Date: Tuesday, June 27th, 2023
Time: 9:45 a.m. – 10:15 a.m. EST
Location: Exhibit Hall Theater #2
This interactive panel will challenge how we bring inclusion to the forefront of flexible clinical trials. The audience will help us explore why clinical trials still lack diversity, despite years of focus and effort on inclusivity. Topics will include improving data collection while maintaining and enhancing integrity, identifying and encouraging diverse groups of people to take part in clinical trials, and reducing burdens that may be brought on by frequency and timing of data collection.
Chief Medical Officer at Clario
Dr. Todd Rudo provides medical & scientific leadership and is passionate about leveraging scientific expertise to support our customers’ success, Dr. Rudo has focused on optimizing solutions across therapeutic areas. His team provided expert consulting services on scientific and regulatory strategy, and ensures our product portfolio is scientifically robust, generating high quality data to support clinical trial endpoints. Dr. Rudo has a particular interest in applying innovative technologies to improve the scientific rigor of clinical trials. With nearly 20 years of clinical cardiology and pharmaceutical research experience, Dr. Rudo has focused predominantly on drug safety and has worked in various therapeutic areas.
Chief Diversity, Inclusion, and Sustainability Officer at Clario
Clario has a long history of ensuring diversity, inclusion and sustainability, something the organization is committed to improving under the leadership of Otis, who is Chief Diversity, Inclusion and Sustainability officer. He also works with employees, customers and shareholders to ensure they fulfil their environmental, governance and social responsibilities. With over 20 years’ experience of working in pharmaceuticals, Otis is passionate about the industry and holds expertise across clinical informatics, business analytics, sales, project management and research and development. He has held positions at a number of global companies including Merck, ICON and Syneos Health.
Executive Director/Professor, Tufts CSDD; Founder/Board Chair, CISCRP and Tufts University School of Medicine, United States
Ken Getz is the Director and a professor at the Tufts Center for the Study of Drug Development, Tufts University School of Medicine. He is also the chairman of CISCRP – a nonprofit organization that he founded to educate and raise public and patient awareness of the clinical research enterprise. A well-known speaker at conferences, symposia, universities, investor meetings and corporations, Ken also holds a number of board appointments in the private and public sectors. He received an MBA from the J.L. Kellogg Graduate School of Management at Northwestern University and a bachelor’s degree, Phi Beta Kappa, from Brandeis University.
Vice President, Head of Global Clinical Operations at Takeda
Dr. Karen Correa is the Vice President, Head of Global Clinical Operations at Takeda; where she is responsible for the advancement of the portfolio and execution of global clinical trials. Her 30 years of clinical research experience cover a large range of settings and venues including, benchwork, clinical site, CRO, as well as both large and small pharma organizations and has spanned across multiple therapeutic areas. She also leads the “Diversity in Clinical Trials” at Takeda and is known as an SME on this topic for the past 25 years. Dr. Correa serves as a board member of East Carolina University Alumni Board and CAMcare Health Corporation, a Federally Qualified Healthcare Center in South Jersey.
Associate Director Mobile Clinical Services, PMP, MBA, Fortrea
Alicia has over 8 years of home health, clinical operations, and project management experience across all therapeutic areas and study development phases. Being one of the first EMEA employees involved in the decentralization of global clinical trials, she has a broad clinical understanding from both CRO and pharmaceutical perspective. Alicia, as part of the MCS Leadership team, has first-hand experience conducting business globally. In fact, her main responsibilities include leading the EMEA business unit, which she continuously accomplishes by building cohesive, high performance project management teams who by collaboration are able to deliver results.
Date: Monday, June 26th, 2023
Time: 1:30 p.m. – 2:30 p.m. EST
For the decentralized clinical trial modality to thrive, the data privacy concerns of multiple stakeholder groups must be addressed. This panel of industry luminaries will discuss how technology can continue to bring therapies to market faster while increasing diversity.
Learning Objectives:
Identify data privacy concerns from multiple perspectives: patient/participant, sponsor, innovator, technology provider; Determine how to meet all stakeholders’ needs for the sake of diversity, equity and inclusion; Describe how to increase stakeholders’ trust so that the clinical trials community can utilize new technologies such as decentralized clinical trials to bring life changing therapies to market faster.
EVP, Chief Information, Product, & Technology Officer at Clario
Always striving for excellence, Jay heads up Clario’s development, information technology and strategic sourcing initiatives. With over 25 years’ experience of working as a global technology leader, Jay has a wealth of knowledge which helps drive changes that are critical to managing data protection. An expert in improving and implementing data policies, Jay is well placed to ensure the complete privacy and protection of data belonging to Clario’s customers and patients.
Founder and CEO, Savvy Cooperative
Jen Horonjeff, Ph.D., is a patient advocate and the founder & CEO of Savvy Cooperative, the first and only patient-owned co-op that helps innovators connect directly with diverse patients to get the insights they need to build better and more inclusive healthcare solutions. Jen was named one of the 50 Most Daring Entrepreneurs of 2018 by Entrepreneur Magazine for her work at Savvy. She grew up with multiple autoimmune conditions and survived a brain tumor as an adult. She is also a patient-centered outcomes researcher, a human factors engineer, and a former FDA advisor. Jen strives to give patients a platform to have their experiences be heard, included, and equitably valued.
Program Director, Decentralized Trials and Research Alliance (DTRA)
Jane has focused on improving clinical trials and patient experience for more than 25 years. Her passion is driving innovation into the trial design and execution to get medicines to patients faster. She’s is an initiative co-lead and program director for the Decentralized Trials Research Alliance, an non-profit focused on the adoption of DCT methods to support patient optionality. She worked at Roche / Genentech for 17 years in many roles, including operational program manager for hematology ultimately working on driving patient-facing technology into global trials. In prior lives, she held various roles in DCT optimization at LabCorp and ran global trials at Lilly and Sanofi.
Director, DCT Solution Enablement, ICON
Aurore has more than 15years experience in Life Sciences with experience in clinical and project management through working on international studies, mega trials and pediatric studies from Phase II to Phase IV. She has a high focus and interest on processes, technologies, central monitoring, decentralized trials, Aurore has dedicated the past 5 years on creating and implementing processes to ensure efficient, effective and successful delivery of projects.
Presented during: Leveraging Data Scientists and Data Managers in Clinical Data Management Session
Date: Wednesday, June 28th, 2023
Time: 10:30 a.m. – 11:30 a.m. EST
Learning Objectives:
Describe the role of clinical data managers in the protocol design process: Discuss how to leverage data science and statistics principles, tools, and processes for clinical data management; Recognize need for wider organizational involvement for embracing data scientist function.
Senior Director, Clinical Data Systems and Services at Clario
Dr. Joby John is a versatile Clinical Research executive with over 20 years of experience in managing end to end clinical services like EDC, CDM, SDTM, SAS, IWRS, eTMF to name a few. She has worked with a wide array of global Pharma companies, CROs and FSPs in setting up and managing multiple clinical domain teams. She is passionate about Clinical Data Management and its evolution and has presented/chaired sessions in multiple Industry forums like DIA and SCDM. Currently she is working as Senior Director, Clinical Data Systems and Services at Clario, based in Cary, North Carolina Dr. John is a dentist by education and attained her Bachelor of Dental Surgery at Rajiv Gandhi University of Health Sciences.
Date: Tuesday, June 27th, 2023
Time: 2:35 – 3:05 pm EST
Location: Exhibit Hall Theater #2
Associate Director, Digital Health and Innovation at Fortrea
Walter’s area of responsibility involves managing a team to oversee implementation of digital service in support of connected health trials. He brings 10+ years of experience in clinical trial systems across pharmaceutical, healthcare IT and CRO industries with experience across Phase I through Phase IV. He has broad functional experience spanning strategic planning, business development, and program management. He is experienced with program management with varied DCT platforms i.e. eCOA, consent, telehealth, EDC and eTMF.
Principal Scientific Advisor at Clario
Dr. Kelly Dumais is a scientist with over 13 years of experience in behavioral and life science research. She has expertise in the implementation of electronic clinical outcome assessments (eCOA) and the development and validation of patient reported outcomes (PROs) to support labeling claims. She is currently a Principal Scientific Advisor at Clario, a global data and technology company that helps to minimize risk in clinical trials. She consults on best practices for questionnaire design and eCOA design/use to drive data integrity and patient engagement and develops custom site rater training and participant training for improving accuracy in COA reporting and improving inter-and intra-rater reliability.
VP Business Development at Circuit Clinical
Laura Warwick is passionate about ground breaking science, collaborating with visionary minds, and building solutions to tough problems. Her experience ranges from bench research in drug discovery, clinical development across phase 1-4, to commercial drug/diagnostic launches. She is currently a Vice President at Circuit Clinical which is dedicated to empowering patients to choose clinical research as a care option and transforming the way physicians and their patients find, choose, and participate in clinical research.
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