Finding Solutions To Barriers In Clinical Trials
Join us on July 19, 2024, at TMC3 in Houston for a critical conference focused on overcoming barriers in clinical trials. This event aims to provide a comprehensive understanding of the various challenges, including community engagement, clinical operations, and technical logistics, with a special focus on government-sponsored trials, rural and underserved communities, and sustainable practices. Attendees will explore innovative solutions, case studies on centralized and decentralized trial approaches, and strategies for rapid response mobilization during surge demands. Ideal for clinical professionals, public health practitioners, and industry stakeholders, this conference promises valuable insights and practical strategies. Register now to be part of this important dialogue.
Agenda - July 19, 2024
| 7:15-8:00 a.m. |
Registration / Breakfast / Networking |
| 8:00-8:30 a.m. |
Welcome, scope, objective for the day. |
| 8:30-10:00 a.m. |
Community Experts - Panel Moderator: George Udeani, PHARMD, DSC, FCP, FCCP Deborah Vollmer Dahlke, Dr.PH, MPAff Jason B. Moats, PhD, FSCEO, CTT Amanda J. Onwuka, PhD Veronica Sandoval, JD, PhD Salim R. Surani, MD, MPH, MSHM, FACP, FCCP, FAASM, FCCM |
| 10:00-10:30 a.m. |
Audience Q/A |
| 10:30-11:00 a.m. |
Break / Networking |
| 11:00-12:30 p.m. |
Clinical Experts - Panel Moderator: Kenneth S. Ramos, MD, PhD Joy Alonzo, M.Engineering, PharmD Jaime E. Fergie, MD, FAAP, FIDSA, FSHEA Mary Dale Peterson, MD, MSHCA, FACHE |
| 12:30-1:00 p.m. |
Audience Q/A |
| 1:00-2:00 p.m. |
Lunch (box lunch, networking) |
| 2:00-3:30 p.m. |
Technical Experts - Panel Moderator: Jim Colson, VP Digital Health Wout Brusselaers, Founder and CEO at Deep 6 AI Michael Glassman, Co-Founder & President at Crescendo Health Hongfang Liu, VP of Learning Health at UTHealth Houston Matthew Quinn, Science Director at TATRC |
| 3:30-4:00 p.m. |
Audience Q/A |
| 4:00 p.m. |
Closing remarks |
Speakers
Community Experts Panel
The community session of the conference aims to address community barriers in clinical trials, with a specific focus on the intersection of social justice and equity. Additionally, the role of community health workers in advancing access to clinical trials will be examined, as well as the significance of effective emergency management strategies in the continuity of clinical trials during catastrophic events, ensuring the safety and well-being of participants. Through this objective, we aspire to foster discussions and propose actionable solutions that prioritize inclusivity, fairness, and emergency management in clinical trials within our communities.
Moderator: George Udeani, PHARMD, DSC, FCP, FCCP
George Udeani is the Professor and Head of the Department of Pharmacy Practice at Texas A&M University, where he has been serving since 2020. With a robust background in medicine and pharmacy practice, he has made significant contributions to the academic community, including his current role as a Professor of Medicine since November 2023. George is actively engaged in the academic and professional development of his students and colleagues, frequently participating in conferences and educational sessions.George holds a Doctor of Science (DSc) in Cancer Research from Warnborough College and completed postdoctoral training in Drug Discovery and Development at the National Institutes of Health - National Cancer Institute. With a career spanning several decades, he has demonstrated a profound commitment to advancing pharmacy practice and medical education. His dedication to research and mentorship continues to shape the future of healthcare professionals at Texas A&M University.
Deborah Vollmer Dahlke, Dr.PH, MPAff
Dr. Deborah Vollmer Dahlke is CEO, of DVD Associates, LLC, and an accomplished public health researcher, and author, who is passionate about applying mobile technology in cancer research. At her DVD Associates (DVDA), she provides strategic consulting and grant writing for early-stage cancer drug development companies and has helped secure between $1.2 to $1.4 billion in the past 12 years. Dr. Dahlke has also been involved in designing, developing, and evaluating mHealth applications for health behavior change. Prior to her current role, Dr. Dahlke worked with early-stage companies and in management consulting. She co-founded Zilliant, a successful enterprise pricing software company, raising over $14 million in venture capitalization.
Dr. Dahlke received her BS degree from Indiana University, an MPAff from the LBJ School of Public Affairs, the University of Texas at Austin, and a Doctor of Public Health from Texas A&M University. Dr. Dahlke is an Adjunct Associate Professor at the Texas A&M School of Public Health, and Senior Fellow at the Texas A&M Center for Population Health and Aging, and an Alpha Tau Chapter Delta Omega Society member.
Jason B. Moats, PhD, FSCEO, CTT
Jason Moat is Professor, and Director, USA Center for Rural Public Health Preparedness, Texas A&M University. Dr. Moats received his BS degree from Southern Illinois University and his MS and PhD degrees in educational human resource development from Texas A&M University. Dr. Moats has certifications from Texas A&M Engineering and Experiment Station, as Fire Chief Executive Officer, and Bush School of Government and Public Service, Texas A&M University in Homeland Security. His teaching interests include disaster and emergency management policy, strategy, and operations, emergency planning, and homeland security. Dr. Moats’ research interests include disaster management, and technology acceptance in public safety and public health.
Amanda J. Onwuka, PhD
Amanda Onwuka is a social epidemiologist and health services researcher at RTI International. Dr. Onwuka’s research in social epidemiology underscores the importance of structural determinants of health and the mechanisms by which health is facilitated or disrupted by environmental conditions. She is a skilled statistician and thoughtful epidemiologist, considering innovative study designs and analytical methods to identify modifiable characteristics that may yield advancements in health equity. Dr. Onwuka also serves as a strategic advisor to several federal agencies on equitable grantmaking and innovation, identifying opportunity levers in the research and development process to ensure the accessibility and affordability of health innovations. She is a sought-after speaker known for her informative and compelling content and speaking style, an educator who has mentored dozens of students and early career researchers on research methods in public health and an author of over 50 peer-reviewed publications. Dr. Onwuka received her Bachelor of Arts in Community Health and English Literature from Tufts University, Master of Public Health from Tufts University School of Medicine, and PhD in epidemiology from the University of Michigan.
Dr. Veronica Sandoval is a Principal in the Patient Inclusion and Health Equity team in the Chief Diversity Office at Genentech. Dr. Sandoval's policy and medical background, in combination with the personal and professional connection of her Latina and health equity efforts, bring a valuable perspective to Genentech’s enduring work in the health equity and inclusive research environment. Dr. Sandoval has over seven years of experience in medical affairs and has supported a variety of therapeutic areas, including asthma, inflammatory bowel disease, women’s health, autism spectrum disorder, and influenza. Dr. Sandoval has also practiced as a litigation lawyer concentrating on complex patent cases in the life and pharmaceutical sciences. Dr. Sandoval received her BA in molecular and cell biology from the University of California, Berkeley, a PhD in neuropharmacology from the University of Utah, and a JD from Seattle University School of Law.
Dr. Salim Surani is an Adjunct Clinical Professor of Medicine at Texas A&M University and a Pulmonary, Critical Care & Sleep Medicine Specialist. He earned his MPH from Yale University and his MHA from the University of Texas, Dallas. He received his medical degree from Dow Medical College, Pakistan, and completed an Internal Medicine Residency at the University of Illinois at Chicago, and a Pulmonary Fellowship at Baylor College of Medicine, Houston. Dr. Surani has authored over 500 peer-reviewed journal articles and has written over 50 books and book chapters. He has established himself as a Master Clinician and has given numerous lectures Nationally and Internationally. He serves as the Vice Chair for the Fellow of the American College of Chest Physicians (FCCP) Committee and Chair of the CHEST infection and global disaster response network for the American College of Chest Physicians. He has served as Program Director for the Pulmonary and Pulmonary & Critical Fellowship Programs, in Corpus Christi area Health-Systems. He also serves on the National VA Advisory Board on Sleep Quality & Research. Additionally, Dr. Surani has served in leadership positions for several national and international committees.
Clinical Experts Panel
The moderated session on clinical perspectives will provide a venue for stakeholders to identify barriers to success in the implementation of clinical trials, especially within the context of clinical trial design and execution, engagement and recruitment of underserved populations and the need for system-level changes to improve medical access for all. The panel will build upon the experience of experts who bring unique perspectives in the areas of clinical trial implementation in underserved rural communities and partnerships that support community investment and workforce development. The panel will:
Explore strategies for equitable participation.
Highlight mechanisms to contribute to sustainable and scalable clinical research programs.
Discuss business plans and funding mechanisms to allocate financial resources to support decentralized clinical trials.
Discuss the optimal characteristics of clinical sites to increase capacity to conduct representative clinical trials. Identify resources for collection and sharing of condition-specific demographic data.
Moderator: Kenneth S. Ramos, MD, PhD
Dr. Ramos is an accomplished physician-scientist with designations in the National Academy of Medicine and National Academy of Sciences. He is a transformational leader recognized throughout the world for his scientific contributions in the areas of genomics, precision medicine and toxicology.
With formal training in pharmaceutical sciences, chemistry, biochemistry, pharmacology, and medicine, Dr. Ramos is helping to steer the changing landscape of medicine, biotechnology and healthcare. In this context, he leads several translational, clinical research, and educational programs that integrate diverse approaches to elucidate genomic mechanisms of disease and to develop novel therapies for several oncologic, pulmonary, and vascular diseases.
Dr. Ramos has provided academic, executive, administrative, and scientific leadership in the areas of genetics and genomic medicine and toxicology at various academic institutions and over the course of his career has positively influenced the career of numerous clinicians and scientists engaged in medical, veterinary and pharmaceutical practice. He is deeply committed to initiatives that advance modern technological applications to improve quality of healthcare and reduce disease burden and health-associated costs.
In her current role, Dr. Joy Alonzo provides leadership on numerous collaborative efforts to design, evaluate, innovate, and implement clinical and technological strategies across Texas. Her work addresses gaps in care associated with access, lack of resources, and knowledge dissemination, with a strong focus on the needs of underserved and underrepresented populations. As Co-Chair of the Texas A&M Opioid Task Force, she has initiated multiple interventions aimed at substance use disorders, particularly strategies to address Opioid Use Disorder. Her innovative interventions, which include telehealth, Wi-Fi-enabled resources, artificial intelligence, data analytics, and smartphone technologies, are specifically designed to reach underserved populations and tackle unaddressed issues in specialty care such as mental and behavioral disorders.Dr. Alonzo collaborates with a wide range of key partners, including the University of Texas College of Pharmacy and School of Social Work, Texas A&M School of Public Health, Texas A&M School of Medicine, Texas A&M School of Nursing, the Texas A&M Experimental Engineering Station, and the Texas A&M Rural Community Health Institute. Her work also involves partnerships with MD Anderson, ONDCP, DEA, HIDTA, TX HHS, UTMB Medical School, rural health departments, and numerous government, community, and commercial entities. Dr. Alonzo is particularly passionate about promoting interventions to address emerging public health problems, disseminating patient and clinician engagement tools, educational programs, processes, protocols, and direct interventions to tackle these issues, especially those that are drug-driven or have specific pharmacotherapeutic solutions.
Dr. Jaime E. Fergie is the Director of Pediatric Infectious Diseases and Hospital Epidemiologist at Driscoll Children’s Hospital. He also serves as a Professor of Pediatrics at Texas A&M University College of Medicine and an Adjunct Clinical Associate Professor at the University of North Texas Health Science Center at Fort Worth. Dr. Fergie is the Medical Director of the Global Institute for Hispanic Health, a collaborative initiative between Driscoll Children's Hospital and Texas A&M University aimed at advancing clinical research in the Hispanic community. He earned his medical degree from Caracas Central University of Venezuela, completed his pediatric residency at the Children’s Hospital of Oklahoma, and pursued an infectious diseases fellowship at the University of Tennessee, Memphis, St. Jude Children’s Research Hospital, and Le Bonheur Children’s Medical Center. Board certified in Pediatrics and Pediatric Infectious Diseases, Dr. Fergie is a fellow of the Infectious Disease Society of America, the American Academy of Pediatrics, and the Society for Healthcare Epidemiology of America.Throughout his distinguished career, Dr. Fergie has made significant contributions to pediatric infectious diseases and public health. He has held leadership roles including past chair of the Infectious Diseases Committee of the Texas Medical Association and served on the executive committee of the Nueces County Medical Society. Dr. Fergie was a member of the National Vaccine Advisory Committee and has published extensively in his area of specialty. He is the president of the Corpus Christi Pediatric Society and served as president of Children’s Physician Services of South Texas for eight years. His commitment to advancing healthcare for underserved communities is evident through his work with the Global Institute for Hispanic Health, where he continues to lead efforts in clinical research and epidemiology.
Dr. Joseph B. McCormick is the James H. Steele Professor of Epidemiology at UTHealth Houston School of Public Health and the Founding Dean of the Brownsville, Texas campus of UTHealth Houston. With an extensive background in chemistry, mathematics, and medicine, Dr. McCormick's career began with an undergraduate degree from Florida Southern College and an MD from Duke University School of Medicine. His early professional years included teaching in the Democratic Republic of the Congo and serving in the CDC Epidemiology Intelligence Service. Dr. McCormick has made significant contributions to the fields of HIV/AIDS and Ebola research, and his work has been extensively documented in numerous scientific publications and books, including "The Coming Plague" and "Level 4: Virus Hunters of the CDC." He has received humanitarian awards from Florida Southern College and Duke University School of Medicine for his impactful work.In 2001, Dr. McCormick founded the Brownsville campus of UTHealth SPH, in a city recognized by the US Census Bureau as one of the poorest in the nation. As Dean for 19 years and a current full-time faculty member, he established the first clinical research unit in the Rio Grande Valley and the Cameron County Hispanic Cohort (CCHC). This cohort, the largest in the US for Mexican Americans, allows for the comprehensive study of chronic disease prevalence and progression in South Texas. Dr. McCormick's innovative model includes recruiting and training local staff from the community, leading to the success of numerous NIH-funded research projects and clinical trials. His work continues to advance the understanding of cardiometabolic diseases through multiomic studies, and his collaborations span prestigious institutions such as Vanderbilt University, MD Anderson, and UTHealth McGovern SOM. Dr. McCormick remains a dedicated teacher, practitioner, and researcher, contributing significantly to public health and education in Cameron County, Texas.
Mary Dale Peterson is the Executive Vice President and Chief Operating Officer at Driscoll Children's Hospital, where she has dedicated 40 years to improving pediatric healthcare. Under her leadership, the hospital has achieved remarkable milestones, including being ranked among the top 10 in the nation for its esteemed heart program and the opening of a new $100 million, eight-floor children's hospital in the Rio Grande Valley. Mary frequently shares updates and celebrates the hospital's successes, such as the significant donation from the Dobson family, which marks a new era for Driscoll's heart program and the upcoming inauguration of Driscoll RGV. Mary holds a Doctor of Medicine (MD) from The University of Texas Medical Branch and a Master's degree in Health Care Administration and Management from Trinity University. Her extensive experience and educational background have equipped her with the skills necessary to lead and innovate in the field of pediatric healthcare. With 107 followers on LinkedIn, she actively engages with her professional network, highlighting the impactful work being done at Driscoll Children's Hospital and her commitment to the health and well-being of children in South Texas.
Technical Experts Panel
The objective of this panel is to discuss technical aspects impacting barriers and enabling novel solutions to clinical trials, especially as it relates to the design, recruitment, and execution of decentralized use cases. Topics will be wide ranging and influenced by interaction with conference attendees. Examples include distributed system integration (e.g., via HIPAA cloud capabilities), standards to enable greater system interoperability and data sharing (e.g. FHIR), user experience design as related to decentralized clinical trials (e.g. the use of generative AI), technologies enabling upskilling of clinical and community participants (e.g. distributed workflow systems), and more.Moderator: Jim Colson, VP Digital Health
Jim Colson is the Vice President of Digital Health at Texas A&M Health Science Center, based in Austin, Texas. With a strong background in leadership and digital innovation, Jim focuses on advancing digital health solutions using AI, machine learning, IoT, and cloud technologies.
Before his current role, Jim was the CTO at Cubic Corporation, driving transformative platforms. At IBM, where he spent over 20 years, he served as IBM Fellow and VP/CTO Watson Customer Engagement, leading the transformation of 220+ products into integrated SaaS platforms. His efforts significantly boosted revenue and user experience through AI capabilities.
Jim holds an MS in Computer Science and an MS in Mechanical Engineering from The University of Texas at Austin. He also serves as a board advisor for the Autonomy Institute and SecurityGate.io, continuing to influence the future of digital health with his expertise and leadership.
Wout Brusselaers is the Founder and CEO of Deep 6 AI, a leading company in Clinical Trial Acceleration Software. Based in Pasadena, Deep 6 AI uses AI and NLP to expedite clinical trials and healthcare innovation. Before founding Deep 6 AI, Wout organized the NELA Tech Community and founded WishQube, a social commerce platform. He has also worked as a management consultant at Thinking Arch Consulting and held various leadership roles at Inter-Con Security Systems, Inc.
Wout holds a Licentiate degree in Economics from Vrije Universiteit Brussel, graduating magna cum laude, and an MFA in Film Production from Chapman University. As a strategic leader, he continuously innovates and enhances operational efficiency through rigorous analysis and hands-on management. His achievements include winning the SXSW Accelerator Enterprise and Smart Data category for Deep 6 AI's innovative use of AI in clinical trials.
Michael Glassman, Co-Founder & President at Crescendo Health
Michael Glassman is the Co-Founder and President of Crescendo Health, a San Francisco-based company dedicated to improving clinical trials and medical research. Prior to this, he led core products at Grand Rounds, Inc., and founded Votech to enhance voter turnout through data.
Michael holds a Sc.B in Biophysics and Classics from Brown University, where he was Student Body President and graduated magna cum laude. He also earned an MBA from Stanford University Graduate School of Business, where he was President of the Government & Politics Club.
Hongfang Liu is the Professor and McWilliams Chair of Biomedical Informatics at UTHealth Houston, where she also serves as the Director of Translational AI Excellence and Applications in Medicine (TEAM-AI) and VP of Learning Health System. With over 20 years of experience in data science, informatics, and artificial intelligence, she is dedicated to accelerating data-driven scientific discovery and real-world translation in biomedicine and healthcare. Her work is grounded in people-centric, value-added, and evidence-based principles.Before her current roles, Hongfang was a Professor in Biomedical Informatics at Mayo Clinic, where she explored the use of natural language processing in clinical and translational research. She has also held academic positions at Georgetown University Medical Center and the University of Maryland Baltimore County. Hongfang holds a Ph.D. in Computer Science from The Graduate Center, City University of New York, and an MS in Computer and Information Sciences from Fordham University. She is recognized for her contributions to AI and informatics and her commitment to mentorship, having guided numerous junior faculty to achieve career excellence.
Matthew Quinn is the Science Director at the Telemedicine & Advanced Technology Research Center (TATRC) in Potomac, Maryland. He leads the center's efforts in telemedicine and advanced medical technology, contributing to innovative healthcare solutions. Previously, he served as a Senior Advisor for Health Information Technology at the Health Resources and Services Administration (HRSA), influencing health technology policy to improve care quality. At Intel Corporation, he was the East Coast Managing Director for Healthcare and Life Sciences, spearheading initiatives in precision medicine and population health analytics. Matthew also held the position of Director of Healthcare Initiatives at the Federal Communications Commission (FCC), where he launched the mHealth Innovation Expo and authored regulatory frameworks for health IT. Additionally, he has experience as a Computer Scientist at the National Institute of Standards and Technology (NIST), driving research to improve the usability of health IT systems.
Registration
July 19, 2024
Helix Hall at TMC3
Parking is available in the Collaborative Building Garage, accessed from Lehall Street.
Parking validations will be available at registration.