Head of Digital Trials, Client Solutions | Flatiron Health

Topic of Bernadette’s talk: Patient compensation

Bernadette Tosti is a seasoned global business executive with nearly 20 years of leadership experience in the life sciences and clinical trial technology space. She currently serves as Head of Digital Trials Client Solutions at Flatiron Health, where she leads cross-functional teams to deliver exceptional customer experiences and drive operational excellence across the digital trial lifecycle.

Bernadette has held senior leadership roles at organizations including Science 37, Quest Diagnostics, and IQVIA, where she consistently delivered transformative results—such as accelerating patient enrollment, scaling global operations, and launching innovative technology platforms. She is also a founding partner at BGT Partners LLC, advising life sciences companies on optimizing clinical trial processes and enhancing patient and provider engagement.

Known for her strategic vision, operational rigor, and people-first leadership style, Bernadette is passionate about expanding access to clinical trials and bringing therapies to market faster. She holds a BA from Boston College.

Bernadette Tosti

Chief Clinical Trial Officer | Florence Healthcare

Topic of Catherine’s Talk: Site friction / data digitization and streamlining

Catherine Gregor is the Chief Clinical Trial Officer at Florence Healthcare, a leading B2B SaaS company transforming how clinical research is conducted around the world. In her executive role, she oversees Customer Strategy, Global Compliance, and Thought Leadership, driving innovation and operational excellence across the organization. With more than 16 years of experience in the clinical research industry, Catherine is passionate about building connected platforms that modernize and streamline the clinical trial process.

Catherine holds an MBA in Healthcare Management from Belmont University, along with both MA and BA degrees in History from Loyola University Chicago. She is a Certified Clinical Research Professional (CCRP) and a Certified Clinical Research Coordinator (CCRC). Beyond her work at Florence, she serves on the boards of the Association of Clinical Research Professionals (ACRP), the Association of Contract Research Organizations (ACRO), and the Global Quality Standard for Clinical Research Sites (GCSA), where she champions innovation and quality standards in clinical research.

Catherine Gregor

Co-Founder & CEO | Acclinate

Topic of Del’s Talk: Inclusive participant recruitment

Dr. Del Smith is the visionary co-founder and CEO of Acclinate, a pioneering company that leverages sustained community engagement with AI-driven technology to empower historically marginalized communities in making informed decisions about clinical trial participation.

With a rich background spanning higher education, including his 14 years culminating as a dean at an HBCU business school, along with leadership roles at healthcare giants like McKesson, Del brings a powerful and unique perspective to advancing health equity through innovative solutions.

Del Smith

Founder & CEO | Research Works

Topic of Kaye’s Talk: The dummy system for site stuff

Kaye Doiron is a trailblazing thought leader and innovator in clinical trial research, redefining how research reaches and serves diverse communities. As the founder of Research Works INC and Research Works San Juan, Kaye has built a new model for what clinical research can be: accessible, human-centered, and driven by compassion and excellence.

A fierce advocate for healthcare equity and site sustainability and success, Kaye has spent her career challenging outdated systems and pioneering solutions that break down barriers to access. Through initiatives like Research Works on Wheels, one of the first mobile clinical research units in the country, she has brought cutting-edge trials directly into underserved communities — reshaping the traditional site-centric paradigm.

Under her leadership, Research Works INC has remained fiercely independent, consistently ahead of industry trends, and nationally recognized for innovation — all without the backing of outside funding. Her work not only transforms how clinical trials are conducted but also redefines how the industry thinks about partnerships, patient engagement, and the vital role of human connection in science.

Kaye Doiron

Director, Office of Medical Policy - Center for Drug Evaluation and Research | FDA

Topic of Khair’s Talk: Issues in innovative clinical trial design, use of real-world data, etc.

Khair Elzarrad is a distinguished policy leader and translational scientist with deep executive experience spanning the full spectrum of therapeutic development—from early-stage models to clinical trials. He has played a pivotal role in shaping national and global policies to modernize clinical trial design and advance regulatory frameworks, particularly around emerging technologies like artificial intelligence.

Khair is driven by a commitment to accelerating innovation and improving how we generate and apply evidence in healthcare. As a seasoned executive, he has successfully led large, multidisciplinary teams through complex, high-stakes initiatives. He currently manages and mentors a team of over 160 professionals, including physicians, scientists, lawyers, and policy experts, guiding strategic priorities and operational execution with multimillion-dollar budgets.

Widely recognized for his leadership, Khair engages regularly with governments, international organizations, academia, NGOs, and patient communities. In 2023, he was honored with the prestigious Arthur S. Flemming Award for Leadership and Management.

Khair ElZarrad

VP, Readiness & Enablement | Medidata

Topic of Michelle’s talk: A patient with incurable cancer’s call to the industry to show up differently

Michelle is VP of Organizational Readiness and Enablement at Medidata where she leads large-scale strategic initiatives that help teams adopt new technologies, processes, and mindsets—ensuring organizations are not only equipped for innovation but prepared to deliver on it. She brings over 25 years of experience in the pharmaceutical industry, including big pharma, CRO and Central Laboratories, with leadership and technical expertise in global data management, clinical trial management, clinical monitoring, investigator and client training, strategic planning, road mapping, technology and innovation.

Most recently, Michelle was the External Applications Portfolio Lead for a market leading Central Laboratory, where she was the business owner for a multimillion dollar portfolio of products for data integration, analytics, as well as investigator and client portal technology.

Michelle leverages her distinct global background and breadth of experience bringing a unique point of view to her professional endeavors to build meaningful, innovative alliances, partnerships and strategies.

Michelle Stump-Kerry

Founder and CEO | Diligent Pharma

Topic of Lisa’s talk: Measuring what matters / the heart in this work and what that matters.

Patricia Leuchten is Founder of WCG Avoca and Founder and CEO of Diligent Pharma. She has more than 30 years of experience in the pharmaceutical industry and is a leading authority on global clinical outsourcing, strategic alliances and driving change in clinical trial execution through collaboration.

In 1999, she founded The Avoca Group, a consulting and research firm focused on the elevation of quality in clinical trial execution. The Avoca Group has played an important role in the industry as the first consulting firm to track trends in clinical research and clinical outsourcing and to measure the health of relationships between sponsors and CROs. In 2011, Patricia launched the Avoca Quality Consortium a member-based, pre-competitive collaborative comprised of clinical operations, quality, and outsourcing professionals from pharma, biotech, CROs, and clinical service providers. Since its inception, the rapidly growing Avoca Quality Consortium is transforming clinical development by driving efficiency, improving quality, and mitigating risk in clinical trial execution. In 2019, Patricia launched Diligent Pharma, The Diligent Qualification Platform (DQP) is a centralized technology platform for streamlining vendor qualification in clinical trial execution. Diligent is transforming the current approach to identifying and qualifying clinical trial vendors and is driving innovation while mitigating risks and addressing the need for speed and high quality in the process.

Patty Leuchten

Co-Founder and CEO | QLS Advisors

Topic of Shomesh’s talk: TBA

Dr. Shomesh E. Chaudhuri co-founded QLS Advisors in 2019 and currently serves as the firm’s CEO and Co-CIO. Dr. Chaudhuri has developed portfolio intelligence platforms for several biopharma companies, consulting directly with CEOs, CFOs, and their staffs to help align their financing structures with their scientific and medical objectives. He has also led the development of the firm's core analytics platform, including QLS’s machine-learning driven forecasts of clinical trial outcomes, and has overseen the implementation of the entire QLS technology infrastructure and computational architecture.

Prior to QLS, Dr. Chaudhuri was a postdoctoral associate at MIT’s Sloan School of Management where he designed new funding vehicles and business models to access previously untapped pools of capital to support biomedical innovation. He has published articles in top finance and biotech journals including JAMA Oncology, the Journal of Financial Economics, and Management Science and is the co-author of the textbook Healthcare Finance: Modern Financial Analysis for Accelerating Biomedical Innovation. He holds a B.S, in engineering sciences (bioengineering) from Harvard University and an M.S. and Ph.D. in electrical engineering and computer science from MIT.

Shomesh Chaudhuri

Author of Rebel Health

Topic of Susannah’s talk: A field guide to the patient-led revolution in medical care

Susannah Fox is a health and technology strategist whose life’s work has been to explore and map the terrain created by patients, survivors, and caregivers. Her book, Rebel Health: A Field Guide to the Patient-Led Revolution in Medical Care (MIT Press, 2024), showcases how consumers are building up our collective capacity for better health and how the health care ecosystem can leverage the power of connection with those they serve. Fox is a former Chief Technology Officer for the U.S. Department of Health and Human Services during the Obama Administration, where she led an open data and innovation lab.

As an entrepreneur-in-residence at the Robert Wood Johnson Foundation she built project teams to bring patient and caregiver insights into work of the nation’s largest philanthropy dedicated solely to health. Fox directed the health portfolio at the Pew Research Center’s Internet Project where she researched the intersection of health, social media, and patient engagement and first coined the phrase peer-to-peer health care. Fox serves on the board of Cambia Health Solutions and advises organizations — big and small, nonprofit and for-profit — on how to navigate the intersection of health and technology.

Susannah Fox

Global Regulatory Affairs Innovation and Technology Lead |
Eli Lilly & Company

Topic of Tony’s talk: Regulatory & pharma collaboration on efficiencies, effectiveness, measurement

Tony is a strategic innovation leader with 15+ years of experience driving patient and business outcomes in Pharma, Digital Health, and Medical Devices. Currently, he leads Digital Transformation and Innovation for Global Regulatory Affairs, incorporating AI and advanced computing to accelerate submissions and approvals.

He is passionate about improving health outcomes through building and leading high-performing teams, fostering a culture of collaboration and excellence, and leveraging 21st century technology solutions.

At Lilly, Tony founded and scaled Digital Health and patient-centric blood sampling, now deployed in dozens of clinical trials, cutting millions in costs and reducing timelines. He is driving cross-industry collaboration as the leader of an Innovative Healthcare Initiative consortium with 50+ partners, and works with regulators in the EU and US.

He has delivered AI solutions salving thousands of manual labor annually, benefiting 1000+ global users. Part of several company-wide core teams, Tony drives cross-functional strategy with C-suite visibility.

Harvard Medical School trained, Tony has received multiple top Innovation Awards, held appointments as Visiting Professor at Massachusetts General Hospital and Brown University, and served as CEO of a healthcare startup.

2025 Main Stage Speakers