Faculty – 16th Clinical Performance Metrics & Analytics Summit

Sharon Brower, CQA
Director, Clinical Training, Process & Continuous Improvement, Global Clinical Operations, BRISTOL-MYERS SQUIBB

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Sharon Brower is a 25 year veteran of the BioPharma industry and has a bachelor’s in Philosophy and a Master’s in Linguistics from the University of Madrid. She is currently the Head of Clinical Training, Process & Continuous Improvement at Bristol-Myers Squibb based in Princeton, NJ. She was previously the Head of Training & Auditing at Roche and the Head of Training and Compliance at BioClinica. Sharon has spent 25 years developing and implementing programs to improve processes around Training, Auditing, Documentation, and Continuous Improvement. She is a frequent keynote speaker at industry conferences sharing her experiences with building effective document management systems, role-based training programs, and continuous improvement models which all aim to reduce audit findings, increase efficiency, and promote a proactive approach to dealing with issues as opposed to reactive “fire-fighting.”

Priya Chaturvedi, Ph.D.
Executive Director, Quality Assurance-Head Vaccines and ID, MERCK

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Priya Chaturvedi is the MRL Quality Assurance-Therapeutic Area (TA) Head for Infectious Diseases and Vaccines. In addition to her TA role, she has responsibility for Quality Assurance in Asia Pacific region. She joined Merck Pharmaceuticals in 2016. Prior to that, she was at Pfizer Pharmaceutical where most recently she was the Business Unit Quality Oversight Lead, responsible for compliance and quality oversight of medical affairs activities, and the clinical affairs portfolio. Prior to that, she was the Director of Compliance and Oversight and had responsibility for quality oversight of a large portfolio of clinical studies. Prior to joining Pfizer in 2010, Priya spent 12 years at GSK in different clinical, project management and discovery roles.

She received her doctorate from Temple University, School of Medicine, PA.

Kathryn M. Cole, RD, LDN
Director of Feasibility, PMG RESEARCH

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Kathy joined PMG Research in 1997 and is currently responsible for the network feasibility team at PMG Research. She has served in various roles within PMG inclusive of Clinical Trial Coordination, Site Management, Quality Assurance, Information Technology, and Business Development. Kathy has spent the last 14 years dedicated to PMG trial feasibility and precision trial placement. “Securing the right trials and enrolling patients are critical components to uphold PMG’s mission of bringing clinical research to as many lives as possible. I am very dedicated to using technology and data analytics in selecting appropriately matched trials for the patient communities we serve. I am equally as passionate about using data analysis to predict performance, reduce cost, and ultimately drive successful outcomes for our industry partners.”

Leesa Gentry
Senior Vice President, Global Clinical Operations and Program Management, EVOTEC (US), INC.

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Leesa Gentry’s career in R&D spans nearly 27 years. She has held nearly every role from Study Coordinator to Global Project Director working in clinical sites, CROs, pharma and biotech organizations. While at PPD, she managed one of the largest global phase 3b trials ever performed. While at Otsuka she successfully launched one of the first new treatments for TB in over 40 years. In her current role as Sr. VP at Evotec, she is tasked with building the organizations clinical development platform. Ms. Gentry holds master’s degrees in both Gerontology and Psychology from the University of Central Missouri and University of Mary-Hardin Baylor respectively.

David Hamilton
Associate Director, Clinical Development and Analytics, Strategy and Operations, NOVARTIS

Jennifer Hill
Associate Director, Clinical Operations, ENDO PHARMACEUTICALS

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Jenn earned her B.S. in Biology from Bucknell University. She has 18 years of clinical trial experience. Jenn began her career at CROs. In 2001, Jenn joined Kendle International as a Clinical Trial Support Specialist, and then moved to PPD as a CRA. After 5 years at CROs, she moved into a Clinical Scientist role at Wyeth. While at Wyeth, Jenn got therapeutic experience as a Clinical Scientist in CNS and Internal Medicine. While at Wyeth, Jenn moved into Clinical Operations as a Global Trial Leader. As a GTL, Jenn was responsible for managing global vendors and leading the regional study management team through the execution of global clinical trials. During her tenure at Wyeth, Wyeth was acquired by Pfizer where Jenn moved into the Associate Director position as a Clinical Project Manager in charge of overall trial execution and budget management in multiple therapeutic areas. She also had responsibility for leading multiple legacy studies through the transition to Pfizer’s new processes and SOPs. Following Pfizer, Jenn moved back to a Clinical Scientist role at Endo Pharmaceuticals in 2013-2014 before taking on another Clinical Operations Lead role at Paratek Pharmaceuticals responsible for the successful execution of a pivotal Phase III global clinical trial for a new antibiotic. In October, 2016, Jenn re-joined Endo Pharmaceuticals as an Associate Director in Clinical Operations before moving into her current role in Clinical Data Informatics and Analytics. At Endo, she has had the opportunity to make significant contribution to new processes and initiatives as well as successful execution of clinical trials.

In Jenn’s spare time, you can find her spending time with her husband of 12 years, Scott, and their 3 children, Isabelle (8), Madelyn (6), and Alexander (1).

Shameer Khader, Ph.D.
Senior Director, Advanced Analytics, Data Science and Bioinformatics, ASTRAZENECA

Tim Koch

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Tim Koch has spent the last 17 years working in Big Pharma including time at Johnson & Johnson, GlaxoSmithKline, and Novartis, with prior experience in the Financial Services Industry and the Hospital Setting. He is a Lean Six Sigma Black Belt who’s deepest passion is Analytics and Metrics but has a broad range of experience from Finance to IT to Quality Assurance to Resource & Risk Management. He is known as a domain expert in Clinical Trial Optimization via Data and Technology, supporting the operational delivery of thousands of Trials from feasibility/site selection to recruitment planning/tracking to instream monitoring, resource management and risk evaluation to leading health authority inspections. Tim has been an innovative pioneer, infusing an evidence-based analytical culture in countless areas of the business, building multiple Analytics units from the ground up and launching >30 industry-first analytics platforms to >20,000 users in Drug Development. In his current role as Global Head of Key Account Mgmt, he partners closely with the Trial Mgmt Leadership team providing consultation, solutions and know-how anchored around the use of data, analytics, processes and technology during Trial Delivery.

Chandi Kodthiwada
Director, Product Management, SAAMA TECHNOLOGIES

Kristine Koontz
Head of U.S. Clinical Operations, GSK

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Kristi Koontz brings over 20 years of global pharmaceutical experience in clinical development and medical affairs. Kristi has held a variety of roles including oncology delivery and medical affairs team leadership, establishing corporate academic and alliance partnerships, life cycle strategies, external engagement initiatives, and advocacy partnerships. Kristi is currently the Head of US Clinical Operations for GSK. She holds a BS in Biology from The Pennsylvania State University, an MBA from LaSalle University, and is currently in process of completing a PhD in Business Psychology from The Chicago School. She lives in Malvern, PA with her husband and two daughters, loves to travel, read, and spend any free time by the beach.

Sheri Kuss
Director, Clinical Quality Lead, PFIZER

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Sheri Kuss has over 25 years of clinical research experience in the industry working at pharmaceutical, medical device, CRO and biotechnology companies. Sheri’s vast range of expertise has developed from her roles within clinical trial monitoring, clinical trial management, operations, clinical quality assurance, compliance, training and continuous improvement. Sheri has a proven track record of establishing and delivering inspection readiness and regulatory compliance training tools and programs as a direct result of her experiences hosting and preparing for regulatory agency inspections. In the area of operational excellence, she demonstrated success in leading business process teams and improving upon existing quality management systems through continuous improvement initiatives. Sheri’s Sponsor and CRO experiences give her a unique quality insight and a practical approach to the risks and operational compliance issues related to the conduct of clinical trials and quality management systems.

Faye O’Brien
Director, Performance and Metrics, ASTRAZENECA

Jonathan Rowe, Ph.D., M.S., M.A.
Executive Director, Head of Clinical Development Quality Performance and Risk Management, PFIZER

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Jonathan Rowe has 20 years of experience supporting pharmaceutical companies in the development of medical therapies from the clinical, operational and business perspectives. Currently, Jonathan holds the position of Executive Director, Head of Clinical Development Quality Performance and Risk Management at Pfizer, where his responsibilities include monitoring, modeling and predicting the Pfizer GCP Quality Management System, leading the analysis of Pfizer’s Clinical Trial Quality Performance and ensuring clinical trial quality risk management is built into all trials. At Pfizer he has held a number of roles including Clinical Director, with responsibility for the Phase IIIb and IV Lipitor program; Director, Intellectual Property Strategy Management; and Senior Director of Process and Performance. Jonathan spent a number of years in “small pharma” as the Head of Intellectual Property and Portfolio Strategy for Amarin and Dignity Sciences. Jonathan earned his Ph.D. and M.S. at the Albert Einstein College of Medicine and his M.A. from Binghamton University.

Kristin Stallcup
Senior Director, Xcellerate Customer Success, COVANCE

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Kristin Stallcup brings 15 years of industry experience in various trial management capacities. Currently she serves as senior director responsible for implementation and adoption of the Xcellerate Informatics suite into business process. Previously she served in central monitoring as business lead for the development and implementation of Xcellerate Risk and Issue Management and was also responsible for providing clients with Covance Xcellerate Monitoring methodology and technology implementation. Kristin has held other industry positions ranging from clinical research associate to project director. Kristin received her MSHS in clinical research management from George Washington University, her BS in molecular biology from Vanderbilt University, and has Project Management Professional (PMP) certification.

Michele Teufel
Feasibility and Recruitment Partner, ASTRAZENECA

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I have spent the last 20 years working within Clinical Operations. In this time, I have delivered early and late phase clinical studies across various therapeutic areas. In these roles, I was responsible to ensure project standards and scientific requirements from study design concept through submission. Currently, I am leading Patient and Site Engagement across Clinical Operations within AstraZeneca. In this role I work with clinical development teams to gather patient and site input to our protocols prior to finalization. This work is allowing teams to directly hear the feedback and influencing changes to protocols.

Mayuri Trehan
Associate Director, CELGENE

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Mayuri is a Process Improvement and Change Management leader managing strategic initiatives and clinical development programs in the pharma/biotech industry for over 16 years. She has handled the launch of Key Performance Indicators (KPIs) and created an approach for the identification of Key Risk Indicators (KRI’s) to manage clinical trials more efficiently. She has led the Quality Management System (QMS) governance forum and has managed a PMO with oversight of a portfolio of process improvement projects. Mayuri is a certified Project Management Professional (PMP), Lean Six Sigma Black Belt and Organization Change Management leader. She volunteers for the Project Management Institute New Jersey Chapter (PMINJ) as the Process Excellence Lead. In addition, Mayuri is serving as a Mentor in the 2017 Healthcare Businesswomen’s Association (HBA) Mentoring Program.

Alec Vardy
Executive Director, Clinical Data Management, JAZZ PHARMACEUTICALS

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Alec has worked in the pharmaceutical industry for over 35 years. He entered the industry as a Biostatistician and made the switch to Data Management in 1998. For the last 15 years, Alec has been working in small to medium Biotechnology companies in the San Francisco Bay area in a variety of therapeutic areas and has been involved in several successful drug approvals. In small companies, with limited resource and seemingly ever-changing timelines, efficiency is critical, and Alec has always made infrastructure building an important component of his work during these last 15 years. At Jazz Pharmaceuticals, he is co-leader of Centralized Monitoring implementation, an activity from which his presentation arises.