Data Integrity for Clinical Research Summit -

Data Integrity for Clinical Research Summit
May 22 - 23, 2017
Morristown, NJ

The Data Integrity for Clinical Research Summit will showcase how to develop all standard procedures for information from inspection to completion

Faculty – Data Integrity for Clinical Research Summit

Angel Amaya
Senior Clinical Research Associate, NOVARTIS

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Angel Amaya is a Clinical Research Associate who works with investigational sites to conduct clinical trials in accordance to international guidelines, standard procedures and applicable regulations. With nine years of experience in the industry, Angel has worked in diverse areas including data management at INC Research, followed by pharmacovigilance and clinical monitoring at Novartis Pharmaceuticals. He holds a bachelor degree in biology from the National Autonomous University of Mexico (UNAM). Based on his previous experience, Angel is convinced that every effort to protect the integrity and reliability of the data is fundamental for ensuring the safety and well-being of the patients, our primary focus.

Raj Bandaru
Senior Director, Data Sciences Strategy, SANOFI

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Raj Bandaru is statistics and informatics professional with over two decades of experience spanning various data and analytics focused leadership roles in the pharma industry. He has applied traditional statistical modeling and more recently big data analytics and informatics approaches to a wide range of problems from biological research, clinical development and operations to commercial and marketing decision analytics resulting in over 50 peer reviewed publications and patents.

Raj is currently the global head of a data sciences and knowledge management practice at Sanofi Pharmaceuticals developing cloud based analytics platforms and data services for quantitative systems pharmacology, drug disease modeling and trial simulations. Prior to this he ran a clinical and RWE data analytics consulting practice for several years and was also the head of the translational informatics and clinical operations digital innovation at AstraZeneca.

Raj did his graduate training in statistics at Rutgers University NJ, as well as a Masters in Population Genetics and more recently an MBA in operations research from Babson college in Boston, MA where he lives and works currently.

Robert J. Boland
Associate Director, Emerging Science and Innovation Strategy, JOHNSON & JOHNSON

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As a member of the ESI Leadership Team, Robert is responsible for driving strategic initiatives, leading operational projects, managing the portfolio and measuring value creation for the Emerging Science and Innovation (ESI) function of Johnson & Johnson Consumer R&D. In addition, Robert leads ESI’s efforts to cultivate a culture of innovation and cutting-edge research across the Consumer R&D organization and in developing an upstream portfolio of early science that will help ensure the long-term sustainability and growth of the Johnson & Johnson Consumer business. As a member of the broader External Innovation Group, Robert is leading organizational business strategy across Digital Platforms, Digital Data, and Connected Products.

Robert originally joined Johnson & Johnson in 2012 as Senior Manager, External Innovation R&D IT and was responsible for Oversight, Direction, Development and Management of the US External Innovation Portfolio and Budget spanning the Neuroscience and Immunology TA’s, along with the improving J&J’s Clinical Trial Innovation capabilities, Internal IT and IT Informatics capabilities while scouting and accessing Open and Disruptive innovative solutions in key “white spaces”. Robert was also responsible for driving US Open and Pre-Competitive collaborations and consortia’s that supported organizational commitments to furthering R&D goals while building key business relationships and partnerships with IT peers, External Innovation Groups in TA’s and FA’s, Johnson & Johnson’s Innovation Centers, and working with Janssen Healthcare Innovation (JHI) to enable transformational and innovative solutions.

Before joining J&J, Robert was Head of Merck Research Laboratories (MRL) Technology Innovation Group leading an expert team that made significant contributions to designing and managing innovation programs that evaluated and applied cutting edge business models and information technology solutions to unmet MRL (Merck Research Laboratories) needs while leading and delivering low risk experimentation to high value targets across the enterprise.

Robert is an author, a recognized industry thought leader, and honors graduate, who currently holds an Executive MBA from the Lebow College of Business, Drexel University, and a BsC in Computing Technology, Drexel University College of Computer Science and Engineering along with Global Leadership Strategy from the Wharton School of Business, University of Pennsylvania. Robert is also a member of the Mack Institute for Innovation Management at the Wharton School and sits on the NSF’s Industry Advisory Board for the Center for Visual and Decision Informatics.

Nathalie Bourgouin, PMP
Director, SKILLPAD

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With more than 25 years of experience in pharmaceuticals and biotech in North America, Nathalie Bourgouin is a leader in compliance, quality and project management with a solid background in risk-based clinical quality assurance processes, training and auditing. She has planned and audited numerous sites and vendors as part of several global studies. At Skillpad, Nathalie leads the Compliance Consulting group with a focus on clinical trials and research compliance. She is the content expert of the new Premium Suite of Clinical Inspection Readiness e-Lessons supporting sponsors. Nathalie did her B.Sc. at McGill University and her M.Sc. at the University of Guelph and is a certified Project Management Professional (PMP).

Anna Capaldi
Quality Control Submission Lead Biosimilars, PFIZER

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Anna Capaldi is Director, Quality Control Submissions Team Lead for the Pfizer Biosimilars portfolio.  She has 25+ years  of experience in the pharmaceutical industry, including many years of delivering technology solutions to meet industry needs.  Anna has led business technology teams in global medical affairs and global medical communications.  She has also developed and directed global submission-readiness teams.  Anna received her B.A. in psychology and her Master of Science in pharmaceutical quality assurance and regulatory affairs from Temple University. She is a medical missionary with Flying Doctors of America and has participated directly in missions to bring professional healthcare to remote and underserved areas.

David Fryrear
Senior Director, Clinical and Pharmacovigilance QA, ABBVIE

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David W. Fryrear, Senior Director, Clinical and Pharmacovigilance QA, ABBVIE

David Fryrear is a Senior Director in Research and Development Quality Assurance at AbbVie. In this role, he is the global head of clinical, pharmacovigilance and regulatory affairs quality assurance and has responsibility for R&D documentation standards and Quality Knowledge Management. David leads a global team of quality assurance professionals who are responsible for the quality oversight; continuous improvement projects; and the conduct of risk-based compliance audits for regulated clinical development, patients safety and regulatory affairs activities. He has spent much of his career developing and improving quality systems, including those supporting product development, device and safety. At AbbVie, he and his team have been focused on the implementation of integrated, cross-GxP quality strategies; quality and business process ownership; and the advancement of AbbVie standards and systems across R&D for documentation, TMF, issue management and oversight processes.

Recently, he has been leading a talent development movement in AbbVie’s Regulatory, Quality and Safety (RQS) organization. David is passionate about developing quality professionals who are curious and understand what matters and why. He and his colleagues aim to deliver sustainable, innovative solutions for sponsor oversight that enable achieving the objectives of clinical research, getting important new therapies to patients faster. David is an advocate of Quality Knowledge Management and champions leveraging well-managed knowledge as an agility solution to the challenges that emerge in the complex and rapidly evolving state of biopharmaceutical R&D.

Prior to joining AbbVie in January of 2013, he had been at Eli Lilly for 23 years, the last 12 in leadership positions in quality assurance. David has a B.S. in chemistry from Centre College and an M.S. in pharmaceutical science from Butler University.

Paige Goodlove

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Paige has more than 17 years of experience in the pharmaceutical industry, both in operations and quality assurance. As a GMP quality professional, Paige had a variety of responsibilities in the quality control laboratory, including lab management, method validation, in process testing and test result release in support of manufacturing. With quality-related experiences under her belt, Paige led the management of global clinical trials in several phases of development and across multiple therapeutic areas. Additionally, as a Green Belt, Paige has used the Six Sigma methodology to advance/improve processes in manufacturing, clinical operations and quality.

Presently, as a GCP quality professional at Eli Lilly, Paige is responsible for the development and maintenance of global quality standards for safety, efficacy and data integrity. She holds a Bachelor of Science in biology and a Master of Science in microbiology from Southern Illinois University.

John Hannon
Global Business Lead, Automation and IT, COMMISSIONING AGENTS, INC.

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John Hannon is an Executive Consultant and Business Area Leader for Automation and IT at Commissioning Agents. With over 29 years in the pharmaceutical, IT, and process automation fields, he has been instrumental in starting up cutting-edge biotech facilities for companies such as Baxter, Monsanto, Amgen, Genentech, Wyeth, and Cook.

He has managed multi-million dollar projects and project teams across the US and Europe, and is responsible for delivering hundreds of high-profile, mission-critical projects for biotech, pharmaceutical, and medical device customers. Currently he leads CAI’s IT and Automation business area – responsible for the development of automation, MES, and other IT system projects within the international client base.

With a demonstrated knowledge of quality assurance and regulatory compliance across the pharmaceutical industry, Mr. Hannon has led national and international seminars with ISPE, contributed to several publications such as Pharmaceutical Technology, and has led speaking venues related to risk-based approaches to smarter integrated system delivery compliant to the FDA, USDA, and EU regulatory agencies. He is an active and sought-after consultant for complex IT and automation problems in the pharmaceutical industry.

Mr. Hannon holds a Bachelor of Science in Electrical Engineering from Georgia Tech, has completed studies at Harvard Business School, is a Certified Pharmaceutical Industry Professional and holds Professional Engineering certification in the state of North Carolina. Most recently he has worked with pharmacetical clients to resolve data integrity related regulatory citings.

Greg Koski, M.D., Ph.D.



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Greg Koski, Ph.D., M.D., is President and CEO of the Alliance for Clinical Research Excellence and Safety (ACRES).  He currently serves on the Board of Directors for SAFE-BioPharma Association and is a Senior Scientist at the James Mongan Institute for Health Policy.  Greg is an Associate Professor of Anesthesia, Harvard Medical School and Honorary Anesthetist, Massachusetts General Hospital.  He is an internationally recognized leader in clinical research, advocating a systemic approach to transforming the infrastructure and ecosystem for conducting clinical research globally.

As the first Director of the Office of Human Research Protections at the U.S. Department of Health and Human Services (OHRP), Dr. Koski championed a “culture of conscience” in human research, emphasizing the values and processes of professionalism and quality improvement, moving beyond mere regulatory compliance.  Aware of growing globalization of clinical research, he created the Program of International Activities within the OHRP.

Greg has been influential in many efforts to enhance human subjects research, including the development of accreditation for human research protections programs and certification of physician investigators, including consulting with the World Health Organization (WHO) to coordinate and strengthen global mechanisms for ethical conduct of human research and engaging with the World Medical Association to clarifying the intent and applicability of the Declaration of Helsinki regarding the use of placebos in clinical trials.

Today, he leads ACRES public interest efforts to build a shared, open global system for clinical research to benefit all stakeholders by aligning ethical principles with good business, scientific and medical practices while accelerating the development of medicines.

Bodo Lutz
Global Clinical Quality Assurance, Compliance and Data Integrity Officer, NOVARTIS

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Dr. Bodo Lutz is a trained environmental engineer and biologist by education. He received his Ph.D. from the Technical University of Munich, Germany.

Dr. Lutz is an assigned GCP/GcLP Data Integrity Officer for clinical development and as Clinical Quality Risk Manager is responsible for the audit program as part of the vendor and investigational site management process and for the internal self-inspection program related to the development of biopharmaceutical products within the global clinical Quality Assurance department.

Prior to this he held several positions in clinical quality assurance and management at CROs and biotech, medical device and pharmaceutical companies where he also conducted audits on internal processes and at service providers and investigational sites, and he provided consultancy to improve the cooperation of business partners in clinical research.

Before joining the pharmaceutical industry he worked in several scientific programs — e.g., HIV-infection and AIDS therapies improvements and human cancer research — and performed experimental studies to investigate degradation processes of genetically modified DNA and protein after ingestion.

Debra Mayo, PharmD, MHA
Vice President, Global Scientific Communications, TEVA

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Debra holds a Bachelor of Science degree in Pharmacy from Temple University and a Master of Science degree, with a concentration in Health Care Administration and Health Care Education, from Saint Joseph’s University in Philadelphia. She completed her Pharm D at the University of Florida.

In her current role as Vice – President of Global Scientific Communications at Teva, Debra leads the medical communications and knowledge management groups. She oversees the strategic planning and execution of the Scientific Communications Plans and guides the management of a Global Knowledge Management System. Last year the scope of internal and external communications was expanded in the Sci Comm group to bridge identified information gaps through the use of digital communication channels. Patient centric activities, managed through Medical Affairs became a profound responsibility also.  Debra has held a variety of other roles in Medical Affairs over the years, including a very well-rounded experience working for a medical communication agency.

James Myers
Executive Director Quality Assurance and Compliance, IONIS PHARMACEUTICALS

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James Myers has accumulated more than 25 years of experience in clinical research and quality assurance. His experience has been with large pharma, biotech and CROs. He currently heads a GCP/GLP quality assurance department at a small firm, where he is responsible for the development, implementation and administration of clinical QA policies and systems to ensure that trials are conducted and data is generated, documented and reported in compliance with internal standards, GCP/GLP and applicable regulatory requirements.

Irene Pak
Associate Director, Disease Area Information Science, BRISTOL-MYERS SQUIBB

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Irene has 15 years of pharmaceutical industry experience in delivering innovative and practical digital solutions that offer a competitive edge in the utilization of data as an asset to address critical business needs. Her areas of technical domain expertise include information science in translational research, automated data curation workflows, data and visual analytics, and big/complex data integration and transformation. Her areas of scientific domain expertise include vaccine design, immuno-oncology, and clinical biomarker data.

Molly Rodgers
Senior Immuno-Oncology Data Lead, BRISTOL-MYERS SQUIBB

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Molly began her BMS career as a Research Scientist in the Applied Genomics department. After six years at BMS as a bench scientist, Molly moved to the Worldwide Clinical Data Management organization at Merck, spending the next six years at Merck as a Data Management Specialist. In this role Molly supported the data management operations for all phases of clinical trials. Molly then spent two years at Sanofi-Aventis as a project planner responsible for all OPX2 clinical trial timeline planning and management. Molly returned to BMS as a Protocol Data Manager (PDM) in March 2010 and was promoted to Senior PDM in December 2012. She accepted the positon of Data Lead (DL) in May 2014. Since returning to BMS, Molly has supported the data operations for the immuno-oncology portfolio. In this role, Molly is responsible for overseeing all aspects of data management from CRF design, data collection/cleaning to database lock. Molly has experience in operationalizing the data review strategy at both a compound and study level ensuring data currency, completeness, quality and integrity across all phases of oncology studies from phase 1 to late phase, including expanded access protocols and investigator-sponsored research trials.

Molly currently holds a leadership position on Bristol-Myers Squibb’s Data Quality Operations Forum which strives to ensure that BMS’ data review and cleaning tools contribute to the goal of delivering high-quality data for use in analyses, CSRs and submissions to the health authorities.

Leslie Sam
Director, Global Quality Systems, Safety, Efficacy and Customer Information, ELI LILLY AND COMPANY

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For more than 20 years, Leslie has held a number of positions in drug and device clinical research, including roles ranging from in-house CRA, clinical project management, clinical quality and Six Sigma Black Belt. Currently, she is the Director of Global Quality Systems for Safety and Efficacy Information at Eli Lilly and Company, where she leads a team of quality assurance professionals who are responsible for the design, development and maintenance of global quality standards. Leslie is also a member of the planning committee for the annual Drug Information Association (DIA) meeting, and an active member in both Linking Leaders Clinical Quality Roundtable Network and TransCelerate BioPharma, Inc initiatives.

Shrinivas Savale

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Shrinivas S. Savale, Ph.D., is a consultant with 20 years of professional experience in drug research and development in pharmaceutical organizations, CRO set-ups, and academia. He offers consultancy services in the areas of early clinical development, including bioequivalence for small molecules (conventional and NDDS) and biosimilars/biologicals; GxP compliance, including data integrity, regulated bioanalysis, biopharmaceutics and CRO qualification; and electronic solutions deployment for the automation of bioanalytical/clinical laboratory workflows (LIMS, SDMS)/clinical workflow (Phase I/BA-BE) to pharmaceutical organizations and CROs.

He is also associated with Gannet Pharma Solutions as Principal Consultant. He worked with Torrent Pharmaceuticals Ltd. as General Manager–Bio-Evaluation with operational responsibility of BA/BE studies for ANDAs and Phase I studies; Clinigene International Ltd. as Head-Bioanalytical Research; and Torrent Research Center as Scientist-II at Medicinal Chemistry Division. He received his Ph.D. in Pharmaceutical Sciences from the Gujarat University (Ahmedabad).

Currently he is a member of Clinical PK-PD subcommittee of Biosimilars Focus Group (BSFG), AAPS, and also served on its steering committee. He was the Founding Chairperson, Regulated Bioanalysis–APA India and is an active member of its organizing committee. He served as a member of the steering committee for Global Bioanalysis Consortium (GBC) on the harmonization of bioanalytical guidance (via APA-India) representing the Asia-Pacific region. Dr. Savale has been a Reviewer for various scientific journals and an invited speaker at various international conferences. He has 19 publications, a book chapter and many presentations at various scientific conferences.

Ana Sharma, MPH
Global Head, Strategy and Operations for Clinical Development Quality, NOVARTIS

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Ana Sharma is the Global Head, Strategy and Operations for Clinical Development Quality at Novartis. In this role, Ana is responsible for driving the vision and implementation of organizational strategy for activities such as culture change initiatives, operational excellence, project level oversight and end-to-end risk management for clinical quality.

Ana has 13 years of experience in quality. She recently held positions such as Global Head, Pharmacovigilance Quality Assurance; Global Head, Clinical Quality Operations and Systems; and Global Head, Clinical Quality Assurance Auditing.

Ana has a Bachelor of Science degree in biology and a Master of Public Health degree in epidemiology and biostatistics. Her personal and career interests are ensuring global public health.

Barbara Skinn
Operations Portfolio Lead, Global Clinical Operations, BRISTOL-MYERS SQUIBB

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Barbara began her tenure with Bristol-Myers Squibb (BMS) as Manager, Scientific Operations, in 2006, where she managed Oncology Investigator Sponsored Research (ISR) conducted by various networks throughout the USA. In July 2010, Barbara was promoted to Director, Collaborative Science Center of Excellence (CSCoE). She oversaw clinical trial management teams in five therapeutic areas (immunoscience, virology, cardiovascular, metabolics and neuroscience) to ensure effective and timely conduct of ISR around the globe. Barbara assumed the role of Operations Portfolio Lead in Immuno-Oncology in April 2015. She now oversees BMS sponsored studies, health economics and outcomes research (HEOR) and expanded access within her assigned oncology portfolio.

Barbara is a Registered Nurse, and has held a variety of nursing and research positions both in Canada and the USA. Barbara has CRO, imaging core lab and pharmaceutical research experience. In addition, Barbara has directed patient care and clinical trial services in cancer centers within academic and community settings. She has worked as a nurse educator and has been an instructor in oncology nursing and pain management at community colleges/universities.

Sameer Thapar, PharmD
Assistant Professor and Advisor, Drug Safety and Pharmacovigilance, RUTGERS UNIVERSITY

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Dr. Sameer Thapar holds a doctorate of pharmacy, is Oracle Health Science Consulting’s Director of Global Pharmacovigilance, and is on faculty as Assistant Professor for the Drug Safety and Pharmacovigilance track of the Master in Clinical Trial Sciences program at Rutgers University. Dr. Thapar has 18 years of experience in operations within the pharmaceutical, biotech and CRO industries, with cross-functional experience in medical affairs, clinical operations, quality assurance and subject matter expertise in pharmacovigilance operations and compliance.  He has built global departments and defended in successful FDA, MHRA and EMA health authority inspections.  He is an active advisor in several US-based life science industry conferences and participates as an invited speaker and panelist in global industry conferences.

Kerrick Wilson
Quality Assurance Manager, GLAXOSMITHKLINE

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Kerrick Wilson works at GlaxoSmithKline (GSK) as a manager in their strategic resource partners quality assurance group. Kerrick has been working at GSK for 17 years and is based in Research Triangle Park, NC. Kerrick has mainly worked with GSK partners and suppliers over the past 10 years through managing supplier relationships as well as audit planning. Over the past two years, Kerrick has taken on the responsibility of overseeing the training of GSK’s Global Quality Assurance auditors on data integrity. While Kerrick has primarily focused on GCP in the past, with data integrity training he has involved all the GXPs.

Allan Wilson, M.D., Ph.D.

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Allan Wilson, M.D., Ph.D., was Full Professor and Head of the Section of Addiction Psychiatry at the University of Ottawa for more than 25 years. He co-founded IMC in 2002, and is now fully devoted to the study of medication compliance. Allan has worked as a consultant in the healthcare field for public and private sectors, and his research interests lie in clinical pharmacology, biotechnology and large data systems. He is an internationally known researcher in the field of addiction medicine, and has published more than 100 academic papers in the areas of pharmacology and clinical outcome research.

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