Faculty – Central Monitoring Summit


Joanne Benedict, M.Sc.
Senior Advisor, ROCHE

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Joanne Benedict is a Senior Advisor in Roche Genentech’s Process, Training, and Systems group. She develops business strategies, processes, and systems which support continuous improvement and innovation in clinical trials. Specializing in operations, technology, and process optimization, she is also experienced with change management including training programs which maximize embedding of new business processes.


Lisa Berdan, PA, MHS
Executive Director, Global Megatrials, DUKE CLINICAL RESEARCH INSTITUTE

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Ms. Berdan is the Senior Director of Global Cardiovascular Outcomes trials at the Duke Clinical Research Institute in Durham NC. She has been involved in global cardiovascular outcomes trials for over 20 years and has successfully developed an industry-recognized business unit of over 90 clinical operations professionals dedicated to these large international programs. These trials are pivotal phase 3 or phase 4 trials in patients with diagnoses such as ACS, atrial fibrillation, chronic CAD, CKD, diabetes and peripheral arterial disease.

Ms Berdan is responsible for leading the strategy, growth and expansion of this business unit as well as serving on the DCRI Executive Committee. She represents the DCRI on the CTTI (Clinical Trials Transformation Initiative) Steering Committee as well as responsible for developing the DCRI operational strategy for transforming the traditional clinical trial model to more pragmatic approaches including the use of EHR, common data models and the use of e-consent. She is trained as a Physician Assistant and has been an author or coauthor on more that 30 articles in peer reviewed journals.


David Bocobo
Senior Central Monitor — Risk Based Monitoring, BRISTOL-MYERS SQUIBB

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David Bocobo is a Senior Central Monitor (CMN) at Bristol-Myers Squibb (BMS). In his 20 plus years of experience in the pharmaceutical industry he has held a variety of roles in Biostatistics and Data Management, ranging from managing a group of statistical programmers, to serving as a Data Lead, to development and implementation of end to end tools and systems for analysis, reporting, data cleaning and site monitoring. David’s driving interest is in the application of new and innovative technology to enhance efficiencies. David currently serves as a member of the Central Monitoring Group where he supports Risk-Based Monitoring. As the Business Lead for the Central Statistical Analytics (CSA) application, he has been responsible for the adoption and implementation of this tool at BMS. David received his B.A. from Columbia University.


Sina Djali
Head of Risk Management – Central Monitoring Integrated Data Analytics and Reporting Global Clinical Development Operations, JANSSEN R&D

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Sina Djali has more than 25 years of experience in drug and clinical development in various companies and academia. Currently he is the Senior Director of Risk Management-Central Monitoring at Janssen Pharmaceuticals. In this role Sina is responsible for incorporating risk management principals in the day-to-day R&D clinical operations. Prior to this role, Sina was the Quality Representative for Cardiovascular and Metabolism Therapeutic Area at Janssen. Previously he was responsible for the Clinical Process and System Department at Tibotec Pharmaceuticals, where he developed a data-driven QRMS. Prior joining Tibotec he held several positions in regulatory affairs and clinical QA departments at Wyeth and Aventis Pharmaceuticals.


Oksana Gecha
Head of Central Monitoring Global Data Strategies and Solutions (GDSS), BRISTOL-MYERS SQUIBB

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Oksana Gecha is the Head of Central Monitoring (CMN) at Bristol-Myers Squibb (BMS). She has 25 years of experience in the pharmaceutical industry, specifically as a Line Manager in data management and site management. Oksana has a passion for developing teams, coaching and motivating others while managing expectations in an evolving specialized Biopharma environment. Oksana currently oversees a team of global CMNs in support of Risk-Based Monitoring (RBM) methodology. Oksana is responsible for driving the adoption of a new analytics tool, Centralized Statistical Analytics (CSA), which provides CMNs the ability to mitigate risks by assessing clinical trial data trends and outliers indicative of poor performing sites. With the advent of new technology such as CSA, CMNs are poised to successfully support RBM resulting in improved data integrity. Oksana received a B.S. from the University of Delaware and an M.S. from Rutgers University.


Jennessa Martin
Regulatory Affairs Coordinator, FIBROCELL SCIENCE


Jaylaxmi Nalawade
Senior Manager – Drug Safety and Risk Management, LUPIN LIMITED

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Dr. Jaylaxmi Nalawade is a Medical Doctor with seven years of pharmaceutical industry experience in centralized management of global pharmacovigilance activities. She is an experienced professional in Medical Writing, Risk Evaluation and Mitigation Strategy (REMS), & Risk Management Planning and Implementation, Safety data exchange agreements. Jaylaxmi is currently working as a Senior Manager in Drug Safety and Risk Management department of Lupin Limited (India). In her current role, she has led several pharmacovigilance initiatives within cross-functional processes and teams including regulatory affairs, marketing, business development, quality assurance and New Product Launch teams in India and overseas subsidiaries in the U.S., Europe, Australia. She has worked in integration teams for effective implementation of pharmacovigilance activities in the U.S., Europe, & Australia. She is also a medical expert for review of aggregate safety reports. Prior to Lupin, she was an Assistant Manager in Medical Affairs in Unichem Laboratories (India) and as a Medical Reviewer in Pharmacovigilance group with Tata Consultancy Services (India). She has completed her MBBS from Maharashtra University of Health Sciences, followed by a Post Graduate Diploma in Clinical Research and Regulatory Affairs (PGDCRRA) from Haffkine Institute for Training, Research, & Testing.


Kimberly D. Nessel, MSN
Director, Clinical Scientist CVM, THE JANSSEN PHARMACEUTICAL COMPANIES OF JOHNSON & JOHNSON

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Kimberly D. Nessel has more than 20 years of experience in the pharmaceutical industry. She held positions in both Clinical Research and Clinical Operations, spanning all phases of drug development. During her career, she had a leadership role in multiple cardiovascular mega-trials, including Phase III global registration trials. She has extensive experience in the organization and management of trial leadership committees, including Clinical Adjudication and Independent Data Monitoring Committees. In addition, she has crafted and implemented medical monitoring and data surveillance plans for late-stage clinical studies. At present, she is Director, Clinical Scientist within the Cardiovascular and Metabolism Therapeutic Area at Janssen Research and Development. In this role, she is an integral member of the Cardiovascular Clinical Team and contributes extensively to both pediatric and adult clinical studies. She holds both a Bachelor of Science and Master of Science in Nursing.


Morten Thorup Pedersen
Risk-Based Monitoring Specialist, NOVO NORDISK A/S

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With a background as a site monitor, I have worked six years in clinical trial management of large phase 2-4 trials before taking on the job as RBM Specialist implementing risk-based monitoring in a large pharmaceutical company. With a solid understanding of the data collection processes at sites combined with my thorough understanding of Novo Nordisk data systems, I am now designing the reports used for centralized monitoring as part of the risk-based approach.


Elizabeth Robinson, RN, MSHS
Executive Director, Clinical Compliance and Operations, HORIZON PHARMA

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Beth Robinson is the Executive Director, Clinical Compliance, and Operations at Horizon Pharma, plc. From 2002-2016, Beth was also an instructor in the Certificate in Clinical Trials Management program at University of Chicago’s Graham School. She taught the Fundamentals of Clinical Monitoring course and the regulatory portions of the Drug Development Process course. In her 20+ years of industry experience, Beth has worked and consulted in data management, clinical operations (monitoring and study management), medical writing, quality (SOPs, training, auditing, risk evaluation), GCP consulting, and regulatory affairs. Prior to her industry experience, Beth worked as a study nurse coordinator among other clinical roles.


Anne M. Smith
Consultant, Central Monitoring, ELI LILLY AND COMPANY

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Anne Smith is currently a Central Monitoring Consultant in Clinical Risk Management at Eli Lilly and Company. Anne spent the past three years with the RBM team, initially performing central monitoring oversight and execution activities on trials and is now the central monitoring work stream lead. Anne has over 20 years experience in the pharma industry with a focus on data management, project management, and most recently, risk-based monitoring. She has held positions with both pharmaceutical companies and CROs, including 10 years at Eli Lilly & Co. Anne has participated in the RBM work stream for TransCelerate and the co-authored a paper on Site Risk Assessment with that group.


Steve Young
Chief Operations Officer, CLUEPOINTS

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Steve holds a Masters degree in Mathematics from Villanova University. He worked for three biopharmaceutical companies over a span of 15 years, where he assumed leadership positions in clinical data management and led the successful enterprise roll-out of EDC at both J&J and Centocor. He spent an additional six years with Medidata and then OmniComm, leading the development of analytics and risk-based monitoring (RBM) solution portfolios and providing RBM and clinical operations consulting to many organizations. He also led a pivotal RBM-related analysis in collaboration with TransCelerate and has co-authored two patents related to RBM methods.