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Biostatistics Research Center

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17th Merck-Temple Conference

The future of biopharmaceutical statistics: A management view.

Raymond Bain and Steve Miola, Merck & Company
Bruce Schneider and Cyrus Hoseyni, Wyeth
Graphical displays of safety data in clinical trials.
Richard Heiberger, Temple University
Joseph Heyse, Merck, discussant
Multiple testing and false discovery rate.
Yoav Benjamini, Tel Aviv University
Sanat Sarkar, Temple University
Peter Westfall, Texas Tech University, discussant

 

Conference Schedule

8:15-9:00
Registration and Continental Breakfast

9:00-9:10
Introductory Remarks
Boris Iglewicz, Temple University

 

Session 1: The Future of Biopharmaceutical Statistics: A Management View.

9:10 – 9:45
Statisticians in the Pharmaceutical Industry: Challenges and Opportunities for Leadership.
Bruce Schneider & Cyrus Hoseyni, Wyeth

9:45 – 10:20
Technical, Collaborative and Critical Thinking Skills in Quantitative Scientists: A Biopharmaceutical Management Perspective on Need, Training and Development
Raymond Bain & Steve Miola, Merck & Company

10:20 – 10:40
Break

10:40 – 11:20  
Session 1 Discussion

 

Session 2: Graphical Displays of Safety Data in Clinical Trials.

11:20 – 11:55  
Graphical Approaches to the Analysis of Safety Data from Clinical Trials
Richard Heiberger, Temple University

11:55 – 12:10  
Discussant
Joseph Heyse, Merck & Company

12:10-12:30
Session 2 discussion

12:30 – 2:00
Lunch

 

Session 3:  Multiple Testing and False Discovery Rate

2:00 – 3:10
Recent Advances in Multiple Comparisons: What Error-Rate Will Serve Your Goals?
Yoav Benjamini, Tel Aviv University & Sanat Sarkar, Temple University

3:10 – 3:25
Discussant
Peter Westfall, Texas Tech University

3:25 – 3:55
Session 3 discussion

3:55 – 4:00
Closing remarks

 

Abstracts

The future of biopharmaceutical statistics: A management view.

Statisticians in the Pharmaceutical Industry: Challenges and Opportunities for Leadership

Bruce Schneider and Cyrus Hoseyni, Wyeth Pharmaceuticals
Pharmaceutical industry continues to face unprecedented challenges in its pursuit of discovery, development and marketing of new medicines: higher regulatory and commercial hurdles, complex disease areas and unmet needs, low rate of productivity and, the political environment just to name a few.  At the same time, the current environment presents significant opportunities for the statisticians to play a critical role in being part of the solution.  In this talk we share the experiences of senior leaders who have utilized their quantitative skills and statistical thinking in conjunction with “acquired” soft skills to play an influential role in leading and guiding the R&D organizations and the decision-making process.

 

Technical, Collaborative and Critical Thinking Skills in Quantitative Scientists: A Biopharmaceutical Management Perspective on Need, Training and Development

Ray Bain and Steve Miola, Merck Research Laboratories
The biopharmaceutical industry faces unprecedented challenges in the treatment and prevention of human disease (e.g. declining success rate in product development, rising R&D costs, growing reimbursement pressures and greater scientific, regulatory and public scrutiny). But the opportunities are also significant (e.g. rising disease incidence globally, high unmet medical needs, new R&D technologies, and new emerging markets).  The goal of innovative R&D is to deliver therapies that provide true value to patients while optimizing productivity, increasing probability of success and decreasing cycle times.

Given these challenges and opportunities, there is an increasing need for professionally trained and continually developed quantitative scientists to address the current gap between the analytics demand and the supply of quantitative scientists.  Statisticians are at the center of research design, evidence collection, analysis, interpretation and communication to meet the needs of multiple customers.  A diverse set of ever-changing technical statistical skills is required throughout product discovery, pre-clinical development, clinical development and a product’s post-approval promotion.  But being technically competent is not enough. An effective statistical consultant role-model requires an interest and competency in collaboration (both internally and externally) and critical thinking skills.

Our talk will provide a management perspective on the training of statistical scientists including the development of curriculum guidelines, and fellowships and summer internships for graduate students in statistics.  Continuing education and development will also be highlighted including the integration of personal development with performance, formal and informal practices to develop soft skills and preparing for the workforce of the future.

 

Graphical displays of safety data in clinical trials.

Graphical Approaches to the Analysis of Safety Data from Clinical Trials 
Richard M. Heiberger, Temple University
Patient safety has always been a primary focus in the development of new pharmaceutical products.  Safety issues in clinical trials are usually reported in tables.  Formal analysis of safety data is much less developed than for efficacy data.

Safety data provides an ideal opportunity to use graphical methods to present concise summaries and communicate main messages.  Graphs can be used in an exploratory setting to help identify emerging safety signals and in a confirmatory setting as a tool to elucidate known safety issues.

I spent a research leave year at GSK where I joined a company-wide team investigating graphical issues for display of clinical trial information.  We developed several graphical displays for routine safety data collected during a clinical trial, covering a broad range of graphical techniques.  The displays focus on key safety endpoints in clinical trials: the QT interval from electrocardiograms, laboratory measurements for detecting hepatotoxicity, and adverse events of special interest.  We illustrate eleven specific graphical designs, many of which display the data along with statistics derived from them.  We discuss in detail the statistical and graphical principles underlying the production and interpretation of the displays.

This talk is based on a paper coauthored with Ohad Amit and Peter W. Lane of GSK that appeared in 2008 in Pharmaceutical Statistics.

 

Multiple testing and false discovery rate.

Recent advances in multiple comparisons: what error-rate will serve your goals?

Yoav Benjamini, Tel Aviv University and Sanat Sarkar, Temple University
Research in the area of multiple comparisons has been flourishing in recent years due to its increased relevance in modern scientific investigations. As a result of this activity, many alternative ways to define and deal with problems of simultaneous and selective inferences have been put forward. In this talk, we shall present a wide variety of error-rates that can be used to quantify the impact of multiplicity – familywise error-rate (FWER), false discovery rate (FDR), k-FWER, k-FDR, positive FDR, weighted FWER, weighted FDR, local FDR, and others -  and  briefly discuss the appropriate methods to address them. Issues that an analyst should consider when deciding an appropriate approach for the problem being faced will also be presented. Finally, we shall discuss together with the participants the matching of an error-rate to a problem, building upon the participants’ own experiences and the multiplicity problems they face in practice.

 

Speakers

Raymond Bain Merck & Company
Ray Bain received his PhD from the Department of Statistics and Biometry, Emory University School of Medicine in 1981.  From 1981 to 1986 he was an Assistant Professor of Biometry, Medicine and Community Health at Emory University and a member of the Georgia Center for Cancer Statistics.  From 1986 to 1999, he was a member of The Biostatistics Center at George Washington University where he was Co-Director of the Center and Research Professor of Statistics. While at the Center he was a NIH-Sponsored Coordinating Center Principle Investigator for multicenter clinical trial programs in the areas of diabetes, maternal-fetal and neonatal medicine, and prostatic disease.  He joined Merck Research Laboratories (MRL) in 1999 as Executive Director of the Clinical Biostatistics and Research Decision Sciences (BARDS) organization with oversight for the cardiovascular, infectious disease and neuroscience late drug development programs.  Since 2001, Dr. Bain has headed the Global BARDS organization with responsibility for MRL Early and Late Development Statistics, Epidemiology, Health Economic Statistics and Scientific Programming groups.  The Global BARDS organization develops and applies quantitative scientific methods in the targeting, discovery, development, manufacturing and commercialization of drugs and vaccines.

 

Yoav Benjamini Tel Aviv University
Yoav Benjamini (PhD Princeton ’81) is a professor of Statistics at Tel Aviv University, where he also heads the statistical consulting unit. His research is in the theory and applications of statistics, the latter including biostatistics, genomics, functional brain imaging, computational biology in behavior and meteorology. Together with Hochberg he initiated the concept of the False Discovery Rate into multiple testing, and ever since has been contributing to its development in theory and practice. He serves on scientific advisory boards of public organizations in Israel and recently finished a term as the president of the Israeli Statistical Association.

 

Richard Heiberger, Temple University
Richard M. Heiberger is Professor of Statistics at Temple University. He is coauthor of the graduate-level textbook ‘Statistical Analysis and Data Display: An Intermediate Course with Examples in S-Plus, R, and SAS’ (Springer, 2004) and the supplementary text ‘R through Excel: A Spreadsheet Interface for Statistics, Data Analysis, and Graphics’ (Springer, August 2009).  He participated in the design of the S-Plus and R linear model and analysis of variance functions while on research leave at Bell Labs.  He is the author of and contributor to various R packages. His undergraduate degree in Mathematics is from Oberlin College and his Ph.D. in Statistics is from Harvard University.  He is an Elected Fellow of the American Statistical Association (ASA) and the Chair Elect of the ASA Section on Statistical Computing.

 

Joseph Heyse Merck
Dr. Heyse joined Merck Research Laboratories in 1976 as a statistician supporting the Pre-clinical and Safety Assessment research programs. In 1985 he was asked to provide statistical support to worldwide health economic research programs being undertaken by the Company. This work led to the establishment of a Health Economics Statistics Department under Joe’s direction in 1999. The Department has responsibility for providing technical statistical and economic support to Merck research programs in Quality of Life and Pharmacoeconomics. In 1994 Joe was given additional responsibility for supporting statistical aspects of Phase I-V clinical development programs for drug and vaccine projects for a broad range of therapeutic areas. During this period Joe has had the statistical oversight for the successful clinical development and regulatory filings of more than 15 novel drug and vaccine products. He is currently Vice President, Early Development Biostatistics and provides statistical technical guidance to over 80 statisticians at the M.S. and Ph.D. level. The group is currently collaborating on research supporting drug and vaccine discovery, early clinical development, biomarker qualification and application, molecular profiling, and investigational research.

Academically, Joe received B.S. and M.S. degrees in Mathematics at Villanova University, an MBA from Temple University, and a Ph.D. in Statistics, also from Temple. His research interests are in economic evaluations of health care and statistical methods for multiple comparisons/multiple endpoints, and longitudinal data models. He has more than 80 publications in statistical and subject-matter journals.

He was elected Fellow of the American Statistical Association in 1997.

 

Cyrus Hoseyni Wyeth
Cyrus Hoseyni is Vice President of Global Biostatistics & Programming and Chief Statistician for Wyeth Pharmaceuticals.  Prior to joining Wyeth, Cyrus held the position of Executive Director & Site Head of Biostatistics & Reporting, Pfizer Global Research & Development.  He has over 20 years of experience in the pharmaceutical industry, assuming roles of increasing responsibilities from project statistician (pre-clinical and clinical) to leading global organizations.  He has extensive experience in directing statistical and regulatory aspects of developing new medicines and a strong track record for establishing statistical organizations recognized for statistical leadership, influence, innovation, and competency at all levels.   He is a member of Wyeth’s Medical Executive Committee and co-chair of the Clinical Review Committee.   His academic background consists of a Ph.D. in Biostatistics with emphasis on cancer research and quantitative risk assessment, and Master’s degrees in Mathematics & Economics from the University of Southern California.  His professional activities have included serving as a member of PhRMA’s Biostatistics & Data Management Technical Group for three years and serving as program and workshop chair for several Biopharmaceutical Statistics meetings.

 

Steve Miola, Merck & Company
Steve Miola received his PhD from the Department of Biometrics, Temple University School of Medicine in 1979. He joined Merck & Co. in 1977 as a biostatistician and held positions of increasing responsibility in the Department of Biostatistics and Research Decision Sciences (BARDS) organization. He was awarded a Henry W. Gadsden Fellowship from the Company in 1986 to improve the collaboration between Marketing and Research during the New Drug Application process. He later joined the Human Health Division and was named Director of Innovative Media, Department of Marketing Communications in 1994.  In that capacity he was responsible for all electronic communications between US field-based representatives and health care providers, and the development of the Internet as a channel of communication for all of Merck’s US-promoted products. In 2003 he rejoined the BARDS organization with responsibility to lead the Department’s effort to train and develop its talent.

 

Sanat Sarkar Temple University
Dr. Sanat K. Sarkar, Professor and Senior Research Fellow in the Department of Statistics, Temple University, has received his PhD in Statistics from Calcutta University in 1982. Dr. Sarkar has made some fundamental contributions to the development of multiple testing. His research has been funded by NSF (National Science Foundation) and NSA (National Security Agency), and often been cited in peer-reviewed journals. He has delivered invited talks at numerous national and international conferences.  Dr. Sarkar has co-organized a major conference on Multiple Comparisons funded by the NSF and served on the organizing committees of several international conferences on the same topic. He is on the editorial boards of   the American Statistician and Sankhya. He has supervised 17 Ph.D. dissertations.  Dr. Sarkar has been recognized as a fellow by both the Institute of Mathematical Statistics and the American Statistical Association, and as an elected member of the International Statistical Institute. He was awarded the Musser Award for excellence in research by the Fox School, and inducted several times to the Dean’s Research Honor Roll.

 

Bruce Schneider Wyeth
Bruce Schneider is Executive Vice President and Chief of Operations for Wyeth Research.  He has spent his entire career at Wyeth in a variety of technical and general management roles.  He initially progressed from Manager, Biostatistics through a series of positions to Vice President, Clinical Operations with responsibility for worldwide data management, clinical programming, biostatistics, clinical writing and field monitoring.  He then moved into a broader R&D role with responsibility for Wyeth’s drug development operating model (strategy, teams, systems and governance), its portfolio management system, interactions with co-development partners and organization-wide business improvement programs.  He also has oversight responsibility for the multi-billion R&D budget and a variety of administrative support functions.  He has a deep understanding of regulatory processes around the world with special expertise and responsibilities for R&D efforts in Japan.  He is a member of Wyeth’s R&D and Pharmaceutical Executive Management Teams.  His academic background consists of a bachelor’s degree in applied mathematics from Brown University and a doctorate in applied statistics from Temple University.  He has been involved in PhRMA and its predecessor organization, ultimately serving as chair of its Biostatistics Subsection, is a member of numerous professional societies and has received several awards for outstanding contributions at Wyeth and in the community.

 

Peter Westfall Texas Tech University
Peter Westfall (Ph.D. UC-Davis, 1983) is Paul Whitfield Horn Professor of Statistics and James Niver Professor of Information Systems and Quantitative Sciences at Texas Tech University.  He has consulted with various pharmaceutical companies for 20 years, and has published over 100 articles and three books on statistical theory and practice.  Using funds from a grant from the Pharmaceutical Manufacturers’ Association, he developed the SAS/STAT® procedure PROC MULTTEST, which performs resampling-based multiple testing adjustments; using funds from another recent grant from a private pharmaceutical company, he developed a publically available clinical trials simulation system (http://www.biopharmnet.com/innovation/trial_simulation/cts1.php) that can be used to design studies optimally.  Peter is past editor of The American Statistician, a Fellow of the American Statistical Association, and a Fellow of the American Association for the Advancement of Science.

 

Registration

Charges:
General – $100
Merck & Wyeth- $70
Full time graduate students – $30

Registration includes: Continental Breakfast, Lunch, Break, Parking.

Registration:
Registration and web information will start on September 1, 2009. Please send check (Made out to Temple University [Biost]),  email address, and company name to:

Boris Iglewicz, Director,
Biostatistics Research Center,
Department of Statistics, Temple University 006-12,
1810 N. 13th Street,
Philadelphia, PA 19122-6083

For additional information, contact Boris Iglewicz, Director, email: borisi@temple.edu or telephone (215) 204-8637.

 

Directions

DOUBLE TREE GUEST SUITES, PLYMOUTH MEETING
640 W. Germantown Pike, Plymouth Meeting PA 19462
(610) 834-8300

From Airport: Take 95 South to 476 North to the last exit #20(Germantown Pike-West). Merge with Germantown Pike and follow for 3 lights. Make a right onto Hickory Rd. at the 3rd light. The hotel is the 3rd building on the left.

New York/ New Jersey Turnpike: Take the New Jersey Turnpike to exit #6, which is PA turnpike. Go west to exit #333- Norristown. Follow signs to Plymouth Rd. Go to the 1st light and make a left. Go to the next light and make a right onto Germantown Pike. Go to the second light and make a right on Hickory Rd. The hotel is the second driveway on the left.

Washington D.C., Wilmington, and Delaware: Take I-95 North to Route 476 North. Take Route 476 to the Germantown Pike West exit #20. Go to the third light, Hickory Rd., and make a right. The hotel is the 2nd driveway on the left.

Route 476: Take 476 to the Germantown Pike West exit #20. Go to the third light, Hickory Rd., and make a right. The hotel is the 2nd driveway on the left.

From downtown Philadelphia: I-76 west Plymouth Meeting exit #331B (Route 476). Take Route 476 north to Germantown Pike exit. Go to the third light, Hickory Rd., and make a right. The hotel is the 2nd driveway on the left.

Daniel Heitjan (President of ENAR) and Tingting Zhan

Boris Iglewicz (Ph.D. Advisor) and Tingting Zhan