Dr. Plasse has more than 35 years’ experience managing clinical research bringing new medications to market. He is trained as an internist and medical oncologist. He has worked for several companies, both large and small, and during his career has developed cytotoxics, biologic agents and targeted small molecules. Outside oncology, he has also been involved in development of drugs for obstetric, gastroenterologic and infectious disease indications.

Dr. Isaac Rodriguez-Chavez is a biomedical leader with expertise in Virology, Microbiology, Immunology, Vaccinology, and Viral Oncology. His expertise spans basic, translational, pre- clinical and clinical research (phase I – IV global trials). He also has expertise in digital health technologies, clinical research development and operations, regulatory affairs, approval or licensure of medical products, and quality control and quality assurance.

Dr. Rodriguez-Chavez joined PRA Health Sciences as a Senior Vice President for Scientific and Clinical Affairs, leading our newly developed Global Center of Excellence for Decentralized Clinical Trials (DCTs) using Digital Health Technologies (DHTs). He also has other executive leadership roles across the organization that deal with scientific and medical affairs.

Overall, Dr. Rodriguez-Chavez has over 32 years of work experience in several national and international organizations, including the U.S. Food and Drug Administration (FDA), National Institute of Health (NIH),

industry and non-profit research organizations. Recently, he worked at the FDA, Center for Drug Evaluation and Research (CDER) as a Senior Officer for Clinical Research Methodologies, Regulatory Compliance and Medical Policy Development. He led FDA work on DCTs using DHTs, and he was directly involved in programs for the modernization of clinical research that impact multiple disease areas.

Other past positions he held included CEO and Founder of a biomedical consulting firm, 4Biosolutions Consulting; Vice President for Research, Texas Biomedical Research Institute; Director of the AIDS and Immunosuppression Program, National Institute of Dental and Craniofacial Research (NIDCR), NIH; Senior Clinical Scientist, Schering Plough Corporation; Director of Portfolio for HIV Vaccine Programs, National Institute of Allergy and Infectious Diseases (NIAID), NIH; Scientist at St. Luke’s/Roosevelt Hospital, Columbia University; Lead Scientist, Polar Biotechnology Company (Venezuela); and Scientist in Viral Immunology, Venezuelan Institute for Scientific Research, IVIC.

He issued the first U.S. Good Clinical Laboratory Practice (GCLP) Guidelines to improve the consistency of clinical laboratory endpoints supporting trials globally, published numerous scientific and technical articles, and has been an invited speaker in 68 global conferences.

He has a B.S. in Biology (Venezuela), M.S. in Microbiology (Venezuela), M.H.S. in Clinical Research (Duke School of Medicine), and a Ph.D. in Virology and Immunology (University of Delaware). He did two post-doctoral trainings in Viral Immunology and Viral Oncology at the National Institute on Aging (NIA) and the National Cancer Institute (NCI) at NIH.

Dr. Rodriguez-Chavez is a Board Member of the Scientific Leadership of the Digital Medical Society (DiME). He is also a leadership member of the Research Committee of DiME. He is a regulatory Advisor of the Institute of Electrical and Electronics Engineers (IEEE) fostering initiatives on DCTs and DHTs. He is a Leadership Council member of the Decentralized Trials & Research Alliance (DTRA) and he is a board member of the Hypertrophic Cardiomyopathy Association (HCMA). He is also an active member is fourteen professional associations, including the American Association of Immunologists, American Society for Virology, American Society of Microbiology, Society of Quality Assurance, Association of Clinical Research Professionals, New York Academy of Sciences, International AIDS Society, International Association for Dental Research, American Association for Dental Research, and Regulatory Affairs Professional Society.

Dr. Rodriguez-Chavez enjoys diversity of cultures and communicating with people in English, Spanish, Italian, Portuguese, and French.

LinkedIn: https://www.linkedin.com/in/isaacrc/

Executive intrapreneur turned digital health entrepreneur, my career includes 18+ years leading global drug development, clinical research and decentralized trials for life science organizations.

As CEO of THREAD, I lead our efforts to change the way clinical research is conducted focused on decentralized approaches, enabling the use of our one platform for conducting modern research studies and leading partnerships with our customers. After launching and growing THREAD, we were acquired in 2019 by JLL Partners and Water Street with strategic investment for continued growth and focus on accelerating drug development for our customers.

Named one of the Top 100 Influencers in Digital Health, I also provide expertise and execution experience in digital health, clinical trials and decentralized, remote, virtual, community-based clinical research.

I enjoy being a keynote speaker at global industry events, guest lecturer at Duke University on digital health/innovation/entrepreneurship and a published author featured in various conferences, journals, articles and media outlets.

Ralph has over twenty years of experience in statistics related to HIV/AIDS drug development and is currently Head of Biostatistics and Data Management, ViiV Healthcare, a company engaged in the research, development and commercialisation of medicines for HIV/AIDS.

Prior to joining ViiV Healthcare, Ralph was most recently Functional Leader for HIV, Hepatitis, and Global Public Health programs within the Infectious Diseases and Vaccines Therapeutic Area of Late Development Clinical Biostatistics of Janssen Pharmaceuticals.

Ralph previously held positions of increasing responsibility at: GlaxoWellcome, where he supported HIV Biometrics activities; Trimeris, where he provided statistical leadership for HIV fusion inhibitors; and Tibotec, where he was responsible for the Biometrics support for HIV and other antiviral and infectious disease programs within the global virology franchise.

Ralph has a PhD Degree in Biostatistics from the University of North Carolina.

Arnaub Chatterjee is Senior Vice President of Product and Ecosystem at Acorn AI, a Medidata Solutions company. Medidata is a global provider of cloud-based and analytic solutions in life sciences and in his role, he leads the development and go-to-market of data science products within the company. In addition to his role at Medidata, he also serves as Teaching Associate in the Department of Health Care Policy at Harvard Medical School and Lecturer in the Department of Policy Analysis and Management at Cornell University.

Prior to Medidata, Arnaub was Associate Partner in the Pharmaceutical and Medical Products group at McKinsey & Company, where he advised pharmaceutical and technology companies on a range of topics, including clinical trial design and utilizing novel data and analytics to improve regulatory and commercial success. Before his time at McKinsey, he served as Director at Merck's Data Science and Insights group within the Center for Observational and Real World Evidence.  He previously served in the Obama Administration as an advisor to the Office of the Chief Technology Officer at the U.S. Department of Health and Human Services (HHS). He also worked in the Office of the Secretary at HHS as a lead policy analyst on healthcare fraud and abuse initiatives around the Affordable Care Act. Prior to government service, he spent a number of years as a strategy consultant at Deloitte Consulting, supporting pharmaceutical companies on building strategies around data and analytics.

His work has been published in journals such as the Harvard Business Review and Nature and he has presented at conferences ranging from South by Southwest to the American College of Cardiology.  He sits on the board of the College of Human Ecology at Cornell University and is a member of the World Economic Forum’s Global Future Council of Biotechnology.  He holds graduate degrees in health administration (MHA) and public administration (MPA) from Cornell University and received his undergraduate degree from the University of Michigan. He is a native of Minnesota but presently resides in Boston with his family.

Rosamund is Vice President of Parexel’s Patient Innovation Center and spends her time devoted to simplifying the patient journey in clinical trials. Focused on the reduction of geographical, financial and practical barriers to study participation, Rosamund is excited by the industry shift towards a truly patient centric approach. Her first job in an oncology clinic at Massachusetts General Hospital (USA), sparked her passion for putting patients at the center of clinical research planning and implementation. Subsequent roles in patient recruitment in both the pharma and CRO industries have enabled her to innovate and explore better ways to communicate with patients. This includes addressing literacy and health literacy, exploring technological advancements, and constantly scanning the environment to help generate new ideas to make clinical trial participation more accessible and convenient. Always looking for the next best thing in patient recruitment, Rosamund is delighted to share her learnings around patient centricity and innovation in patient engagement.

Todd Johnson has more than 25years of experience in pharmaceutical development and clinical systems–from beginning his career as a clinical site monitor to developing operational performance dashboards and KPI/data reporting strategies. Having successfully managed clinical programs and assets, Todd is knowledgeable in ICH/GCP, has clinical operations experience across multiple therapeutic areas, and has assisted in several successful IND and NDA submissions.

Before joining Halloran, Todd led Clinical Information and Informatics groups at Astellas and PPD, with an emphasis on operational performance metric/KPI assessment, data quality, benchmarking, dashboard development and reporting. He worked closely with cross-functional teams in study start-up, clinical operations, data management, clinical programming, biostatistics, medical writing, and pharmacovigilance to help them identify KPIs (and data sources) that drive their business decisions. He specializes in designing data and analytical strategies, including master data management, data quality, data literacy, data access and data visualization components. He is passionate about data quality and ensuring the right data is used to make better decisions.

Todd earned his Bachelor of Science in biology from the University of Michigan and a Master of Public Health in epidemiology and biostatistics from the University of Illinois at Chicago School of Public Health. He also earned a Master of Business Administration in entrepreneurship and econometrics and statistics from University of Chicago Booth School of Business and is currently enrolled in Northwestern University’s Master of Science program in predictive analytics.

Niklas Morton serves as senior vice president of PPD® Digital. In this role, he oversees the operations and delivery of digitally enabled and decentralized/virtual studies, along with PPD’s robotic automation capabilities.

Prior to his most recent appointment, Morton was senior vice president of site and patient access, overseeing the site intelligence and activation, strategic feasibility, strategic site collaboration and clinical innovation teams. In that role, he led more than 1,400 professionals engaged in the identification and activation of the right research sites for each trial to access the most patients in the shortest cycle times.

Since joining PPD in 1998 as a biostatistics manager, Morton has advanced through various roles of increasing leadership and responsibility within the company. He spent nearly five years in PPD’s project management department, where he had section-head responsibility for PPD’s Europe, Middle East and Africa (EMEA) hematology/oncology group.

He also has served as senior vice president of global biostatistics, programming and medical writing, where he worked with business development and client management activities in full-service and functional service partnership relationships while leading more than 800 professionals engaged in the design, analysis and reporting of clinical trial data.

During his tenure at PPD, Morton also led the company’s cross-functional initiative to develop and implement data standards in the acquisition, aggregation and analysis of clinical trial data, resulting in the launch of Preclarus®, a comprehensive clinical data

solution that consolidates and standardizes data from multiple sources to give PPD teams and clients transparent, real-time access to all clinical trial operations, patient and lab data.

Morton earned a master’s degree in medical statistics from the University of Leicester and a bachelor’s degree in statistics from the University of Glasgow, both in the U.K.

David Coman is the chief executive officer of Science 37, which makes it easier for people to participate in clinical research by connecting patients with doctors and nurses through telemedicine visits and home health screenings, then managing trial logistics from an integrated, comprehensive platform.

David came to Science 37 from ERT, where he led its data and analytics business after serving as the company’s chief strategy officer. As the leader of ERT’s data and analytics business, David reimagined the way the pharmaceutical industry looks at performance and risk management for clinical trials while more than doubling the company’s bookings from analytics over a two-year period. In his strategy role, David spearheaded the acquisition of four companies in a 12-month period, generating more than $1 billion in enterprise value, while repositioning ERT as the market leader in clinical trial data generation.

David joined ERT from Quintiles (now IQVIA), where as chief marketing officer and founder of its Digital Patient business, he helped lead the company’s growth from $2.7 billion in 2007 to $4.3 billion in 2015. It was here that David pioneered some of the industry’s first decentralized clinical trials while also driving significant growth and enterprise value.

Prior to Quintiles, David was the chief marketing officer at Dendrite International, which is also now owned by IQVIA. Earlier in his career, David held a variety of marketing leadership roles in telecommunications, including AOL Local & Long Distance (Talk America), Excel Communications, and Aerial Communications.

David earned his B.A. in advertising from Michigan State University and his MBA in marketing, entrepreneurship, and finance from the Kellogg Graduate School of Management at Northwestern University.

Abel is the Life Science Advisor to BlueVoyant, who is part of the Istari portfolio network

He joined ISTARI in October 2020 as Managing Director, Life Sciences and Industrials. ISTARI is a Temasek platform company focused on helping the best companies in the world manage down digital risk. 

At Bayer, Abel was head of IT and Digital Transformation for Bayer Pharma Division since 2017, and member of Bayer Group IT Board. Before joining Bayer, Abel was Global CIO, Sandoz, a Novartis Division (2012-17) as well as head of IT for Novartis Technical Operations (~85 plants) looking after manufacturing, supply chain and quality. He was a member of the Novartis IT Board.

Past positions include Cemex (CIO EMEA), Dell (General Manager, Mexico) and Boston Consulting Group (Principal, Monterrey and Dallas offices). He holds a degree in electronics engineering from Tec de Monterrey, Mexico, and an MBA and Public Management degree from Stanford Graduate School of Business.

Todd is a healthcare digital strategist who has a more than decade of experience driving and designing digital strategy for patient-centric programs designed to educate patients and caregivers, engage patients with their providers, and improve adherence to therapy.

Todd’s experience spans the digital space from Opportunity Development to Program Design to Outcomes and Insights. He’s worked with digital marketing analytics, CRM systems, business intelligence tools and measurement approaches for closed-loop MCM programs to demonstrate ROI. He’s directed market research, needs assessment and delivered thought leadership for marketing approaches to executive leadership teams.

Todd holds a PhD in Instructional Technology from Indiana University and a MPH in Health Behavior and Health Education from the University of Michigan. With an undergraduate degree in Industrial Design, he applies design thinking to marketing and communication challenges.

Vasundhara Sridharan is a Principal UX Researcher and behavioral scientist with over 6 years of experience in designing and researching digital health behavior change.

At Medullan, she combines approaches from psychological science, design thinking and business strategy to create innovative solutions in digital health.  She approaches digital health with a user-first approach, and advocates for the voice of the user to be reflected across every stage of product development form solution concepting, experience design, UX evaluation and assessment to adoption and impact assessment.

She believes that research needs to evolve as people evolve. As the world becomes more digitally driven,  this is the philosophy she brings to her research to serve the future of digital health and the ever-changing digital health user base.

Vasundhara’s holds a PhD in Psychology from the University of Washington, Seattle.

Adriano supports Medullan’s growth by designing, developing and promoting the adoption of innovative, high-impact digital health solutions for our clients.

Adriano is a data-driven consultant with 12+ years of experience serving a breadth of clients in leadership and management roles, in consumer experience transformations, digital business model development, digital and mobile strategy, and decentralized virtual clinical trials.

Work at Medullan has included strategy and product design for life-sciences, pharma, bio-pharma, provider organizations, health innovation accelerators, and private-sector companies with a focus on implementation and adoption of novel technology, processes, and care delivery models.

Past experience includes working with the medical devices, diagnostic services, insurance, wellness and healthcare sectors.

Dr. Amy Williams is a Director of Proactive Services for BlueVoyant. Prior to working for BlueVoyant she served as VP of Cybersecurity for Unlimited Technologies and PSB Exero. Prior to that, Dr. Williams served as Director of Cyber for the Citizens Crime Commission of NYC. Before working for the CCC she was a chaired Trustee Professor for Bentley University, hired to foster collaborations between businesses and academic researchers on cybersecurity. She is recognized as an expert on HIPAA, NIST 800-171 and CMMC, the cyber security of physical security and data privacy as well as process improvement for information security. She has received numerous leadership awards including the first ever Visionary Leadership Award from the American Accounting Association (AAA). Dr. Williams has authored dozens of practitioner and peer reviewed scholarly articles and served on editorial staffs of information technology publications. She has been a frequent invited speaker at international and national cyber security conferences, and has chaired 20+ national task forces and leadership committees. Dr. Williams received her Masters and PhD degrees from Virginia Tech and holds the CISSP certification.