Justin is an IT leader with extensive experience delivering technology solutions for sales, marketing, and commercial operations in the healthcare and life sciences industry. He is passionate about building empowered teams and transforming innovative ideas into impactful solutions. With a background in leading complex programs and driving process improvement, Justin is known for his collaborative approach and ability to partner closely with the business.

Ali is the VP, Clinical Affairs at Abbott Cancer Diagnostics. Ali oversees the development, execution and quality of clinical studies to support product development and post-market evidence generation. Patient advocacy and health equity are key areas of focus in study design, implementation, and outcomes. Her therapeutic area experience includes gastroenterology, oncology, hematology, neurology, dermatology, and nephrology. She is a member of the Healthcare Businesswomen’s Association, Chicago Chapter, is actively involved with MDIC, and sits on the board of directors for Triage Cancer.

Dr. Brenda Price, director of regulatory operations at Abbott Rapid Diagnostics Infectious Disease, has more than 25 years experience in regulatory, quality, and technical leadership within the in vitro diagnostics industry. She leads global programs spanning medical event reporting, regulatory intelligence, product stewardship, and enterprise regulatory IT systems and is passionate about delivering intelligent technology solutions that enable human-centered processes, reduce error, and support strong, sustainable regulatory compliance.

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 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.

Jay is a technology and transformation leader with over 20 years of experience helping healthcare and medical device organizations modernize how they work. He leads teams across clinical, medical, regulatory, and patient safety systems, with a strong focus on applying AI in practical, responsible, and business-driven ways. Much of his work sits at the intersection of innovation, governance, and execution, helping organizations turn emerging technologies into real-world impact.

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 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 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.

Elizabeth leads global quality management, regulatory affairs, and clinical operations across Bio Rad’s diverse life science and clinical diagnostics portfolio. In this role, she is responsible for ensuring compliance with global regulatory requirements, advancing quality systems and culture, and supporting the safe and effective delivery of innovative diagnostic solutions worldwide. With extensive experience in regulated environments, Elizabeth partners closely with cross-functional teams to drive operational excellence, continuous improvement, and successful implementation of global quality and regulatory initiatives.

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.

Venkiteshwar Manoj is Head of Global Medical Affairs at Carl Zeiss Meditec. Venkiteshwar has over 15 years of expertise in FDA and global medical device regulations, GCPs, ICH guidelines, and all phases of clinical study development and life cycle management

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 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 brings two decades of clinical research expertise to the stage, specializing in IVD, clinical safety, and pharmaceutical strategy. Throughout her career, she has masterfully navigated complex therapeutic landscapes such as infectious disease, HIV, interventional cardiology, hypertension, gastrointestinal disorders, and migraine, driving projects from conception to timely completion. Known for her ability to cultivate alignment across multidisciplinary teams, Jill combines high-level project management with an analytical approach to consistently exceed organizational goals.

With 15 years of experience in Data Management, Thomas has supported numerous CROs and sponsors, primarily within the Cardiology and Oncology sectors. Now at DCN, he leverages the firm’s specialization in IVD studies to provide end-to-end support. From protocol design and site selection to final statistical reporting and regulatory submissions, DCN empowers clients to navigate the complexities of clinical research with confidence.

Keri Leone is a global medical affairs professional with over 20 years experience in chronic disease management of diabetes and cardiovascular disease. She also has more than 15 years experience building, growing, and leading international commercial, clinical, and medical science teams at Dexcom. She currently leads strategic domestic and international medical science, education, and communication initiatives for continuous glucose monitoring and manages a team of Medical Science Liaisons focusing on medical education and communications, evidence strategy and real world evidence and strategic KOL development.

Daniel is a member of the Case for Quality team in CDRH’s Compliance and Quality Staff. Daniel has been with FDA for 17 years in a variety of roles, most notably as a branch chief for Cardiovascular Devices in the Office of Compliance, and as an Assistant Director for Obesity and Hepatobiliary Devices in OHT3. Prior to FDA, Daniel was a Validation Specialist for 8 years in the pharmaceutical industry.

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.

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 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 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.

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 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, high quality promotional content.

Pharmaceutical and MedTech sectors at Johnson & Johnson, Stephanie is passionate

Dan spent the first 15 years of his career working in clinical trials and in the regulatory trenches, with experience spanning both pharmaceuticals and medical devices. Over the past decade, Dan has transitioned into the technical domain, leading initiatives from initial UDI scoping through serving as project manager for multiple Regulatory Information Management (RIM) platform implementations supporting global regulatory operations.

Ron is a strategic leader at the intersection of healthcare and technology, currently serving as Senior Director of Enterprise Transformation and Business Process Engineering at Novocure. With over a decade of experience, Ron specializes in driving large-scale digital innovation and operational excellence. Prior to Novocure, he led Intelligent a product portfolio focused on automation at R1 RCM and spent over five years in Deloitte’s Strategy & Operations practice. A specialist in navigating complex organizational shifts, Ron is dedicated to building future-ready enterprises through global product strategy and digital-first transformation.

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.

Christina Arnt has more than 25 years experience as a medtech quality and regulatory leader guiding global medical device organizations through complex compliance challenges. As VP of Medical Device Compliance at QualityHub, she helps companies translate regulatory requirements into effective, audit-ready quality systems that strengthen compliance, accelerate product readiness, and safeguard patient outcomes.

Prior to joining QualityHub, Christina held leadership roles at Baxter Healthcare, St. Jude Medical, and Zimmer Biomet, where she oversaw global quality systems across a broad medical device portfolio.

Scott Sherrill leads product strategy, AI integration, and partnerships for Redica Systems with the goal of making sure customers genuinely love the product. During his time at Redica, he’s helped shape how medtech companies use regulatory intelligence to work smarter, move faster, and stay ahead of a constantly shifting compliance landscape.

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 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.

James serves as Vice President of Quality Assurance at Sirtex Medical, bringing extensive leadership experience in quality and compliance across the medical device, diagnostics, and life sciences sectors. His expertise includes managing global quality systems, clinical quality assurance, regulatory inspection preparedness, and leading international quality teams. He has successfully overseen enterprise-wide eQMS implementations and complex remediation initiatives, consistently driving strong compliance while supporting product development and manufacturing excellence.

Shereen is a seasoned leader in regulatory affairs, with over 15 years of experience in the medical device industry. As the senior manager of regulatory operations at Smith & Nephew, she leads a team dedicated to optimizing regulatory systems, driving process innovation, and delivering strategic insights through data analytics and performance metrics. Shereen has played a key role in global regulatory submissions and has led transformative initiatives within the regulatory environment. Shereen brings a forward-thinking perspective to regulatory operations, combining industry knowledge with a commitment to continuous improvement and cross-functional collaboration.

Michelle is the Vice President of Global Quality Systems and Regulatory Compliance at Smith+Nephew, where she leads enterprise-wide quality systems, post-market surveillance, and field actions. With over 20 years of leadership experience in the medical device and pharmaceutical industries, Michelle is recognized for building scalable, data-driven quality management systems and strengthening global inspection readiness. She regularly advises executive leadership on risk management and regulatory strategy, backed by an MBA in Operations Management and a Certificate in Regulatory Affairs.

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.

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.

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.

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 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 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.