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.
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).
Global Associate Director - Device Quality
Mike Barnett is a Global Associate Director in Device Quality at AstraZeneca where he has responsibilities for the quality system requirements for Combination Products and Medical Devices.
He has over 26 year’s experience with various positions in Quality Control/Quality Assurance within AstraZeneca and holds a BSc (Hons) in Chemistry from Nottingham University.
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.
Manager, Regulatory Affairs CMC
Inta is a Regulatory Affairs CMC Manager at the biopharmaceutical company Alkermes, Inc. She began her career in Analytical Development and Claims testing for personal care products before joining the pharmaceutical industry as a Chemistry and Analytical Development coordinator for a generics company. She then transitioned into Regulatory Affairs CMC where she provided pre and post approval life-cycle management support for primarily solid oral dose drugs. At Alkermes, Inta provides Regulatory CMC development and life-cycle management support for biologic and long-acting injectable drug combination products.
Inta holds a B.S. in biomedical science and a minor in chemistry from St. Cloud State University in Minnesota.
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 – Medical Devices & Combination Products, Global Regulatory Affairs
Tim joined AstraZeneca in 2007 to lead a team responsible for developing delivery devices for AZ’s new drug portfolio. This encompassed all dosage forms and had a significant focus on inhalation and injection devices.
Tim’s current role is to lead the Medical Devices & Combination Products group within AstraZeneca Global Regulatory Affairs. The group is responsible for developing and implementing regulatory strategies and processes for both new and existing medical devices and combination products. This encompasses conventional pharmaceuticals, biologics and AZ’s activities in Digital Health. Tim is an active member of a number of medical device & combination product groups and associations including the Combination Products Coalition and IPAC-RS.
Before joining AstraZeneca, Tim led the Regulatory Affairs group at Valois Pharma (Part of the Aptar Group – a Manufacturer of Drug Delivery Devices) Tim was responsible for Valois’ regulatory strategy and provided technical and regulatory input to new product development.
Vice President, Global Scientific Affairs and Technical Services
West Pharmaceutical Services
Fran DeGrazio has been in the pharmaceutical packaging industry for over 35 years with extensive expertise in the area of delivery of injectable drug products, such as vial/closure combinations, prefillable syringe systems and injectable combination products.
Throughout her tenure at West, Fran has served in various functions within the analytical laboratory, research and development and quality assurance/regulatory areas.
She is currently an active member of the PDA PMF Visible Particulate Task Force leadership team and the IPAC-RS Materials Working Group. She has also received the Healthcare Business Woman’s Association Luminary Award for West Pharmaceutical Services in 2017 and the Philadelphia Business Journal Healthcare Innovators Award in 2018.
Associate Director, Global CMC Regulatory Affairs, Medical Devices and Combination Products
Heather Guerin is an Associate Director, Global CMC Regulatory Affairs, Medical Devices and Combination Products at Janssen. She has responsibility for developing worldwide regulatory strategies related to Janssen drug delivery devices and combination products. Prior to Janssen, Heather was with the DePuy Synthes/Synthes Craniomaxillofacial and Spine divisions for five years where she supported US and global filings for orthopaedic implants and instruments.
Heather holds a Ph.D. in mechanical engineering from the University of Pennsylvania and a B.S. in mechanical engineering from Villanova University. She is a registered Professional Engineer in the state of Pennsylvania.
Director, Development Projects, Global Regulatory Affairs, RD Chief Regulatory Office
Sue is a Director in Global CMC Regulatory Affairs with GSK. In her role she is responsible for leading the CMC regulatory activities of cross-functional teams supporting multiple projects, primarily inhaled/respiratory combination products, with oversight of the development of GSKs regulatory strategy for devices and combination products. She also manages a team of CMC regulatory affairs professionals supporting a range of small molecule products in development.
Sue joined GSK in 1988 as an analyst leading the analytical development of inhaled products, primarily MDIs (both CFC and HFA) which included valve design and development and extractables/leachables testing. On moving to regulatory affairs her scope expanded to also cover DPI and nasal products, including the Diskus and Ellipta GSK products; spanning clinical trial, marking application and post-approval variation global submissions.
Sue has a B.S. in chemistry with analytical chemistry and toxicology from Hull University, and an M.S. in pharmaceutical analysis and quality control from Kings College, London University. She currently sits of the IPAC-RS Board of Directors, chairs the IPAC-RS North America Outreach Working Group and is a member of the CPC Steering Team and the CPC Marketing Applications Working Group.
Combination Products Regulatory Advisor
Kristina Lauritsen, Ph.D., serves as a Combination Product Policy Advisor within the Center for Drug Evaluation and Research (CDER) at the FDA. In this role, she is responsible for engaging in development of CDER's policies related to combination product review and regulation, including activities such as guidance development, facilitating coordination with the FDA's Office of Combination Products, CBER and CDRH, and representing CDER in cross-center combination product working groups. Kristina originally joined FDA in 2003 as a device reviewer in CDRH. She later joined the Office of Combination Products and spent several years there prior to joining CDER in 2014. She holds a B.S. in Biology from Shippensburg University, and a Ph.D. in tumor biology from Georgetown University.
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 seven 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.
Manager, Regulatory Affairs CMC Combination Products and Medical
Krystin Meidell joined Biogen in 2018 and is currently with the Regulatory CMC Medical Devices and Combination Products group where she supports combination product and medical device regulatory policy and strategy. Krystin’s experience includes global regulatory and analytical roles in medical devices, diagnostics, drug delivery, and combination products, with a focus in software and companion diagnostics. She holds a bachelor of science degree in chemical engineering from Carnegie Mellon University and is an active member of the Combination Products Coalition.
Senior Medical Officer, Office of Combination Products
As senior medical officer in FDA’s Office of Combination Products, Maryam Mokhtarzadeh provides clinical and regulatory leadership and expertise across a broad range of medical products including complex combination products. Maryam previously served as a medical officer in CDRH, providing clinical and regulatory expertise in ophthalmic products and other medical devices. After receiving her undergraduate degree at Princeton University and her M.D. at the Johns Hopkins University School of Medicine, Maryam completed an ophthalmology residency and a fellowship in ocular surface diseases and corneal transplantation. In addition to her role in the Office of Combination Products, she also practices at the National Eye Institute as a board-certified ophthalmologist providing direct patient care in the Ophthalmic Genetics and Visual Function Branch and serves as the FDA IRB chair.
Sr. Director, Global Value Chain Quality Design
Johnson & Johnson
Susan Neadle has a distinguished career at Johnson & Johnson, where she has held roles of increasing responsibility in medical devices, pharmaceuticals, and Enterprise functions for almost 25 years. In her current role, she is responsible for Johnson & Johnson’s Design Council, advancing world-class practices in product design to drive agility and robustness in the development of customer-centered health care solutions across J&J. She also leads J&J’s Combination Products CoP.
Over her extensive career, she has played integral leadership roles in R&D product and process development and in Quality Engineering. Among several achievements during her tenure at J&J, Susan led the team that defined and implemented the business model, integrating global cross-functional requirements, to meet Combination Products health authority regulations into Janssen (J&J’s Pharmaceutical segment). Susan was awarded the Janssen Supply Chain Inclusion Award in recognition of her global cross-functional leadership and collaboration. She has applied her Design Excellence Blackbelt skills to drive significant business impacts, and has been awarded the Johnson Medal, J&J’s highest honor for innovation excellence. 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.
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.
Director, Regulatory Strategy and Policy, Lubrizol Advanced Materials, Inc and Chair, IPEC Americas Regulatory Affairs Committee
Meera Raghuram is currently the Director, Regulatory Strategy and Policy for the Life Science Division of Lubrizol Corporation. She has over 20 years of experience in complex technical and strategic regulatory issues related to pharmaceutical excipients, drugs/devices, personal care products, human health and environmental risk assessments and liability management. She is a member of the IPEC-Americas Executive Board and serves as the Chair of IPEC-Americas Regulatory Affairs Committee. She takes an active role globally on advocacy issues, understanding global regulatory trends and finding innovative solutions for global regulatory compliance. She has also been involved in advocacy and leadership on critical environmental issues with various industry organizations including the American Chemistry Council and ASTM International. In her previous position, she was responsible for management of remediation liability for Lubrizol and has successfully worked with US (state and federal) and international regulatory agencies to bring resolution to issues. Meera has a B.S degree in pharmacy from the Indian Institute of Technology and a M.S. in pharmaceutical sciences from Purdue University, Indiana.
Director, Regulatory Policy, Corporate Regulatory Affairs
As part of the Public Policy and Government Affairs team located in Washington DC, Fatemeh monitors the US regulatory landscape for emerging regulatory policy issues of importance to BD, and interacts on behalf of the Company with FDA. She represents BD in industry working groups and coalitions to advance BD's goal of helping patients access safe and innovative medical technology. Fatemeh joined BD after over 11 years in the Center for Devices and Radiologic Health (CDRH) at the US Food and Drug Administration (FDA). Fatemeh's CDRH experience includes serving as a Lead Scientific Reviewer and Biomedical Engineer in the Office of Device Evaluation, including assignments in the Office of Combination Products, the Office of the Commissioner, and the Office of the Center Director where she worked on new regulations and policy. From 2013 to early 2018, she served as a Policy Analyst in the Office of In Vitro Diagnostics and Radiological Health (OIR), where she led OIR’s 510(k) review program, trained review staff, drafted guidance documents and work instructions regarding the 510(k) program, and assisted in the implementation of the Medical Device User Fee Act (MDUFA) and regulatory policy for the 510(k) program. During her tenure at OIR, Fatemeh was the public face of OIR on several FDA policy issues and she worked closely with AdvaMed in addressing industry questions and concerns regarding OIR 510(k) review practices. Fatemeh is the recipient of multiple awards during her tenure at the FDA. Fatemeh received her B.S. in biomedical engineering and M.S. in electrical engineering from George Washington University.
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.
Global Regulatory Head, Combination Products, Devices, Digital Health
Genentech, a member of the Roche Group
Chin-Wei Soo is the Global Regulatory Head, Combination Products, Devices, and Digital Health at Roche/Genentech. He is accountable to provide technical regulatory oversight to Roche’s entire device, combination product, and digital health portfolio, covering all large (BLA) and small molecules (NDA) throughout the product lifecycle. Chin chairs the Combination Product Coalition (CPC) digital health working group.
Chin has 18 years of regulatory and quality experience, including strong expertise in combination products and digital health. Prior to joining Genentech, he was with Medtronic and Boston Scientific where he successfully led regulatory submissions and implemented quality management principles that resulted in approvals of IN.PACTTM drug-device coated balloon, TAXUSTM drug-device coated stent, and implantable, programmable drug infusion pumps.
Chin graduated from Iowa State University with a bachelor’s degree in industrial and manufacturing systems engineering, a master of science in bioscience regulatory affairs from the Johns Hopkins University, and a doctorate in regulatory policy from the University of Southern California School of Pharmacy.
Assistant Director, Division of Drug Delivery, General Hospital, and Human Factors
CAPT Alan Stevens is a supervisor in the CDRH review division responsible for evaluating many drug delivery devices used within the United States, which includes devices like syringes, injectors, intravascular ports, and infusion devices. Before his current assignment, he spent 10 years as an engineering reviewer in the General Hospital Devices Branch and three years as a compliance officer in CDRH’s Office of Compliance. CAPT Stevens received his undergraduate mechanical engineering degree and master’s degree in reliability engineering from the University of Maryland.
Senior Research Fellow
John Towns, Ph.D., is Senior Research Fellow in Global Regulatory Affairs at Eli Lilly and Company with responsibilities for Lilly’s portfolio of stand-alone devices and combination products. John’s prior experiences include Senior Director of CMC Regulatory Affairs and Head, Bioanalytical Development. John has presented and published on injectable combination products with a focus on Human Factors, and his research interests center on the reduction of medication errors through clear product differentiation, clarity of instructions for use and appropriate user training. John is also involved with several external organizations to set standards to clarify and harmonize the filing requirements for combination products.
John received his B.S. in chemistry from Cal Poly San Luis Obispo, CA and his Ph.D. in analytical chemistry from Purdue University.
Executive Vice President, Medical Device International Services
Kim Trautman has over 30 years of experience in medical device quality systems and international regulatory affairs. She is focused on expanding international regulatory affairs and compliance services for NSF’s medical device clients, including expanding medical device training services worldwide and spearheading the development of an independent, third-party regulatory certification program.
Ms. Trautman was previously Associate Director for International Affairs in the U.S. Food and Drug Administration’s Center for Devices and Radiological Health (CDRH) where she led the CDRH’s international efforts and initiatives. She was responsible for writing the current U.S. FDA Medical Device Quality System regulation and preamble published in 1996. She also developed and implemented the extensive quality system regulation roll out and training programs, and led continuing harmonization efforts with ISO 13485.
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.
Combination Products Policy Analyst
Dr. Andrew Yeatts is currently serving as a Combination Products Policy Advisor in CDRH’s Office of Policy. He has represented CDRH on Agency working groups to develop cross-cutting guidance and policy related to combination products. Andrew has also worked to implement legislation such as the Combination Product Provisions of 21st Century Cures. Prior to his current role Andrew served as a combination product policy analyst in CDRH’s Regulation, Policy, & Guidance Staff and as a CDRH Product Jurisdiction Officer since 2016. Andrew joined CDRH in 2012 as a researcher within the Office of Science and Engineering Laboratories where he investigated multiplexed platforms to detect toxins and pathogens. In 2014 Andrew joined the Office of Device Evaluation in the Plastic and Reconstructive Surgery Devices Branch 2 as a biomedical engineer and lead reviewer. Prior to joining FDA, Andrew received his Ph.D. in bioengineering from the University of Maryland and his undergraduate degree in biomedical engineering from Bucknell University.