate and up-to-date location information. Several types of technology are available for RTLS, each with unique features and applications. In short, in today's competitive business environment, an accurate grasp of personnel location information is one of the critical factors necessary for the successful operation of an organization. The integration and deployment of RTLS technology will be important in ensuring workplace safety, improving productivity, optimizing resource utilization, and bringing greater competitive advantage to enterprises. One commonly used technology for RTLS is RFID (Radio Frequency Identification). RFID tags are attached to objects or worn by individuals, allowing them to be identified and tracked using radio waves. This technology is widely adopted in industries such as logistics, healthcare, and retail for inventory management, asset tracking, and personnel monitoring. Overall, the impact of RTLS on workplace safety and security cannot be overstated. It provides organizations with invaluable tools for emergency preparedness/response planning while promoting proactive measures for accident prevention. Additionally, it enhances overall security by controlling access points effectively and minimizing asset loss through efficient tracking capabilities. Another popular technology used in RTLS is Wi-Fi-based positioning systems. By leveraging existing Wi-Fi infrastructure, these systems can determine the location of devices within a designated area. They rely on signal strength measurements from nearby access points to triangulate the position accurately. Wi-Fi-based RTLS finds applications in indoor navigation systems, security monitoring, and workforce optimization. Bluetooth Low-Energy (BLE) beacons are also utilized for RTLS purposes. These small wireless devices transmit signals that can be detected by smartphones or other receivers equipped with BLE capabilities. By measuring the signal strength from multiple beacons, an accurate position 32 www.insightscare.com June 2024

36. Personalized Medicine A New Opportunity for Contract Research Organizations T tioned to capitalize on this transformation. Precision medicine, also referred to as personalized medicine, leverages advanced analytics, genomics, and other technol- ogies to tailor treatments to individual patient characteris- tics. he rise of precision medicine is transforming the pharmaceutical and biotech industries, and contract research organizations (CROs) are ideally posi- Precision Medicine Driving Innovation in Clinical Trials Precision medicine, particularly in oncology, has necessi- tated innovations in clinical trial design. Traditional clinical trials often focused on specific tumor types, but precision medicine has led to the development of novel study designs such as basket trials, umbrella trials, and platform trials. These "master protocols" allow researchers to test multiple therapies and target various diseases under a single overarching protocol, increasing operational efficiency and enhancing patient recruitment from a broader population. CROs Adapting to the Precision Medicine Industry As the pharmaceutical industry embraces precision medicine, CROs are adapting their service offerings to support these new approaches. Leading CROs like ICON and PPD have made strategic acquisitions and investments to strengthen their capabilities in areas such as real-world evidence, patient recruitment, and genomic sciences. These capabilities are crucial for navigating the complexities of precision medicine clinical trials. Opportunities for CROs in Precision Medicine The growth of precision medicine presents several opportu- nities for CROs: 34 www.insightscare.com June 2024

37. 35 www.insightscare.com June 2024

38. 1. Expertise in Adaptive Trial Designs: CROs with experience in innovative trial designs like basket trials and umbrella trials are well-positioned to support sponsors in the precision medicine space. 2. Integrating Genomics and Biomarkers: CROs that can seamlessly integrate genomic and biomarker data into the clinical development process will be valuable partners for precision medicine programs. 3. Leveraging Real-World Evidence: CROs with robust real-world evidence capabilities, such as PPD's acquisition of Evidera, can provide crucial insights to support precision medicine development and commercialization. 4. Accelerating Patient Recruitment: CROs with specialized patient recruitment solutions, like Syneos Health's decentralized clinical trials offerings, can help precision medicine sponsors reach the right patient populations more efficiently. Real-World Evidence and Its Importance Real-world evidence (RWE) is another critical area where CROs can provide value. RWE involves collecting and analyzing data from real-world settings to support clinical development and commercialization. CROs with strong RWE capabilities can offer insights that enhance the precision medicine development process. For example, PPD's acquisition of Evidera has bolstered its RWE offerings, making it a more attractive partner for precision medicine sponsors. Enhancing Patient Recruitment Patient recruitment is a perennial challenge in clinical trials, and it is particularly acute in precision medicine due to the need for specific patient populations. CROs that offer specialized patient recruitment solutions can play a pivotal role in addressing this challenge. Syneos Health's decentral- ized clinical trials offerings are an example of how CROs are innovating to improve patient recruitment and retention in precision medicine trials. As the pharmaceutical and biotech industries continue to embrace precision medicine, CROs that can adapt their services and expertise to this evolving landscape will be well-positioned to thrive. By partnering with innovative CROs, precision medicine developers can navigate the complexities of this new era and bring life-changing therapies to patients faster. Strategic Adaptations by CROs Leading CROs have recognized the need to adapt to the precision medicine landscape and have taken strategic steps to enhance their capabilities. Investments in genomics, real- world evidence, and patient recruitment are just a few examples of how CROs are positioning themselves to support precision medicine. ICON, for instance, has expanded its genomic capabilities to better serve precision medicine clients. Precision Medicine’s Impact on Clinical Trial Design Precision medicine has significantly impacted clinical trial design, necessitating more personalized approaches to research. Traditional trials often lack the flexibility to accommodate the nuanced needs of precision medicine. However, adaptive trial designs, such as basket trials, umbrella trials, and platform trials, have emerged as critical methodologies in this field. These designs allow for multiple therapies and diseases to be studied simultaneously under a single protocol, improving efficiency and patient recruitment. Conclusion The advent of precision medicine represents a significant opportunity for CROs. By adapting their services and expertise to meet the demands of this evolving field, CROs can position themselves as essential partners in the development of personalized therapies. The integration of adaptive trial designs, genomics, real-world evidence, and specialized patient recruitment solutions will be key to their success. As the pharmaceutical and biotech industries continue to evolve, CROs that can navigate the complexi- ties of precision medicine will be well-positioned to thrive, ultimately helping to bring life-changing therapies to patients more efficiently. The Role of Genomics and Biomarkers A key component of precision medicine is the integration of genomic and biomarker data into clinical development. CROs that excel in this area can provide significant value to sponsors by ensuring that the right patients are selected for the right treatments. This integration helps to optimize clinical outcomes and supports the development of more effective therapies. - Natalie May 36 www.insightscare.com June 2024

40. 38 www.insightscare.com June 2024

41. Cancer Research Growing Research Services The Demand for Contract undergone a remarkable transformation. The number of investigational cancer products has skyrocketed, reflecting the intensified efforts to combat this devastating disease. This surge in research activity has been accompa- nied by increasing complexity in clinical trials, largely due to more stringent regulations imposed by regulatory bodies such as the United States Food and Drug Administration (FDA). I n the past two decades, the field of cancer research has 2. Financial Considerations Developing novel cancer therapies is an expensive endeavor. The heterogeneous nature of cancer necessitates substantial investments throughout the development process, from early stages to market approval. Many promising preclinical candidates fail to reach human testing due to prohibitive costs. CROs help address this challenge by offering cost-effective strategies and access to their global network of high-quality research sites. As the challenges of conducting successful trials mount, cancer research sponsors are increasingly turning to contract research organizations (CROs) for support. These specialized entities have emerged as crucial partners in the quest for innovative cancer therapies, offering a unique blend of expertise, digital innovation, and extensive study experience. 3. Regulatory Compliance As regulatory requirements become more stringent, ensuring compliance has become increasingly challenging. CROs, with their in-depth understanding of regulatory landscapes across different regions, help sponsors navigate these complex requirements efficiently. 4. Global Reach Cancer trials often require large, diverse patient popula- tions. CROs, with their global presence and established networks, are well-positioned to facilitate patient recruit- ment across different geographical regions, ensuring diverse representation in clinical trials. The Rising Demand for CRO Services Several factors contribute to the growing reliance on CROs in cancer research: 1. Complexity of Clinical Trials 5. Technological Expertise CROs invest heavily in cutting-edge technologies for data management, patient recruitment, and trial monitoring. This technological prowess allows sponsors to leverage advanced tools without significant upfront investments. Cancer trials have become increasingly intricate, requiring specialized knowledge and resources. CROs offer scaled infrastructure, efficient data management technology, and experienced project management teams, making them invaluable partners for sponsors navigating this complex landscape. 39 www.insightscare.com June 2024

42. The Impact of CROs on Cancer Research 2. Ethical Considerations With trials becoming more global, navigating diverse ethical and cultural landscapes presents ongoing challenges. CROs must ensure that trials are conducted ethically across all regions, respecting local customs and regulations. The integration of CROs into the cancer research ecosystem has had several notable impacts: 1. Accelerated Drug Development By streamlining processes and leveraging their expertise, CROs have helped accelerate the drug development timeline. This efficiency is crucial in the race to bring new cancer therapies to patients. 3. Patient-Centric Approach There is a growing emphasis on patient-centric trial designs. CROs are adapting to this shift by developing innovative approaches to patient engagement and incorpo- rating patient feedback into trial designs. 2. Increased Focus on Specialty Drugs The support provided by CROs has enabled pharmaceutical companies to allocate more resources to developing specialty drugs, including those for cancer and central nervous system disorders. This shift reflects a growing emphasis on addressing complex diseases with high unmet medical needs. 4. Precision Medicine As cancer treatment moves towards personalized approaches, CROs must adapt their strategies to support trials focused on targeted therapies and biomarker-driven patient selection. 5. Real-World Evidence Regulatory bodies are increasingly recognizing the importance of real-world evidence. CROs are exploring ways to integrate real-world data into clinical trials, complementing traditional randomized controlled trials. 3. Enhanced Global Collaboration CROs facilitate global collaboration in cancer research by connecting sponsors with research sites and patients worldwide. This global approach not only accelerates patient recruitment but also ensures that trial results are representative of diverse populations. Conclusion 4. Adoption of Innovative Technologies CROs are at the forefront of adopting and implementing innovative technologies in clinical trials. From artificial intelligence-driven data analysis to wearable devices for patient monitoring, these technological advancements are revolutionizing how cancer trials are conducted. The role of CROs in cancer research continues to evolve and expand. As we look to the future, these organizations will likely play an even more integral role in driving innovation, improving efficiency, and ultimately accelerating the development of life-saving cancer thera- pies. 5. Improved Preclinical Research Preclinical CROs play a crucial role in the early stages of drug development. By offering specialized expertise and advanced technologies, they help sponsors gain deeper insights into potential drug candidates through sophisticated studies on pharmacokinetics, drug metabolism, cellular efficacy, toxicity, and bioequivalence. By leveraging their global reach, technological expertise, and deep understanding of the clinical trial landscape, CROs are well-positioned to address the complex chal- lenges of modern cancer research. Their contributions will be crucial in shaping the future of cancer treatment, bringing hope to millions of patients worldwide. As the field of cancer research continues to advance, the partnership between sponsors and CROs will undoubtedly strengthen, driving progress towards more effective treatments and, ultimately, better outcomes for cancer patients globally. Challenges and Future Directions While CROs have significantly contributed to advancing cancer research, several challenges remain: 1. Data Security and Privacy As clinical trials become increasingly digitized, ensuring the security and privacy of patient data is paramount. CROs must continually invest in robust cybersecurity measures to protect sensitive information. - Natalie May 40 www.insightscare.com June 2024