Risk Assessment: Questions to the Committee 1.What estimate(s) should be used to reflect the prevalence of vCJD in the U.K.? Proposal: We propose using.

Slides:

Advertisements

Similar presentations

FDA Workshop “Data and Data Needs to Advance Risk Assessment for Emerging Infectious Diseases for Blood and Blood Products” November 29, 2011, Gaithersburg.

Advertisements

Removal of Prions by Plasma Fractionation Processes

Draft Guidance for Industry: Preventive Measures to Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease (CJD) and Variant Creutzfeldt-Jakob.

Impact of vCJD on Haemophilia Practice

Analysis to Inform Decisions: Evaluating BSE Joshua Cohen and George Gray Harvard Center for Risk Analysis Harvard School of Public Health.

Sensitivity Analysis for Observational Comparative Effectiveness Research Prepared for: Agency for Healthcare Research and Quality (AHRQ)

Surveillance, Forecasting, & Nowcasting in an Influenza Pandemic Peter G Grove Health Protection Analytical Team Department of Health.

Chance, bias and confounding

Is Nucleic Acid Testing for Organ Donors the ‘Right’ Choice? Reference: Humara A, Morrisb M, Blumbergc R, et al. Nucleic acid testing (NAT) of organ donors:

U.S. Food and Drug Administration Notice: Archived Document The content in this document is provided on the FDA’s website for reference purposes only.

Presumptive Transfusion Transmissions of vCJD: Introduction to Consideration of Current FDA-recommended Safeguards FDA TSE Advisory Committee 16 th Meeting.

Statistics for Health Care

By Dr. Ahmed Mostafa Assist. Prof. of anesthesia & I.C.U. Evidence-based medicine.

Parvovirus B19 NAT for Whole Blood and Source Plasma Introduction and Background Mei-ying W Yu, PhD DH/OBRR/CBER/FDA 75 th Blood Products Advisory Committee.

Transmissible Spongiform Encephalopathies Advisory Committee 23 rd Meeting Gaithersburg, MD – August 1, 2011 CJD and vCJD Donor Policies: Blood and Blood.

Harvard Center for Risk Analysis Evaluation of the Potential for BSE in the United States Joshua T. Cohen Keith Duggar George M. Gray Silvia Kreindel Harvard.

Topic 1. Validation of Procedures to Prevent Contamination and Cross-Contamination with TSE Agents of Human Tissue Intended for Transplantation TSEAC June.

Deferral of MSM by Andrew I. Dayton, M.D., Ph. D. The HIV epidemic in the U.S.A. is generally recognized to have started just after Currently MSM.

FDA’s Current Considerations of Parvovirus B19 Nucleic Acid Testing (NAT) Mei-ying W. Yu, PhD Division of Hematology CBER/FDA Extraordinary SoGAT Meeting.

Epidemiology The Basics Only… Adapted with permission from a class presentation developed by Dr. Charles Lynch – University of Iowa, Iowa City.

Development of FDA Recommendations for deferral of donors based on risk of BSE exposure Alan E. Williams, Ph.D. Director, Division of Blood Applications.

C L E A R A N T TM Limiting Batch Size: Effects of Batch Size on Risk of Contamination with Infectious Agents Thomas J. Lynch, J.D., Ph.D. Senior Vice.

CHP400: Community Health Program- lI Research Methodology STUDY DESIGNS Observational / Analytical Studies Case Control Studies Present: Disease Past:

Statistics for Health Care Biostatistics. Phases of a Full Clinical Trial Phase I – the trial takes place after the development of a therapy and is designed.

Biomedical Research Objective 2 Biomedical Research Methods.

FVIII PRODUCT USAGE IN CLINICAL SETTINGS TSEAC October 31, 2005 Mark Weinstein, Ph.D. Office of Blood Research and Review CBER, FDA.

FDA Blood Products Advisory Committee 95 th Meeting 21 July 2009 Update: 21 st Meeting FDA Transmissible Spongiform Encephalopathies Advisory Committee.

1 PHSKC 4/01 Epidemiology of HIV/AIDS Seattle-King County, WA HIV/AIDS Epidemiology Program Public Health - Seattle & King Co. (206) On the web.

Risk Assessments: Models for Estimating the Risk of Transmitting TSE by Human Tissue Intended for Transplantation Rolf E. Taffs, Ph.D. Center for Biologics.

Proposed algorithm for approval of human TSE tests in Europe.

1 B19 Testing of Plasma for Fractionation: Current Thinking Mei-ying W Yu, PhD Division of Hematology CBER/FDA SoGAT XVII May 26-27, 2004.

TSE Clearance Studies for pdFVIII: Study Methods and Clearance Levels TSE Advisory Committee September 18, 2006 Dorothy Scott, M.D. Office of Blood Research.

19 September 2006 Gaithersburg, MD David Peretz M.Sc., D.Sc. Senior Scientist CHIRON Submission To FDA TSE Advisory Committee Meeting.

18 th Meeting of FDA TSE Advisory Committee: 31 October 2005 Summary FDA Blood Products Advisory Committee 85 th Meeting 03 November 2005 Holiday Inn Gaithersburg.

Variant Creutzfeldt-Jakob Disease Impact on U.S. Military Service Members Lt. Col. David Lincoln Deputy Director Armed Services Blood Program Office Unclassified.

EPIDEMIOLOGY The study of the distribution and determinants of health related states and events in specified population and application of this.

RISK COMMUNICATION APPROACH TSEAC 15 December 2006 Mark Weinstein, Ph.D. FDA, Center for Biologics Evaluation and Research.

Air Toxics Risk Assessment: Traditional versus New Approaches Mark Saperstein BP Product Stewardship Group.

Draft Risk Assessment for UK manufactured Factor XI and Potential vCJD Exposure Steven Anderson, PhD, MPP Office of Biostatistics & Epidemiology Center.

Case-Control Studies Abdualziz BinSaeed. Case-Control Studies Type of analytic study Unit of observation and analysis: Individual (not group)

Modeling Risk of vCJD in US Donors – Residual Risk and Efficiency of Donor Deferral Alan E. Williams, Ph.D. Director, Division of Blood Applications Office.

Review of Publicly Available Information on TSE Clearance by Steps Used to Manufacture FVIII Products TSE Advisory Committee October 31, 2005 Dorothy Scott,

Variant CJD and Plasma Products Risk assessment methods, assumptions and public health actions in the UK Kate Soldan & Anna Molesworth February 2005 Communicable.

Hong Yang, Ph.D. Office of Biostatistics and Epidemiology FDA-Center for Biologics Evaluation & Research Transmissible Spongiform Encephalopathies Advisory.

Minimizing the Risks of TSE Agents in Human Tissues Melissa A. Greenwald, M.D. Division of Human Tissues Office of Cellular, Tissue and Gene Therapies;

TSE Task Force Prion reduction evaluation in the manufacturing of plasma protein therapies Dr. Henry Baron, Chair, PPTA TSE Task Force.

BSE: World update FDA TSE Advisory Committee Gaithersburg, MD September 18, 2006 Lisa A. Ferguson, DVM Senior Staff Veterinarian USDA, APHIS, Veterinary.

Validation of Nucleic Acid and Serological Tests to Screen Blood and Plasma donors for Acute infection with West Nile virus Hira Nakhasi, Ph.D. Director,

Preliminary Risk Assessment Model for U.S. Plasma Derivatives and vCJD Steven Anderson, PhD, MPP Office of Biostatistics & Epidemiology Center for Biologics.

HHS Secretary’s Advisory Committee on Blood Safety and Availability Summary for FDA’s BPAC July 2010 Jerry A. Holmberg, Ph.D. Senior Advisor for Blood.

Identification and Deferral of Tissue Donors for Possible BSE/vCJ-D Exposure: Estimating the Impact Alan E. Williams, Ph.D. Director, Division of Blood.

Risk assessment: The Safety of Blood Products presented by Dr. Thomas R. Kreil Baxter BioScience on behalf of the PPTA Pathogen Safety Steering Committee.

VCJD World situation and Updates RG Will National CJD Research and Surveillance Unit Edinburgh, UK TSEAC meeting 1 st August 2011.

Topic 1: FDA Draft Guidance “Revised Preventive Measures to Reduce the Possible Risk of Transmission of CJD and vCJD by Blood and Blood Products” Dorothy.

Donor Suitability and Blood and Blood Product Safety in Cases of Known or Suspected West Nile Virus Infection - Update - Alan E. Williams, Ph.D. Director,

Deferral of Blood and Plasma Donors for History of Transfusion in BSE Countries of Europe Alan E. Williams, Ph.D. Director, Division of Blood Applications.

David M. Asher, MD Division of Emerging & Transfusion-Transmitted Diseases Office of Blood Research & Review Center for Biologics Evaluation & Research.

Questions to Committee about Potential Cancer Risk with Use of Topical Immunosuppressants (Calcineurin Inhibitors) Question 1: Messages about Risk A. Based.

FDA Risk Management Strategy for Potential Exposure to vCJD from Plasma Derivatives TSE Advisory Committee December 15, 2006 Dorothy Scott, M.D. OBRR/CBER.

Draft Quantitative Risk Assessment of vCJD Risk Potentially Associated with the Use of Human Plasma-Derived Factor VIII Manufactured Under United States.

TOPIC II Potential Screening Assays to Detect Blood and Plasma Donors Infected with TSE Agents: Possible Criteria for Validation Pedro Piccardo, MD LBPUA,

FDA’s vCJD Risk Communication on US Plasma- Derived Factor VIII and UK Plasma-Derived Factor XI BPAC April 27, 2007 Mark Weinstein, Ph.D. FDA, Center for.

Bad Blood? An Investigation of the MSM Ban on Blood Donation Lauren Lacy Abstract In 1983, the Food and Drug Administration (FDA), responding to the AIDS.

Question 1 A new test to diagnose urinary tract infections (UTIs) is being evaluated. The sensitivity of the test is 70% and the specificity is 90%. In.

Drug Development Process Stages involved in Regulating Drugs

Present: Disease Past: Exposure

Joint Statistical Meetings 2018

Objective 2 Biomedical Research Methods

Presentation transcript:

Risk Assessment: Questions to the Committee 1.What estimate(s) should be used to reflect the prevalence of vCJD in the U.K.? Proposal: We propose using the surgical tissue surveillance data as the assumed prevalence of vCJD in the U.K. to provide a more conservative estimate for possible exposure in the risk assessment than those from epidemiological models based on observed clinical cases of vCJD. However we propose that the risk assessment also be done using epidemiogical predictions based on diagnosed clinical vCJD cases as an alternative assumption of prevalence (with adjustments for possible latent infections during the incubation period).

Risk Assessment: Questions to the Committee 2. How effective are current donor deferrals for geographic risk of vCJD? Proposal: Based on the currently available surveys of unreported risk for other conditions (and allowing for a margin of error), we propose to estimate that the FDA-recommended deferral policy has a 90% - 99% efficiency for deferring donors with the specified increased vCJD risk. 3.What intravenous infectivity range (in ID 50 ) should be selected for plasma, based on animal studies? Proposal: The FDA FVIII model will use a statistical distribution of infectivity, with a minimum value of 0.1 IC ID50, a most likely value of 10 IC ID50, and a maximum value of 310 ID ID50. Since the BSE agent in primates may more closely reflect the human situation than rodent models, we propose to model the IC/IV ratio for infectivity over a range of 1 to 5.

Risk Assessment: Questions to the Committee 4.Is there sufficient evidence to estimate when during the incubation period human plasma is infectious? Proposal: Because of uncertainties about incubation periods of food-borne vCJD and the time during the incubation period at which infectivity appears, FDA proposes to adopt a conservative approach, and assumes plasma to be potentially infectious throughout the incubation period.

Risk Assessment: Questions to the Committee 5.Does the committee agree with FDA’s proposed approach for estimating clearance of vCJD infectivity from FVIII by manufacturing processes? Proposal: FDA proposes to model three clearance ranges, to represent likely minimum (2-3), mid-range (4-6) and maximum (7-9) Log 10 clearance of the vCJD agent from products manufactured using a variety of methods.

Risk Assessment: Questions to the Committee 6. What experiments might enable refinement of these clearance estimates and allow comparison of clearance offered by various steps in the methods used to manufacture plasma-derived FVIII?

Risk Assessment: Questions to the Committee 7. What data should be used to estimate how much FVIII is used by typical patients? We plan to analyze data from the ongoing UDC survey (1998- present) to estimate the numbers of patients using specific product brands, and the distribution of disease types, e.g.HA severe, moderate, mild; Type III vWD. We also plan to extrapolate data from the survey in six states to estimate the total number of U.S. patients, and product consumption per patient, with stratification by clinical setting. If there is inconsistent information from these two analyses it will be reconciled using patient based medical record data.

Risk Assessment: Questions to the Committee 8. What is the effect of plasma pool size (I.e number of donors per final product) for FVIII recipients? Proposal: FDA proposes to estimate plasma pool size as a range, between 20,000 and 60,000 donations, with a bimodal distribution to reflect expected Source and recovered plasma pool numbers. FDA will seek additional data from plasma fractionators. 9. Can a cumulative effect from repeated exposures to low doses of the vCJD agent be incorporated into the risk model? Proposal: to allow for the theoretical possibility of cumulative effects, the model will provide the cumulative risk for a 1-year period.

Risk Communication: Question to the Committee 10.Given the present scientific uncertainties in the underlying assumptions of the FVIII risk assessment, does the Committee believe that the risk assessment model could provide a useful basis for risk communication to patients, their families, and health care providers?