CRO Innovators of Excellence 2024's Top Solution Providers

1. November | Issue 02 | 2024 CRO Innovators of Excellence: 2024’s Top Solution Providers Steve Mason Co-Chief Operating O?cer Altasciences An Advanced Approach to Drug Development

2. It is this quality that sets this year’s selected organizations apart from the rest: the orgs’ flexibility and scientific method savvy. As one consolidates the markets, these CROs have transformed from mere service solution providers to real players in embarking on the molecule to medicine process. The New Face of Clinical Research I William Pollard’s profound words: “Without change, there is no innovation, creativity, or incentive for improvement.” Each of these words rings a bell that echoes the changes we see unfolding in the Contract Research Organization (CRO) industry. n the quiet halls of research laboratories and the bustling corridors of clinical trials, a revolution is unfolding. As I pen this note, I’m reminded of The organisations presented in this edition show that in the sphere of clinical research, stagnation is regression. It is represented by them, as industry challenges demonstrate that when it comes to innovation, it is not just a choice but a necessity. Our latest edition, CRO Innovators of Excellence: 2024’s Top Solution Providers is arrived at a pivotal moment. We’re not merely observing change – we’re documenting a fundamental shift in how modern medicine comes to life. The CRO industry is evolving at an unprecedented pace, driven by technological breakthroughs and adapting to increasingly complex drug development demands. Welcome to this special series of profiles of these luminaries who are not only adapting to change but leading the way in improving healthcare delivery. - Nalie May - Natalie May

3. CONTENTS CXO 22 Pioneering Culturally Sensi?ve Mental Health Support for Migrants Articles Leveraging CRO Exper?se 18 Cost Reduc?on Strategies for Pharmaceu?cal Companies Con?nuous Tes?ng 28 The Secret to Adap?ng Your CRO Strategy in Real-Time

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5. CRO INNOVATORS OF EXCELLENCE: 2024's TOP SOLUTION PROVIDERS Featuring Person Company Brief Advanced Clinical is a global clinical development organiza?on providing Contract Research Organiza?on (CRO), Func?onal Service Provider (FSP), and strategic resourcing services to enhance clinical research outcomes. Leo Sheridan CEO Advanced Clinical advancedclinical.com Altasciences is a contract research organiza?on specializing in early-phase drug development, offering integrated services from preclinical tes?ng to clinical trials and manufacturing. Steve Mason Co-Chief Opera?ng Officer Altasciences altasciences.com Biognosys AG is a Swiss leader in next-genera?on proteomics, offering advanced mass spectrometry solu?ons for research and clinical applica?ons, enhancing biomarker discovery and drug development. Biognosys AG biognosys.com Oliver Rinner CEO CenExel Clinical Research is a na?onwide network of clinical research sites focused on developing life-changing therapies through excep?onal pa?ent engagement and scien?fic exper?se across various medical fields. Tom Wardle CEO CenExel Clinical Research cenexelresearch.com Salimeen is an innova?ve company focused on revolu?onizing mental wellness services for immigrants, aiming to enhance mental care accessibility and support within diaspora communi?es. Bryan Ahmed Founder Salimeen salimeen.com

6. An Advanced Approach to Drug Development I was inspired by how chemistry and biology came together in disciplines like pharmacology, and how diseases and conditions could be treated by manipulating and modifying those processes.

7. CRO Innovators of Excellence: 2024’s Top Solu?on Providers manipulating and modifying those processes. That is what led me to a career in drug development. Leading the Way to a Promising Future in Pharmaceutical Innovation! D process has followed a conventional path where drug sponsors engage multiple Contract Research Organizations (CROs) and Contract Development and Manufacturing Organizations (CDMOs) to handle different phases or components of their research and development. Breaking away from the traditional fragmented approach that often delays progress in the industry, its commitment to seamless integration and transformative solutions. Can you share with our readers a brief overview of your professional journey? rug development is a complicated process that involves a series of steps, each with its own set of challenges and requirements. Historically, this In late 1999, I met Chris Perkin [CEO of Altasciences since 2010] while working at Huntingdon Research Centre in the UK, and shortly after, I moved to Montréal, Canada, to join the CRO at which Chris was the General Manager. Over the next few years, I built the Safety Pharmacology Department for that CRO and was then given the opportunity to move to China to establish their Shanghai preclinical facility. While I was in China, I moved to another CRO and became Vice President of Preclinical Services. In 2014, I joined Altasciences, as the General Manager for our clinical unit in Kansas City, before becoming Co-COO in 2017 and was given the responsibility of building the preclinical side of our business from the ground up. Altasciences stands out for Altasciences, an integrated CRO/CDMO, provides pharmaceutical and biotechnology firms with a comprehensive solution for early-stage drug development, from lead candidate identification to clinical proof of concept and beyond. Operating across nine facilities in the U.S. and Canada, with an additional office in the UK, Altasciences delivers a reliable and adaptable strategy, and the full array of CRO support services, for preclinical and clinical pharmacology studies, including bioanalysis, formulation, manufacturing, and analytical services. Can you elaborate on Altasciences’ vision behind creating a flexible approach that eliminates the need for multiple service providers during the early stages of drug development? Drug development has been traditionally conducted in one way: drug sponsors contracting multiple CROs and CDMOs to complete different aspects or phases of their research and development. For the sponsor, this has meant multiple contract negotiations, and data, project, and methodology transfers which take time, are prone to error, and can further prolong R&D timelines. Not to mention issues with barriers to communication and the burden of project management resting on the sponsor. Everything is siloed. At the core of Altasciences’ mission is the dedication to removing barriers that impede the flow of critical data and insights in research and development, ultimately expediting the delivery of life-saving medications to those in need. Steve Mason, the distinguished Co-Chief Operating Officer at Altasciences, is one of the leaders guiding this visionary path. With nearly three decades of experience in building preclinical businesses, Steve’s leadership ensures that all of Altasciences’ preclinical services and sites operate seamlessly with all departments. For an IND application, for example, a sponsor will require both preclinical data and several other regulatory documents, including the Investigator’s Brochure that the doctors will refer to for both clinical protocol writing and clinical conduct. Often, each requirement is handled separately, and small biotech and biopharma companies need to work with both preclinical and clinical CROs, as well as with consultants to help review that data and put it into a compliant format for the IND application. Our recent interview with Steve offers a peek into his professional journey and Altasciences' role in redefining drug development, setting new standards for excellence in every endeavor. What inspired your interest in life sciences? At Altasciences, we safely remove the bottlenecks and gatekeepers that stop the data from flowing seamlessly and efficiently. We don’t cut corners—we simply remove the inefficiencies to help sponsors get better drugs to the people who need them, faster—that is always the end goal. For as long as I can remember, I always wanted to know how things work. As a child, this naturally developed into a fascination with science. I was inspired by how chemistry and biology came together in disciplines like pharmacology, and how diseases and conditions could be treated by

8. considerable adjustments as we've seen novel approaches such as psychedelics, gene therapies, and other treatment modalities become the pipelines of medicines in the future. Excellence is ingrained in our culture; in fact, it is one of Altasciences’ core values. An effective way of ensuring we stay ahead is by speaking with our clients to ensure that we’re evolving with them and always improving and innovating to better meet their changing needs. In addition to regular meetings and check- ins with clients throughout our partnerships, our client experience (CX) team documents the client’s perception of their journey with us at all touchpoints—from searching for a CRO/CDMO to the last invoice. They listen, track, and analyze client feedback through various means, such as satisfaction surveys, audits and visits, and governance meetings. This CX data is reviewed by executive leadership on a regular basis to determine how we can drive improvements and design a better overall experience for our clients. How has the company strategically navigated its global presence? In just the last five years, we’ve made significant acquisitions to scale our services and capacity, expand our geographic reach, as well as meet the ever-evolving needs of our clients. For example, there was a high demand for preclinical studies, so we added three more preclinical facilities to our offering for a total of four across the U.S.A. In addition, we added a third clinical pharmacology unit in L.A. and expanded our existing bioanalytical labs, as well as acquired a CDMO facility in Philadelphia. With a total of nine facilities in Canada and across the U.S., an office in the UK, we have all time zones covered. In 2022, we opened the office I mentioned in the UK—our first foothold in Europe—to better support our clients overseas. Since then, we’ve hosted three symposia overseas: the first in Switzerland in 2022 and two in England in 2023 and 2024. For our European clients who experience stringent processes and longer review times with the European Medicines Agency (EMA), our global presence provides them with the option of conducting their studies through two additional regulatory pathways with the U.S. FDA and Health Canada, each with their share of benefits. As Co-COO, can you share a particular project you are especially proud to be part of? We’ve spent a significant amount of time in the last couple of years working with the downsized Sinclair Nanopig™ as an alternative species for nonclinical toxicology testing.

9. type of holistic visibility on a client’s drug development plan is unique and enables us to proactively plan and prepare for the next phase while the current phase is ongoing—for quicker and smoother transitions. We don't cut corners—we simply remove the ine?ciencies to help sponsors get better drugs to the people who need them, faster—that is always the end goal. What are Altasciences’ key focus areas and strategic goals in continuing to be a leader in integrated drug development solutions? A few focus areas for us is expanding our presence in Europe; continuing to nurture and grow our relationships with clients where we can partner for multiple research aspects and end-to-end programs (this is where clients can experience the greatest benefits of Proactive Drug Development); and finally, continuing to refine our solution offerings by listening to client feedback, which could mean further acquisitions and/or expansions to our facilities. This has been a detailed project, collecting background data to support the use of this species for drug development; and we’re starting to see it take off now. Industry-wide, the use of swine in research to replace traditional species, such as dogs and nonhuman primates, is something we want to see accelerate and become more mainstream, and Altasciences is proud to be a leader in this space. A strategic goal I can speak on in more detail has been the process of transitioning one of our most recent preclinical acquisitions to specialized late discovery and PK, with a focus on gene therapy, antibody, and cell-based therapies to add to our biologics’ capabilities. We believe that the future growth of Altasciences can be enhanced by connecting with our clients earlier in the drug development cycle, prior to regulatory studies, with the intention of partnering with them throughout their early-phase development journey. How does Altasciences align with the theme of innovation and excellence, and what sets it apart as a top solution provider in 2024? We pride ourselves on challenging the status quo. Altasciences has successfully pushed change in an industry that has been historically slow to change. Our vertical and horizontal integration isn’t the standard in our industry. All our scientific operations report directly into the two co-chief operating officers; myself and my colleague Marie-Hélène Raigneau ensure that, from preclinical studies to clinical trials, to bioanalysis and manufacturing, to regulatory affairs, all services and teams are moving in unison to deliver a seamless outsourcing experience for our clients. Shine of Success • Most recently, Altasciences was recognized with a 2024 CRO Leadership Award in the Capabilities category, as voted by clients in ISR’s annual CRO Quality Benchmarking survey. Altasciences has been consistently recognized by the CRO Leadership Awards in multiple categories since 2014. Steve Mason was named a Top 25 Executive of Montréal for 2023 by C-Suite Spotlight. Excellence is ingrained in our culture; in fact, it is one of Altasciences’ core values. We provide services and solutions of the highest quality and strive to exceed expectations, no matter the project’s size—whether a client partners with us for one study, one solution, or for an end-to-end program. As an integrated CRO/CDMO, our scientific and operational teams work together on a client’s project from the very beginning to the very end. Together, they build the client’s roadmap, anticipate, and mitigate potential roadblocks, and react in real-time as needed. Having this •

10. Leveraging CRO Expertise I t is a great challenge for the pharmaceutical industry to provide drugs of high quality at low prices to patients, health care providers, and regulatory agencies. In this scenario, pharmaceutical companies must employ innovative techniques that would reduce costs without compromising on the quality or the safety factor as competition heightens and profit margins narrow. This article examines a number of practical strategies that can assist these businesses in improving productivity, streamlining processes, and eventually cutting expenses. Outsourcing Non-core Functions Outsourcing non-core tasks is one of the best ways to cut costs in the pharmaceutical industry. Businesses can cut overhead expenses dramatically by assigning specialized external partners to handle duties like data management, IT support, and even certain R&D. By utilizing the experience of outside suppliers, outsourcing enables businesses to concentrate on their core skills, especially in areas with cheaper labor costs. Significant cost savings can also result from strategic alliances with other pharmaceutical businesses. Costs and risks might be shared by working together on research projects or pooling resources for clinical trials. For instance, businesses can combine their resources to carry out extensive research that would be unaffordable if done alone. Lean Manufacturing Principles Increasing operational efficiency can also be achieved by putting lean manufacturing principles into practice. The goal of lean approaches is to maximize output while reducing waste, whether it be in the form of labor, resources, or time. Pharmaceutical firms can boost output and decrease cycle times by identifying bottlenecks and streamlining production operations. For instance, implementing just-in-time (JIT) inventory techniques can lower the risk of obsolescence and holding expenses. By ensuring that materials only arrive when needed for production, this strategy greatly reduces the cost of carrying inventory. Zero-Based Budgeting (ZBB) Instead of using prior budgets as a starting point, zero-based budgeting (ZBB) demands all spending to be justified for every new month. This approach pushes departments to www.insightscare.com November 2024 19

11. prioritize necessary expenses and conduct a critical assessment of their spending. Pharmaceutical businesses can find areas where they can reduce costs without compromising quality or innovation by putting ZBB into practice. productivity gains, this approach also motivates strategic partnerships that divide the cost of R&D. Lean manufacturing techniques also make processes less complex by eliminating waste and utilizing all available resources. For example, using just-in-time inventory management reduces carrying costs to almost zero because production schedules improve. Also, the zero-based budgeting ensures that one actually checks how he is spending and can reduce even the biggest business to severely lessen costs without having to compromise on quality. Studies show that by cutting down wasteful spending, businesses using ZBB can save up to 25%. By encouraging a culture of transparency and accountability in financial management, this method enables businesses to more efficiently direct resources toward strategic goals. Efficient Patient Engagement Strategies New opportunities for cost savings will come from higher levels of patient engagement and the future of decentralized clinical trials. With digital means of communication and remote monitoring, pharmaceutical companies can reduce the costs associated with recruitment and improve retention in clinical trials. Enhancing patient participation in clinical trials is essential for cutting recruitment and retention expenses. Clinical trial awareness and participation can be increased by effective communication techniques, which can speed up enrollment and reduce delays. Pharmaceutical firms can reduce marketing costs and reach a wider audience by using digital channels for outreach and interaction. By using these modern strategies, pharmaceutical companies can alleviate costs to bring benefits to the bottom line: improved patient outcomes and a more sustainable business model. Additionally, by making participation easier for patients, the use of patient-centric study designs can increase retention rates. This speeds up the entire medication development process in addition to lowering the expenses related to dropout rates. - Natalie May Decentralized Clinical Trials The transition to decentralized or hybrid clinical trials is one of the great opportunities that pharmaceutical businesses will present for reducing costs. Since the technology allows pharmaceutical businesses to make virtual visits and monitoring from a distance, they save on travel and operating expenses instead of carrying out site visits. For one, decentralized studies increase the comfort of patients, which could translate to better retention and recruitment. The companies can bring new drugs into the market earlier, spending less on traditional trial methods. Conclusion Pharmaceutical companies, which are under heavy market pressures, must establish efficient cost-cutting measures. The expertise of CROs may be utilized for the outsourcing of non-core services so that overhead might be reduced and there is concentration on core competencies. Besides www.insightscare.com November 2024 20

12. About the Author Bryan Ahmed Founder Salimeen www.insightscare.com November 2024 22

13. The Problem M differences, stigma around mental health, lack of familiarity with the healthcare system, and logistical challenges such as finding time and transportation for appointments. These barriers can result in untreated mental health conditions, which can exacerbate the stress and trauma associated with migration and resettlement. PTSD, and adjustment disorders. These conditions can be compounded by the stress of resettlement, isolation from their home culture, and discrimination in their new environment. igrants from the MENA region often face significant barriers to accessing mental health care. These include language and cultural Tailored Solutions Salimeen addresses these challenges by offering a range of tailored services. The platform provides access to therapists and psychiatrists who are not only fluent in the user’s native language but also culturally competent. This ensures that the care provided is sensitive to the user’s cultural background and personal experiences, fostering a therapeutic environment where migrants feel understood and respected. The Vision Salimeen envisions a world where mental health care is accessible, culturally sensitive, and tailored to the unique needs of migrants. The platform aims to bridge the gap between migrants and mental health professionals by offering a marketplace that connects users with licensed and verified service providers who understand their cultural background and speak their language. By leveraging technology and a network of experts, Salimeen aspires to provide high-quality, affordable, and accessible mental health care to migrants around the globe. How It Works • A User-Friendly Marketplace Salimeen operates as a marketplace where users can browse profiles of mental health professionals, read reviews, and choose the provider that best meets their needs. The platform uses third-party verification to ensure that all service providers are licensed and qualified, giving users confidence in the quality of care they will receive. Culturally Sensitive Mental Health Support Cross-Border Prescription Services • Understanding the Needs Salimeen’s approach begins with a deep understanding of the cultural, linguistic, and social contexts of its users. Migrants from the MENA region often experience a range of mental health issues, including anxiety, depression, One of Salimeen’s most innovative features is its ability to offer cross-border prescription services. This groundbreaking capability allows migrants to receive prescriptions from licensed professionals in their home www.insightscare.com November 2024 23

14. Community Outreach and Impact countries, ensuring continuity of care and access to necessary medications without the bureaucratic hurdles often associated with international prescriptions. • Building Trust and Awareness Technological Integration Salimeen recognizes the importance of community outreach in building trust and awareness among migrants. The platform engages with community organizations, cultural centers, and advocacy groups to promote its services and educate migrants about the importance of mental health care. Through partnerships and grassroots efforts, Salimeen aims to reach as many migrants as possible and encourage them to seek the support they need. Salimeen leverages advanced technology to enhance the user experience. The platform incorporates secure video conferencing for remote therapy sessions, ensuring that users can access care from the comfort and privacy of their homes. Additionally, Salimeen uses AI-driven algorithms to match users with the most suitable providers based on their specific needs and preferences. • Measuring Success The Team Behind Salimeen Success for Salimeen is measured not only by the number of users but also the impact on their mental health and well- being. The platform collects data on user satisfaction, treatment outcomes, and engagement to continuously improve its services and demonstrate its effectiveness. By prioritizing the needs and experiences of its users, Salimeen ensures that it remains responsive and relevant. • Expertise and Diversity Salimeen’s team is a diverse group of experts with extensive experience in digital health, mental health, and technology. One of the co-founders is a digital health expert who has worked with the World Health Organization and various governments in the GCC, bringing invaluable insights and connections to the project. The team’s varied backgrounds and collective expertise enable Salimeen to address the complex challenges of providing culturally sensitive mental health care on a global scale. Competition and Differentiation • The Competitive Landscape While there are several digital mental health platforms on the market, few cater specifically to the unique needs of migrants from the MENA region. Competitors include general mental health apps like BetterHelp and Talkspace, as well as region-specific services. However, these platforms often lack the cultural competence and language support that Salimeen offers. Salimeen’s Unique Advantages Salimeen sets itself apart through its focus on cultural sensitivity, its marketplace model, and its innovative cross-border prescription services. By offering a tailored solution that addresses the specific challenges faced by MENA migrants, Salimeen provides a level of care that is unmatched by its competitors. The platform’s commitment to quality, accessibility, and cultural competence positions it as a leader in the field of digital mental health. www.insightscare.com November 2024 24

15. Continuous Testing C onversion Rate Optimization has emerged as the key component that businesses aim at to maximize their financial performance and online presence. The process of implementing a CRO plan is difficult but also involves real-time adjustments owing to shifting user behavior, industry trends, and technological advancements. data. It increases conversion rates and user engagement, with experiences customized using real-time data. Using Data Analysis Effective CRO begins with a solid understanding of your current performance metrics. Key performance indicators (KPIs) such as conversion rates, bounce rates, and average session duration provide insights into user behavior. Tools like Google Analytics, Mixpanel, or Hotjar can help you gather and analyze this data. When the digital environment is rapidly advancing, it will be important to keep adjusting your CRO strategy in real- time in order not to fall behind. That could involve ongoing tests and the absorption of new technologies for data-based improvements in user experience and conversions. They enable you to track where your visitors are coming from. Organic search, social media, or paid ads? Knowing this helps one allocate resources effectively. It further analyzes how users navigate through your site. Where do your users drop off most? Which pages have the highest engagement? This data is important for knowing exactly where to improve. This article examines the essential components of effectively modifying your CRO strategy at any time. Importance of Real Time Adaptation The sphere of digital media is very dynamic. New technologies emerge, consumer preferences change, and competition dynamics shift. Such companies that do not modify their tactics for conversion rate optimization are on the verge of falling behind. Real-time adaptation lets business organizations keep track of how users behave on their website and immediately make changes to improve the user experience. Role of A/B Testing One of the best strategies for real-time conversion rate optimization is A/B testing. You can find out which version of a webpage or element (such as a CTA button) works better by comparing two versions. It provides real-time data analysis that helps in making decisions based on real-time trends rather than previous Conducting tests on a regular basis as opposed to seldom. This continuous procedure enables you to continuously www.insightscare.com November 2024 29

16. improve elements in response to user behavior and feedback. Additionally, make sure your tests are performed long enough to reach statistical significance before modifying them in response to the findings. By enabling predictive analysis of user behavior, the combination of AI and machine learning further transforms CRO efforts by helping companies to foresee trends and quickly make well-informed modifications. Testing procedures that are automated increase productivity and yield insights that human approaches could miss. Personalization The secret to improving user experience and boosting conversions is personalization. Leveraging user interaction data allows you to customize offers and content to each user's preferences. using technologies that enable content to be changed dynamically according to user demographics or behavior. Engagement can be greatly increased, for instance, by displaying various goods or messages according to prior interactions. The secret to a successful CRO is a dedication to continuous adaptability. Businesses can develop a responsive approach that not only satisfies present demands but also foresees future changes in user behavior and market trends by utilizing real-time data, continuous testing, personalization, and cutting-edge technologies. In the end, this proactive strategy leads to increased conversion rates and better financial performance in addition to improving user satisfaction. Integration of AI and Machine Learning - Natalie May Your CRO approach can be completely transformed by incorporating AI and machine learning into data analysis and implementation. By using previous data, AI systems can predict trends in user behavior, enabling you to make proactive changes to your approach. Automating A/B testing procedures with machine learning algorithms allows for quicker analysis of findings than human techniques and the provision of insights that could otherwise go unnoticed. Conclusion With the constantly changing dynamics of the new-age digital marketplace, competitiveness can only be sustained if the Conversion Rate Optimization (CRO) plan changes in real time. It calls for businesses to embrace flexibility as well as adopt a proactive approach to CRO because user behavior, technology, and market dynamics are all constantly changing. This calls for not just knowledge of contemporary performance measures but also continuous testing and data analysis for informed decisions. An essential component of a successful CRO is continuous testing. Businesses can find out which aspects of their website users find most engaging by routinely running A/B tests. By allowing for modifications in response to real-time data, this iterative process guarantees that solutions stay applicable and successful. Additionally, personalization is crucial for improving user experience; adjusting offers and content to suit each user's tastes can greatly increase engagement and conversion rates. www.insightscare.com November 2024 30