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 Badelt, PhD is a seasoned expert in combination products, engineering management, and business development. He has over 20 years of experience in the design and launch of combination products and medical devices, including auto injectors, connectivity solutions, patient management software, insulin-pumps, pre-filled syringes, and on-body devices. Steve founded consulting firm Suttons Creek, Inc, which serves as the device team for pharma on over 45 global programs.
In his spare time, Steve advises several startups, speaks nationally about combination products and connectivity, serves as a Graduate Professor at Loyola Marymount University, and is an Emeritus Ambassador for the International Council on Systems Engineering.
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
Irene Z. Chan received a B.S. in pharmacy and Pharm.D. from Rutgers University. Upon graduation, she completed a PGY1 Pharmacy Practice Residency then worked with the Indian Health Service (IHS) for over five years in both inpatient and outpatient pharmacy settings, serving in various leadership roles. In 2009, CDR Chan transferred to the FDA, where she currently serves as Deputy Director in the Division of Medication Error Prevention and Analysis (DMEPA), responsible for leveraging her knowledge of regulatory principles, human factors, and risk management to provide oversight of safety recommendations regarding drug nomenclature, labels, labeling, packaging, and product design.
Senior Director Regulatory Affairs - Medical Devices & Combination Products
Director, DIPAP, OPPQ, OPQ, CDER
Laurie is currently the Director of the Division of Internal Policies and Programs (DIPAP) in the Office of Policy for Pharmaceutical Quality (OPPQ) in the Office of Pharmaceutical Quality (OPQ) at the Center for Drugs Evaluation and Research (CDER). DIPAP is responsible for the development and evaluation of CDER internal policies and programs related to pharmaceutical quality, including application assessment and inspection.
Prior to joining OPPQ, Laurie had more than 20 years of experience at the FDA. Laurie first joined the FDA in 1993 as a full-time research biologist investigating the response of immune cells to perturbation by physiological ligands or pharmaceutical agents, such as monoclonal antibodies. In 2003, Laurie assumed product quality regulatory assessment responsibilities and became a product quality team leader in 2013. During this time, Laurie’s product quality related regulatory responsibilities included inspections and application assessments for monoclonal antibodies, novel antibody products, Fc-fusion proteins, and combination products.
Senior Quality Assurance Associate II
Product Specialist & Medical Device Auditor , MHS
TÜV SÜD America
Dr. Kumar have been with TÜV SÜD America for more than one year. Most recently he was a scientific reviewer and biocompatibility expert at the Center for devices and radiological health at FDA. Today Dr. Kumar is as a product specialist and medical device auditor in the areas of cardiovascular, neurovascular and drug-device combination products.
Dr. Kumar is passionate about adding value to his clients mission by providing excellent and reliable service. Building on his past regulatory experience he is able to provide key insights that help medical device companies to reduce the size of their regulatory program and bring new medical products of public health importance into the market.
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
Demetra Macheras is currently Director, Regulatory Policy and Intelligence at AbbVie. She assesses and coordinates comments on proposed regulatory policies for the U.S. and Canada regulatory environments and ensures appropriate AbbVie personnel are aware of emerging and final regulatory policies. She also provides regulatory and strategic support to global project teams.
Demetra has over 21 years of industry experience and has held positions in Regulatory Affairs, Quality Assurance, Compliance, and Operations. She earned a B.S. in mechanical engineering from the University of Illinois in Urbana/Champaign and an M.B.A. from the Lake Forest Graduate School of Management. Demetra is also very active in a number of external trade associations.
Director, Digital Devices and Combination Products
Ryan McGowan is the Director of Digital Devices and Combination Products in Regulatory Affairs at AstraZeneca. He has responsibility for developing regulatory strategies for the approval of digital health products including software as a medical device. Prior to joining AstraZeneca, Ryan was a premarket reviewer and combination products team leader at FDA’s Center for Devices and Radiological Health where he evaluated and influenced regulatory policy for drug delivery constituent parts of combination products.
Head, Combination Products CoP and Sr. Director, Global Value Chain Quality Design
Johnson & Johnson
Susan joined Johnson & Johnson in 1995. In her current role, she is responsible for Johnson & Johnson’s Combination Products Community of Practice, as well as for connecting R&D teams across segments of J&J to proactively embed quality into new products and processes. Over her extensive career, she has played integral leadership roles in R&D product and process development and in Quality Engineering in both Medical Devices and Pharmaceuticals.
In her prior role, Susan led J&J’s Pharm Sector (Janssen) Combination Products CoE and Quality Engineering. Among several achievements during her tenure at Janssen, Susan led the team that defined and implemented the business model, integrating global cross-functional requirements, to meet Combination Products health authority regulations. She has been 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’s astigmatic product portfolio. She holds numerous patents and publications.
Susan earned an M.S. in polymer science & engineering, and a B.S. in biology/chemistry, as well as Fellowship in the American Academy of Optometry.
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.
Senior Manager, Regulatory Affairs Device
Chelsea O’Connell, MS, RAC joined Amgen in 2011 and is currently a Senior Manager, Regulatory Affairs Device developing global combination product strategy and managing submissions for electromechanical and hand-held delivery devices across various drug therapeutic areas. She developed and maintains the combination product change control regulatory reporting process within Amgen and is an active participant across several industry groups related to this topic. Previous to Amgen, she worked for several medical device companies in ophthalmology and cardiology.
She earned a B.S./M.S. from California Polytechnic State University in Biomedical Engineering. She is a member of the Combination Product Coalition and TC 84 working groups.
Eli Lilly and Company
Rahul Patil joined Lilly’s Delivery Device and Connected Solutions group in June 2016 in the newly created role of reliability engineering and is responsible for developing and executing an integrated, long-term reliability strategy for Lilly’s drug delivery device portfolio.
Before joining Lilly, Rahul worked at Rolls-Royce Energy Systems in Ohio, where he responsible for developing the safety and reliability assessments for the gas turbine packages. Prior to this, Rahul has held positions at B/E Aerospace (now Rockwell Collins) and Smiths Aerospace (now GE Aviation) where he was involved in the reliability design and testing of airplane interiors and aero-structures.
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
Gretchen Vandal is currently a Director in Device Regulatory at Sanofi. Prior to joining Sanofi in 2017, Gretchen was a Global Regulatory Lead for digital health devices at Biogen, where she was responsible for the development and implementation of regulatory strategies for the full digital health device portfolio, including SaMD, integrated hardware/software systems, clinical trial technology devices and wearables. In addition, Gretchen was also the Asset Lead for the cross-functional Digital Health Asset Team which oversaw selection, design and development, launch, and post-market activities for digital health devices at Biogen. Before joining Biogen in 2014, Gretchen spent 13 years with Amgen Inc., where she held a number of roles in both Quality and Regulatory Affairs.
Gretchen holds a Bachelor of Science in microbiology from the University of Rhode Island, a Master of Science in regulatory affairs for drugs, biologics, and medical devices from Northeastern University, and a Master of Business Administration from Northeastern University.
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.