2022 Speakers

Federico (Fede) Anzil

Advanced Technology and Digital Manufacturing Manager, Lima Corporate

Federico Anzil graduated from the Polytechnic University of Milan and holds a master of science degree in biomedical engineering. He is currently leading Advanced Manufacturing activities and the development of Digital Manufacturing projects in Lima Corporate as a global provider of niche and tailored orthopedic solutions.

Throughout his 10-year career at Lima, Anzil has largely contributed to the development of the strategic vision of the company, leveraging the development of special processes and the integration of new technologies.

Pat Baird

Regulatory Head of Global Software Standards, Philips

Pat Baird works at Philips as the Head of Global Software Standards. He likes to think of his job as “Policy Engineering” – understanding the unmet needs (and frustrations) of regulators and  developers, and developing standards, whitepapers, and training to meet those needs. His current passion is related to artificial intelligence in healthcare; he is co-chair of multiple AI committees including AAMI, ISO/IEC TC215, CTA, MITA, MDIC.

Jeff Ballyns

Associate Director Regulatory Policy, BD

Jeff Ballyns, PhD Is an Associate Director of Regulatory Policy at Becton Dickinson and Company (BD). BD designs, manufactures, and sells a wide range of medical devices, including in vitro diagnostic (IVD) products worldwide. He is responsible for gathering, assessing, and communicating new regulatory policy requirements impacting BD businesses.

Prior to joining BD, Ballyns worked in the Center for Devices and Radiologic Health (CDRH) at the U.S. Food and Drug Administration for 8 years. While at the FDA, he served as a lead reviewer, Branch Chief and Division Director in the Division of Radiological Health within the Office of In Vitro Diagnostics and Radiological Health. He was responsible for the pre-market review and post-market regulation of radiological imaging devices and artificial intelligence (AI) image analysis software applications. Ballyns received his bachelor’s and PhD degrees from Cornell University in mechanical and aerospace engineering and biomedical engineering respectively.

Burns Blaxall

Executive Director, Precision Medicine, The Christ Hospital Health Network

Burns C. Blaxall, PhD, is the founding Executive Director of Precision Medicine at The Christ Hospital Health Network (TCHHN).  He leads a transition from reactive to proactive healthcare delivery by harnessing the power of personal diagnostic and genomic data.  Using approaches ranging from cutting edge hereditary disease risk assessment, genetic counseling and testing to pharmacogenomics and genome-guided clinical care pathways, Precision Medicine at TCHHN aims to provide proactive, individualized care for every patient.

George Brunner

Chief Data Scientist, Acumen Analytics

George Brunner is the Chief Data Scientist at  Acumen Analytics. Acumen Analytics, based outside of Philadelphia and founded in 2004, is an award winning WBE technology solution provider for the pharmaceutical, biotech, manufacturing, and technology industries. Acumen is a leader in using data, technology, advanced analytics, innovation, and expertise to help drive transformation in the life sciences. Acumen helps organizations combine innovation with technology not just to improve but to accelerate outcomes and make the impossible possible. Acumen team members combine decades of Life Science experience with intelligent, resilient, future forward technology solutions, data, and a passion for possibilities.   

He has worked in Life Sciences companies for over 20 years, starting with Nanosystems, Inc a subsidiary of Kodak Sterling, Elan Corporation a pharmaceutical and drug delivery company headquartered in Dublin, Ireland and Johnson and Johnson in it Consumer Products OTC Drug division where he headed up the Laboratory Computing Group which provided IT, Analytics and Validation services to both R&D and Quality Labs in the US and Puerto Rico.  

He holds a Bachelor degree in Mathematics from Temple University and an MBA from Villanova University. He has taught Operations Mgt, Advanced Analytics, Six Sigma and Contemporary IT Mgt courses at both Villanova and St. Joseph’s Universities.

Koen Cobbaert

Senior Manager, Quality, Standards & Regulation, Philips

Koen Cobbaert works for Philips as a quality, regulatory, and standards expert. Through trade associations COCIR and DITTA, he represents the industry at the European Commission and the IMDRF on matters related to software and artificial intelligence. He also contributes to various standardisation organizations focusing on software and artificial intelligence.

In the legislative domain, Koen chairs COCIR’s and DITTA’s software focus groups, representing its members at respectively the European Commission MDCG workgroups on Borderline and Classification and New Technologies and at the international level at the International Medical Device Regulators Forum (IMDRF) workgroup on artificial intelligence. Koen is also an advisor in the SaMD workgroup at the Global Harmonization Working Party (GHWP). Currently, Koen is engaged in various proposed EU legislation relating to artificial intelligence and data (AI Act, Machinery Regulation, General Product Safety Directive, Data Act…). Aside from various publications through trade associations, Koen also edited the book Software as a Medical Device, published through the Regulatory Affairs Professionals Society (RAPS).

In the standardization domain, Koen is a member of CEN-CENELEC’s Industry Advisory Forum, and he is delegated as a Belgian expert to IEC JTC 1 SC 42 on artificial intelligence, CEN-CENELEC JTC21 on artificial intelligence, ISO TC215 JWG7 on health informatics, and to the IEC SC62A Advisory group on Software, Networks, and Artificial Intelligence (SNAIG).

Koen has a Master of Science in electrical engineering and safety risk management. He has over 15 years of hands-on experience establishing regulatory and market-access strategies for medical device software, performing worldwide regulatory submissions, and moderating risk management and clinical evaluation for software applications for general radiology, oncology, neurology, cardiology, orthopaedics, and clinical pathology. He has worked on software applications for pattern recognition, computer-aided detection, reasoning engines, clinical pathways, and other clinical decision support systems, including mobile apps, embedded software, and software operating in the cloud.

Alex Cadotte

Director, Software & Digital Health, MCRA

Dr. Cadotte specializes in FDA interactions and strategy, development of regulatory submissions, medical and regulatory writing, review and analysis of pre-clinical and clinical data, design of clinical trials, regulatory review of marketing materials, and regulatory strategy for medical devices. He specializes in medical device software, Software as a Medical Device (SaMD), Software in a Medical Device (SiMD), Artificial Intelligence / Machine Learning (AI/ML) devices, Clinical Decision Support, Predetermined Change Control Plans, and Computer Aided Devices including Triage, Notification, Detection, and Diagnosis (CADt, CADe, CADx, and CADe/x).

Dr. Cadotte was the Team Lead for Imaging Software review at FDA, leading a team of scientists, clinicians, and engineers in the regulation of imaging software devices marketed in the United States. His specialty being computer aided devices including Computer Aided Triage and Notification (CADt) and Computer Aided Detection and Diagnosis (CADe, CADx, CADe/x) devices which included the majority of AI/ML devices currently reviewed by CDRH. He previously served as a Health Scientist and Team Lead with Digital Health at FDA where he worked on software review and the Pre-Certification Program. He was also a member of the CDRH Artificial Intelligence Machine Learning Working Group where he contributed to the white paper “Proposed Regulatory Framework for Modifications to Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device” and the “Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device (SaMD) Action Plan.”

Dr. Cadotte received a M.S and Ph.D. in Biomedical Engineering, specializing in Neuroengineering and Multivariate Time Series Analysis, from the University of Florida. He also received a Bachelor of Science in Chemical Engineering from Virginia Tech.

Matthew Diamond

Chief Medical Officer for Digital Health, FDA-CDRH Digital Health Center of Excellence

Matthew Diamond, MD, PhD is the Chief Medical Officer for Digital Health at FDA’s Center for Devices and Radiological Health (CDRH), where he is the senior clinical expert and focal point of contact for clinical issues related to digital health medical devices. In his role at the CDRH Digital Health Center of Excellence, Dr. Diamond provides leadership for digital health policy development and implementation for emerging technologies including artificial intelligence.

Jesse Ehrenfeld

President Elect American Medical Association

Jesse Ehrenfeld, MD, MPH, is President-Elect of the American Medical Association, a Senior Associate Dean, tenured Professor of anesthesiology and Director of the “Advancing a Healthier Wisconsin Endowment” at the Medical College of Wisconsin. Dr. Ehrenfeld divides his time between clinical practice, teaching, research and directing a $560-million statewide health philanthropy. A consultant to the World Health Organization Digital Health Technical Advisory Group, Dr. Ehrenfeld is co-chair of the AAMI AI committee and previously served as co-chair of the Navy Surgeon General’s Taskforce on Personalized and Digital Medicine and as a special advisor to the 20th U.S. Surgeon General.

Board certified in both anesthesiology and clinical informatics, Dr. Ehrenfeld’s research, which focuses on understanding how information technology can improve surgical safety and patient outcomes, has been funded by the National Institutes of Health (NIH), the Department of Defense, the Robert Wood Johnson Foundation, the Anesthesia Patient Safety Foundation, and the Foundation for Anesthesia Education and Research.

Shawn Forrest

Digital Health Specialist at Digital Health Center of Excellence, FDA

Shawn Forrest led and supervised pre- and post-market reviews of primarily cardiovascular digital health devices for about 15 years before joining the Digital Health Center of Excellence in 2021. He now leads projects related to artificial intelligence/machine learning (AI/ML)-enabled medical devices and medical device interoperability.

Todd Goldstein

Director of 3D Design and Innovation, Northwell Health

Todd Goldstein’s is the Director of Northwell Health’s Department of 3D Design and Innovation. The department focuses on utilizing 3D technologies both in the clinic and in the laboratory. Dr. Goldstein’s Lab focuses on anatomical models, patient specific treatments, and tissue engineering. Most recently his team has developed and deployed multiple devices for COVID-19 pandemic response. Additionally, he has developed amphibious prosthetic legs for both civilians and wounded warriors.

Lacey Harbour

Regulatory Affairs Manager, Thermo Fisher Scientific

Lacey Harbour is a classically trained molecular biologist turned Regulatory, Quality, and Clinical Strategist with experience that ranges from the Clinical Laboratory, R&D, Pharmaceuticals, and Medical Devices industries.  Leveraging her diverse background, she has led and/ or supported teams that have brought orthopedic, in vitro diagnostic, SaMD, dental, physiotherapeutic, and other FDA Class I to Class III devices to the global market with high quality. 

Starting from the exposure of validating predictive systems in the operational and diagnostic sides of the clinical laboratory, proving safety and effectiveness of machine learning algorithms in the total product life cycle of healthcare has been a passion for many years.  As an advocate of protecting patients while taking a risk based, least burdensome approach, joining think tanks like AFDO/RAPS is an honor as the ultimate goal is to ensure that the future of medical care is maintaining the state of the art while maintaining safety and effectiveness and, hopefully, will encourage global accessibility of good health care products. 

Eric Henry

Senior Quality & Regulatory Compliance Advisor, FDA & Life Sciences Practice, King & Spalding

Eric Henry is a 30-year industry veteran currently serving as Senior Quality Systems and Compliance Advisor in the FDA and Life Sciences practice of the law firm King & Spalding.  In this role, he advises King & Spalding clients on a variety of regulatory compliance matters including Quality System establishment and remediation, establishment of quality organizations, audit and inspection management and response, compliance-related due diligence reviews for M&A, training, and serving as expert witness during litigation. 

Prior to King & Spalding, he led global quality, compliance, and technology organizations for several large and medium-sized medical device companies.

James Hunter

Associate Director, Point of Care, BD

James Hunter is an Associate Director of Product Management in BD’s Point of Care business. In this role, he is responsible for setting digital product strategy and launching digital products that make testing simple and available to all. Hunter joined BD from Scanwell Health, where he helped launch the BD VeritorTM At-Home COVID-19 Test with BD. He brings 10 years of experience launching new services and offerings at leading healthcare companies.

Cynthia Ipach

President and CEO, Compliance Insight

Cynthia Ipach, President and CEO of Compliance Insight, Inc., founded the company in 2000.  With over 30 years of experience in the pharmaceutical, medical device, dietary supplement, and biologic industries, Cynthia has supported hundreds of companies in their pursuit of FDA compliance. 

Ipach began her career in Analytical Research and Development and later moved to Regulatory Affairs and Quality Assurance positions within the Pharmaceutical Industry.  In 2000, she left the corporate environment and her position as Director of Scientific Affairs for Pharmacia to start the Quality Assurance and Regulatory Affairs consulting firm known as Compliance Insight, Inc., whose mission is to align with client compliance initiatives to move beyond the regulations to compliance that makes sense.

Recently, she has been active in the AI in Operations Group (AIO) of AFDO/RAPS (formerly Xavier Health).  She also contributed to the “Perspectives and Good Practices for AI and Continuous Learning Systems in Healthcare” whitepaper, August 2018 and co-lead the team that developed the AI Maturity Level Characterization Model 2020 and the Maturity Level Characterization of Artificial Intelligence (AI) Capabilities for Self-Assessment whitepaper, June 2021.

Ling Koh

Regulatory Affairs Manager, BD

Ling Koh is a Regulatory Affairs Manager in BD’s Point of Care business with eight years of experience developing smartphone-based diagnostic applications for urinary tract infections, malaria, Covid-19, and the flu. Koh first started as an R&D engineer at a traditional in vitro diagnostic company, then moved into a hybrid R&D/regulatory role at Scanwell Health (a 4-person start-up at the time) before joining the BD family. With a deep understanding of both the assay and the app, she offers a holistic and technical perspective in an emerging SaMD landscape.

Toni Manzano

Co-founder and CSO, Aizon

Toni Manzano is co-founder and CSO of Aizon, a cloud company that provides big data and an AI SaaS platform for the Biotech and Pharma industry. Since 1996 he has led software projects for international pharmaceutical companies covering the entire production process and supply chain (R&D, clinical trials, production, laboratory, quality assurance, warehousing, and logistics). In pharma manufacturing he was specifically dedicated to biotech processes, always improving critical operations. Manzano has also led projects implementing solutions based on the 3 ICH (Q8, Q9, and Q10) and executing audit, qualification, and validation tasks. Today he is in the scientific committee of the PDA Europe supporting annual events for the innovation and technology in pharma.

Manzano also worked as a researcher at the University of Barcelona as a physicist, and he teaches Big Data and Artificial Intelligence subjects related with the Pharma Industry in specific postgraduate courses at the University (UAB). He has written numerous articles in the Pharma field and holds a dozen international patents related to the encryption, transmission, storage, and processing of large volumes of data for regulated environments in the cloud. Manzano is a physicist, master in information and knowledge society, and post-graduate in quality systems for manufacturing and research pharmaceutical processes.

Rohit Nayak

CEO, Electronic Registry Systems, Inc.

Rohit Nayak currently leads Electronic Registry Systems, Inc., a cancer informatics firm that is at the forefront of providing cancer programs nationwide with a valuable foundation of data and insights that provide the best cancer care for every patient. He also serves as an advisor/board member for several early stage companies and not-for-profit organizations.

Nayak has a successful track record as strategic global leader and change catalyst, leveraging digital innovation, commercial execution, and P&L management skills across Fortune 500, start-up, and emerging growth organizations, most recently in healthcare. Notably, he’s led a healthcare technology start-up from vision to capitalization to execution and eventual sale/exit to a Fortune 500 company.

Most recently, Nayak led the formation of the global Digital Health team at Baxter – he was responsible for driving innovative software-enabled solutions to leverage their medical device portfolio. Prior to Baxter, Nayak had several roles of increasing responsibility at Quest Diagnostics, where he was responsible for successfully developing and growing a P&L, delivering customer-facing healthcare analytics solutions across the ambulatory, acute, and payer markets. He previously co-founded and led an ePrescribing healthcare software company that was subsequently acquired by Quest Diagnostics.

Patrick Pavlick

Director of Diagnostic and Informatics, Rare Diseases, Sanofi

Pat has been part of the US Rare Medical Diagnostic team at Sanofi for over 5 years. This team is responsible for shortening the diagnostic odyssey associated with rare lysosomal storage disorders. Pat spearheads Project Searchlight, an AI/ML initiative designed to mine aggregated electronic health records to assess patients and identify those needing confirmatory testing for diagnosis. Before joining Sanofi, Pat had over 20 years in pharma and biopharma with roles in sales, marketing, and leadership.

Bakul Patel

Senior Director, Global Digital Health Strategy & Regulatory, Google

Bakul Patel is the Senior Director, Global Digital Health Strategy & Regulatory,  focused on helping build a unified digital health strategy for Health@Google that’s aligned with global regulatory needs. Patel is responsible for global regulatory affairs strategy  and regulatory science engagement with public and private stakeholders for health efforts at Google and Alphabet. 

Patel’s vision for his role at Google: help realize the potential of digital health, which is poised to be a game-changer in heralding a new era for healthcare generally — one that is ubiquitous and ready to deliver care to all individuals, including preventing and predicting disease and keeping people healthy and out of the hospital. 

Prior to joining Google, he held the position of Chief Digital Health Officer of Global Strategy and innovation and Director for Digital Health Center of Excellence at the FDA, where he provided thought leadership and shaped responsible regulation for this emerging field of digital health. 

In his 13-year tenure at the FDA, he was instrumental in setting a national strategy and policy for how digital health technologies and software can be evidence based. In 2013 he coined the term software as a medical device (SaMD), and ultimately built a framework that set the foundational standard medical device regulators globally.  He is known for the launch of the software precertification pilot program and, more recently, the framework for Artificial Intelligence/Machine Learning (AI/ML)-Based Software.

Patel brings several years of leadership experience in several sectors including the telecommunications industry, semiconductor capital equipment industry, wireless industry, and information technology industry. He earned a master’s degree in electronic systems engineering from the University of Regina, Canada, and an MBA in international business from The Johns Hopkins University.

Vishaka Rajaram

Director of Operations Transformation, Price Waterhouse Cooper

Vishaka has over 16 years of experience delivering strategic, tech-enabled Quality Transformations for biopharmaceutical, medical device, and emerging technology companies in the Life Science Industry.

Her end-to-end Quality Systems experience in the life science industry spans the product lifecycle from new product development to commercial operations to post market quality.

Vishaka is especially passionate about technology as an enabler of Quality and has helped clients develop short- and long-term enterprise quality system strategies, and implement electronic systems including cloud-based eQMS, eDMS, PLM, automations and analytics to drive predictive quality and improve operational performance.

Shruti Rajagopalan

Regulatory Compliance Manager, Google

Shruti Rajagopalan is a Medical Device and Compliance expert with broad technical background and experience in design, development, Artificial Intelligence/ Machine Learning, and commercialization of consumer and medical devices. She is an SaMD and medical device launch expert in global markets. Rajagopalan currently leads the Regulatory Affairs team at Google.

Matthew Schmucki

Data Analyst, Corporate Quality & Strategy, AstraZeneca

Matt is a Data Analyst for AstraZeneca’s Corporate Quality & Strategy department. He supports the Quality Management Systems by addressing business problems related to data and analytics. For over the past decade, Matt has supported many types of products from oral solid dose to biopharmaceutical combination products with startups, CMOs, and top pharmaceutical and biopharmaceutical companies. Matt is a mechanical engineer from the University of Cincinnati with his Doctorate in Business Intelligence. Matt is also a Guest Lecturer for Xavier University for both the Quality Science Regulations and Industrial Product Development programs. These lectures introduce undergraduate students to concepts and practices fundamental to the pharmaceutical and medical device industries.

Sundar Selvatharasu

Chief Compliance Officer – GxP Operations, Sierra Labs

Sundar Selvatharasu is an FDA compliance expert known for his pragmatic advice to strategize and execute value-based solutions for emerging technologies in the biopharma, medical devices, healthcare, and cannabis industries. He constantly collaborates with current and former regulatory agency officials across different regions to train and to impact regulations on technology adoption. Selvatharasu has led multiple audits globally for some of the largest drug and device companies. He is a regular speaker at conferences and has published on topics of security, data integrity, compliance, and agile quality systems.

Kip Wolf

Head of Technical Operations and Portfolio Management, X-Vax Technology, Inc.

Kip Wolf is Head of Technical Operations and Portfolio Management at X-Vax Technology, Inc. He has more than 25 years of experience as a management consultant, during which time he has also temporarily held various highly visible leadership positions at some of the world’s top life sciences companies. Wolf has temporarily worked inside the life sciences industry on 2 occasions, both during periods of significant transformational change: first inside Wyeth, pre-Pfizer merger; and, again inside Merck, post-Schering merger. In both cases he led business process management (BPM) groups: at Wyeth, in the manufacturing division; and at Merck, in the research and development division. Wolf consults, teaches, speaks, and publishes regularly on topics of data integrity and quality systems.