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Combination Products Conference


Speakers

  • David  Amor

    David Amor

    • VP Quality Regulatory Affairs
    • Pear Therapeutics, Inc., United States

  • Session Chair  Invited

    Session Chair Invited

    • United States

  • Ryan  McGowan

    Ryan McGowan

    • Associate Director, Combination Products
    • AstraZeneca, United States

    Ryan McGowan is an Associate Director in Regulatory Affairs at AstraZeneca where he has responsibility for developing regulatory strategies for the approval of combination products and medical devices. 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

    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 SW Turow, JD, MPH

    Rachel SW Turow, JD, MPH

    • Executive Counsel, Regulatory Law
    • Teva Pharmaceuticals Ltd., United States

    Rachel Turow is Executive Counsel – Regulatory Law at Teva Pharmaceuticals Ltd. In this role, Rachel provides regulatory legal support to Teva’s specialty pharmaceutical business, and supports Teva’s drug-device combination products and digital health projects. Previously, Rachel was Director, Regulatory Policy, at Novo Nordisk Inc. where she helped the company strategically respond to FDA policy and regulatory issues. Prior to joining Novo Nordisk, Rachel spent five years at FDA in policy roles. 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 Stanford University.

  • James  Wabby, MS

    James Wabby, MS

    • Executive Director, Regulatory Affairs, Devices and Combination Products
    • Allergan, United States

    James Wabby is the Executive Director of Regulatory Affairs (Device and Combination Products) at Allergan in Irvine, California. He has over 15 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 Barlow Weiner, JD

    John Barlow Weiner, JD

    • Associate Director for Policy, Office of Combination Products, OSMP
    • FDA, United States

    John Barlow Weiner is the Associate Director for Policy in the Office of Combination Products. Prior to joining OCP, Mr. Weiner was an Associate Chief Counsel in FDA's Office of Chief Counsel and in private practice. He received a BA from Princeton University and a JD with honors from the Columbia University School of Law.

  • Bill  Zeruld

    Bill Zeruld

    • Business Development - Digital Strategy
    • Otsuka America Pharmaceuticals, Inc., United States

    William Zeruld is a senior executive dedicated to driving innovation in healthcare through transformative strategies, partnerships, and business development activities to deliver cutting-edge solutions. He has gained unique insights having led strategy and operations in organizations across the spectrum of healthcare - digital health companies, hospitals/health systems, payers, life science companies, and non-profit entities. At Otsuka, he is responsible for partnerships, formulating strategies, and delivering innovative programs to drive Otsuka's digital health and medicine portfolio. Mr. Zeruld's professional experience is backed with an MBA from Wharton with a dual concentration in Health Care Management and Finance.

  • Kirsten H. Paulson

    Kirsten H. Paulson

    • Senior Director, Global CMC Medical Devices
    • Pfizer Inc, United States

    Kirsten Paulson is Sr. Director, Worldwide Regulatory CMC and Medical Device Lead at Pfizer. Previously, she was the Senior Officer, Medical Device Initiative of The Pew Charitable Trusts and Head of the PPD RA Medical Device and Diagnostics group. She began her career as an FDA reviewer. Kirsten has a BS from Boston University and an MS in Bioengineering from Penn State.

  • Kevin  Bardonner

    Kevin Bardonner

    • 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

    James P. Bertram

    • Policy Analyst, CDRH
    • FDA, United States

    James Bertram is currently a policy analyst in the Office of Device Evaluation and product jurisdiction officer in CDRH at FDA. In this capacity James collaborates across the Agency on cross-cutting policies, many of which apply to the review and regulation of combination products.

  • Melissa B. Burns, MS

    Melissa B. Burns, MS

    • Senior Program Manager, Office of Combination Products
    • FDA, United States

    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. CDR Burns worked for several years in the private sector including positions with a medical device manufacturer, a large acute-care hospital, a healthcare architecture firm, and a consulting firm. CDR Burns 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

    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

    Kate Cook, JD

    • Executive Vice President, Drugs and Biological Products
    • Greenleaf Health, United States

    Kate Cook is Executive Vice President for Drug and Biological Products at Greenleaf Health, a regulatory consulting firm. She previously worked at FDA in legal and policy positions in the Office of Chief Counsel, the Center for Biologics Evaluation and Research, and the Center for Devices and Radiological Health, where she served as associate director for regulations and policy. Over twenty years, she has been involved in every aspect of policy development. Ms. Cook graduated from New York University School of Law, and was a New York County Assistant District Attorney and an attorney in private practice before joining the FDA.

  • Vijay  Damodaran

    Vijay Damodaran

    • Advisor/Director, Global Quality
    • Eli Lilly & Company, United States

    Advisor/Director - Quality, Medical Devices & Combination Products, Eli Lilly & Company

  • Sugato  De

    Sugato De

    • 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.

  • Lesley  DeRenzo

    Lesley DeRenzo

    • Regulatory Counsel, Office of Generic Drugs, CDER
    • FDA, United States

  • Sheryl L. Lard Whiteford, PhD

    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 31 years of experience at FDA, Dr. Lard serves as the center's Chief 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

    Kristina Lauritsen, PhD

    • Combination Products Review Advisor, CDER
    • FDA, United States

    Kristina Lauritsen, PhD is the senior Product Jurisdiction Officer for the Center for Drug Evaluation and Research 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. She came to CDER 4 years ago after working for several years in the Office of Combination Products and CDRH. She holds a B.S. in Biology from Shippensburg University, and a Ph.D. in tumor biology from Georgetown University.

  • Yuri  Maricich

    Yuri Maricich

    • Chief Medical Officer and Head of Clinical Developmen
    • Pear Therapeutics, United States

    Dr. Maricich leads the Clinical/Regulatory team at Pear Therapeutics as the Chief Medical Officer and Head of Clinical Development. He leads and manages the clinical development programs from Discovery/TPP to Therapeutic, Translational, Clinical Development, through Regulatory submission and prosecution.Dr. Maricich is a licensed, board-certified physician, investor, clinical developer and strategist. Dr. Maricich earned his M.D. degree at the University of Washington School of Medicine, M.B.A from Harvard University, and his undergraduate at the University of Notre Dame. He completed internal medicine training at the University of Virginia Health System.

  • Tina  Murphy, PhD

    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.

  • Ola  Oyinloye

    Ola Oyinloye

    • Associate Director - Medical Devices and Combination Products
    • AstraZeneca, United States

    Associate Director - Medical Devices & Combination Products AstraZeneca

  • Suzette  Roan

    Suzette Roan

    • Sr. Director, Regulatory Affairs – Devices and Combination Products
    • Sanofi US, United States

    Suzette Roan is Senior Director, Regulatory Devices, at Sanofi, where she supports combination product regulatory. Suzette has 23 years professional experience and her career includes global regulatory and analytical roles in pharmaceuticals, devices and combination products at Pfizer, Biogen and Sanofi. She has experience with inhalation, prefilled syringe, autoinjector and on body delivery systems. Suzette holds a BS in Chemistry and a JD from the University of Connecticut and a MS in Management from Albertus Magnus College. She is an active member of ISO/TC 84 working groups and is currently chair of the Combination Products Coalition Marketing Submissions working group.

  • Sarah H. Stec

    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

    Alan Stevens, MS

    • Branch Chief, General Hospital Devices Branch, ODE, CDRH
    • FDA, United States

    Alan Stevens is branch chief of FDA's General Hospital Devices Branch where he supervises the premarket review of drug delivery devices. These include syringes, injectors, infusion pumps, etc. He was an FDA premarket reviewer from 2006-2016 and has a graduate degree in reliability engineering from University of Maryland.

  • Kim  Trautman

    Kim Trautman

    • Executive Vice President Medical Device International Services, NSF Medical Devi
    • NSF International, United States

    Experienced Medical Devices and InVitro Diagnostics Executive Vice President with 26 years of working at the U.S. FDA Center for Devices and Radiological Health (CDRH) and working with Regulatory Agencies around the globe. Industry experience as well as regulatory agency experience. Demonstrated history of working collaboratively with industry, regulators and patient groups for the betterment of public health. Executes medical device regulatory services and recently developed a formal Education/Training business, as well as an Authorized Medical Device Single Audit Program (MDSAP) Auditing Organization and a new Notified Body in Ireland for EU IVDR/MDR Designation.

  • Cory  Wohlbach

    Cory Wohlbach

    • Sr. Director
    • Teva Pharmaceuticals, United States

  • Kevin  Wurch

    Kevin Wurch

    • 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

    Scooter Plowman, MD, MHS, MBA

    • Medical Director
    • Proteus Digital Health®, Inc., United States

  • Thinh X. Nguyen

    Thinh X. Nguyen

    • Director, Office of Combination Products, OSMP, OC
    • 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 postmarket 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 Premarket 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

    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

    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 Macculloch Johnson, MS

    Diane Macculloch Johnson, MS

    • Senior Director, North American Regulatory Affairs Policy and Intelligence
    • Johnson & Johnson, United States

    Diane is responsible for providing key strategic direction and regulatory intelligence across the North America device sector. Supports shaping of growth plans by translating the impact of regulatory environmental changes/trends on Strategic Business Plans. 20yrs of experience in the device industry, specializing predominantly in RA. Worked for four start-up firms. Five years as a senior scientific reviewer at FDA CDHR, with a focus on cardiovascular. B.S. and MS. in Materials Engineering.

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