PHT Home > 2010 U.S. User Group Meeting: Topics & Speakers
Topics & Speakers
All meeting attendees leave with enhanced information about ePRO and are educated and empowered to take leadership roles at their companies with respect to PRO, ePRO, and the regulatory environment. The agenda is balanced between PHT speakers who provide background information about technology trends, regulatory updates, and validation processes, and sponsor, site, and CRO presenters who discuss how they use ePRO within their clinical trials, including lessons learned, the positives and negatives of using ePRO in a trial.
The Physician's Perspective to PRO collection
Valdo Arnera, General Manager of Europe, PHT Corporation
Valdo joined PHT Corporation in 2000, and founded the company's European affiliate in January, 2001. During his more than 20 years of experience in the pharmaceutical industry, he has held positions ranging from Clinical Research Physician to Vice President of Medical Affairs. Skilled in both science and management, Valdo currently serves as the General Manager of PHT's European operations. He is also an active co-chair of the DIA's eClinical Special Interest Area Communities (SIAC). He is also a member of the Program Committee for the Annual DIA Meeting and the 2010 EuroMeeting. Prior to joining PHT, Valdo founded the first European Central Clinical Laboratory dedicated to clinical trials, SciCor (now Covance Central Laboratory), and practiced medicine in various positions. Valdo received his French State Doctor's Degree in Medicine from the University of Clermont-Ferrand I.
Using ePRO and EDC
David Borbas, Director, Data Management, Jazz Pharmaceuticals, Inc.
David has over 15 years of clinical and management experience in the areas of Critical Care, Emergency, Hemodialysis and Critical Care Transport. He started in clinical research by organizing and tracking data Phase 3 sepsis trials. David sought to combine his interest in clinical care and information technologies and worked for 5 years in IT management at California Pacific Medical Center in San Francisco. There, he was responsible for Lab, Medical Records, Finance, Decision Support, and other ancillary medical systems. David then transitioned into Data Management at SurroMed, a small biomarker discovery company now a part of PPD. For Millennium, David established the Data Management team for the company's South San Francisco location. In March of 2005, David joined Jazz Pharmaceuticals and created the Data Management team. He works in Fibromyalgia, Neurology and Psychiatry. David has a Bachelor's degree in Nursing from the University of Pennsylvania and a Master's of Science in Information Systems from Claremont Graduate University.
PHT Spotlight and Product Update
Scott Bradley, Product Manager, PHT Corporation
Scott Bradley, BSEE, MEM, MBA joined PHT in 2007 with nine years of networking and medical device experience, and was previously a global product manager for IT Solutions at Draeger Medical. Scott is a graduate of West Point and as a Captain in the US Army, led international networking projects in the Pacific. At PHT, Scott is responsible for the LogPad, SitePad Tablet and eSense product lines. In his free time, he teaches at Northeastern University as part of the Masters of Science of Health Informatics program.
Key Components for a Successful ePRO Study
Dwight Cooper, Vice President, Client Services, PHT Corporation
Dwight Cooper joined PHT in 2001 as Director of Engineering and recently served as PHT's Global Director of Technical Services. As the Vice President of Client Services, Dwight is responsible for managing PHT's customer relationships including all aspects of project delivery, monitoring and support. Dwight has more than 15 years of experience providing leadership to delivery teams developing applications for the pharmaceutical industry, and 20 years of experience designing and developing commercial software applications. In his roles at PHT, Dwight has been responsible for the technical implementation of each clinical trial and the core product software development process. Prior to joining PHT, he co-founded Beehive Software, and spent five years providing software consulting services for pharmaceutical manufacturers including Eli Lilly. Dwight has a B.S. in Electrical Engineering and an M.S. in Computer Science from Union College.
Industry Overview
Phil Lee, President and CEO, PHT Corporation
Phil joined PHT in 2003 and has more than 20 years of experience in the software industry with over a decade in the clinical research technology. Phil served as President and CEO of Clinsoft (now part of Phase Forward) where he helped the company achieve market dominance in clinical data management systems and adverse event reporting systems. Prior to PHT, Phil was the President of Object Design and Excelon Corporation. Phil has also held senior level positions at Oracle Corporation, Interleaf Inc. and BBN Software Products (Bolt Beranek and Neuman). Phil holds a Bachelor of Science and Masters of Engineering degrees from Cornell University.
Understanding the PRO Guidance as it relates to ePRO
Barbara Marino, Director, Clinical Operations and Scientific Advisor, PHT Corporation
Barbara works directly with PHT clients to ensure they design a LogPad or StudyPad solution to best meet the needs of their clinical trial. Prior to PHT, Barbara was an outcomes researcher at Children's Hospital. Barbara is an RN and has a Ph.D. in Psychology. She joined PHT in 2000.
Using the SitePad Tablet
Darlene Panzitta, President and Founder, DSP Clinical Research
Darlene Panzitta is the President/Founder of DSP Clinical Research, a full service contract research organization located in Parsippany, New Jersey. Darlene has been working in the pharmaceutical industry for over 14 years and is still actively involved in the day to day study management of several Phase III and IV clinical trials at DSP. Prior to founding DSP in 2003, she worked as a Manager of Clinical Development at Berlex Laboratories. While at Berlex, she was responsible for the overall management and execution of Phase I to IV clinical development programs for women's health and andrology. Earlier in her career, Darlene worked at Organon and Knoll Pharmaceuticals in the drug safety and monitoring groups. She has extensive experience in scientific evaluation, implementation and execution of Phase I to IV clinical development programs in a variety of therapeutic areas, with extensive experience in Women's Health and Reproductive Endocrinology. Darlene holds a B.S. in Science and an M.S. in Biology.
Realizing the Promise of ePRO and Future Applications
Stephen Raymond, Founder, Chief Scientific and Quality Officer, PHT Corporation
Steve co-founded PHT Corp. in 1994 with the goal of improving clinical research by obtaining better information from the human subjects of clinical trials. Steve serves PHT in a multitude of capacities, including chief scientific officer, quality officer and visionary. Steve received his PhD from MIT in biology, where he taught electrical engineering. He practiced bench research in the neurophysiology of anesthesia at Brigham and Women's Hospital. Steve holds several patents for innovations used to capture health related data from patients.
Welcome and Opening Remarks - ePRO Days
Sheila Rocchio, Vice President, Marketing and Product Management, PHT Corporation
Sheila is responsible for global marketing and product management. Sheila joined PHT as a product manager more than seven years ago and is intimately familiar with all aspects of the PHT product suite. Prior to PHT, Sheila was a product manager for MicroStrategy and a consultant for American Management Systems. Sheila has a B.S. from MIT and an MBA from Boston College.
