FDA invites Dr. Niazi as a speaker and panelist The American Statistical Association Biopharmaceutical Section Regulatory-Industry Statistics Workshop was originally a meeting for the FDA statisticians that later expanded to include all statisticians interested in statistical practices for all areas regulated by the FDA. This year over 800 people are expected to attend this workshop on Sep. 25-27, 2017 in Marriott Wardman Park, Washington D.C.1 Dr. Niazi is providing insight into Statistical Evaluation of Generic Transdermal Delivery Systems and Tropical Patches, as one of his areas of expertise and plans to participate in several sessions relating to biosimilars. The FDA provides the following comment on the Niazi session: “With the passage of Generic Drug User Fee Act (GDUFA), there is an increased emphasis on research for generic drugs, especially in the field of statistical evaluation of generic transdermal delivery systems and topical patches (hereafter referred as TDS products). Office of Generic Drugs (OGD) in FDA CDER recommends two types of studies for TDS products Abbreviated New Drug Applications (ANDAs): one is bioequivalence (BE) with pharmacokinetic (PK) endpoints study, and the other one is the skin irritation, sensitization and adhesion study. For skin irritation, sensitization, and adhesion study, the applicant usually conducts two studies, an adhesion study and an irritation/sensitization study. To support regulatory approval, in addition to the bioequivalence of PK endpoints, the test product must adhere at least as well as the reference product, be no more irritating than the reference and be no more sensitizing than the reference. This session will discuss statistical issues, challenges and approaches in the adhesion study and irritation/sensitization study for generic TDS products.” Given below is a listing of all session with highlights for biosimilar interest and Dr. Niazi’s presentations. PROGRAM
1
Tuesday Sept 26, Parallel Session 1 ( 1:15 to 2:30 p.m.)
200359 Panel Session: Better characterization of disease burden by using recurrent event endpoints
200296 Parallel Session: Sample Size Re-Estimation in Regulatory Applications, Experiences and Lessons Learned
200377 Parallel Session: Statistical Opportunities in Disease Interception – Screening, Intervention, and Evaluation of BenefitRisk Trade-Offs
200311 Parallel Session: Advances in handling nonproportional hazard issues under different clinical settings
200392 CMC2 Session: Statistical Considerations when assessing product stability and/or Shelf-Life
Tuesday Sept 26, Parallel Session 2 (2:45 to 4:00 p.m.)
200361 Town Hall Session: Enhanced regulatory and sponsor interactions for modern drug development
200385 Panel Session: Bayesian Methods in Assessing BenefitRisk Preference in a Structured Framework
200317 Parallel Session: Recent Advancements in Statistical Methods and Tools for Go/No-Go Decision Making
200393 CMC1 Session: Product quality tests and clinical evaluation for transdermal patches
Tuesday Sept 26, Parallel Session 3 (4:15 to 5:30 p.m.)
200375 Parallel Session: Statistical Issues and Challenges in Regulatory Animal Drug Studies
200301 Parallel Session: Adaptive randomization: a balance between innovation, bias reduction, regulatory and ethical considerations 200338 Parallel Session: Different Approaches to the Increase of a Sample Size When the Unblinded Interim Estimate of the
200355 Parallel Session: Recent Bayesian Applications/Examples in Clinical Trials
200369 Parallel Session: Win ratio: Recent methodological developments and applications in clinical trial design and analysis
200394 CMC3 Session: Statistical advances in demonstration of analytical similarity
http://ww2.amstat.org/meetings/biopharmworkshop/2017/workshopinfo.cfm
200315 Parallel Session: Statistical Evaluation of Generic Transdermal Delivery Systems and Topical Patches 200360 Parallel Session: Adaptive design for biosimilar product development
200363 Parallel Session: Drug combination dose finding studies in oncology
Treatment Effect Looks Promising.
5:30 p.m. to 6:30 p.m.
Mixer to immediately follow
Wednesday Sep 27, Parallel Session 4 (8:30 to 9:45)
200352 Parallel Session: Pragmatic Trials – Past, Current and Future?
Wednesday Sep 27 9:45 a.m. to 10:30 a.m. Wednesday Sep 27, Parallel Session 5 (10:45 to 12:00pm)
Poster Session - Atrium
200310 Parallel Session: Statistical Challenges for Medical Tests with Reference Databases
Wednesday Sep 27, Parallel Session 6 (1:15 to 2:30pm)
200351 Parallel Session: Statistical Issues in Agreement studies
200340 Parallel Session: What Industry and FDA see: How Adaptive Our Clinical Trials Are
200342 Parallel Session: Recommendations from the Clinical Trials Transformation Initiative Data Monitoring Committee Project
200326 Parallel Session: Choosing Estimands and Sensitivity Analyses in Clinical Trials – The Impact of the ICH E9(R1) Addendum
200314 Parallel Session: Best Practices in ConcentrationQTc Modeling Recommendations from the ICH E14 Scientific White Paper
200328 Parallel Session: Patientreported outcomes (PROs) in oncology and hematology trials-past, present and future
200345 Parallel Session: Unlocking the power of exploratory analysis in clinical research
200302 Parallel Session: Simulation Practices for Adaptive Trial Designs
200335 Parallel Session: Estimand, Causal Inference, and Missing Data
200386 Parallel Session: Statistical Challenges and Potential Solutions for Small Clinical Trials
200336 Parallel Session: Listening to Patients: Developing, Validating, and Analyzing Patient Reported Outcomes for Clinical trials
200306 Parallel Session: Challenges in using metaanalysis for regulatory decision making
200322 Parallel Session: ICH E17 on Multi-Regional Clinical Trials (MRCTs)
200387 Parallel Session: New Applications of Missing Data Methodologies in Clinical Trials
200368 Parallel Session: How we determine and communicate who benefits from which treatment and by how much
200332 Parallel Session: Challenges and Utility of Analyses of Actigraphy Data
Wednesday Sep 27, Parallel Session 7 (2:45 to 4:00pm)
200388 Parallel Session: Developing and Validating Classifiers in the Context of Diagnostic Devices
200305 Parallel Session: Evaluation of treatmentswitching in oncology and hematology registration clinical trials What and how should it be done?
200318 Parallel Session: Seeing is believing: effective use of statistical graphics across drug development
200358 Parallel Session: Real World Evidence in Clinical Trial: New Era of Informed Decision Making Session
200346 Parallel Session: Subgroup Analysis in Clinical Trial: Where are We Now?
200391 Parallel Session: Multiplicity Issues in Clinical Drug Development