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 Closing Remarks 12-02-2020, 4:30 pm Chair’s Opening Remarks 13-02-2020, 8:50 am View In Agenda

Biography: Les serves as Vice President of Clinical Development of Erasca, bringing more than 20 years of experience as a scientifically-driven oncology drug developer in early phase clinical development and translational medicine. Les joined Erasca from Neon Therapeutics, where he led the clinical development of the personalized neoantigen vaccine program.  He also led the clinical development of their shared neoantigen vaccine program resulting in the recent filing of the IND for this program. Prior to this, he served as the Program Team Leader of IPI-549, a PI3K-gamma inhibitor, at Infinity Pharmaceuticals. At Infinity, Les was responsible for the strategic and operational aspects of the molecule including the first-in-human study, IND filing and development of the overall clinical strategy. He began his career at Eli Lilly and Company in their early phase Oncology drug development group where he was the clinical lead on multiple programs, responsible for Phase I and II development. Les worked closely with the pre-clinical development teams to optimize the characteristics of the drug development candidates with a focus on clinically relevant biomarkers. He earned his Ph.D. in Medical Biophysics from the University of Toronto.

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!".

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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: Operational Strategy in T-cell Engagers and Bispecific Studies 12-02-2020, 3:30 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

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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: Adaptive Trials in Oncology - Can a More Flexible Trial Model Offer a Higher Data Yield while Ensuring the Data is all Relevant? 12-02-2020, 2:30 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

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Session Details: Conducting a virtual clinical trial: Utilizing Technology for Efficient Trials 12-02-2020, 9:00 am View In Agenda

Biography: Experienced Clinical Research Scientist with 20+ years of experience in pharmaceutical drug discovery and development in CRO and industry settings. Most recent clinical development experience in multiple sclerosis space leading to the successful marketing authorization of Zeposia (ozanimod) in the US and Europe. Therapeutic areas: Dermatology, Gastroenterology, Immunology/Inflammation, Neurology, and Oncology (Hematology and Solid Tumors).

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

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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

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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: 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

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Session Details: Unique aspects of designing and managing CAR-T trials 13-02-2020, 2:00 pm View In Agenda

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Session Details: Small Pharma Outsourcing Strategies in Oncology 13-02-2020, 4:00 pm View In Agenda

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Session Details: From Pediatric to Adult Indication: Expanding a Product Life Cycle 12-02-2020, 11:30 am View In Agenda

Biography: Lydia King, PhD, MPH, is the Director of Biostatistics at Ce3 Inc.  In this role, she provides strategic direction for biostatistics across multiple study teams, ensuring appropriate statistical techniques for all endpoints.  Dr. King offers more than 20 years of experience in SAS programming, study design, and statistical analysis, with an emphasis in oncology trials in most recent years.   Prior to her work in clinical trials, Dr. King spent a decade in academia where her research and analytical skills were displayed at professional conferences as well as in peer-reviewed publications.  Dr. King holds a Bachelor of Science from the University of Alabama, a Master of Public Health from Emory University, and a PhD in Epidemiology from the Medical University of South Carolina.

Session Details: Real-time evaluation of complex efficacy endpoints in oncology trials 12-02-2020, 2:00 pm View In Agenda

Biography: Melissa Hill MPH is a clinical programmer at Ce3 Inc. In this role, she balances the requirements of multi-disciplinary teams to develop cross-functional tools for reviewing clinical trial data in real-time.  Prior to her role as a clinical programmer, Ms. Hill worked at the Yale University Center for Perinatal, Pediatric, and Environmental Epidemiology as a Research Associate.  Specifically, she provided programming support, performed biostatistical analyses, and coordinated research teams for NIH funded grants.  Ms. Hill has co-authored a book Data Management Essentials using SAS and JMP (2016) as well as multiple peer-reviewed publications of epidemiological analyses (2010-2015) and regularly shares her work at relevant industry conferences.  Melissa holds a Bachelor of Arts from Villanova University and a Master of Public Health from Yale University.

Session Details: Real-time evaluation of complex efficacy endpoints in oncology trials 12-02-2020, 2:00 pm View In Agenda

Biography: Julie Martin, M.Sc., MBA, Director, Clinical Operations, Scimega Research has developed an expertise in managing a wide array of oncology clinical trials set in early and late clinical development stages including collaborative efforts with larger CROs. At Scimega she is responsible for the strategic planning, conduct and oversight of oncology clinical trials across Canada, and for the development of project proposals. In addition, Mrs Martin serves as Director, Business Development, and is a member of Scimega’s managing Board of Directors. She received her Master of Science in Biochemistry from the University of Montreal and holds a Masters of Business Administration from Concordia University. Mrs. Martin is a member of the American Society of Clinical Oncology (ASCO) and the Society of Clinical Research Associates (SoCRA).

Session Details: Why Scoring High on Critical Trial KPIs Matters Most 12-02-2020, 9:30 am View In Agenda