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Combination Products Conference

Innovation and New Frontiers


  • Nathan  Brown, JD

    Nathan Brown, JD

    • Health Care and Life Sciences Partner
    • Akin Gump Strauss Hauer & Feld LLP, United States

    Nathan Brown is a partner in the Health Care and Life Sciences Group at Akin Gump LLP, where he advises medical device, medical technology, and pharmaceutical companies on FDA-related regulatory and compliance issues. He previously served as special assistant to the chief counsel at FDA, as FDA detailee to the Senate HELP Committee, and as senior counselor to the ACRA in FDA's Office of Regulatory Affairs.

  • Carla  Cartwright, JD, LLM

    Carla Cartwright, JD, LLM

    • Director, Federal Affairs
    • Johnson & Johnson, United States

    Carla is a member of the Johnson & Johnson Federal Affairs team. FDA matters, oncology and immunology are in her portfolio. Prior to joining Federal Affairs, Carla was the US policy lead on patient engagement, expedited approval pathways, and disease interception. Prior to joining J&J, Carla was an attorney and team leader in FDA's Office of the Chief Counsel where she advised CDER on legal and policy issues, working closely with the Offices of Policy and Legislation. Carla is a graduate of Washington University in St. Louis and has a JD from Yale Law School.

  • Kirsten H. Paulson, MS, RAC

    Kirsten H. Paulson, MS, RAC

    • 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.

  • Kim  Quaintance-Lunn

    Kim Quaintance-Lunn

    • Vice President, Regulatory Policy, NA
    • Bayer, United States

    Kim Quaintance-Lunn serves as the Vice President and Head, NA Regulatory Policy at Bayer. She works with colleagues to analyze regulatory policy and advocate for changes in the regulatory environment, serves on global and US Regulatory Leadership teams, and assists in the development of regulatory strategies. Kim previously served as Senior Director, Global Regulatory Policy and Intelligence, Eisai Inc, and Associate Director for Regulatory Affairs, Office of New Drugs, CDER.

  • 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.

  • John Barlow Weiner, JD

    John Barlow Weiner, JD

    • Associate Director for Policy
    • 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.

  • Debra  Michaels, MSc

    Debra Michaels, MSc

    • Senior Manager, Content Strategy and Policy Assessment
    • DIA, United States

    As a Senior Scientist for DIA, Debra Michaels provides guidance on educational content strategy and development. She is the lead for DIA’s Patient Engagement thought leadership initiative and has collaborated on several projects to advance patient centric practice among stakeholders. Debra brings clinical, public health, and biopharmaceutical industry experience to her current role, including 2 years as Associate Director for Patient Advocacy with a rare disease therapy development project.

  • Kalah  Auchincloss

    Kalah Auchincloss

    • Senior Vice President, Regulatory Compliance
    • Greenleaf Health, Inc., United States

    Kalah is a Senior Vice President at Greenleaf Health, Inc. Before joining Greenleaf, Kalah spent six years at FDA, most recently, as Deputy Chief of Staff for Commissioner Robert Califf, and subsequently for Commissioner Scott Gottlieb. While at FDA, Kalah spent time on Capitol Hill as the FDA detailee to the Senate HELP Committee, and in FDA’s Center for Drug Evaluation and Research (CDER) as a regulatory counsel and then as Director of CDER’s Office of Unapproved Drugs and Labeling Compliance. Before joining FDA, Kalah was an associate at the law firm Foley Hoag LLP. Kalah holds a B.A. from Williams College, a J.D. from Georgetown, and an M.P.H. from Harvard.

  • 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.

  • Heidi F. Gertner

    Heidi F. Gertner

    • Partner
    • Hogan Lovells US LLP, United States

    Heidi Gertner is a partner at Hogan Lovells in their drug regulatory group. Heidi began her professional career with a focus on bioethics and law, completing two post-doctoral bioethics fellowships-at the Cleveland Clinic and at NIH. Heidi then worked at the FDA's Office of Chief Counsel for 13 years. At Hogan Lovells Heidi focuses on drug advertising and promotion, combination products, drug safety, clinical trials and human subject protection, Rx-OTC switches, and OTC drug regulation. She is also an adjunct professor at American University's Washington College of Law.

  • Angela  Krueger

    Angela Krueger

    • Acting Deputy Director, Office of Device Evaluation, CDRH
    • FDA, United States

    Ms. Angela Krueger serves as the Acting Deputy Director for Engineering and Science Review for the Office of Device Evaluation (ODE), Center for Devices and Radiological Health (CDRH) at the US Food and Drug Administration (FDA). In this position, she provides leadership for scientific and policy issues that impact the premarket review of medical devices and combination products reviewed in ODE/CDRH. Ms. Krueger provides oversight and strategic direction for ODE’s policy, guidance and regulation development, implementation of statutory provisions, and policies and processes related to combination product review and the De Novo classification program. Ms. Krueger holds degrees in Chemistry and Journalism from Butler University.

  • Robert A. Lionberger, PhD

    Robert A. Lionberger, PhD

    • Director, Office of Research and Standards, Office of Generic Drugs, CDER
    • FDA, United States

    Robert Lionberger, Ph.D. serves as Director of the Office of Research and Standards (ORS) in the Office of Generic Drugs (OGD). Dr. Lionberger leads implementation of the GDUFA science and research commitments. ORS also provides pre-submission advice on complex generics through pre-ANDA meetings, product specific guidance and correspondence responses. He received his undergraduate degree from Stanford University and a PhD from Princeton University both in Chemical Engineering.

  • 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.

  • Diana  Salditt

    Diana Salditt

    • Senior Director, Regulatory Advocacy and Policy
    • Medtronic, United States

    Diana K. Salditt is a Senior Director, Regulatory Advocacy and Policy Corporate Regulatory Affairs at Medtronic Minneapolis, MN. Diana Salditt leads the regulatory advocacy and policy group at Medtronic. The group works with Medtronic geographies and businesses and with external organizations to advocate for regulation that promotes and protects public health and supports patients and other stakeholders. Diana directs the advocacy program, manages advocacy partnerships, and supports development of internal regulatory policy. She is a Fellow of the Regulatory Affairs Professionals Society and has a broad range of product and regulatory experience.

  • Cartier  Esham, PhD, MSc

    Cartier Esham, PhD, MSc

    • EVP of Emerging Companies Section, VP of Science and Regulatory Affairs
    • Biotechnology Industry Organization, United States

    Cartier Esham serves as Executive Vice President for Emerging Companies at the Biotechnology Innovation Organization (BIO). In this role, Dr. Esham manages and directs BIO’s policy development, advocacy, research and educational initiatives for BIO’s emerging companies, which comprise approximately 90% of BIO’s membership. Prior to joining BIO, Dr. Esham was a Vice President and Director of Research at Dutko Worldwide, a private consulting firm in Washington, D.C. Esham has a Ph.D. in Microbiology from the University of Georgia, a Master's degree in Marine Biology from the University of North Carolina at Wilmington and a Bachelor of Science Degree from the University of Kentucky.

  • Demetra  Macheras, MBA

    Demetra Macheras, MBA

    • Director, Regulatory Policy and Intelligence - Regulatory Affairs
    • AbbVie, Inc., United States

    Demetra Macheras is currently Director, Regulatory Policy and Intelligence at AbbVie. She assesses and coordinates comments on proposed regulatory policies for the U.S. and Canada regulatory environments and ensures appropriate AbbVie personnel are aware of emerging and final regulatory policies. She also provides regulatory and strategic support to global project teams. Demetra has over 21 years of industry experience and has held positions in Regulatory Affairs, QA, Compliance, and Operations.

  • Diane   Maloney, JD

    Diane Maloney, JD

    • Associate Director for Policy, CBER
    • FDA, United States

    Diane Maloney, J.D., is the Associate Director for Policy, Office of the Director, Center for Biologics Evaluation and Research (CBER), Food and Drug Administration (FDA). She oversees regulation and policy development for CBER as well as the Center’s participation on cross-cutting agency initiatives. She has served in this capacity since 2000. Ms. Maloney was formerly Associate Chief Counsel for Drugs and Biologics in FDA's Office of the Chief Counsel (OCC) from 1985 to 2000, focusing on a variety of cross-cutting agency matters, including human subject protection, clinical trials, product approval, and infectious disease issues.

  • 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.

  • Cory A. Wohlbach

    Cory A. Wohlbach

    • Senior Director, Regulatory Affairs
    • TEVA Pharmaceuticals United States of America Inc, United States

    Cory Wohlbach, Senior Director, Regulatory Affairs, US Generics, Teva has been actively involved in the pharmaceutical industry for 18 years. Cory joined Teva, the world’s leading provider of generic medicines, in January 2011. In his 18 years in the industry, Cory has held positions in Quality Control, Quality Assurance and Regulatory Affairs at Sanofi Pasteur, MedImmune and Teva. His regulatory experience includes APIs, sterile products (injectable, otic, ophthalmic, inhalation), complex sterile products, biologics, biosimilars, vaccines, devices and drug/device combination products. He holds a B.S. in Biology from Muhlenberg College in PA.

  • Melissa B. Burns, MS

    Melissa B. Burns, MS

    • Senior Program Manager
    • 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.

  • Resmi  John

    Resmi John

    • Associate Director, Regulatory Affairs
    • Bayer, United States

    Resmi John is an Associate Director, Regulatory Affairs at Bayer.

  • Kurt R. Karst, JD

    Kurt R. Karst, JD

    • Director, Prescription Drugs and Biologics, Corporate Transactions, Enforcement
    • Hyman, Phelps & McNamara, PC, United States

    Kurt R. Karst provides regulatory counsel to pharmaceutical manufacturers on Hatch-Waxman patent and exclusivity, drug development, pediatric testing, and orphan drugs, including lifecycle management, approval, post-marketing, and exclusivity issues. He is co-founder and primary author of HPM's FDA Law Blog, co-author of Generic and Innovator Drugs: A Guide to FDA Approval Requirements, and has authored several articles.

  • Nicole  Smith

    Nicole Smith

    • Senior Director, Global Regulatory Affairs Policy & Intelligence Medical Devices
    • Johnson & Johnson, United States

    Nicole Taylor Smith is Senior Director and leader of the Global Regulatory Intelligence organization within Johnson & Johnson’s Medical Devices Global Regulatory Affairs Policy & Intelligence. Previous to her role at J&J, Nicole served as Acting Deputy Country Director and Assistant Country Director in the U.S. Food and Drug Administration’s China Office, located within the U.S. Embassy in Beijing. Prior to her service in China, Nicole served as Associate Chief Counsel in U.S. FDA’s Office of Chief Counsel, and also worked at the international law firm, King and Spalding, on its FDA/Healthcare team.

  • Alan  Stevens

    Alan Stevens

    • ME in Reliability Engineering
    • 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.

  • Grace  Stuntz

    Grace Stuntz

    • FDA Policy Advisor
    • Senate HELP Committee, Republican Staff, United States

  • Elizabeth  Baker

    Elizabeth Baker

    • Group Manager Licensing Division
    • Medicines and Healthcare Products Regulatory Agency (MRHA), United Kingdom

    A pharmacist with a Masters in Biopharmacy Liz began her career in pharmaceutical R&D. She has over 20 years’ experience in regulation. She is now a Group Manager in the medicines Licensing Division of MHRA responsible for multidisciplinary teams of assessors. In addition to wide-ranging activities in medicines licensing Liz is involved in handling medicine-device combination products, oversight of Notified Body consultations on ancillary medicinal products and in the policy and practice on the medicines-device borderline at national and European level. Liz also participates in the EMA’s Innovation Task Force, Innovation Network and sits on the British Pharmacopoeia Pharmacy Expert Group.

  • Remy  Brim

    Remy Brim

    • FDA, United States

    Remy L. Brim is the Senior FDA Policy Advisor to Senate HELP Committee Ranking Member Patty Murray. She recently led Senate efforts to advance the 21st Century Cures Act and the FDA Reauthorization Act. Dr. Brim was previously the Senior Health Policy Advisor for Senator Elizabeth Warren. As a Bioethics Fellow at the NIH she addressed ethical conflicts in ongoing clinical trials and researched bioethical issues in the U.S. health care system. Her career began as a scientist focused on the pre-clinical development drug products. She is a graduate of a Michigan State University and the University of Michigan.

  • Mike  Koenig

    Mike Koenig

    • Bayer HealthCare Pharmaceuticals, United States

    Mike Koenig is a Deputy Director, CMC Regulatory Affairs at Bayer, where he is responsible for a wide range of products including combination products and radiopharmaceuticals. Prior to his current role in regulatory, he was the head of the QC laboratories at Berlex Laboratories. Mike has an MS in chemistry.

  • Douglas C. Throckmorton, MD

    Douglas C. Throckmorton, MD

    • Deputy Center Director for Regulatory Programs CDER
    • FDA, United States

    As Deputy Director for Regulatory Programs, Dr. Throckmorton shares the responsibility for overseeing the regulation of research, development, manufacture and marketing of prescription, over-the-counter, and generic drugs in the United States. He is committed to ensuring that the benefits of approved drugs outweigh their known risks. Dr. Throckmorton received his medical degree from the University of Nebraska Medical School and completed his residency and fellowship at Case Western Reserve University and Yale University, respectively. Prior to coming to the FDA in 1997, he conducted basic science research and practiced medicine at the Medical College of Georgia, Augusta, Georgia and Augusta Veterans Administration Hospital.

  • Linda  Ricci

    Linda Ricci

    • Associate Director, Office of Device Evaluation
    • FDA/CDRH, United States

    Linda Ricci, CDRH/ODE, is an Associate Director focusing on Digital Health.

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