Agenda - Department of Biomedical Engineering - University of ...

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Sep 26, 2011 ... Jordan Hall Conference Center, Charlottesville, Virginia. 8:30 am - 9:00 am ... o Arkendra De, FDA Mathematical Statistician o Chris Moskaluk ...
Agenda for FDA Medical Device Technology Innovation Partnerships With focused discussion on emerging technologies in cancer and cardiovascular medicine

September 26, 2011 Hosted by the University of Virginia Jordan Hall Conference Center, Charlottesville, Virginia

8:30 am - 9:00 am Introduction to Medical Technology Innovation Partnerships Second Year Workshop o David Chen, UVA Coulter Program Director o Kwame Ulmer, FDA Deputy Director of Science & Policy o Francis Kalush, FDA Diagnostics and Personalized Medicine Network Leader

9:00 am - 9:30 am Initiatives in Science and Innovation at FDA Center for Devices and Radiological Health o Michelle McMurry-Heath, FDA Associate Director for Science

9:30 am - 10:15 am "I am an academic but want to translate my technology, what can FDA do for me?" The purpose of this session is to discuss how researchers and emerging entrepreneurs can engage FDA regulators proactively to remove barriers and promote new technology and its regulation. o Kwame Ulmer o Youseph Yazdi

10:15 am - 10:30 am Break 10:30 am - 11:30 am Is there a path forward with personalized medicine in cancer? A regulators and statistical perspective This panel will discuss new frontiers in personalized medicine, specifically in vitro diagnostics, in Cancer and key elements innovators in diagnostics should consider. o Francis Kalush, FDA Diagnostics and Personalized Medicine Network Leader o Donna Roscoe, FDA Scientific Reviewer o Arkendra De, FDA Mathematical Statistician o Chris Moskaluk MD, PhD, UVA Faculty in Pathology and Director of Biorepository

11:45 am - 1:00 pm Focused lunch discussions: o Cancer Biomarkers Review of different FDA working groups, for example in vivo diagnostics, imaging, and biorepositories  Michelle Mc-Murry Heath  Chris Moskaluk  Donna Roscoe  Arkendra De  Francis Kalush  Annie Saha, FDA Regulatory Health Specialist, Office of the Director  Meijuan Li, FDA Mathematical Statistician  Chris Moskaluk MD, PhD, UVA Faculty in Pathology and Director of Biorepository o Cardiovascular Device Development New issues in cardiac EP and emerging devices  Kwame Ulmer  John Karanian, FDA Research Physiologist and Pathology  Kathy Weil, FDA Supervisory Nurse Consultant, Division of Bioresearch Monitoring  Lynn Henley, FDA Biologist, Office of Device Evaluation  Janine Morris, FDA Branch Chief and Supervisory Mechanical Engineer  Richard Gray, FDA Biomedical Engineer  Brian Wamhoff, PhD, UVA Faculty in Cardiology

1:15 pm - 3:00 pm Educational sessions o Overview of Pre-IDE submissions and IDE regulations with Lynn Henley This session will focus on regulatory aspects of medical device research. It will provide an overview of the Investigational Device program, discussing significant-risk and non-significant risk studies, exempt studies, and other provisions of the IDE regulations. Investigators will learn how to begin communication with FDA and whether they need to submit a Pre-IDE. Case studies will be presented in an interactive fashion. Issues pertaining to "Sponsor/Investigator" studies, such as basic physiological research, will be addressed. Attendees will learn what constitutes valid scientific evidence necessary for FDA submissions, stages of device clinical trials, and expanded access to investigational devices. Custom and humanitarian devices will also be discussed. o Bioresearch Monitoring (BIMO) Requirements - Investigator Roles and Responsibilities for FDARegulated Medical Device Clinical Studies with Kathy Weil This session will inform clinical investigators about the role and responsibilities of the Division of Bioresearch Monitoring within the Center for Devices and Radiologic (CDRH) Health and why this CDRH division is important to them. It will cover the roles and responsibilities for clinical

investigators who oversee FDA-regulated medical device, clinical studies, but through the perspective of an inspection and how the Codes of Federal Regulations (CFRs) for Title 21, Part 812 (Investigational Device Exemptions), Part 50 (Protection of Human Subjects), and Part 54 (Financial Disclosure by Clinical Investigators) pertain specifically to their responsibilities as clinical investigators of significant risk devices. To provide context to the real world of clinical studies, case examples from actual inspections will be reviewed to demonstrate how these regulations are key to the clinical investigators and the clinical studies they run. o Preclinical Testing Considerations: Device Development and Validation with John Karanian This session will review the device development process from bench to bedside. The concepts underlying pre-clinical pre-market device regulation will be presented. Regulatory aspects of the conduct of pre-clinical studies of the safety and effectiveness of medical devices will be reviewed. The types of pre-clinical data that may be needed to enter into a clinical trial or for a successful marketing application will be discussed with case examples, including laboratory-based experience in the evaluation of failure modes for devices and combination products to treat vascular and oncologic disease. o Clinical Study Design Considerations with Janine Morris This session will review the basic principles of good clinical study design that would support FDA approval or clearance for medical devices. The regulatory perspective for clinical studies will be discussed as well as the common challenges when designing a clinical study to support a marketing application. Various clinical study designs will be reviewed and discussed including an interactive session to “design your own” based on the principles discussed. Case studies will include reviewing the key principles in design for low risk prostate cancer as well as examples involving other design challenges, e.g., subjective outcomes, placebo effects, combination therapies. Key objectives of this session will be:  How to identify the correct patient population for your innovation  How to identify the most appropriate control and study endpoints  Determining the length of follow-up appropriate for your innovation  Understanding the balance of preclinical data requirements and post approval requirements  Understanding the differences between clinical practice and using practice guidelines compared to conducting an investigational study to support a marketing application.

3:00 pm - 4:00 pm

Needs on Medical Device Training for National Medical Device Curriculum Development o Francis Kalush o Michelle McMurry-Heath o Youseph Yazdi

4:00 pm - 4:30 pm Closing remarks o Tom Skalak, UVA VP for Research