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.
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.
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.
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.
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 joins Greenleaf following a distinguished career of more than 20 years at the U.S. Food and Drug Administration. During John’s time at the agency, he led several of its priority initiatives.
At Greenleaf, John continues his commitment to healthcare innovation as the firm’s President and Principal of Compliance & Regulatory Affairs, providing strategic consultation to FDA-regulated clients on enforcement and compliance matters.
From 2009 – 2014, 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. During this time, John was responsible for all phases of criminal and civil litigation related to violations of the Federal Food, Drug, and Cosmetic Act, and other federal laws. In 1997, John was promoted to Senior Advisor for Regulatory Operations and Policy within FDA’s Office of the Commissioner; he was later named Director of the Center for Drug Evaluation and Research’s (CDER) Office of Compliance. In 2000, John accepted his position as Director of ORA’s Office of Enforcement. Two years later, John was promoted to Associate Commissioner for Regulatory Affairs (ACRA).
In 2005, John left FDA to spend four years working in industry, first as Divisional Vice President for Federal Government Affairs at Abbot, then, in 2007, as Executive Vice President for Health at the Biotechnology Industry Organization (BIO).
John has received multiple honors, including the Health and Human Services Secretary’s Award for Distinguished Service (1997, 2000, 2003, 2004, 2005 and 2011) and the FDA Award of Merit (2000, 2003 and 2005). John received his J.D. from the College of William and Mary and is a graduate of Pennsylvania State University with a B.A. in History.
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).
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.
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.