About Kathy

Katherine (Kathy) Taylor is Head of Risk Evaluation & Adaptive Integrated Monitoring (REAIM). In her role she leads the implementation, delivery, and all aspects of Adaptive Integrated Monitoring (AIM), Global Clinical Trial Operation’s (GCTO) continuous improvement initiative to further the organization’s risk-based quality management (RBQM) through advanced analytics.

As the head of REAIM, Kathy champions cross-functional engagement and alignment on the AIM strategy and execution of AIM activities in clinical trials. This includes development of central monitoring plans (CMPs) and clinical data specifications aligned with critical data, process, and risk assessments. She ensures execution of central analytics and monitoring activities, including Quality Tolerance

Limit analysis, Key Risk Indicator analysis and Central Statistical Analytics to support identification of important study issues that require monitoring, management, and adaptation of study plans.

BACKGROUND:

Kathy has 25 years of experience managing the quality of clinical trial conduct and execution, strategic implementation of quality-by-design principles, building high-performing teams, database management expertise and leading all aspects of GCP health authority inspections. She is a sought-out industry speaker for optimizing inspection readiness and the exacting risk-based quality management methodologies.

Kathy is committed to creating a more diverse, equitable, and inclusive work environment. She is a member of the inaugural GCTO Diversity & Inclusion Council as well as Merck’s League of Employees of African Descent (LEAD), serving on the Group Mentoring Project Team.

Kathy holds a master’s degree in business administration (management) from Eastern University and a bachelor’s degree in natural science/biology from Indiana University of Pennsylvania.

About Blake:

Blake Jensen is VP, Clinical Development Quality at Adagio Therapeutics. He has 20 years of experience in quality and compliance, including prior experience as an Investigator with the US FDA. Blake has worked in both CROs and sponsor companies where he has been responsible for QMS development, quality risk management and quality governance, as well as traditional audit and CAPA programs.

About Cris:

Risk Based Quality Management Operational Business Lead:

• RBQM Solution Architects
• RBQM Process & Technology SMEs
• Data Surveillance Analyst Team

Subject Matter Expert:

• End to End Risk Management
• Centralized Data Monitoring
• Integrated RBQM / DCT Strategies
• Adaptive Data Driven Monitoring Strategies
• RBM Technology

19+ years Clinical Research Experience:

Expertise spans across multiple therapeutic areas and indications, medical devices, electronic databases, and statistical analysis platforms

About Amit:

Amit is responsible for leading the transformation of Alexion’s clinical development operations and Quantitative sciences (DOQS) which involves use of several cutting edge technology, analytics,  partnership programs with a variety of partners and process redesign with a goal to accelerate the execution of the portfolio, drive patient centricity into clinical development, unlock value of data& strengthen risk posture. Post-acquisition of Alexion by Astra Zeneca (AZ), he leads the post-day 1 integration activities for Clinical Development to harmonize and secure access to advanced AZ capabilities across technology, analytics, geographic footprint expansion and frameworks. In addition, he is the Digital lead for rare disease, where he is responsible for the development and execution of innovative digital efforts for heterogenous use cases in the rare disease.

Prior to joining Alexion, Amit was the head of Clinical Innovation and Product Development for 2 years at Saama Technologies where he led the build of AI-enabled analytics platform for Risk Based Monitoring, Operational and clinical analytcs with unique innovations such a virtual assistant for exploratory analysis, smart data query etc. The platform is used by 40+ customers in the bio-pharmaceutical industry. For his leadership and innovations he was awarded the PM360 “Elite” Disruptor award for 2020.

Amit was the Executive Director for Global head of Clinical Operations , Analytics, Patient Engagement/Recruitment and Analytics at Celgene for 4 years responsible for operational execution of the development portfolio across all the Celgene franchises and leveraging analytics and cutting-edge patient engagement/recruitment strategies and tactics to support the Celgene portfolio.

Prior to joining Celgene, Amit worked for Bristol-Myers Squibb (BMS) for 16 years in different clinical operations roles and regions including Asia-pacific. He has lead large multi disciplinary teams for successful regulatory filings (NDA and BLA in US and EU) teams in immunology and virology. In his last role at BMS, he was the head of the North American regional operations group at BMS where he was instrumental in introducing use of analytics in driving data driven decision making to improve operational performance.

Amit holds a Masters Degree in Neuropharmacology from Massachusetts College of Pharmacy in Boston, Masters in Pharmacognosy from University of Mumbai (India) and Bachelors in Pharmacy from University of Pune (India).

About Olivia:

Olivia began her career as a clinical research associate at a contract research organization prior to becoming a lead clinical research associate and then a project manager, overseeing the operations of clinical trials in multiple therapeutic areas. After several years in project management, Olivia transitioned to the risk-based monitoring space. She supported the start-up of RBM within the CRO, including process design, procedural document development, RBM platform support and performing central monitoring activities. In 2019, Olivia joined CSL Behring to lead the central monitoring group and the implementation of Risk Based Quality Management practices.

About Steve:

Steve Gilbert is a Statistician at Pfizer in Cambridge, MA.  He has worked in clinical trials since the late 1990’s, first in CROs and then in Pharma, supporting all phases of drug development in numerous therapeutic areas. Steve is a member of the Statistical Research and Innovation group, which provides statistical consulting and technical support across Pfizer.  Steve’s consulting includes the risk- based monitoring, clinical statistics and quality research.

He is externally engaged with multiple PHUSE groups related to QTLs and has previously served on TransCelerate QTL efforts. Steve is a member of the ASA, ENAR and DIA; he served on the DIA missing data working group and is a member of the DIA study endpoints committee. Steve holds a PhD in statistics and a Bachelor’s in Biology.

About Demetris:

Demetris started his career as a Laboratory Scientist and transitioned into the Clinical Development where he held roles of increasing responsibilities in Monitoring, Trial Management and Data Management.

He has led multiple Clinical Operations integrations resulting from mergers and acquisitions as well as technology, process and organizational re-engineering projects during his tenures at Schering Plough, Merck, Novartis and Pfizer.

Since 2017 Demetris leads Pfizer’s Data Sciences and Risk Based Monitoring functions in a transformation to an internal operating model across multiple geographies.

He currently serves on multiple Boards, including SCDM’s Advisory Board, has served on the Board of Trustees and was the 2016 Chair.

About Ken:

Ken Getz is the Executive Director and a professor at the Tufts Center for the Study of Drug Development, Tufts University School of Medicine, where he conducts grant-funded research on pharmaceutical R&D management and execution; protocol design optimization; contract service provider and investigative site management; e-clinical technology and data usage; and patient engagement.  He is the chairman of CISCRP – a nonprofit organization that he founded to educate and raise public and patient awareness of the clinical research enterprise.  A well-known speaker at conferences, symposia, universities, investor meetings and corporations, Ken has published extensively in peer-review journals, books and in the trade press and writes a bi-monthly column nominated for a Neal Award in Applied Clinical Trials. He holds a number of board appointments in the private and public sectors and serves on the editorial boards of Pharmaceutical Medicine and Therapeutic Innovation and Regulatory Science.  Ken received an MBA from the J.L. Kellogg Graduate School of Management at Northwestern University and a bachelor’s degree, Phi Beta Kappa, from Brandeis University.  He is the founder of CenterWatch, a leading publisher in the clinical trials industry, and one of several businesses that he has created and sold.