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

Chief Human Resources Officer | YPrime

Topic of Lindsay’s talk: Collaborative invention requires psychological safety

As Chief Human Resources Officer of YPrime, Lindsay Daniel leads the development and execution of the company's people strategy to support growth, strengthen culture, and enable team performance. With more than 15 years of experience across industries including financial services, healthcare, and life sciences, Lindsay brings deep expertise in talent management, organizational development, and HR operations to YPrime.

Lindsay's career includes leadership roles at Macquarie Group and The Advisory Board Company, where she built scalable HR frameworks that aligned with business goals and fostered inclusive, high-performing environments. Her passion for empowering people and driving strategic transformation has helped shape cultures that support innovation, collaboration, and long-term success.

Lindsay Daniel

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

R&D Head of Business Performance & Analytics CRDO office |
Astellas Pharma

Topic of Mo’s talk: Why Data Matters

Mo is focused on the creation and execution of strategic programs which aim to serve the needs of patients, and further drug development. Enriching the clinical experience, and expediting delivery. Mo loves to center in on the human element in a world often fueled by digitalization and technology. His experience working at the site level with patients and within several corporate environments from Sr Leadership roles to C-Suite has allowed him to be able to effectively convey this message and ensure that it can be realized in practicality across multiple endeavors focused around remote data capture, conversational analytics, predictive models and novel technologies. He is a strong advocate for sustainable change within the pharma ecosystem which would better the lives for patients worldwide.

Mo Ali

Founder and CEO | Diligent Pharma

Topic of Patty’s talk: Protocols of Courage

Patricia Leuchten is the Founder and CEO of Diligent Pharma, a quality and compliance organization with tech-enabled service offerings that help mitigate risk in clinical trials. Leuchten has over 30 years of experience as a business owner and entrepreneur in the pharmaceutical industry with a focus on change management and innovation in clinical trial execution. At Diligent, she’s leading efforts to drive innovation in quality and compliance practices while transforming and streamlining Vendor risk management.

Before founding Diligent Pharma, she established The Avoca Group, a pioneering Life Sciences consulting firm, which has since been acquired by WCG Clinical. 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.

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

Senior Director Operational Excellence and Clinical Compliance |
CSL Behring
Topic of Steve’s talk: Trial Navigator - a collaborative effort to help patients access clinical trials

Steve spent more than a decade as a teacher and social worker prior to a career shift to medicine and vaccine development. He has 27 years of experience in clinical operations, project management, regulatory and medical affairs. This experience was gained through both regional and global positions at GSK and CSL. Steve is fortunate that in his current position, he is able to think about ways to make clinical research more efficient and try to implement ideas that are developed with colleagues both inside and outside the pharmaceutical industry.

Steve Walker

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