Faculty – The 2nd Data Integrity & Protection 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.

Kristen Bolt

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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.

Bhaswat Chakraborty
Senior VP and Chair, Research and Development, CADILA PHARMACEUTICALS

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Dr. Bhaswat Chakraborty, a Pharmacologist by training from Canada, has been the Senior VP and Chair, R&D Core Committee of Cadila Pharmaceuticals, India for more than last 12 years. Prior to that, he was the Director of Biopharmaceutics, Biovail CRO, Toronto for 4 years. In these two roles, he has led and directed >800 bioequivalence and clinical trials. Before joining the private sector, Dr. Chakraborty has been the Senior Efficacy & Safety Reviewer and acting head of a division with Therapeutic Products Directorate (Canadian FDA) for eight years wherein he has reviewed ~300 ANDAs and ~20 NDAs.

Dr. Chakraborty is an honorary Professor at a few universities in India and abroad. He has supervised about 24 Masters and five Ph.D. students. He is also on the editorial board of several refereed international journals. He has also served as the chairman of the Pharma and healthcare sector of Confederation of Indian industries, Gujarat chapter for two years.

Sigrid Guhr
GMP QA Qualification and Validation, ABBVIE

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Sigrid Guhr leads GMP QA Qualification & Validation (EU) for equipment, facilities, utilities and computerized systems. Mathematician, more than 30 years of experience in the pharmaceutical industry, started as a programmer, worked as a validation consultant, then as validation manager for computerized systems used by pharmacovigilance. Activities include validation, qualification, compilation of quality management systems for the software life cycle, vendor audits, risk analysis, concepts for data integrity assurance.

Oliver Herrmann

Daniel Hickmore
VP of Health and Life Sciences, ARKIVUM

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A life scientist who has spent the last twenty years in the health and life sciences technology sectors. Daniel is VP of Health and Life Sciences for Arkivum running the European and American life sciences divisions for Arkivum. Daniel leads a dedicated and talented team who support both public sector and private sector customers. Daniel’s role is to help unlock the potential of our solutions, enabling them to deliver tangible benefits. Daniel is committed to working with Arkivum customers to achieve radical changes in the way data is managed, and at the same time reduce cost, through the adoption of transformational approaches to long-term data lifecycle management. Daniel is a technology and industry strategic visionary successfully bringing both together for the development of new disruptive industry solutions and is a resourceful technology visionary that successfully builds and leads teams to allow businesses to manage technology with technology.

Bernice Kuca

James Mann
Head Data Integrity Programme Management, NOVARTIS

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James is a leader with broad industry experience in pharmaceuticals, biologicals, Advanced Therapy Medicinal Products development, technical operations, quality and strategy. He has worked for GSK companies for 11 years, then with Novartis companies 14 years.

He has gained significant international experience working across the Americas, European, Asian and Pacific regions. That experience includes heading a range of change management programmes to implement strategy, achieve operational excellence, improve quality/culture, and outsourced/vendor relationship management.

James currently leads a global quality improvement program in the Novartis Drug Development & Country Organisation teams. It focuses on the clinical and patient safety environments and advancing effective applications of digital technologies.

Patricia Pengelly
Associate Director Clinical QA, ABBVIE

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Patricia is currently an Associate Director Clinical Quality Assurance at AbbVie Ltd, where she has managerial responsibility for a team of EU-based clinical QA auditors. As a member of the Clinical QA Leadership Team, she is responsible for contributing to the development of the overall clinical QA strategy, while taking a lead for the EU region. Responsibilities include preparing for and supporting key EU inspections (including MHRA) as well as supporting the implementation of new regulations/guidance in the EU region. Prior to joining AbbVie, Patricia was a GCP/GPvP Operations Manager at the MHRA managing a team of GCP and GPvP inspectors. Key responsibilities included developing GCP and GPvP inspection strategy, supporting EMA inspection-related activities and recruitment and development of new inspectors. As a Senior Pharmacovigilance and GCP inspector, Patricia also performed more than 100 GPvP inspections in the UK and overseas as well as commercial and non-commercial sponsor GCP inspections.

Eldin Rammell

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Eldin began his records management career in 1986 at Glaxo. He held a variety of information and records management positions of increasing seniority, which continued following his move to Pfizer in 1993. His experience spans most areas of information and records management, including: DMSs and ERMS/EDMSs; file plans and retention schedules; classification schemes and taxonomies; microfilming; disaster recovery; data protection; imaging and workflow solutions; mergers and acquisitions; litigation support; change management; archive and active file management. In 2004, Eldin established Rammell Consulting, a management consultancy specialising in the provision of expert records management support, primarily to the pharmaceutical and biotech industries. He has worked with several companies on the development and implementation of eTMF systems and supporting processes.

Elke Ufer
Quality Manager Compliance, Clinical Operations (GI-DD-CO), GRÜNENTHAL GMBH

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In 1995, Elke began her career in clinical research and initially specialized in medical devices. Working in the Clinical Research Organization environment and subsequently in industry, Elke held positions including monitoring, project and quality management. Elke has established standard operation procedure processes, has set-up monitoring groups and subsequently led them. As a Quality Assurance Specialist, she became an industry representative to EUCOMED and was actively involved in 2009 in the review of ISO 14155. After joining Grünenthal, 6 years ago, Elke has supported drug development teams in quality related activities; including audit and inspection preparation, conduct and CAPA processes, as well as review of validation processes and process documentation of GCP IT systems.