9:45 a.m. 10:30 a.m. Poster Session Atrium 10:45 a.m. 12:00 p.m. PS5a: Statistical Challenges for Medical Tests with Reference Databases 12:00 p.m. 1:15 p.m. The ultimate goal is to be flexible and at the same time maintain the standards for our evaluation of the drug s safety and efficacy. Initially a historical account will be presented that will show how the original idea that random effects models are the key to developing personalized medicine can be traced back to pharmacological and genetic research developed in the second half of the past century. In the first part of this course, step-by-step introductions to basic biology and genetics will be presented, and is followed by overviews of cutting edge technologies such as microarray and next generation sequencing technologies that have been widely used to generate omics data. Recently a new interest of PCTs emerges for marketing authorization application of new drugs with an increasing regulatory attention to using real world evidence in drug approval. Trends to Watch: Health Care Product Development in North America, Brief Communications. Abstract, Elaborate on how to assess reasonable risk and dose selection based on preclinical data, Goals & Objectives. in It compares each patient in the treatment group with every patient in the control group to determine the winner/loser/ties within each pair. PRO has attracted a lot of attention from many researchers in that the information directly from patients can provide valuable insight that others such as observers can t. PRO is an instrument to capture data from patients that is used to measure treatment benefit or risk in medical product clinical trials. United States Pharmacopeia has a general chapter on product quality tests for topical and transdermal drug products [3], however, there is no regulatory guidance on evaluating adhesion for new drug development. Chan School of Public Health, ASA Biopharmaceutical Section Regulatory-Industry Statistics Workshop, PhD Student Award Recipients Larry Han and Cathy Xue, Donald Hopkins Predoctoral Scholars Program, Summer Program in Biostatistics and Computational Biology, PhD Student Award Recipients Larry Han and Cathy Xue, Summer Program Concludes with a Successful Pipelines into Biostatistics Symposium, Helping public health agencies improve emergency risk communication, Mothers Blood May Carry the Secret to One Type of Autism, Myrto Distinguished Lectureship & Lagakos Alumni Award NOMINATIONS DUE FRIDAY, Pipelines in Biostatistics Symposium 7/14, Academic Departments, Divisions and Centers. Pharmacology skills for drug discovery. Pharmacological applications taken from the extensive professional experience of the instructor will be shown. Bayesian Scientific Working Group (BSWG) of the DIA was formed in 2011 to achieve this version. Methods for efficiently utilizing innovative designs and statistical analyses, and even borrowing external or historical trial data, will be discussed. This year s program includes two plenary sessions, 42 parallel sessions, eight short courses, 32 roundtable discussions, and 20 posters. Depending on the specific setting some estimands may be more appropriate than others. These cookies do not store any personal information. For example, from immunogenicity perspective, the sponsor may not have reliable estimate of anti-drug activity rate for the reference product.

Organizer(s): Joseph C. Cappelleri, Pfizer Inc. LINCOLN 5 Organizer(s): Lin Huo, CBER/FDA; Fairouz Makhlouf, FDA; Srinand Nandakumar, Medivation; Satrajit Roychoudhury, Pfizer Inc. Methods like those used to deal with missing data in surveys are commonly applied in clinical trials, with disastrous results, requiring implausible interpretations of what would have happened under different conditions. Funding Announcement: Improving Methods for Conducting Patient-Centered Outcomes Research, Achieving Regulatory Success: Areas of focus for biotechnology companies. Examples include seizures in epilepsy; relapses in multiple sclerosis; and exacerbations in pulmonary diseases such as chronic obstructive pulmonary disease.

Over the last 20 years, the workshop has grown from a within-agency discussion to a multi-organization international statistical meeting. As medical tests are becoming more sophisticated (e.g., reference databases for multiple outputs for Ophthalmological testing, reference databases for highly sensitive assays such as Troponin), there are new study design and statistical analysis challenges associated with reference databases and reference intervals. The Promise and Challenge of Adaptive Design in Oncology Trials Clinical oncology trials are more complex and time consuming than those in any other therapeutic, I N S T I T U T E O F M E D I C I N E Shaping the Future for Health SMALL CLINICAL TRIALS: ISSUES AND CHALLENGES Clinical trials have a long history of well established, documented, and validated methods, Clinical Trial Designs for Incorporating Multiple Biomarkers in Combination Studies with Targeted Agents J. Jack Lee, Ph.D. Department of Biostatistics 3 Primary Goals for Clinical Trials Test safety and, Stat & Quant Mthds Pharm Reg (Spring 2, 2014) Lecture 2,Week 1 1 The review process developed over a 40 year period and has been influenced by 5 Prescription User Fee Act renewals Time frames for review, Critical Path Institute Accelerating drug development for Alzheimer s Disease through regulatory science Martha A. Brumfield, PhD President and CEO Accelerating the Path to a Healthier World 1 Critical. Subjects and earnable credit may vary from semester to semester.

Speakers: Lakshmi Vishnuvajjala, CDRH/FDA; Ravi Varadhan, The Johns Hopkins University; Susan H. Gawel, Northwestern University Institute of Public Health and Medicine, Feinberg School of Medicine; Xiaoqing (Quinnie) Yang, Abbott Diagnostics R&D Statistics External Validation: Two Case Studies Yu Du, The Johns Hopkins University PS7b Parallel Session: Treatment Switching in Oncology and Hematology Registration Clinical Trials: What and How Should It Be Done? Chair(s): William W. Wang, Merck & Co., Inc. Panelist(s): Bruce Binkowitz, Shionogi Inc.; Aloka Chakravarty, CDER/FDA; Lisa LaVange, CDER/FDA; Romi Singh, Pfizer Inc.; Steve Snapinn, Amgen Drug development has rapidly been globalized. These approaches depend on specifying cut points for intensity such as <100 activity counts (sedentary activity), activity counts (light activity), etc. We look forward to an exciting three-day workshop, starting with eight half-day short courses on Monday, September 25, and followed by two days of presentations and discussions in plenary, parallel, town hall, and poster formats. When multiple drugs are investigational, it becomes difficult to attribute observed safety signals to drugs, hence makes it difficult to make escalation decisions. Belgium, 7751 Brier Creek Parkway Regulatory Considerations on Multiple Endpoints in Clinical Trials Lisa LaVange, FDA Multiple Endpoints and Multiple Testing: An Academic s View of Issues and Solutions Ralph D Agostino, Boston University Analysis of Clinical Trials with Multiple Objectives Alex Dmitrienko, Mediana Inc. PS3b Parallel Session: Different Approaches to the Increase of a Sample Size When the Unblinded Interim Estimate of the Treatment Effect Looks Promising THURGOOD MARSHALL SOUTH Organizer(s): Dalong Huang, FDA/CDER; Annie Lin, FDA; Mikhail Peter Salganik, Pfizer Worldwide Research & Development, Pfizer Inc.; Jian Zhao, PPD, Inc. Based on data gathered via these evidence-gathering activities and feedback from discussion at an expert meeting the project convened, the project team, made up of a diverse group of stakeholder from across the clinical trials enterprise, developed recommendations intended to improve the quality and efficiency of DMCs. A variety of randomization designs have been proposed in the literature for cluster randomized trials and individual subject randomized trials.

Even though a variety of approaches have been proposed to cope with the challenges associated with the conduct and analysis of small-sized trials, it is not clear whether a consensus has been reached in terms of what level of evidence can be used to make regulatory decisions.

The session is designed to expose the audience to key scientific considerations in a fundamental question in manufacturing, namely how to best establish product shelf-life. Thus, both biological and mathematical arguments support the development of methodological instruments for personalized medicine based on GLMMs. Reliability of a PRO measure involves its consistency or reproducibility as assessed by internal consistency and test-retest reliability. Similar bias may occur in the third situation, where patients who drop out may respond to the treatment systematically differently from those who stay. In spite of the many years of research and discussion in the regulatory and statistical literature the evaluation of general usefulness of the promising zone design and ranking of the usefulness of the different sample size re-assessment rules are still opened to debate. In this overview, we illustrate how to construct well-designed graphs for study design and analysis, with specific applications to drug safety, subgroups, and post-market surveillance. Web Tools for Agreement Statistics Lawrence Lin, JBS Consulting Services Inc. Assessing Agreement with Relative Area Under the Coverage Probability Curve Huiman X. Barnhart, Duke University Medical Center ASA Biopharmaceutical Section Regulatory-Industry Statistics Workshop, 30 A Statistical Method for Method Comparison Studies When Perfect Agreement Is Not Expected Yuqing Tang, FDA PS6b Parallel Session: Challenges in Using Meta-Analysis for Regulatory Decision-Making THURGOOD MARSHALL SOUTH Organizer(s): Kun Chen, AbbVie Inc.; Qin Li, FDA/ CDRH; Lisa Weissfeld, Statistics Collaborative, Inc.; Zhiheng Xu, FDA/CDRH A well-designed meta-analysis can provide valuable information for safety and effectiveness assessment in the regulation of medical products. There are varied and expanding statistical tools available for FA. Several subcommittees will be formed to handle different tasks and support the two co-chairs.

Xin Fang, FDA/CDRH; Xiting Yang, FDA TL03 Application of Bayesian Models in Basket Trials Na Hu, Boehringer Ingelheim China Big Data TL04 Data Integration with the Changing Landscape of Technology Dong Wang, FDA/NCTR Comparative Effectiveness TL05 Pragmatic Trials: How Did/Do They Work for You? Do these answers vary from superiority trials to non-inferiority or bioequivalence/biosimilar trials? Role of the DMC, including issues related to DMC access to blinded data and independence; 2. Applying the Rasch Model to Validate and Interpret a Kidney Symptom Index for Patients with Metastatic Renal Cell Carcinoma Joseph C. Cappelleri, Pfizer Inc. Patient-Reported Outcome (PRO) in Oncology and Hematology Trials: Past, Present, and Future Arnold N.K. To make the poster competition more rewarding to participants, we will offer financial awards to the winners. The final concept paper for ICH E9 Revision 1 (2014), Addendum to Statistical Principles for Clinical Trials on Choosing Appropriate Estimands and Defining Sensitivity Analyses in Clinical Trials, pointed out that Incorrect choice of estimand and unclear definitions for estimands lead to problems in relation to trial design, conduct and analysis and introduce potential for inconsistencies in inference and decision making. ASA Biopharmaceutical Section Regulatory-Industry Statistics Workshop, 12 TL18 Consideration of Clinical Aspects in Oncology Trial Design Sabrina Wan, Merck & Co., Inc.; Keaven Anderson, Merck & Co., Inc. Patient-Reported Outcomes TL19 Developing Standards for Clinical Outcome Assessment (COA) Data Collected in Clinical Trials: Experiences, Considerations, and Potential Solutions Marian Mullin Strazzeri, FDA/CDER Real World Evidence TL20 Translate Real World Data into Real World Evidence to Support Regulatory Decision-Making Jianxiong Chu, FDA/CDRH TL21 TOWNHALL Use of Real World Evidence and Real World Data for FDA Approval and Clearance Terri Johnson, FDA TL22 Cluster-Randomized Trials: Considerations for Power and Analysis Todd Durham, QuintilesIMS; William Hawkes, QuintilesIMS Tuesday Luncheon Roundtable Room Assignments TL01, TL02, TL03, TL04 Wilson A TL05, TL06 Taylor TL07, TL08, TL9, TL10 Wilson B TL11, TL12, TL13, TL14 Wilson C TL15, TL16, TL17, TL18, TL19 Madison A TL20, TL22 Truman TL21 Marriott Balcony B TL23, TL24, TL25, TL26, TL27 Madison B TL28, TL29, TL30 Taft TL31, TL32 Tyler Lunch Only No Discussions Lincoln 2,3,4 Role of Statisticians TL23 Chat with the Publications Officer of the Biopharmaceutical Section Richard Zink, JMP Life Sciences, SAS Institute Safety TL24 Blinded Safety Signal Monitoring for the FDA IND Safety Reporting Final Rule Greg Ball, Merck & Co., Inc. TL25 Patient Support Program Data: How Can We Leverage This Data for Safety Surveillance? ASA Biopharmaceutical Section Regulatory-Industry Statistics Workshop, 26 An Evidence Synthesis Approach for Optimized Combination in Cancer Drug Development Fei Ma, Novartis Pharmaceuticals Corporation Dose-Ranging Design and Analysis Based on MCP-Mod to Identify the Target Dose Fang Liu, Merck What Do the Experts Believe?

Discussants: Lee-Jen Wei, Harvard University; Jim Hung, FDA/CDER Design and Monitoring of Survival Trials Accounting for Treatment Crossover Xiaodong Luo, Sanofi Logrank-Hazard Ratio Test-Estimation Practice May Not Be Routine When Moving Beyond the P-Value World Hajime Uno, Dana-Farber Cancer Institute/Harvard Medical School Comparison of Hazard Ratio and Restricted Mean Survival Analysis for Cardiorenal Drug Trials John Patrick Lawrence, FDA PS1e CMC2 Session: Statistical Considerations When Assessing Product Stability and/or Shelf Life LINCOLN 5 Organizer(s): Yoko Adachi, CFSAN; Stan Altan, Johnson & Johnson; Jeff Budd, Beckman Coulter; Tsai-Lien Lin, FDA/CBER; Estelle Russek-Cohen, (retired CBER); Yaji Xu, FDA This session brings together experts in CMC issues but each speaker works on a distinct class of products. In this session, the concerns of conventional missing data methods will be discussed and new and innovative methods will be introduced in these areas. First and foremost, with the high cost of conducting translational clinical research, it is common to collect as much data as possible on as many endpoints as possible. In the medical device regulation, a 510(k) regulatory pathway is that to be marketed devices should be demonstrated to be at least as safe and effective, that is, substantially equivalent, to a legally marketed device (predicate). As stated in the 2010 FDA guidance on adaptive designs, detailed documentation on the simulation report and results should accompany the study protocol. Methods developed based on log-rank test can still be used to test for significance of the treatment effect but may not provide the best estimate of treatment effects. Introduction. First, all components are considered equally important, and second, in timeto-event data analyses, the first event analyzed may not be the most important component. Recurrent event endpoints are well established in indications where recurrent events are clinically meaningful, treatments are expected to impact the first as well as subsequent events and where the rate of terminal events such as death is very low. First In Human Pediatric Trials and Safety Assessment for Rare and Orphan Diseases Andrew E. Mulberg, MD, FAAP Division Deputy Director OND/ODE3/DGIEP FDA Partnership is the Key Coming together is a beginning; Statistics Graduate Courses STAT 7002--Topics in Statistics-Biological/Physical/Mathematics (cr.arr. Luncheon discussion topics are divided into zones and housed in different rooms.

Some Caveats for Outcome Adaptive Randomization in Two-Arm Clinical Trials Peter F. Thall, MD Anderson Cancer Center Validity and Power Considerations on Hypothesis Testing Under Minimization Zhenzhen Xu, FDA Outcome Adaptive Randomization in Multi-Arm Clinical Trials: Simulation Study Results Kyle Wathen, Johnson & Johnson PS2c Panel Session: Bayesian Methods in Assessing Benefit-Risk Preference in a Structured Framework ROOM: THURGOOD MARSHALL EAST Organizer(s): Tom Gwise, FDA; Jeremy D. Jokinen, AbbVie Inc.; Saurabh Mukhopadhyay, AbbVie Inc.; Arianna Simonetti, FDA/CDRH/OSB/DBS Chair(s): Saurabh Mukhopadhyay, AbbVie Inc. Panelist(s): Telba Irony, CBER/FDA; Bennett Levitan, Janssen R&D; Ram Tiwari, FDA Decisions about treatments are complex and often involve trade-offs between multiple, often conflicting, assessments of benefit and risk.

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