2024 Speakers

Chad Adams has more than 25 years working in healthcare operational management of which 20 years have been in research. His experience includes a broad background of operational management in healthcare administration, with specific training and experience in integrating technology that address gaps for barriers to successful portfolio performance of clinical trials. Mr. Adams actively participates in advisory boards for multiple industry organizations and actively helps build research organizations. Mr. Adams brings a high level of analytical skills, combined with novel approaches, to his current role as AVP of Research within HonorHealth and as COO of the HonorHealth Research Institute.

Dr Nadir Ammour brings more than 20 years’ experience in managing global projects in clinical development. He is working to bring eHealth/Digital innovation in clinical development to deliver new medicines to patients faster. He led several projects in that space such as the Verkko remote trial, wearables trials, use of electronic health records for research and is now leading efforts at bridging care and research. Dr Ammour was a member of the Executive Committee of the EHR4CR consortium project and led the EHR2EDC consortia. He is presently working on several consortia projects to advance the concept of clinical trials as a treatment option.

Seema is a Director of Clinical Operations at Genentech. She is a seasoned leader with over 20 years of experience in clinical research and expertly operationalized complex Phase I-IV trials across multiple therapeutic areas. Seema's strategic approach to project lifecycle management and her talent for optimizing clinical operations have consistently driven successful outcomes. As a respected professional in her field, Seema continues to shape best practices in clinical operations, inspiring teams to push boundaries and achieve excellence in clinical trial innovation.

Kimberly Barnholt has spent over 20 years in the healthcare industry in various roles spanning from academic research, to disruptive start-up, to global pharmaceutical company. In all roles, she has focused on bridging science, data, and operational disciplines to challenge the status quo and transform how we can deliver more impact for our patients. At Genentech, she has served as a Program Leader for cross-industry collaborations and cross-R&D data ecosystem transformation. Currently, Dr Barnholt is leading an Evidence Generation team of data strategists and clinical innovation and technology leaders to integrate new approaches to clinical trials.

Michael has worked in the clinical research technology space for 18 years focused on solutions to help research organizations successfully streamline their trials to help bring therapies to patients. After joining Devana Solutions, now part of RealTime eClinical Solutions, Michael’s focused shifted from post-enrollment to pre-enrollment technology, implementing the power of the Devana technology in multi-site research centers, health systems and academic organizations to become a wraparound of the entire tech stack to provide critical end-to-end functionality from pipeline management, study startup workflows and metric capture and analysis. Michael’s passion is understanding the unique needs of each client partner to provide the best possible outcomes for maximizing their potential.

Christina Brennan, MD has devoted her career to clinical research and currently serves as Northwell Health’s Vice President of Clinical Research. Committed to the advancement of science and medicine, Dr Brennan has more than 22 years of extensive clinical research experience, including over 17 years in clinical research management roles. She is on the board of trustees for the Association of Clinical Research Professionals. She is the immediate past president of the NY Metropolitan Chapter of the Association of Clinical Research Professionals. She is on the steering committee of the Clinical Trial Transformation Initiative (CTTI), with Duke University and the FDA. She is on the leadership council for Society for Clinical Research Sites (SCRS), where she also sits on the oncology advisory board and technology site advocacy group. She is an adjunct professor for a Masters of Science program with Yeshiva University. She is also an active member of the Women in Bio and the American College of Healthcare Executives. Dr Brennan also has authored chapters in textbooks, coauthored many manuscripts and abstracts, and has presented at numerous scientific and research meetings.

Susan Budinger started her research career at Duke in 1991, soon after her graduation as a proud Blue Devil. During the next 2 decades in oncology cooperative group research, she delighted in identifying research design and process pain points and exploring ways to address them, with the goal of improving the lives of researchers and participants. In 2013, she joined the Duke Office of Clinical Research to promote centralized research support, programs and policies designed to assist and guide the Duke research community. As Director of Research Operations, she leads a team of exceptional project managers and collaborates with other administrative offices to create and manage pathways into clinical research careers for students and interns.

Jennifer Byrne’s career has been devoted to leading teams and building relationships to transform the clinical research landscape into an integrated component of clinical care. In 2018, she founded Javara with a vision to revolutionize the industry by accelerating access to clinical trials – for patients, sponsors, and healthcare systems alike. Prior to Javara, Jennifer served as CEO for PMG Research; she is also the founder of Greater Gift (501(c)3). Jennifer has earned many industry honors during her tenure, recognized most recently as a PM360 ELITE, CenterWatch Top 20 Innovator and PharmaVOICE Woman of Influence. Jennifer is a graduate of Texas A&M University.

Joan Chambers is a senior consultant advising research projects and the Center’s membership programs. She brings more than 30 years of senior management experience — across a variety of strategic and operating roles - in the life sciences industry. Joan serves on a number of boards and committees including US PharmaTimes, Citeline Awards, the Pharmaceutical Business Conference Group, and One Rare. Ms Chambers is an active member of the Drug Information Association (DIA), has published extensively in trade journals, and is a frequent speaker at industry conferences.

Candice Fitzgerald – MMedSc, BAppSc Global Head Clinical Development & Operations – Regions

Ms Fitzgerald has 20+ year’s experience in clinical operations and medical affairs for various multi-national pharmaceutical and biotech companies (Roche, AstraZeneca, Alexion, Boehringer-Ingelheim) and contract research organisations (CROs). She has held various positions at a Director level in medical affairs / clinical operations managing large teams with responsibilities spanning team leadership, senior management teams, compliance oversight, CRO Functional Service Provider (FSP) model partnerships, cross functional commercial and R&D teams, strategic medical planning, direction, change management and governance.

Ms Fitzgerald moved from Australia to Germany with her 4 boys and husband in 2021. Since this time, she has led and been involved in key Medicine Excellence transformation projects with the aim of reducing Clinical Development cycle times and creating highest value for our patients and clinical trial sites. Ms Fitzgerald holds a Master of Medical Science (Drug Development), University of NSW, Australia and a Bachelor of Applied Science (Health Information Management), University of Sydney, Australia.

Diana L. Foster, Ph.D., is the CEO and Chief Diversity Officer at TOTAL Diversity Clinical Trial Management, a full-service organization committed to enhancing diversity and inclusion in clinical trials. With decades of experience, Dr. Foster is a recognized leader in clinical research, particularly in patient enrollment and site engagement strategy. Formerly the Vice President of Diversity, Equity, and Inclusion at SCRS, she pioneered initiatives like the Global Impact Partner Programs. In addition to her role at TOTAL, Dr. Foster serves as the President of the Association of Diversity in Clinical Trials, an industry consortium advancing DEI awareness within Pharma. She is also a published author of several authoritative books, including Global Issues in Patient Recruitment and Retention and Diversity in Clinical Trials: Best Practices and Perspectives, co-authored with Dr. Jerome Adams. Dr. Foster holds a Ph.D. in Research Theory and Statistics and has been honored as one of the 100 Most Inspiring People in the Life-Sciences Industry.

Teresa C. Gallagher, Ph.D., MPH is CEO and Co-Founder of Sparrow Search, “Connecting Patients with Clinical Trials.” Her career has been defined by her interest in access to medical care and use of health services, including clinical trials. Her interests also include clinical trial and health literacy. Dr Gallagher is a former Professor of Community Health at the University of Illinois at Urbana-Champaign and conducted research on access to medical care at Yale University School of Medicine, Stanford University School of Medicine, and U.C.L.A. School of Medicine. She has a Ph.D. in Education, a Masters in Public Health, and completed a fellowship in health services research at U.C.L.A. School of Public Health.

Faith Holmes, MD, brings more than 30 years of experience in direct patient care, and 11 years of medical practice management to her role as Elligo’s Chief Medical Officer. Her unique perspective plays an important part in building the company’s network of Research Ready physician practices and preparing them to conduct research. Dr Holmes’ rich perspective — including experience in family medicine, hospice, and palliative medicine that spans solo practice and single specialty and multispecialty group practices — allows her to build rapport with study managers, site staff, and investigators, and provide medical and scientific knowledge to support future growth. Dr Holmes has served as the Principal Investigator for interventional, diagnostic device, and observational trials in several therapeutic indications in Elligo’s eSolutions model and at the Elligo Clinical Research Center. She earned her BS in chemistry and biology from Trevecca University, her MD from ORU School of Medicine, and is board certified in family medicine and hospice and palliative medicine.

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Adam Kinsey is currently Associate Vice President and Regional Head of North America for Global Clinical Trial Operations (GCTO) at Merck Research Laboratories. Mr Kinsey has over 26 years of clinical research experience, with the last 8.5 years at Merck. He has been a key leader within GCTO, most recently serving as Executive Director, Clinical Sciences & Study Management and Therapeutic Area Section Head for Melanoma, Hepatobiliary Cancers, and Innovative Strategies. Previously, Mr Kinsey was Clinical Research Director in Oncology where he led country operations activities in the United States for Merck’s oncology pipeline. He started his career as a Clinical Research Associate (CRA) and has traversed through various roles in clinical operations of increasing responsibility and scope. Mr Kinsey also has experience across a wide array of therapeutic areas with companies of different sizes and operating models. He holds a bachelor’s degree in biology from Rice University and completed post-baccalaureate coursework at Houston Baptist University as well as coursework towards a Master of Public Health (MPH) degree at the University of Texas School of Public Health in Houston.

Dr Abby Levine leads product strategy for Evidation’s Consumer platform, focusing on solutions for enterprise partners. Her product initiatives at Evidation include FluSmart, a digital flu monitoring program powered by machine learning. Dr Levine has a background in Anthropology, and holds a BA and MA from Stanford University, and a PhD from UCLA.

David Levitz, MD, is an attending physician and Assistant Professor at Montefiore Einstein. Dr. Levitz’s clinical focus is in classical hematology, diagnosing and treating a diverse range of disorders such as sickle cell disease, thrombosis, anemias, bleeding disorders, hemoglobin disorders, thalassemia, autoimmune hematologic diseases, and other rare diseases. He also has interests in phase I clinical trial drug development.

After receiving his Bachelor of Science at University of Connecticut in 2013, Dr. Levitz came to Einstein to obtain his Doctor of Medicine, earning it in 2017. He pursued postgraduate training at Tufts Medical Center, completing his internal medicine residency in 2020. Dr. Levitz then returned to Montefiore to complete his hematology/oncology fellowship, taking on the role of Chief Fellow in his final year.

Dr. Levitz’s research focus is in translational drug development for solid oncology and malignant hematology. He has shared his work through peer-reviewed journals and poster presentations.

Dr. Levitz is board certified in Internal Medicine and Hematology and Oncology. He is a member of the American Society of Hematology and the American Society of Clinical Oncology.

Trevan Locke is an Assistant Research Director at Duke-Margolis working on issues related to biomedical innovation and clinical research. He oversees Duke-Margolis' involvement as a founding member of the Advancing Clinical Trials at the Point of Care Coalition and workstreams on evidence generation for Duke-Margolis' Real-World Evidence Collaborative. Previously, he worked as a Regulatory Science and Policy Analyst at the American Association for Cancer Research on regulatory issues impacting the development of cancer therapies, including considerations for equitable clinical trial enrollment. Dr. Locke completed a Bachelor of Engineering in Chemical and Biomolecular Engineering at Vanderbilt University and a PhD in Chemical and Biochemical Engineering at Rutgers University.

Prior to joining Novartis, Sean Lynch was VP, Clinical Operations at DCT provider, Curebase. Mr Lynch has previously worked as Senior Director of Clinical Project Management at biotechnology research company, TrialSpark. He also served as Senior Director of Global Sales at clinical research organization (CRO), Syntactx. He worked for nearly seven years at healthcare IT and clinical research company Quintiles (now IQVIA) in Clinical Data Management roles.

Dr Shalini Mohan joined Genentech in 2015 in Global Safety Science in which she was responsible for the pharmacovigilance for multiple molecules and supported late stage clinical trials, one of which led to the filing and approval of tocilizumab for giant cell arteritis. Dr Mohan currently leads a team focused on advancing health equity through inclusive research and supporting access to trials and healthcare for underserved populations in the US. She conducted the largest randomized placebo-controlled trial for COVID-19 pneumonia that was successful in enrolling over 80% historically underrepresented patients. This trial has become foundational for Genentech’s mission to be a leader in health equity research. Prior to Genentech Shalini was a Clinical Research Fellow in Oncology and Dermatology and a Postdoctoral Fellow at Stanford University. She has authored more than 25 peer-review publications and received multiple awards including the 2023 Genentech Professional BusinessWomen of California (PBWC) Industry Leader Award.

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Leticia Murray currently serves in the role of Innovation Capability Associate Director of Diversity in Clinical Trials in Novartis Global Clinical Operations. Ms Murray bring more than 20 years of experience in the pharmaceutical industry, during which she has focused on global patient recruitment strategy and improving access for under-represented populations at the vendor and site level. Ms Murray obtained her MBA from Darden School of Business and has since focused her efforts on product development and long-term strategy.

Donna M. O’Brien, MHA, is a National Advisor with Manatt Health providing strategy development and program implementation advice to healthcare providers and research institutes. Prior to this, Donna served as Consultant to the Director of the NCI for nine years to support the development and implementation of a new program model for cancer care delivery and research expansion in 30 hospitals in 22 states. She was a member of the team that designed the NCI Community Oncology Research Program (NCORP). She was also an executive at MD Anderson Cancer Center in Houston and Executive Vice President of the Catholic Health Long Island.

Tiffany Pearce is a graduate of Ferris State University where she earned her bachelor’s degree in Healthcare Administration.  She is currently the Director of Clinical Trials at Henry Ford Health where she has spent 26 years directing Phase 1-4 oncology clinical trials. In 2023 she began working in Research Administration  where she has been involved in research growth strategies, creating infrastructure supportive of centralizing clinical trial functions, and implementation of a post award monitoring program.

Karen Peterson is the Founder and Chief Patient Advocate of Karen’s Club, Ms Peterson was inspired to help other patients of color, understand the complex and sometimes skeptical world of clinical trials.  A Stage IV Triple Negative Breast cancer survivor, Ms Peterson is also a founding member of the Patient Community Council at Foundation Medicine, a consultant for Blue Note Therapeutics and a Cancer Research Institute- Immuno Advocate.  Ms Peterson was the featured patient speaker at the Biden Cancer Initiative’s 2019 presentation at ASCO, and the 2020 Inaugural AACR Cancer Disparities Progress Report presented to Congress.  Her inspiring story has been shared with Cure, Essence, Health and People magazines as well as ABC Radio Networks “Perspective” and The Today Show.  Lastly, Ms Peterson successfully completed the exclusive 2021 Robin Hood/Blue Ridge Labs Fellowship Program, where she co-created (with her partner Nava Friedman) the highly anticipated advocacy platform https://www.karensclub.org/

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Sydnie Reed leads Pharma Partnering and Portfolio Management at N-Power Medicine. Prior to joining N-Power, she held various roles in clinical development, commercial, strategy and business development at J&J and Pfizer in Japan and China and, most recently, led Portfolio Management for the Oncology TA at Roche Genentech. With a commitment to enabling equitable access to therapies across geographies and demographic groups, she recognizes the fundamental challenge in achieving this lies in broad access to clinical trials and is passionate about bringing these opportunities to more oncologists and patients around the world.

Alexander Saint-Amand is the CEO and Co-Founder of Topography Health and was previously the CEO and Co-Founder of GLG, a global research platform. When his mother fell ill during his college years without a conclusive diagnosis, Alexander founded GLG to create a platform for obtaining second opinions. GLG rapidly grew into the world’s leading insight network, encompassing 200,000 physicians and scientists, as well as other sector experts. Thousands of patients, loved ones, and caregivers sought treatment options and clinical trial insights through GLG, revealing significant gaps in clinical trial access and physician participation. To address these issues, he founded Topography Health, which is dedicated to revolutionizing the physician experience in research and significantly enhancing patient access. Alexander and his team of clinicians, technology experts and operational leaders partner directly with practices, systems and their physicians to expand clinical research access. Topography is backed by a16z and Bain Capital Ventures. 

Rachel Sher is a prominent Food and Drug Administration (FDA) regulatory leader with sophisticated experience in policy and legislative strategy who helps support life sciences companies as they navigate the broader FDA regulatory process across all stages of a product’s life cycle.

With nearly 20 years of experience in the health policy space, specifically in the pharmaceutical and medical device arenas, Rachel provides a multifaceted approach to solving issues clients face in the medical products area, advising on compliance with the many complex legal and regulatory requirements governing successful product review, launch and marketing. She also helps clients facing serious challenges in this process consider a subsequent or corresponding legislative strategy to advance any additional needs surrounding their development programs.

Rachel previously served as the Vice President of Policy and Regulatory Affairs for the National Organization for Rare Disorders (NORD), where she led its federal policy and regulatory work with respect to the FDA and other federal agencies, as well as on Capitol Hill and in the states. Sher also served as Deputy General Counsel at the Association for Accessible Medicines (AAM), where she helped oversee the AAM’s legal affairs, including the review of advocacy and policy statements. Prior to her time at AAM, Sher worked in the Commissioner’s Office at the FDA where she led the agency’s engagement on the 21st Century Cures Act legislative process, which involved working directly with FDA leadership and medical product centers to give strategic advice and guidance. Prior to heading to the FDA, Rachel spent ten years on Capitol Hill working as FDA Counsel for the Committee on Energy and Commerce, where she had the rare opportunity to oversee the entire FDA-related portfolio, drafting and negotiating all major FDA legislation enacted during her tenure.

As Chief Information Officer – PatientLink Enterprises, Renee Smith brings to bear her experience as a technology executive in the Pharmacy, Provider, and Clinical Trials spaces, deep expertise in data interoperability, and career-long obsession with patient involvement. For over 30 years, Ms. Smith has developed applications, delivered solutions, and led strategic technology transformations for Fortune 100 companies. Her acumen for seeing around corners, articulating a vision, defining strategies, assembling exceptional talent, and delivering the right technology solution sets her apart. Transforming and diversifying clinical trials and enabling clinical trials as a care option is Ms. Smith’s Goal. It is her professional mission and personal ministry to change lives through equitable access to better health.

After spending time in public health and clinical nutrition, Denise started work at Duke as a clinical research coordinator in 2000 for NIH funded trials in oncology. In 2009, her Research Management Team in the School of Nursing received support from Duke’s CTSA to leverage the group’s services and launch REDCap for the School of Medicine. For 10 years, Ms Synder has been the Associate Dean for Clinical Research for Duke University School of Medicine. In this role, she leads the Duke Office of Clinical Research (DOCR), a central support office of expertise in coverage analysis, study logistics, data management, regulatory oversight, workforce innovation, and guidance for clinical research operations for Duke as a site.

Dr Zozus is a professor at the University of Texas Health Science Center at San Antonio’s Joe R. and Teresa Lozano Long School of Medicine. She has dedicated her career to advancing methods for data quality assessment and control in health care and health-related research including collection and management of data for clinical studies, and assessment and use of EHR data in clinical studies. In addition to leading clinical research informatics at UT Health San Antonio her research pursues advancing the design, conduct and reporting of clinical studies through interoperability, automation, decision support and data mining. She is the PI of the AnCilliary Studies to Evaluate Real-World Data Quality (ACE-RWD Program) assessing data from EHR interoperability such as data obtained using the Health Level Seven (HL7) Fast Healthcare Interoperability Resources (FHIR®) standards for use in clinical studies.