Speakers Sponsored by
Caroline rhim, PHD
Executive Director, NSF International
Dr. Rhim received her doctorate degree in Biomedical Engineering from Duke University, and her Bachelor and Master of Science degrees in Materials Science and Engineering from M.I.T. Prior to joining NSF International, Caroline served as an FDA Branch Chief for the Anterior Spine Devices Branch at the Center for Devices and Radiological Health (CDRH). Caroline also led the review of premarket submissions as a lead scientific reviewer in both the Division of Orthopedic Devices and Division of Cardiovascular Devices. During her tenure at FDA, she was involved in streamlining the premarket and postmarket review process, as well as the classification efforts for posterior cervical screw systems.
iris marklein, PHD
Dr. Marklein received her doctorate degree in Bioengineering and Biomedical Engineering before her move to regulatory affairs at FDA. Iris began as a Biomedical engineer and scientific reviewer in the Division of Orthopedic Devices at FDA, and progressed to become a scientific reviewer of devices, combination products, and cell therapies in the Division of Cellular and Gene Therapies. In 2017, Iris became the Team Lead for devices and combination products in the Division of Cellular and Gene Therapies, and continued in this position for almost two years before concluding her time at FDA to become an Assistant Professor of Practice and Regulatory Affairs Advisor at the University of Georgia.
jemin dedania, ms, rac
Associate Manager Regulatory Affairs, Stryker
Mr. Dedania began working for FDA after achieving his B.S. in Biomedical Engineering at University of Tennessee followed by an M.S. in the same field at the New Jersey Institute of Technology. For six years, Jemin worked as a Biomedical Engineer at FDA, reviewing technical data and research protocols for orthopedic device submissions, and conducting tests on submitted devices to determine performance safety. While at FDA, Jemin became a Senior Biomedical Engineering Lead Reviewer, which he maintained for nearly two years before leaving the agency. He currently works as a Staff Regulatory Affairs Specialist at Stryker. He will receive his MBA from The Johns Hopkins University Carey Business School this year.
Principal Regulatory affairs specialist, medtronic
Ms. Leismer received her Bachelors in Biomedical Engineering from Johns Hopkins University. She is currently a Principal Regulatory Affairs Specialist at Medtronic supporting the legacy Neuromodulation business. Prior to joining Medtronic, Sarah worked as a Biomedical Engineer at the FDA for five years, leading the review of premarket submissions as a lead scientific reviewer of orthopedic spine devices. She also participated in a collaborative reviewer program acting as both an ODE reviewer and OSB MAUDE analyst and received the FDA Outstanding Service Award for this work. After leaving FDA, she joined the regulatory affairs team at Greatbatch Medical and later QiG Group (now Nuvectra) supporting a variety of device types in different stages of the total product lifecycle. Sarah's interests include regulatory strategy and planning during the early stages of product development and the interpretation and adaptation required in light of the rapidly evolving regulatory landscape of the US and EU markets.
Nada Hanafi, MSc, MPH
Chief Strategy officer, experien group
Nada initiated her career at Biomat Sciences as an R&D engineer supporting dental products. She joined CDRH’s Office of Device Evaluation (ODE) in 2004 and led FDA review teams for original (and sometimes controversial) devices, including a silicone gel-filled breast implant PMA, a drug-eluting neurovascular stent IDE and two novel neurological stent HDEs for the treatment of atherosclerotic disease. As a Senior Science Health Advisor at CDRH, Nada led cross-Center and Agency programs for the advancement of FDA’s mission, including the Health of Women (HoW) program, the Network of Experts program and the Patient Preference Initiative. She collaborated with the Center for Tobacco and the National Institutes of Health (NIH) to improve regulatory efficiency and to strengthen data collection and she was the CDRH Liaison and Subject Matter Expert to FDA’s Office of Women’s Health (OWH) and the Office of Minority Health (OMH). Nada joined Experien Group in 2017 after 12 years at FDA, where she helps medical device and combination product manufacturers generate regulatory/clinical roadmaps for success as Chief Strategy Officer.
Nada holds an M.S. in Biomaterials and a B.E. in Biomedical Materials Science & Engineering from Queen Mary College, University of London. She earned her M.P.H. from Johns Hopkins Bloomberg School of Public Health. Nada is a Certified Quality Improvement Associate (CQIA) and a Certified Quality Auditor (CQA) from the American Society for Quality (ASQ).
Michael Nilo, MS
principal consultant, nilo medical consulting
Michael has 10 years of experience in the medical device industry, including direct experience with FDA device review processes and intricacies. Michael has extensive experience with clinical trial development for medical devices, quality system regulations, and all manner of FDA interactions. Prior to starting Nilo Medical Consulting Group, Michael worked first as a lead reviewer in both the Interventional Cardiovascular Devices Branch and the Dental Devices Branch before working as a Senior Regulatory Affairs Specialist at Biotronik, Inc., where he worked with international teams to develop regulatory and testing plans to meet FDA requirements. While at FDA, he examined pre-market submissions for cardiac medical devices and reviewed dental devices such as implants, abutments, bone-grafting materials, bone plates, and trans-mandibular joint implants.
Michael graduated Summa cum Laude from University of Pittsburgh with a degree in Bioengineering before receiving his Masters of Science in Biomedical Engineering from University of Alabama at Birmingham.
Dulciana Chan, MS
senior regulatory specialist, Acknowledge rs
Ms. Chan received her B.S. in Biomedical Engineering from Johns Hopkins University in 2002, and her M.S.E. in Bioengineering from the University of Maryland in 2010. Directly following her undergraduate degree, Dulciana began her FDA career as a research associate in the Center for Devices and Radiological Health (CDRH), Office of Science and Engineering Laboratories (OSEL). A year later, she became a Biomedical Engineer at FDA, and for 14 years operated in various branches of the administration, including as a scientific reviewer and policy analyst in the Office of Device Evaluation (ODE), and as an OSEL principle investigator. Dulciana has extensive experience in the areas of electromagnetic compatibility (EMC) testing and electrical safety, and is an asset to Acknowledge Regulatory Strategies, where she is now a Senior Regulatory Specialist.
principal consultant, arina consulting
Allison Kumar has over 15 years of regulatory experience, and is currently the CEO and Principle Consultant at Arina Consulting, LLC. Prior to founding Arina Consulting, Allison spent over ten years at FDA, working as a biomedical engineer, and later as a Senior Program Manager in the Emergency Preparedness and Medical Countermeasures (EMCM) Program. In her role as a Senior Lead Reviewer, Allison reviewed research protocols, as well as scientific and technical data related to peripheral vascular devices and novel combination products submitted in support of 510(k)s, IDEs, and PMAs. As Senior Program Manager in the EMCM Program, Allison worked to advance innovation and enhance the regulatory approval process for novel medical technologies that address unmet public health and patient needs.
Allison continues to provide specialized and strategic direction to academia, industry, and government partners, and is a key opinion leader on scientific and regulatory policy issues in areas such as combination products, cardiovascular devices, general hospital and advanced surgical devices, medical mobile apps, critical care medicine, traumatic brain injury, healthcare-associated infections, and medical countermeasures.
Cheng zhang, phd
director regulatory affairs, inovio pharmaceuticals
Dr. Cheng Zhang currently serves as the Director of Regulatory Affairs, Medical Devices for Inovio Pharmaceuticals, a company that develops novel biologic/device combination products and associated diagnostic tests. His responsibilities include regulatory submissions to and correspondence with U.S. and international regulatory agencies, as well as ensuring compliance with national and international standards and regulations and internal policies and SOPs. Prior to joining Inovio, Dr. Zhang worked in FDA/CDRH, where he started as a scientific reviewer in Office of In Vitro Diagnostics and Radiological Health / Division of Immunology and Hematology Devices. He reviewed a wide variety of pathology, genetics, hematology, and immunology IVD devices, highlighted by the de novo authorization of the first next generation sequencing device (Illumina MiSeqDX) and the first direct-to-consumer genetic test (23andMe Bloom syndrome carrier status test). He then progressed to become the Branch Chief of the Hematology Branch, leading a team of 15 reviewers, medical officers and consumer safety officers. Dr. Zhang received his B.S. and M.S. from Zhejiang University in China, Ph.D. degree from Oregon State University, and M.B.A. from University of Massachusetts.
Allison Komiyama, PhD, RAC
principal consultant, acknowledge rs
Dr. Komiyama received her Ph.D. in Neuroscience from Stanford University and her B.A. in Molecular and Cell Biology from University of California, Berkeley. She received her Regulatory Affairs Certification (US) in 2014. While working at FDA as a biologist and reviewer in the Office of Device Evaluation, she acted as a lead reviewer and consult on 510(k) Premarket Notifications, Investigational Device Exemption (IDE) applications and Premarket approval (PMA) submissions. Her specialty was in biocompatibility requirements for implanted devices. She also researched neurotoxicity and systemic toxicity of medical devices in the Office of Science and Engineering Labs in support of FDA recognized ISO and ASTM standards. She started AcKnowledge Regulatory Strategies in order to serve clients who manufacture implantable and other patient-contacting medical devices.
Stayce Beck, PhD, mph
vice president clinical partnerships, dexcom
Dr. Beck received her Ph.D. in Biomedical Science from the University of California San Diego, and her B.S. in Chemical Engineering from the University of Texas at Austin. She also received her Master of Public Health (MPH) in Epidemiology from University of Maryland Baltimore. Dr. Beck worked at FDA for over ten years, spending time as a scientific and regulatory reviewer, a chief of the Diabetes Diagnostic Devices Branch, and Deputy Office Director of Personalized Medicine and Molecular Genetics. In her branch office, which is under the direction of the FDA´s Center for Devices and Radiological Health, Stayce oversaw scientific and medical matters involved in assuring that new and existing diabetes devices manufactured by companies and made available to the public meet the FDA´s strict standards for safety and quality. Following her departure from FDA, Dr. Beck became the Vice President of Clinical and Strategic Partnerships at Dexcom, where she still works presently.
senior director ra/qa, convatec
David Pudwill received his B.S. in Biomedical Engineering from Case Western Reserve University in Cleveland, Ohio, which he utilized to get a position as a field engineer at St. Jude Medical before beginning his 9 years at FDA. While at FDA, David was a Biomedical Engineer, Chief of the Implantable Electrophysiology Devices Branch, and Congressional Affairs Specialist. David currently works at ConvaTec as the Senior Director of Ostomy Franchise Regulatory Affairs and Quality Assurance.