Doug Engfer is Co-Founder, President and CEO for invivodata, inc. where he is responsible for setting and overseeing the organizational strategy to meet the needs of invivodata’s global clients. Mr. Engfer has more than 25 years of professional experience in the computer industry, with an emphasis on building and growing productive organizations that expand their customers’ top-line revenue. Immediately prior to founding invivodata, Mr. Engfer was Founder and President of The Windward Group, a software development services firm noted for the development of the Palm® connected organizer, FedEx® Ship™ desktop shipping software and Apple’s QuickTime® and QuickTime for Windows multimedia software. Doug earned his B.A. degrees in U.S. History and Classical Latin from the University of California, Davis.

Saul Shiffman, Ph.D., is Co-Founder and Chief Science Officer for invivodata, inc. where he is responsible for advising on the scientific aspects of product development and delivery. Over the past 20 years, he has repeatedly been recognized for defining the concepts for real-time, real-world collection of PRO data – which led to the development of electronic patient diaries – as they are known today.
 
Dr. Shiffman is professor of psychology (clinical and health psychology), psychiatry and pharmaceutical sciences at the University of Pittsburgh, has served on various scientific panels for the National Institutes of Health, and he has served as a consultant to the pharmaceutical industry and a site investigator for more than a decade. He has authored or co-authored over 325 published papers on a variety of topics related to psychopharmacology, substance abuse, dependence, relapse, coping, and computerized assessments of behavior, and has presented widely in medical and scientific forums. 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 a Consultant to the pharmaceutical industry and a site investigator for over a decade. In 2007, Dr. Shiffman was awarded a Lifetime Achievement Award by Good Clinical Practice Journal for these contributions. Dr. Shiffman earned his Ph.D. from UCLA.

• Read Dr. Shiffman’s feature article in Applied Clinical Trials, “Two Decades of Change for PROs: How patient-reported data collection has been transformed since in 1987”
• Read Dr. Shiffman’s article in Applied Clinical Trials, “Increasing Study Sensitivity Early in Trials”
• Purchase Dr. Shiffman’s book “The Science of Real-Time Data Capture: Self-Reports in Health Research” (co-authored with Arthur Stone, Audie Atienza & Linda Nebeling)

Jean Paty, Ph.D., is Co-Founder and Chief Scientist and Regulatory Officer for invivodata, inc. where he is responsible for working with scientific, technical and clinical operations components of the company to ensure that all aspects of the business meet FDA and international data standards for the pharmaceutical industry.
 
Dr. Paty has published extensively on the regulations guiding development and implementation of ePRO. He has worked with industry and regulatory agency groups on ePRO best practices, and he has collaborated with invivodata Co-founder Dr. Saul Shiffman since 1990 on the development of real-time, real-world solutions to study patient experience. Dr. Paty earned his B.S. in Psychology from the University of Toronto and an M.S. and Ph.D. in Psychology from the University of Pittsburgh.

• Read Dr. Paty’s article from Applied Clinical Trials, “Give the Patient a Clear Voice” (February 2012)
• Read Dr. Paty’s Closing Thought in Applied Clinical Trials, “The Patient Matters: Thanks FDA”  (February 2011)
• Read Dr. Paty’s article from Applied Clinical Trials, “Measurement is Strategic” (October 2010)

Access recordings of Jean’s webinars:

Is Your PRO Instrument Ready for Regulatory Inspection?
Interpreting Regulatory Feedback on PRO Instruments: Now What?

Bob Young is Chief Operating Officer for invivodata, inc. where he is responsible for global operations and global sales, marketing, and alliances. Bob has more than 20 years of experience managing business development, product development, customer service, and QC functions for a variety of software, hardware and networking companies.
 
Prior to joining invivodata, Mr. Young held senior management positions with Axtive Software Corporation, Answersoft, Cardinal Technologies and Novell – where he led the marketing efforts that helped grow his division from $700 million in revenues to more than $900 million in just two years. Mr. Young earned his B.S. in Business Development from California State University, Chico and his M.B.A. from Brigham Young University.

Gary Mitcheltree brings over 20 years of senior financial management experience to invivodata. He has a proven record of successfully guiding high-growth technology companies from the earliest stages through introduction to public markets. His background includes raising private equity funding, acquisitions, and expansion into international markets.
 
Prior to joining invivodata, Mr. Mitcheltree was the Vice President of Finance for Pepperweed Consulting, a national provider of IT management services. Prior to that, he served as the Chief Financial Officer for Carnegie Learning and ECI Telecom, DND Inc. where he guided the financial operations for venture backed high-growth technology environments helping to raise over $100M in private equity and was a key contributor to a $90M acquisition of Laurel Networks by ECI Telecom. He earned a B.S. degree in accounting from the Indiana University of Pennsylvania.

Rebecca Baker is Vice President of global alliances for invivodata, inc. where she is responsible for the company’s global business partnerships including CROs, technology and medical device companies. Ms. Baker has nearly 20 years of experience in the medical/pharmaceutical industry including in-clinic as well as drug and software business development experience.
 
Prior to joining invivodata, Ms. Baker worked for a variety of large and small healthcare related companies including Oracle, where, as part of Oracle’s Life Science group, she expanded sales of their flagship product, Oracle Clinical. Rebecca earned her Biology/Life Science degree from Cornell University.

Jon McClelland is Senior Vice President of Products for invivodata, inc. where he is responsible for leading the Product Development and Product Management teams in the implementation and delivery of invivodata’s ePRO solutions. He has more than 15 years of experience in managing and executing software development projects.
 
Prior to joining invivodata, Mr. McClelland was the Senior Project Manager for The Windward Group, where he managed the software product development for numerous clients, including FedEx, Palm Computing, Hewlett Packard and Phone.com. He earned a B.A. degree in electrical engineering at Northwestern University.

As Vice President of Customer Experience for invivodata, Jason Eger is responsible for the overall satisfaction of invivodata’s global customers, including all aspects of invivodata’s eSolutions and Consulting. In this capacity, he oversees the development and ongoing progress of the invivodata “Customer Experience” program and drives all functional areas to support the communication and resolution of issues to invivodata’s customers. Mr. Eger’s experience in project management and consulting dates back to 2000, including significant experience with the delivery of invivodata’s field- and site-based eCOA solutions. He earned his M.B.A. from the Penn State University.

Arthur Stone, Ph.D., serves as Chairman, Scientific, Clinical and Regulatory Advisory Panel. He also is Board Professor and Vice Chairman of the Psychiatry Department and Director of the Applied Behavioral Medicine Research Institute at the State University of New York (SUNY) at Stony Brook.
 
Dr. Stone previously served as President of the Academy of Behavioral Medicine Research. He is an Editorial Board Member of numerous scientific journals and a former Editor-in-Chief of the Annals of Behavioral Medicine and of Health Psychology – the premier journal in its field. Dr. Stone has served on several National Institutes of Mental Health review panels and he currently is Chairman of the RPHB-3 review panel of the National Institutes of Health.

• Purchase Dr. Stone’s book “The Science of Real-Time Data Capture: Self-Reports in Health Research” (co-authored with Saul Shiffman, Audie Atienza & Linda Nebeling)
• Read the groundbreaking research that proved the value of ePRO over patient diaries in Dr Stone’s “Patient non-compliance with paper diaries”, published in the British Medical Journal (May 2002)

Wolfgang Summa, Ph.D., is Vice President of Worldwide Operations for invivodata, inc. where he is responsible for managing the successful implementation of invivodata’s ePRO solutions in clinical trials around the world. He rejoins the company after having previously served as vice president of Europe and Asia, leading the European operational and business development team and driving the expansion of patient diary solutions in the European and Asian markets.
 
Dr. Summa brings more than 15 years of Clinical Research experience to invivodata’s growing worldwide operations team. He has significant experience in the operational management of new eClinical technologies and their resulting process changes, including electronic data capture, ePRO, and eLearning solutions. Additionally, he is currently serving his second term on the Clinical Data Interchange Standards Consortium (CDISC) European Coordinating Committee. He previously held positions as executive Vice President for Europe & Asia/Pacific based at OmniComm Systems’ facility in Bonn, Germany and Vice President of Global Operations and Managing Director in Europe for DATATRAK International. Dr. Summa earned his MSc, Ph.D. in cell biology from Rheinische Friedrich-Wilhelms-Universität Bonn.