Faculty – 6th Clinical Trials Phase I & Phase IIA Summit


Wesley Day
Lead Global Clinical Development, MTDA

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Dr. Day leads global clinical development for Mitsubishi Tanabe Pharma Development America (MTDA), where the focus is on unmet medical needs and rare diseases primarily associated with CNS and Immune therapeutic areas.  He has over twenty-five years’ experience in global drug development and in clinical and regulatory strategy and operations at all stages, from discovery through commercialization.  Wes held senior positions in clinical development and regulatory affairs at Pfizer.  Before joining MTDA, he was Vice President of Clinical Development at Vivus, where he led development efforts that resulted in NDA/MAA/sNDA approvals in metabolic disease (Qsymia), women’s health (Evamist), and sexual dysfunction (Stendra and Spedra).


Martin Gutierrez, M.D.
Director of the Drug Discovery , JOHN THEURER CANCER CENTER

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Martin Gutierrez, M.D., brings extensive expertise as the Director of the Drug Discovery – Phase I Unit at the John Theurer Cancer Center. The John Theurer Cancer Center, member of the NCI-designated Georgetown Lombardi Comprehensive Cancer Center Consortium, is New Jersey’s largest and most comprehensive cancer program. Under his leadership, JTCC works closely with industry, the National Cancer Institute (NCI), the National Institutes of Health (NIH), and other academic institutions to expand its Phase I clinical research portfolio. He has nearly two decades of drug discovery experience—including many years with the NCI-NIH—helping to bring new treatments to patients during their earliest stages of evaluation.


Susan Lubin
Director, CP and Oncology Operations, BRISTOL MYERS SQUIBB

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Susan has 25 years of experience in clinical research with a focus in early development phase 1 trials. She is currently the Director of Marketed Products and Late Stage Clinical Pharmacology Operations at Bristol-Myers Squibb. Susan has extensive experience working in the outsourcing arena with major CROs in the roles of outsourcing manager for operations and clinical safety. Early in her pharmaceutical experiences, Susan was the administrator of the BMS Clinical Pharmacology Unit. Susan is a RN with a master’s degree in health care administration from Rider College.


Chelsea McCabe
Project Manager, JOHN THEURER CANCER CENTER

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Chelsea McCabe currently serves as the Project Manager of Phase 1 Research Division at the John Theurer Cancer Center, part of Hackensack University Medical Center. She has nearly three years of experience in Phase I research and, over eight years of experience in the Oncology field. Chelsea received a Bachelor of Science in Chemistry from Rutgers University where she is actively pursuing her master’s in clinical Trial Management.


Bruce Morimoto
Vice President, Drug Development Operations, ALKAHEST

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Bruce has more than 20 years of experience in both biotechnology and clinical research companies. His experience includes leading project teams in the development of innovative medicines, as well as providing strategic guidance, designing preclinical and clinical development programs, and advancing the development of new therapies.  Bruce joined Alkahest from Celerion, where he was Vice President, Scientific Affairs; having previously served as Vice President, Drug Development at Allon Therapeutics where he managed Allon’s neurodegeneration and dementia therapeutic programs.  He started his career on the faculty in the Chemistry Department at Purdue University where his independent research focused on neuronal signal transduction.  Bruce earned his doctorate in biochemistry from UCLA and completed a postdoctoral fellowship at the University of California Berkeley.


Laurie Myers
Global Health Literacy Director, MERCK & CO., INC.

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Since 2010, Laurie has led Merck’s global health literacy efforts in support of improved patient communications, including medication labeling, packaging, clinical trial materials, lay summaries, and patient education. Laurie has worked to include respondents with low health literacy into patient labeling research, earning a national health literacy award. She works and speaks internationally. She has co-chaired two US working groups on lay summaries and health literacy in clinical trials, at the MRCT (Multi-Regional Clinical Trials Center of Brigham and Women’s and Harvard). She served as an invited member of the EMA lay summaries working group, where she helped to influence guidance to reflect principles of health literacy, numeracy, and readability. She did a plenary session at the 2017 Asia Health Literacy Conference and recently at an EU labeling conference, highlighting global best practices in patient labeling. She was an invited speaker by the FDA at a 2017 labeling conference, with an international audience of over 2000 people in 42 countries. She has co-authored multiple publications, and serves on the US National Academies Health Literacy Roundtable. She won an MM&M Top 40 Healthcare Transformers Award last year. She has a Bachelor’s degree from Yale and an MBA from Wharton.


Jim Nissel
Director, Clinical Trial Management, Translational Development – Clinical Pharmacology, CELGENE

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Jim Nissel is currently a Senior Director of Trial Management in the Clinical Pharmacology department at Celgene (based in Summit, NJ) and has been with Celgene for 11 years.  He holds B.S. in Emergency Health Services Management and an M.S. in Management.  Jim has worked in the pharmaceutical industry for 19 years in phases 1 through 4, beginning his career as a CRA at a small CRO.  Jim is also an Adjunct Professor at NYU School of Graduate Studies in Clinical Research for 10 years focusing on clinical trial management/operations and regulatory affairs.  Jim and his family reside in Mendham, NJ.


Rosemarie Pincus
Principal Medical Writing Scientist, Oncology Division, JOHNSON & JOHNSON

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Rosemarie Pincus, Principal Medical Writing Scientist, has worked at Johnson & Johnson for 21 years in the Medical Writing Department, Oncology Division.  Her expertise is in guiding teams to write clear, concise, strategically designed Phase 1-4 protocols and amendments that meet country-specific and regulatory requirements.  Rosemarie is actively involved in training new writers and clinical teams to understand the content needed for particular sections of the protocol template and is also involved with the TransCelerate Community to advance the use of the electronic digital protocol template.  She has a Ph.D. in Biochemistry from Rutgers University and spent 15 years in preclinical research understanding mechanisms of action of anticancer drugs in tumor cells before joining J&J.


Jim Sabogal
Head of Healthcare and Life Sciences, T-SYSTEMS NORTH AMERICA


William B Smith, MD, FACC, CPI
CEO, ALLIANCE FOR MULTISPECIALTY RESEARCH

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Dr. William Smith is the Founder, President, and Principal Investigator of VRG and NOCCR, the AMR centers in Knoxville, TN and New Orleans, LA. He is also one of the original founders of AMR. Dr. Smith is board certified in Internal Medicine, Critical Care Medicine, Nephrology, and Cardiology. He has been involved in more than 1,700 clinical trials over the past 35 years. He is a frequent lecturer and author and publishes extensively.


Laura Vessey
Director, Early Clinical Development, MERCK

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Laura Vessey is a Director in Early Development Oncology at Janssen where she is a manager responsible for the operational delivery of the early oncology clinical portfolio. Over the past 30 years, Laura has focused her career in Early Clinical Development from Phase 0 through Phase IIA in oncology, neuroscience, cardiometabolic, immunology, and infectious disease. She began her career at The Upjohn Company (now Pfizer) as a chemist in the lab and then early clinical development, she moved to Merck where she was involved in multiple therapeutic areas for over twenty years and is now at Janssen focusing on early clinical oncology. Laura holds a B.S degree from Hope College in Michigan and resides with her family in Princeton, NJ.