News & Events
HCRI Medical Device Development Workshop: A Case Study Approach, May 28-29, 2008, The Harvard Club of Boston, Boston MA
Day One
Wednesday, May 28, 2008
7:30 – 8:00 AM Registration & Networking Breakfast
8:00 – 8:05 AM Chairman’s Welcome
Spencer Goldsmith, President, Harvard Clinical Research Institute
Regulatory Strategy Overview and Pre-Clinical Phase FDA Interaction
8:05 – 11:00 AM Lectures
8:05 – 8:45 AM Discussion of Current FDA Structure and FDA Approval Process
This session will focus on an overview of the organization of FDA, types of regulatory submissions, and the regulations governing cardiovascular medical devices and combination products.
Speakers: H. Semih Oktay, Ph.D.
President
CardioMed Device Consultants
Elisa D. Harvey, D.V.M., Ph.D.
Senior Regulatory Consultant
CardioMed Device Consultants
8:45 – 9:25 AM Pre-Clinical Dos and Don’ts
This session will focus on how to properly plan and conduct preclinical studies that will successfully support moving into clinical trials and eventually support a marketing submission.
Speakers: H. Semih Oktay, Ph.D.
President
CardioMed Device Consultants
Elisa D. Harvey, D.V.M., Ph.D.
Senior Regulatory Consultant
CardioMed Device Consultants
9:25 – 10:05 AM How to Interact with FDA
A perspective by former FDA reviewers/staff personnel, this session will focus on practical information to optimize written and face-to-face interactions with FDA review staff and management from the pre-IDE stage to the review of marketing submissions.
Speakers: H. Semih Oktay, Ph.D.
President
CardioMed Device Consultants
Elisa D. Harvey, D.V.M., Ph.D.
Senior Regulatory Consultant
CardioMed Device Consultants
10:05 – 10:20 AM Networking Refreshment Break
10:20 – 11:00 AM Animal Studies
This session will focus on the different aspects of pre-clinical evaluation of devices; in particular, it will describe how to create an integrated package of computational, bench top and animal model systems in preparation for clinical trials. This presentation will use real-life examples that draw on many disciplines.
Speaker: Elazer Edelman, M.D., Ph.D.
Director
Harvard-MIT Biomedical Engineering Center
Thomas D. and Virginia W. Cabot Professor
Health Sciences and Technology, MIT
Professor of Medicine
Harvard Medical School
11:00 AM – 5:00 PM Working Group Sessions
11:00 AM – 12:00 PM Working Group Session: Interactive Case Study Strategy
During this hands-on component of the workshop, participants will be divided into working groups in which they will review and analyze a device-specific case study from bench to bedside. Today’s component focuses on the device concept- through early FDA interaction phase. All cases are completely fictional and any resemblance to real companies is purely coincidental.
12:00 – 2:00 PM Attendee Working Lunch
2:00 – 5:00 PM Working Group Session: Case Study Presentations and Feedback
Results of the interactive case study strategy session are presented to instructors and other groups for feedback.
3:30 – 3:45 PM Networking Refreshment Break
5:00 – 6:00 PM Networking Cocktail Reception
6:00 PM Close of Day One
Day Two
Thursday, May 29, 2008
7:30 – 8:00 AM Registration & Networking Breakfast
Clinical Phase FDA Interaction
8:00 – 11:00 AM Lectures
8:00 – 8:45 AM Developing a Clinical Trial Strategy: an Integrative Approach
The optimum trial design is formulated from a balance of scientific, clinical, and practical concepts that are modified by treatment specific pre-clinical information, early experience, and regulatory requirements. A case-based approach will be used to illustrate common decision points in clinical trial strategy.
Speaker: Laura Mauri, M.D., M.Sc.
Chief Scientific Officer
Harvard Clinical Research Institute
Assistant Professor
Harvard Medical School and Brigham and Women's Hospital
8:45 – 9:25 AM Statistical Issues in Clinical Trial Design
When designing clinical trials, choices need to be made regarding significance levels for multiple endpoints, appropriate analysis sets, methods for missing data imputation, the appropriate control group, whether comparisons to active controls will be non-inferiority or superiority, and whether to use incidence analysis or time-to-event for binary outcomes. We will review these issues and discuss our experiences handling them in device clinical trials.
Speaker: Ralph D’Agostino, Ph.D.
Executive Director of Biostatistics and Data Management
Harvard Clinical Research Institute
Professor and Chair Mathematics and Statistics
Boston University
9:25 – 10:05 AM Statistical Issues in the Conduct and Analysis of Clinical Trials
General issues that arise during the conduct and analysis of clinical trials include: maintaining the mask, adapting the trial design (e.g., re-estimation of sample size based on interim analysis results), assessing treatment-by-center interaction, pooling multiple control groups, and assessing the statistics of rare events. We will review these and other issues in device trials and suggest approaches to address them.
Speaker: Joseph Massaro, Ph.D.
Senior Biostatistical Consultant
Harvard Clinical Research Institute
Associate Professor of Biostatistics
Boston University
10:05 – 10:20 AM Networking Refreshment Break
10:20 – 11:00 AM Event Adjudication and Data Monitoring Committees
This lecture will review the individual roles of the Clinical Events Committee and Data Monitoring Committee (also known as Data and Safety Monitoring Board) in the adjudication of clinical endpoints, monitoring of research subject safety, and preserving trial integrity.
Speaker: Donald E. Cutlip, M.D.
Executive Director of Clinical Investigations
Harvard Clinical Research Institute
Associate Professor of Medicine
Harvard Medical School
11:00 AM – 5:00 PM Working Group Sessions
11:00 AM – 12:00 PM Working Group Session: Interactive Case Study Strategy
During this hands-on component of the workshop, participants will be divided into working groups in which they will review and analyze a device-specific case study from bench to bedside. Today’s component focuses on FDA interaction during the clinical development phase. All cases are completely fictional and any resemblance to real companies is purely coincidental.
12:00 – 2:00 PM Attendee Working Lunch
2:00 – 5:00 PM Working Group Session: Case Study Presentations and Feedback
Results of the interactive case study strategy session are presented to instructors and other groups for feedback.
3:30 – 3:45 PM Networking Refreshment Break
5:00 PM Close of Workshop
FACULTY
Donald E. Cutlip, M.D.
Executive Director of Clinical Investigations
Harvard Clinical Research Institute
Associate Professor of Medicine
Harvard Medical School
Ralph D'Agostino, Ph.D.
Executive Director of Biostatistics and Data Management
Harvard Clinical Research Institute
Professor and Chair Mathematics and Statistics
Boston University
Elazer Edelman, M.D., Ph.D.
Director
Harvard-MIT Biomedical Engineering Center
Thomas D. and Virginia W. Cabot Professor
Health Sciences and Technology, MIT
Professor of Medicine
Harvard Medical School
Elisa D. Harvey, D.V.M., Ph.D.
Senior Regulatory Consultant
CardioMed Device Consultants
Joseph Massaro, Ph.D.
Senior Biostatistical Consultant
Harvard Clinical Research Institute
Associate Professor of Biostatistics
Boston University
Laura Mauri, M.D.
Chief Scientific Officer
Harvard Clinical Research Institute
Assistant Professor
Harvard Medical School and Brigham and Women's Hospital
H. Semih Oktay, Ph.D.
President
CardioMed Device Consultants
Tuition and Group Rate
Tuition for the 2-day course is $1,950. The total charge includes a non-refundable $200 processing fee. Visa, MasterCard, or American Express will be accepted for payment. Tuition includes lunches, a networking reception, continental breakfasts, and morning and afternoon refreshment breaks. Tuition does not include other meals or accommodations. There is a group rate of $1750 per attendee when 3 or more register from the same company.
Continuing Education Credits
HCRI is a Regulatory Affairs Professionals Society (RAPS) RA Professional Development Portal provider. HCRI is committed to enhancing the ongoing professional development of regulatory affairs professionals and other stakeholders through appropriate regulatory affairs learning activities and programs. HCRI has agreed to follow RAPS-established operational and educational criteria, and is subject to random audits for quality assurance purposes. This seminar provides 12 Regulatory Affairs Certification (RAC) recertification points.
Target Audience
This workshop is designed for the following audience:
- Decision-makers in R&D, regulatory affairs, and clinical affairs of medical device development organizations
- Executive management staff of medical device development organizations
Registration and Information
Registration for this event is limited to 30 participants. Please access the registration form below or request a form by contacting Dane Vannatter at (617) 632-1379 or info@hcri.harvard.edu .
Accommodations
Course lectures will be held at The Harvard Club of Boston at 374 Commonwealth Avenue, Boston, MA 02215. To inquire about overnight rooms at The Harvard Club, please call The Harvard Club front desk at (617) 536-1260 and mention Harvard Clinical Research Institute. Other nearby hotels are: The Elliot Hotel at (617) 267-1607, The Sheraton Boston at 617-236-2000, and The Hilton Boston at (617) 236-1100.
Arrival, Departure and Transportation
Participants are encouraged to arrive by the evening of Tuesday, May 27, 2008. Registration will be available starting at 7:30 AM on Wednesday, May 28. Taxi cabs are available from Boston's Logan Airport for transportation to and from The Harvard Club. Directions can be obtained at www.harvardclub.com . The Harvard Club provides parking behind their building in the Newbury Street lot for $8 per hour with a $25 maximum per vehicle per day.
Cancellation Policy
Full tuition will be refunded, minus a non-refundable $200 registration fee, for cancellations received via email to info@hcri.harvard.edu or via fax to (617) 632-1536 through May 1, 2008. No tuition will be refunded for cancellations received after May 1, 2008. Substitutions may be made at any time. Should the workshop be postponed due to events beyond the control of HCRI, tuition will be applied to the rescheduled event. HCRI reserves the right to alter the venue if necessary, and is not responsible for any airfare, hotel, or other costs incurred by registrants if the course is cancelled or postponed.
ADA/OEO Nondiscrimination Policy
Harvard Clinical Research Institute (HCRI) considers all applicants and participants without regard to race, color, national origin, age, religious creed, sex or sexual orientation. HCRI is an Equal Opportunity Employer. We encourage participation by all individuals. If you have a physical disability, please inform us by May 1, 2008 to help us better serve you.
About Harvard Clinical Research Institute
The Harvard Clinical Research Institute (HCRI) (www.hcri.harvard.edu) supports the investigation of cutting-edge medical therapies and technologies through world-wide research initiatives of industry-, government-, and investigator-sponsors. HCRI's mission is to facilitate greater academic involvement in clinical research. It does so by collaborating with Harvard Medical School clinical trialists to serve as a leading center of trial design, data management & analysis, site management, and clinical project management.
About CardioMed Device Consultants
CardioMed Device Consultants (www.cardiomedllc.com ) provides a broad range of regulatory consulting, engineering consulting, and regulatory department training services. With a focus on cardiovascular and general hospital devices, CardioMed's collective education, experience, and broad knowledge of FDA processes and requirements are intended to provide value for both large and small manufacturers of medical devices.
