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.
With more than 24 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 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 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.
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.
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.
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.
Shrinivas S. Savale, Ph.D., is a consultant with twenty years of professional experience in drug research and development in pharmaceutical organization, CRO set-up 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, CRO qualification and electronic solutions deployment for 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 Steering Committee for Global Bioanalysis Consortium (GBC) on harmonization of bioanalytical guidance (via APA-India) representing Asia-Pacific region. Dr. Savale has been a Reviewer for various scientific journals and an invited speaker at various international conferences. He has nineteen publications, a book chapter and many presentations at various scientific conferences.
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 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.
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., 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.