Steve has spent over 25 years in industry, with increasing responsibility for pre- and post -market regulatory support of biologics, devices, drugs, and combination products. Steve joined BD in 2005, and in 2014 began his current role as Director of Regulatory Policy, Technology and Communication. Steve is active in a number of medical device, combination product and IVD policy issues on behalf of BD through his involvement in AdvaMed and other industry coalitions. Steve obtained his Ph.D. in immunology from Kansas State University and has an MBA from the University of St. Thomas, St. Paul, Minnesota.

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.

Sudip S. Parikh, PhD, serves as Senior Vice President and Managing Director for DIA Americas. He previously served as Vice President and General Manager of Health & Consumer Solutions at Battelle, leading its Healthcare Improvement, Public Health Research, and Consumer, Industrial, and Medical Technology Development teams in R&D supported by government and commercial clients. Dr. Parikh is a board member of Research America, the Friends of Cancer Research, and the Food Innovation Center. He was a Presidential Management Fellow at the National Institutes of Health, and was awarded a National Science Foundation Graduate Research Fellowship while earning his PhD in Macromolecular Structure and Chemistry from The Scripps Research Institute

David has supported regulatory, manufacturing, and quality for biopharmaceutical and combination products for two decades. Since earning his law degree, Mr. Paul has applied this education and experience within Eli Lilly's Regulatory Policy & Strategy organization, where he has been active in legislative, regulatory, and stakeholder initiatives. David is also very active in his community through his volunteer work.

John Towns PhD is Senior Research Fellow at Eli Lilly with responsibilities for Lilly’s portfolio of stand-alone devices and combination products. John’s prior experiences include Senior Director of CMC Regulatory Affairs and Head, Bioanalytical Development. John has presented/published on injectable combination products and his research interests center on the requirements for delivery systems entering into clinical trials and reduction of medication errors through clarity of instructions, appropriate user training and clear product differentiation. John received his BS in Chemistry from Cal Poly, CA and his PhD in Analytical Chemistry from Purdue.

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 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).

Wade Ackerman is a partner in Covington’s Food, Drug, and Device practice. Until June 2016, Mr. Ackerman served as Senior FDA Counsel to the U.S. Senate Health Education, Labor & Pensions Committee where he was involved in legislative initiatives, oversight hearings, and other Senate activities concerning the FDA and the Federal Food, Drug, and Cosmetic Act. He worked with the FDA and other stakeholders as Congress examined legislative reforms in key areas, including drug and device innovation, diagnostics, health software, and combination products. Through private practice and roles at the FDA and on the Hill, Mr. Ackerman developed a unique insight into the legal and regulatory issues surrounding the marketing of FDA-regulated products.

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.

Zach Rothstein is Associate Vice President for Technology & Regulatory Affairs at the Advanced Medical Technology Association (AdvaMed). In this position, Zach advocates for fair, efficient, and effective regulatory policies for medical devices. In particular, Zach’s efforts are primarily focused on digital health, software, cybersecurity, labeling, and postmarket surveillance. Prior to joining AdvaMed, Zach was Deputy Senior Counsel for Public Policy, at Samsung Electronics, where he was responsible for the company’s medical device and healthcare regulatory and policy issues. Zach was previously an Attorney in the FDA and Healthcare practice at the law firm of Morgan, Lewis & Bockius LLP.

Dr. Paul Seligman is currently Executive Director for Global Regulatory Policy at Amgen. Prior to joining Amgen in 2012, he had a 28+ year public health career in the Federal government. At the FDA he served as the Director of Latin America Regional Office, as Associate Director for Safety Policy & Communication, & as the Director of the Office of Pharmacoepidemiology&Statistical Science in CDER. He is a retired Commissioned Officer from the USPHS having attained the rank of Rear Admiral.

Dr. Siegel leads organizations responsible for R&D of biologics and for regulatory support for pharmaceuticals. Dr. Siegel is actively engaged in policy development in the regulatory, biotechnology, and clinical development arenas. Prior to joining J&J, he spent 20 years at CBER, FDA.

Jeff Allen, Ph.D. serves as the President and CEO of Friends of Cancer Research (Friends). During the past 25 years, Friends has been instrumental in the creation and implementation of policies ensuring patients receive the best treatments in the fastest and safest way possible. As a thought leader on many issues related to Food and Drug Administration, regulatory strategy and healthcare policy, he is regularly published in prestigious medical journals and policy publications, and has contributed his expertise to the legislative process on multiple occasions. Dr. Allen received his Ph.D. in cell and molecular biology from Georgetown University, and holds a Bachelors of Science in Biology from Bowling Green State University.

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.

Christina Kuhn is a senior associate in Covington’s Washington, DC office, where she advises clients on a broad range of FDA regulatory issues. Her practice focuses on FDA medical device matters, but also includes advising on pharmaceuticals and biotechnical products. She regularly works clients across the spectrum of medical devices technologies, including eHealth products, diagnostics, and combination products. She counsels companies on clinical development and premarket regulatory strategies as well as on postmarket compliance requirements and responses to enforcement actions. She is also a regular contributor to Covington’s InsideMedicalDevices blog.

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.

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.

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.

Pat Baird recently joined Philips as the Head of Global Software Standards, responsible for actively participating in the development of software standards and translating those standards into usable business processes. Previously he was Director of Risk Management at Baxter Healthcare. Drawing on 20 years’ experience in product development, he has published and presented over 50 papers on topics such as software development, change management, stakeholder management, and risk management. In addition to an MBA, he has a Masters in Healthcare Quality and Patient Safety from Northwestern University.

Head of regulatory affairs at Roche and Genentech from 2002 to 2016. Currently head of strategic innovation at Roche and Executive adviser to Foundation Medicine.

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.

As Deputy Director of the Office of Combination Products since 2003 Dr. Love leads the development of combination product initiatives for premarket review and post market regulation. Previously from 1993-2003, Dr. Love served as Director, Division of Medical Imaging and Radiopharmaceutical Products. She joined FDA in 1988 and has a range of FDA review and leadership experience in therapeutic, diagnostic, and combination product areas. Dr. Love is an internist with rheumatology, and allergy-immunology academic and clinical practice experience.

BAKUL PATEL was the Director for Digital Health Center of Excellence, at the Food and Drug Administration (FDA). Mr. Patel is responsible for providing leadership, development, implementing, execution, management and setting strategic direction and regulatory policy and coordinate scientific efforts for digital health, software and emerging technologies. Mr. Patel, in 2013, created the term “software as a medical device”(SaMD) and under his leadership the International Medical Device Regulators Forum (IMDRF) established the globally harmonized definition of SaMD. Mr. Patel subsequently led global regulators at IMDRF to create and author the globally harmonized regulatory framework for SaMD.

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.

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.