Digital Health - QA/RA, Apple, United States
Session Chair Invited
Manager, DIA, United States
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Associate Director, Combination Products, AstraZeneca, United States
Ryan McGowan is the Director of Digital Devices and Combination Products in Regulatory Affairs at AstraZeneca. He has responsibility for developing regulatory strategies for the approval of combination products and digital health products including software as a medical device. Prior to joining AstraZeneca, Ryan was a premarket reviewer and combination products team leader at FDA’s Center for Devices and Radiological Health where he evaluated and influenced regulatory policy for drug delivery constituent parts of combination products.
Nancy Stade, JD
Partner, Sidley Austin LLP, United States
Nancy Stade is a partner in the Food, Drug, and Medical Device regulatory practice of Sidley Austin, LLP, where her practice focuses on counseling medical device companies, manufacturers of combination products, life sciences companies, and makers of consumer products used in health and fitness. Nancy previously held a variety of senior positions at the FDA, including Deputy Director for Policy of the Center for Devices and Radiological Health, where she led the development and implementation of FDA’s device regulatory policy.
Rachel Turow, JD, MPH
Managing Counsel, FDA Regulatory, Walmart, Inc., United States
Rachel Turow is Associate General Counsel, Regulatory Law & Policy at Teva Pharmaceuticals and Head, U.S. Regulatory Policy. In this role, Rachel provides regulatory legal support to Teva’s specialty and generic pharmaceutical businesses, and supports Teva’s drug-device combination products and digital health projects. Rachel also serves as head of regulatory policy for the U.S. Previously, Rachel was Director, Regulatory Policy, at Novo Nordisk Inc. Prior to joining Novo Nordisk, Rachel spent five years at FDA. She was a Regulatory Counsel in CDER’s Office of Regulatory Policy and she served as Special Assistant to Jeff Shuren, Director of CDRH. Rachel holds a JD and MPH from the University of Michigan and a BA in Biology from
James Wabby, MHS
Global Head, Regulatory Affairs, Emerging Technologies and Combination Products, AbbVie, United States
James Wabby is the Global Head, Regulatory Affairs - (CoE) Emerging Technologies, Devices, and Combination Products at AbbVie in Irvine, California. He has 22 years of experience in increasing quality compliance and regulatory affairs responsibilities within the GxP regulated environment pertaining to Nutritional, Cosmetic, Branded Pharmaceutical, Generic, Biologic, Medical Device and Combination Product areas. James received his undergraduate and graduate degrees from Duquesne University and received his Health Care Compliance Certificate from Seton Hall University Law School. He is a member of various regulatory and quality work groups including RAPS, OCRA and the ASQ Orange Empire Section.
John Weiner, JD
Associate Director for Policy, Office of Combination Products, OCPP, OC, FDA, United States
John Barlow Weiner is the Associate Director for Policy in the Food and Drug Administration's Office of Combination Products, which is tasked with ensuring the sound and consistent regulation of combination products and also with the classification and assignment for regulation of medical products (drugs, devices, biological products, and combination products).
Business Development - Digital Strategy, Otsuka America Pharmaceuticals, Inc., United States
Senior executive with track record of delivering strategies and corporate development initiatives that grow and transform healthcare companies. 20+ years in: digital health, life sciences, medical devices, payers, and providers. Wharton MBA with dual concentration in Health Care Management and Finance.
Kirsten H. Paulson, MS, RAC
, Pfizer, Inc., United States
Kirsten Paulson, RAC, is the Senior Director, Global CMC-Medical Devices at Pfizer Inc., with the lead for Combination Products, diagnostics and software medical devices. She was previously the Senior Officer, Medical Device Initiative of The Pew Charitable Trusts and Head of the PPD Medical Device and Diagnostics group. She began her career as an FDA medical device reviewer. Kirsten has a BS from Boston University and an MS in Bioengineering from Penn State.
Research Scientist, Global Regulatory Affairs, CMC-Devices, Eli Lilly and Company, United States
Kevin Bardonner has supported Lilly’s insulin pen platforms for almost 7 years, first as a project manager and now as a regulatory scientist. Kevin’s current focus is identifying global regulatory pathways for Lilly’s digital diabetes health portfolio (open loop). Kevin has over 15 years of experience in the pharmaceutical industry, including roles as a financial analyst supporting R&D and as a manager in Lilly’s clinical trial material management division. Kevin holds master’s degrees from Northwestern University in business and engineering management (MBA/MEM), and he obtained his BS degree in mechanical engineering from the U.S. Military Academy at West Point.
James P. Bertram, PhD, MS, RAC
Director, Office of Combination Products, OC, FDA, United States
James Bertram is currently an Assistant Director with the Regulation, Policy, and Guidance Staff in CDRH/OPEQ. In this capacity, James and his team collaborate across the Agency on cross-cutting policies, many of which apply to the review and regulation of combination products.
Melissa Burns, MS
Senior Program Manager, Office of Combination Products, OCPP, OC, FDA, United States
CAPT Melissa Burns is a Senior Program Manager in FDA’s Office of Combination Products (OCP). In this role, she is responsible for coordinating activities related to combination product review and regulation including development and review of guidance documents, regulations, and procedures and policies. Prior to joining OCP, Melissa worked for several years in FDA CDRH. Melissa worked for several years in the private sector including positions with a medical device manufacturer, a hospital, a healthcare architecture firm, and a consulting firm. Melissa received a Bachelor of Science degree in Mechanical Engineering from Virginia Tech and a Master of Science degree in Biomedical Engineering from The University of Connecticut.
David B. Clissold, JD, MA
Director, Hyman Phelps & McNamara, United States
David B. Clissold has broad-based experience advising pharmaceutical, biotechnology, medical device, food, and dietary supplement clients on regulatory and legislative matters. He provides guidance throughout the product lifecycle, which includes clinical trials and drug development, advertising and promotion, orphan drug designations, and Hatch-Waxman exclusivity. Mr. Clissold also helps clients with a range of enforcement actions, including FDA inspections and Application Integrity Policy actions. In recent years, Mr. Clissold has steered Hyman, Phelps & McNamara’s team of attorneys focusing on FDA’s regulation of tobacco products and nicotine replacement therapies.
Kate Cook, JD
Principal, Regulatory Policy, Greenleaf Health, United States
Kate Cook joined Greenleaf Health following a 22 year career with FDA, serving in the Office of Chief Counsel, the Center for Devices and Radiological Health, and the Center for Biologics Evaluation and Research. She provided crucial direction on strategic initiatives related to the regulation of drugs, biological products, medical devices and combination products. Kate now leads Greenleaf's services supporting clients with expertise and guidance on FDA regulatory policies and programs, working with clients to bring innovative medical products to patients.
Advisor/Director, Global Quality, Eli Lilly & Company, United States
Advisor/Director - Quality, Medical Devices & Combination Products, Eli Lilly & Company
Principal Consultant, PAREXEL International, United States
Sugato De is a Principal Consultant at PAREXEL International, where he uses his extensive scientific, technical, and regulatory expertise to advise companies on clinical development and regulatory strategies for medical devices, in vitro diagnostics and combination products. Prior to joining PAREXEL, Sugato held several positions with the FDA’s Center for Devices and Radiological Health over 11 years, most recently as a Senior Policy Advisor to the Center Director. In this role, he was heavily involved in the development of new policy development and implementation for combination products, early-stage clinical trials, and digital health technology.
Regulatory Counsel, Office of Generic Drugs, CDER, FDA, United States
Sheryl L. Lard Whiteford, PhD
Associate Director for Quality Assurance, OCD, CBER, FDA, United States
Sheryl Lard-Whiteford, MS, PhD, is the Associate Director for Quality Assurance in the Center for Biologics Evaluation and Research (CBER). With 32 years of experience at FDA, Dr. Lard serves as the center's Chief Product Jurisdiction Officer, working closely with the Office of Combination Products and center counterparts to help ensure consistency and predictability in product jurisdiction decisions, generate guidance on product classification practices and address cross-center review issues. She also works within CBER on matters related to CBER product classification, assignment and regulatory path considerations as well as serving as the center’s Ombudsman, and supervisor for its quality management group.
Kristina Lauritsen, PhD
Combination Products Regulatory Policy Advisor, OEP, CDER, FDA, United States
Kristina Lauritsen, PhD serves as a Combination Product Policy Advisor within the Center for Drug Evaluation and Research (CDER) at the FDA. In this role, she is responsible for engaging in development of CDER's policies related to combination product review and regulation, including activities such as guidance development, facilitating coordination with the FDA's Office of Combination Products, CBER and CDRH, and representing CDER in cross-center combination product working groups. Prior to joining CDER in 2014, she spent four years in the Center for Devices and Radiological Health, followed by seven years in the Office of Combination Products. She holds a B.S. in Biology from Shippensburg University.
Yuri Maricich, MD, MBA
Chief Medical Officer and Head of Development, Pear Therapeutics, United States
Dr. Maricich leads the Clinical/Regulatory/Quality group at Pear Therapeutics as the Chief Medical Officer and Head of Development. He leads and manages the development programs from Discovery/TPP stage, thru Translational, Clinical Development, Regulatory submission and review as well as Medical Affairs. In addition to overseeing subsequent pipeline programs across a broad-spectrum of disease areas (such as CNS/neuroscience, cardiovascular, and oncology), he led reSET (1st prescription digital therapeutic) and reSET-O (1st combination of drug and software treatment) programs. Dr. Maricich completed his education and training at Harvard University, the University of Washington, the University of Notre Dame, and the University of Virginia.
Tina Murphy, PhD
Global Program Regulatory Director, Regulatory Affairs Innovation, Novartis Pharmaceuticals Corporation, United States
Tina is responsible for developing regulatory strategies for digital projects across Novartis Development Units and NIBR. In this role, she manages programs focused on utilizing digital devices such as sensors and wearables for the measurement of novel digital endpoints. She provides regulatory expertise in the area of digital medicines, medical devices, SaMDs and combination products. Prior to Novartis, she was a regulatory consultant for ICON plc where she advised clients on US and EU regulatory requirements, and authored regulatory submissions for FDA, Notified Bodies, and WHO. Tina holds a Ph.D. in pharmacology from Boston University School of Medicine.
Associate Director - Medical Devices and Combination Products, AstraZeneca, United States
Associate Director - Medical Devices & Combination Products AstraZeneca
Suzette Roan, JD, MS
Senior Director, GRA Device Combination Products, Sanofi, United States
Suzette Roan joined Sanofi as Sr Director, Device Reg Affairs in Sept. 2017 and is responsible for combination product and diagnostic device regulatory strategies for products in the portfolio. Prior to Sanofi, Suzette worked at Biogen for 3 years leading the combination product regulatory team. Previous to her time at Biogen, Suzette was with Pfizer for 19 years, with roles in Analytical Development, Outsourcing and Reg CMC. She has experience with pulmonary inhaler, prefilled syringe, autoinjector and on body delivery systems. Suzette holds a BS in Chem from Univ of CT, a MS in Mgmt from Albertus Magnus College and a JD from Univ of CT School of Law. She active member in ISO/TC 84 and is chair of the CPC Submissions working grou
Sarah H. Stec
Senior Counsel, Regulatory Law, Johnson & Johnson, United States
Sarah H. Stec is a Senior Counsel, Medical Device Regulatory Law at Johnson and Johnson. She has experience in assisting life sciences companies understand new and evolving regulatory duties, including how those international regulations can work together as well as providing guidance on international corporate and regulatory issues. Her experience gives her a unique view on the legal and regulatory requirements for medical device manufacturers. Sarah previously worked with Squire Patton Boggs (US) LLP and LNE/G-MED North America, Inc.
Alan Stevens, MS
Acting Division Director, Division of Drug Delivery, General Hospital and Human , FDA, United States
Alan Stevens is acting Division Director of FDA's Division of Drug Delivery, General Hospital and Human Factors. His division is responsible for regulation of drug delivery and general hospital device premarket submissions and postmarket safety and compliance. The division also provides evaluation of human factors information. Prior to his current assignment, he was the Assistant Director for the CDRH Injection Devices Team and spent ten years as a premarket reviewer and three years as a compliance officer in CDRH. He has a masters degree in reliability engineering and undgraduate degree in mechanical engineering from the University of Maryland.
Kimberly Trautman, MS
Managing Director and Vice President, MEDIcept Inc., United States
Experienced Medical Devices, IVD and Combination Product Expert with over 30 years of experience, including 24 years working at the U.S. FDA CDRH. Author of the 1996 Medical Device Quality System regulation and member of the authoring group for Combination Product GMPs in Part 4. US Expert on GHTF and IMDRF 1991-2016, working with Regulatory Agencies around the globe. At FDA conceived and developed the Medical Device Single Audit Program (MDSAP) and in the private sector opened an Auditing Organization and a new Notified Body in Ireland for EU IVDR/MDR Designation. Executes regulatory and QMS services to include consulting, auditing, and education. Masters degree in Biomedical Engineering.
Global Vice President, Biosimilar Regulatory Affairs, Teva Pharmaceuticals, United States
Director, Program Management, Otsuka America Pharmaceuticals, Inc., United States
Kevin Wurch, Director, Clinical Program Management at Otsuka Pharmaceutical Development & Commercialization, Inc. (Otsuka) has centered his career in drug and device development and program management across cardiovascular and central nervous system therapeutic areas. Joining Otsuka five years ago, Kevin manages the Digital Medicine Program encompassing clinical studies, product management and regulatory submissions. Kevin holds a MS from Stevens Institute of Technology, BS from James Madison University and is a certified Project Management Professional (PMP).
Scooter Plowman, MD, MHS, MBA
Medical Director, Proteus Digital Health®, Inc., United States
Thinh X. Nguyen
Director, Office of Combination Products, OCPP, FDA, United States
Mr. Nguyen is the Director of the Office of Combination Products (OCP) since January 2008. OCP is primarily responsible for making jurisdictional determinations, ensuring timely premarket reviews, ensuring consistent and appropriate post-market regulations, and developing policy, guidance documents, and regulations. Mr. Nguyen joined the agency in 1993 as a scientific reviewer in the Office of Device Evaluation (ODE), Center for Devices and Radiological Health (CDRH). From 2000 - 2007, Mr. Nguyen was the Chief of the Pre-Market Approval Program in CDRH where he was primarily responsible for ensuring the uniform and consistent application of the PMA regulations and policies across CDRH and CBER.
Kirk Seward, PhD
Co-founder, President, Chief Science & Technology Officer, Mercator Medical, United States
As founder, President and Chief Science and Technology Officer at Mercator MedSystems, Dr. Seward has invented and pioneered micro-infusion device technologies to deliver drugs and biologics deep in the body with precision, reducing off-target effects. With applications in vascular disease, hypertension, cardiac regenerative medicine, cancer, and respiratory diseases, micro-infusion technology research has led him from device R&D into clinical research and regulatory compliance. He has navigated drug and device regulation in the U.S. and is working at the forefront of regulatory changes to address gaps in the approval pathways for novel devices delivering generic drugs.
Christy L. Foreman
Senior Consultant, Biologics Consulting, United States
Christy Foreman recently joined Biologics Consulting as a Senior Consultant after spending 28 years working for the federal government with 22 of those years spent at the FDA. While at FDA she served in many capacities in both premarket and postmarket roles, including as a reviewer, Deputy Office Director and Director of the Office of Device Evaluation, as well as a Branch Chief and Deputy Division Director in the Office of Compliance, CDRH. She also spent time as the Associate Director for Regulatory Programs in the Office of Compliance and Enforcement in FDA's newest center, the Center for Tobacco Products.
Diane Johnson, MS
Senior Director, North American Regulatory Affairs Policy and Digital Health, Johnson & Johnson, United States
DIANE MACCULLOCH JOHNSON Diane Johnson is responsible for regulatory policy shaping for North America for the Johnson & Johnson Medical Device Companies, as well as serving as the regulatory Digital Health Policy Lead. She is responsible for identifying key emerging regulatory policy issues and shaping the outcomes through continued interactions with HAs. She also supports government affairs in shaping legislation. Activities are focused on laws, regulations, and guidance that will drive Business and Strategic Plans. She has over 30 years of experience in the device industry, specializing predominantly in Regulator Affairs. For five years, she was a senior scientific reviewer at FDA’s CDRH, with a focus on cardiovascular devices.
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