Nick joined Siemens PLM in 2016 and is responsible for driving Digital Enterprise for Life Sciences companies; connecting a model-based Digital Twin with a collaborative Digital Thread.
Prior to Siemens, Nick managed the Safe Skin clinical program and patient support surfaces portfolio at Hill-Rom, using analytics and technology to help reduce “never events” in the hospital setting.
Earlier in his career, Nick worked for Siemens Industry in various marketing, strategy and analytics positions across the Digital Factory business.
He has an M.B.A. from Xavier University and B.S. in marketing and management from University of Cincinnati. He is active in Xavier Health programs including the CPQA team.
Director, Health Solutions
Microsoft US Health and Life Sciences
Shawn Remacle is Director of Health Solutions for Microsoft US Health and Life Sciences and for the past 10 years has worked various industry market development positions supporting strategic engagements with enterprise/mid-market healthcare customers and industry partners. For the 10 years prior to working for Microsoft, Shawn was the Chief Information Officer at a multi-hospital, integrated health provider in North Carolina.
Director, Product Development
Executive Vice President, Medical Devices & Combination Products (Vice President Regulatory Affairs, MDMA)
Heather Rosecrans brings more than 30 years of public health and medical device experience to Greenleaf Health Inc. Prior to joining Greenleaf, Rosecrans served as Director of the 510(k) Pre-Market Notification Staff at the U.S. Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH). In this role, Rosecrans was responsible for implementing administrative and regulatory policy for the 510(k) Program, the 513(g) Program, Classification and Reclassification, de novo petitions and other premarket regulatory requirements. Rosecrans’ accomplishments include drafting guidance documents and regulations regarding the 510(k) program, training staff, and assisting in the implementation of the Medical Device User Fee Modernization Act (MDUFMA) and Food and Drug Administration Modernization Act (FDAMA). Rosecrans’ extensive experience at CDRH, and specifically the 510(k) office, enabled her to become one of the nation’s leading experts on the program. Rosecrans’ tenure also allowed her to play a pivotal role in the program’s development and reform. Rosecrans has represented and spoken on behalf of CDRH in multiple forums, including national conferences, FDA advisory committee meetings, and international symposiums. Her published work includes numerous guidance and regulatory documents. She has also worked collaboratively with CMS and other regulatory agencies.
Eda Ross Montgomery
Senior Director, Technical Steward
Eda Ross Montgomery, Ph. D.is currently Head of PRO.GO, Process Governance and Data Management, Technical Operations, at Shire, where she is responsible for process validation and continuous process verification for Shire’s Plasma and Biologics products. She is also responsible for providing visibility to product and project performance and for strategy and execution around support for major process investigations. She held previous leadership positions in both Technical (R&D and Commercial) and Quality at Shire, Vertex, Bristol-Myers Squibb, and DuPont Pharmaceuticals.
Eda has over 25 years of experience in the pharmaceutical industry and over 15 years experience implementing Quality by Design across all phases of the product lifecycle. She obtained her B.S. in chemistry from Rensselaer Polytechnic Institute and Ph.D. in analytical chemistry from U of North Carolina at Chapel Hill.
Associate Vice President, Technology and Regulatory Affairs
Zach Rothstein is Associate Vice President for Technology & Regulatory Affairs at AdvaMed. In this position, Zach advocates for medical device regulatory policies that are transparent, predictable, consistent, timely, and science-based. Zach’s particular areas of focus include digital health, medical device software, cybersecurity, labeling, and postmarket surveillance.
Prior to joining AdvaMed, Zach was Deputy Senior Counsel for Public Policy at Samsung Electronics where he was responsible for the company’s medical device and healthcare regulatory and policy issues. In this position, Zach counseled Samsung’s global business units through all stages of product development on U.S. regulations affecting digital health, Health IT, and medical devices. Zach also planned and executed the company’s FDA and healthcare regulatory and legislative policy objectives.
Prior to joining Samsung, Zach was an Associate Attorney in the FDA and Healthcare practice at the law firm of Morgan, Lewis & Bockius LLP.
Melinda Ruiz (invited)
District Recall Coordinator
Berkman Sahiner holds a Ph.D. in electrical engineering from the University of Michigan. He has been in the Health Care Industry for over 25 years, first as a faculty member at the University of Michigan Radiology Department for over 15 years, and since 2009, as a researcher with the Division of Imaging, Diagnostics and Software Reliability at the FDA.
He has led many projects as the PI of multiple grants, including grants from the NIH, U.S. Army Medical Research and Materiel Command, Office of Women’s Health at the FDA and the Critical Path at the FDA. He is an author/co-author of over 100 peer-reviewed journal publications and holds two international patents. He is an associate editor of Medical Physics and Technology in Cancer Research and Treatment Journals. He is the chair of American Association of Physicists in Medicine (AAPM) Computer Aided Detection in Diagnostic Imaging Sub-Committee.
His interests include computer-aided diagnosis, machine learning, image perception, clinical study design, and performance assessment methodologies.
Adam Saltman (invited)
Medical Officer, Office of Compliance
Adam E. Saltman, M.D., Ph.D. obtained his undergraduate degree from Harvard University, his M.D. and Ph.D. degrees from Columbia University, and trained in general and cardiothoracic surgery on the Harvard/Deaconess Surgical Service. In 2013, he joined FDA as a Medical Officer in the CDRH Office of Compliance. In addition to reviewing manufacturer recalls, signals, and manufacturer communications, Dr. Saltman has been leading CDRH’s cross-cutting policy revisions concerning benefit-risk and corrections and removals, projects for which he has developed decision analysis tools that advance FDA’s mission to protect and promote the public health.
Dr. Saltman is a fellow of several professional societies, has published more than 100 peer-reviewed articles, has advanced training in Health Informatics, and is certified as a Quality Improvement Associate by the American Society for Quality.
Senior Director, Secure Supply Chain
Matt has over 13 years of experience in the medical device, pharmaceutical and life sciences industry; working both for manufacturers, wholesalers and for a large consulting firm. He has held various roles in the areas of product development, lean six sigma, business system implementation, and operational leadership. His most recent responsibilities have included leading a global medical device serialization effort, device UDI implementation and, until joining AmerisourceBergen, he was the serialization program lead at a mid-size pharmaceutical company.
He is currently the business lead for the serialization efforts at AmerisourceBergen and also manages the team responsible for supporting existing and future DSCSA business tasks.
Cincinnati Children's Hospital Medical Center
Dan Santel is a biomedical informatics Research Fellow at Cincinnati Children’s Hospital, researching applications of artificial intelligence in healthcare with Dr. John Pestian. After receiving his Ph.D. in high energy physics at the University of Cincinnati in 2013, he worked at Certica Solutions (née Cincinnati-based Academic Benchmarks) using AI to help academic publishers match materials to state education requirements. From there, he joined Dr. Pestian’s team at Cincinnati Children’s. Amongst other things, the Pestian research group is currently developing an iPhone app that detects suicidal language in spoken conversations. Dan's current research includes the use of AI and natural language processing in identifying other psychiatric disorders from conversational language.
Senior CPV Engineer
Matt Schmucki began working in the pharmaceutical industry in 2008 supporting the startup of Amylin Pharmaceuticals. He later joined Patheon Pharmaceuticals supporting granulation production before joining AstraZeneca in 2013. He is still with AstraZeneca and is responsible for the West Chester site's Continued Process Verification Program. Matt is a graduate of the University of Cincinnati where he earned his B.S. in mechanical engineering. He later returned to also earn his M.B.A. as well as his M.S. in business analytics.
Vice President of Quality and Regulatory Affairs
Fisher & Paykel
Lindsey Schwierjohann (invited)
Consumer Safety Officer, Drug Specialist
Fred Senatore, M.D.
Medical Officer, CDER/OND/DCRP
Vice President, Global Quality Assurance and Regulatory Affairs
Thermo Fisher Scientific
Marjorie Shulman (invited)
Chief of Premarket Notification (510(k)) Section
Marjorie Shulman is the Director for the Premarket Notification (510(k)) Program in the Office of Device Evaluation (ODE), Center for Devices and Radiological Heath (CDRH), Food and Drug Administration. Ms. Shulman has been with CDRH since 1984. Before serving on the 510(k) Staff she was on the Premarket Approval Staff. Ms. Shulman is also the Reclassification/Classification Coordinator for CDRH. Some of her accomplishments include drafting guidance documents and regulations regarding the 510(k) program, training staff, and assisting in the implementation of the Medical Device User Fee Modernization Act (MDUFMA), FDA Modernization Act (FDAMA) and the Food and Drug Administration Safety and Innovation Act (FDASIA). Ms. Shulman has been on numerous policy setting groups within the FDA. Most recently she has been very active with the 510(k) Working Group whose mission it is to evaluate the 510(k) program and explore actions CDRH could take to enhance 510(k) decision making, 21st Century Cures and reauthorization of MDUFMA. Ms. Shulman received her undergraduate degree from the University of Maryland, University College, and received her MBA from Hood College in May 1997.
Director of the Center for Devices and Radiological Health (CDRH)
Jeffrey E. Shuren became the director of the Center for Devices and Radiological Health at the Food and Drug Administration (FDA) in January 2010. He previously served as Acting Center Director, beginning in September 2009. The center is responsible for assuring the safety, effectiveness, and quality of medical devices; assuring the safety of radiation-emitting products (such as cell phones and microwave ovens); and fostering device innovation. Dr. Shuren received his B.S. and M.D. degrees from Northwestern University under its Honors Program in Medical Education. He completed his medical internship at Beth Israel Hospital in Boston, his neurology residency at Tufts New England Medical Center, and a fellowship in behavioral neurology and neuropsychology at the University of Florida. He received his J.D. from the University of Michigan. Dr. Shuren has held various policy and planning positions within FDA from 1998 to 2009, including acting deputy commissioner for policy, planning, and budget; associate commissioner for policy and planning; special counsel to the principal deputy commissioner; assistant commissioner for policy; and medical officer in the Office of Policy.
Portfolio Development Executive
Jeff Spencer helps companies use their data more effectively driving innovation and decision making throughout the total product lifecycle. Recent projects have focused on quality improvements for medical consumable products, improving operational global operational efficiencies and predicting device performance that drives the patient experience. In over 24 years with Siemens Jeff has also worked to help clients build business cases to justify process transformation, architect solutions and use the power of visualization as a tool for communication. Jeff is a graduate of Iowa State University and is active in Siemens efforts with the FDA to bring process innovation into the case for quality.
President and Principal, Compliance and Regulatory Affairs
John Taylor is the President and Principal of Compliance and Regulatory Affairs for Greenleaf Health, following a distinguished career of more than 20 years at the U.S. Food and Drug Administration. John held three high-profile positions at FDA: Counselor to the Commissioner; Acting Deputy Principal Commissioner; and Acting Deputy Commissioner for Global Regulatory Operations and Policy. As Counselor to the Commissioner, John served as the principal advisor to Commissioner Margaret Hamburg on issues that impacted the agency’s programs, policymaking, management, budget and administration. In his role as Acting Deputy Commissioner for Global Regulatory Operations and Policy, John provided leadership and direction to more than 4,000 employees in FDA’s Office of Regulatory Affairs (ORA) and Office of International Programs (OIP). John began as an attorney within FDA’s Office of the Chief Counsel (OCC) in 1991. In 2005, John left FDA to spend four years working in industry, first as Divisional Vice President for Federal Government Affairs at Abbott, then, in 2007, as Executive Vice President for Health at the Biotechnology Industry Organization (BIO).
Robert Tollefsen (invited)
National Expert Investigator
Robert Tollefsen is the National Expert Investigator for Drugs and Computer Systems in the Division of Field Investigations within the Office of Regulatory Affairs in FDA.
He began his career in FDA in 1991 as a chemist in the drug section of what is now FDA’s Pacific Regional Laboratory Northwest. Tollefsen is called upon to participate in FDA’s more complex inspections of primarily drug and biotech companies across the US and throughout the world. He is an instructor at numerous national training courses for FDA investigators and FDA analysts to include; pre-approval investigations (advanced drug school), basic drug school, orientation to international inspections, computer system validation, introduction to inspections of pharmaceutical laboratories and computer aided inspections.
He has given presentations at numerous academic and industry seminars across the US and internationally and has participated as an instructor at the University of Washington’s course on biomedical regulatory affairs. Tollefsen received his BS with double majors in chemistry and biology and minor in mathematics from Eastern Washington University with honors.
Executive Vice President, Medical Device International Services
Kim Trautman has over 30 years of experience in medical device quality systems and international regulatory affairs. She is focused on expanding international regulatory affairs and compliance services for NSF’s medical device clients, including expanding medical device training services worldwide and spearheading the development of an independent, third-party regulatory certification program.
Ms. Trautman was previously Associate Director for International Affairs in the U.S. Food and Drug Administration’s Center for Devices and Radiological Health (CDRH) where she led the CDRH’s international efforts and initiatives. She was responsible for writing the current U.S. FDA Medical Device Quality System regulation and preamble published in 1996. She also developed and implemented the extensive quality system regulation roll out and training programs, and led continuing harmonization efforts with ISO 13485.
Francisco (Cisco) Vicenty
Program Manager, Case for Quality, Office of Compliance
Cisco Vicentyis currently the Program Manager for the Case for Quality (CfQ) within the Office of Compliance, Center for Devices and Radiological Health (CDRH), FDA. This effort is part of the CDRH strategic priorities for 2016 and 2017. This strategic priority will improve access and outcomes for patients by engaging industry, payers, providers, and patients to increase focus on the quality and performance of medical devices.
Cisco began his career at FDA as a compliance officer in the Cardiac Rhythm and Electrophysiology Branch in the Office of Compliance at CDRH. He then worked as a project manager for the FDA’s Case for Quality initiative. Prior to his current role, Cisco was the Branch Chief of the Respiratory, E/N/T, General Hospital, and Ophthalmic Devices Branch in the Division of Manufacturing and Quality, within the Office of Compliance.
Prior to working with FDA, Cisco Vicenty was a Quality and Reliability Engineer with the Micro-Electronics Business Unit at IBM responsible for emerging server technology lines and network systems along with high volume gaming systems from Nintendo, Sony, and Microsoft.
Quality Head, Professional Services - Informatics & Analytics
Abbott Laboratories, Diagnostic Division
Mohammed has over 19 years of experience in Software Engineering, Compliance and the Healthcare industry. He led several teams that delivered healthcare products at Abbott Laboratories, GE Healthcare and Allscripts. Mohammed contributed to many efficiency improvements at Abbott by designing a modern Agile methodology-based Quality Management System.
Mohammed currently heads the Quality Assurance organization for a Professional Services unit at Abbott that develops business and clinical insights using Data Science and Analytics. He also leads a team that develops algorithms for efficient Complaints Investigations. Mohammed was also the co-founder and CTO for Casheer, a Fintech startup in Crypto Currency space. Mohammed holds a master’s degree in computer science and also has a bachelor's engineering degree in electronics and Instrumentation.
Pharmaceutical and Compliance Consultant
Bill Webb has over 30 years of experience in Pharmaceutical Quality Operations, and in his most recent role, was responsible for internal US WorldMeds Quality Assurance and Quality Control, and international Quality oversight of CMOs and CLOs. Other previous experience includes Director Quality Assurance and Quality Control North America for Aptalis Pharmatech. In that role he was responsible for multi-site Quality Systems compliance, international supplier audits and qualifications. Additionally, while at the Forest Pharmaceutical facility in Ohio, Mr. Webb was responsible for Quality at various levels. Mr. Webb is currently engaged in pharmaceutical and compliance consulting.
Executive Director, Quality Data Sciences
Dan is currently the Executive Director for Quality Data Sciences (QDS) at Amgen, Inc. QDS consists of Quality Data Sciences, Knowledge Management & Analytics, Global Quality Engineering (QE), Statistical Engineering, and Quality Excellence. Quality Data Sciences creates and maintains data science solutions that unlock Amgen data and leverage those data to efficiently provide insights and intelligence for the Quality Operation. Knowledge Management & Analytics owns & maintains the Knowledge Marketplace where experience-based knowledge is collected and used by all Amgen staff members. It also assists with visualization/interpretation of data science results. Global QE and Statistical Engineering complete all statistical requirements for product filings, provide statistical support for delivery devices/suppliers, complete product quality analyses for Annual Product Reviews and provides QE expertise to manufacturing sites and other functions that do not have QE support. Quality Excellence drives Lean QC in all Amgen laboratories, owns the Root Cause Analysis program and leads critical root cause analyses. In addition to leading QE and Operational Excellence groups at Amgen manufacturing site and corporate levels for the past 17 years, Dan has led multiple cross-company initiatives. For example, he led the development and implementation of Quality Risk Management, the Standardized Root Cause Analysis program and innovative graphical analysis approaches to resolve significant product investigations.
Prior to joining Amgen in 2000, Dan led an expansion consulting practice focused on Statistical, Technical and Information Services for Pharmaceutical and Medical Device firms, completed similar activities as an independent consultant and served for 12 years as an officer in the US Air Force. During his last four years in the Air Force, Dan was an Associate Professor of Mathematics at the US Air Force Academy and was the Outstanding Military Educator in Mathematics in 1992. As a seminar leader and college professor, he has educated over 2,000 students in all levels of mathematics.
Dan holds a M.S. in applied mathematics from Harvard University and a B.S. in Mathematics from the US Air Force Academy. He is co-author of Straight Talk on Designing Experiments and is an American Society for Quality Certified Quality Engineer (CQE).
Director, Global CMC Regulatory Affairs
Janssen Research & Development
Leslie Weiss, RPh, MBA, is a Director, Global CMC Regulatory Affairs at Janssen Research & Development, LLC, a division of Johnson and Johnson. She leads a team of CMC professionals who support the introduction of new registrations globally as well as navigate the challenging and exciting world of post approval changes, working closely with the supply chain. Leslie is part of the Continuous Manufacturing team responsible for developing and implementing the global regulatory strategy for CM. Leslie has a pharmacy degree from Rutgers University and a MBA in Health Administration from Widener University. She has spent the past 10 years within CMC Regulatory Affairs with more than 24 years of service at Johnson and Johnson.
Jan Welch (invited)
Director, Office of Medical Device and Radiological Health Operations
Jan Welch serves as director of the Office of Medical Device and Radiological Health Operations, within the Office of Regulatory Affairs (ORA), Food and Drug Administration (FDA). Ms. Welch leads organizational change to a commodity-based program emphasizing specialization and vertical integration of regulatory processes.
Ms. Welch previously led the Office of Compliance in FDA’s Center for Devices and Radiological Health, overseeing the assessment and enhancement of medical device quality through broad-based FDA change initiatives and daily operations. She was also a quality system expert providing expert opinion on medical device legal cases; developing and presenting extensive training on the quality system regulations, and representing FDA and the U.S. in several international guidance and standards activities.
Previously Ms. Welch worked at the Office of Compliance in the Center for Biologics Evaluation and Research. Before joining FDA, she worked for the American Red Cross, the National Institutes of Health,, and Vanderbilt University Medical Center.
Ms. Welch holds a Bachelor of Science in biology from Wake Forest University in Winston-Salem, NC, and a Master of Health Science in immunohematology from the Medical University of South Carolina in Charleston, SC.
Divisional Vice President of Medical, Clinical, Quality and Strategic Support
Monica joined Abbott in 2007 and provides strategic support and technical expertise to the medical device Divisions within Abbott. Prior to joining Abbott, Monica worked for the Food and Drug Administration (FDA). In her 12 years of FDA related experience, she held the positions of Medical Device National Expert, Compliance Officer, Medical Device Specialist, and Investigator. Prior to FDA, her career included 14 additional years of employment in the regulatory, computer, healthcare, and pharmaceutical industries holding the positions of Research Assistant, Quality Control Technician, Microbiologist, Supervisor, Manager, Specialist, Director, and Consultant. Monica has a bachelor's degree in microbiology from the University of Texas at Austin.
Executive VP for Healthcare
Eric Vollmecke serves as the Executive VP for Healthcare for S&P Global, a leading firm in the development of societal enhancement technologies. Eric has a very distinguished military and civilian career, and serves on the Board of Directors for the Network Centric Operations Interoperability Consortium which facilitates interoperability defense and healthcare solutions between government and industry.
Ombudsperson, Office of Regulatory Affairs
Jessica L. Zeller is the Office of Regulatory Affairs (ORA) Ombudsperson at the U.S. Food and Drug Administration and has held this position since its inception in 2015. She is responsible for informally addressing concerns, complaints, and disputes arising between ORA and external parties, including industry, government entities (federal, state, territory, and tribal), and other members of the public. Ms. Zeller began her career at FDA in 2004 as a litigation attorney in the Office of Chief Counsel and subsequently was the deputy director of the Office of Compliance and Enforcement at FDA’s Center for Tobacco Products. Before returning to FDA as ORA ombudsman, Ms. Zeller spent two years as lead FDA attorney for Procter and Gamble. She holds a Bachelor of Science University Scholar degree (biology) from Xavier University and J.D. and M.A. (bioethics) degrees from the University of Virginia.
Mark is a consultant with PwC's Health Industries Advisory practice based out of the San Francisco, CA, office. He has experience working with pharmaceutical and medical device companies to complete programs in quality system design and implementation in the U.S., India, and Ireland, post-merger integration, deals due diligence, and organizational assessments. Mark joined PwC with a background in neural engineering and clinical radiology laboratories. Mark holds a bachelor of science in biomedical engineering and a master of science in biomedical engineering from the University of Southern California.
Global Head of Quality
Vice President for Commercial Technology North America
Bob Zinser, semi-retired, was formerly Vice President for Commercial Technology North America at Patheon. Patheon is a provider of pharmaceutical development and commercial manufacturing services to the pharmaceutical industry. In this role, Bob was responsible for commercial technologies used at the Toronto, U.S. and Puerto Rico sites of Patheon. He has spent 45 years in the pharmaceutical industry, with extensive experience in Quality Control, Manufacturing, Packaging, Supply Chain, Contract Management, Business Management and five years as Cincinnati Site Director. Bob holds bachelor of science and master of science degrees in chemistry, and an M.B.A. in management, all from Xavier University.