Topics/Speakers

Conference Topics/Speakers

Return Home

Topics to be Covered:

Historical Perspective on ePRO
Saul Shiffman, PhD, Chief Science Officer & Doug Engfer, CEO
invivodata, inc.

PROs within Clinical Programs - Strategy to Execution
Katarina Halling, Senior PRO Advisor, Health Economics and Outcomes Research
AstraZeneca

Evolving FDA Expectations for PRO
John H. Powers III, MD FACP FIDSA, Clinical Assistant Professor of Medicine, School of Medicine
George Washington University & University of Maryland

Case Study: eDiary Supported FDA Submissions
R. Michael Gendreau, MD, PhD, Vice President Clinical Development, Chief Medical Officer
Cypress Bioscience, Inc.

Case Study: Developing a PRO Strategy
Sam Tomioka, Manager, Clinical Development
Dainippon Sumitomo Pharma America (DSPA), Inc.

PRO Endpoint Model Development in a Regulated Clinical Trial Environment
Alan Shields, PhD, Scientific Consultant
PRO Consulting

ePRO Experiences in Japan
Satoshi Azuta, MBA, Consultant
Cegedim Dendrite K.K.

The Key Components of ePRO Success
Jean Paty, PhD, Chief Scientist and Regulatory Advisor
PRO Consulting

Best Practices in Conducting ePRO Trials in Europe
invivodata, inc. & Large Pharmaceutical Company

The Site Perspective: ePRO Best Practices
Bobbi Tafara, CCRC, Director of Clinical Operations and Co-Founder
Suncoast Clinical Research

Realizing the Benefits of ePRO-EDC Integration
Rick Piazza, Vice President of New Product Development
Medidata Solutions Worldwide

Building and Managing an ePRO System for Your Trial
Michael Posey, Product Manager
invivodata, inc.

eDiaries and Data Capture Options for ePRO
Ken Kolenik, Product Manager
invivodata, inc.

Featured Speakers:

Speaker list will be updated as additional speakers are confirmed.

Chris Connor
Senior Research Analyst, Clinical Development Strategy and Technology
Health Industry Insights, an IDC company

As senior research analyst for Health Industry Insights, Chris Connor provides research and market analysis on key topics within the life sciences area. Leveraging his experience in clinical development and IT, Connor focuses on assessing the effect of eClinical software and solutions with the potential to deliver value in the late stage drug development and clinical trial areas. Connor's research expertise includes adaptive clinical trial design, electronic data capture (EDC), clinical trial management systems (CTMS), electronic patient reported outcomes (ePRO), digital imaging, and identifying emerging technologies and market trends in the life science industry.

Prior to joining Health Industry Insights, Connor was responsible for business operations at WorldCare Clinical, a pioneer in telemedicine and clinical trial imaging services. While at WorldCare, Connor defined requirements for 21 CFR Part 11 eClinical management solutions over multiple therapeutic areas and clinical phases. Prior to WorldCare, Connor was a principal in a consulting firm dedicated to best practices in new product innovation and development. Previously, Connor led product management efforts at Lucent Technologies, Brix Networks and 3Com Corporation.

A frequent speaker at industry conferences on such forward-looking topics as integrating EDC and electronic health records (EHRs). Connor is also sought after as an expert resource for the news media, recently as a judge for Bio-IT World Magazine's 2008 Best Practices competition.

R. Michael Gendreau, M.D., Ph.D.
Vice President Clinical Development, Chief Medical Officer
Cypress Bioscience, Inc.

Dr. Gendreau brings 20+ years of experience in the development, clinical evaluation and commercialization of drug, biologic, medical device, and diagnostic products. He has clinical and regulatory experience with both therapeutics and diagnostic products. He led the Cypress team that designed and managed Cypress' pivotal trial program in fibromyalgia, which included a number of innovations including the development of new indication endpoints and the use of electronic diaries. He successfully negotiated a Special Protocol Assessment commitment from FDA for the company’s Phase III development program, which set the stage for drug approvals in the fibromyalgia indication. Prior to the initiation of the fibromyalgia program, Dr. Gendreau led the team that designed and managed Cypress' successful Phase III pivotal trial program and subsequent FDA submissions (1996-1999) for the Company's former rheumatoid arthritis treatment, the Prosorba column.

Prior to Cypress, he served in various senior management roles in research, clinical development and regulatory affairs. Dr. Gendreau received his B.S. degree in Chemistry from Ohio University, and his M.D./Ph.D. degree in medicine and pharmacology from The Ohio State University.

Rick Piazza, MS, PharmD
Vice President of New Products
Medidata Worldwide

As the Vice President of New Products, Rick is responsible for the introduction, management, and implementation of new products into the clinical trials market and to assist in the definition of the Medidata product strategy. Rick brings over 20 years of experience in the pharmaceutical and eClinical industries. Rick formerly held a range of senior management positions at etrials, a provider of clinical trials software and services. Most recently, Rick was vice president of product strategy where he was responsible for leading the development of the company's clinical trials commercial software applications, establishing the company's quality assurance program and implementing a formal software development lifecycle policy for software engineering. As associate director of clinical trials management at Health & Sciences Research, a full service contract research organization and clinical site, Rick brought three major Phase III projects to NDA submission and product approval.

John H. Powers, III MD FACP FIDSA
Clinical Assistant Professor of Medicine, School of Medicine
George Washington University & University of Maryland

Dr. Powers is a physician/investigator on faculty as an Assistant Clinical Professor of Medicine at the George Washington University School of Medicine. Prior to his current position Dr. Powers was the Lead Medical Officer for Antimicrobial Drug Development and Resistance Initiatives in the Office of Antimicrobial Products, Center for Drug Evaluation and Research, at the US Food and Drug Administration where he was responsible for issues related to clinical trials and policy in antimicrobial research. Dr. Powers was a co-chair for the Inter-Agency Task for on Antimicrobial Resistance of 11 federal agencies responsible for implementing the Public Health Action Plan to Combat Antimicrobial Resistance. Prior to joining the FDA, Dr. Powers was assistant professor in the Division of Infectious Diseases at the University of Maryland School of Medicine and he still is on the faculty there as an Assistant Clinical Professor of Medicine. Dr. Powers also actively sees patients weekly in clinic and attends on the infectious diseases service.

Dr. Powers received his bachelor’s degree and graduated magna cum laude from the University of Pennsylvania. He received his medical degree and residency training from Temple University School of Medicine, where he also served as Chief Resident. He completed his infectious diseases training at the University of Virginia School of Medicine. Dr Powers is board certified in internal medicine and infectious diseases.

Bobbi Tafara, CCRC
Director of Clinical Operations and Co-Founder
Suncoast Clinical Research

Suncoast Clinical Research, founded in 1998, is a trial management organization that manages, on average. 40-50 active studies As the Director of Clinical Operations, Bobbi oversees the clinical research coordinators who follow subject’s participation in clinical trials. She is responsible for employee training, data management, and clinical skills. As a hands-on administrator, she is very familiar with the electronic modalities that enhance the clinical trial process. Additional areas of responsibility include locating clinical trials relevant to physician network interests, contracting for participation and negotiating appropriate budgets/grants, coordinating all communication and status reports to sponsors, CROs, and IRBs, and assuring completion of all clinical record keeping in accordance with protocol requirements and Good Clinical Practices.

With a bachelor's degree in business administration, 20 years managing large medical practices in New Jersey, and medical training as a physician's assistant, Bobbi brings her expertise to the operational processes of clinical sites. She coordinated her first clinical trial in 1985, having since managed over 300 clinical trials. Bobbi earned her certification from the Association of Clinical Research Professionals in 2001.

Jean Paty, Ph.D.
Chief Scientist and Regulatory Advisor
PRO Consulting

Dr. Paty has published extensively in the area of the regulations guiding development and implementation of ePRO, and has worked closely with industry and regulatory agency groups on ePRO best practices. His 17 years of work developing ePRO solutions to study patient experience has been well-referenced in peer reviewed journals and in a variety of conferences and events, where he has presented his findings on the scientific, clinical, and regulatory implications of PRO data collection in clinical trials. Dr. Paty has a B.S. in Psychology from University of Toronto and an M.S. and Ph.D. in Psychology from University of Pittsburgh.

Alan Shields, Ph.D.
Scientific Consultant
PRO Consulting

A full-time scientist with PRO Consulting, Alan Shields most recently worked as an Assistant Professor of Psychology at East Tennessee State University, Research Associate in the Harvard Medical School, and Director of the Assessment and Treatment Outcome Lab. Dr. Shields specializes in the areas of measurement and psychometrics with special emphasis on evaluating the performance of tests used in the behavioral and medical sciences; further, he has substantial experience in training professional and non-professional staff to administer such instruments. Dr. Shields’ has provided measurement consultation and assessment training on trials and projects across a spectrum of pathology including cancer, diabetic neuropathy, gastrointestinal disorder, HIV/AIDS, and a variety of addictive behavior and CNS disorders.

Dr. Shields has published numerous measurement focused manuscripts including a recent paper aimed at helping clinical researchers implement FDA recommendations on the use of PRO instruments and several others documenting the quality of data collected via electronic methods. Dr. Shields received his Ph.D. in Clinical Psychology from the University of Montana and, later, served jointly as an Instructor of Psychology in the Harvard Medical School and Research Psychologist at McLean Hospital.

Saul Shiffman, Ph.D.
Chief Science Officer
invivodata, inc.

Dr. Shiffman is a Professor of Psychology (Clinical and Health Psychology) at the Universityof Pittsburgh. He is widely published on scientific methods for collecting data on real-world behavior and experience. With Dr. Arthur Stone, he has defined the Ecological Momentary Assessment (EMA) approach to data collection. Dr. Shiffman has edited several special sections of leading health journals on these methods. He developed the first palm-top computer solution for collecting EMA diary data. In addition to serving on scientific panels for the National Institutes of Health, he has served as aconsultant to the pharmaceutical industry and a site investigator for over a decade. Most recently, Dr. Shiffman was the winner of the Good Clinical Practice Journal’s Lifetime Achievement Award.

Topics and speakers are subject to change.

Register Now!

Sign up below for ePRO Pulse™, invivodata's industry newsletter