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.
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.
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.
Director, Office of Policy for Pharmaceutical Quality
FDA - CDER
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.
Sandra Boyd, ASQ, RAC, joined Biogen in 2007 and is currently Associate Director in Corporate Quality - Device Systems where she leads the team responsible for the quality oversight of design and development of medical devices/combination products and the incorporation and maintenance of these products into Biogen’s Quality Management System. Throughout her career she has held positions in the R&D of antibiotics, polymers, and semiconductors; healthcare; and pharmaceutical quality for medical device/combination products, small molecule, and biotechnology. She holds a M.B.A. with a concentration in New product development from NC State University and a B.S. in biochemistry from the State University of New York.
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.
Sr. Director, Regulatory Affairs, CMC – Combination Products and Medical Devices
Mr. Chapman had 25 years of product and software development experience as developer and manager in the medical device and other industries before joining FDA in 2005. He was Chief of General Hospital Devices Branch for his last 5.5 years there. He specialized in software-based medical devices, medical devices with embedded software, infusion pumps, combination products, and new methods for regulatory review of premarket submissions. He has a masters degree in software engineering from the University of Minnesota. Mr. Chapman joined Biogen in 2016 as Senior Director for Regulatory Affairs CMC for Medical Devices and Combination Products.
Senior Drug Program Expert (CSO)
Jim started with FDA in 1983 as an Investigator (CSO) in the Dallas District/Houston Station Office. In 1989, he was promoted and transferred to the San Juan District Office as a Drug and Biologics Specialist. In 1991, Jim was promoted and become a Supervisory Investigator and transferred to the Baltimore District Office. In 1994, he accepted a lateral transfer to FDA/ORA Headquarters – the Division of Field Investigations, as a Drug Program Expert. In 2009, Jim was promoted to a Senior Drug Program Expert. He became a member of FDA’s foreign drug inspection cadre in 1993 and has been involved with national FDA/ORA training of field drug investigators since 1996. Jim is also the ORA inspectional representative to the FDA Inter-Agency Combination Products cGMP Workgroup.
Jim earned a B.S. in Environmental Science (with a Technical Writing Option) from The Pennsylvania State University in 1982. In 1989, he completed all the coursework for a M.B.A. from the University of Houston. Jim is a past recipient of FDA’s Award of Merit.
Sr. Manager, Human Factors Engineering
Amgen, Device and Final Drug Presentation Technologies
Ms. Fenster has thirty years’ experience developing intuitively optimized interfaces for mission critical business applications. She is a persuasive advocate for human factors engineering and human-computer interaction and is dedicated to developing powerful user-centered design for combination products and medical devices.
Ms. Fenster leads Amgen’s Human Factors Engineering group to support all user-centered design and research activities to ensure successful regulatory submissions for combination product programs.
She is an active member of the Human Factors and Ergonomics Society and the Association for the Advancement of Medical Instrumentation. She holds a bachelor’s in humanities, another in psychology, and a master’s of science in human-computer interaction from DePaul University.
Head of Regulatory Compliance, Enterprise Combination Products
Johnson & Johnson
Steve Holcroft’s career in the healthcare industry has spanned over 26 years in Quality Assurance, Quality Control, Operations, Regulatory Affairs, Regulatory Compliance, and Research & Development in the pharmaceutical and medical device industries.
He has spent the last 20 years at Johnson & Johnson where he has served in Senior Quality and Regulatory leadership roles of increasing responsibility across Johnson & Johnson’s Pharmaceutical and Medical Device Segments. His compliance organizations have been effective at creating organizational partnerships, achieving international Health Authority objectives, using process excellence to reduce cost and continue business growth. His focus on organizational and leadership development, enabling quality culture for business growth, and the strategic utilization of innovative quality approaches are principals that have been key elements to his success.
Steve is currently serving as the Head of Regulatory Compliance for Johnson & Johnson’s Enterprise Combination Products organization where he was been tasked with developing the global regulatory compliance strategy for Johnson & Johnson’s cross sector legacy (+)$15 Billion dollar global combination products portfolio. Steve is a graduate of Elizabethtown College where he obtained a bachelor of science degree in bio-chemistry.
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.
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.
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.
Accelerated Product Convergence
Alberto Velez is the Owner of Accelerated Product Convergence, LLC. APC was created to support organizations in the structured implementation of combination product systems. He has been partnering with Chimera Consulting to train organizations in the application of this methodology. He is a recognized expert in Organizational Development for Combination Products with over 40 years’ experience in the healthcare industry. The last 15 years has been has been applying combination product system to over 35 projects in product development, manufacturing and quality. Alberto is a frequent speaker on combination products topics at industry meetings and workshops. Has over 30 years of management experience in medical device and combination product quality assurance, FDA readiness, product development and organizational effectiveness in the pharmaceutical and medical device industries. He has applied the CGMP’s/QSR’s to several different divisions in the Johnson & Johnson family of companies as well as other smaller health care organizations. Alberto led several R&D teams to develop and launch new technologies in Endoscopic Surgery, Esophageal Reflux Disease, and Enteral Feeding. Educational background is in Chemical Engineering, Industrial Engineering and Quality Engineering.
Director of User Centered Design
Sara is currently the Director of User Centered Design at Eli Lilly and Company. She has held previous experience from Phillips HealthCare and Baxter Healthcare. She has held a number of positions in these companies including User Centered Design Lead, Sr. Manager of Human Factors and Industrial Design, and Sr. Human Factors Engineer. Through these responsibilities, she has led cross functional teams, interacted with regulatory agencies, as well as built and executed strategic plans. While at these organizations, she has been responsible to ensure intended end-users are effectively represented and their needs are fully considered throughout the product lifecycle.
Sara has a B.S. in human factors engineering and biomedical engineering design from Tufts University, where she has also completed her M.S. course work in human factors engineering. As a member of the human factors committee of the Association for Advancement of Medical Instrumentation (AAMI), Sara has contributed to the development and revision of technical information reports and standards.
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.