Our CPS Strategic Committee is made up of the following FDA officials and industry experts:
Senior Medical Director, Medical and Clinical Affairs
Khaudeja is a physician with a master's in clinical research (UCSD), pharmaceutical engineering certification, a database administrator and a certified Project Management Professional. She is an Abbott President’s Award winner, avid Toastmaster and certified coach. Khaudeja has more than 25 years professional experience, including clinical practice. She has held several global safety positions at Guidant, Abbott (Vascular, Diagnostics, and Established Pharma Division), and AbbVie Inc. Her career includes global medical/clinical and safety leadership roles in devices, diagnostics, pharmaceuticals and combination products.
Director, Regulatory Policy and Technology Corporate Regulatory Affairs
Steve has spent over 25 years in industry, with 20+ years of increasing responsibility for pre- and post -market regulatory support of biologics, devices, drugs, and combination products. His formal regulatory experience began in 1992, when he joined Allergan Pharmaceuticals as Director, Worldwide Regulatory, and Responsible Head for the company’s Botox biologic.
In 1994 he joined Baxter’s Fenwal Division as Vice President, Regulatory Affairs, and for the next 10 years he led a global regulatory team with responsibility for the division’s 510(k), PMA, and NDA products used in blood component processing and delivery. While at Baxter Steve also gained extensive experience with CE marking of medical devices in the EU, including Class III devices incorporating medicinal products. In 2005 Steve joined Becton Dickinson and Company (BD) as Director of Regulatory Affairs in BD’s Corporate research center, BD Technologies, where his responsibilities included providing support for technology development efforts in areas including diagnostics, cell and tissue technologies, and advanced diabetes care. In 2011 he also took on responsibility for the Women’s Health and Cancer Regulatory team in BD’s Diagnostics Systems business. In August 2014 he transitioned to a new Corporate Regulatory Affairs role as Director, Regulatory Policy, Technology, and Communications for BD. He is active in a number of medical device and IVD policy issues on behalf of BD through his involvement in AdvaMed and several 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.
Global Quality Leader – Drug Delivery System Development
Francis Blacha is currently Global Quality Leader, Drug Delivery System Development, Device Manufacturing and Diagnostics for Eli Lilly and Company. Previous to joining Lilly, Francis held various leadership positions in Quality at Pfizer and Glaxo Inc. Francis has over 25+ years of quality assurance/quality control experience in pharmaceuticals and medical devices. He has extensive experience in guiding project teams in all aspects of risk management and the application of design control requirements throughout the product lifecycle for combination products, diagnostics and medical devices. In addition to frequently presenting at industry forums on the topic of risk management, Francis currently serves on the strategic committee for MedCon, an annual medical device conference co-sponsored by FDA and Xavier University and is a member of the advisory board for Xavier’s QARAInstitute. Francis received his B.A. in chemistry from Catawba College and his M.S. in chemistry from North Carolina State University.
Senior Quality Assurance Associate II
Head, Combination Products CoE and Sr. Director, Design-to-Value and Product Quality Management
Johnson & Johnson
Susan Neadle has responsibility for Johnson & Johnson’s Pharm sector Combination Products Quality and Compliance. Over her extensive career, Susan has played integral leadership roles in product and process development of over a dozen new products. She was awarded the Johnson Medal, J&J’s highest honor for innovation excellence, for invention and development of the lens design central to J&J Vision Care’s astigmatic product portfolio. She holds numerous patents. Susan’s experience also includes enabling and applying advanced product and process analytics to drive proactive process capability and product quality. Susan earned an M.S. in polymer science & engineering, and a B.S. in biology/chemistry, as well as Fellowships in the American Academy of Optometry and the British Contact Lens Association. Prior to joining J&J, she held R&D, Quality, and Commercialization positions at Unilever, Organon Teknika and IBM. In these positions she worked in controlled release technology, biomedical diagnostics, and materials analysis.
Director, Office of Combination Products
Mr. Nguyen is the Director of the Office of Combination Products (OCP) in the United States Food and Drug Administration since January 2008. OCP is primarily responsible for making jurisdictional determinations, coordinating premarket reviews, ennsuring consistent and appropriate postmarket regulations, and developing policy, guidance, and regulations. Prior to joining OCP, Mr. Nguyen spent seven years as the Director for the Premarket Approval Section in the Center for Devices and Radiological Health where he played a key role in the passage of the Medical Device User Fee and Modernization Act of 2002 (MDUFMA) and the Medical Device User Fee Amendment of 2007 (MDUFA) legislations. During this time, he had established significant policies and written numerous guidance documents relating to the PMA programs (e.g., expedited review, user fees, PMA actions). Prior to coming to the FDA, Mr. Nguyen worked as a senior electronics engineer for the Naval Electronics Systems Engineering Center, Portsmouth, Virginia, from 1986 to 1993, where he was responsible for developing hardware/software for testing aircrafts and radar systems. Mr. Nguyen received a bachelor's degree with honors in electrical engineering from North Carolina State in 1986.
Suzanne O’Shea has three decades of FDA regulatory experience. Suzanne served as Regulatory Counsel at FDA headquarters for 21 years, most recently in the Office of Combination Products. She has also worked in the FDA Regulatory Group of a major law firm. She works with drugs, biological products, devices, combination products and human tissue products.
Suzanne’s wide-ranging areas of expertise include 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.
Suzanne provides due diligence in mergers and acquisitions of companies that manufacture FDA-regulated products. She serves as an expert witness when FDA processes are relevant to litigation.
Senior Director, Global CMC-Medical Device Lead
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 B.S. from Boston University and an M.S. in bioengineering from Penn State.
Director, Xavier Health
Dr. Marla A. Phillips joined Xavier University in 2008 as the Director of Xavier Health, where she leads initiatives with FDA officials and Pharmaceutical and Medical Device professionals. Marla began working in the pharmaceutical industry for Merck in 1996 where she took on roles of increasing responsibility, culminating in position of Head of Quality Operations at the Merck North Carolina facility. She holds a B.S. in chemistry from Xavier University, and a Ph.D. in organic chemistry from the University of North Carolina – Chapel Hill.
Associate Director, Regulatory Affairs CMC Combination Products at Biogen Idec
Suzette Roan joined Biogen in 2014 and is currently Associate Director in Regulatory CMC – Device Regulatory, where she leads the combination product team responsible for regulatory strategies for the development and commercial combination product portfolio. Prior to Biogen, Suzette was with Pfizer for 19 years, with roles in Analytical Development, Outsourcing and Regulatory CMC. She has experience with pulmonary inhaler, prefilled syringe, autoinjector and on body delivery systems.
Suzette holds a B.S. in chemistry from the University of Connecticut, a M.S. in management from Albertus Magnus College and a J.D. from the University of Connecticut School of Law. She is an active member of the Combination Products Coalition, PDA, AAMI Combination Products Committee and ISO/TC 84 working groups.
Mr. Thiel has over 25 years of Medical Device industry experience, including product development, software and connectivity related to Medical Devices (including interfaces with consumer electronics) as well as regulatory affairs and compliance, and Quality System experience with U.S. and EU regulations. He assists Anson clients in successfully commercializing wireless, mobile, and networked technologies in compliance with the rules and policies of the FDA and other regulatory agencies. Mr. Thiel participated in the AAMI Technical Committee that developed ANSI/AAMI/IEC 62304. Mr. Thiel has also completed a lead auditor course for ISO 13485 – Quality Management System specific for medical devices, including software.
As of July 1, 2013, the Anson Group has become part of Navigant Consulting, Inc. Navigant Consulting, Inc. (NYSE: NCI) is an international firm of advisors and consultants dedicated to assisting counsel and their clients with the accounting, financial, economic, engineering and data/information management aspects of business disputes and litigation. Our litigation services cover the entire spectrum, from discovery management to expert services and settlement administration. We have approximately 2,000 professionals, including Certified Public and Management Accountants, economists, statisticians, financial analysts, healthcare professionals and information management specialists, among others, who are fully devoted to providing counsel and their clients with independent, objective analysis and advice.
Prior to joining Anson in 2011, Mr. Thiel held a leadership position with a major Medical Device manufacturer.
Epstein Becker Green
Bradley Thompson is a Member of the Firm at Epstein Becker & Green, P.C. There, he 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. He frequently counsels companies on premarket clearance and approval strategies and on marketing strategies. When medical device companies become concerned that perhaps their employees have not followed FDA requirements, they often engage Mr. Thompson to investigate. With a special focus on drug delivery companies, Mr. Thompson also advises such companies on the unique aspects of combination product development and manufacturing.
Associate Director for Policy, Office of Combination Products
John Weiner is the Associate Director for Policy in the Food and Drug Administration’s Office of Combination Products, which is tasked with the classification and assignment for regulation of therapeutic products (drugs, devices, biological products, and combination products), and with ensuring the sound and consistent regulation of combination products. Prior to joining OCP, Mr. Weiner was an Associate Chief Counsel in FDA’s Office of Chief Counsel, advising the agency on various issues including regulation of drugs and cross-cutting topics including the regulation of products that use nanotechnology. Before coming to FDA, Mr. Weiner was in private practice in the areas of food and drug, environmental, and related aspects of public international and trade law. He has published and lectured on topics in all three areas. Mr. Weiner received a B.A. from Princeton University and a J.D. with honors from the Columbia University School of Law.