2023 Speakers

Adrelia Allen, PharmD, is a 22-year veteran of the pharmaceutical industry working in sales and clinical research at Merck. She has held positions of increasing experience as a Clinical Research Associate, Clinical Trial Project Manager, and Clinical Research Manager (CRM). She is currently the Executive Director of Clinical Trial Patient Diversity, where she is responsible for the strategy and execution of activities for the diverse representation of patients in clinical trials. Dr Allen has a Doctor of Pharmacy degree from Florida A&M University College of Pharmacy.

Ella Balasa is a patient advocate, consultant, and a person living with cystic fibrosis. She has committed her time to empowering patients and advancing healthcare strategies. She speaks publicly about the value of patient perspective and has a passion for distilling clinical information for patient communities. Through opportunities working with healthcare organizations on content strategy, writing, speaking, clinical trial development, and sharing the patient experience, she aims to affect the healthcare landscape by raising awareness of rare diseases, promoting self-advocacy to patients, and valuable insights to organizations. More of her work and experiences can be found at www.ellabalasa.com.

Kristen Bernardi Rader is a COA Partnership Management Team Lead at language services provider RWS Group. In this capacity, Ms. Rader guides pharmaceutical sponsors, CROs, and eCOA vendors in executing their localization strategies for Phase I-IV clinical trials. Ms Rader has worked in the translation and validation of outcomes assessments since 2011. She has supervised COA translations across numerous therapeutic areas, from oncology to immunology to rare disease. These complex projects span six continents and include scales in dozens of languages. With a linguistics background and focus on cultural nuance, Ms Rader is able to understand global clinical research programs’ unique requirements. She strives to give patients a native experience and enables clients to succeed in their global trials.

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 Principle 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.

Jessica Braid started her career within healthcare consultancy which gave her exposure to a variety of disciplines including International and National Market Research, Medical Communications, Real World Evidence Generation, Health Economics and Outcomes Research. Working in consultancy gave her a broad understanding of the pharmaceutical development process from early development to post launch and established her passion for patient-centered outcomes research. Ms Braid joined the patient-centered outcomes research (PCOR) team at Roche in 2018, located in Welwyn. There, her role is to advise clinical development teams on incorporating patient-centric endpoints into drug development programmes from Phase 1 through to Phase 3. As part of this role, she worked specifically in rare neurological diseases and gained exposure to digital measurement, a novel way to measure patient-relevant outcomes beyond the traditional clinical outcome assessment types (PRO, ObsRO, PerfO, ClinRO).

Her current role within the PCOR team at Roche is to lead the Digital Innovation Chapter. This role allows her to work cross-functionally to drive the application of patient-centered measurement science to digital measures across Genentech and Roche. Ms Braid is passionate about ensuring the patient experience is pivotal in decision-making on what outcomes we assess in clinical trials and how we assess them. Digital measurement opens the door to a new world of patient experience data so ensuring we optimize its use is critical to future success.

Tyler Bye oversees the strategic deployment of solutions tailored for each indication and personalized to each site’s individual needs. With 15 years of clinical research experience, Mr Bye implements best practices and lessons learned across therapeutic areas and indications that resonate with the target patient profile. Previously, he has worked directly with patients as part of a comprehensive cancer center and has developed and implemented global protocols from a sponsor perspective.

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.

Eileen Doherty is the Head of Enabling Business Information Solutions (EBIS) team within Janssen R&D Global Development. The EBIS team enables the right technology solutions in clinical trials. Ms Doherty specializes in simplifying the “user experience” for their stakeholders, including clinical trial participants, sites, and internal study team members from clinical operations and R&D. Through advancements implemented by the EBIS team such as Telemedicine and ePRO (Patient Reported Outcome), clinical trial participants can reduce their travel to clinical trial sites and work through extensive paper questionnaire. As a proven and trusted leader, Ms Doherty, believes the most important customers are their clinical trial participants and sites.

Ms Doherty joined J&J from UCB Biosciences in 2018. During her 17 years at UCB, Ms Doherty’s experience included leading teams covering clinical data management, standards and programming, risk-based monitoring, reporting and analytics, SUSAR/safety reporting, as well as clinical trial systems. Earlier in her career, she worked in technology consulting, and had roles in both Clinical and Statistical Programming at a large contract research organization (CRO.) Ms Doherty holds a bachelor’s degree in Latin American Studies and Mathematics from the University of North Carolina at Chapel Hill.

Ray Dorsey, MD is the David M Levy Professor of Neurology  at the University of Rochester. The Center seeks to provide care and research opportunities to anyone anywhere. Dr Dorsey and his colleagues have written Ending Parkinson’s Disease, a book that provides a prescription for ending this debilitating condition.

Dr Dorsey previously directed the movement disorders division and neurology telemedicine at Johns Hopkins and worked as a consultant for McKinsey & Company. His research has been published in leading medical, neurology, and economic journals and has been featured on National Public Radio, in The New York Times, and in The Wall Street Journal. In 2015, the White House recognized him as a “Champion for Change” for Parkinson’s disease.

Emma Eikermann is a product manager at Mural Health. In this capacity, among other responsibilities, Emma is responsible for steering long-term product strategy, designing and implementing new product features, and optimizing existing features to best service participants, sites, sponsors, and CROs. Prior to Mural Health, Ms Eikermann was a project manager for a custom app development group who worked extensively with clinical researchers to create new apps for their patients. Ms Eikermann’s past experience also includes direct experience as a site coordinator working in Phase 2 and Phase 3 trials at two major academic centers. Additionally, taking part in type 1 diabetes research, Ms Eikermann has also been on the participant side of clinical research.

Cindy Geoghegan is a patient advocate, advisor and activist with over 30 years of health policy and communications experience, having held senior staff and board positions with several leading cancer non-profit organizations including Susan G. Komen, Y-ME National Breast Cancer Organization and others. She began her advocacy career shortly after her breast cancer diagnosis in 1995. Ms Geoghegan has provided the patient perspective on research teams and projects funded by Stand Up to Cancer, the National Cancer Institute, the American Association for Cancer Research, the American Society of Clinical Oncology, the Patient-Centered Outcomes Research Institute and has served on the steering committee of the Clinical Trials Transformation Initiative (CTTI), the Duke University/FDA joint venture focused on more efficient clinical trials. Ms Geoghegan is currently a member of the Johns Hopkins Kimmel Cancer Center’s External Advisory Board, and on the Founding Members Council for the Digital Medicine Society, where she also serves on its research committee. Ms Geoghegan has co-authored more than a dozen publications with researchers focused on patient preferences and improving patient outcomes.

Kapil Gombar, Director, Clinical Technologies and Innovation at AbbVie is fascinated by the convergence of technology and medicine. It has dramatically changed the drug development lifecycle while enabling a better understanding of the subject population. Mr Gombar feels rather fortunate to have seen and contributed to this transformation through multiple roles spanning over 20 fascinating years and has had the amazing opportunity to implement large scale strategic initiatives from concept through delivery across leading pharma and biotech giants. Mr Gombar now leads the clinical technologies and innovation team at AbbVie which strategizes around new technologies that can enhance and optimize our clinical ecosystem.

Brian Greene has over 20 years of experience working directly in pharma, digital health and CRO industries. He has worked across multiple functions including, business development, marketing and operations. Mr Greene has an extensive background managing teams and supporting the development and deployment of digital platforms and patient engagement services. His digital platform experience includes remote monitoring for payers and providers and digital therapeutics and decentralized clinical trials for pharma.

Prior to joining ICON, Mr Greene held positions with Care Innovations and Glaxo Smithkline in the United States.

Bert Hartog, PhD is currently Senior Director, Clinical Innovation at Janssen R&D Operations, where he leads transformational innovation projects that have the goal to shape the future of clinical trial execution at Janssen and position Janssen as a role model in patient-centered clinical research.

Dr Hartog is a professional in the pharmaceutical industry, with 20+ years’ experience in Clinical Operations, QA, IT and Project Management. He started his career with a Masters in Biomedicine from Utrecht University in the Netherlands, as CRA with Eli Lilly. During this time he completed his PhD in Medicine at Utrecht University. In 1998, he moved to London to start work as head of Medical Quality Assurance with responsibilities for the EMEA region. In this role, he introduced risk self-assessment tools for local clinical operations departments. In 2001 he became IT manager at Lilly’s R&D site in the UK. In this role, he established a PMO and got deeply involved in project management. In 2005 he left the UK to start work at Johnson & Johnson from Belgium; first in corporate IT & compliance where Sarbanes-Oxley was first introduced. In 2008 he returned to his passion in clinical research, as Director Clinical R&D with Janssen, where he led the clinical operations departments in the Benelux and Nordic countries for 4 years. With this experience, he joined a large transformation program at Janssen’s clinical development operations. His responsibilities included the introduction of a new CTMS and a next generation eTMF solution, as well as setting up a new business function to own these technical capabilities. Since summer 2015 he has become part of the Janssen R&D Operations Innovation team.

Stacey Higgins is a distinguished professional in the pharmaceutical industry. As an Associate Director at AbbVie Pharmaceutical, Stacey oversees the COA and Digital Implementation Team that focuses on strategic implementation of COA licensing and translations for clinical trials. With an extensive career spanning 17 years, Ms Higgins’s expertise has played a crucial role in streamlining processes and driving innovation within AbbVie and across industry collaborations.

Ms Higgins’s career journey led her to AbbVie after making significant contributions at Eli Lilly. During her tenure at Eli Lilly, she laid the groundwork for fostering cross-industry relationships, collaborating closely with COA owners and thought leaders across various sectors.

Ms Higgins has a passion for optimizing timelines and ensuring that life-changing medications reach patients in need as quickly as possible.

Danielle Horton has 20+ years of experience in the clinical trial industry; striving to solve organizational challenges through people-focused solutions and supporting cross-industry thought leaders through the evaluation of innovative approaches to clinical trials and unique partnership projects (Hybrid Virtual Trials, eStrategy, Trailblazer Consortium, Primary Care Network, Clinical Trial Care Option, R&D Integration Forum). Ms Horton utilizes her skills to develop processes and tools, incorporating appropriate technology solutions and collaboration models which support implementation of Innovative solutions. Her approach to expand the portfolio of solutions and capabilities enables drug discovery and development, drive prioritization of digital needs across R&D. Further, she works to enhance the value of the pipeline that provide superior experience for the patients while taking into consideration both operational and analytical aspects as well as a longer strategic vision. Ms Horton is a creative and influential thought leader who is able to balance the need to be a strategic partner with a roll-up-your-sleeves attitude.

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.

Hassan Kadhim is the Business Engagement Leader for Clinical Operations and Development for Vertex Pharmaceuticals. Prior to this role, he was the Global Head of Clinical Trial Business Capabilities & Clinical Innovation at BMS, where his team governed the business technology capabilities strategy within Global Development Operations, and drove changes and innovation towards better outcomes for clinical trial stakeholders. Mr Kadhim is passionate about transforming the clinical research arena in the pharma industry through the use of technologies and patient-centric clinical trials, and is a firm believer of the need for clinical innovation grounded in strong business practices for sustainability, change management and adherence to compliance and regulatory commitments. Mr Kadhim regularly appears and speaks at industry events around improving the clinical trial experience with digital tools, and wrote “The Remote Clinical Trials Model” whitepaper in 2016, to formalize a new patient-centric clinical trial research model leading to what we know today as Decentralized Clinical Trials. Mr Kadhim actively collaborates across industry collaborations such as Transcelerate and others to advance relevant and high-value industry challenges.

He has degrees in bioinformatics and pharmaceutical sciences, both from the University of Montreal in Canada.

Dina Katabi is the Thuan and Nicole Pham Professor of Electrical Engineering and Computer Science at MIT. She is also the director of the MIT’s Center for Wireless Networks and Mobile Computing, a member of the National Academy of Engineering, and a recipient of the MacArthur Genius Award. Professor Katabi received her PhD and MS from MIT in 2003 and 1999, and her Bachelor of Science from Damascus University in 1995. Katabi's research focuses on innovations in digital health, applied machine learning and wireless sensors and networks. Her research has been recognized with ACM Prize in Computing, the ACM Grace Murray Hopper Award, two SIGCOMM Test-of-Time Awards, the Faculty Research Innovation Fellowship, a Sloan Fellowship, the NBX Career Development chair, and the NSF CAREER award. Her students received the ACM Best Doctoral Dissertation Award in Computer Science and Engineering twice. Further, her work was recognized by the IEEE William R. Bennett prize, three ACM SIGCOMM Best Paper awards, an NSDI Best Paper award and a TR10 award. Several start-ups have beenspun out of Katabi's lab such as PiCharging and Emerald.

Shafaat Ali Khan, MBBS is a seasoned clinical research professional with a passion for revolutionizing the way clinical trials are conducted. As a Clinical Research Lead in Lilly’s Site and Investigator Engagement organization, Dr Khan spearheads efforts to operationalize and execute highly decentralized clinical trials, driving efficiency and innovation in the field. He also leads multidisciplinary teams at Lilly to closely collaborate with sites and investigators to drive innovation across the drug development lifecycle.

With a strong focus on patient empowerment, Dr Khan is on a mission to enhance patient education and improve access to novel investigational therapies and diagnostics. By leveraging advanced technologies and patient-centric approaches, Mr Khan strives to break down barriers and ensure that more individuals can benefit from cutting-edge treatments.

Dr Khan received a Bachelor of Medicine, Bachelor of Surgery (MBBS) degree from Baqai Medical University and continued on to complete a Postdoctoral Fellowship in Cardiovascular Science Research from Emory University School of Medicine.

Jiao Li is a Digital Technology Lead of Digital Strategy Dept. at Chugai Pharmaceutical, a member of Roche Group. She joined Chugai as founding member of the Digital Biomarker Group, which focuses on leveraging digital health technologies to support drug development and maximize post-market drug value. Currently she is leading the first digital health project at Chugai in collaboration with external partners as Digital Technology Lead. She brings work experience in consulting and IT, and holds a Master’s in Biomedical and Health Informatics from the University of North Carolina at Chapel Hill.

Anthony Londino founded Med-Con Technologies in 2012 and leads the company and its executive team. He has a successful track record with over thirty years of sales and executive management knowledge and experience, supporting Fortune 100 companies in the pharmaceutical industry. He is passionate about helping customers to resolve issues and reach their goals and objectives.

Natasha Massias is a seasoned dynamic learning development and eCOA/ePRO professional with ten years in the clinical trials industry. Her expertise within the field is technical product training, and she has facilitated hands-on, instructor-led trainings to over 300 sites throughout her career.

As Vice President of eCOA at IQVIA, Anthony Mikulaschek manages all operations, data management, quality management, training and eCOA project work associated with IQVIA eCOA. Mr Mikulaschek has extensive experience in validated system implementation, systems integration, business process reengineering, IT operations, and consulting. He has successfully led the development, delivery, and management of technology solutions for over 30 years including 26 years in the Pharmaceutical sector.

Joanne Monaghan, RN, CCRC, is a highly experienced healthcare professional with a passion for patient care and clinical research. With a career spanning over two decades, she has established herself as a dedicated and knowledgeable registered nurse since 1993. Ms Monaghan’s expertise and commitment to delivering exceptional care has made a significant impact on the lives of countless patients.

In 2005, Ms Monaghan transitioned her career into the field of clinical research, assuming the role of a clinical research coordinator. With her strong clinical background and meticulous attention to detail, she quickly excelled in managing complex research studies and ensuring compliance with regulatory requirements. Ms Monaghan’s in-depth understanding of study protocols, data collection, and participant recruitment has contributed to the successful execution of hundreds of clinical trials.

Since 2021, Ms Monaghan has taken on the role of Site Director at Boston Clinical Trials, a prestigious research institution renowned for its groundbreaking contributions to medical advancements. As Site Director, she oversees the coordination and management of multiple research projects, working closely with interdisciplinary teams to ensure the smooth operation of clinical trials. Ms Monaghan’s leadership skills, problem-solving abilities, and effective communication have played a crucial role in fostering a collaborative and efficient research environment.

Beyond her professional accomplishments, Ms Monaghan remains dedicated to ongoing education and professional development. She actively participates in workshops, conferences, and seminars to stay abreast of the latest advancements in clinical research and nursing practices.

In her spare time, Ms Monaghan enjoys giving back to the community through volunteer work, spending time with her family and her 6 year old German shepherd.

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 leads the business development efforts for CenExel, now the US leader of independent clinical research sites.

Ashley Parrott Lee supports the Clinical Trial Division within Abbott Point of Care for immediate lab test results devices which are globally used in healthcare. She supports US and Global clinical trials to help expedite patient enrollment and later phases. Ms Parrott Lee has been with Abbott for 5.5 years on the Point of Care team but have been selling into the medical device arenas of hospital surgery, interventional and outpatient for 16 years with a passion for new technology development.

Bray Patrick-Lake, MFS, recently joined FDA CDRH’s Digital Health Center of Excellence where she supports partnerships and projects related to patient-generated health data, digital measures, decentralized trials and remote monitoring to promote patient access to digital health technologies to improve their health. She began her career as the founder/executive director of a patient advocacy organization. Most recently she served as Senior Director of Strategic Partnerships at Evidation Health, where she developed field shaping collaborations to support the regulatory and clinical acceptance of digital measures, and design digital health programs that engaged patients in achieving next best health actions. She has served on the Digital Medicine Society’s Scientific Leadership Board and DataCC steering committee, and steering committees for Reagan Udall Foundation IMEDS and Medtech Color. Past service includes the All of Us National Advisory Panel, National Academies of Sciences, Engineering and Medicine Health Science Policy Board, and PCORNet’s Executive Leadership Committee. Additional roles include Director of Stakeholder Engagement for the Clinical Trials Transformation Initiative (CTTI) where her work involved bringing patient advocacy organizations, industry, academia and government stakeholders together in CTTI’s efforts to improve clinical trials. Later as Director of Patient and Stakeholder Engagement at the Duke Clinical Research Institute she led patient engagement efforts for numerous industry sponsored studies and federal research programs. During this time, she co-chaired the Advisory Committee to the NIH Director that authored the vision for Precision Medicine Initiative’s Cohort Program (now All of Us Research Program), which led to her role as Interim Director of Engagement.

Andrew Pearlmutter is an Associate Director of Patient Centered Outcomes Science at BioMarin, with over 6 years of experience in patient-centered outcome (PCO) measurement design and implementation, with a focus on supporting digital health technology development and integration in clinical trials. Before joining BioMarin, Mr Pearlmutter was a Digital Biomarkers Consultant at Koneksa Health, a leading digital biomarker solutions provider. Mr Pearlmutter was also an inaugural member of Sanofi’s Digital Innovation team, where he led Sanofi’s efforts to build, test, and scale app- and wearable-based digital endpoints and health technologies in Parkinson’s Disease, Multiple Sclerosis, and rare diseases – including driving concept elicitation, regulatory engagements and clinical validation.

Jennifer Richards, PhD is the senior delivery scientist at VivoSense, a science and analytics company that develops and validates digital clinical measures and provides end-to-end services for their delivery in regulated clinical trials. In this role, Dr Richards works collaboratively with the VivoSense team and pharmaceutical companies to both identify concepts of interest in various therapeutic areas and successfully execute the implementation of digital health technologies as clinical outcomes within clinical trials.

Prior to joining VivoSense, Dr Richards was a faculty member at Colorado State University for 10 years where she taught physiology and conducted research.  Dr Richards earned her PhD in vascular physiology from Colorado State University and her MS and BS from The University of British Columbia in Kinesiology.

Ash Rishi is founder and CEO of COUCH Health, a global creative health engagement agency that serves to make health research inclusive. Its focus covers a range of solutions, including patient insights and engagement through to recruitment and retention within health research. Mr Rishi has over 15 years of experience in the industry, navigating the diverse needs of big pharma through to smaller biotech companies. With experience that covers the full medicine lifecycle, from pre-clinical to lifecycle management, his passions lay in working to make research more inclusive and has founded Demand Diversity a non-profit in 2023.

Katie Rowe is the Operational Implementation Manager at mdgroup specializing in technology implementation and adoption. She is an experienced healthcare product and system analyst with over 15 years dedicated to launching mobile applications, optimizing the patient journey, strengthening data capture, and institutional process augmentation through embracing new technology. She has led positive tech outcomes spanning insurance, behavioral health, community-based hospital systems, and clinical trials. Ms Rowe is thrilled to bring her passion of bridging the gap between tech and operations dedicated to supporting mdgroup technology and making remarkable patient experiences.

Stephen Ruhmel, MPH is an Associate Director at The Janssen Pharmaceutical Companies of Johnson & Johnson currently working in Janssen Clinical Innovation (JCI), a team dedicated to delivering clinical trial efficiencies and innovation for patients, investigators and the industry at large. He has worked across teams at Janssen and J&J for over 14 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.

Mr Ruhmel has worked with internal and external partners to develop speech-based capabilities in clinical trials, including conversational AI and speech biomarkers, with the objective of creating novel clinical outcome measures in the areas of Neuroscience and Alzheimer’s. He has also led projects in geofencing for safety event detection and digital measures for immundermatology, among others.

Prior to his current role, 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.

Krista Russell is a clinical researcher and digital health scientist, eager to bring digital capabilities to solve complex challenges. She is passionate about improving health outcomes for patients through the adoption of the right technology solutions.

Ms Russell is Head of the Digital Health Solutions team at Takeda. Her team is partnering with teams to take on fundamental challenges to further Takeda’s vision of streamlining Digital, Data and Technology in clinical trials. Prior to Takeda, Krista developed, validated, and managed business and clinical technology tools.

Ms Russell’s passion for technology began with her career in the United States Navy. Her career passion for the use of high-quality, safe technology for patient care began while working with Veterans at high risk for suicide. She has worked extensively with patients and sites to implement and validate new technology solutions over the past two decades. She is a certified clinical research coordinator and clinical project manager, having spent over a decade conducting and managing hundreds of clinical trials before transitioning to sponsor work. Ms Russell holds a BS in Health Information Management from Saint Louis University and an MS in Health Informatics from Liberty University.

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.

Ren Shogren has 10 years of experience in marketing, training, innovation, development, sales, digital marketing, and proficiency. She is currently focused on supporting innovation with the use of user voice and innovation methodology as the Creative Director for Innovate In What You Do, LLC. In addition, Ren is also the CEO and founder of her own small business, Wired On A Whim where she makes handmade jewelry, candles, and home décor.

Michelle Shogren is the CEO of Innovate in What You Do! LLC. Most recently, she was the Senior Director of Innovation in Pharma R&D at Bayer. She has over 20 years of experience in Clinical Research across many different roles. Ms Shogren began her journey as a research nurse and site director. From there she became a Clinical Research Associate at a CRO, and finally joined Bayer in 2008 where she has held multiple roles in: Clinical Operations; Training and Quality; and now in Business Excellence and Innovation. Ms Shogren has also participated as a patient in 2 clinical trials and experienced trials through the role of a caregiver for both parents while they were in clinical trials. This experience allows her to consider the firsthand viewpoint of a patient, caregiver, site, CRO and sponsor when looking at innovative opportunities. Ms Shogren ’s greatest passion is customer focused innovation and responding to the voice of the patients and sites.

Erica Smith, PhD is an accomplished business development and marketing professional with a strong scientific background. Working in both the pharmaceutical and biotech industries, Dr Smith has played an integral role in transforming the sales and marketing organizations of several companies throughout her career, including positions at SHS, Cognivia, Lovelace Biomedical, Charles River Laboratories, and Pfizer. Dr Smith received her PhD in Biomedical from the University of Michigan in Ann Arbor.

Anthony K. Taylor, DHSc, MSPharm, is an experienced leader, executive, former clinical research scientist and U.S. Army medic with comprehensive industry knowledge and a proven record for delivering results within large, mid-size, and small pharmaceutical organizations. Dr Taylor is Project Management Professional (PMP®) Certified and has a solid background in leading global clinical programs and teams. He has been in the pharma industry for almost 20 years and has held positions of increasing responsibility. When he is not leading large cross-functional initiatives, Dr Taylor enjoys spending time with his family and playing tennis in the U.S. Tennis Association (USTA). He is recently married, has two children, and lives in the Chicago-area with his family.

Jaydev Thakkar, Chief Operating Officer of Biofourmis currently leads global operations across various business functions, including Customer Success, Sales and Marketing Operations, Clinical Research Operations and Supply Chain. Mr Thakkar has over 25 years of experience in leadership roles at organizations that include fortune 100 companies and rapidly growing start-ups. Prior to Biofourmis, Mr Thakkar was instrumental in founding a Digital Health and Innovation group at world’s leading biotech, Amgen, where he served for 14 years. During this time, Mr Thakkar led its “beyond the therapy” digital innovation strategy to maximize product value and clinical outcomes across the patient journey—from clinical development through product launch and post-marketing. At Amgen, Mr Thakkar also led information technology operations for the company’s large portfolio of global clinical trials—including some of the largest ever in the industry, with more than 27,000 participants across 50 countries and more than 1,000 sites. Before Amgen, Mr Thakkar was a telecommunications, technology and finance consultant who co-founded a technology startup and also managed his family’s manufacturing business in India.

Aman Thukral is the head of Digital Operations and Clinical Systems at AbbVie. He has over thirteen years of experience in clinical development, technology planning & business-technology alignment. He is responsible for eCOA operations, wearables, and sensors,  piloting new technology initiatives and digital partner for patient engagement in his current role. Before this position, he had worked at Deloitte, Cognizant & GlaxoSmithKline at various levels.

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.

Amy West is a senior healthcare executive with over 25 years focused on disrupting markets by championing digital transformation and commercial innovation strategies that drive positive patient experiences and outcomes.

In her current role leading US Digital Transformation and Innovation for Novo Nordisk, Ms West is a change agent to drive exploration and market validation of disruptive innovation throughout the enterprise. She leads a team of industry pioneers to identify customer pain points, market trends, and emerging health tech opportunities focused on improving patient experiences and outcomes that will also benefit the broader healthcare stakeholder ecosystem.

An industry-leading marketer, Ms West is a frequent speaker and has been recognized with awards including MM&M Top 40 Healthcare Transformer, PM 360 Elite Leader of the Future and Trailblazer, and DTC Perspectives Top 25 Marketer of the Year. She is an adjunct faculty member, Women’s Health Tech advisor, and Breakthrough Alliance Advisory Board member to the Columbia School of Business HITLAB and a MATTER Advisory Board member and Community Mentor, a global healthcare innovation start-up community.

At Novartis, Jennifer Yip’s mission is to find novel approaches to leveraging data and technology to design better clinical trials, accelerate patient recruitment, drive patient engagement, and re-imagine clinical trial data collection and management for the US Medical Affairs organization. Before joining Novartis, Ms Yip held global clinical and commercial digital innovation roles at other big pharma and led global product marketing in eClinical, healthcare, and ad tech technology organizations.