4th Clinical Trials Phase I & Phase IIA Summit -

4th Clinical Trials Phase I & Phase IIA Summit
October 19 - 20, 2017
Philadelphia, PA

Understand the operational challenges of early phase development and leverage innovative strategies to conduct efficient, cost-effective clinical trials

Faculty – 4th Clinical Trials Phase I & Phase IIA Summit

Clayton Dehn, M.S.
Senior Vice President Early SVC and Strategic Development, CLINICAL TRIALS OF TEXAS, INC.

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Clayton Dehn is the Sr. V.P., Early Phase Services and Strategic Development at Clinical Trials of Texas, Inc., a multitherapeutic research site based in San Antonio. He is a research physiologist with expertise in endocrine and metabolic disorders. He is the co-inventor of a process and substance for disturbing the inheritance pattern of ion-channelopathic disorders, and the sole author of the first publication cautioning against the risk of SGLT-inhibition inducing ketoacidosis in insulinopenic populations. In addition to serving on the editorial board of three peer-reviewed journals, he has also served by gubernatorial appointment on the Arizona Biomedical Research Commission.

Rachael Easton
Senior Director, Translational Medicine and Clinical Pharmacology, SANOFI

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Rachael has 10 years of experience in the design and implementation of first-in-human through proof-of-concept clinical studies. Within Sanofi, she currently leads a group in the U.S. and Asia which is responsible for developing and executing early development strategies across therapeutic areas. Rachael received her MD and Ph.D. degrees from Washington University School of Medicine and trained in Endocrinology, Diabetes and Metabolism at the University of Pennsylvania.

Lorie Fitzpatrick
Chief Medical Officer, RADIUS HEALTH, INC.

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Dr. Lorraine A. Fitzpatrick completed her undergraduate education at Wellesley College with honors in Molecular Biology. She graduated from the Pritzker school of Medicine at the University of Chicago and completed her residency training in Internal Medicine at Columbia-Presbyterian Medical Center in New York. Dr. Fitzpatrick trained in Mineral Metabolism and Endocrinology at the National Institute of Diabetes, Digestive, Arthritis and Kidney Disorders at the National Institutes of Health. Dr. Fitzpatrick joined the staff at the Mayo Clinic and rose to the rank of Professor of Medicine. Dr. Fitzpatrick has held many national and international positions. She has published over 250 papers in the field of mineral metabolism.

Dr. Fitzpatrick worked in drug development at GlaxoSmithKline as the Medicine Development Leader, leading an international team representing multiple disciplines including clinical development, safety, regulatory, manufacturing, commercial, operations, epidemiology, and global health outcomes. In 2015, Dr. Fitzpatrick joined Radius Health, Inc., as Chief Medical Officer where she leads Clinical Affairs, Medical Affairs and Pharmacovigilance.

Kristian Hubbard
Outsourcing Manager, Clinical Science and Operations Department, BRISTOL-MYERS SQUIBB

Jill Kearney
Director of Global Clinical Development Operations, JANSSEN R&D

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Jill has worked in the pharmaceutical industry for over 20 years. She has worked in a variety of roles from CRA, Global Trial Leader, ClinicalProgram Manager to her current role as Program Leader of the Early Development Oncology group at Janssen R&D. She has managed a variety of clinical trials from large international registration programs, complicated adaptive trial designs, to First-in-Human trials. Currently, Jill works across several initiatives to improve early development trial execution. In addition, she is currently responsible for developing cross-therapeutic area processes to reduce risk in the preparation and administration of study drug.

Susan Lubin
Director, Clinical Safety Monitor, Clinical Pharmacology Medical and Operations Group, 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.

Victor Lucariello

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After college internships, Victor has worked in the pharmaceutical industry for over 15 years, initially working in the labs and progressively moving to a combination of science with finance & business. While at Celgene, during 2010–11 he was responsible for developing and implementing new procedures for site budget development to reflect current business and study needs. As process owner, he created a new site budget appendix format with a separate payment terms document, which has been in use since Jan 2012. These templates have evolved over time to improve negotiation efficiency and even to incorporate industry trends. Victor continues to lead and participate in many initiatives for process improvement within CR&D, coordinating with clinical functions as well as finance and project management.

In his current role, his main responsibilities are budget forecasting for clinical trials and development of investigator grants; from providing high-level estimates for a study concept, preparing detailed estimates for governance presentations, and to the creation and approval of global site budget templates based upon a finalized protocol. Since first working on investigator budgets in 2006, Victor has experience with investigator- and sponsor-initiated budgets for clinical pharmacology through post-marketing studies, primarily in oncology but other therapeutic areas as well. Victor graduated Rutgers University in the pre-medical track with a B.S. focusing on human biology.

Dr. Johan Luthman
VP Neuroscience Clinical Development, EISAI

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Johan Luthman is Vice President & Head of Clinical Development, Neurology Business Group, Eisai Pharmaceuticals, where he is engaged in overseeing clinical development programs from preclinical development to phase 3, with current programs in Alzheimer’s disease & other dementing disorders, epilepsy, sleep disorders and obesity.

Before joining Eisai, Johan was VP & Franchise Integrator, leading translational medicine and biomarker activities in neuroscience as well as Senior Program Leader for Early Development Neuroscience & Ophthalmology at Merck Research Laboratories, based in PA, USA, overseeing projects from preclinical candidate to proof of concept in Phase 2. Prior to Merck, Johan lead GeNeuro SA, Geneva, as CEO during its build-up phase to stand-alone biotechnology company. Before then, Johan was SVP & Therapy Area Head of Neurology, Immunology & Inflammation Research and Head of PoC strategy in Neurology at MerckSerono, based in Geneva, CH. He joined Serono in 2005, as Head Neuroscience & Immunology Research. Johan began his pharmaceutical career in 1991 in Astra, Sodertalje, Sweden. In Astra/AstraZeneca he worked as project leader as well as director of research departments, before leading Translational Science in Neurology & Analgesia. During his years in the industry, Johan has been engaged in numerous Public-Private pre-competitive consortia efforts, including acting as chairman of the ADNI Industry group in 2012, and chair efforts within C-Path Institute.

Johan studied medicine and dentistry at the Karolinska Institute. In parallel with clinical practice, he obtained a Ph.D. in neurobiology in 1989. He continued as a Research Fellow in Pharmacology & Psychiatry at the University of Colorado. Johan was subsequently appointed associate professor in Neurobiology at Karolinska Institute and received an honorary professorship in pharmacology from the University of Chile. He obtained business training at SIMI, Copenhagen and Thunderbird and MIT/Sloan Management Institute.

Jennifer Newman
Global Clinical Project Leader, CELLDEX THERAPEUTICS

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Jennifer Newman is currently the Global Clinical Project Leader for two early-stage programs at Celldex Therapeutics in New Haven, CT. Drawing on 20 years of experience in clinical development, Jen’s expertise in scenario planning and forecasting has been valuable to informing important development path decisions. In an industry that has been continuously and sometimes suddenly changing, the ability to alter plans and redirect resources quickly can keep programs on track. She has worked across several therapeutic areas, including extensive experience in cardiovascular/metabolic and oncology, and has had the good fortune to have continuity on a few compounds from early phase through successful submission and lifecycle management. Prior to joining Celldex, had roles at Boehringer Ingelheim Pharmaceuticals and Bristol-Myers Squibb.

Dr. Margarita Nunez
Medical Director and Principal Investigator, HIGH POINT CLINICAL TRIALS CENTER

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Dr. Nunez is the Medical Director and Principal Investigator at High Point Clinical Trials Center. She has over 20 years of clinical research experience and has conducted over 450 trials in both early and late phase. She received her medical degree from New York Medical College and completed her residency in internal medicine at the University of South Florida College of Medicine. Upon the completion of her residency she completed a two-year fellowship in geriatric medicine and subsequently joined the faculty at the University of South Florida where she taught Internal Medicine and Geriatrics for three years. Her responsibilities at USF including being associate medical director at Hospice of Hillsborough County in addition to working at the Memory Disorder Clinic. Before entering her work in clinical trials, she practiced internal medicine at a rural health clinic in Central Florida for an additional three years before becoming Principal Investigator and Medical Director at Comprehensive Clinical Development in St. Petersburg Florida. Dr. Nunez joined the team at High Point Clinical Trials Center in January of 2013.

Robert Pyke, M.D., Ph.D.

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Robert E. Pyke, M.D., Ph.D., runs Pykonsult, LLC, consulting in sexual medicine clinical development. He was Chief Medical Officer for S1 Biopharma, Inc., developing agents for sexual dysfunction; worldwide medical lead for flibanserin to treat Hypoactive Sexual Desire Disorder at Boehringer Ingelheim; and US medical lead for phase 2/3 antidepressant, antiparkinsonian, anxiolytic, antipsychotic, and analgesic projects elsewhere. He also engaged in private clinical psychopharmacology practice. A member of the International Society for the Study of Women’s Sexual Health and former Adjunct Clinical Professor, Western Michigan University, Pyke is certified in clinical pharmacology and has about 100 published works on CNS drugs.

Marcus Stavchansky, Pharm.D.
Director, Pharmacy Services, COVANCE

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Dr. Stavchansky is Director of Pharmacy Services for Covance, overseeing three clinical pharmacy teams in North America. He has 17 years of experience as a registered pharmacist in Texas and over nine years of experience in the Phase I CRU space at Covance a subsidiary of LabCorp of America. Dr. Stavchansky serves as adjunct faculty at over five colleges of pharmacy in Texas, Florida, and Massachusetts where he hosts students interested in experiencing the life of a pharmacist in clinical pharmacology research. Dr. Stavchansky has converted two of the three Covance Phase I CRUs from USP compliant pharmacies to cGMP compliant pharmacies where manufacturing of investigational drug products within the same facility the dose administration is executed. This is the first of its kind in the U.S. where GMP QA oversite and a robust Quality Management System allow for the manufacture of all types of drug formulations for First in Human, SAD/MAD, and other adaptive trial designs can be created without the need for a very stable product.

Chad Swanson
Director, Clinical Neuroscience, EISAI

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Dr. Swanson is currently Director of Neuroscience Clinical Development, Neurology Business Group, Neurodegenerative Diseases at Eisai, Inc, where he serves as the study director for a large, highly novel Phase 2b proof of concept study of a monoclonal antibody (BAN2401-G000-201) in Early AD. Before joining Eisai, Dr. Swanson held clinical research positions in neurodegeneration at Merck and Schering Plough. Prior to his tenure in clinical research and development, Dr. Swanson was Senior Scientist and US Head of Neurochemistry, Target Discovery and Assessment, at Lundbeck, Inc, where he led a number of discovery programs and ran a lab devoted to discovery and preclinical research in psychiatric disease. Dr. Swanson received his Ph.D. from the Medical University of South Carolina in Physiology and Neuroscience, and his BS degree from the University of Wisconsin – Madison in Zoology with Neurobiology emphasis.

Barry Ticho, M.D., Ph.D.
Chief Medical Officer, STOKE THERAPEUTICS, INC.

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As Chief Medical OfficerBarry leads Stoke’s efforts to develop first-in-class therapeutics to treat orphan diseases based on insights from the laboratory of Professor Adrian Krainer of Cold Spring Harbor Laboratory. Previously Barry was Head of Development for CVMD at Moderna Therapeutics. He was also Head of External R&D Innovation for Cardiovascular and Metabolic Diseases at Pfizer and prior to that he was Vice President of ClinicalDevelopment at Biogen. Barry obtained his M.D. and Ph.D. degrees from the University of Chicago and completed Pediatrics training at Northwestern University and a Cardiology fellowship at Children’s Hospital in Boston. He was on clinical staff at Harvard Medical School and Massachusetts General Hospital and conducted laboratory research on the regulation of cardiac development.

Laura Vessey
Director of Translational Pharmacology Clinical Operations and Outsourcing Merck Research Laboratories, MERCK

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Laura Vessey is a Director in Early Stage Development (ESD) Operations at Merck where she is a manager and is responsible for ESD Outsourcing. Vendor selection, relationships, and performance are of the utmost importance, along with the key decisions made around what studies/programs to outsource.

Over the past 28 years, Laura has primarily focused her career in Early Clinical Development from Phase 0/1 through Proof of Concept (POC). She has worked at three major pharmaceutical companies (The Upjohn Company, GSK, and Merck) in multiple therapeutic areas, including oncology. Another area of interest is Accelerating Proof of Concept (APOC) for the compounds in early development. As the industry consolidates and resources are at a premium, it has become imperative to achieve POC as efficiently/effectively as possible and to outsource strategically.

Laura holds a B.S degree from Hope College in Michigan and resides with her family in Plainsboro, NJ.

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