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Bethesda North Marriott Hotel and Conference Center

Oct 25, 2017 7:00 AM - Oct 26, 2017 3:30 PM

5701 Marinelli Road, , North Bethesda, MD 20852 , USA

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

, 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.

Kim  Quaintance-Lunn

Kim Quaintance-Lunn

Vice President, Regulatory Affairs Americas, Bayer AG, United States

Kim Quaintance-Lunn is the Vice President, Regulatory Affairs Americas and a Distinguished Science Fellow at Bayer, a Director at Large for the FDA Alumni Association, and Chair of DIA's Americas Regional Advisory Council. At Bayer, Kim serves in a leadership capacity for US Regulatory Affairs, functions as the expert on FDA standards, regulations, legislative actions and processes, and is the lead for several patient focused initiatives. Kim joined Bayer in February 2014 as Head of US Regulatory Policy. Kim previously served as the Senior Director, Global Regulatory Policy and Intelligence at Eisai, Associate Director for Regulatory Affairs in CDER’s Office of New Drugs, and began her career as a research scientist at Pfizer.

Rachel  Turow, JD, MPH

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

John  Weiner, JD

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).

Debra L. Michaels, MS

Debra L. Michaels, MS

Associate Director, Scientific Programs, DIA, United States

In her content-focused role at DIA, Debra Michaels provides guidance on educational content strategy and development across the DIA Americas portfolio of educational programs as well as subject matter expertise in selected areas. 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 work as a patient advocate for the Pompe and MPS Disease communities in a rare disease biopharma company.

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

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.

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 OGD’s implementation of the GDUFA science and research commitments including internal research activities and external research grants and collaborations to ensure the therapeutic equivalence of generic drug products. 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 in Chemical Engineering, and a PhD from Princeton University in Chemical Engineering.

Thinh X. Nguyen

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.

Diana  Salditt

Diana Salditt

Principal Consultant, Salditt Regulatory Consulting LLC, 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

Chief Scientific Officer, Biotechnology Innovation Organization (BIO), 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, 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., Canada, ICH, and WHO 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 27 years of industry experience and has held positions in Regulatory Affairs, QA, Compliance, and Operations. Demetra is also active in a number of external industry associations.

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 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.

Cory  Wohlbach

Cory Wohlbach

Global Vice President, Biosimilar Regulatory Affairs, Teva Pharmaceuticals, United States

Melissa  Burns, MS

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.

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, MS

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.

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.

Michael  Koenig, MS

Michael Koenig, MS

Group Head – Regulatory Affairs Established Products, Bayer, United States

Mike has over 25 years of pharmaceutical industry experience, ranging from QC labs to CMC development and Regulatory Affairs. He has worked with a variety of combination products, including drug eluting intrauterine devices, prefilled syringes, and most recently received one of the first FDA approvals for a mobile app in combination with a drug and autoinjector.

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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