Speakers
2025 Speakers
Speakers
Denton Hickey
Alcon
Director, Regulatory Intelligence
Denton Hickey
Alcon Director, Regulatory Intelligence
Denton has been with Alcon for 28 years, including 14 years in various QA roles within manufacturing. He led the QA workstream in a 10 year transformational SAP implementation and most recently is the director of regulatory intelligence.
Denise Kendall
Alcon
Supervisor Clinical Data Management
Denise Kendall
Alcon Supervisor Clinical Data Management
Denise has been at Alcon for five years and has a strong passion for working with the ARC studies. She finds great fulfillment in helping pave the way for the future of eye care.
Sarah Giorgio
BD
Senior Manager, Clinical Systems Architecture, Operations, and Strategy
Sarah Giorgio
BD Senior Manager, Clinical Systems Architecture, Operations, and Strategy
Sarah is focused on building interoperable, scalable clinical systems that leverage automation and business logic to ensure business and regulatory compliance. Bridging strategy and execution, Sarah works closely with business and central teams to translate complex requirements into practical, future-ready solutions that support innovation from development through commercialization.
Julie Kersey
BD
Manager, Clinical Data Management
Julie Kersey
BD Manager, Clinical Data Management
Julie is a seasoned clinical data management leader with over two decades of experience across biopharmaceutical and medical device environments. She drives process optimization, advances standardization, and champions innovative technologies and integrated data streams including RTSM, eCOA and CDB, leveraging extensive experience in database design, data review, and oversight of cross-functional data teams to support clinical and operational excellence.
Christy Zeigler
BD
Director, Clinical Data Management
Christy Zeigler
BD Director, Clinical Data Management
Christy has 25+ years of experience across the pharmaceutical and medical device industries in sponsor and CRO settings. For nearly five years, she has partnered with Veeva and leads a team of clinical data managers and database programmers supporting multiple BD business units. Christy delivers end-to-end data management—from study start-up through database lock—by championing interoperable workflows (EDC, eCOA, CDB) that reduce burden, accelerate insights, and strengthen compliance.
Robin Solinsky
Bright Research
VP, Technology and Innovation
Robin Solinsky
Bright Research VP, Technology and Innovation
Robin works at the enterprise level of data management, focusing on growing and scaling Bright Research’s database technologies across both business and clinical operations. Her role covers security oversight, vendor management, and quality control, as they align with regulatory requirements for an ever-adapting landscape. Over the last few decades, Robin has spanned quality engineering, clinical project management, monitoring, data management, regulatory, and stats oversight.
Noah Cumby
CONMED
Corporate Program Manager
Noah Cumby
CONMED Corporate Program Manager
With over a decade of experience at CONMED, Noah drives innovation and ensures regulatory excellence in medical technology. He holds a PMP certification and specializes in project leadership, process optimization, and compliance strategies. Noah combines technical expertise with strategic vision to advance regulatory and quality initiatives.
Peter Iossa
CONMED
Business Administrator
Peter Iossa
CONMED Business Administrator
Peter serves as CONMED’s primary Veeva system administrator, specializing in non-device software validation. He also helps manage the technical infrastructure and compliance strategies for CONMED’s quality systems.
Jill Hutton-Pugh
DCN Dx
Clinical Trial Manager
Jill Hutton-Pugh
DCN Dx Clinical Trial Manager
Experienced clinical research professional with over 20 years of IVD, clinical safety, and pharmaceutical experience where she delivered strategic insights founded in a meaningful analytical approach. Many years of comprehensive project management experience, extensive knowledge and experience in clinical safety, and demonstrated success with cultivating extensive cross-functional team alignment. Worked with multidisciplinary teams achieve and surpass their goals, ensuring timely project completion and milestone fulfillment working across multiple therapeutic areas including infectious disease, HIV, interventional cardiology, hypertension/CHF, gastrointestinal disorders, and migraine.
Thomas Martinache
DCN Dx
Associate Director of Data Management
Thomas Martinache
DCN Dx Associate Director of Data Management
Thomas has worked in Data Management for the last 15 years. He has worked at various CROs and sponsors, mostly on Cardiology and Oncology studies. DCN, specializes in IVD studies, helping clients run studies and manage the challenges those can present. DCN works with them from protocol creation, through sites and system selection, all the way to the statistical reports and submissions.
Karrie Hodges
GE Healthcare
Senior Data Manager
Karrie Hodges
GE Healthcare Senior Data Manager
Karrie has over 20 years of experience leading data management for global pharmaceutical and medical device studies. She specializes in database and CRF design, vendor oversight, and cross-functional data strategy, with additional expertise in privacy compliance as it relates to clinical data management. Karrie has extensive expertise with many EDC tools and has supported multiple successful regulatory submissions worldwide.
Steven Speranza
Gore Medical
Global IT Leader – Product & Innovation
Steven Speranza
Gore Medical Global IT Leader – Product & Innovation
Steve is an IT leader in the medtech industry with deep experience enabling R&D and medical functions, including clinical, regulatory, and medical affairs. He’s known for aligning technology strategy with product and patient-focused outcomes while accelerating product development, strengthening compliance, and modernizing digital capabilities across the value chain.
Kaylin Tribble
Gore Medical
Clinical System Administrator
Kaylin Tribble
Gore Medical Clinical System Administrator
Kaylin is a clinical operations and systems professional with 12 years of experience supporting regulated clinical research across medical device and life sciences organizations. She brings deep expertise in clinical systems, including five years of hands‑on Veeva Vault Clinical configuration, three years leading global clinical trials, and over a decade of project management experience.
Julie Sutton
Intuitive
Director, Global Marketing Operations
Julie Sutton
Intuitive Director, Global Marketing Operations
Julie has 20 years of experience, primarily in the pharmaceutical and medical device industries, with deep expertise in Veeva PromoMats. Julie is passionate about creating value for the organization by optimizing processes and systems, while driving growth, innovation, and positive outcomes.
Shelly Lincoln
iRhythm Technologies
VP, Global Marketing & Commercial Strategy
Shelly Lincoln
iRhythm Technologies VP, Global Marketing & Commercial Strategy
With 20 years of experience in the healthcare industry, Shelly has held roles across global marketing, commercial strategy, and sales leadership, giving her a 360-degree view of the commercial lifecycle. She brings a pragmatic, outcomes-focused approach to driving growth, aligning cross-functional teams, and translating strategy into measurable impact across the medtech ecosystem.
Stephanie Carter
Johnson & Johnson Vision
Associate Director, Promotional Integrity
Stephanie Carter
Johnson & Johnson Vision Associate Director, Promotional Integrity
Stephanie is responsible for the global copy approval process across Johnson & Johnson Vision and serves as the business owner for Veeva PromoMats. With her team, she leads key initiatives to strengthen and streamline processes, including the recent implementation of Veeva AI. With seventeen years of experience in both the Pharmaceutical and MedTech sectors at Johnson & Johnson, Stephanie is passionate about enhancing user experience, simplifying processes, elevating innovation, and empowering teams to take collective responsibility in delivering compliant, highquality promotional content. Johnson Vision and serves as the business owner for Veeva PromoMats. With her team, she leads key initiatives to strengthen and streamline processes, including the recent implementation of Veeva AI. With seventeen years of experience in both the Pharmaceutical and MedTech sectors at Johnson & Johnson, Stephanie is passionate about enhancing user experience, simplifying processes, elevating innovation, and empowering teams to take collective responsibility in delivering compliant, highquality promotional content.
Meghan Rimmele
Novocure
Manager, Business Process Engineering
Meghan Rimmele
Novocure Manager, Business Process Engineering
Meg is the program manager for Novocure’s quality, safety, and regulatory transformation (QSRT) program. She partners with business and enterprise technology teams to modernize Novocure’s regulated technology landscape, anchored in a phased, platform-led approach with Veeva and targeted enterprise integrations. Meg is focused on aligning leaders around a clear future-state vision, making intentional tradeoffs, and driving business and technical readiness as the program moves from strategy into execution.
Jeanne Jacoby
Sequel Med Tech
Sr. Director, Medical Affairs
Jeanne Jacoby
Sequel Med Tech Sr. Director, Medical Affairs
Jeanne is a senior health technology leader dedicated to bridging the gap between complex medical innovation and patient-centered outcomes. Drawing on over 15 years of experience—from clinical practice as a Nurse Practitioner to leadership roles at Bigfoot Biomedical and Beta Bionics—she translates clinical expertise into strategic advancement. Currently at Sequel Med Tech, Jeanne champions the strategic dissemination of digital tools and diabetes technology to empower both providers and patients. By aligning medical affairs with technological execution, she ensures the delivery of digital therapeutics that drive better health outcomes and operational excellence every day.
Lynn Meyers
Siemens Healthineers
Senior Director Clinical Operations
Lynn Meyers
Siemens Healthineers Senior Director Clinical Operations
Lynn Meyers leads the clinical operations team at Siemens Healthineers, supporting in-vitro diagnostics product registrations. Lynn has over 25 years of clinical research and leadership experience executing clinical trials for the medical device, in-vitro diagnostics and consumer products industries. A champion of people-first leadership, Lynn is dedicated to fostering inclusive and diverse environments where people’s unique strengths can be recognized and nurtured.
Irene Barriocanal
Terumo
Clinical Study Support Systems Lead
Irene Barriocanal
Terumo Clinical Study Support Systems Lead
Irene is a biologist with more than 16 years of experience in clinical research, specializing in optimizing digital systems that support clinical study operations. She works closely with global and cross‑functional teams to streamline processes, enhance data quality, and ensure Terumo’s platforms truly meet scientific and operational needs. Irene is passionate about improving the efficiency and impact of clinical studies through technology, collaboration, and continuous improvement.
Takumi Ohira
Terumo Corporation
Clinical Operations, Clinical Affairs Global HQ
Takumi Ohira
Terumo Corporation Clinical Operations, Clinical Affairs Global HQ
Takumi has 3+ years’ experience as a CRA, including PMDA applications. He currently works at Terumo’s clinical affairs global headquarters, supporting global systems such as CTMS and eTMF.
Michelle Wetherby
Terumo Neuro
Director of Clinical Research
Michelle Wetherby
Terumo Neuro Director of Clinical Research
Michelle is a clinical and strategic leader with nearly 30 years experience in leading clinical programs, optimizing workflows, and influencing executive level stakeholders. She has deep expertise across structural heart, stroke, vascular, and cardiac arrhythmia therapies, with a track record of accelerating evidence generation and supporting commercialization.
Gary Falcetano, PA-C, AE-C
Thermo Fisher Scientific
Senior Manager, Medical & Scientific Affairs, Allergy
Gary Falcetano, PA-C, AE-C
Thermo Fisher Scientific Senior Manager, Medical & Scientific Affairs, Allergy
Gary is a seasoned medical affairs leader and clinician with over 25 years of experience in emergency medicine, primary care, and allergy/immunology. As Senior Manager of Global Medical & Scientific Affairs at Thermo Fisher Scientific, he leverages more than 14 years of tenure to drive scientific communications and molecular diagnostics strategy. From his early career as a paramedic to serving as a Captain in the U.S. Army Reserve, Gary bridges clinical practice and industry innovation, translating complex requirements into published insights on asthma and allergy to support operational and medical excellence.
Deborah Kasprowicz
Vantive US Healthcare
Global Head, Worldwide Medical Strategy and Delivery
Deborah Kasprowicz
Vantive US Healthcare Global Head, Worldwide Medical Strategy and Delivery
Deborah is a strategic and operational leader in clinical research at Vantive, with more than 20 years of experience. She leads a global team responsible for designing and delivering high quality clinical evidence across the product lifecycle, from early feasibility through post market studies. Her team contributes to the advancement of evidence-based decision making in renal and acute organ therapies through strong scientific rigor and cross functional partnerships.
Rachel Callender
W. L. Gore
Global MLR Leader
Rachel Callender
W. L. Gore Global MLR Leader
Rachel is a global medical, legal, and regulatory (MLR) leader with experience supporting medical device organizations through process transformation and compliant content delivery. She currently leads global MLR strategy and operations, partnering closely with teams to modernize workflows using platforms like Veeva. Rachel brings a practical, people-first approach to change and is passionate about simplifying complexity, empowering teams, and turning MLR into a true business enabler.