Faculty – Investigator-Initiated Trials (IIT) Forum

Harvey Arbit, Pharm.D., MBA

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Dr. Harvey Arbit has a BS in pharmacy, a PharmD, and an MBA.

He has over 40 years of experience in the pharmaceutical and medical device industries where he held director and vice president level positions in the areas of regulatory affairs, clinical research, quality assurance, and product development.

Dr. Arbit joined the University of Minnesota Academic Health Center where he established the IND/IDE Assistance Program. This program has been recognized as a model for providing regulatory support to investigator-initiated studies in academic medical centers. Dr. Arbit served as its Director as well as the Leader for Regulatory Knowledge and Support in the Academic Health Center’s Clinical and Translational Science Institute. Currently, Dr. Arbit is president of Arbit Consulting, LLC, specializing in regulatory knowledge, strategy and support for industry, academia, and investigator-initiated sponsored clinical research. He is adjunct professor at University of Minnesota College of Pharmacy and adjunct professor at Albany College of Pharmacy and Health Sciences.

Talia Biran
Vice President, Clinical Development and Medical Affairs, ONCOLYS USA, INC

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Talia Biran joined Oncolys USA in 2017, as Vice President, Clinical Development and Medical Affairs with over 25 years of experience in Global Medical affairs. Having worked at Janssen, Merck and Novartis, and Lexicon, she contributed to the development and launch of Abiraterone Acetate (Zytiga ®, prostate cancer), Vorinostat (Zolinza®, CTCL), Letrozole (Femara®, breast cancer) , Octreotide (Sandostatin LAR®, neuroendocrine tumors (NETs) and acromegaly) and most recently , Telotristat Ethyl ( Xermelo, ® Carcinoid Syndrome Diarrhea) (Licensed Ex-US to Ipsen Inc)
Prior to Oncolys, Talia played a pivotal role at Lexicon Pharmaceuticals as Executive Director, where she established the US medical affairs infrastructure for Oncology and Diabetes programs and led the development and launch of Lexicon’s first drug candidate, Telotristat Ethyl ( Xermelo, ® Carcinoid Syndrome Diarrhea) (Licensed Ex-US to Ipsen Inc)
Talia holds a Master of Science (M.Sc) in Microbiology from Tel-Aviv University, Department of Life Sciences, in Tel-Aviv, Israel. Her thesis, under the supervision of Professor Sara Lavi, focused on Gene Amplification of SV-40 and its link to tumorigenesis.

Kimberly Cheshire-Kinney
Global Operations Head, IIS and Collaborative Studies-MAO, Global Clinical Development Operations, JANSSEN R&D

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Kim is the Global Operations Head, IIS-Collaborative, Medical Affairs Operations (MAO) for Janssen. In her role she has primary global accountability for the IIS and collaborative study global framework (policy, processes, systems, vendors). She oversees harmonized global implementation of the framework due to a differentiated capability for MAO-managed Investigator Initiated Studies (IIS) and collaborative studies arising from increasing demand, strategic partnerships, evolving space and compliance risk (e.g. FCPA, GCP). Her 20+ years of industry and therapeutic experience also includes Interventional and Non-Interventional Studies in Real World Evidence, CNS, Infectious Disease, Cardiovascular, Oncology and Women’s Health.

Anton Ehrhardt
Former Vice President, Global Medical Affairs, MITRA BIOTECH

Former President, IISRA

Dana Gardner
Director, Scientific Affairs, MERCK

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Dana Gardner is currently the Director of Scientific Affairs, Oncology at Merck where she oversees operations for the Oncology Merck Investigator Studies Program (MISP). Her team also provides strategic support for scientific engagements and congresses and project management support for creating, maintaining, and executing on company-wide medical and scientific strategies. She has over 10 years of experience managing investigator-initiated studies at Merck and she played a pivotal role in the expansion of Merck’s current investigator-initiated studies program in Oncology. Her 25+ years of industry experience also includes positions in clinical research, compliance and manufacturing.

Dana received a BA degree in Biology from the University of Delaware and a Master’s Degree in Biology from Villanova University.

Jennifer Gaskin
Director, Head of Global Medical and Scientific Affairs, KARYOPHARM THERAPEUTICS INC.

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Jennifer J. Gaskin, CCRP, CMQ-OE, is the Director of the Global Medical Research department at Karyopharm Therapeutics, Inc. Immediately preceding her current role she was the Operations Director at the Alliance for Clinical Trials in Oncology subsidiary Alliance Foundations Trials, LLC. Her experience includes leading several initiatives in inspection readiness and participating in FDA, MoH, and Health Canada Inspection teams. She has directed the selection and oversight of clinical operations vendors at multiple companies. Her clinical research experience also includes managing research units, along with clinical and research projects in both the private and academic sectors.

Christy Gilchrist, Ph.D., CRA
Director, Cancer Research Institute, SAINT VINCENT HOSPITAL

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Christy Gilchrist, PhD, CRA is currently the Director of Clinical Programs for the HSHS St. Vincent Hospital (HSHS SVG) Cancer Research Institute (CRI). She has over 20 years’ experience in supporting research studies across many aspects—scientific design, budget preparation, assessment tool creation and validation, data collection, study director, study staff member, statistical support and analysis, regulatory, internal audit, central research administrative support, contract negotiations, reporting, and compliance. She comes from university/academic, non-profit, and community hospital backgrounds. She created an IRB from scratch as well as set up HIPAA compliance procedures for research. Her greatest passion lies at the nexus of sponsor/CRO/site relations in partnering for clinical trial success and finding unique ways to leverage existing resources to advance investigator-initiated trials. She has chaired site operations tracks within pharmaceutical-oriented conferences, advocated for new approaches to ensuring adequate knowledge and skills for study staff at the Drug Information Association (DIA) conferences, and eagerly partners with her sponsor colleagues to creatively improve clinical and post-market phase efforts.

Tricia Gunter, BA, CCRP
Senior Clinical Project Manager, Global Medical Research and Global Medical and Scientific Affairs Operations, KARYOPHARM THERAPEUTICS INC.

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Ms. Gunter is a certified clinical research professional with over 15 years of experience in both sponsored research and investigator-initiated research arenas, having worked in both academic and pharmaceutical settings. She has a strong background in site management and monitoring, having spent 10+ years as a lead CRA (in-house and field-based), monitoring cardiac and oncology device and drug studies. This was followed by several years in project management as well as senior management at oncology research companies in Boston, MA.

Currently, Miss Gunter is a Senior Clinical Project Manager at Karyopharm Pharmaceuticals based in Newton, MA. In her current role, she is responsible for the oversight and management of several oncology Investigator Initiated Trials, as well as departmental and company initiatives. She holds her BA in Biology from Boston University and is an active member of both SoCRA and ACRP, participating on various committees with both organizations.

Allecia A. Harley, MPH, CRA
Former Associate Vice President, Office of Research Affairs, RUSH UNIVERSITY

Robert Jones
Global Program Lead, Collaborative Studies, Medical Affairs Operations, JANSSEN

Jeremy Keeton
ONC Investigator Initiated Trials Project Manager, ELI LILLY AND COMPANY

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Started at Eli Lilly as an organic chemist in 2002. Spent majority of my career supporting pharma-sponsored ONC trials both in-house and field based roles.

Peter Shaw, MBBS, DRCOG
Chief Medical Officer, BIOVENTUS

Archie Stone, Ph.D
Vice President, Medical Affairs, ALCRESTA THERAPEUTICS

Sudeesh K. Tantry, Ph.D.
Vice President, Clinical Medical Affairs, GLENMARK PHARMACEUTICALS

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Dr. Sudeesh Tantry is currently responsible for global medical affairs at Glenmark Therapeutics providing overall medical affairs leadership and expertise. He was previously responsible for several global clinical programs at Glenmark Pharmaceuticals that included both innovative and generic product portfolio. He has extensive global clinical development, clinical operational, medical affairs and product marketing related experience accumulated over several years. He has accomplished several successful NDA/sNDA submissions, subsequent one-cycle review and approvals by the regulatory agencies, followed by successful commercial product launches. He has worked closely with the commercial organization, business development, partners and other key stake holders in marketing/commercialization of new or life cycle extension products. He also has extensive experience in generic product development and ANDA submissions. Prior to Glenmark, he was responsible for several global clinical programs at Teva Pharma leading successful regulatory submissions and product approvals/launches. Prior to that, he was with Altana Pharma and later at Nycomed Pharma (post-merger) in a similar capacity.

Dr. Tantry has extensive formal training with several advanced degrees including a MS degree, an earned PhD degree from New Mexico State University and post-doctoral fellowships at the Wistar Institute (University of Pennsylvania) and Hershey Medical Center (Penn State University). In addition, he has completed a two-year advanced executive management training at the prestigious Wharton School of Management (University of Pennsylvania). He has published extensively in peer-reviewed journals and has presented at various national and international scientific and industry conferences.

Kirk Taylor
Senior Vice Present, Regional Medical Affairs, North America, EMD SERONO

Manisha Verma, M.D., MPH
Director, Research Department of Digestive Diseases and Transplantation, Einstein Healthcare Network, Assistant Professor of Medicine, SIDNEY KIMMEL MEDICAL COLLEGE