2024 Speakers

Mackenzie Abramson is a dedicated advocate, driven by her personal journey and commitment to amplifying voices of patients, caregivers, and advocacy groups. Diagnosed in her mid-20’s with a rare disease, Mackenzie pursued advanced education to raise awareness for public health initiatives and rare diseases. Her advocacy efforts have reached an international scale, involving active participation and speaking with organizations such as Patients as Partners, Global Genes, The Everylife Foundation for Rare Disease and Congress, NIH Rare Disease Day, and more.

Mackenzie's work at Global Genes and consulting business (Tenacious Advocacy Consulting Team) focuses on rare and chronic diseases, mental health, and women’s health patients while partnering with the healthcare, pharmaceutical, and biotech industries to create meaningful change. Drawing on her experience in research, communications, public health programming, and patient operations, Mackenzie specializes in bridging the gap between patient communities and industry stakeholders, ensuring that patient needs and insights are at the forefront of research, development, and care initiatives.

Mackenzie is committed to empowering patients, transforming the way their voices shape the future of healthcare, and enhancing patient engagement throughout the development lifecycle. By sharing her story and insights, she hopes to inspire others to navigate their healthcare challenges with tenacity and resilience.

Afia Afzal is the Sr Director, Applied Innovation in the Global Development R&D Data Science organization at Johnson & Johnson Innovative Medicine (JJIM), where she leads a team dedicated to accelerating trial operations through Data Science. In this role, Afia is driving the development and deployment of cutting-edge AI/ML and Digital Health solutions across JJIM’s therapeutic areas. Additionally, her team focuses on developing and embedding productivity efforts and tools to enhance transparency and improve decision-making across the portfolio, ensuring that operations are not only innovative but also efficient.

In her 10 years at Johnson & Johnson, Afia has held multiple strategic roles. As the former Sr Director of External Innovation & Alliance Management, she led efforts to establish key partnerships with biotech companies, academic institutions, and governmental organizations, bringing advanced AI/ML technologies and multi-modal datasets into Johnson drug development pipeline. She played a critical role in driving innovations like early disease detection algorithms and regulatory-grade real-world evidence (RWE) for high-priority projects. In a prior role on the in the R&D Data Science Portfolio Management team, Afia spearheaded high impact use cases across Oncology, Cardiovascular, and Pulmonary Hypertension portfolios, contributing to transformative clinical operations and enhanced patient outcomes.

Afia has 15 years of leadership experience across healthcare, medical device, pharma, and consumer sectors, where she has developed and deployed innovative solutions and technologies. She is driven by a deep passion to improve patient outcomes and provide equitable access to life saving therapies. Afia holds a BS in Biomedical Sciences, a Post Baccalaureate in Public Health, and an MBA from Rutgers University.

Nishit Agarwal, MS, is a Senior Data Science Engineer at Medidata, where he leverages his expertise in medical AI, wearable sensor technology, and biomedical signal processing to drive innovation in healthcare. Holding a master’s degree in bioengineering from Northeastern University, he specializes in extracting meaningful insights and novel biomarkers from various sensor modalities, including ECG, PPG, EMG, and EEG. Mr Agarwal has made significant contributions to the field of medical technology, particularly through his work on developing remote functional capacity tests using wearable sensor data. This innovative approach enables healthcare professionals to assess a patient's physical capabilities from anywhere in the world, revolutionizing how we conduct clinical trials and improving patient outcomes. Through his work at Medidata, Mr Agarwal has played a pivotal role in shaping the future of clinical trials, where technology and innovation converge to improve human health. His contributions are a testament to the power of interdisciplinary collaboration and the potential for wearable devices to transform our understanding of medical research.

Jillian Agnew, RN, CCRC, is the Senior Clinical Research Nurse at St. Johns Center for Clinical Research in St. Augustine, Florida. She received her Certification in Clinical Research (CCRC) in 2021 and is currently the lead study nurse for all cardiovascular trials at her site.

Prior to research, Ms Agnew worked in multiple areas of nursing including Emergency, Home Health, Public Health and Trauma Critical Care at the University of Maryland R. Adams Cowley Shock Trauma Center in Baltimore, Maryland. Critical care will always be near and dear to her heart, but research has quickly become her favorite kind of nursing. “I really enjoy the relationships I develop with my research patients. I love seeing pictures of their kids, grandchildren, pets, etc. It shows how much they appreciate the amount of time you are investing in them. I also love that I have a career that brings me so much job satisfaction. Every day, I feel like I am making a difference and working towards a larger goal for the greater good.”

Outside of work, Ms Agnew and her family enjoy geocaching, game nights with friends and spending time at the beach.

Jakob Alme joined Sage Therapeutics in 2021. As the Head of Digital Health, he is focused on rethinking care and how it is delivered to help patients and families impacted by brain health disorders. In this role, he leads the function’s efforts in implementing digital health strategies across the organization, ranging from preclinical and translational through development, commercialization, and on-market planning. Prior to his time at Sage, Mr Alme led the digital health asset design for immunology at AbbVie, and also held roles in clinical operations, compliance, and data sciences. He holds a BS in Health and Human Performance from the University of Montana.

Eileen Babcock PA-C, MBA is a Senior Director of Clinical Operations at AstraZeneca Biopharmaceuticals R & D. In this capacity she has engaged in the design and delivery of dozens of clinical trials across multiple therapeutic areas including cardiovascular, respiratory, immunology, infectious disease, oncology and most recently, rare diseases. In previous roles, Ms Babcock has worked in rural health delivery. As a representative of the Pharma industry, her passion is health equity and diversity. She has published on operational effectiveness and partnership models.

Sandeep Bhat is a Senior Leader, Digital Health Partnerships and Digital Engagement, Global Clinical Operations for GSK. Mr Bhat champions transformation in global clinical research through initiatives in innovation, information exploitation (Data Science, AI/ML), emerging technology, and paradigm shifts (Decentralized Clinical Trials / DCT). As a scientist, consultant, ops professional, and technologist, he has seen industry advancement and provided advisory and mentorship in Life Sciences for 27 years. His undergraduate and graduate degrees are from the University of Pennsylvania, both in Bioengineering.

Kai Bode is a Principal Scientist at Merck Research Laboratories (MRL). In his role, Mr Bode supports the evaluation and implementation of digital health technologies for clinical research in an effort to mitigate the risk and maximize the potential of innovative solutions.

Kristie Boswell is a board-certified family nurse practitioner with five years’ experience working full time in Clemson Rural Health (CRH)’s mobile outreach program. In addition to her practice, Kristie serves as the Assistant Director for Mobile Health Operations and coordinates mobile clinics for CRH’s satellite brick and mortar offices in Walhalla, Clemson, and Orangeburg. She is the primary nurse practitioner on the mobile health unit and travels throughout the Upstate and Midlands of South Carolina serving rural patients of diverse backgrounds. Kristie’s areas of expertise include women’s health, reproductive health, substance user health, and rural outreach. Kristie has written APRN protocols related to women’s health, MAT, PrEP, and hepatitis C (HCV) for Clemson Rural Health clinicians and integrated these practices into mobile health unit service delivery. Most recently, she achieved her HIV Specialist certification from the American Academy of HIV Medicine. Her goal is to continue expansion of Clemson Rural Health’s mobile health operations and further increase access to care for our rural populations.

Greg Christie is a renowned thought leader in human-centered product development and design. As the Chief Product Officer at StudyKIK, he has gained recognition for his contributions to clinical research technology. Mr Christie’s work on the oncology app concept earned StudyKIK the SCOPE Participant Engagement Award, emphasizing his commitment to a collaborative and user-focused approach that prioritizes participant experience in cell and gene therapy trials.

Under Mr Christie’s leadership, StudyKIK was selected as a finalist for the esteemed Prix Galien UK 2023 Award in the ‘Best Digital Health Solution’ category. This distinction celebrates the patient-centric design and transformative impact of StudyKIK’s study companion applications across various therapeutic areas, including immunology and women’s health.

Mr Christie recently received the prestigious 2023 PM360 ELITE 100 Award in the Tech-Know Geek category for his contributions in reshaping the medtech landscape through innovative and patient-centric products.

Guiding StudyKIK’s Product and Design teams, Mr Christie brings a wealth of experience from his previous roles at technology organizations such as Goldstar Events, Evite, and prominent publications including Elle, Woman’s Day, Car and Driver, Road & Track, and Popular Photography. His expertise spans product development, design, branding, and marketing, positioning him as a versatile and influential leader in the field.

Ebony Dashiell-Aje, PhD, is a leading expert in clinical outcome assessment (COA) design and implementation, advising on COAs, study endpoint issues and regulatory science. As a health outcomes researcher and methodologist, Dr Dashiell-Aje is driven by her passion for public health and promoting patient-focused medical product development. Dr Dashiell-Aje has notably contributed her research expertise in academic, consulting and regulatory environments to arrive at evidence-based solutions, and to shape health policy.

Christopher Dell, MBA, is a member of the Patient Technologies team at Pfizer where he is responsible for the successful implementation of eData clinical technology – mainly focused on eCOA but also supporting connected devices. Mr Dell has been with Pfizer for almost 8 years. Prior to his current engagement at Pfizer, Mr Dell spent over 5 years at 2 different ePRO vendors, managing the successful implementation of various projects in device-based, IVR and IWR modalities. Mr Dell was also with Wyeth for 4 years and Pfizer for 2 years between 2006 – 2012 as part of a team that defined the ePRO standards at the time.

Maha's, MS, MRA, CCRC, educational background is in Clinical Research Regulatory Affairs, Biotechnology and Life Sciences. At Penn Medicine, our goal is to bring new treatments and innovative approaches to improve patients’ lives.

Ms Dutt’s portfolio at the Office of Clinical Research includes navigating clinical research sites through the complex maze of resources we offer at Penn Medicine. This includes patient recruitment, training requirements, research application implementation and maintenance; and, most importantly facilitating patients and caregivers as they try to find the right trial for their needs.

Marie Emms has over 25 years of experience in healthcare communications, spanning public relations, medical education and R&D patient engagement. Marie is currently Head of Patient Engagement & Recruitment at BMS responsible for growing, developing and supporting a team to accelerate recruitment and enrollment globally. Prior to her role at BMS, Marie was the Global Head of Investigator & Patient Engagement at Johnson & Johnson.

She specializes in the development and execution of strategic integrated communications programs to support sites and their patients through the clinical trial journey, from initial awareness and consent through to compliance and adherence. Marie has worked on a wide range of therapeutic areas across neonatal, pediatric, adult and geriatric studies.

Marie’s unique Commercial and Clinical insight, as well as her spirit of partnership, encourages and ensures successful collaboration. Marie defines what it means to be a leader in today’s rapidly changing healthcare industry. She has a genuine and singular passion to improve the lives of patients – a passion that motivates and energizes her colleagues and everyone with whom she interacts.

Daniel Eversole, PhD, is an Associate Director of Digital Strategy within the Data Sciences Institute at Takeda. In this role, Dr Eversole supports clinical trial teams in the identification and deployment of Digital Health Solutions that improve trial execution and enable the capture of clinical features not available during traditional study visits.

Prior to joining Takeda, Dr Eversole managed multiple product portfolios that delivered digitals tools for translational oncologists to identify novel, clinically robust multi-comic biomarkers that better predict response. Dr Eversole earned his Ph.D. and M.S. in Biomedical Engineering from The University of Texas at Austin and a dual B.S. Optics and Biomedical Engineering from The University of Rochester.

Christina Fawcett, a certified Project Management Professional (PMP), boasts a rich career spanning over two decades in the execution of clinical trials across diverse designs, phases, and therapeutic areas. Currently, she holds the position of Director of Digital Health Delivery, where she spearheads a team responsible for the effective implementation of digital and decentralized solutions within GSK's global clinical operations portfolio. Her leadership ensures quality standards, broadens participant involvement, and minimizes operational inefficiencies. Prior to this, Christina honed her skills in study delivery within CROs, notably as a Senior Director at PRA Health Sciences. Here, she led the Decentralized Clinical Trial Operations team, pioneering DCT protocols for various sponsors, including a groundbreaking fully decentralized Phase IIIb interventional trial.

As the Corporate Global Head of Accessibility at Merck & Co., Inc., Stephen Framil, DMA has been an ardent advocate and practitioner of equitable access across the range of human experience: including the built environment, food sustainability, education, performing arts, and the digital landscape. With over 30 years of executive leadership in business strategy and innovation, policy and governance, procedure and operations, and portfolio management expertise, Dr Framil continues to lead and champion accessibility in multinational corporations, non-profit education, and the performing arts.

Sohit Gatiganti is the CPO and co-founder of Grove, enabling clinical research organizations to recruit and engage participants at scale using data and AI. While at Stanford Medicine, Sohit saw the difficulties doctors, researchers, and patients faced in trying to find clinical trials and committed himself to developing a more efficient, patient-centric solution. At Grove, he leverages his expertise across AI and healthcare to collaborate with leading clinical research organizations and AI engineers to make clinical trials more accessible.

Before Grove, Sohit was an AI researcher at Stanford Medicine where he developed multiple cutting-edge AI tools, including a clinical trials search engine that significantly improved and accelerated how doctors match patients to appropriate trials.

Sohit holds a BS in Computer Science (AI) and a MS in Management Science from Stanford University. With a strong background in taking products from concept to launch at various early-stage startups, Sohit is passionate about leveraging his expertise to drive transformative change in the clinical trials industry.

Patrick Gee, Sr, PhD, JLC, is Founder & Chief Executive Hope Dealer, iAdvocate, Inc. Dr Gee graduated from the American University School of Public Affairs in 2012 with a Doctor of Philosophy in Justice, Law & Criminology. Dr Gee is a former Peritoneal/Hemodialysis patient due to suffering from Diabetic Kidney Disease. He has been a Post-Kidney Transplant Recipient since April 2017. Dr Gee is also a retired Major/Chief of Security from the Virginia Department of Corrections; and currently serves as the Founder & CEHD of iAdvocate, Inc., a non-profit Faith-based Health & Wellness organization. He is also an Ordained Minister at Mountain Movers Ministry in Richmond, VA. As a Patient Representative for the Diabetes Kidney Disease-Collaborative Task Force and an advocate for those living with chronic kidney disease and the morbid conditions that contribute to this disease, such as diabetes, cardiovascular disease, hypertension and obesity, Dr Gee uses his personal experiences to teach, coach, mentor and educate others on how best to manage their outcomes. He also ensures that underserved, undervalued and disenfranchised communities of color have a voice in their quality of life and equitable healthcare access. He also serves as Chair of the Kidney Health Initiative's Patient Family Partnership Council and is on ASN's APOL-1 Kidney Disease Steering Committee.

Geoff Gill is currently the Founder and CEO of Verisense Health, Inc. He has spent the last 15 years overseeing the acquisition and analysis of wearable sensor data, most recently as the President of Shimmer Americas, where he was responsible for Shimmer’s businesses in clinical trials and consumer neuroscience. Before Shimmer, he was the SVP of Operations at Innerscope Research, where he oversaw the conduct of approximately 700 consumer neuroscience studies involving over 100 thousand participants using wearable sensors. He has also led the development of blood, gas and electrolyte sensors as VP of R&D at Bayer Diagnostics.

Lani Hashimoto is dedicated to connecting trials to patients with 25 years of clinical trial experience, operational expertise, and extensive industry relationships. Joining Novartis in October 2013, she has worked on innovation and operations teams. this year including grassroots efforts to engage with patients. In 2018, she joined the TransCelerate Patient Experience initiative and has been co-leading the team for the last two years. Ms Hashimoto recently transitioned to a patient engagement role in US late phase trials focused in the US.

Adama Ibrahim is a UK top 100 influential tech leader passionate about diversity and inclusion practices. She is an innovation award winning pharma industry advisory consultant, founder, disruptor, strategy expert, blockchain advocate, technology enabled clinical trials and patient engagement thought leader with over 20 years in the NHS on commission by the DOH and in Industry. Ms Ibrahim has a deep experience of R&D transformation and led strategies and implementation of decentralized digital clinical trials and regulated digital platforms. She is a driver for change through identifying unmet customer needs, digital strategies, implementation and expansion of disruptive digital platform technologies across drug development and commercial lifecycles and customer journeys.

Dr Maria Jison is a distinguished Pulmonary-Critical care physician at AstraZeneca and serves as Global Clinical Head in the Respiratory & Immunology therapeutic area, overseeing the late phase clinical development strategy for the Fasenra portfolio. Her career reflects a deep commitment to patient advocacy and the underserved, blending direct patient care, public health, and technological innovation. Dr Jison has held pivotal roles in the eICU during its early stages and at the FDA Center for Devices and Radiologic Health. Driven by her passion for patients and fostering innovation, Dr Jison developed the AIRE Mobile Unit, AstraZeneca's mobile clinical trial pilot program. This newly launched initiative has quickly become a catalyst for collaborations in health equity both in the community and within the company. With a goal of broadening access to clinical trials for underrepresented populations, this initiative underscores Dr Jison's commitment to ensuring equitable access to cutting-edge research and treatments for all patients.

Matt Jones brings a unique blend of battlefield experience and technical expertise to his role as Director of Product Management at Spencer Health Solutions. Having transitioned from piloting helicopters to leading product development, his focus remains on precision and mission success – in this case, ensuring patients have the tools they need to effectively manage medications at home.

Mr Jones understands the real-world challenges of medication adherence. By prioritizing the patient experience throughout the design process, he fosters a user-centric approach at Spencer Health Solutions. This has resulted in the creation of the world's most effective smart medication dispenser.

Nagesh Kadaba is an accomplished Innovation Management, Technology, and Intellectual Property executive with more than 25 years of experience.  He has a Ph.D. in AI/Computer Science, MS. IP Law, BS EE.  Dr Kadaba is the most prolific inventor with over 100 patents for UPS, including 11 patents in Healthcare Cold Chain Logistics used during COVID-19 vaccine distribution.

Bharat Koyani, Associate Director in the Digital Biomarker team at Regeneron Pharmaceuticals, is leading the development of digital biomarker efforts for targeted indications. With over a 5 years of experience in implementing digital biomarker in Phase I-III clinical trials, Mr Koyani has been instrumental in identifying fit for the purpose DHT. Mr Koyani earned his MSHS from the George Washington University.

Elliott Labouré is a Senior Clinical Outcome Assessment (COA) Partnership Manager at RWS, where he specializes in Linguistic Validation and eCOA implementation. As part of the RWS Team, Mr Labouré plays a crucial role in supporting sponsors, eCOA providers, developers, academics and everyone in between to ensure that COAs are accurately translated, culturally adapted and linguistically validated for use in clinical trials worldwide. At this year’s conference, he will be discussing the race to faster eCOA implementation in clinical trials, sharing insights into how RWS is partnering with eCOA providers to streamline processes while maintaining high quality deliverables for patients.

Dr Erica Lively is the practice director for Exponent's Data Sciences practice, where she assists clients with the design and execution of data acquisition programs using advanced sensors and oversees our capabilities in artificial intelligence, machine learning, data wrangling, data analysis, and forecasting, including quantitative risk assessment and data visualization. She applies this expertise to developing high-quality datasets for consumer products, wearables, and digitally enhanced clinical studies and helping clients use those data to build a safer, more equitable, and more technologically advanced world. Her work leverages multidisciplinary teams with expertise in life sciences, engineering, human factors, regulatory compliance, and litigation support to help clients acquire the highly complex data they need to be market leaders.

Skilled at designing, managing, and executing human participant studies using prototype and commercially available technology, Dr Lively's experience helps clients build high-quality data sets used to develop products that perform for a wide variety of applications. She focuses on using methodologies that prevent data bias, collecting personal data with consideration for privacy, and managing the risks and resources associated with high-value data collection. Additionally, Dr Lively has experience executing studies throughout design and validation cycles.

Dr Lively holds a PhD in Electrical Engineering from the University of California, Santa Barbara. Her graduate research focused on infrared lasers and detectors. In addition to her technical work, she has long focused on addressing issues surrounding technology from an interdisciplinary perspective. As a Science Policy Fellow at the National Academy of Engineering, she participated in studies to improve healthcare through the implementation of systems engineering tools. She has also studied the issues and implications related to media framing of emerging nanotechnologies.

Kurt Lumsden is the VP Study Operations at Hawthorne Effect, Inc. responsible for delivery of services to clients. He has over 30 years’ experience in Healthcare and Clinical research including roles at sites, sponsors, and eClinical solution providers and Clinical Research Organizations. Additionally, and is an expert in Decentralized Clinical Trials, phases I-IV and global services (North America; LATAM; EU; APAC; Africa) across multiple therapeutic area, including pharmaceutical and medical device trials. Mr Lumsden obtained an MBA from City University, a BS in Perfusion Technology from Rush University, a BA in Healthcare Leadership from National-Louis University and is a Registered Nurse with broad clinical experience obtained at healthcare organizations in the US and UK, including Intensive Care, Operating Room, Behavioral Health and Home Care services. He has held previous positions with Fortrea, Labcorp, GlobalCare Clinical Trials, Parexel and ClinPhone.

Tran Le is the CEO and co-founder of Grove, enabling clinical research organizations to recruit and engage participants at scale using data and AI. Diagnosed with multiple chronic conditions, Tran experienced firsthand the frustrations of enrolling in clinical trials. At Grove, she leverages her expertise and collaborates with a top-tier team of clinical research leaders and AI engineers to deliver personalized experiences to patients seeking clinical trial treatments.

Previously, Tran was an AI researcher at Stanford Medicine, developing machine learning models to enhance patient engagement and emergency department efficiency. She also built security products at Salesforce and co-founded Develop for Good, a nonprofit backed by Google and leading tech figures that connects tech talent with nonprofits globally.

Raised between rural Vietnam and Silicon Valley, Tran champions purposeful, people-centric entrepreneurship in the AI era. Her TEDx Talk at Stanford University, “Building With People and Purpose in the Age of AI,” sparked conversations among thousands of entrepreneurs in Silicon Valley and beyond. Tran holds a BS in Computer Science (AI) and an MS in Management from Stanford University.

Madelaine MacKay has 20 Years experience in the clinical research industry with a background in global project management and clinical management. For the past 8 years her focus has been on strategic implementation and operationalization of technology that incorporates research activities into the patient’s lifestyle. Currently at ICON, Ms MacKay is the head of the Platform Solution Enablement team within eClinical Development and Delivery that helps sites connect with their patients for modern clinical trials.

Mackenzie McKinney brings over 10 years of experience in Health Care, Project Management, and Clinical Research. In her current role as Senior Manager of Patient Centricity, she leads the delivery of innovative clinical trial solutions, focusing on enhancing the participant and site experience. Her expertise spans various areas, including Mobile Health, eConsent, eCOA, and Innovative Care Options.

As Vice President of Commercialization for the Patient Suite at IQVIA, Anthony Mikulaschek is responsible for the commercialization IQVIA's eCOA, eConsent, and IRT platforms. This includes pricing and sales strategies, opportunity configuration, market needs review, IQVIA technology market placement and strategy. Mr Mikulaschek has extensive experience in validated system configuration, implementation, systems integration, business process reengineering, IT operations, and consulting. He has successfully led the development, delivery, and management of technology solutions for over 37 years including 29 years in the Pharmaceutical sector.

TBA

Amanda Moore has nearly 20 years of clinical operations and development experience in the biotechnology and pharmaceutical industry with a track record of leading innovation in clinical trials, pioneering operating committee relationships, and oversight of global development programs. Ms Moore joined Abeona in October 2020, holding positions of increasing responsibility, and most recently served as Senior Director, Head of Program Leadership. Previously, she has served in clinical operations and development roles with Biogen, Reckitt Benckiser, Sage Therapeutics and Intercell. Ms Moore holds a master’s degree in Health Science from the George Washington University.

Andrea Murison is Senior Director of Business Development at Kayentis, with 16 years of experience in the field of Clinical Outcomes Assessments (COA). She began her career focusing on licensing, copyright, and linguistic validation, later supporting teams specializing in qualitative research, developing and modifying COAs, psychometric analyses, and statistical analyses. This experience has helped her understand the importance of the application of metrology in Patient-Reported Outcomes (PROs). At Kayentis, Ms Murison leverages her experience in COAs to support the digital implementation of eCOAs in clinical trials. At Mobile Tech in Clinical Trials, she will be speaking about the race to faster eCOA implementation.

Casey Orvin has a long and exemplary career history in pharmaceutical research services. Most recently, he was serving as the Senior VP of Pharmaceutical Relationships at StudyKik, a full-service patient recruitment and retention technology company. Mr Orvin is also serving as the Honorary President of the Society for Clinical Research Sites (SCRS), a global organization representing nearly 10,000 clinical research sites in 47 countries within the pharmaceutical industry. Mr Orvin began his career leading a large pharmaceutical research site network, Research Solutions. In 2007, he was recruited to join Clinical Research Advantage/Radiant as Executive Vice President of Business Development and successfully led a network of over 75 research sites conducting clinical trials for pharmaceuticals, vaccines, and medical devices. Under Mr Orvin’s leadership, several crucial partnerships were formed with major pharmaceutical companies which fueled the company’s rapid growth both geographically and within the medical community. Mr Orvin facilitated the acquisition of two competitors, securing the company’s spot as what was at the time the largest clinical research site network in the US. In 2015, Casey and the executive team at Radiant merged with Synexus, a division of PPD. With Mr Orvin’s guidance, Synexus continued to expand to 215 global clinical sites in 4 continents and over 15 countries. Mr Orvin is passionate about representing the site voice within the industry while ensuring every research patient’s journey is a positive one. As a thought leader in the industry, Mr Orvin is regularly invited to be a keynote speaker and panelist and is often quoted by the leading publications covering the clinical research landscape. In 2020, he was recognized in PharmaVoice as one of the 100 Most Inspiring People in the industry. Mr Orvin currently leads the commercial team for Alcanza, a large owned and integrated network of research sites dedicated to reducing barriers to clinical research with sites located in underrepresented patient populations across the US and Puerto Rico.

Katerina Placek, PhD, is a Senior Manager in Digital Health Sciences at Takeda where she advises clinical teams on the selection and implementation of digital tools in clinical trials. She leads device validation studies, assesses new technologies, and supports teams in digital biomarker development across therapeutic areas, specializing in Neurology. Prior to her role in Digital Health Sciences, Dr Placek was a Manager in Quantitative Sciences at Takeda where she worked as a data scientist in Neurology, including on projects involving digital endpoints. Dr Placek holds a PhD in Neuroscience from the University of Pennsylvania, an MSc in Experimental Psychology from the University of Oxford, and a BA in Psychology from St. Mary's College of Maryland.

Stephen Ruhmel, MPH is the Clinical Strategy Lead for Digital Endpoints at Sanofi. In his role, he is responsible for identifying, creating, validating, and operationalizing both fit-for-purpose and novel digital endpoints in Sanofi’s clinical studies. Prior to this role, Mr Ruhmel was an Associate Director at J&J Innovative Medicine, focused on delivering clinical trial efficiencies and innovation for patients, investigators and the industry at large. He has worked in the pharmaceutical industry for over 15 years in Global Public Health, Global Development, Digital Health, R&D, and IT. With a proven record of improving business performance as a technologist, researcher, and public health advocate, Mr Ruhmel’s career mission is to dramatically improve healthcare for underserved populations globally by leveraging the latest healthcare technology.

Previously, Mr Ruhmel developed and launched a SXSW-award-winning crowdfunding platform, CaringCrowd, which has raised over $4 million across 600+ nonprofit-led public health projects. Globally, he has contributed to projects throughout Africa, including a six-month secondment with Aga Khan University in Nairobi, Kenya, where he led a mixed methods cross-sectional study to evaluate a five-year nursing and midwifery program across Kenya, Uganda, and Tanzania.

Mr Ruhmel received a bachelor’s degree in Information Sciences and Technology from Penn State and a Master of Public Health from Rutgers.

Leonard Sacks, MD received his medical education in South Africa, moving to the USA in 1987, where he completed fellowships in immunopathology and Infectious Diseases. He worked as an attending physician in Washington DC and South Africa and he joined the FDA in 1998 as medical reviewer in the Office of New Drugs. Subsequent positions included acting director of the Office of Critical Path Programs and associate director for clinical methodology in the Office of Medical Policy in the Center for Drug Evaluation and Research. In this capacity he has led efforts to support the use of electronic technology in clinical drug development. Besides his involvement in the design and analysis of clinical trials, he maintains a special interest in tuberculosis and other tropical diseases and has published and presented extensively on these topics. He  holds academic appointments as Associate Clinical Professor of Medicine at George Washington University, and at the Uniformed Services University of the Health Sciences.

Rucha Shah has been living with a rare disorder. Her commitment lays in advocating for accessible healthcare and improving health outcomes for the broader patient community, especially the next generation of patients. Currently, Ms Shah leads a patient advocacy group for patients and caregivers at the Children’s Hospital of Philadelphia and the Hospital of University of Pennsylvania. She also collaborates with various national organizations and pharmaceutical companies on bringing forth initiatives which make meaningful connections within the disease community, improve the quality of life for patients and to increase awareness within the larger community.

Ms Shah attained her Master of Science degree in Clinical Research Organization and Management from the Drexel University School of Medicine in Philadelphia, PA. She further completed certificate coursework in Advancing Health Equity from ECOG-ACRIN Cancer Research Group and Research Advocacy Network as well as certificate coursework in Artificial Intelligence in Pharma and Biotech from the Massachusetts Institute of Technology. Professionally, Ms Shah works as a clinical research project manager within the oncology space. She strives to apply the "lessons learned" from her patient advocacy experiences to her professional work by building the trials to be more patient centric and accessible.

Recent Works: Woolford T, Andemariam B, Blaylark R, Colasanti R, Shah N, Jonassaint C, Trimnell C, Sheth S, Davis J, Gallagher E, Zaidi AU, John H, Shah R. Setting Industry Standards for Patient Engagement, Partnership and Care: The Patient Vision Project. Poster and Oral presentation at NORD. October 16, 2023. Washington DC, USA.

Alex Simmonds, MBA is a proven life sciences and tech startup leader, innovator, entrepreneur, strategist. He is an ex-Accenture, ex-Genentech, now back at BMS as Drug Development Innovation Lead, mixing up new things in clinical development and solving hard problems for patients and sites with the three essential D’s of innovation: Digital, Data and Design.

Zackary “Zak” Smith works on a variety of Tufts CSDD studies focusing on drug development performance, efficiency, economics and innovation adoption. Many of these projects involve creating, compiling, and analyzing very large datasets. Mr Smith completed his BS at Florida Southern College and received his MA from Brandeis University. He is a former research analyst at Tufts CSDD and has worked as a research assistant at Harvard University and at the University of Massachusetts.

Wessam Sonbol is a healthcare technology leader dedicated to advancing clinical research through digital innovation. As CEO and founder of Delve Health, he has pioneered the use of wearables, remote monitoring, and AI-driven analytics to transform decentralized clinical trials across multiple therapeutic areas, including cardiovascular, metabolic, neurology, rare-disease and oncology research. His expertise lies in real-time patient data capture, digital endpoint collection, and automated engagement strategies to enhance trial efficiency and outcomes.

With over 20 years in clinical research and healthcare analytics, Wessam has held leadership roles at Optum, Comprehend Systems, and other Pharma organizations, focusing on data-driven decision-making, patient retention, and regulatory-compliant digital health solutions. His work has been instrumental in integrating biometric wearables, digital scales, ECG monitors, smart inhalers, and remote patient-reported outcomes (ePROs) into clinical research to improve adherence, protocol compliance, and real-world data collection.

Wessam offers a strategic vision for leveraging wearable technology and AI-driven insights to accelerate drug development and improve patient outcomes.

As the Clinical Digital Health and Innovation Lead within Global Clinical Development at Chiesi, Dr Eva Topole spearheads diverse cross-functional collaborations with the aim to integrate digital health solutions into patient-centric clinical trial designs, aiming to alleviate patient and site burden. Her primary focus extends to defining novel endpoints that align with patients' needs, achieved through collaboration with clinical teams across various respiratory therapeutic areas. Leveraging her clinical expertise and profound knowledge of respiratory therapeutic area, coupled with a passion for innovation, Dr Topole collaborates with relevant functions in R&D to build capabilities that enhance clinical trials, ensuring they better cater to patients' needs and provide insightful data across different respiratory therapeutic areas.

Before joining the pharmaceutical industry, Dr Topole served as a Senior Consultant in Respiratory Medicine and led the Functional Respiratory Diagnostic Department at the University Clinic of Respiratory Disease and Allergy in Golnik. Subsequently, she assumed the same role at the University Medical Center Ljubljana.

Edward Triebell is the Executive Director, Product Development of Digital Health, at MRN and is responsible for the launch of new products and services in the digital health and data centric operating environment of clinical trials. His career has focused on the forefront of disruptive innovations in the telecommunications, semiconductor, SaaS/PaaS software platforms, mobile/cellular data networks and the healthcare industry for over 30 years. His career started in designing engineering and then migrated into significant roles in project engineering, program management, global sales, product marketing, and strategic business development for enterprises focused on digital technology innovation. Within the healthcare industry, Mr Triebell has been involved with strategic programs that included the creation of a private satellite-based telemedicine platform for the Mayo Clinic network of hospitals to accomplish remote diagnosis and surgical treatments with high resolution imaging/videos, RFID solutions for patient tracking within Emergency Departments as well as audited tracking of patient biological samples, outsourcing radiological contouring services for cancer treatments using a joint-venture with a leading cancer hospital in China, and pivoting an Internet of Things (IoT) software platform into a leading ePRO (electronic Patient-Reported Outcomes) platform. Mr Triebell’s educational background includes a Bachelor of Science degree and Master’s degree coursework in Electrical Engineering, graduate coursework for his Master’s degree in Business Administration and completion of an Executive Management program at the Aresty Institute of Executive Education at the Wharton School, University of Pennsylvania.

Rob Wilson is Currently VP Commercial Strategy at VivoSense.  He is a Digital Health expert with extensive experience in wearable sensor hardware and software technology, algorithm and digital endpoint development and the clinical and regulatory environment. Mr Wilson is a former Senior VP Business Development and Corporate Strategy for ActiGraph. He led ActiGraph's strategy and business development and created a leading hardware and software wearable ecosystem for the clinical trial market. He has extensive consulting and investment banking expertise. Mr Wilson is the former Head of Healthcare Corporate Finance and director of healthcare venture fund relationships at both First Union and RBC Capital Markets for the Royal Bank of Canada.