Faculty – Central Monitoring Summit

Lisa Berdan

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Ms. Berdan has been involved in CV megatrials for more than 20 years and has successfully developed an industry-recognized operational business unit including over 70 clinical operations professionals who are dedicated to these large international programs in ACS, atrial fibrillation, chronic CAD, diabetes and peripheral arterial disease. These trials are typically full service and have at least 5,000 patients enrolled in multiple countries. These trials include ASCEND HF, EXSCEL, IMPROVE IT, ROCKET AF, TECOS, TRACER, TRILOGY and the two newest programs awarded in the last few months, Roche dal-O2 and AZ-PAD.

Ms. Berdan is responsible for leading the strategy, growth and expansion of this significant area of business as well as overseeing the operational implementation of all commercial (industry-funded) CV megatrials. She represents the DCRI and participates in companywide initiatives, including 1) expanding collaboration with our global ARO partners, 2) collaborating with the CREATE leadership team to develop this site-focused clinical research training program as well as expanding global site relationships and networks and 3) advising and collaborating with BCRI in their development efforts. She also provides senior mentoring, advice and support to Business Development and Operations as needed.

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

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

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

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 Nessel

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

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