Our Combination Products Summit Strategic Committee is made up of the following FDA officials and industry experts:
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.
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.
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
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.
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 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.
Associate 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.
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.