Agenda

Shannon specializes in Clinical Operations Systems and has 15 years’ experience in managing and supporting CTMS and eTMF. She currently manages 4 teams providing operations support for Medtronic Sponsored clinical trials, which includes CTMS, eTMF, Vendor Management and Forecasting. In February 2023 she led a successful implementation of eTMF- eISF framework in partnership with Veeva.

Hasan leads the regulatory affairs systems and publishing team at Baxter. His role includes provide leadership and oversight for regulatory strategy and decision making. He also oversees regulatory operations which includes systems, publishing, compliances, artificial intelligence, machine learning and technical roadmap for RA systems.

Kelly is a Regulatory Affairs Manager at Exact Sciences, where she provides regulatory guidance to project teams. Kelly was the co-project manager for the Vault RIM implementation, which went live in February 2022.

Jaya is a solutions-driven IT program and project manager with more than 10 years of experience leading large-scale technology projects from initiation through implementation. She has a proven track record of strategically guiding teams to on-time and on-budget project implementations. Jaya manages Exact’s Clinical Operations and Regulatory Veeva platform projects and strategic initiatives. Prior to joining Exact, Jaya was a Health Information Exchange and Interoperability advisor and project manager leading healthcare data exchange and integration projects for State Medicaid Agencies.

Captain Kimberly Lewandowski-Walker has been a Regulatory Officer with CDRH since 2018. Prior to working at CDRH, she served as a medical device investigator with FDA ORA for 16 years, and as one of ORA’s National Expert investigators for medical devices for ten of those years. At CDRH, she a member of the MDSAP team, working on various other projects, such as ISO 13485 transition projects, pre market reviews for contact lenses and dry eye products, and serving as an internal expert for compliance reviews.

As a seasoned leader in quality, regulatory, and operations, Mitch has leveraged a wealth of experience leading multi-functional teams in a broad set of industries and companies, from startups to multinational Fortune 500 companies. His background includes quality assurance, regulatory affairs, manufacturing, R&D, process engineering, distribution, supply chain, and program management.

Lesly joined the Intuitive in late 2020, bringing more than 20 years of experience as a purpose-driven marketing, branding, and strategy expert at pharmaceutical products and medical device companies. One of Lesly’s core strengths is incorporating new forms of technology into product portfolios to ensure they are positioned for sustainable and scalable success.

With more than 15 years of regulatory experience, Madhavi has deep knowledge of regulatory advertising and promotion. She currently leads global regulatory intelligence and advertising and promotion at Intuitive Surgical. She previously held various leadership roles within Abbott focusing on regulatory advertising and promotion, integration management for mergers and acquisitions, and global harmonization of policies, systems and standards. Madhavi also led the establishment of a quality management system for medical device data systems (MDDS) and telemedicine products with Cisco.

Abbas is a Manager of the Enterprise Quality Management IT team at Cardinal Health, where he drives transformational change and delivers sustainable results that are aligned with the business objectives. Abbas has a proven track record of aligning technology, building relationships, solving complex problems, and delivering outcomes of the highest quality.

Valerie has 25 years’ experience in medical device, combination products, and pharmaceutical manufacturing facilities with roles in quality and compliance. Currently she is responsible for overseeing the global audit program; continuous improvement and CAPA programs, and the business owner for the current QMS system. Valerie is the project lead for Vault QMS processes at Cardinal Health and responsible for implementing these QMS processes across the enterprise.

Matt brings more than 25 years in the medical device industry to his role as an executive leader at Smith+Nephew. He currently leads a global team and is responsible for generating, analyzing, and communicating evidence to expedite new product approval, expand market adoption and maintain product access in key markets.

Jennifer has been involved in clinical research and regulatory affairs for more than 25 years. She is the President of Cook Research Incorporated (wholly owned subsidiary of Cook Medical Incorporated, Bloomington, Indiana). Cook Research Incorporated is involved in product development, testing, clinical studies, medical and scientific writing, and regulatory submissions for medical devices, combination devices and cell-based therapies. Jennifer also serves as Cook Medical’s global leader for Clinical Affairs and is a member of the executive leadership team. Jennifer’s professional service in the medical device industry includes positions with MDMA, MDIC, NEST, and is co-chair representing the US industry for the ISO global standard.

Liz McNamara brings nearly 30 years’ experience solving complex business problems using technology and data. Liz joined the FDA in 2019 and is the director of CDRH’s Digital Transformation (DT) initiative since 2018. She has over 25 years of increasing responsibility and a proven track record in the planning, development, and implementation of complex health information technology applications and solutions. Liz has functional expertise in digital transformation, product development, program management, organizational change management, enterprise analytics, IT service management, and system selection. Prior to joining FDA, her roles have included Director at Blue Cross Blue Shield Association, Program Manager at NIH, and Principal of Healthcare Consulting at CSC and Health IT Solutions LLC.

Salil has over 18 years of combined industry and consulting experience in Operations excellence for bio-pharmaceutical and medical device industry. He co-leads PwC’s Quality Management consulting team and helps clients manage evolving global regulatory and customer expectations, industry trends, and technology advances. His experience spans the operations value chain including manufacturing operations, distribution practices, quality systems, regulatory operations, and post market business processes. He has led numerous teams to simplify processes, improve organizational effectiveness, and implement pragmatic technology solutions with a bias towards driving tangible business outcomes (operational efficiency, accelerated launches, quality productivity, scale/capacity). "

Lisa is an experienced medtech executive with 20+ years in the medical device/pharma/biotech industry in product development, manufacturing/operations, regulatory, and quality. She has managed small molecules/biologics/parenterals, cardiac products (monitoring to implants), respiratory (monitoring to ventilators), orthopedics/spine (instruments to implants including human tissue), catheters, combo products, SaMD, digital and imaging products, as well as global central quality teams, including global complaints and post market surveillance. Lisa is passionate about quality being a strategic enabler to the business and ensuring a positive patient experience. She currently serves as Vice President of Quality at GE HealthCare overseeing image guided Therapies, women’s health and the x-ray businesses.

As group marketing manager, Natalya champions Abbott’s high-powered brand across the vascular portfolio, driving creative consistency and clear communication across the globe. Through her passion to bring digital capabilities to life, Natalya has pioneered patient education tools to support cath lab discharge processes. She also spearheaded a virtual events platform adoption across the regions and currently leads the worldwide integration of Vault PromoMats to reach a new level of marketing compliance. Natalya leads high achieving cross-functional teams, identifying and developing top talent in the organization.

Jeanna is a Regulatory Affairs Professional who utilizes her ability to conceptualize, generate new ideas, analyze problems and develop effective solutions. Jeanna uses her experience and high standards of accuracy to lead and mentor data governance team members striving for ongoing continual improvement and support systems operations.

Phil has 14 years of Clinical Data Management industry experience and a Masters degree in Software Engineering. Prior to coming to the medtech industry, he worked for 12 years in Silicon Valley as a developer and project manager in corporate Information Technology for HP and NetApp. Outside of work, he enjoys exercise, music, and time with family gaming and geeking out on TV shows.

Leianne is the Head of Clinical Data Operations at Alcon and business owner for Veeva Vault CDMS & CDB. She is an established leader in clinical research with 15 years of experience leading global teams in operations, data management, standards, programming and systems.

In her current role, Marla is primarily focused on the exciting opportunity to deploy a new QMS tool to employees at LivaNova Neuromodulation. Most recently, she led the deployment of Vault QualityDocs and Training applications. Her 30+ years of experience in the biotech industry has included quality software deployment, administration, validation, document control, training, and device tracking. As a technical writer, she enjoy developing validation documentation and executing test cases.

Becki leads the Global Ad Promo Center of Excellence within the Regulatory Shared Services function at Medtronic. With more than 15 years experience in the medical device industry, and more than 25 years of legal, regulatory and compliance experience, she strives to make requirements easy to understand, implement, and sustain. Becki has a passion for operational excellence and continuous improvement, which ultimately contributes to the health and benefit of the patients Medtronic serves.

Rosetta manages promotional advertising content through approval process and develops best practices for a streamlined approach to claims implementation and management. As a leader she oversees SOP development, management of cross-functional review teams and training for content approval and distribution.

Todd is an IT professional with 29 years of experience, 20 of those with Alcon, the world leader in eye care. His focus has been implementation and support of enterprise applications spanning ERP, manufacturing, distribution and R&D.

Monica has been part of ILMN for over 4 years and leads the IT team for all vaults that are across ILMN. As Vault Enterprise Technical owner, Monica collaborates with the business team and strives to unify operations across the CQMR space (Clinical, Quality, Medical, Regulatory) to build a center of excellence, while delivering quality health services globally.

Jason leads the clinical data management strategic and operational activities at Terumo Medical Corporation, one of the world’s leading manufacturers of medical devices and supplies. Jason brings 18 years of experience working in Clinical Data Management roles in both pharmaceutical and medical devices with a background in industrial psychology. He is a quality-driven solutions manager, leveraging his experience and passion utilizing diverse strategic approaches, processes, and technologies to identify and implement business solutions supporting the quality and integrity of clinical systems, data, and data management activities.

Joris is vice president of clinical trials innovation at Exact Sciences, a medical device company that develops and provides tests for earlier detection, treatment guidance and monitoring along the cancer continuum. Before joining Exact Sciences, he spent 18 years in Pharma R&D at Novartis and at Janssen, where he led the development of a variety of clinical trials innovation technologies and capabilities in the US, in Europe, and in developing countries. Joris holds a PhD in Artificial Intelligence from the University of Amsterdam.

Heidi leads a team of clinical operations professionals who plan, design, conduct, and report on clinical trials for eye care. Together with their partners, internal and external, Heidi and her team at Alcon generate clinical evidence to support our products. Ask her about the Opportunity Bus!

Jay is currently VP of Medical Device Solutions and Services at USDM Life Sciences. Prior to joining the firm in 2014, he was Senior Advisor for Patient Safety, in FDA’s Center for Devices and Radiological Health. He held a variety of positions over his nearly 27 years at FDA. Jay had primary responsibility for the development and implementation of FDA’s Unique Device Identification System and the development of the GHTF and IMDRF UDI guidance documents.

Over 20 years of clinical research experiences within the Medical Device and Pharmaceutical sector for Steris, Johnson & Johnson, Covidien, Novartis, and Terumo. Rob is Responsible for conducting clinical studies in the US, EU, LATAM, and ASIAPAC, which resulted in over 10 class II / III product approvals and supported over 50 publications. Therapeutic experiences include: Preclinical, Cardiology, Peripheral Vascular, Oncology, Neurovascular, Orthopedics, and Consumer.

A 24-year FDA veteran, Kim is a medical device, IVD, and combination product expert. During her time at FDA, she wrote the current QS Regulation, worked on the authoring committee for 21 CFR Part 4, and conceived and developed MDSAP. She has served on the ISO TC 210 Working Group for ISO 13485 since its inception in 1994. She is also a member of ASTM E55 Combination Product Definitions standard and a foundational member of IMDRF.

Barbara has 33 years experience in medical and pharmaceutical manufacturing with roles in both regulatory and quality. She has used Vault QualityDocs since 2014 and is currently the Director, Project Management, eQMS at Cardinal Health, responsible for implementing Vault QualityDocs and QMS systems across the enterprise.

Ravi is an IT Professional with more than 15 years of experience, 10+ in the medical device industry. He is Director, Commercial ERP, Global Master Data and Clinical, Quality and Regulatory applications for LivaNova, a Global medical device manufacturer of cardiovascular and neuromodulation products. Ravi holds a masters degree from University of Houston in Supply Chain and Project Management and is a certified PMP and Six Sigma Green Belt.

Kareem is a New York-based leader in PwC's pharmaceutical and life sciences management consulting practice, where he specializes in transformation across the medical device value chain. He has advised clients on a range of topics, including operations, quality strategy and systems, M&A diligence, integration, carve-out, and value capture, and regulatory affairs and compliance.

Pardeep has spent the last 25 years in the oncology genetics and genomics arena in different roles and is a board-certified genetic counsellor with a PhD in medical genetics. She joined Agilent Technologies in October 2022 as a medical science liaison.

Greg has 30+ years of experience and has been with Alcon for 14 years, the world leader in eye care. His focus has been business partnering and support of enterprise applications supporting commercial, quality and R&D.

Justin has 20 years of experience across various business and IT roles at Alcon, the world leader in eye care. In his current role, he focuses on partnering with Alcon's Clinical Research & Development organization supporting all IT needs.

David Sheleheda holds a wealth of clinical research experience encompassing both the medical technology and pharmaceutical industries. He is currently the Global Head of Clinical Operations at Integra Life Sciences leading the gathering of clinical evidence for the complete lifecycle of Integra’s medical technology. Prior to Integra, David drove successful global clinical programs across multiple therapeutic areas for Novo Nordisk, Abbott Laboratories, and Pfizer.

As a key partner in transforming Global Medical Affairs within BD, Sarah directs the development of innovative and interoperable clinical systems to drive a robust evidence generation program. As an architect of object-focused clinical systems, she works to simplify and transform clinical operations and clinical data management. Her passion is delivering scalable future-state clinical systems that drive inspection-ready new product development (NPD) to commercialization capabilities.

Ann is the global regulatory affairs operation director for Cook Medical. In this role, Ann is responsible for overseeing the identification, development, and implementation of global regulatory affairs processes and supports the implementation and integration of a regulatory information management system. Ann has over 15 years of medical device experience working in new product development, regulatory affairs and policy development in quality management systems.

Francisco (Cisco) began his career at FDA as a Compliance Officer, Cardiac Rhythm/Electrophysiology Branch, Office of Compliance at CDRH. Prior to this role, he was Branch Chief, Respiratory, E/N/T, General Hospital, & Ophthalmic Devices Branch in the Division of Manufacturing and Quality, Office of Compliance. Before joining the FDA, Cisco was a quality and reliability engineer in micro-electronics at IBM, responsible for emerging server technology lines and network systems, along with high-volume gaming systems from Nintendo, Sony, and Microsoft.

Steve has more than 30 years of quality and regulatory affairs experience including executive leadership roles in global companies across the medical device and invitro diagnostics industries. Prior to joining Philips as Chief Patient Safety and Quality Officer, he served as EVP of QA/RA for Cardinal Health, as well as holding executive leader roles with Zimmer Biomet, Danaher Diagnostic, and Boston Scientific. Additionally, Steve served as an industry board member and instructor for six years for the regulatory affairs master’s degree program at St. Cloud State University. He earned a bachelor’s degree in engineering and industrial technology and MBA, both at California State University Long Beach.

Dr. Nick West is CMO and DVP of Global Medical Affairs for Abbott’s Vascular Division. He graduated in medicine from the University of Cambridge and St. Thomas’ Hospital Medical School, London. He trained in interventional cardiology at the John Radcliffe Hospital, Oxford and Green Lane Hospital, Auckland, New Zealand and practiced at the Royal Papworth Hospital, Cambridge. He was a founding member of the Cambridge-based biotech startup, PlaqueTec Ltd, and sits on the UCLA School of Biodesign Innovation Council.

Dr. Nick West is CMO and DVP of Global Medical Affairs for Abbott’s Vascular Division. He graduated in medicine from the University of Cambridge and St. Thomas’ Hospital Medical School, London. He trained in interventional cardiology at the John Radcliffe Hospital, Oxford and Green Lane Hospital, Auckland, New Zealand and practiced at the Royal Papworth Hospital, Cambridge. He was a founding member of the Cambridge-based biotech startup, PlaqueTec Ltd, and sits on the UCLA School of Biodesign Innovation Council.