Partner, Hogan Lovells LLP
David M. Fox is a leading authority on the regulation of prescription and over-the-counter drugs, biological products, combination products, and controlled substances. He began his Food and Drug Administration (FDA) career in its Office of the Chief Counsel as assistant chief counsel for enforcement and associate chief counsel for drugs. During his FDA tenure and in private practice, David has been deeply involved in precedent-setting disputes between pioneer and generic drug sponsors under the Hatch-Waxman Act. In 2012, he founded biosimilarslawblog.com, a forum for commenting on the emerging field of biosimilars. He has also published leading texts on drug-device combination products and the regulation of controlled substances by FDA and Drug Enforcement Administration (DEA).
Consultant, King & Spalding LLP
Quynh Hoang is a Senior Regulatory Consultant in the FDA & Life Sciences practice group of King & Spalding’s Washington, D.C. office. She specializes in the FDA’s premarket process (for medical devices and combination products containing device (e.g., 513(g), 510(k), De Novo, IDE, HDE, PMA, RFD, and Reclassification Petition), as well as, in the FDA’s postmarket process for adverse signals. Ms. Hoang joined King & Spalding after 24 years at the FDA’s Center for Devices and Radiological Health. Her experience at the FDA included 19 years in the premarket review of cardiac, ophthalmic and neurological devices, where she served as an Electrical Engineer Reviewer, Chief of the Vitreoretinal and Extraocular Devices Branch or Chief of the Neurodiagnostic and Neurosurgical Devices Branch. Highlights of her accomplishments include leading the review of the first ophthalmic excimer laser systems that are the precursors of todays’ LASIK Eye Lasers and receiving recognition as the FDA’s Peer-Reviewed Expert in Laser Refractive Surgical Devices. For the neurological device area, she was a key contributor to the review policies and to the reorganization in 2009 as well as the current structure of the Division of Neurological and Physical Medicine Devices. On the postmarket side, Ms. Hoang was an Expert Issue Manager tasked with leading teams of premarket, postmarket and communication experts in identifying the response options for the Center.
President, HS Design
Tor Alden is a principal of HS Design (HSD), a product development firm specializing primarily in the medical and health-care marketplace. As a principal in HSD, Alden has expertise in new product development, design research, strategy, project management and new business development. During his more than 20 years in product design and development, he has received over 30 patents and several design awards, including MDEA, IDEA, CES Innovations and Good Design. Before joining HSD, he was vice president at Logic Product Development, where he directed user research, strategy and industrial design. An active member of the Industrial Designers Society of America, Alden has served as both chair and section chair, most recently as medical section chair. He currently sits on the advisory board of the department of design at Kean University, where he is an adjunct professor. Alden received his bachelor’s in industrial design from Syracuse University and his master’s in technology management from Stevens Institute of Technology.
Katlin McKelvie Backfield
Attorney at Law, Backfield PLLC
With over 15 years of experience in the area of pharmaceutical regulatory law, including more than 10 years at the Food and Drug Administration, Katlin uses her extensive expertise to help companies navigate the pre- and post-approval stages of drug development. Katlin served as Associate Chief Counsel for Drugs with the Office of Chief Counsel at FDA for nine years. She was a regulatory counsel in the Office of Prescription Drug Promotion in the Center for Drug Evaluation and Research at FDA from 2006 to 2008. Prior to joining FDA, Katlin was an associate at Hogan Lovells, LLP, and a law clerk for the Honorable Douglas P. Woodlock of the U.S. District Court for the District of Massachusetts. She graduated cum laude from Georgetown University Law Center in 2001 and received her undergraduate degree from Davidson College. Katlin serves on the planning committee for the Food and Drug Law Institute's Advertising and Promotion Conference to be held in September 2017 and is a member of FDLI's Academic Programs Committee. She is based in Washington, D.C.
Khaudeja Bano, MD
Senior Medical Director, Abbott
Khaudeja Bano is a physician with a master’s in Clinical Research (UCSD), Oracle DBA, PMP and Pharmaceutical Engineering Certification. She is an Abbott President’s award winner, avid Toastmaster and certified coach. Khaudeja has more than 25 year’s professional experience, including clinical practice for nine years. She has held several global safety positions at Abbott Vascular (AV), Abbott Diagnostics (ADD), Abbott Established Pharma Division (EPD) and now AbbVie. Her career in safety includes leadership roles in devices, diagnostics, pharmaceuticals and combination products. Khaudeja has a diverse background in medical affairs, device safety, pharmacovigilance, risk management, clinical research/operations, project management, quality and information systems. She has extensive global experience. Khaudeja has professional experience as a physician in India and Saudi Arabia, and as an Abbott/Abbvie employee in Europe and the United States.
Senior Director, Promotional Regulatory Affairs, AstraZeneca
Glenn N. Byrd is a senior director, promotional regulatory affairs, at AstraZeneca. He has more than 21 years of regulatory experience including 10 years at the US Food and Drug Administration. Byrd’s industry experience has focused on advertising and promotional compliance, regulatory strategy, clinical trial design and management of consulting firms and CROs, combination products, and medical devices. He holds an MBA from Hood College.
Consultant, Parexel International
Sugato De, Principal Consultant, at PAREXEL Consulting, is a seasoned, accomplished engineer with wide-ranging experience in the development and regulation of medical devices and in the creation and implementation of scientific and regulatory policy. Mr. De has more than 11 years of experience in the Center for Devices and Radiological Health (CDRH) at the FDA and has specialized expertise in the development of performance assessment methodologies for drug-delivery systems and in the development of clinical trials to establish the safety and efficacy of medical devices. He also served as CDRH’s lead representative on the review of over 50 combination product reviews submitted via INDs, NDAs and BLAs and has comprehensive knowledge of regulatory strategies for the approval of these products. As a senior policy advisor in the Office of the Center Director, Mr. De was heavily involved in the development of new policy development for combination products. Mr. De uses his extensive scientific, technical, device development and regulatory experience to assist clients in the development of nonclinical and clinical development plans and regulatory strategies with FDA to achieve their company objectives.
Partner, King & Spalding LLP
Lisa M. Dwyer is a partner in King & Spalding’s Washington, D.C. office and a member of the FDA & Life Sciences practice group. Lisa has more than 15 years experience working with legal and policy matters involving all FDA-regulated products. From 2010-2015, she served in the Commissioner’s Office at FDA as a Senior Policy Advisor, in the Office of Policy, and as the Deputy Chief of Staff to the Commissioner of Food and Drugs. In these roles, Lisa provided strategic counseling to FDA’s Commissioner and other senior leadership on the agency’s most significant and complex issues, including: off-label marketing, oversight of laboratory developed tests (LDTs), oversight of next generation sequencing LDTs/in vitro diagnostics (part of President Obama’s Precision Medicine Initiative), advancing antimicrobial drug development and use, modernizing the legislative framework for cosmetics (including user fees), public-private partnerships, menu labeling, implementation of the Family Smoking Prevention and Tobacco Control Act of 2009, opioid misuse and abuse, and the Commissioner’s Transparency Initiative. In addition, she often served as a liaison for the FDA or worked closely with other parts of the federal government, including the Department of Health and Human Services, the National Institutes of Health, the Centers for Disease Control and Prevention, the Drug Enforcement Administration, and Congress.
Partner, Hogan Lovells
Heidi Gertner works at the forefront of the drug regulatory industry. She provides insight to large and small pharmaceutical companies and research institutions in dealing with government regulators to maximize business potential. With her wealth of drug regulatory knowledge and creative thinking skills, Heidi finds solutions to client problems and is a tireless advocate. She helps clients resolve their enforcement differences with the FDA and facilitates positive relationships with the agency. Heidi anticipates and helps clients dealing with cutting-edge issues, both by assessing policy initiatives and finding new business opportunities. Heidi began her professional career with a focus on bioethics and law, completing two post-doctoral bioethics fellowships, one at the Cleveland Clinic Foundation, and another at the National Institutes of Health. Heidi honed her legal skills at the FDA's Office of Chief Counsel, where she advised government regulators on almost all aspects of drug regulation for 13 years. Heidi joined Hogan Lovells in 2014 and calls the D.C. office her home base.
President, UserWorks, Inc.
Dr. Horst is an experimental psychologist and human factors engineer with extensive experience in applied behavioral research, systems development, and usability engineering. He founded UserWorks, as Man-Made Systems Corporation in September, 1989, and since then has been involved in all aspects of the company's technical work, business development, and management.
Senior Medical & Policy Advisor, King & Spalding LLP
Beverly Lorell is the senior medical and policy advisor with the firm’s FDA & Life Sciences Practice Group in Washington, D.C. She specializes in the clinical trial design for drug, device and biologics studies; review of pre-market submissions; recalls; and assessment of matters involving a risk to health. She also specializes in physician and industry relations and develops independent scientific panels to advise health industries. Previously professor of Medicine at Harvard University, Beverly has more than 25 years of experience as a practicing interventional cardiologist and heart failure specialist. She is an internationally recognized clinical and basic science investigator with extensive experience in multi-center clinical trials and preclinical proof-of-concept translational science. Prior to joining King & Spalding, Beverly served as vice president and global chief medical and technology officer at Guidant Corporation. Her responsibilities there included evaluating emerging technologies and regulatory challenges, determining product development priorities and influencing clinical research strategies. She also participated in the firm’s board for business development.
Bradley Merrill Thompson
Member, Epstein Becker & Green P.C.
Bradley Merrill Thompson counsels medical device, drug, and combination product companies on a wide range of FDA regulatory, reimbursement and clinical trial issues. Mr. Thompson regularly defends companies receiving FDA warning letters, on a wide gamut of subjects including good manufacturing practice, compliance and off label promotion.
Vice President & Senior Research Fellow, Global Regulatory Affairs — Devices, Eli Lilly and Company
Janine M. Morris, recently joining Eli Lilly and Company (Lilly) as their VP for Global Regulatory Affairs for devices at the new Cambridge Innovation Center, will be providing strategic regulatory leadership in Lilly’s connected care portfolio. Prior to joining Lilly, Janine had a distinguished career at the Food and Drug Administration (FDA) for over 26 years. She began her career as a scientific reviewer of neurological devices at the Center for Devices and Radiological Health (CDRH) and her passion for science and engineering navigated her through an expansive career involving a wide range of products and disciplines. In her last remaining years at FDA she held leadership positions including Director for the Division of Radiological Health (CDRH) and Deputy Director for the Office of Special Medical Programs (OSMP) in the Office of the Commissioner (OC) where the Office of Combination Products is one of 5 other offices in OSMP.
Lead Quality Systems and Compliance Consultant, King and Spalding
Steven Niedelman serves as lead quality systems and compliance consultant to the FDA & Life Sciences practice team at King & Spalding, specializing in regulatory, enforcement and policy matters involving industries regulated by the FDA. He provides strategic advice, insight and guidance to the medical device, pharmaceutical, biologics and food industries to ensure compliance with the requirements of the federal Food, Drug and Cosmetic Act. He joins King & Spalding from Crowell & Moring LLP, where he was a senior consultant in its health care group. Previously, he was executive vice-president of Quintiles Consulting. Mr. Niedelman consults with manufacturers, importers, new product developers, as well as with firms involved in or facing enforcement actions. Mr. Niedelman retired from the FDA in 2006 after a 34-year distinguished career, where he served as the Deputy Associate Commissioner for Regulatory Affairs and as Chief Operating Officer of the Office of Regulatory Affairs. He ensured consistent interpretation of FDA’s regulatory policies by directly overseeing offices at the headquarters of the Office of Regulatory Affairs (ORA), including the Office of Regional Operations, Office of Enforcement and Office of Criminal Investigations. Additionally, Mr. Niedelman assisted in the day-to-day management of FDA’s nearly 3,400 field staff responsible for investigative and laboratory operations. While at ORA, Mr. Niedelman served as the principle liaison to the Center for Devices and Radiological Health, and was a member of the Global Harmonization Task Force (GHTF) Steering Committee, FDA/Medical Device Industry Grassroots Initiative Steering Committee and the CDRH Post Market Initiative Steering Committee. He also served on the Steering Committee to the Pharmaceutical cGMP for the 21st Century” initiative as well the Counterfeit Drug Task Force. Prior to joining the Office of the Associate Commissioner, he was the Director and Deputy Director of FDA’s Office of Enforcement, where he was responsible for oversight and consistency of compliance policy, enforcement and recall activities to ensure fair implementation by FDA’s five product centers. During his tenure, Mr. Niedelman presided as the Chairman of FDA’s Compliance Policy Council. He currently participates as a member of the Medical Devices Committee at the Food and Drug Law Institute and as a member of the Editorial Review Board for FDAnews GMP publications directed at the pharmaceutical and medical device industries. Mr. Niedelman has also served as Vice President of the FDA Alumnae Association.
Director, Navigant Consulting
Suzanne O’Shea has over three decades of regulatory strategy and compliance experience in the Life Sciences industry in roles at the U.S. Food and Drug Administration (“FDA”) headquarters in Rockville, Maryland, and in private legal practice. Suzanne is a Director at Navigant, where she is frequently called upon by clients to assist in navigating FDA regulations affecting pharmaceuticals, biologics, combination products, medical devices, and human cell, tissues, and cellular/tissue products. Former Regulatory Counsel at the FDA for over two decades, Suzanne served in the FDA’s Center for Drug Evaluation and Research, the Office of the Chief Mediator and Ombudsman, and the Office of Combination Products. Suzanne’s wide-ranging areas of expertise include, but are not limited to strategic analysis of regulatory pathways depending on unique client circumstances, evolving areas of regulation such as mobile medical apps, laboratory developed tests, pharmacy compounding. Section 361 status of human tissue products, and cross-labeling requirements for combination products. She also advises clients in the areas of informed consent, investigator disqualification proceedings, Form 483/Warning Letter responses, quality agreements, good manufacturing practices for combination products, and review of promotional materials for products of all types.
Senior Director, Global CMC-Medical Device, Pfizer
Kirsten Paulson, RAC, is the Senior Director, Global CMC-Medical Devices at Pfizer Inc. 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.
Partner, King & Spalding LLP
Elaine Tseng is a partner with King & Spalding’s FDA & Life Sciences Practice Group in San Francisco. She previously served as Regulatory Counsel at the U.S. Food and Drug Administration, where she received the U.S. Secretary of Health and Human Services’ Distinguished Service Award and other FDA honors. In addition to her government experience, Elaine’s advising is enriched by her in-house experience in the life sciences industry, where she served as corporate regulatory counsel under secondment at a multinational life sciences company. Elaine has more than 15 years of experience specializing in FDA matters with a particular focus on pre- and post-market regulatory requirements and policies applicable to medical devices and diagnostic products, including ophthalmic, orthopedic, cardiovascular, and neurovascular devices, in vitro diagnostic devices (IVDs) and laboratory developed tests (LDTs), software products, and drug/biologic/device combination products. She also has substantial experience with FDA regulation of pharmaceuticals, including biopharmaceuticals, and tissue products (hCT/Ps). Elaine’s practice involves proactive compliance and regulatory strategy counseling on areas ranging from clinical studies to regulatory approval and marketing compliance, including cGMP/quality systems compliance, adverse event and recall handling/reporting, and product promotion; advising on structuring business transactions and ventures to minimize regulatory risk; investigating and assessing potential regulatory compliance concerns; and representation of clients in interactions with the FDA, including administrative appeals, petitions for regulatory action, and participation in the FDA Advisory Committee deliberations. In addition, Elaine has extensive experience conducting FDA regulatory due diligence assessments in connection with corporate transactions involving regulated entities