2023 Faculty

Rick Arlow
President, Founder
Complion, Inc. 

Founded Complion, first eReg solution for sites, after seeing the challenges first hand in a medical scientist program funded by NIH (MD/PhD).

Jessica Budzinski
Sales Engineer II
Greenphire

Jessica began her career at Greenphire almost 5 years ago supporting the implementation and maintenance of mid-large pharma studies, and has gone on to become a trusted expert in Greenphire’s technology solutions. Leveraging her Bachelor’s in mathematics with a concentration in statistics and past experience in ePRO management, Jessica analyzes the scope and functional needs of each client and to build an interconnected technology workflow that supports the entire lifecycle of their clinical trials from start to finish.
 

Brian Burkhardt
Co-Founder/Executive Director
Oliver Patch Project

Brian Burkhardt is the Executive Director and Co-Founder of the Oliver Patch Project (OPP), a program conceptualized by him and his wife when their son, Oliver, was diagnosed with Leukemia in May of 2020. Their program’s mission, to “Empower Children battling cancer through the Power of Patches” is a fun, free and engaging platform open to any child currently diagnosed with cancer residing in the United States.

Brian has over twenty years of professional experience as an internationally recognized Fine Artist, Creative Director, and Brand Strategist. His diverse background provides a non-traditional and conceptual approach which keeps the fun, magic and “out of the box” thinking in everything he does.

Bree Burks, RN, MSN
VP of Strategy, Site Solutions
Veeva Systems

Bree Burks has been involved in clinical research as a nurse, research coordinator, team manager, and director of a large central clinical trials office within three leading academic medical centers. At Veeva, she focuses on improving technology for research sites around the globe.

Jennifer Byrne
CEO
Javara

 

Jennifer Byrne’s career has been devoted to advancing the clinical research enterprise to better connect patients and providers to clinical trials. Her passion and commitment to transforming clinical research into an integrated component of healthcare are at the forefront of Javara’s mission.

Michelle R. Cencelewski
VP of Clinical Operations
ObjectiveHealth

Michelle Cencelewski, as Vice President of Clinical operations I excel as a Promoter, Builder & Nurturer of Clinical Research Teams & Centers of Excellence. I have more than 14 years of clinical research experience having started out as a Certified Clinical Research Coordinator. Having always been a natural leader I strive to lead and develop teams while navigating the ever-changing landscape of the clinical research field. My experience, having worked on over 80 clinical trials across ten indications and varying in phases allows me to have a vast area of knowledge and experiences throughout the industry throughout the years. Since joining the ObjectiveHealth team in 2019, I have worked to strive for the development of centers of excellence through my knowledge and leadership.

April M. Coburn
Associate Director, Therapeutic Area, Site Activation Liaison
ICON, PLC

Since 2006, April has been an active participant within clinical research. From her initial roles in TMF Services and Early Development Services, to her later experience as a Medical Writer and Study Start-Up Senior Manager, April has helped lead change in our ever-evolving industry throughout the years. She contributed to the integration of multiple TMF systems, trained teams globally on Start-Up processes, served as a Site Relationship Manager within ICON for Sarah Cannon, and now acts as a Site Activation Liaison Director within ICON’s Center for Vaccines and Emerging Infectious Disease, developing site and network relationships globally, with over 70+ relationships in 60+ countries. April’s experiences provide her with a unique perspective on an industry that is so valuable in bringing patients in need life-changing treatments.

Patrick Conley, MS, CBSP, NREMT
Director, IBC Operations
Clinical Biosafety Services

Patrick Conley is dedicated biosafety professional and industrial hygienist focused on developing value driven safety programs and services supporting basic research, translational medicine, patient care, and community education. Patrick has a bachelor’s in Microbiology and a master’s degree in Industrial Hygiene, as well as is a certified Biosafety Professional, a licensed Emergency Medical Technician, and a certified Mold Consultant.

Prior to coming to Clinical Biosafety Services, Patrick spent 7 years working on sexually transmitted diseases, invasive diseases, biotoxins, and select agents and toxins and 13 years as a Director within the University of Texas Southwestern Medical Center’s Office of Safety and Business Continuity. Through his director’s role, Patrick oversaw UT Southwestern’s institutional biosafety committee, chemical safety committee, select agent and toxin program, biosafety program, chemical safety program, industrial hygiene program, hazardous waste program, and environmental compliance program. Additionally, through his role as the hazmat section chief of the UT Southwestern Environment Care Committee, Patrick managed all hazardous materials and waste programs within the UT Southwestern ambulatory clinics and hospital facilities.

Terri Conneran
Founder/Lung Cancer Survivor
KRAS Kickers

Battling stage III lung cancer since 2017, it was as a result of KRAS biomarker (2019) she began her quest for KRAS Knowledge Research & Advocacy for Survivorship with a simple goal to kick cancer’s KRAS. Wanting to connect with other people with a KRAS oncogene, the KRAS Kickers is a global online support network that is tumor agnostic of RWD from people living in the real world. Identifying needs to bridge the KRAS-holes in healthcare having webinars, meetups and forums the members engage with leading doctors, researchers, and advocates to learn about new developments and clinical trials. Further connecting the community sharing their journeys to give hope. As hope shared truly is hope multiplied.

Wilfredo De Jesus-Monge, MD, MSc
Chief of Research
Hospital HIMA San Pablo Caguas

Dr. Wilfredo E. De Jesus-Monge is a physician with 20 years of site-based clinical research experience (mainly in Oncology) with site roles that include assistant and coordinator, blinded rater, grant writer, research committee Chair, Director, Chief, Sub-Investigator, and Principal Investigator. His formal Oncology research training includes a Postdoctoral MSc in Clinical Research from the University of Puerto Rico (PR) and a Postdoctoral Research Fellowship in Cancer Biology from UMass Chan Medical School, Worcester, MA.

Dr. De Jesus-Monge is currently Chief of Clinical Research at Hospitales HIMA•San Pablo, Caguas, PR, where he is also Investigator and Lead Clinical Research Associate for the Children’s Oncology Group, Principal Investigator for the 2022 Term Infrastructure Award from St. Baldrick’s Foundation (largest non-government funder of childhood oncology research), Associate Leader and Grant Writer for the 2022-2024 Navigation Capacity-Building Initiative Grant from American Cancer Society, and Principal Investigator for an annual cancer epidemiologic study in PR. In addition, he is Assistant Professor in Research (Ad Honorem) at San Juan Bautista School of Medicine, Caguas, PR.

Dr. Wilfredo E. De Jesus-Monge will also share during the Poster Session his site’s application of oncology patient navigation principles to address barriers to subject participation, retention, and compliance.

Jennifer Doraski
US Site Partnership Manager, Oncology
Sanofi

Jennifer Doraski has worked in the clinical research industry since 2001, primarily in clinical operations, regulatory and quality functions.  She has worked in multiple roles across Site, CRO and Sponsor settings.  For the past five years, in her role as US Oncology Site Partnership Manager at Sanofi, Jennifer capitalizes on her previous experience to build transparent, collaborative site relationships and promote strategic operational excellence.  Recent focus includes Country and site feasibility strategy for Phase 1-2 oncology trials across the platform and simplification of study start up processes based on site and industry feedback and current landscape.  Jennifer is also a sponsor member of the SCRS Oncology Board, planning committee and site education working group. 

Dana Dornsife
Founder, Chief Mission and Strategy Officer
Lazarex Cancer Foundation

Dana Dornsife is Chief Mission and Strategy Officer at Lazarex Cancer Foundation, a nationwide non-profit organization she founded in 2006. The unique mission of Lazarex is to improve cancer health outcomes, FDA cancer clinical trial diversity and enrolment, and patient access to care by providing assistance with clinical trial navigation, reimbursing trial related travel costs, and partnering with at-risk communities to mobilize resources.

In 2016, Dana expanded the mission at Lazarex to bring sustainable and transformational change to clinical trial enrollment, retention, minority participation and equitable access with IMPACT (Improving Patient Access to Cancer Clinical Trials). Most recently, Lazarex created collaboration around a public health initiative, the Lazarex Cancer Wellness HUBs. This bold initiative is aimed at creating a replicable model to address cancer health disparities and improve cancer health outcomes. Dana is a graduate of Drexel University in Philadelphia, serves on several Boards, and participates in many philanthropic initiatives with her husband Dave Dornsife.

Dave Espenshade
Vice President, CRO Partnerships
Greenphire

Dave Espenshade has over 25 years of experience in the life sciences sector, and has been responsible for shaping the commercial strategy and expansion of relationships with Contract Research Organizations at Greenphire for the last six years. He employs a wealth of knowledge across all aspects of the clinical trial management lifecycle: from patient recruitment and retention, to regulatory document management and publishing, and implementation of data-driven payments, Dave is expert in finding tailored software solutions that achieve results.

Diana Foster, PhD
CEO
Total Diversity

Dr. Diana L. Foster currently serves as the Chief Executive Officer for Total Diversity Clinical Trial Management. She has worked with Total Diversity since inception and has guided Total Diversity as it has become a full-service contract research organization.

Daniel J. Fox, MPH, PhD
Founder/CEO
Clinical Research Payment Network; Land of Lincoln Clinical Research

Dr. Fox is a translational scientist and entrepreneur dedicated to ensuring clinical sites have everything t hey need to succeed and patients have the easiest possible experience participating in clinical trials. He has worked in academia, small biotech, global manufacturing, private clinical site administration, consulting, and has now established his own organization to serve clinical sites in the research industry. Dr. Fox’s passion for fully funded clinical trials and clinical site rights ensures his sites, his sponsors, and importantly the patients he serves are successful throughout the entire clinical research process.

Peter Fredette
Director, Clinical Partnerships, Liaison
EQRx

Peter Fredette has over 25 years experience in drug development, pre-clinical and clinical research. Peter’s deepest experience is in oncology, therapeutic clinical research although his experience extends to all phases of drug development, across many therapeutic areas. Peter is passionate about clinical trials as a care option for patients, and building long-term alliances that bring research professionals and patients closer together.

Almenia Garvey
Sr. Director, Site Network Development and Site Engagement
Oncacare

Almenia has over 25 years’ experience in clinical research and during this time she has had the opportunity to work on a number of projects combining healthcare andtechnology. She specialises in site selection strategy,investigator identification and investigator relationshipmanagement. Almenia has a passionate interest in drivingdiversity in all aspects of clinical trials. She is on the board of Directors for Nvolve, a non-profit that focuses on preparing young women for STEM careers and the Advisory Board for (CISCRP)The Center for Information and Study on Clinical Research Participation.

Catherine Gregor
Chief Clinical Trial Officer
Florence Healthcare

Catherine Gregor is a transformational leader and business advisor with close to two decades of experience in clinical research. She currently serves as the Chief Clinical Trial Officer for Florence Healthcare, a software company focused on connecting sponsors and sites worldwide. Catherine is a subject matter expert and key opinion leader on patient-centric, decentralized and hybrid trial design. She has worked in multiple therapeutic areas in both academic and community hospitals, with her most recent appointment being Director of Clinical Research Administration for the Vanderbilt-Ingram Cancer Center.

Nadege Gunn
Medical Director
Impact Research Institute

Gastroenterologist and a Certified Principal Investigator. Former United Sates Air Force Major and Chief of Gastroenterology at Eglin Air Force Base in Florida. She is the founder of Impact Research Institute, a clinical trial facility that serves a large rural and underrepresented population.

Betsy Henk 
Director, SCRI, Quality Assurance
Sarah Cannon Cancer Institute

Betsy Henk has been actively involved in Oncology Research for more than 30 years. She began her career as a data manager (Clinical Research Coordinator) for cooperative group studies. She started performing quality audits approximately 20 years ago.

Jennifer Hoffman
Global Patient Engagement Lead
Sanofi

My name is Jennifer Hoffman and I work as a Global Patient Engagement Lead within our Patient Informed Development and Health Value Translation Lead Team here at Sanofi. In collaboration with multiple patient advocacy organizations and patient groups, I am honored and privileged to speak with patient advisors and their caregivers to have a better understanding of their disease/condition while obtaining their critical feedback on our clinical development.

Jennifer Hunter, CCRP, BAAS
Director of Research Operations
Mary Crowley Cancer Research

Jennifer Hunter joined Mary Crowley Cancer Research, an early-phase oncology clinical trial site network, in 2013 and currently serves as the Director of Research Operations. In this role, she oversees study development, budget and project management, regulatory affairs, trial management, medical records, quality assurance, and data management. Believing that people are any organization’s greatest asset, her core focus is empowering the team and developing new leaders. She values innovation, boldness, and solution-focused, strategic vision workshop sessions. Jenn and the MCCR team have conquered various system implementations, process improvements, and organizational restructuring. These opportunities have created a culture of continuous improvement with core values of quality, innovation, and collaboration.

Kathleen Hurtado
Associate Vice President, Office of Research Administration
Cancer Treatment Centers of America

Kathleen Hurtado, RPh, is a senior pharmaceutical executive and clinical research expert.​ Throughout her 30-year career, Kathleen has held leadership positions with Fortune 500 pharmaceutical companies, national academic and clinical research institutions, and national and regional hospital systems. She currently is associate vice president of the Office of Research Administration for Cancer Treatment Centers of America.  An expert in clinical research administration, compliance, and regulatory management, Kathleen is SciMar’s pharmaceutical alliances and partnerships advisor. 

Alison Ivey, MS, MBA, RN, OCN, CCRP
Director, Clinical Research
University of Florida Health Cancer Center

Alison Ivey is the Director of Clinical Research for the University of Florida Health Cancer Center. In this role she helps drives strategic planning for center-wide research initiatives and oversees a growing oncology research portfolio of more than 350 interventional trials across UF and ten affiliate sites within the state of Florida. As Director, she is highly engaged in all aspects of study activation, budgeting, contracting and post-award financial management. Alison has a Bachelor of Arts in Anthropology form the University of Florida, a Bachelor of Nursing from Johns Hopkins University, a Master of Science in Clinical Research Management from Arizona State University and a Master of Business Administration from Louisiana State – Shreveport. She a member of several professional societies including the American Society of Clinical Oncology, the Oncology Nursing Society and the Society of Clinical Research Associates.

Edmond Kato Kabagambe, DVM, MS, PhD, MBA
Vice President of Research Administration 
Penn Medicine Lancaster General Health

Dr. Edmond K. Kabagambe, is a VP of Research Administration at Penn Medicine Lancaster General Health. He trained as a veterinarian and holds degrees in epidemiology (MS, PhD) and business administration (MBA) from Louisiana State University and Vanderbilt University, respectively. In addition to research administration, he has been a principal investigator or co-investigator on a number of research studies funded by NCI, NIH and the American Heart Association. His current interests include workforce development and enhancement of research infrastructure that optimizes clinical research while increasing participation of minority patients and those in medically underserved areas.

Daniel Kavanagh, PhD, RAC
Senior Scientific Advisor, Gene Therapy
WCG

Dr. Kavanagh serves as scientific and regulatory lead for gene transfer research at WCG, and works closely with sponsors, CROs, and institutions using WCG Institutional Biosafety Committee (IBC) services and other clinical trial support services for cell and gene therapies. Prior to joining WCG, Dr. Kavanagh was Assistant Professor of Medicine and IBC Vice Chair at Harvard Medical School. He holds a Regulatory Affairs Certificate (RAC-US) from the Regulatory Affairs Professional Society.

Selin Kurnaz, PhD
Co-founder & CEO
Massive Bio

After completing her PhD at the University of Michigan, receiving multiple engineering degrees, Selin spent more than a decade specializing in delivering revenue enhancement, margin optimization and capital efficiency improvements for Healthcare and Life Science companies. She started Massive Bio to bring the latest knowledge in cancer care to patients.

Nathan Levens
Vice President of Site Solutions
Realtime Software Solutions

Nathan Levens has over 15 years of clinical research experience and spent over 4 years as the Quality Assurance Manager for one of the largest multi-specialty, phase 1-4 research sites in the United States. Nathan has a deep understanding of research site processes and regulatory compliance challenges that shape our industry. He now teaches sites how to transition from paper-based regulatory and source documentation processes to electronic solutions, such as RealTime-eDOCS and RealTime-eSOURCE, to boost efficiency, drive compliance, and improve collaboration between sites and sponsors.

Adrian McDonald, BSc(Hons)Nursing
Director, Site Optimization and Engagement
Illingworth Research Group (A Syneos Company) 

Qualified as a Nurse has several years experience in acute medicine and clinical research. Adrian has worked as a research nurse both on and off-site, as a site study coordinator, project manager and Line manager. Adrian’s experience spans several therapeutic areas including respiratory, neurology, cardiology and general medicine. Adrian currently leads Illingworth’s efforts in forming long lasting partnerships with Sites through understanding the site’s needs to develop processes that reduce the burden on Sites while still ensuring they have control over the clinical services they are delegating to the Illingworth team. 

Kelly McKee, MS
Vice President, Decentralized Clinical Trials 
Medidata

Kelly McKee serves as vice president of Decentralized Clinical Trials (DCTs) in Patient Cloud at Medidata. She is responsible for creating new solutions to engage clinical trial patients pre-trial, in-trial, and post-trial, as well as developing patient and product communications around all Patient Cloud Products for decentralized and hybrid clinical trials. Kelly is a proven clinical trial leader and trailblazer in operationalizing global patient-focused solutions across organizations including innovations in clinical trial awareness, access, and improvements in patient experiences. Prior to Medidata, she spent over 20 years within clinical operations and patient recruitment at top-tier pharmaceutical companies including Sanofi, Merck, Eli Lilly and Co., and Vertex Pharmaceuticals. Kelly is passionate about celebrating the role that clinical trial participants bring in making new medicines and vaccines possible and was named one of Life Sci Voice’s Top Industry Leaders in 2022, PharmaVoice’s 100 Most Inspiring Leaders in 2020, Centerwatch’s Top 20 Innovators of 2018, and PharmaTimes’ Clinical Researcher of the Year, Clinical Research Teams, in 2012. She holds a bachelor’s degree in biology from Bryn Mawr College and a masters degree in clinical research administration from George Washington University. 

Jake Meyer
Senior Manager, Business Operation Services
Advarra

Jake oversees the coverage analysis and budget negotiation services at Advarra. He has 8 years of experience leading pre-award operations, which includes CTMS builds, MCA and internal budget development, and budget and contract negotiations. This experience is from both the site level and as a service provider.

Nkechi Moghalu, DPT
Associated Director, Site Engagement Management
Daiichi Sankyo

Dr. Nkechi Moghalu received both her doctorate degree and B.S in Health Sciences from Touro College, School of Health sciences, Bayshore New York. She received her B.A in Anthropology and minor in Chemistry from Georgia state university. She has held different positions in Clinical operations, working with RBQM, Monitoring oversight and Site Engagement. She currently functions
as an Associate director looking over Site Engagement at Daiichi Sankyo.

Emilia Mondragón, MSN, RN
Clinical Research Lead
Medical Research Network

Emilia has over 14 years of experience in the clinical trial and life science industry as a clinical research coordinator and research nurse. Prior to joining the Medical Research Network (MRN) she worked as a research nurse manager at Science 37 in decentralized clinical trials (DCT). As a clinical research lead at the MRN, Emilia focuses on providing the clinical knowledge and expertise required to enable MRN to provide DCT services to participants safely, effectively, and consistently on a global scale. Emilia is passionate about making trials more accessible for patients and their families, advocating for participant healthcare provider diversity, and developing aspiring clinical research professionals. Emilia earned her Bachelor of Science in Biological Anthropology at the University of Michigan-Ann Arbor and Master of Science in Nursing from Depaul University – Chicago.

Lindsey Morales
Associate Director, Clinical Site Partners
Gilead, Associate 

Lindsey Morales has worked in the clinical research industry for the last 18 years at sponsors, CROs and research sites.  Her background includes roles in site relationship management, site identification, feasibility, study start-up and site monitoring.  She currently serves as an Associate Director in Clinical Site Partners at Gilead Sciences.  Lindsey holds a Bachelor’s degree from Texas A&M University and is based out of her home office in Frisco, Texas.  

Nojan Namakian
Executive Director of Clinical Trial Activation & Strategic Partnerships
City of Hope

Nojan works at City of Hope as the ED, Clinical Trial Activation & Strategic Partnerships overseeing the translation of pre-clinical ideas to the execution and activation of innovative therapeutic clinical studies, and also partnering with companies outside City of Hope to offer patients hope for more innovative and successful treatments than would otherwise be available. Prior to joining City of Hope, Nojan worked at Sienna Biopharmaceuticals leading Clinical Program & Alliance Operations; Theranos Inc. in Program and Strategic Development; and UCLA Hematology/Oncology in Clinical Research.

Susan Night, JD, LLM
Vice President Site Engagement and Network Strategy
TD2

Susan has 20+ years in health care strategic planning, regulation, policy and law. Her work focuses on the intersection of policy, ethics and law. She is the co-author of several key books: Risk & Reward, A “How-To” Guide to Choosing an MSO (MGMA) and The Texas Medical Jurisprudence Examination: A Self-Study Guide. Prior to joining TD2, Susan led the clinical research operations in community oncology practices for McKesson Specialty Health, US Oncology Research.

She received her B.S. for University of Oklahoma and her JD and Health Law degree from St. Mary’s University School of Law and University of Houston Law Center.

Holly Oakley, CCRC
Associate Director – Investigator Engagement
Lilly

 

Ari Oglesby, CCRP
Associate Director, Clinical Research Programs
University of California, San Francisco

Ari is originally from Minneapolis, MN and attended the University of Minnesota, Twin Cities. Her undergraduate research focused on murine models, first in circadian rhythms and then in chronic pain and fibromyalgia. She spent a brief period working in post-market reporting in implantable devices before switching to pre-market oncology clinical trial work at the University of California, San Francisco. Ari has worked on cancer clinical trials for the past 7 years on the research site side and currently manages UCSF’s Cutaneous, Head and Neck, and Radiation Oncology clinical trial teams.

Dan Otap, CCRP
Sr. Alliance & Partnerships Lead-gRED:
Genentech

 

Dan Otap is a Senior Alliance & Partnerships Lead within Genentech’s Research and Early Development unit (gRED). Dan’s clinical trial operations and compliance background uniquely position him to provide attuned insight into relational site engagement. Dan serves on various internal Roche/Genentech work streams related to clinical trial execution and innovation. He holds positions with the Association of American Cancer Institute (AACI) as well as the Society of Clinical Research Sites (SCRS). Dan has presented at various clinical research conferences and has authored multiple peer reviewed publications spanning clinical trial topics ranging from Community Oncology Practices, to overall site/sponsor relationships.

Dan holds a Bachelor of Science degree in Psychology with a minor in Religion from Southeastern University in Lakeland, Florida.

 

Dawn Overcash
Director, Strategic Site Collaborations
PPD, part of Thermo Fisher Scientific

Dawn is part of the Sites and Patient’s Center of Excellence, within the Operational Strategy Unit at PPD with more than 25 years industry experience, in clinical research. Dawn supports therapeutic leadership, developing Oncology Strategies, recognizing networks, sites and investigators of strategic importance with the end goal of executing trials through a targeted site-centric solution. Dawn has experience working with pharma partners, global sites, and therapeutic leaders in establishing relationships, aligning with strategicimperatives, priorities and growth plans focusing on the right sites with the right patients. Prior to working in Strategic Site Collaborations, Dawn was Region Head for the North America Site Intelligence & Activation Department with a mission to improve start-up cycle times through efficient processes.

Adam Penna, JD
Associate Director, Clinical Research
Merck

Adam Penna has been with Merck in Clinical Operations for over 7 years. He has a background in finance and corporate law and has previously worked with a US healthcare access non-profit. Adam is presently an Associate Director, Clinical Operations overseeing teams of Regulatory and Financial Clinical Operations Managers who work with clinical trial sites to negotiate contracts, budgets, and informed consent documents.

Kathleen Phan
Associate Director, Oncology Site Operations
Care Access

Kathleen Phan is the Associate Director of Oncology Site Operations at Care Access with extensive experience as a medical research professional, working directly with patients and oncologists in both community and academic settings. She is determined to de-stigmatize the clinical trial process and engage the diverse and historically underrepresented community in oncology clinical research. Kathleen leads her team in establishing innovative clinical research sites and patient support solutions to increase accessibility to new cancer therapeutics in the community.

Jeffrey Repper
Executive Vice President, Strategic Site Solutions
Transformative Pharmaceutical Solutions

Jeff has 16 years of experience in the Life Sciences industry. At TPS, he leads the Site Solutions function, with the overall responsibility of delivering these solutions. Prior to joining TPS, Jeff served as the Vice President of MediSync Clinical Research, a network of clinical trial sites. At MediSync, he was responsible for building and managing the business unit including sites operational oversight, sponsor relationships, trial quality, safety and performance, and MediSyncs’ profit and loss. Prior to joining MediSync, he was a Clinical Research Associate at Medpace Inc.

Kim Ribeiro, MS
Head, Diversity & Patient Inclusion
AbbVie

Kim Ribeiro, MLS (ASCP) CM, MS, has over 10 years of clinical trial patient experience with her most recent position being at AbbVie. She has a strong focus on strategy development for patient engagement, recruitment and retention planning as well as digital outreach and raising clinical trial awareness in underrepresented populations. Most notably, Kim is a published author, has served as an executive faculty member at several conferences, and has been recognized as one of the ASCP’s Top 40 under 40 global medical technology professionals.

 

Evette M. Riegel
VP, Project Delivery Hematology/Oncology
PPD, part of Thermo Fisher Scientific

Evette is a VP, project delivery, supporting the PPD/Thermo Fisher Hematology/Oncology therapeutic unit. Evette has been in the industry for 26 years in various roles within Biopharma/Biotech and CRO including CRA, project management, project director and current role as VP, Business Segment lead. Prior to her career within the industry, Evette was a critical care nurse. Evette is home based outside Philadelphia.

 

Steven Ringel
Vice President and General Manager
Tempus Labs

As a rare disease patient, Steven has learned firsthand about the drug discovery and development process. Seeing the emergence of data and AI and its potential to bring more therapies to patients faster, Steven jumped into the precision medicine field 7 years ago, working to connect technology and healthcare operations to deliver life-changing insights at the point of care. Aligned with this mission, Steven leads the TIME trials business unit at Tempus. TIME leverages multiple innovative approaches to radically lower the barriers to access for novel therapies.

Patricia Salter
Senior Director, Head of Global Decentralized Clinical Trial Operations
IQVIA

Patricia started her clinical research career in 2006 at Quintiles. During her time at Quintiles and now IQVIA, Patricia held positions of increasing responsibility in project management, customer management, clinical operations, and Operational Transformation. In 2020, Patricia went on secondment from her position leading the North America Clinical Support office to support the DCT team to operationalize the COVID vaccine work. This included the oversight of the tech strategy development, building customer relationships and working with cross functional teams to address issues. From there, Patricia led the development and deployment of the DCT Transformation Program which includes the development of a sustained operating model for DCT Hybrid studies. Patricia is now Head of the Global DCT Operations team.

Geoffrey Schick, MBA, CHRC
Director, Strategic Site Partnerships
WCG

Geoffrey Schick currently works as Director, Strategic Site Partnerships for WCG where he advises client institutions on research administration, compliance and operations. With extensive expertise in healthcare and research, Geoff has lead teams through all aspects of complex assignments, strategic redesign and consolidation, financial management, resource allocation, and change management. Prior to joining WCG, Geoff held multiple high-level positions in research administration at several large hospitals and health systems. Geoffrey is actively credentialed since 2017, as a Certified Healthcare Research Compliance professional through HCCA.

Kathy Scott
Associate Director, Site Alliances
Parexel

Ms. Scott has 35 years of clinical development experience spanning roles within pharmaceutical companies, a Site Management Organization, a Regulatory Science Consultant Company, and full-service Clinical Research Organizations. Her expertise from these roles is extensive and includes, but is not limited to, scientific information management, clinical trial monitoring, clinical operations management, clinical trial site management, project management, clinical plan development, quality assurance auditing and managing strategic site relationships. In her current role, Ms. Scott is dedicated to applying her in-depth knowledge of clinical trial processes to engage and develop long-term strategic relationships with the most experienced research and healthcare institutions. Ms. Scott serves as a central point of contact for her partnering sites to deliver clinical trial efficiencies and support across all of their Parexel trials.

Kay Scroggins, BSN
President/CEO
Clinical Trials of Texas, LLC (A Flourish Research Site) – retired

In 2001 Kay Scroggins began Clinical Trials of Teas, Inc. (CTT). Over the next 20 years CTT grew to be one of the largest stand alone research sites in the U.S. In 2021 Kay-as sole owner of CTT-sold the company to NMS Capital (a private equity firm). CTT is now site within Flourish Research, LLC, a research company made up of 10 sites throughout the U.S. who are focused on the efficient, exceptionally well planned conduct of clinical trials all the while focusing on participant safety and delivering objective, high quality data within sponsors’ timelines. After a career in nursing which began in 1980 and was primarily based at Scott and White Hospital, Temple, Texas, Kay moved to San Antonio. Her career as a nurse included experience in PACU, ICU, Peri-operative nursing, Nursing Education and Research and then clinical research. This foundation was preparatory for leadership roles and diving deep into clinical research. These paths forward were fostered by nursing professionals at Big Spring State Hospital, University of Mary Hardin-Baylor, Scott and White Hospital and by other nurses and physician investigators who helped to teach and mentor Kay. Stepping into an entrepreneurial role as business owner in 2001 was a 21 year journey that was challenging but brought opportunities to learn regulatory affairs, business acumen, financials, KPIs/objectives, HR regulations, management, leadership and understanding of the importance of company culture and core values, etc. Now retired Kay spends time focusing on hobbies, continues to learn and teach, serves on the SCRS Planning Global Summit Planning Committee as well as the Flourish Research Board of Directors. She continues to speak at conferences and to serve as a consultant among colleagues.

Cheryl Seabrook-Brown
Regional Senior Clinical Research Associate
Merck 

Cheryl Seabrook-Brown is currently a Regional Senior Clinical Research Associate at Merck. She is a graduate of South Carolina State University and holds certifications in the field of Optometry. Her career spans over 20 plus years working in clinical research with both Pharmaceutical and Clinical Research Organizations. Her titles have included: Study Coordinator, In-house CRA, Independent Consultant, Project Manager and Regional CRA. She was recently selected for the McKinsey Leadership Essential for 2023. Several medications and devices have been FDA approved during her career, which have helped people live longer and enhance their quality of life. Volunteering in my community and church round off my hobbies: Zion Academy School Board, Zion Baptist Church Museum Board, Girl Scout volunteer troop leader, Alpha Kappa Alpha Sorority, antiquing, traveling but most of all spending time with family. She lives in Fayetteville, Georgia with her husband Carl O. Brown, daughter Carlyle Brown and pet Carter Brown.

Bouchra Sefiane-Rucker
Senior Local Study Associate Director/Site Engagement Lead
AstraZeneca

Clinical Research Professional with 17+ years of combined research experience including project coordination. Proven ability to lead, develop, and coach through strong leadership and effective communication skills. Able to coordinate activities that ensure quality, consistency, and integration of study data and progress operational deliverables to time cost and quality objectives from Study Specifications through study close-out activities and Clinical Study Reports. Have worked with and lead cross-functionality, with internal and external partners, on global studies across different phases of drug development. Excels at working in a collaborative environment and adept in making effective decisions under pressure, while managing multiple stakeholders needs.

Specialties: ICH GCP, FDA Regulations, Oncology, Respiratory Therapy Areas, IVRS-CTM interfaces, WBDC systems, Global Site Management, Contract Negotiations, Vendor Management, Data Management, Site Engagement and Partnerships

David Silberman, MPH
Co-Founder and CEO
Clinical Research Fastrack

David Silberman is the CEO and Founder of Clinical Research Fastrack and a seasoned health education entrepreneur who has created and operated educational programs and non-profit organizations in California, Arizona and across the nation. David has the unique ability to develop strong organizations and construct vibrant communities. As a founder of National Laser Institute, David helped build this company into the largest medical aesthetics training center in the United States. At Clinical Research Fastrack his focus is on offering an engaging curriculum delivered by a team of experts who serve as passionate and knowledgeable instructors. Clinical Research Fastrack has trained over one thousand new clinical research professionals over the past few years. These clinical researchers are now working across the industry at research sites, CROs and sponsors. He earned his BA in Politics from the University of California, Santa Cruz, and a Master’s Degree in Public Health from the University of California, Los Angeles. In addition to his professional career, David has served as a community volunteer and has a strong passion for helping people achieve their career goals.

Sandy Smith, RN, MSN, AOCN
SVP, Clinical Solutions & Strategic Partnering
WCG

Sandy works with research sites, sponsors, and patient advocacy groups in support of WCG’s mission to accelerate the development of new medical therapies by improving the conduct and quality of clinical trials. She provides consultation to research sites by strategically aligning clinical solutions to improve and create efficient processes in the areas of ethical review, biosafety, trial initiation, research financial services, staffing augmentation, and support for investigator-initiated trials with DSMBs, clinical endpoints, and statistical consulting. Prior to joining WCG, Sandy was Vice President of US Oncology Research, an oncology site management organization of independent practices and hospital research programs with approximately 1,000 investigators and 175 research sites.

Jeff Sorenson, BSEE, BMA
CEO and Co-Founder
Yunu 

Jeff Sorenson is a 30-year industry veteran with broad expertise in medical imaging, including AI, ML, and oncology RWE. He is co-founder & CEO of Yunu, a VCbacked eClinical solution company transforming imaging workflows and data management in clinical trials producing valuable information for drug discovery. Previously, he served as CEO of TeraRecon, growing it into a market share leader with over 800 unique health system customers, and leading the company to a successful exit in the spring of 2020.

Eden Stein, MBA, MSc, PMP, CCRC
Executive Director, Patient Insights & Engagement
Centricity Research

 

Bernadette Tosti
Chief Product Officer
ProofPilot

Tosti brings a powerful combination of industry expertise and background in product development and patient engagement to ProofPilot. Before being an advisor for several health technology companies, Tosti held various leadership roles at Quest Diagnostics, including Executive Director, Information Ventures, Clinical Trials, where she created a clinical trials-focused data, technology, and services business line for the company. Tosti also held the role of Vice President, Patient Experience, at Science 37 and Global Head of Recruitment & Retention at IQVIA.

Sofie Vanderplaetsen, MSc
Executive Director, Project Delivery
PPD, part of Thermo Fisher Delivery

Sofie Vanderplaetsen is an Executive Director within Project Management in PPD, part of Thermofisher Scientific, with more than 20 years of clinical research experience in both pharma and CRO settings. Sofie is also a member of the PPD Rare Disease and Paediatric Center of Excellence of PPD. She holds a master’s degree in Medical Biochemistry from the University of Antwerp and a Postgraduate in Biomedical Sciences & Clinical Research from the University of Liège.

Karri Venn, RD, CCRC
COO, President of Operating Board
Centricity Research

Karri Venn brings over 24 years of clinical research experience working at clinical research sites.  Ms. Venn has brought experience, knowledge and drive to many of the positions held at LMC Healthcare since 1999.  In 2006, Ms. Venn was promoted to Director, Research of LMC Clinical Research, in 2015 to President, Research of LMC Manna Research and 2021 to COO, President of Centricity Research (formerly LMC Manna, True North and IACT Health).  Under her tenure, she has been responsible for the successful openings of 13 LMC Healthcare clinics across Canada, including Canada’s only Diabetes Clinical Research Unit and establishing the largest Canadian non-academic Endocrinology Research program, and the integration of various primary care and specialty clinical research sites to form one of the largest integrated research organizations in North America that include therapeutic expertise in all phases of research inclusive of real world/big data.  Centricity Research has more than 40 site locations across 4 provinces and 2 states.

Ms. Venn has led the project management teams for > 2000 clinical trials and led the response to > 50 Sponsor & Regulatory audits.  Centricity Research has become a reputable program and has received the distinct award as a Centre of Excellence in Diabetes clinical research, PRIME status with IQVIA, awarded in the Top 50 Great Places to Work for Canada and SPRIA winners at the 2017 SCRS conference.  A founding member and present CEO of hyperCORE International, a leading Super Network of clinical sites which comprises of 100 sites, 5 countries and 10 site networks.

Ms. Venn has been certified in project management through the Project Management Institute, as well as longstanding certification as a Clinical Research Coordinator and Diabetes Educator.

Today, she is a founding Board member of the Canadian Association of Independent Clinical Research Sites (CAICR), hyperCORE International, and great supporter of both Society for Clinical Research Sites (SCRS) & Association of Clinical Research Professionals (ACRP).

David Vulcano, LCSW, MBA, CIP, RAC
Vice President, Clinical Research Compliance & Integrity
SCRS Honorary President, HCA Healthcare

David is a well-known thought leader and change agent in the clinical research industry through numerous associations, boards, initiatives, publications, presentations and contributions. A native of New Orleans, he has a Master’s degree in both Social Work and Business Administration and maintains the additional credentials of Certified IRB Professional (CIP), Regulatory Affairs Certification (RAC) and Fellow for the Association of Clinical Research Professionals (FACRP). Among other things he is the a Vice President for Clinical Research Compliance & Integrity for HCA Healthcare, providing research-related compliance and strategy consultation to their portfolio of hospitals, physician practices and healthcare technology companies. He also currently serves as the Honorary President for the Society for Clinical Research Sites (SCRS) and President of the Music City Angels. David and his wife are empty-nesters living south of Nashville, Tennessee where they involve themselves in work, family life as well as other charitable and entrepreneurial opportunities.   

Arla Yost, CCRP, PMP
Clinical Research Operations Director
UCSF Helen Diller Family Comprehensive Cancer Center

Arla attended UC Santa Cruz for her BS in Health Sciences and the University of British Columbia for a Masters (MSc) in  Interdisciplinary Oncology. While in Vancouver she worked in clinical and translational research at the British Columbia Cancer Agency. She moved back to California in 2016 and currently serves as the Clinical Research Operations Director at the UCSF Helen Diller Family Comprehensive Cancer Center. Arla is both SOCRA Clinical Research Professional (CCRP) and PMI Project Management Professional (PMP) certified. With over 10 years experience in health care and oncology she has held many different roles in field and loves working with people and building new programs.

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