PITTSBURGH, PA – Feb. 3, 2012–– invivodata inc. ^®, the industry leader in reliable electronic solutions and strategic consulting services for successful Clinical Outcome Assessment (COA) data collection in global clinical research, today announced that it’s co-founder and chief science officer, Dr.Saul Shiffman, has been recognized by the Carnegie Science Center as an honorable mention in the Entrepreneur Category of its 2012 Carnegie Science Awards.

“Carnegie Science Awards recognize and promote outstanding science and technology achievements in westernPennsylvania,” said Ann Metzger, Co-Director of Carnegie Science Center.  “We are pleased to add Dr. Shiffman to a distinguished list of 300 individuals and organizations that have been honored since 1997 for improving lives through their commitment and contributions in science and technology.”

Dr. Shiffman is being recognized for his ground-breaking research in the scientific methods and processes that drive patient behavior to produce valid and reliable data and for his development of the first handheld computer solution for collecting patient data during clinical research, which are the foundation of today’s electronic Patient Reported Outcomes (ePRO) industry.

”Working with Saul and watching his concepts for real-time, real-world data collection through ePRO become so widely adopted has been exhilarating,” said Doug Engfer, invivodata President and CEO. “We founded invivodata to further develop the commercial applications of this technology and are extremely gratified by the positive effect it continues to have on the clinical research industry.”

“I am proud to have been recognized by this award. Helping develop PRO science in clinical trials has been a rewarding endeavor, and having the work recognized in this manner is both gratifying and humbling. This honor also reinforces our belief in the importance of keeping clinical research focused on the patient, which is our top priority,” said Dr. Shiffman.

About invivodata
invivodata is the only fully-integrated Clinical Outcomes Assessments (COA) company delivering regulatory-proven strategic consulting and practical electronic solutions to biopharmaceutical companies who depend upon patient-centered research.  From reliable and scientifically sound consulting that helps research teams effectively develop, execute, and document COA  strategies to electronically collecting COA data in global clinical development programs, invivodata helps its customers strategically use patient-, clinician-, and observer-reported outcomes data (PROs, ClinROs & ObsROs) to support labeling claims, enhance reimbursement strategies, and meet other clinical program objectives. Through partnerships with leading CROs and eClinical technology providers, invivodata seamlessly integrates into the clinical trial ecosystem, helping to minimize operational risk and maximize efficiencies.  invivodata’s electronic solutions and strategic consulting services have been used in over 600 clinical programs and are built upon the industry-leading ePRO system in delivering primary efficacy data for global drug approvals.  invivodata inc. is a privately held company with global headquarters in Pittsburgh, PA., USA; its European headquarters is in London, England; and its technology development center is in ScottsValley, CA., USA.  For more information, visit www.invivodata.com.

PITTSBURGH, PA – Jan. 17, 2012–– invivodata inc.® the industry leader in reliable electronic solutions and strategic consulting services for successful Outcome Assessment (OA) data collection in global clinical research, has provided updated information on PROficiency™ 2012:  PROs and Beyond, its 5^th annual conference on the collection of patient perspective in clinical research.  The conference is being held April 17-19, 2012 in Naples, FL.  Updated conference information, including a complete program agenda and expanded list of international speakers can be found at http://www.invivodata.com/proficiency-2012/proficiency-2012-agenda.

By attending PROficiency 2012, clinical researchers will have access to current, critical information on the regulations and practical considerations of selecting, implementing, and justifying all OAs to ensure they are fit for purpose and appropriate for their context of use.  With a combination of general assemblies and sessions following tracks pertaining to the use of OAs in both Phase 2/3 and late stage research, attendees can customize the conference to suit their needs and specific interests.

“We’ve designed the conference agenda to address the many questions clinical researchers have about recent regulatory changes pertaining to selecting, evaluating, and providing evidence to support endpoints for their clinical development programs,” said Dr.Jean Paty, invivodata Co-founder and Chief Scientist and Regulatory Advisor. “We are thrilled to have these discussions led by a faculty comprised of knowledgeable, international biopharmaceutical developers and researchers with specific experience and insight to the Food and Drug Administration (FDA) and European Medicines Agency (EMA).”

Joining scientists from invivodata and its regulatory consulting division, PRO Consulting^®,  the faculty for PROficiency is comprised of international biopharmaceutical and industry experts, including:

-Olivier Chassany, MD, PhD, Medical Head of the Department of Clinical Research and Development, Assistance Publique – Hôpitaux de Paris

-John H. Powers III, MD FACP FIDSA, Associate Clinical Professor of Medicine at the George Washington University School of Medicine and former 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

-Maria Diviney, Principal Data Manager, Global Data Science, Astellas Pharma Europe B.V.

-Michael Hufford, Ph.D., Chief Operating Officer, NeuroCog Trials

-Sean Stanton, Co-Founder & Owner, Compass Research, LLC

“Our objective is for attendees to walk away from the conference with knowledge of the scientific and regulatory considerations of capturing patient perspective in clinical development,” saidBob Young, invivodata Chief Operating Officer.  “We are confident that the practical topics being presented will provide attendees with valuable information that can be used day-to-day in their clinical research, whether their key stakeholder is a regulatory body or a reimbursement organization.”

invivodata is offering 30% off registration fees for attendees who register before February 13, 2012.  For additional information and to register for PROficiency 2012, please visit http://www.invivodata.com/proficiency-2012.

About invivodata

invivodata is the only fully-integrated Outcomes Assessments (OA) organization delivering regulatory-proven strategic consulting and practical electronic solutions to biopharmaceutical companies who depend upon patient-centered research.  From reliable and scientifically sound consulting that helps research teams effectively develop, execute, and document OA  strategies to electronically collecting OA data in global clinical development programs, invivodata helps its customers strategically use patient-, clinician-, and observer-reported data to support labeling claims, enhance reimbursement strategies, and meet other clinical program objectives. Through partnerships with leading CROs and eClinical technology providers, invivodata seamlessly integrates into the clinical trial ecosystem, helping to minimize operational risk and maximize efficiencies.  invivodata’s electronic solutions and strategic consulting services have been used in over 600 clinical programs and are built upon the industry-leading ePRO system in delivering primary efficacy data for global drug approvals.  invivodata inc. is a privately held company with global headquarters in Pittsburgh, PA., USA; its European headquarters is in London, England; and its technology development center is in ScottsValley, CA., USA.  For more information, visit www.invivodata.com.

January 25, 2012 @ 11:00 -12:30 PM ET

Presented by:

- Laurie Burke, MPH,RPh Director for Study Endpoints and Labeling, Office of New Drugs, CDER, FDA

- Ethan Basch, M.D., M.Sc.,  Associate Attending Physician, Department of Medicine Associate Outcomes Research Scientist, Department of Epidemiology and Biostatistics, Health Outcomes Memorial Sloan-Kettering Cancer Center

- Jennifer Petrillo, PhD, PRO Expert, Novartis Pharmaceuticals

Moderated by:

Chad Gwaltney, PhD, Senior Scientist PRO Consulting

Description:

Comparing the safety and efficacy of new medical products to existing products can yield important information for all stakeholders in the healthcare industry. Patient-reported outcomes (PROs) may be used to assess the relative safety and tolerability of active treatments in comparative studies. This presentation, delivered through the Drug Information Association (DIA) will outline methodological and regulatory considerations when using PROs in this manner and describe applied examples.

For more information and to register, click here:  http://www.diahome.org/DIAHome/Education/FindEducationalOffering.aspx?pr

Friday, December 16, 2011 @ 11:00 AM Eastern

Presenter: 

Arthur Stone, Ph.D., Distinguished Professor and Vice Chairman of the Psychiatry Department and Director of the Applied Behavioral Medicine Research Institute at Stony Brook University and Chairman of invivodata’s Scientific, Clinical and Regulatory Advisory Panel

Description:

This webinar will review the rationale for trial participants recording assessments of their treatment-related experiences on a daily basis and what the clinical concerns are regarding the use of paper diaries. Dr. Stone will present information from his pivotal research on subject compliance with paper and electronic diaries, in which he conclusively demonstrates a significant degree of subject hoarding with paper diaries (British Medical Journal, 2002).   He will then provide an update on the clinical development community’s reaction to these findings and how researchers are now approaching the collection of patient data in their efforts to evaluate the efficacy of new medical treatments.

Register now!

Presenters:

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

Jean Paty, Ph.D., Founder and Senior Vice President, Scientific, Quality and Regulatory Affairs, invivodata, inc.

Description:

On October 19, FDA conducted a public workshop to discuss measurement principles for Clinical Outcome Assessments (COAs) used in clinical trials for new drugs. COAs include patient-reported outcome (PRO) measures, clinician-reported outcome (ClinRO) measures, and observer reported outcome (ObsRO) measures. The workshop outlined FDA’s expectations for the development and qualification  to establish that COAs are fit for purpose and appropriate for their context of use.

In this webinar, former FDA official Dr. John Powers and invivodata/PRO Consulting’s Dr. Jean Paty will review the key take-aways from the FDA workshop and discuss the implications to researchers using COAs in new medical product development.  Specific focus on choice and development of different types of outcomes will be reviewed, including the importance of content validity, reliability, construct validity and other measurement properties for all types of outcomes that are strategic to product development.

Register now!

• invivodata and PRO Consulting’s Dr. Jean Paty will co-facilitate the workshop “Mixing Modes of Patient-Reported Outcomes Data Collection in Clinical Trials:  ISPOR PRO Good Research Practice Task Force Report.”

• PRO Consulting’s Dr. Chad Gwaltney will co-facilitate the workshop “Establishing the Content Validity of Patient-Reported Outcome (PRO) Instruments.”

The series drew representatives from over 80 biopharmaceutical companies, ranging from small biotech organizations to 9 of the world’s top 10 pharmaceutical companies.  Attendees participated in case studies and presentations by international biopharmaceutical professionals and industry experts sharing real-world experience with successful PRO concepts, strategy, implementation, and regulatory submission.  Upon completing one of the conferences, an International Payer Strategy Leader at Genentech commented “Very knowledgeable speakers and lots of valuable information on PRO development and implementation relevant to those in clinical development roles.”

“We’re extremely pleased with the outcome of this series,” said Dr. Jean Paty, invivodata Co-founder and Chief Scientist and Regulatory Advisor of PRO Consulting. “Our intent was to provide a forum for researchers to network and learn from leading PRO experts, advance their knowledge of the scientific and regulatory considerations of capturing the patients’ perspective in clinical development, and receive practical input that they could use day-to-day in their clinical research.”

Post-conference surveys indicated that 96% of attendees said the knowledge gained from the meeting would make them more effective in their job.  After participating in the series, an Associate Clinical Program Director from Astellas Pharma Europe remarked, “Great meeting!  Very informative, good discussions, some new insights gained…truly back to the patient!”

invivodata’s fall conference series was an extension of PROficiency 2011 – its ongoing educational initiative focused on PROs in clinical research.  To download replays of recently held programs and for information on upcoming PROficiency educational events, visit www.invivodata.com/eweb.

About invivodata

invivodata is the only fully-integrated PRO Solutions Organization delivering regulatory-proven strategic consulting and practical ePRO solutions to biopharmaceutical companies who depend upon patient-centered research.  From crafting PRO measurement strategy to collecting PRO data electronically, invivodata helps its customers strategically use patient reported data to support labeling claims, enhance market access, and meet other clinical program objectives. Through partnerships with leading CROs and eClinical technology providers, invivodata seamlessly integrates into the clinical trial ecosystem, helping to minimize operational risk and maximize efficiencies.  invivodata’s solutions have been used in over 350 clinical programs and are built upon the industry-leading ePRO system in delivering primary efficacy data for global drug approvals.  invivodata inc. is a privately held company with global headquarters in Pittsburgh, PA., USA; its European headquarters is in London, England; and its technology development center is in Scotts Valley, CA., USA.  For more information, visit www.invivodata.com.

About PRO Consulting

PRO Consulting, a division of invivodata, inc., provides consulting services to help clinical research teams effectively develop, execute, and document patient reported outcome (PRO) strategies to support their clinical research objectives. The PRO Consulting team has worked on over 150 clinical studies in 50+ indications, has more than 265 years of cumulative experience in psychometrics, PRO study design, and migrating and validating electronic solutions to collect PRO data, and has extensive experience working with the FDA and other regulatory bodies.

Occurring throughout Europe and the US, this series of 1-day educational events is designed to provide current, practical information on the effective use of Patient Reported Outcomes (PRO) throughout all stages of clinical research.

The PROficiency 2011 Regional Conference Series will feature general sessions led by international biopharmaceutical professionals and industry experts, sharing their knowledge and experience with successful PRO concepts, strategy, implementation, and regulatory submission.

The Basel conference will be hosted on Thursday, 13 October, the day after the DIA Clinical Forum ends at the Hotel Euler, right beside the train station.

PRO Consulting’s Dr. Brian Tiplady will present “Web-based ePRO: Validation, equivalence, and data quality”