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Marina Malikova, Ph.D., MSci, MA, C.C.R.A., RAC, has over 15 years of experience in the clinical research field, with 8
years’ experience on executive level. She has managed Phase I – IV studies
involving investigational drugs, devices, biologics and combination products. She has worked on Industry-sponsored and Investigator-initiated trials in the
fields of Surgery, Cancer Diagnostics and Interventional Radiology. Dr.
Malikova graduated from the Institute of Biochemistry, Russian Academy of
Science, in Moscow, Russia with a PhD in Biochemistry. She has a strong
background in biomedical sciences and has completed her postdoctoral fellowship
in the field of cell signaling and cell migration. She also holds a Master’s
Degree in Clinical Investigation, Certification in Project Management from
Boston University and dual board certified in Regulatory Affairs (RAC) for
pharmaceutical products and medical devices by Regulatory Affairs Professionals
Society (RAPS). She also holds professional certification in Clinical Safety
and Pharmacovigilance by Drug Information Association (DIA). |
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Julie Martin, Advanced Master in ICT Law, DPO, has a legal
background and specializes in Information and Communication Technology (ICT)
law. She has expert knowledge in Data Protection law, especially regarding
General Data Protection Regulation (GDPR). She is DPO certified from Maastricht
University in the Netherlands. She is also interested in Artificial Intelligence,
and won second place at the Digital Law Moot Court 2018 organized by Paris-Sud
University. She received an Advanced Master’s degree in Information and
Communication Technology (ICT) Law from the University of Namur in Belgium and
also received a Master’s in Law degree from the Catholic University of
Louvain-la-Neuve in Belgium. |
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Shelia
Russell McCullers, M.S., D.M., is a Quality Assurance Manager with 30 years of
scientific experience including quality assurance, regulatory compliance,
clinical research, auditing, biotechnology quality control, safety monitoring,
biomedical diagnostic testing and training. Dr. McCullers has conducted audits
and hosted several successful inspections including internal inspections, EMA,
CLIA and FDA. While serving in the military, she researched toxins that were
potential biological weapons, and she was a member of the Human Use Committee
in support of clinical trials at the United States Army Medical Research
Institute of Infectious Diseases (USAMRIID). She has conducted research on the
health effects and trends of tobacco use for NCI. As a Clinical Research
Information Specialist, she prepared IND Annual Reports for submission to the
FDA on behalf of the NCI. While researching sepsis, Dr. McCullers discovered a
novel antibody to an adhesion molecule. She has completed training in Quality
Assurance, GMP, GLP, GDP and GCP including the Protection of Human Research
Subjects courses. While working as a Quality Manager, Dr. McCullers maintained
a Key Performance Indicator score of greater than 90% for each quarter, and she
submitted Medical Incident Reports, health department notifications, deviations
and CAPAs with 100% on-time delivery. |
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Anne McDonough, M.P.H., C.C.R.A., M.I.C.R., C.Sci., has over 16 years of experience in a variety of roles in clinical research. Ms. McDonough started her career working in investigational sites for HIV trials, spent over 10 years working in the American and European divisions of an international CRO, and is currently a freelance clinical research consultant based in London providing monitoring, project management, clinical science, medical writing, and training services. She has broad international experience in a full range of clinical trials (Phases I to IV, pharmaceuticals, biotechnology products, diagnostics, devices, and vaccines) and in a variety of therapeutic areas. She also currently serves on the exam committee for the CCRA exam (Association of Clinical Research Professionals) and is past chair of the European exam committee. |
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Denis R. Miller, M.D., earned his AB and MD degrees at Cornell
University and completed his post-doctoral training at Children’s Hospital,
Boston and Harvard Medical School. He has over 25 years of experience in
academic medicine in pediatric hematology/oncology at Cornell, Memorial Sloan
Kettering Cancer Center, and Northwestern University. Most of his clinical and
laboratory research focused on hematologic malignances. He was a long-standing
member and Vice Chairman of Children’s Cancer Group, a past president of the
American Society of Pediatric Hematology/Oncology, and the Scientific Director
of the Cancer Treatment Research Foundation. He has published over 300
peer-reviewed articles, chapters, books, and abstracts and was on the editorial
boards of the British Journal of Hematology and American Journal of Clinical
Oncology. Deny has 17 years of experience in industry and has worked for Roche,
Aventis, and J&J PRD as well as at multiple CROs. |
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Linda Miller, M.D., has more than 20
years of experience in industry where she worked with Organon and Eisai as
Director of Clinical Development, with Clinsys as VP of Clinical Development
and Chief Scientific Officer, and PPD as Executive Director for Global Product
Development. She served as Editorial Coordinator for the classic textbook,
Blood Disease in Infants and Children. Dr. Miller received her MS and MD
degrees from Rutgers University and completed her residency in pediatrics at
New York Hospital-Cornell Medical Center. Her primary area of research and many
of her publications are the design and conduct of new agent studies and early
phase drug development.
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Jarrard Mitchell, M.B.A., CQA, is a Certified Quality Auditor (CQA) and serves as a Quality Assurance Manager and operational leader with over 15 years of Pharmaceutical and Clinical Research Organization (CRO) experience. He has global audit experience and broad therapeutic indications including but not limited to: HIV, MRSA, Organ Transplantation, Oncology, Ebola, various medical devices, and Drugs of Abuse trials. He has regulatory inspection experience with both the FDA and EMA. He is an expert in leading process improvement activities and Corrective Action and Preventive Action (CAPA) investigations. Mr. Mitchell is well versed on complex clinical trial regulations and guidelines of the Food and Drug Administration (FDA), Good Laboratory Practice (GLP), Good Manufacturing Practice (GMP), International Conference on Harmonisation (ICH), Good Clinical Practice (GCP), Human Subject Protection (HSP), European Medicines Agency (EMA), College of American Pathologists (CAP), and Clinical Laboratory Improvements Amendments (CLIA). Mr. Mitchell has an established record of identifying potential noncompliance and formulating practical solutions. He has proven success in developing QA programs with performance improvements that proactively increase quality and compliance. |
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Kirsten Morasco brings over seventeen years of life sciences industry experience to her clients. She began her career in the pharmaceutical industry where she led teams that brought new products to market, managed global projects, and implemented training for new and existing employees. As a consultant, she has assisted her clients with change, process improvement, and meeting compliance standards and requirements. She is skilled in managing global process improvement/harmonization engagements dedicated to developing and implementing management solutions that enhance the speed and efficiency of clients’ processes and enable the implementation of these processes among employees. In particular, Ms. Morasco has developed document management processes for companies implementing a document management system in a compliance environment; developed managed, and implemented controlled documents, including Standard Operating Procedures (SOPs) and Business Practices to ensure compliance with federal and state regulations; developed and delivered instructor-led training for pharmaceutical staff with regards to clinical trial procedures and monitoring; developed and conducted instructor-led Standard Operating Procedures training for pharmaceutical staff; developed educational materials and seminars for the marketing department and administrative staff of a pharmaceutical company; and worked with instructional designers to ensure development and delivery of instructor-led SOP training for a large pharmaceutical company. |
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Jeanne Morris B.S. MT (ASCP), is an ASQ Certified Manager of Quality/Organizational Excellence. Ms. Morris provides GMP, GCP, GPvP, and QMS expertise to the pharmaceutical and medical device industries. She has over 20 years of experience in regulated industry, including 15 years with the United States Food and Drug Administration. Her expertise includes risk assessment and mitigation, regulatory readiness support and mock inspections, process improvement project management, and procedure review and training. Prior to consulting, Ms. Morris held varied leadership positions at Takeda Global Research and Development, Inc., most recently as Director GxP Compliance, where she ensured drug development activities were conducted in compliance with regulations, guidance, and standards. While working for the FDA, Ms. Morris conducted over 300 inspections in the United States and internationally. She was a member of FDA’s national training cadre, and recipient of the prestigious FDA Commissioner’s Award of Merit. |