Healthcare Innovators CSOs Pioneering the Future of Science

1. DRIVING EFFICIENCY AND QUALITY HOW CSOS ARE INNOVATING HEALTHCARE OPERATIONS Healthcare Innovators: CSOs Pioneering the Future of Science HEALTHCARE CSO’S THE ARCHITECTS OF SUSTAINABLE INNOVATION AND GROWTH D AV E Vigerust

2. Success is not the key to happiness. Happiness is the key to success. If you love what you are doing, you will be successful. - Albert Schweitzer

4. Blueprints for Better Care C hief Strategy Officers (CSOs) in healthcare are leading a transformative shift, shaping how organizations approach medical science and patient care. By blending strategic insight with cutting- edge technological advancements, these professionals drive meaningful changes beyond traditional healthcare operations. Their role is instrumental in creating an environment where science, technology, and patient-centered care intersect to form a more efficient and effective healthcare system. CSOs are at the forefront of integrating new tools like artificial intelligence, machine learning, and data analytics into healthcare delivery. These innovations are not just enhancing clinical outcomes; they are improving administrative processes, enabling faster, more accurate diagnoses, and enhancing personalized care. Using data to inform decisions, CSOs transform how healthcare providers access and utilize patient information, ultimately leading to better treatment strategies and outcomes. In addition to adopting new technologies, CSOs play a crucial role in developing strategic partnerships with research institutions, technology companies, and other healthcare organizations. These collaborations open doors to new medical discoveries, innovative treatments, and solutions to global health issues. By investing in research and development, CSOs ensure that healthcare organizations stay at the forefront of scientific advancements. Beyond technology and partnerships, CSOs are also shaping organizational culture. They encourage creativity and collaboration across departments, ensuring innovation is a core value. This approach helps healthcare organizations respond more effectively to the evolving needs of patients while maintaining high standards of care. , , Innovation in healthcare is not about fixing broken things, it's about creating something better. As science continues to drive healthcare forward, CSOs are central to implementing these breakthroughs and ensuring they deliver tangible benefits for patients and providers alike. Their strategic leadership is paving the way for a healthcare system that is more efficient, accessible, and advanced. - Elizabeth Holmes , , - Kevin Smith Managing Editor

5. PUBLISHER: WORLD CARE MAGAZINE Managing Editor Kevin Smith Art and Design Head Nicole Wilson Business Development Jack Miller, Michael Brown, Executives Melissa Anderson, Angela Paul Marketing Manager Grace Jackson Technical Head Luca Ferrari Digital Marketing Manager Sophia Rossi Circulation manager David Brown Accounts Adam Brown Contact Us: Michael Brown michael@worldcaremagazine.com Whatsapp: +1 307 314 9695

6. CONTENTS Cover Story 0 Dave Vigerust Transforming Healthcare Through Personalized Medicine and Innovation. Profiles Dave Miller Dr. Beatrice Setnik Transforming Drug Delivery and Solubility Solutions Advancing Early-Phase Drug Development

7. CONTENTS Articles 1 Driving Efficiency and Quality How CSOs Are Innovating Healthcare Operations 2 Healthcare CSOs The Architects of Sustainable Innovation and Growth

8. C over STORY D AV E Vigerust Transforming Healthcare Through Personalized Medicine and Innovation Medicine should be tailored to the unique characteristics and needs of the individual, as not every patient responds the same way to a particular treatment or medication. , www.worldcaremagazine.com 06

9. Dave Vigerust Chief Scienti?c O?cer Spectrum Solutions, Strategic Biosciences and Cancer Diagnostics of America www.worldcaremagazine.com 07

10. T shift driven by advancements in personalized medicine, non-invasive testing, and precision technologies. The focus has moved beyond traditional treatments, with a growing importance on tailoring medical approaches to individual needs. This shift aims to improve patient outcomes by offering more targeted and effective solutions. Companies in this sector are also expanding their efforts to make diagnostic tools more accessible and affordable, addressing long-standing barriers such as patient access to healthcare and the limitations of conventional medical practices. Innovations in biospecimen collection, diagnostics, and the integration of telemedicine are further contributing to these changes, providing patients with new opportunities to take charge of their health. he healthcare and medical diagnostics industry is undergoing a transformative A life dedicated to serving patients in need of expertise and care is a life well spent. including the creation of advanced diagnostic assays and patient-tailored therapies, is setting new standards in the medical field. Through its integrated approach, Spectrum Solutions continues to shape the future of healthcare by providing groundbreaking tools that enable more effective, personalized treatment plans for a wide range of conditions. , such as heart disease, diabetes, and cancer. Dave observed that patients were often treated according to a one- size-fits-all approach, without consideration for the individuality of each person. He believes that medicine should be tailored to the unique characteristics and needs of the individual, as not every patient responds the same way to a particular treatment or medication. Advancing Personalized Medicine for Improved Patient Outcomes As CSO of Cancer Diagnostics of America (CDA), Dave is spearheading the development of a personalized approach to cancer treatment. CDA's innovative approach involves taking a small sample of a patient's cancer and analyzing it in the laboratory to determine the most effective drugs and therapies based on the individual's unique biology. This contrasts with the conventional method, where patients are placed on a treatment protocol based on the general characteristics of their cancer, which often yields suboptimal results. In fact, current treatment protocols are effective in only about 60% of cases, and for those patients who do not respond, the prior treatment can complicate subsequent therapeutic options. Throughout his career, Dave has been committed to advancing healthcare solutions with a direct and positive impact on patients. His work has spanned various companies focused on improving access to testing and care, with a core objective of translating medical research into products and services that benefit patients. Dave Vigerust, Chief Scientific Officer, has dedicated his career to pushing the boundaries of medical science, particularly in the fields of personalized medicine and diagnostic development. His work spans a variety of areas, from advancing non-invasive testing solutions to exploring the links between oral health and chronic systemic diseases. With a keen understanding of both scientific research and business strategy, Dave has been instrumental in bringing scientific innovations to the forefront of patient care. His efforts are focused on delivering practical applications of cutting-edge research that directly impact patient health, making a difference in both the lives of individuals and the broader healthcare system. In his role as a university professor and academic, Dave concentrated on projects that had the potential to bring tangible benefits to patients. He believes that one of the most effective ways to achieve this is by combining academic research with a business perspective, moving innovations from the laboratory into practical applications. Over the years, Dave has developed a range of diagnostic assays for conditions including diabetes, cardiovascular disease, infectious diseases, and cancer. These essays have always been driven by specific needs within the healthcare community. A pivotal moment in his career came when he recognized the shortcomings of traditional medical approaches, particularly in the treatment of diseases With CDA's approach, the treatment plan is tailored specifically to the patient's cancer, maximizing the likelihood of a successful outcome. By identifying the most effective drugs for each individual, CDA aims to improve treatment efficacy and increase the chances of success in cancer care. This personalized approach represents a significant advancement in cancer treatment and has the potential to Spectrum Solutions, alongside its subsidiaries Strategic Biosciences and Cancer Diagnostics of America, has emerged as a key player in the development of innovative diagnostic solutions. The company's work, www.worldcaremagazine.com 08

11. transform the way cancer is managed. Dave also recognizes that successful scientific innovations must be paired with business acumen to ensure their effective deployment within the medical and advocacy communities. By advancing these innovations through successful business models, he believes that further research and development can continue to disrupt the current medical model, leading to improved patient outcomes and more personalized care in the future. Innovative Diagnostics for Systemic Health Risks Dave has been instrumental in advancing non-invasive biospecimen collection methods for medical, dental, and wellness applications, which are key to improving public health. Many individuals face barriers to accessing diagnostic services or experience fear of blood collection. Dave is leading efforts in a shift toward remote health monitoring, where saliva and other biofluid samples can be collected easily and painlessly. These samples can be preserved for shipping at room temperature without compromising result accuracy. For years, telemedicine, teledentistry, and consumer-directed testing have provided patients with insights into their health and wellness. These platforms improve access, education, and outcomes for patients seeking to manage potential chronic health conditions. Saliva, in particular, is an effective medium for monitoring various health markers. Spectrum Solutions, under Dave's leadership, is at the forefront of this innovation with a vertically integrated system that includes a proprietary collection device and a stabilizing solution designed to preserve samples during transit. The company also has a diagnostic development division, which enables the creation of in-house clinical diagnostic assays. In addition, Spectrum Solutions operates a CLIA www.worldcaremagazine.com 09

12. significant impact on patient care by helping to identify health risks early. With more than 60% of the population potentially suffering from undiagnosed gum disease, Dave's work has far- reaching implications. Gum disease has been linked to numerous systemic conditions, including heart disease, stroke, diabetes, liver disease, and cancer. The global impact of this research is profound. Dave is deeply passionate about helping patients live healthier lives through innovative testing solutions. His work has the potential to impact millions of individuals worldwide, particularly those at risk for chronic conditions. As heart disease remains the leading cause of death in the United States, Dave is driven by the opportunity to reduce this risk and improve the health outcomes of countless patients. Innovative Collaboration Driving Advanced Diagnostic Solutions The teams at Spectrum Solutions, Strategic Biosciences, and Cancer Diagnostics of America consist of highly skilled professionals across a range of fields, including chemical engineering, molecular biology, manufacturing, clinical medicine, regulatory affairs, and biomedical innovation. These teams function as a think tank, identifying needs within the medical community and applying a high level of expertise and innovation to develop the tools required to meet those needs. and CAP-accredited laboratory to conduct these assays and a compounding pharmacy that supplies therapeutics tailored to improve patients' health based on diagnostic results. One of the major projects Dave has championed is SimplyPerio, a product developed over the past 12 years at Spectrum Solutions. This product provides critical insights into how oral health impacts systemic health. Decades of research have shown that pathogenic organisms in the mouth can contribute to gum disease, which in turn can lead to serious conditions such as heart disease, stroke, neurodegenerative diseases, metabolic disorders, and joint diseases. SimplyPerio enables physicians and dentists to detect gum disease and assess the risk of related systemic health issues. Dave and his colleagues have published studies identifying the specific organisms responsible for gum disease and how these microorganisms contribute to heart attack and stroke risk. These efforts are making a Spectrum Solutions stands out as the only company specializing in salivary collection with such a comprehensive range of vertical integration. The company's technical and logistical capabilities are extensive. During the COVID-19 pandemic, Spectrum Solutions was the first to receive FDA Emergency Use Authorization (EUA) for using saliva to detect COVID-19. Since then, the company has expanded its portfolio, developing additional collection devices for hormones, proteins, inflammation, and infectious diseases. For instance, the bioengineers in the clinical diagnostic development division have designed, engineered, and built many of the devices and equipment used by the company. These developments were driven by the realization that existing equipment lacked the accuracy, precision, and sensitivity needed to achieve the company's standards for quality diagnostic delivery. When a tool is unavailable, the team creates it; when www.worldcaremagazine.com 10

13. existing tools fall short, they research and develop improved alternatives. The shift toward personalized treatment plans maximizes the likelihood of a successful outcome by identifying the most effective drugs for each individual , This commitment to innovation and excellence stems from a shared dedication to serving the medical community and patients. The combined expertise, skill, and drive of the teams have propelled the company to the forefront of diagnostic technology. For the Chief Scientific Officer, success is achieved by valuing the ideas and perspectives of others, listening carefully to concepts and objections, and fostering collaboration—an essential element for leading effectively in this role. outcomes by ensuring the correct drug therapies are prescribed. lower profits for some products, but the primary goal is to serve patients. By staying committed to providing the best solutions for clinicians and patients, long-term business success will follow. In addition to issues with insurance coverage, the regulatory environment has become more challenging due to initiatives from the FDA and other organizations aimed at tightening healthcare regulations. These increased regulatory requirements can delay the launch of new products designed to benefit patients, particularly for small companies that lack the financial resources to navigate the complex and time-consuming regulatory process. While these regulations are often framed as necessary for public safety, they can also act as a barrier to innovation, limiting improvements in patient care. Overcoming Healthcare Barriers to Innovation and Patient Access Linking Oral Health to Chronic Disease Risk One of the major obstacles in healthcare today is the current medical and insurance model, which often creates conflicts that impede the delivery of better solutions for patients. The insurance system frequently does not prioritize improved patient outcomes, making it difficult to gather the necessary data to convince stakeholders in the medical community. A clear example of this challenge is pharmacogenomics (PGX), a technology that allows laboratories to analyze a saliva or blood sample to determine how well a patient can metabolize medications by examining specific genes in the liver. Dave's work has made significant contributions to understanding the central role of inflammation in most, if not all, chronic diseases. In particular, his research highlights the widespread issues of gum and oral health, which affect millions globally. The oral cavity serves as a gateway to the body, and what enters through the mouth has a profound impact on overall health, wellness, and longevity. Dave has been instrumental in educating both the dental and medical communities about the far-reaching effects of gum disease. To overcome these obstacles, the strategy is to remain resilient and build a team of subject matter experts across various disciplines. By working collaboratively, the team can effectively address the challenges that hinder innovation and delay the market introduction of new products. His current and past research establishes a clear connection between certain bacterial, viral, and fungal infections in the oral cavity and the onset and progression of several chronic conditions, including heart disease, diabetes, liver disease, and brain diseases. Studies indicate that these infections can contribute to heart attacks, Parkinson's disease, and Alzheimer's disease and can worsen the effects of diabetes and other metabolic disorders. One of Dave's most notable achievements is the development of the SimplyPerio product, which offers both patients and clinicians a comprehensive understanding of oral health. This Despite being around for nearly 50 years, PGX offers valuable insights into the metabolism of all currently marketed drugs. It has been shown to be clinically beneficial for patients with conditions such as heart disease, diabetes, cancer, anxiety, and depression. However, insurance companies often do not cover the cost of PGX testing despite substantial evidence of its clinical utility and cost- saving potential. This results in patients frequently having to pay out of pocket for the test, even though it could significantly improve patient Prioritizing Patient Needs and Scientific Integrity Over Profit The teams at Spectrum Solutions, Strategic Biosciences, and Cancer Diagnostics of America prioritize scientific integrity and patient needs in all their efforts. At times, the pursuit of the best product can conflict with commercial objectives. However, the company's approach is to prioritize the creation of the highest quality products and services. This focus may result in www.worldcaremagazine.com 11

15. product is considered one of the best available for providing insights into oral health for both patients and healthcare providers. Through continued education and testing, there is potential to reduce the prevalence of heart disease, diabetes, and brain- related illnesses, particularly as people age. Dave believes that longevity and sustained health begin in the mouth, and his work is at the forefront of identifying biomarkers that can help mitigate inflammation and other systemic issues linked to poor oral health. Dave's vision is for precision medicine to become a standard tool in healthcare, making it more accessible and allowing individuals to proactively utilize precision tools for their health and wellness. Achieving this vision requires reducing costs and increasing clinicians' comfort with technologies like precision genetics, proteomics, and metabolomics, which provide valuable insights into patient health. and while some paths may lead to success, others may not. When faced with failure, it is important to persevere, as each experience offers valuable lessons that contribute to growth in both science and business. Communicating Complex Science to Diverse Audiences The TEDx talk provided Dave with the opportunity to communicate the values of precision medicine while learning to address diverse audiences in a clear and accessible way. Scientific publications are typically technical and filled with jargon, making it rare for scientists to speak to a broad audience that includes experts, laypeople, and the general public. Most scientists have limited public speaking experience, and the TEDx talk was instrumental in helping Dave improve his ability to convey complex topics in a straightforward, plainspoken manner. Currently, precision medicine is not widely integrated into the curricula of medical, dental, and chiropractic schools, leading to a lack of familiarity with these concepts among clinicians. As a result, training on the benefits, utility, and application of precision medicine takes longer. Dave believes that in the near future, individuals will be empowered to advocate for their own health, and his work will play a key role in providing innovative and disruptive products that will benefit the public. Additionally, Dave developed a fast and cost-effective technique for genetically determining a marker known as haptoglobin, which plays a significant role in chronic diseases. The marker's three forms vary among individuals, with the highest-risk variant found in approximately 37% of the U.S. population. This variant produces a precursor protein called zonulin, which is associated with conditions such as celiac disease and leaky gut syndrome. Zonulin can cause allergens and other substances to pass from the gut into the bloodstream, triggering sensitivities, including gluten intolerance. This variant also significantly increases the risk of heart attack and stroke, particularly in patients with type 2 diabetes, a condition affecting an estimated 80- 100 million people in the U.S. By identifying which haptoglobin variant a patient carries, healthcare providers can assess the risks of leaky gut, leaky gums, and leaky brain. Additionally, this information can help determine a person's cardiovascular risk, potential diabetes complications, and the risk of cancer development. Dave's MyHap2 and Hap2 tests offer the potential to enhance screening and diagnostics, ultimately improving heart, gut, and brain health for millions of people in the U.S. and globally. Improving Patient Outcomes Through Innovation and Education Trusting Your Path and Embracing Failure as Growth Dave describes the work of the company as focused on improving patient outcomes by developing and building innovative technologies in the medical and diagnostic fields. Success is measured by the level of access provided to industry-leading diagnostics, the ability to educate people to advocate for their own health, and the reduction of pain and suffering. Dave believes that a life dedicated to serving patients in need of expertise and care is a life well spent. Dave's best advice is to trust one's internal compass. As individuals pursue their career goals, they will receive advice from various sources—some of which will offer helpful guidance, while others may create doubt and hinder progress. It is crucial to evaluate all advice carefully, trust one's instincts, and choose a personal path. Competition in science, academia, and business is intense, and often, the only true direction is the one a person believes is right. At times, ideas may be dismissed as unrealistic or unachievable, but Dav advises not to be discouraged. Instead, individuals should pursue their ideas, dreams, and goals regardless of the setbacks. Both science and business share a common element: failure. It is a natural part of the journey but not an insurmountable one. Every worthwhile endeavor carries some risk of failure, Advancing Precision Medicine for Broader Access and Self-Advocacy www.worldcaremagazine.com 13

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18. How CSOs are Healthcare Operations I n recent years, Chief Strategy Officers (CSOs) have become key players in reshaping healthcare organizations. Their role is central to aligning business strategies with technological advancements, ensuring that the operational backbone of healthcare systems is both efficient and capable of delivering high-quality care. CSOs are using their expertise to streamline operations, reduce costs, and enhance patient outcomes, ultimately making healthcare services more effective and accessible. Hospitals and healthcare systems often deal with high volumes of patients, limited resources, and the need for accurate, timely information. CSOs are looking for ways to streamline processes that reduce waste and improve the flow of services. A significant part of this effort involves the optimization of workflows. Many healthcare providers still rely on traditional paper-based systems or outdated digital tools. By introducing integrated digital platforms that centralize patient records, appointment schedules, and billing processes, CSOs are reducing redundancies and ensuring that employees can focus on their core tasks rather than getting bogged down in administrative work. The healthcare sector has always had a unique set of operational challenges. These range from the integration of new technologies to the need for continuous process improvements across various departments. CSOs are stepping in to create strategic frameworks that not only improve day-to-day operations but also introduce innovations that lead to long-term success. For example, in many hospitals, patient intake processes have been digitized, allowing for faster data entry and real-time access to information. This approach not only speeds up patient care but also minimizes errors that could occur in manual processes. Additionally, through predictive analytics, CSOs can anticipate demand for services Improving Operational Efficiency One of the main areas where CSOs are driving change is in improving the efficiency of healthcare operations. www.worldcaremagazine.com 16

19. Driving Efficiency and Quality www.worldcaremagazine.com 17

20. IN THE EVER-EVOLVING healthcare landscape, a CSO is the compass guiding organizations toward innovation and patient- centered success. , , www.worldcaremagazine.com 18

21. and allocate resources more effectively, whether it's adjusting staffing levels during peak times or ensuring that medical supplies are available when needed. to accessing their health data through patient portals. By providing patients with more control over their care, such as through telehealth services, healthcare providers are offering greater convenience while maintaining high standards of care. This also helps to increase patient satisfaction, which is a key metric in modern healthcare systems. Data-Driven Decision Making In the healthcare industry, data is an invaluable asset. With the right tools and systems, organizations can leverage data to make more informed decisions that lead to better outcomes. CSOs are spearheading the adoption of advanced analytics in healthcare settings, enabling providers to track key performance indicators (KPIs) and identify areas for improvement. Another area where CSOs are driving change is in the implementation of evidence-based practices. By standardizing care protocols based on the best available research and clinical data, healthcare organizations can ensure that patients receive the most effective treatments. CSOs work closely with medical professionals to integrate these protocols into daily workflows, reducing variation in care and improving outcomes. By using data to monitor patient outcomes, readmission rates, and overall treatment efficacy, healthcare leaders can pinpoint issues in care delivery and address them proactively. In hospitals, this data-driven approach also extends to financial operations. CSOs are utilizing insights from billing and cost data to find areas where expenses can be reduced without compromising the quality of care. Moreover, CSOs are focusing on improving care coordination across different departments and providers. This is especially important in a healthcare environment where patients often see multiple specialists. By creating integrated care teams and ensuring that all providers have access to a patient's complete health history, CSOs are helping to eliminate gaps in care and reduce the risk of medical errors. Furthermore, predictive analytics allows healthcare systems to forecast trends such as patient volume, disease outbreaks, and staffing requirements. This helps organizations to stay ahead of potential issues and allocate resources in a way that ensures maximum efficiency. Conclusion Chief Strategy Officers are playing a crucial role in driving improvements across healthcare organizations. Their strategic focus on operational efficiency, quality of care, technology integration, and data-driven decision- making is reshaping the way healthcare providers deliver services. As the healthcare industry continues to adapt to new demands, CSOs will continue to be instrumental in guiding organizations toward more efficient, effective, and patient-centered care. Enhancing Quality of Care While improving efficiency is a top priority, CSOs are equally focused on ensuring that the quality of care remains high. Quality improvement initiatives are not just about reducing errors; they involve enhancing the entire patient experience from start to finish. CSOs are utilizing technology to create a seamless experience for patients, from scheduling appointments online www.worldcaremagazine.com 19

22. Transforming Drug Delivery and Solubility Solutions T he pharmaceutical industry is constantly advancing, with new technologies playing a key role in transforming drug development. As researchers work to overcome the challenges associated with drug solubility and bioavailability, the need for innovative solutions has become paramount. Traditional methods, often reliant on toxic solvents and excessive heat, have limitations that hinder the development of complex molecules. New approaches are emerging to address these issues, providing hope for more efficient and effective drug delivery systems. Leadership is a discipline supported by extensive research and data. Treat the study of leadership with the same rigor and dedication as you did with science , KinetiSol, the company has been able to eliminate the use of harmful solvents and improve the efficiency of drug development. Their commitment to sustainability and scientific rigor has positioned them at the forefront of advancing pharmaceutical solutions that not only enhance patient outcomes but also reduce the environmental footprint of drug manufacturing. efficient administration of insoluble molecules, making previously undevelopable drugs viable. Reflecting on this breakthrough, Dave stated that KinetiSol had unlocked the therapeutic potential of compounds previously considered impossible to develop due to solubility limitations, representing a significant advancement for the industry and patients worldwide. Dave Miller, the Chief Scientific Officer at AustinPx, has been instrumental in advancing these efforts. With extensive experience in pharmaceutical research, he has led initiatives focused on improving drug solubility and the development of complex drug delivery systems. Under his leadership, the company has made significant strides in overcoming manufacturing barriers and refining drug formulation processes, ultimately enhancing the therapeutic potential of challenging compounds. Revolutionizing Drug Delivery with Innovative Solubility Solutions Advancing Drug Delivery and Overcoming Manufacturing Barriers Dave and his colleague, Brough, recognized the potential of Brough's plastics recycling technology for drug delivery. This insight led to a partnership that transformed the pharmaceutical sector. The KinetiSol process facilitates the formation of complexes between insoluble compounds and water-soluble carriers at the molecular level, eliminating the need for toxic organic solvents or excessive heat. This innovation enabled the development of complex drug delivery systems essential for the After completing his PhD, Dave joined Hoffmann-La Roche as a Principal Scientist. In this role, he gained invaluable insights into the drug development process within one of the world's leading pharmaceutical companies. At Roche, Dave focused on the delivery of insoluble molecules across various therapeutic areas, including oncology and metabolic diseases. His involvement in every AustinPx has emerged as a leader in the pharmaceutical industry by developing groundbreaking technologies that address the challenges of drug solubility and delivery. Through innovations such as www.worldcaremagazine.com 20

23. stage of drug development, from early discovery to post-approval changes, deepened his understanding of the processes involved in bringing new therapies to market. During his time at Roche, Dave's PhD professors and Brough continued their research and promotion of the KinetiSol technology. Their efforts attracted the attention of several large pharmaceutical companies, leading to successful feasibility studies. However, the lack of GMP manufacturing capability at the University of Texas presented a significant obstacle to advancing these studies to clinical trials. Shifting Focus to Drug Reformulation for Improved Clinical Outcomes In 2011, Dave seized the opportunity to accelerate the commercialization of KinetiSol by joining DisperSol Technologies as the VP of R&D. By 2012, the company had established its R&D and GMP manufacturing facility north of Austin and began collaborating with several large pharmaceutical companies. Initially, DisperSol applied KinetiSol to developing molecules in large pharma, but typical causes of NCE (New Chemical Entity) attrition hindered overall success. As a result, the company shifted its strategy in 2014, focusing on the reformulation of existing drug products to improve clinical outcomes through a 505(b)(2) pathway. KinetiSol's capabilities to improve therapeutic outcomes, showcasing the technology's versatility and impact. level of scientific quality in meeting project objectives. Dave noted that one of the key challenges in his role is balancing scientific accuracy with commercial objectives. He explained that this balance is achieved through a strategic combination of advanced technologies, efficient workflows, and a highly trained team, all aimed at maintaining scientific rigor while addressing the competitive demands of the industry. Balancing Scientific Rigor with Commercial Objectives Dave's typical day is multifaceted, involving a range of responsibilities, from interacting with prospective clients to collaborating with internal teams on development challenges. A key aspect of his role is understanding the unique needs of each client and providing scientifically robust solutions. This requires extensive engagement with both clients and internal teams to ensure the highest This strategic pivot proved successful, with six clinical assets at peak, two of which advanced to Phase 3 readiness. During this time, Dave was appointed as the company's Chief Scientific Officer. Driving Innovation and Efficiency in Drug Formulation Reflecting on the shift, Dave noted that the focus on reformulating existing drugs enabled the company to leverage The company's approach focuses on www.worldcaremagazine.com 21

24. hiring talented individuals, giving them the freedom to explore, and creating a framework where good ideas can be investigated and turned into real opportunities. Dave highlights the importance of sharing a bold vision and allowing team members the autonomy to bring it to life. A particularly successful project under Dave's leadership involved developing a tool to control the KinetiSol process through the direct detection of drug crystallinity. After years of dedicated effort, a new spectroscopic tool was developed, significantly improving the efficiency of the KinetiSol process and deepening the company's understanding of the technology. Dave noted that this breakthrough enabled the company to find formulation solutions more quickly and with less API, improving efficiency and opening new possibilities for process advancement. Enhancing Drug Discovery with AI and In-Silico Tools The pharmaceutical industry is undergoing significant advancements, and Dave is particularly enthusiastic about the integration of AI and in-silico tools in drug discovery. These technologies make the drug development process more accessible and efficient. AI algorithms can analyze large datasets to identify potential drug candidates, predict their behavior, and optimize their properties, resulting in improved molecules entering development and accelerating the progression from concept to clinical trials. The focus on reformulating existing drugs enabled us to leverage KinetiSol's capabilities to improve therapeutic outcomes, showcasing the technology's versatility and impact. , Advancing Sustainability in Pharmaceutical Development Another major focus for Dave is sustainability in pharmaceutical development. The industry relies heavily on organic solvents for compound synthesis and www.worldcaremagazine.com 22

25. important to career success than any other competency metric. He also underscores the significance of clear communication, lifelong learning, and achieving a healthy work-life balance. KinetiSol has unlocked the therapeutic potential of compounds previously considered impossible to develop due to solubility limitations, representing a significant advancement for the industry and patients worldwide., Dave advises young scientists that leadership is a discipline supported by extensive research and data and encourages them to approach the study of leadership with the same rigor and dedication as they did with science. He also emphasizes that balancing work demands with personal commitments is crucial for long-term success and well- being. Future Opportunities and Challenges in Pharmaceutical Innovation Looking ahead, Dave anticipates significant challenges and opportunities in the pharmaceutical industry. The increasing issue of insolubility in the small molecule space and the rise of heterobifunctional molecules present substantial opportunities for advanced drug delivery technologies. Additionally, the shift toward sustainability will spur innovation in green chemistry and solvent-free processing technologies, balancing the need for continuous innovation with environmental responsibility. Dave concluded that addressing these challenges will require collaboration across the industry, but they also present opportunities to develop groundbreaking technologies that could transform drug delivery and manufacturing processes. He believes that embracing these opportunities will enhance the efficiency and effectiveness of pharmaceutical development while promoting a more sustainable future for the industry. manufacturing, leading to significant environmental impact. Dave advocates for innovations in green chemistry and solvent-free processing technologies to reduce the environmental footprint of drug development. compromising the health of the planet. Mentoring Future Leaders in Pharmaceutical Science Dave is passionate about mentoring young scientists and guiding them toward leadership roles in the pharmaceutical sector. He stresses the importance of continuous self- improvement, maintaining technical proficiency, and developing emotional intelligence. Dave believes that emotional intelligence is more Dave stated that sustainability is not merely a buzzword, but a necessity for the future of the industry. He emphasized that innovations that lower energy consumption and minimize waste are essential for ensuring continued progress without www.worldcaremagazine.com 23

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28. The Architects of Innovation and Growth C future of healthcare organizations. Positioned at the intersection of leadership, strategy, and operations, these professionals are responsible for creating frameworks that drive innovation while ensuring long-term growth and sustainability. As healthcare systems face increasing pressure to adapt to new technologies, rising costs, and changing patient expectations, CSOs are developing strategies that enable healthcare organizations to meet these demands and thrive. hief Strategy Officers (CSOs) are increasingly playing a crucial role in shaping the with future opportunities, all while maintaining a focus on the long-term health of the organization. Strategic Leadership and Vision Healthcare CSOs are known for their ability to craft long-term strategies that support organizational growth. A core part of their role is identifying areas where innovation can lead to more efficient care delivery and enhanced patient outcomes. They work closely with other senior leaders, including CEOs and COOs, to ensure that the organization's strategic goals align with its mission and values. The role of a CSO is multifaceted, combining business acumen with a deep understanding of the healthcare environment. They are responsible for aligning business objectives with the practical realities of healthcare delivery. By focusing on both operational improvements and patient- centered care, CSOs ensure that healthcare organizations can achieve their goals without compromising on quality. They are the architects of innovation, tasked with designing strategies that balance current needs One of the key aspects of their leadership involves guiding healthcare organizations through mergers, acquisitions, and partnerships. These initiatives are often essential for expanding access to services, improving operational efficiency, and enhancing market competitiveness. For example, when healthcare systems combine or partner with other organizations, CSOs are instrumental in ensuring that these transitions are smooth and that all parties can benefit from the collaboration. This strategic www.worldcaremagazine.com 26

29. Healthcare CSOs www.worldcaremagazine.com 27

30. foresight can be the difference between a successful merger that leads to sustainable growth and a failed one that strains resources and disrupts care delivery. accuracy and speed of diagnoses, leading to better patient outcomes and more efficient use of resources. improve employee satisfaction, which is essential for long-term organizational success. Sustainable Financial Management Conclusion Embracing Technology for Long- Term Growth Achieving long-term growth in healthcare requires a sustainable financial strategy. With rising healthcare costs, reimbursement pressures, and the need for continuous investment in infrastructure, CSOs are tasked with developing financial models that balance affordability with the quality of care. Healthcare CSOs are playing an essential role in shaping the future of healthcare. Through strategic leadership, technology adoption, financial management, patient-centered care, and a commitment to innovation, they are driving sustainable growth and ensuring that healthcare organizations remain competitive in a changing environment. As architects of sustainable innovation, CSOs are laying the foundation for a more efficient, accessible, and high-quality healthcare system, one that meets the needs of both patients and providers for years to come. Technology is a primary driver of innovation in healthcare, and CSOs are often at the forefront of introducing cutting-edge solutions that transform operations and patient care. By focusing on digital tools and platforms, CSOs are helping organizations not only streamline their internal processes but also improve patient engagement and satisfaction. Healthcare CSOs play a key role in identifying new revenue streams, such as partnerships with pharmaceutical companies, research institutions, or technology providers. These collaborations provide access to funding that can support innovation without relying solely on traditional sources of revenue, such as patient fees and insurance payments. Additionally, CSOs focus on improving operational efficiencies that reduce unnecessary costs. For instance, by optimizing supply chains, reducing waste, and consolidating administrative functions, healthcare organizations can reinvest savings into areas that directly benefit patient care. A significant area where CSOs are driving growth is through the integration of electronic health records (EHRs) and other digital platforms that enable seamless communication across departments and healthcare providers. These tools make it easier to share patient data, track outcomes, and coordinate care, ultimately leading to a more efficient healthcare delivery system. In addition, CSOs are embracing telemedicine, mobile health applications, and other remote care solutions that expand access to healthcare services while reducing overhead costs. Cost management and efficiency also extend to the workforce. CSOs work to develop strategies that ensure healthcare staff are used effectively and that staffing models align with patient needs. This includes the integration of task-shifting and automation, where appropriate, to reduce the burden on healthcare workers while ensuring that patients continue to receive high- quality care. These strategies not only reduce operational costs but also Furthermore, CSOs are introducing artificial intelligence (AI) and machine learning (ML) to assist in clinical decision-making, diagnostic processes, and patient monitoring. These technologies help healthcare providers identify patterns and predict potential health issues before they become critical. By adopting AI and ML, healthcare systems can enhance the www.worldcaremagazine.com 28

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34. Advancing Early-Phase Drug Development T he field of drug development is a critical component of advancing medical science and improving patient outcomes. It involves the continuous evaluation and testing of new therapeutic approaches, as well as the careful development of drugs to ensure their safety and efficacy. This process is often initiated through early-phase studies, where scientific research and clinical trials intersect to bring novel treatments from concept to reality. In this industry, the ability to adapt, innovate, and meet ever-changing regulatory standards is key to ensuring the successful progression of therapies. Altasciences, where Dr. Beatrice currently serves as Chief Scientific Officer, is dedicated to advancing early-phase drug development. The company offers a comprehensive range of services, from preclinical testing and clinical research to bioanalysis and manufacturing. By integrating these services within one organization, Altasciences streamlines the development process, allowing for smoother transitions between stages and accelerating timelines. This integration ensures that all phases of drug development work in concert, with scientific and operational teams collaborating to address challenges and meet client needs. In academia, the focus is on novel research and innovation, requiring creative thinking when selecting a thesis and building upon existing scientific knowledge. Dr. Beatrice Setnik, a passionate scientist, has made significant contributions to the drug development sector. With a strong foundation in pharmacology and neuroscience, she transitioned from academic research to the pharmaceutical industry, where she has helped drive forward early-phase clinical trials and medical affairs. Dr. Beatrice's leadership is marked by her commitment to guiding teams in embracing challenges and adopting innovative techniques. Her philosophy centers on inspiring others to advance drug development and pushing the boundaries of research for the benefit of patients. From Passion to Leadership in Drug Development Dr. Beatrice's passion for science began at an early age, guiding her to pursue a Bachelor of Science in Toxicology and a Doctorate in Pharmacology and Neuroscience from the University of Toronto. Initially drawn to forensic science, her career path shifted with her first industry position as a Research Scientist at Kendle Early Stage (formerly Ventana and Decisionline Clinical Research). There, she provided scientific input on various specialty Phase I and II clinical www.worldcaremagazine.com 32

35. trials, including abuse potential studies for central nervous system (CNS)-- active drugs. The experience of designing study protocols and analyzing clinical data sparked a growing interest in the business aspects of a contract research organization (CRO). This led her to a business development role, where she played a key part in creating scientific content and building partnerships with sponsors. Following her time at Kendle, Dr. Beatrice transitioned to the pharmaceutical sector, where she led medical affairs and clinical development for several pain compounds and abuse-deterrent opioids at King Pharmaceuticals and Pfizer. After years of contributing to drug development, she returned to her team in Toronto, now under INC Research, where she headed the scientific and medical writing teams and continued to support early-phase clinical trials and abuse potential evaluations. Since 2019, Dr. Beatrice has served as the Chief Scientific Officer at Altasciences, while also holding the position of Adjunct Professor in the Pharmacology and Toxicology Department at the University of Toronto. She is also the Managing Director of the Cross-Company Abuse Liability Council and leads their Clinical Subgroup. need to assess more data and endpoints in initial first-in-human trials. Dr. Beatrice believes that motivating teams to embrace new challenges and adopt innovative techniques is essential for maintaining leadership in preclinical and clinical research and pioneering novel drug development approaches. guidelines, maintaining a leadership position in meeting regulatory requirements across different countries. In the early phases, Altasciences provides comprehensive solutions, offering a complete IND package and a solid clinical plan to secure IND approval and ensure a smooth transition from preclinical to clinical stages. Leadership in Advancing Early- Phase Drug Development Streamlining Early-Stage Drug Development and Regulatory Support The company continually refines its preclinical, clinical, bioanalytical, manufacturing, and formulation services to align with the changing demands of the industry and its clients' drug development pipelines. This adaptability requires a deep understanding of client needs and the ability to think creatively. Altasciences often pioneer new methods, ensuring they meet regulatory approval through careful review. The company's approach to innovation is marked by One of the key leadership principles recognized by Dr. Beatrice is the importance of inspiring others to take on new challenges. The field of drug development is continuously advancing, driven by new therapies, emerging science, and the evolving requirements of clinical trial methodologies. Early-phase studies have become increasingly complex, with a growing demand for early proof-of-concept evaluations and the The key to early research success lies in ensuring that sponsors have the necessary regulatory support and strategies to facilitate a seamless transition through various phases of drug development. At Altasciences, a global advisory team collaborates with regulatory experts to guide clients through pivotal milestones with regulators. This team stays informed about regulatory changes and new www.worldcaremagazine.com 33

36. preclinical facilities, three bioanalytical laboratories, a formulation and manufacturing facility, and three clinical trial facilities. Dr. Beatrice has played a key role in enhancing the company's specialty services and expertise, particularly in CNS drug evaluation. Under her leadership, the company has conducted a variety of complex studies, including driving simulation, EEG, abuse and dependency potential assessments, and pain model applications. Additionally, the company has been continually expanding its patient access model for integration into early-phase studies. Guiding Future Scientists with Integrity and Passion for Discovery quick adaptation and responsiveness to industry shifts. Bridging Academia and Industry for Scientific Advancement Dr. Beatrice often advises her students at the University of Toronto that, as scientists, it is crucial to uphold integrity and ensure that both animal and human participants are treated with dignity and respect. She believes that when ethics are at the core of scientific work, success naturally follows. In her guidance on career development, Dr. Beatrice emphasizes the importance of choosing a path driven by passion and interest, as this fosters long-term commitment and achievement. She also encourages students to never shy away from asking questions and exploring new ideas, as science is fundamentally about discovery. Dr. Beatrice finds great fulfillment in contributing to the development of new therapeutics, believing that the opportunity to impact patient care is one of the most rewarding aspects of the field. Streamlining Early-Phase Drug Development In academia, the focus is on novel research and innovation, requiring creative thinking when selecting a thesis and building upon existing scientific knowledge. Attention to detail, a passion for discovery, and the application of the scientific method are critical in both academic and industry settings. The skills gained in academia, including medical writing and oral presentations, have proven instrumental in enhancing the scientific team at Altasciences. Publications and presentations on emerging data play a crucial role in the organization's efforts to advance medicine and research. Engaging with stakeholders in the field through these channels helps drive forward the scientific knowledge necessary for the development of new therapies and breakthroughs. Altasciences streamlines early-phase drug development for pharmaceutical and biotechnology sponsors by integrating preclinical safety testing, clinical research, bioanalysis, drug formulation and manufacturing, and a full range of complementary services, including medical writing, clinical monitoring, protocol development, and PK/PD. Sponsors can engage the company for multiple stages of their journey or for a single service. Rather than viewing drug development as a series of isolated steps handled by different CROs and CDMOs, Altasciences treats it as a continuous process. This integration allows the scientific and operational teams from different phases and departments to collaborate as one unified team, leveraging data and insights to guide the development roadmap. By anticipating and addressing potential roadblocks, this approach eliminates communication gaps between development stages, enabling seamless transitions and accelerating timelines by up to 40 Expansion of Capabilities in Early- Phase Drug Development Over the past five to ten years, the company has experienced significant growth and expansion. It has increased its capabilities across multiple sectors to support early-phase drug development, establishing four www.worldcaremagazine.com 34

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