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CDG and the BEACON are proud to present the staff of FDA/CDRH/OIVD in the upcoming eConference:

OIVD's Shortcuts on the Critical Path to Market
February 19, 2008

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Why should you take this eConference:
FDA/CDRH/OIVD is committed to educating inventors and manufacturers about its requirements for approval. Concomitantly, we understand that you are concerned and eager to learn about their expectations. In this eConference you will hear directly from FDA Experts about their latest thinking.

Agenda:
Introduction - Nancy Stark - 10 mins
Overview of the Critical Path Effort - Sousan Altaie - 15 mins
Gene Expression Profiling for Breast Cancer Prognosis - Reena Philip - 15 mins
Overview of FDAs guidance on Pharmacogenetic Tests and Genetic Tests for Heritable Markers - Elizabeth Mansfield - 15 mins
What you need to know from FDAs Statistical Guidance on Reporting Results from Studies Evaluating Diagnostic Tests - Kristen Meier - 20 mins
Human Specimen Repositories: Requirements of FDA Regs. 21 CFR Parts 50 & 56 and enforcement discretion for leftover specimens - Sally Hojvat - 15 mins
The Road To An Artificial Pancreas; FDAs Collaborations With NIH And Other Stakeholders - Arleen Pinkos - 15 mins
Q&A - 45 mins

FDA's "Critical Path" Initiatives focus on the agency's concern about unnecessary obstacles to medical device development.
Abstracts:
Overview of the Critical Path Effort - To present the audience with an overview of Critical Path initiatives at the FDA and explain how they help in shortening the time to bring innovative medical products to the patient bedside and the marketplace.
Gene Expression Profiling for Breast Cancer Prognosis - To make recommendations to manufacturers regarding preparation of premarket notification and labeling, using a gene expression profiling test system for breast cancer prognosis as an example. The recommendations are applicable to other RNA expression assays used for cancer prognosis, such as reverse-transcriptase polymerase chain reaction (RT-PCR) and gene expression microarrays.
Overview of FDAs guidance on Pharmacogenetic Tests and Genetic Tests for Heritable Markers - This overview will introduce the listener to the concepts FDA has identified as important in development and validation of genetic tests.
What you need to know from FDAs Statistical Guidance on Reporting Results from Studies Evaluating Diagnostic Tests - Over the years of reviewing submissions for diagnostic devices, FDA recognized a pattern of common inappropriate statistical practices for reporting results from studies evaluating diagnostic tests. In March 2007, FDA released a final guidance providing some general statistical guidance for evaluating a new qualitative (yes/no) diagnostic test, general reporting recommendations, and identified some common practices that were inappropriate. This presentation highlights important recommendations from this guidance to help Industry understand what statistical information is needed to review diagnostic device performance, and to know how to report statistical results from studies evaluating diagnostic devices.
Human Specimen Repositories: Requirements of FDA Regs. 21 CFR Parts 50 & 56 and enforcement discretion for leftover specimens - The challenge of obtaining informed consent for the use of leftover specimens was identified by research institutions and trade associations as an obstacle to IVD development. A guidance was issued in April 2006 which informed sponsors, IRBs, clinical investigators and agency staff that the FDA intended to exercise enforcement discretion, under certain circumstances, with respect to its current regulations governing the requirement for informed consent when human specimens are used for FDA-regulated in vitro diagnostic device investigations. This presentation will briefly review the "Guidance on Informed Consent for In Vitro Diagnostic Device Studies Using Leftover Human Specimens that are Not Individually Identifiable", and summarize the most frequent issues and comments received pertaining to the document since its publication.
The Road To An Artificial Pancreas; FDAs Collaborations With NIH And Other Stakeholders - The incidence of diabetes mellitus is growing at an alarming rate in the U.S. and throughout the world. Seven percent of the population has diabetes, a disease which has devastating consequences and is the single most costly chronic disease in the U.S. One of the Critical Path Initiatives of the Food and Drug Administration (FDA) is to accelerate the development and availability of a safe and effective artificial pancreas for the treatment of diabetes. As part of this initiative FDA established the Interagency Artificial Pancreas Working Group (IAPWG), a multi-disciplinary group of scientists and clinicians from FDA and the National Institutes of Health. Members of the IAPWG collaborate to develop a broader understanding of the unique clinical and scientific challenges associated with this complex medical product, to identify obstacles in product development, and to develop innovative strategies to minimize those obstacles. The IAPWG strives to meet its goals by promoting cross-fertilization of diverse resources, both within and outside of the group. This talk will focus on the collaborative efforts of the group and how their activities are accelerating and optimizing research and development efforts that will make an artificial pancreas a reality.

Who should attend:
Device Manufacturers
Sponsors
Regulators
Laboratories

Presenters:
The eConference will be co-presented by experts from FDA/CDRH/OIVD.

Sousan S. Altaie, Ph.D. Scientific Policy Advisor Office of In Vitro Diagnostics CDRH/FDA, Dr. Altaie received her Ph.D. in Clinical Microbiology and Immunology from the University of North Texas in Denton in 1989. After completing a two-year Fellowship in Medical Microbiology at the Medical College of Virginia in Richmond, she joined the Department of Pediatrics, Division of Infectious Diseases at the State University of New York as an Assistant Professor, and also was appointed Director of Bacteriology and Serology Laboratories at the Childrens Hospital of Buffalo. In 1995 she joined the Food and Drug Administration in the Center for Drug Evaluation and Research in the Division of Anti-infective Drug Products as a primary reviewer. Six years later she joined the FDAs Center for Devices and Radiological Health as the Chief of Immunology and Molecular Diagnostics Branch. Recently Dr. Altaie became the Scientific Policy Advisor for the Office of In Vitro Diagnostic Devices and is actively working as a member of the Global Harmonization Task Force (GHTF) and International Standards Organization (ISO) working groups. She was appointed the CDRH Critical Path Coordinator in 2004 and is actively involved in the Agencys Critical Path initiative.

Reena Philip, Ph.D. Scientific Reviewer, Office of In Vitro Diagnostics CDRH/FDA. Reena Philip, PhD, has been employed by FDAs Office of In Vitro Diagnostics Evaluation and Safety (OIVD) in the Division of Immunology and Hematology Device evaluation (DIHD) since September 2004. She received her PhD in molecular biology from University of Illinois at Urbana-Champaign in 1997, followed by post doctoral training. Prior to joining OIVD, she spent three years in biotechnology sector. At OIVD, she is an active member of the Omics working group, serves as a scientific reviewer on Immunology, Genetics, Genomics In Vitro Devices (IVD) and participates in drafting guidances. She is the author of many peer reviewed articles.

Elizabeth Mansfield, PhD. Dr. Mansfield is a Science Policy Analyst in the Office of In Vitro Diagnostic Devices at the Center for Devices and Radiological Health, FDA. She received a BA from the University of Pennsylvania in 1986, and a PhD from the Johns Hopkins University in 1993. Prior to her current tenure at OIVD, she was the Director of Regulatory Affairs at Affymetrix, Inc. Dr. Mansfield was previously a scientific reviewer in OIVD, and held postdoctoral fellowships at NCI and NIAMS in the National Institutes of Health.

Kristen Meier, PhD. Dr. Meier is a Mathematical Statistician at the US Food and Drug Administration, Center for Devices and Radiological Health, Division of Biostatistics in Rockville, MD, where she reviews in vitro and in vivo diagnostic device submissions and contributes to FDA statistical guidance development. She received her Ph.D. in statistics from North Carolina State University in Raleigh, NC in 1990. Before coming to FDA in 1995, she worked as a staff fellow in statistics at the National Institute of Environmental Health Sciences, NIH and then as a mathematical statistician for the USDA Food Safety and Inspection Service, where she first became interested in the area of diagnostic tests. Dr. Meier is an active participant in Clinical Laboratory Standards Institute (CLSI) standards development and has served as a member of CLSIs Area Committee for Evaluation Protocols and various subcommittees.

Sally A Hojvat, MSc., Ph.D. Dr. Hojvat currently holds the position of Director of the Division of Microbiology Devices, in the Office of In Vitro Diagnostic Device Evaluation and Safety, at CDRH/FDA. Prior to joining the FDA in 2003, Dr. Hojvats experience included 18 years in the IVD industry, holding management positions in product development, quality control and clinical research. Dr. Hojvat received her B.Sc. from the University of Wales, UK, a M.Sc. in Microbiology from the University of Alberta, Canada, and a Ph.D. in Biochemistry from Loyola University Medical School, Chicago. She also completed post doctoral training fellowships in Clinical Chemistry from Loyola Medical School and in Pharmacology from the University of Chicago. Her academic research publications are concentrated in the fields of Microbiology, Pharmacology and Neuroendocrinology.

Arleen Pinkos, M.T. (ASCP). Ms. Pinkos, a native of Pittsburgh, Pennsylvania, has worked at the Food and Drug Administration since 1993. As a Scientific Reviewer in the Office of In Vitro Diagnostic Device Evaluation and Safety, she has worked with a broad range of medical devices and innovative technologies, including those that noninvasively predict blood glucose concentrations. She is Chair of the Interagency Artificial Pancreas Working Group, a multi-disciplined group of scientists from the FDA and the National Institutes of Health who are collaborating with stakeholders to accelerate the availability of an artificial pancreas. She is also the co-chair of an artificial pancreas working group within the Center for Devices and Radiological Health. She recently received FDAs Scientific Achievement Award for her work in these initiatives. Ms. Pinkos has written peer review articles on the artificial pancreas, point of care testing, and evidence based medicine. Prior to her work at the FDA she received a Bachelor of Science in Medical Technology from Indiana University of Pennsylvania. Ms. Pinkos held clinical laboratory positions at Veterans Administration Medical Centers in New Jersey and Maryland, where she was instrumental in developing the first mobile laboratory which later received a patent. She has also consulted for physician office laboratories, and managed a private physician referral service.

Date, time, registration: The 150-minute event will be presented on February 19, 2008, at 11:00 am Central Time. The registration fee is $595 per computer connection. Event materials will be distributed the day before the eConference for photocopying. Each attendee will receive 0.25 CEU. To register go to http://clinicaldevice.webex.com.

eConferences: What's an eConference? It's as many people as you can position around your computer for the price of one registration; it's a live, real-time, interactive presentation; it's supported with files, websites, and supplemental resources. Learn more about eConferences and view our registration and cancellation policies.

 

Books & Tools

CRA Handbook 2008 - The essential tool for clinical research professionals!
Finding accurate regulatory information while youre in the field is a challenge for every practicing monitor. You know there is a requirement for an issue at hand, but cant quite remember the details. If only you had a copy of the regulations with you.
The CRA Handbook is the field guide for monitoring medical device clinical trials.
It contains full text copies of US regulations, a detailed comparison of requirements
for significant risk and non-significant risk studies, guidelines, checklists, definitions and flowcharts from the Active Implantable Medical Device Directive, the Medical Device Directive,
and ISO 14155 Parts 1 and 2. Chock-full of information, this 194-page powerhouse will give you ready access to information away from the office. Comb-bound and small in size (5.5 by 8.5), the CRA Handbook
is designed to fit easily into a briefcase, lie flat when in use, resist the wear of travel, provide a space for personal notations, and serve as a convenient field reference. Youll want your own personal copy. Click here to order

US Guidances 2008 - FDA issues hundreds of guidances, but just try locating the 30 or so that are specific for clinical research. You will spend hours identifying and downloading them. But we have done the work for you. This comprehensive volume on CD includes every horizontal guidance on pre-approval issues we can find. CD contains a PDF file with bookmarks and links to each chapter for easy use. Click here to order

Europe Laws 2008 - European directives, standards, acts, decrees, guidances, legal opinions, and other legislative and regulatory documents are available, but finding them gathered together in one place is nearly impossible. This extensive volume brings many important European regulatory documents together in a single CD. Click here to order

CDs

Can't attend these high-level eConferences? Clinical Device Group has made them available on CD so you can view the presentations at your convenience. The CD includes the Webex presentation with audio, slides, handouts and Q&A for each session. Here is a list of the latest topics:

- Why Should You Register Your Clinical Trial - Presented by Dr. Rebecca Williams from Clinicaltrials.gov and Dr. Nancy Stark from CDG.

-Surviving Medical Device Recalls - Presented by the staff of the FDA/CDRH/Office of Compliance on August 14, 2007.

- Procedures for Handling Post-Approval Studies Imposed by PMA Order - Presented by Mr. Jeffrey Shapiro, ESq. on September 19, 2007.

-The Establishment and Operation of Data Monitoring Committees - Presented by Mr. Steven C. Schurr, Esq. on October 16, 2007.

- Calculating and Reporting SF-36 Scales - Presented by Ms. Michelle Secic on September 18, 2007.

For a complete list of the titles available, please click here

 

Forum
Join the Clinical Device Forum -- a free online conversation about medical device pre-approval issues -- at www.clinicaldeviceforum.com
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