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Short Course 4: Combination Therapies


Instructors

  • Khaudeja  Bano, DrMed, MD, MS

    Khaudeja Bano, DrMed, MD, MS

    • Executive Medical Director, Combination Product Safety Head
    • Amgen, United States

    Dr. Bano is an Executive Medical Director, Head of Combination Product Safety at Amgen. She 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 a certified coach. Khaudeja has more than 25 years professional experience, including patient care. She has held several global safety positions at Guidant, Abbott (multiple divisions like Vascular, Diagnostics, and Established Pharma), and AbbVie Inc. She currently serves as the working group chair of the Combination Product Coalition's Post-marketing Safety Reporting team.

  • Melissa  Burns, MS

    Melissa Burns, MS

    • Senior Program Manager, Office of Combination Products, OCPP, OC
    • FDA, United States

    CAPT 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. Prior to joining OCP, Melissa worked for several years in FDA CDRH. Melissa worked for several years in the private sector including positions with a medical device manufacturer, a hospital, a healthcare architecture firm, and a consulting firm. Melissa 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.

  • Suranjan  De, MBA, MS

    Suranjan De, MBA, MS

    • Deputy Director, Regulatory Science, OSE, CDER
    • FDA, United States

    Mr. De is the Deputy Director of CDER’s Office of Surveillance and Epidemiology, Regulatory Science Staff at FDA. He provides expert advice and technical direction on regulatory science for developing new tools, standards, and approaches to assess the safety, efficacy, quality, and performance of all FDA-regulated products. He has over twenty years of experience with the FDA, the NIH & in the pharmaceutical industry. His current work includes compounding reporting guidance, data management of FAERS system, Safety Reporting Portal for mandatory post-marketing electronic submissions and the FAERS Public Dashboard.

  • Patricia  Love, MD, MBA

    Patricia Love, MD, MBA

    • Deputy Director, Office of Combination Products, OCPP, OC
    • FDA, United States

    As Deputy Director of the Office of Combination Products since 2003 Dr. Love leads the development of combination product initiatives for premarket review and post market regulation. Previously from 1993-2003, Dr. Love served as Director, Division of Medical Imaging and Radiopharmaceutical Products. She joined FDA in 1988 and has a range of FDA review and leadership experience in therapeutic, diagnostic, and combination product areas. Dr. Love is an internist with rheumatology, and allergy-immunology academic and clinical practice experience.

  • Quynh Nhu  Nguyen, MS

    Quynh Nhu Nguyen, MS

    • Associate Director for Human Factors, DMEPA, CDER
    • FDA, United States

    CDR QuynhNhu Nguyen is an engineer officer and has been with FDA for more than 13 years. She began her work at FDA evaluating human factors (HF) and use safety of medical products with the MedSun project in Office of Surveillance and Biometrics, then with the Human Factors Premarket Evaluation Team in Office of Device Evaluation within the Center for Devices and Radiological Health, and now with the Division of Medication Error Prevention and Analysis (DMEPA).She currently serves as the Associate Director for Human Factors for DMPEA and her current responsibilities include developing policy and best practices for HF reviews to ensure clarity and consistency within the Division.