The FDA/Xavier Combination Products Summit speakers are hand-selected by the Combination Products Summit Strategic Committee to deliver purpose-driven content that dives below the surface, challenge status quo, engage attendees in collaborative dialog, and provide practical information that can be implemented. Our speakers are thought leaders who are sure to facilitate insightful discussion.
Managing Partner and Founder
Suttons Creek, Inc.
Steven W. Badelt, Ph.D. in neuroengineering, is the founder of Suttons Creek, Inc. Steve has 20 years system engineering and medical device experience, and has consulted startups, venture-backed mid-sized, and Fortune 50 companies.
Steve leads the Suttons Creek team and the overall development of the agency, and is a recognized figure in the systems engineering community, regularly working with AAMI, INCOSE and related organizations.
Head Of Medical Affairs
Abbott Molecular Inc.
Khaudeja is a Physician with a Masters 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 medical positions at Guidant, Abbott, and AbbVie Inc. Her career includes global medical / clinical and safety leadership roles in devices, diagnostics, pharmaceuticals and combination products.
She currently serves as the chair for the Post Marketing Safety working group for the Combination Product Coalition (CPC).
Sr. Director, Regulatory Policy, Corporate Regulatory Affairs
Steve has spent 32 years in industry, with 26 years of increasing responsibility for pre- and post-market regulatory support of biologics, devices, drugs, and combination products. His formal regulatory leadership began in 1992, when he joined Allergan 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 BD in Corporate Regulatory Affairs, relocating to RTP in North Carolina as Director of Regulatory Affairs at BD’s Corporate research center, known as BD Technologies. In addition to involvement in Regulatory policy and FDA liaison activities, his BDT role included Regulatory support for technology development in 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, located in RTP and part of BD Diagnostics Systems. In 2014 he transitioned to a newly created Corporate Regulatory Affairs role as Director, Regulatory Policy and is now Senior Director, Regulatory Policy 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 various industry coalitions.
Steve obtained his Ph.D. in immunology from Kansas State University and also holds an MBA in general management from the University of St. Thomas in 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. Francis received his B.A. in chemistry from Catawba College and his M.S. in chemistry from North Carolina State University.
Director, Office of Policy for Pharmaceutical Quality
Ashley Boam currently serves as Director of the Office of Policy for Pharmaceutical Quality (OPPQ) in the Office of Pharmaceutical Quality (OPQ) in the Center for Drug Evaluation and Research (CDER). OPPQ is responsible for developing and clearly communicating science- and risk-based policies and standards related to drug product quality, including application review and inspection. This Office also coordinates OPQ’s work with international regulatory authorities on quality issues, leads CDER’s compendial operations, coordinates CDER’s involvement in quality standard-setting organizations, and addresses policy issues related to drug-device combination products.
Prior to joining CDER in 2013, Ashley spent nearly 20 years in the Office of Device Evaluation (ODE) in FDA’s Center for Devices and Radiological Health (CDRH), serving as a scientific reviewer, a Branch Chief in the Division of Cardiology Devices, and finally as Associate Director for Regulations and Guidance for ODE. Ashley received her MSBE from the University of Alabama at Birmingham and her B.S.E. from Tulane University, both in biomedical engineering.
Senior Program Manager
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. CAPT 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. CAPT 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.
Deputy Director, Division of Medication Error Prevention and Analysis
Senior Director Regulatory Affairs - Medical Devices & Combination Products
Senior Quality Assurance Associate II
Product Specialist & Medical Device Auditor , MHS
TÜV SÜD America
Associate Director, Global CMC Regulatory Affairs, Medical Devices and Combination Products
Jason Lipman joined Janssen in 2013 and is currently Associate Director, Global CMC Regulatory Affairs, Medical Devices and Combination Products, where he is responsible for worldwide regulatory activities related to Janssen drug delivery devices and combination products. Prior to Janssen, Jason was with DePuy Synthes/Synthes Spine for 7 years where he managed a device regulatory team supporting US and global filings for spinal implants and instruments. Prior to this, Jason was with FDA’s CDRH General Hospital Devices Branch responsible for reviews of injection and infusion devices. Jason co-authored the FDA draft guidance on injectors and has represented FDA at international standards and advisory panel meetings. Prior to FDA, Jason held engineering roles during which time he was responsible for development of a needle-free injection device.
Jason holds a M.S. in applied biomedical engineering from Johns Hopkins University and a B.S. in mechanical engineering from Tufts University. He is an active member of the Combination Products Coalition.
Director, Regulatory Policy and Intelligence
Associate Director, Combination Products
Combination Products Team Lead
Mr. McMichael serves as the Combination Products Team Lead within the Office of Device Evaluation for review of drug and/or biologic delivery devices. He has been with CDRH/ODE for three years, primarily responsible for the premarket review of delivery devices as both standalone and combination products. Examples of these devices include syringes, injectors, and infusion systems. Mr. McMichael has experience with every type of submission and application reviewed by CDER, CBER, and CDRH. He has also participated as the device subject matter expert in multiple inspections of drug-device combination product manufacturing facilities. Mr. McMichael received a B.S. with honors in biomedical engineering alongside a minor in engineering business from the University of Virginia in 2015. He is currently pursuing a M.S. degree in applied biomedical engineering from Johns Hopkins University.
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.
Regulatory Affairs Manager
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.
Senior Director, Global Regulatory Affairs
Prior to being Senior Director, Global Regulatory Affairs at Sanofi, Suzette Roan was with Biogen as Associate Director in Regulatory CMC – Device Regulatory, where she led the combination product team responsible for regulatory strategies for the development and commercial combination product portfolio. Before 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.
Site Quality Director - Devices
David Shore is currently Site Quality Leader for Indianapolis Device Manufacturing for Eli Lilly and Company. Prior to joining Lilly, David held various positions in Validation, Operations and Quality at Pfizer supporting Pharmaceutical Production. David joined Lilly 15 years ago and has spent the last 12 years in the medical device Quality organization supporting site production and global supply of medical device components and subassemblies. David has 20+ years of pharmaceuticals and medical device experience. David received his B.S. in chemical engineering from Rose Hulman Institute of Technology.
Branch Chief General Hospital Device Branch
Director, Device Regulatory Affairs - Digital Health/Software Medical Devices
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.