Clinical Operations in Oncology Trials Southern California 2020

Biography: Dr. Rosenberg is a 30 plus year executive with proven experience in driving operational excellence at all levels within the pharmaceutical, biotechnology, eclinical and contract research organization sectors. With his diverse background which includes executive management, clinical and regulatory operations, business development, eclinical technology solutions and new product/licensing evaluations, he brings tremendous hands on insights to optimizing the drug development cycle, from the early start-up stage to global product registration across many key therapeutic areas including CNS and oncology. Dr. Rosenberg is Managing Partner of eP2Consulting, Inc. since 2001. He also currently serves as Head, Clinical Operations at Beat AML, LLC, a division of The Leukemia & Lymphoma Society. Dr. Rosenberg received his Ph.D., from the Kellogg Pharmaceutical Clinical Scientist Program, University of Minnesota, College of Pharmacy and his Bachelor of Science, Pharmacy, from the Philadelphia College of Pharmacy and Science. Contact Information: 4 Quail Court, Mount Laurel, NJ 08054 (c: 609-923-9443)

Session Details: Chair's Opening Remarks 12-02-2020, 8:50 am Case Study: Beat AML Master Trial - The Role of Basket, Umbrella and Platform Trials in Oncology 12-02-2020, 4:00 pm Chair’s Opening Remarks 13-02-2020, 8:50 am View In Agenda

Biography:

Session Details: Speaker Hosted Roundtables 13-02-2020, 9:00 am View In Agenda

Biography: Dr. Glassy graduated from the University of San Francisco in 1974 with a B.S. in Biology and Chemistry.  He then attended University of California, Riverside and received his Ph.D. in biochemistry in 1978.  He did his post-doctoral studies in molecular immunology at the Scripps Research Institute in La Jolla.  Dr. Glassy joined the faculty of the Department of Medicine and Cancer Center at UCSD in 1980 and is currently in the Translational Neuro-Oncology Laboratory at the UCSD Moores Cancer Center.  In addition to UCSD, Dr. Glassy has held several upper management positions in commercial biotechnology.  Currently, he is the Founder and Chairman of Nascent Biotech, Inc.  He has prepared and directed several FDA approved clinical trials involving human monoclonal antibodies to cancer.  Dr. Glassy has over 175 publications in the scientific and medical literature, is the inventor of several issued patents in the human antibody field, is the Editor-in-Chief of the journal, HUMAN ANTIBODIES, and the Program Chairman of the meeting series, "The International Conference on Human Antibodies and Hybridomas".  Glassy is the inventor of pritumumab, the first human antibody used to treat a cancer patient and is the recipient of the 2003 Arthur Furst Award (citation: “Outstanding research advancing science for the betterment of humanity”).  He is also the author of the books, "The Biology of Science Fiction Cinema", “Movie Monsters in Scale”, and "Biology Run Amok!".

Session Details: View In Agenda

Biography:

Session Details: The Emergence of Wearables in Oncology Trials: Utilizing Technology for Efficient Trials 12-02-2020, 9:00 am View In Agenda

Biography:

Session Details: The Importance of Site Selection in Oncology Clinical Trials 12-02-2020, 1:30 pm View In Agenda

Biography: Iris Sison is the Director, Head of Clinical Operations at IGM Biosciences, Inc. She has over 15 years of experience with a variety of leadership and technical roles from the site level, CRO to big and small biotech settings. She has experience in clinical trial management across therapeutic areas in Phase I-IV with a strong emphasis on Phase I oncology in Solid Tumors and Hematology Oncology. Iris has led numerous study teams in operationalizing complex multicenter global studies through innovative study design and development. Over the course of her career, she has played a key role in the development of a number of successful new drugs to market e.g. Avastin, Lucentis, Herceptin, Zelboraf, Keytruda, and Ibrance. Her experience at the site level, CRO and clinical trial management gives her a unique perspective and knowledge for patients, sites and CROs. This insight gives her an understanding of the operational challenges that would need to be managed efficiently and effectively in order to conduct a successful multi-centered global clinical trial. Iris is very passionate about delivering high quality results and continue to strive to be innovative in order to improve the speed and efficiency of drug development and eventually treat and find cures for patients with cancer and other debilitating diseases.

Session Details: Afternoon Refreshments and Networking 12-02-2020, 3:00 pm Speaker Hosted Roundtables 13-02-2020, 9:00 am View In Agenda

Biography: Dr Nancy Sacco is currently the VP and Head of Clinical Development at AnaptysBio, Inc, with 20+ years of experience through all phases of Clinical Development. She has worked with numerous CROs, clinical vendors and clinical investigator sites around the globe and is focused on best practices and optimizing operations toward highest quality deliverables and data.  Prior to AnaptysBio, Dr Sacco led Clinical Operations globally at Revance, Avexis and Takeda, overseeing clinical trials across aesthetics, neuromuscular and psychiatric disorders, metabolic disease, women’s health, infectious diseases/immunology, oncology, and gene therapy/rare disease. She was Executive Director of Strategic Operations at Astellas Pharmaceutics Global Development with responsibilities across US, Europe and Japan.  While at P&G, Warner Lambert/Pfizer, she had operational and leadership roles with increasing responsibilities. Over her career she has contributed to the development of Zolgensma, Xtandi, Myrbetriq, Cresemba, Lyrica, Rozerem and Risedronate.  Beyond drug product development, Dr Sacco represented Astellas on both the Transcelerate and AVOCA consortia where she contributed to the development of Risk-based monitoring, GCP Global Recognition for clinical investigators and Clinical Quality Management initiatives.  https://www.linkedin.com/in/nancy-sacco-888738b/

Session Details: Panel Discussion: What Does Patient Centric Care Look Like? Working with Patient Advocacy Companies in Oncology 12-02-2020, 10:00 am Q&A: Improving Partnerships Between CROs and Trial Sponsors 13-02-2020, 3:30 pm View In Agenda

Biography:

Dr. William Audeh is a medical oncologist specializing in breast cancer, with nearly 30 years of experience as a clinician and clinical researcher at the Cedars-Sinai Cancer Center in Los Angeles, where he continues to be a member of the Medical Staff. Prior to joining Agendia he served as the former Director of the Cedars-Sinai Cancer Center and Medical Director of the Wasserman Breast Cancer Risk Reduction Program. Dr. Audeh also served as Director of the Medical Oncology Training Program for Breast Surgery and Surgical Oncology Fellowships at Cedars-Sinai, and was Associate Clinical Professor of Medicine at the UCLA David Geffen School of Medicine. Dr. Audeh has been the Principal Investigator on a wide variety of national and international clinical and translational trials, and has authored numerous publications in the field of breast cancer, cancer genomics, and targeted cancer therapy. Dr. Audeh received his medical degree from the University of Iowa and an M.S. Degree in Genetics from the University of Minnesota. He went on to complete his residency in Internal Medicine as well as a fellowship in Medical Oncology at Stanford University Medical Center. He is board certified in internal medicine and medical oncology, and is a member of the American Society of Clinical Oncology and American Association of Cancer Research.

Session Details: Reserved for Ce3 Speaker 12-02-2020, 2:00 pm View In Agenda

Biography: Jim Langford has been a leader in the biopharmaceutical clinical development industry for over 25 years, where he has founded and managed several companies to leadership positions in the industry.  He was the founder and President of The PHOENIX, a Contract Research Organization (CRO) that provided clinical research services to the biopharmaceutical industry, until it was sold in in 2002 to an international CRO based in Canada.  While managing The PHOENIX, Jim founded an electronic data capture (EDC) software company, DataLabs, which was spun out as an independent company in 2001.  DataLabs was one of the leading EDC companies at the time of its acquisition by ClinPhone, Plc. in 2006, which was subsequently acquired by PAREXEL International.  In 2009, he formed a consulting company, White Star Consulting, which provides executive management services within several cell and gene therapy companies to assist them in improving their clinical development process in clinical operations, clinical logistics and how they integrate with manufacturing processes. Jim is currently the Vice President of Clinical Operations for AIVITA Biomedical where he is leading their clinical development with a dendritic cell therapy for indications in glioblastoma, ovarian cancer and metastatic melanoma.

Session Details: Integrating New Technologies into Oncology Clinical Trials 13-02-2020, 12:00 pm View In Agenda

Biography: Antonieta Sosa has over 20 years of experience in the pharmaceutical and biotech industry holding positions in Safety, Regulatory Compliance and Clinical Operations in both small biotech and large pharma.  In her current role as Director in the Clinical Innovation group, she is responsible for leading the strategy and hands-on execution of a portfolio of transformational projects dedicated to driving innovation into the clinical operating model.  She holds degrees in Biology and Health Sciences from the University of Southern California.

Session Details: Direct to Patient Trials – What are the Benefits and How Can we Use This More? 13-02-2020, 11:00 am View In Agenda

Biography: Mr. Hooks has been active in clinical research since 2004, having conducted studies in the non-profit, biotechnological, pharmaceutical, academic, medical device and in vitro diagnostic arenas. His research prowess is further derived from years of experience in clinical laboratory, study site and CRO settings. He has managed clinical trials in over 15 countries; specializing in expedited site activation techniques and creative study rescue activities. He enjoys teaching at professional research conferences and volunteering his time as a career development mentor to other research professionals. Mr. Hooks earned a Master of Public Health degree in Epidemiology in 2006, and a Master of Forensic Science degree in 2002. He is a native Oklahoman, and proud alumnus of both the University of Central Oklahoma and the University of Oklahoma Health Sciences Center.

Session Details: Site Selection in Oncology Trials 13-02-2020, 1:30 pm View In Agenda

Biography:

Session Details: View In Agenda

Biography:

Session Details: View In Agenda

Biography:

Session Details: Speaker Hosted Roundtables 13-02-2020, 9:00 am View In Agenda

Biography:

Session Details: Panel Discussion: What Does Patient Centric Care Look Like? Working with Patient Advocacy Companies in Oncology 12-02-2020, 10:00 am View In Agenda

Biography:

Session Details: Speaker Hosted Roundtables 13-02-2020, 9:00 am Discussing the Future of Oncology Trials 13-02-2020, 11:30 am View In Agenda

Biography:

Session Details: The Emergence of Wearables in Oncology Trials: Utilizing Technology for Efficient Trials 12-02-2020, 9:00 am View In Agenda

Biography: Revati Tatake currently serves as a Global Director of Databases and Analytics at GlobalData, where her primary responsibilities are to lead the development and continuous enhancement of integrated databases and analytical tools for providing competitive and business intelligence for pharmaceutical and biotechnology sectors Revati has more than 20 years’ experience, both in academic research and the healthcare industry, during which time she focused on basic and clinical research, drug discovery and competitive intelligence projects across many therapeutic areas.  After academic career at Tata Cancer Research Institute and the University of Connecticut Health Center, she began her healthcare industry career at Boehringer Ingelheim Pharmaceuticals, where she led drug discovery projects involving small molecules, gene therapy and cell therapy for cardiovascular diseases, Rheumatoid arthritis and Diabetes.  In addition to leading drug discovery projects, Revati co-chaired novel target identification group, scouted novel technologies for enhancing drug discovery efforts, established collaborations with experts in academic institutions to complement internal projects and evaluated in-licensing opportunities for their scientific and technical merit.  She is a co-inventor on several issued US patents and applications related to the projects on cell and gene therapies. Before joining GlobalData, Revati worked at Citeline, where she was involved in competitive intelligence and analytics of clinical trials and pharmaceutical products. Revati holds a PhD in Tumor Immunology from Tata Cancer Research Institute. She was a post-doctoral fellow at the University of Connecticut Health Center.

Session Details: Panel Discussion: What Does Patient Centric Care Look Like? Working with Patient Advocacy Companies in Oncology 12-02-2020, 10:00 am Ensuring Clinical Feasibility Planning for Immuno-oncology Trials to Achieve Enrolment Targets 12-02-2020, 12:00 pm View In Agenda