Agenda

Matt is an Innovative leader with expertise in clinical operations, IVD development, and Companion Diagnostic development. He is a vibrant and perceptive professional skilled in building, repairing, and evolving critical partnerships, able to negotiate and build consensus with parties supporting strategic business goals. He has 25+ years’ experience in IVD and successfully executing extensive cohort clinical studies for submission to FDA, and BIMO Inspection management. He is a creative people leader dedicated to the growth and development of valuable and successful organizations with a proven track record of leading large groups of clinical affairs, data management, biostats, and project management personnel to expand capabilities and efficiencies while prioritizing team culture. Matt has an inclusive management style where communication is key to establishing trust and supporting top performance. At Illumina, he has created a center of excellence for clinical study execution by utilizing a process-oriented framework to managing clinical studies. At the core of the center of excellence is a strong team composed of uniquely qualified individuals with varying degrees of clinical operations expertise. His work has resulted in a Clinical Affairs department respected for its expertise and industry knowledge, one whose team members understand their roles, and, most importantly, who are excited and motivated to work together to improve human health by unlocking the power of the genome. Matt has a B.S. in Biology from the State University of New York at Binghamton, an M.S. in Molecular Biology and Immunology from Albany Medical College, and an M.B.A. in Finance from the University of Colorado at Denver. On the weekends and free time, Matt enjoys spending time with his husband, Steven, and their Vizsla, Jaxon. He enjoys cooking, eating great foods, and drinking wines and tequila. When not trying new restaurants in San Francisco, he loves traveling and laying on the beach in Oahu.

With eighteen years in clinical research, Kellie Hazell has supported, monitored and managed pulmonary devices, oncology pharma, and in vitro diagnostics studies. Kellie has been with Illumina for three years and manages Illumina's Veeva platform for the Medical organization, focusing on ClinOps and CDMS.

Lori Holder is the Senior Director of Global Regulatory Operations at Alcon Laboratories, Inc., a leading manufacturer of ophthalmic medical devices. She has over 30 years of experience in the medical device industry through positions at Guidant Corporation, Sulzer Orthopedics, Sulzer Intermedics, and Cyberonics, Inc. She has held positions of increasing responsibility in clinical research, quality assurance, and regulatory affairs, and is currently the head of Alcon’s Regulatory Operations group. Lori has earned her Regulatory Affairs Certification (RAC) and holds a B.S. in Biomedical Engineering from Texas A&M University.

Pat Shafer is a Managing Director within Health Solutions, responsible for delivering services, solutions, and thought leadership for pharmaceutical, biotech, and medical device clients. Pat is a strategic advisor to the FDA and has been co-leading efforts among the FDA, the Medical Device Innovation Consortium (MDIC), and the medical device industry as part of the FDA’s Case for Quality, including defining quality metrics, identifying leading practices for quality management review, and developing a playbook of leading practices for quality and corporate leadership.

Ayaz Malik has spent the majority of his career in building, transforming and enabling marketing and communications teams with a focus on healthcare/medical devices. His passion has increasingly turned to digital marketing and the evolving roles of marketer and communicator. In his current role, Ayaz is responsible for digital strategies that enable strong commercialization of Roche Diagnostics solutions. Previous roles include: Enterprise Marketing Excellence Manager at Roche Diagnostics Corporation USA; Head Roche Diagnostics Global Communication in Switzerland; Head Roche Tissue Diagnostics Marketing Communications in Arizona; Head Zimmer Global Marketing Communications in Indiana; SVP/Principal-Creative Director at Marketing Impact in Indiana; and Creative Director at Caldwell Van Riper in Indiana.

Experienced Clinical Research Monitor and Data Manager with a demonstrated history of working in the research industry. Skilled in Clinical Trial Management, Oncology, Clinical Data Management, Good Clinical Practice (GCP), and Data Collection.

Jay Crowley is the Vice President of Medical Device Solutions and Services at USDM Life Sciences. Prior to joining USDM in 2014, Jay was Senior Advisor for Patient Safety in the FDA's Center for Devices and Radiological Health, where he developed and implemented UDI System regulation. At USDM Life Sciences, Jay focuses exclusively on providing business process, technology, and compliance solutions for the regulated life science industry. Jay held a variety of positions over his nearly 27 years at FDA, including work with design control regulations to reduce the chance of human errors with medical devices, patient safety and adverse event reporting. Jay also worked in the Office of the Commissioner of FDA, and the Office of Compliance at FDA.

As Senior Manager – Supplier Quality Systems, Scott is responsible for processes and IT solutions across supplier and material controls from selection, qualification, procurement, feedback, and change control.

James is a seasoned business and technical leader in the field of IT. His experience spans organizational transformation, acquisition integration, software engineering, solution delivery management, capital/cost management, and process re-engineering. James has worked across several industries, including life sciences and healthcare, aviation, insurance, and manufacturing.

Montoya is responsible for managing regulatory global systems and business processes. Montoya has more than twenty years of experience in life sciences industry, including Roche Pharmaceuticals prior to BD.

Alexandra (Ali) Massoud is the VP, Clinical Affairs at Exact Sciences, overseeing the development, execution, and quality of clinical studies to support product development and post-market evidence generation. Patient advocacy and strategic partnerships are key areas of focus. Prior to joining Exact Sciences in 2015, Ali worked at Quintiles (IQVIA) for 7 years, managing clinical operations, sponsor partnerships, and global set up/implementation of RBM clinical trials. Her other industry experience includes in-house and field base site management roles at Amgen. Her therapeutic area experience includes gastroenterology, oncology, hematology, neurology, dermatology, and nephrology. She is a member of the Healthcare Businesswomen’s Association, Chicago Chapter and is actively involved with MDIC.

In 1982, Heidi was diagnosed with a rare heart arrhythmia and underwent a successful AV ablation procedure leaving her heart 100% pacemaker dependent. Unfortunately, due to pacemaker lead extraction complications in 2006, she experienced reduced heart muscle function and was diagnosed with heart failure. After Heidi had open-heart surgery in 2010, and with the help of her pacemaker data, wearable devices, and mobile apps, she had the insights she needed to get from the hospital bed to the finish line of her first bike race. Today, Heidi is passionate about improving patient outcomes and uses her athletic events to inspire people living with heart issues. She partners with physicians and researchers worldwide to provide insights regarding the patient experience and ideas for engagement.

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.

Janna brings over 20 years of experience from multiple industries. As a Sr. Director with Abbott, she oversees several teams for the Electrophysiology medical device business and leverages her experiences with large production volumes and smaller highly specialized product volumes to apply best practices to find the right fit for each situation. A dynamic change agent with a portfolio of success driving quality and regulatory compliance, strategic planning, and operations for diverse manufacturing organizations, Janna has been instrumental in developing new supply chain management programs, reducing costs, and boosting sales. Janna holds an MBA in Operations Management, backed by an M.S. in Biomechanics.

Rajesh is a Principal in KPMG’s Life Sciences Solution team and focuses on Quality and Regulatory services. He serves Life Sciences organizations in solving their most pressing quality, regulatory and operational challenges across the entire value chain. Over the last 25+ years, Rajesh led several transformational engagements in support of regulatory, quality, supply chain, and manufacturing operations for leading Pharmaceutical and Medical Device companies. He is passionate about evaluating and monitoring Total Cost of Quality, Quality Metrics, and Quality Management Maturity (QMM) by leveraging emerging and disruptive technologies like predictive analytics, machine learning, cognitive, and context-aware computing, among others.

Jim joined CSI in 2014 and has held a variety of roles including leading upstream marketing, downstream marketing, and both marketing communications and CSI’s PAD patient advocacy program. He also leads a cross-function team focused on optimizing CSI’s ad-promo review process to meet the needs of the growing organization. Prior to joining CSI, Jim was a brand manager at General Mills for 12 years and chemical engineer prior to that.

Kate has been in the pharma and device industries since 2008. As a leader in medical affairs and medical affairs operations, she has been instrumental in several Veeva integrations and builds. She has primarily worked with Veeva in its applicability to medical affairs functions and the medical/legal review process.

Larry leads Baxter Healthcare’s Global Regulatory Affairs (GRA) operations strategy and delivery organization, designed to create an aligned and unified approach to regulatory systems and processes across the organization. His primary focus is simplifying regulatory processes and providing strategic support to business partners to enable efficiency and effectiveness on a global scale while delivering with excellence through speed, courage, collaboration, and simplicity across the Baxter portfolio. Prior to Baxter, Larry served in senior leadership roles within Johnson and Johnson and Sanofi-Aventis, spanning local, regional, and global functional areas, within and linked to Regulatory Affairs.

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.

Casey is the Manager of Clinical Systems at Abiomed. Previously, she has held roles of increasing responsibility in clinical research and systems for other Medical Device and Biotech companies. Casey has experience as an end-user, system admin, and project manager leading multiple, successful Veeva migration and implementation projects at various companies in MedTech and Biotech. Her passion for clinical systems fuels the continuous promotion of technology, adoption of new features, and optimized use of systems to support business needs.

An international business leader with over 20 years’ experience in the medical device industry, Anne specializes in Global Clinical and Scientific Program Development, Medical Affairs, Healthcare Compliance, and Implementation of Digital Technologies. As both an Adjunct Professor and Independent Consultant, she has a broad and holistic view of the industry.

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.

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.

Ram Iyer oversees the team of regulatory scientists for the MedSurg division of Cook Medical, supporting regulatory strategy and execution of submissions in global markets for new product development and sustainment. Ram was part of the core group involved in assessing regulatory information management system solutions for Cook Medical. Ram graduated from the University of Southern California with a Ph.D. and M.S degree in Biomedical Engineering.

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.

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.

Chris leads the commercial services team at Exact Sciences. As a senior operational excellence leader, she is focused on empowering people to think and operate differently. Most of her career has been in life sciences driving operations, communications, marketing, sales, and medical education.

Brenda is Director of Clinical Systems Operations at Edwards Lifesciences. She has worked as an employee and consultant in a variety of industries, entering the medical device industry in 2003. She has held positions at Boston Scientific and American Medical Systems prior to joining Edwards in 2011.

Brian Edwards serves as a subject matter expert for digital health regulatory affairs at Boston Scientific. In this role, he has established regulatory assessment procedures for digital health and remote case support and grown an international network of regulatory professionals to monitor the changing regulatory environment for digital health.   Prior to joining BSC, Brian spent time in senior regulatory and quality roles at Zimmer Biomet and Medtronic, among several other medtech companies.   Brian holds a B.S. in Chemical Engineering and M.S. in Biomedical Engineering from the University of Minnesota, as well as an M.S. in Biostatistics from UCLA.

Seth Carmody is the Vice President of Regulatory Strategy at MedCrypt. Drawing on his ten years of medical device experience, Seth provides strategic direction for cybersecurity products and services for the regulated medical device market. Prior to MedCrypt, Seth spent 8 years at FDA, architecting technology policies that impact software-enabled medical devices; namely, the FDA’s medical device cybersecurity guidances.

As the leader for Organizational Learning and Development at Tolmar, Nicole brings her passion for data-driven continuous improvement to the world of people performance. Throughout her career, she has leveraged her knowledge of organizational development and training to lead teams to more effectively and efficiently meet organizational goals.

Montoya is responsible for managing regulatory global systems and business processes. Montoya has more than twenty years of experience in life sciences industry, including Roche Pharmaceuticals prior to BD.

Ayaz Malik has spent the majority of his career in building, transforming and enabling marketing and communications teams with a focus on healthcare/medical devices. His passion has increasingly turned to digital marketing and the evolving roles of marketer and communicator. In his current role, Ayaz is responsible for digital strategies that enable strong commercialization of Roche Diagnostics solutions. Previous roles include: Enterprise Marketing Excellence Manager at Roche Diagnostics Corporation USA; Head Roche Diagnostics Global Communication in Switzerland; Head Roche Tissue Diagnostics Marketing Communications in Arizona; Head Zimmer Global Marketing Communications in Indiana; SVP/Principal-Creative Director at Marketing Impact in Indiana; and Creative Director at Caldwell Van Riper in Indiana.

Chris leads the commercial services team at Exact Sciences. As a senior operational excellence leader, she is focused on empowering people to think and operate differently. Most of her career has been in life sciences driving operations, communications, marketing, sales, and medical education.