2nd Disclosure and Transparency for Clinical Data Summit - Philadelphia, PA

2nd Disclosure and Transparency for Clinical Data Summit
August 13 - 14, 2018
Philadelphia, PA
Philadelphia, PA

Balance Your Commercial Values and Ethical Responsibilities Through the Vigilant Execution of National and Global Data Transparency

Faculty – 2nd Disclosure and Transparency for Clinical Data Summit


Carmen E. Aldinger, Ph.D., MPH, PMP
Administrative and Training Manager, MULTI-REGIONAL CLINICAL TRIALS CENTER OF BRIGHAM AND WOMEN’S HOSPITAL AND HARVARD

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Carmen Aldinger, Ph.D., MPH, joined the Multi-Regional Clinical Trials (MRCT) Center of Brigham and Women’s Hospital and Harvard in October 2014 as Program Manager. She provides oversight for the Return of Aggregate Results, Return of Individual Results, and Post-Trial Responsibilities projects as well as manages MRCT Center training projects and small scale surveys and other operational and procedural aspects of the MRCT Center.

Dr. Aldinger has almost 20 years of experience in global health, including project management and leadership, materials development and capacity building, monitoring and evaluation, collaboration and coordination. Prior to coming to the MRCT Center, she worked as Project Director and Associate Center Director at Education Development Center’s Division of Health and Human Development, Global Programs, and as independent consultant for United Nations agencies.

Dr. Aldinger has a Ph.D. in educational studies from Lesley University, a Master of Public Health in international health from Yale University and a bachelor’s degree in health education from Towson University.


Behtash Bahador
Senior Manager, Quality and Compliance, CISCRP

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Behtash Bahador, Senior Manager, Quality and Compliance, Communicating Trial Results, CENTER FOR INFORMATION & STUDY ON CLINICAL RESEARCH PARTICIPATION (CISCRP)

Behtash Bahador is a Senior Manager at the non-profit Center for Information and Study on Clinical Research Participation (CISCRP). With a background in health communication, Behtash leads quality and compliance assurance on programs that communicate clinical trial results in plain language for patients and the public. He works directly with a wide range of industry sponsors on global implementation and aligning best practices in health communication with regulatory and industry guidelines.


Kristen Bolt
Research Data Management Consultant, BOSTON CHILDREN’S HOSPITAL

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Kristen Bolt is a data management expert with over 15 years of experience working with academic researchers, research administrators, and data contributors. As the former Program Manager for the Multi-Regional Clinical Trials Center she participated in and supported the design of a global clinical trial data sharing platform that will facilitate data sharing and transparency. In her previous positions at Harvard University and Harvard Medical School she designed a process and web application for sharing research metadata across multiple research administration stakeholders; thereby easing the organizational burden and accelerating the approval process for investigators. Her experience includes writing university and department policies to evaluate data sensitivity, data collection practices, and data management plans that also comply with state and federal regulations. She is also the Co-Chair of the Emerging Technologies, Ethics and Research subcommittee of the Harvard Clinical and Translational Science Award.

Kristen is a graduate of Harvard University.


Karla Childers
Senior Director, Strategic Projects, JOHNSON & JOHNSON

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Karla Childers joined Johnson & Johnson in October 2013 in the Office of the Chief Medical Officer where her primary responsibility has been leading the support and coordination of Johnson & Johnson’s Clinical Trial Data Transparency Initiative, including the management of the Yale Open Data Access (YODA) Project collaboration. In this role, she has been active in advocacy efforts supporting the implementation of responsible data sharing, including consultations with various health authorities and engagement with relevant stakeholder groups. Ms. Childers is also responsible for the management and conduct of the J&J Bioethics Committee, which serves as a forum to obtain guidance on bioethical questions within J&J.

Before joining J&J, she was an Associate Director in Global Project Management (GPM) in Merck Research Laboratories (MRL) for four years, where she managed cross-functional drug development teams in various therapeutic areas and stages of development. Prior to joining GPM, Ms. Childers was a bench chemist in MRL’s Process Chemistry group where she developed and executed multi-kilogram syntheses of advanced intermediates and active pharmaceutical ingredients (API). She also spent two years supporting outsourcing efforts in Process Chemistry and managed projects and partner relationships with contract research organizations in China, India, Europe and North America.

She received her Bachelor of Arts Degree in Chemistry from Indiana University-Purdue University in Indianapolis and a Master of Science in Jurisprudence (MSJ) with a concentration in Health Law from Seton Hall Law School.


Yolanda Davis
Quality Assurance Manager — Clinical Trial Disclosure, UNIVERSITY OF MIAMI

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Yolanda Davis currently oversees the Clinical Trial Disclosure (CTD) program under the umbrella of the Office of Research Compliance and Quality Assurance for the University of Miami. This includes providing oversight of Clinical Trial Disclosure activities, supporting research teams in their goal of achieving compliance with the various regulations and requirements associated with CTD and the development and presentation of educational programs to the University’s research community. Ms. Davis’ career includes serving in the capacity of a Clinical Research Associate (Monitor), Data Manager, and Project Manager for Pharmaceutical Companies and Contract Research Organizations. Ms. Davis specializes in the development of business processes and systems that mobilize organizations, while also creating implementation strategies that focus on strengthening quality infrastructures in support of the process changes and providing organizations with the ability to achieve operational excellence. Ms. Davis maintains memberships with the Clinical Trial Registration and Result Reporting National Taskforce, DIA, and SOCRA.


Stephen Doogan
Chief Product Officer, REAL LIFE SCIENCES

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Stephen Doogan has over 10 years of experience designing and developing natural language processing and machine learning healthcare technologies in the life sciences sector. He has developed and managed several patient data analytics applications from concept to commercialization, securing multiple enterprise software engagements with major pharmaceutical organizations. In his current role at Real Life Sciences, Stephen has overseen the development and deployment of ARARA and RLytics software platform used by 12 of the top 20 pharmaceutical companies and has supported over 60 engagements in data anonymization, clinical trial disclosure, clinical and outcomes research


Sulochana Gawande, Ph.D.
Head of Submission Writing and Director of Publications, EISAI

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Sulochana Gawande, Head of Oncology Medical Writing, EISAI

Sulochana (Sulu) Gawande’s academic background is in clinical cancer research, having done her MS and Ph.D. work in characterization of human leukemia and lymphoma cells. Her career in oncology drug development started at Eli Lilly & Company in 1999. There Sulu gained understanding of oncology publication and submission documents. She established and managed teams of medical writers both in the US and India. Later as a Clinical Research Scientist (Lilly), she successfully partnered with the clinical lead physician to build a program to test a new Lilly compound for the treatment of colorectal cancer.

As a submission management and regulatory lead in Novartis Oncology (2008-2013), Sulu submitted and gained approval of INDs, led many interactions with the FDA and Health Authorities, and guided teams in the preparation of various regulatory documents including the DSUR, IBs, responses to deficiency or clinical hold, etc. Additionally, she supervised large teams of medical writers in India and the U.S., managed the disclosure process for Novartis oncology studies, and contributed to the strategy and review of commercial and regulatory documents.

Since May 2013, Sulu has been the Head of Oncology Medical Writing and an executive reviewer for all oncology publications at Eisai. She has supervised three regulatory submissions and working on the fourth one. Sulu is also leading the ct.gov and EudraCT disclosure team and the data transparency process. With her passion for oncology and her experience in clinical, regulatory, and scientific communications, she continues to improve the quality of submission documents and the disclosure process at Eisai.


Julie Holtzople
Clinical Trial Transparency Operations Director, ASTRAZENECA

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Julie Holtzople is the Clinical Trial Transparency Operations Director at AstraZeneca. Julie is responsible for developing and implementing the processes, standards, systems and tools to ensure all AstraZeneca Clinical Trial Transparency policies and standards are fully realized. Currently, Julie is spending a lot of time working on clinical data and document anonymization to support legislation such as EMA Policy 0070. Prior to working at AstraZeneca, Julie spent almost a decade working as a consultant for Ernst & Young and Booz Allen Hamilton. Julie is a graduate of Virginia Tech.


Francine Lane
VP, Global Transparency, TRIALSCOPE

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Francine Lane is the Vice President of Global Transparency at TrialScope. In this role, Lane is responsible for helping TrialScope customers meet and exceed current disclosure expectations globally, giving them the tools they need to meet all the requirements in this evolving industry. Lane also dedicates her time building relationships with external stakeholders – including sponsors, investigators, regulators, and transparency and patient advocates – to help align the goals and expectations of these groups, as well as help identify more consistent ways sponsors can meet industry standards. Prior to her role as Vice President of Global Transparency, Lane served as Director of Product Management at TrialScope.


Stephen Morehouse
Life Sciences Expert, PA CONSULTING GROUP

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Stephen Morehouse has 25 years of expertise in pharmaceuticals, biotech, and diagnostics and has a strong focus on helping clients innovate across their R&D business operations. One key area of focus is working with clients to improve understanding of regulation and improving operations to remain compliant through deployment of technology solutions. Stephen has specific expertise in regulatory policy, Policy 0070, GDPR, clinical operations, clinical data, and health authority submissions.


Oladayo Oyelola, Ph.D.
Director, Clinical Trial Information Disclosure, DAIICHI SANKYO

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Dr. Oladayo Oyelola is Director of Clinical Trial Information Disclosure at Daiichi-Sankyo, Inc. He coordinates and is accountable for corporate strategy and operations of global clinical trial information disclosure and data sharing activities including internal training, process improvements and clinical trial transparency regulatory policy intelligence. He has also served in the same capacity at Sanofi Pasteur Inc., the Vaccine Division of Sanofi and as Head of the Clinical Medical Writing Group, leading regulatory writing activities on clinical projects and clinical study teams for novel vaccine and pharmaceutical products for the US, EU and other international regulatory submissions and marketing approvals.

Dr. Oyelola holds a B.S. in Biochemistry, M.S. in Applied (Nutrition) Chemistry, and Ph.D. in Clinical Chemistry along with professional certifications of the National Registry of Certified Chemists and the American Society for Clinical Pathologists.

He is a recipient of The Rockefeller Foundation Special Postdoctoral Fellowship Award and the National Mentor Role Model Award/Citation of the Minority Access Inc/Office of Minority Health, National Institutes of Health.

He has over 30 years’ experience in clinical and pharmaceutical research and development activities, including years of college undergraduate and graduate teaching and biomedical research. He is a member of the American Association for Clinical Chemists, the American Society for Clinical Pathology, and the Drug Information Association.


Robert A Paarlberg
Principal, PAARLBERG & ASSOCIATES LLC

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Robert Paarlberg is the Principal of Paarlberg & Associates LLC, a consultancy founded in 2010 which specializes in US and EU clinical trial disclosure strategy and operations as well as regulatory policy and intelligence. Bob has more than 35 years of pharmaceutical industry experience with the vast majority of his experience in US and international regulatory affairs.

Prior to founding Paarlberg & Associates LLC, Bob created and directed global regulatory policy and intelligence functions at UCB and Pharmacia (Upjohn). Bob has been actively involved with clinical trial disclosure since 2005 when he was responsible for implementing UCB’s clinical trial disclosure processes. He also established Upjohn’s FDA liaison office in Washington, DC and worked closely with the Government Affairs team on key federal legislative issues.

Bob is the former Chair of DIA’s Clinical Trial Disclosure Community (2013 – 2018). He is also a founding member of the Washington Regulatory Liaison Group.

Bob is a member of Alliance for a Stronger FDA, DIA’s Clinical Trial Disclosure Community, RAPS, and an Advisory Board member of RegLink Associates. Bob is a frequent speaker at conferences on clinical trial disclosure and transparency. He received a M.S. in Analytical Chemistry from Purdue University.

Bob has co-authored two papers in the Drug Information Journal: “FDAAA Basic Results Reporting: First Experience and Challenges” (May 2011) and “Outcome Measures in Study Registries: The Need for a Consistent Approach” (April 2012).


Liz Roberts
Senior Director, Global Lead Transparency and Data Sharing, UCB

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Liz is Senior Director, Global Lead, Transparency and Data Sharing at UCB. She relocated from the U.K. to the U.S. in 2009 and is currently based in Maryland. She is responsible for establishing the strategic framework, guiding principles, and corporate policies that inform transparency and responsible data sharing. In addition, she is responsible for aligning best practices that will enable current and future global disclosure requirements including Global Clinical Trial Registration & Results Disclosure, Clinical Data Sharing, Lay Summaries, and other Transparency-related activities. Liz represents UCB on the TransCelerate workstream for Clinical Data Transparency and is also involved with sharing data for secondary research via ClinicalStudyDataRequest.com (CSDR). Prior to this role in Transparency, Liz had more than 20 years’ experience working as a statistician in the pharmaceutical industry and has an M.Sc. in Applied Statistics.


Nathaniel Root, MSA
Associate Director, Clinical Disclosure and Transparency, IONIS PHARMACEUTICALS, INC.

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Nate received his Bachelor of Science in Biochemistry from the University of Michigan and a Master of Science Administration in research from Central Michigan University. He performed research at the University of Michigan and then merged into medical writing at MMS Holdings, a CRO. While at MMS Holdings, Nate discovered the world of clinical disclosure and helped to develop and grow the disclosure department. After MMS, Nate spent a brief time in study management for the Alliance of Clinical Trials in Oncology before landing back in the disclosure world at Takeda. Since then, Nate has moved to the West Coast to develop and lead the disclosure and transparency initiatives at Ionis Pharmaceuticals where he now resides.


Olivia Shopshear
Senior Director, PHRMA

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Olivia Shopshear is a Senior Director of Science and Regulatory Advocacy at the Pharmaceutical Research and Manufacturers of America (PhRMA). Olivia has extensive multi-disciplinary program management and policy experience in the biopharmaceutical and biodefense industries, ranging from pre-clinical product development to commercial tech transfer to global supply chain management. She currently leads PhRMA’s clinical trial data transparency and quality/manufacturing advocacy programs.


Annadoir Staveleyl
Associate Director of Clinical Trial Disclosure and Transparency, Ethics and Compliance, OTSUKA AMERICA PHARMACEUTICAL, INC.

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Anna Staveley is a compliance professional with 14 years of experience. Nine of those years are in the Pharmaceutical and Biotechnology industries, where she continues to provide internal customers with advice on ethical business practices and strategic insight on navigating new areas of risk within highly regulated industries. She specializes in cross-functional process and system implementation to comply with new regulations. Currently, she is optimizing Otsuka’s global clinical transparency & data sharing group.


Bryan Stefanski
Compliance Director, SIEMENS HEALTHCARE

Asba Tasneem, Ph.D.
Informatics Project Leader, DUKE CLINICAL RESEARCH INSTITUTE

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Dr. Tasneem is a Clinical Research Informatics Leader at Duke Clinical Research Institute where she manages DCRI’s data sharing program, Supporting Open Access for Research (SOAR). Under this program, DCRI has collaborations with Bristol-Myers Squibb, SAS, and American Heart Association (AHA). Dr. Tasneem joined DCRI in 2010 to develop an Aggregate Analysis Dataset of ClinicalTrials.gov (AACT Database). One of her manuscripts about this project was showcased at the American Medical Informatics Association Spring Summit, calling it “one of the top 25 papers in the field of clinical research informatics.” From 2014 to 2018, Dr. Tasneem worked at the Office of Research Informatics, Duke University School of Medicine, where she managed a 22-site clinical data research network with patient population of 50 million.

Prior to joining Duke, Dr. Tasneem was a Bioinformatics Scientist at the National Library of Medicine (NLM/NIH) where she developed conserved domain models for identified superfamilies using genome sequence analysis and structure-sequence comparisons. Her experience in private sector includes working at Strategy& as a Biomedical Informatics subject matter expert. Her academic research included tracking large-scale evolutionary trends in Ligand Gated Ion Channels and discovering nicotinic acetylcholine receptors homologs in bacteria.


Laura Troast
Director, Clinical Data Disclosure and Transparency, MERCK

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Laura Troast is Director of Clinical Trial Registration and Results Disclosure in the Clinical Data Disclosure and Transparency department at Merck & Co., Inc. Over the past ten years, Laura has overseen activities surrounding the registration and disclosure of results for Merck studies on ClinicalTrials.gov, EudraCT and ENCePP. Her concentration is in leveraging data integrity technical solutions in balance with the Microsoft Office suite of applications. She holds a B.S. in Biochemistry & Molecular Biology from Penn State University and an M.S. in Regulatory Affairs for Drugs, Biologics, and Medical Devices from Northeastern University.


Lauryn Uribe, B.S., MBA
Manager, Disclosure and Transparency, GILEAD

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Lauryn Uribe is an Manager at Gilead Sciences in the Disclosures & Transparency group. Along with another colleague, she coordinates and leads all clinical trial disclosures activities including registration and results submissions, process and standards development, and training. She has approximately five years of experience in disclosures and transparency and over 12 years of experience in the biopharmaceutical industry. Using her MBA, she has streamlined processes, created efficiencies, and helped in developing an entirely in-house process that works.


Thomas Wicks
Chief Strategy Officer, TRIALSCOPE

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Thomas is responsible for the product strategy of PharmaCM, TrialScope’s Clinical Trial Transparency Solution, which was acquired from Deloitte. He has more than 19 years of experience with performance and content management solutions, specializing in applications for life sciences such as clinical trial disclosure, structured product labeling, and submissions management and has been a been on the PharmaCM team since 2007.

Prior to its acquisition of PharmaCM by TrialScope, Thomas served as the General Manager of PharmaCM at Deloitte and the Director of PharmaCM Product Management at Intrasphere Technologies before that. Before to joining Intrasphere, Thomas worked in leadership, client-facing positions for Revelwood Inc. and Shepherd Systems, focused on performance management solutions.


Julie Wood
Director of Strategy and Operations, VIVLI

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Julie Wood was previously at the Cochrane Collaboration, where she was the Head of Communications and External Affairs for the past three years.

During her time at Cochrane, she developed the team that focused on communications, media, dissemination, translations, strategic partnerships, branding and events, and fundraising. Wood was instrumental in the delivery of Cochrane’s re-brand, where she coordinated and launched the first-ever Global Evidence Summit.

Prior to joining Vivli, she spent a year working for a Microsoft partner and more than 12 years at Oxfam Great Britain, the development agency. Her final role at Oxfam GB was as the Director of Corporate Communications.


Mohamad Zahreddine
CIO, TRIALASSURE

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