Clinical Operations in Oncology Trials 2020: A Virtual Experience

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Session Details: Exploring the Use of Technology as a Tool for Successful Patient-Centric Oncology Trials Resulting in Enhanced Patient Retention 15-07-2020, 11:00 am View In Agenda

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Session Details: Assessing Clinical Trial Data Volume and Diversity and its Impact on Data Management Timelines 15-07-2020, 9:10 am View In Agenda

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Session Details: Clinical Analytics for Safety Assessment 15-07-2020, 10:40 am View In Agenda

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Session Details: Session reserved for ERT 15-07-2020, 9:40 am 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: How to Score High on Critical KPIs Under the ‘New Normal' 15-07-2020, 9:30 am View In Agenda

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: Lessons Learned from Master/Basket Trials Clinical Operations 15-07-2020, 10:00 am View In Agenda

Biography: Jessica Cordes studied Molecular Life Science in Luebeck and started her business career for 2 years at the Central Lab MDS Pharma Services as project manager. She moved then to GlaxoSmithKline where she worked as country project leader for 4 years. In 2013, she moved to MorphoSys, working for four years in an international role as clinical trial leader. 2017 she moved to Medigene headquarter as clinical trial manager and is now leading the Clinical Operations group since 2018

Session Details: Patient engagement supporting recruitment in an ATMP-Clinical Trial 15-07-2020, 10:10 am View In Agenda

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Session Details: Patient engagement supporting recruitment in an ATMP-Clinical Trial 15-07-2020, 10:10 am View In Agenda

Biography: Andreas is a health-care professional and entrepreneur in the field of patient-centered health-care. He is a state-registered pharmacist and earned a PhD in Pharmacology from the Johann Wolfgang Goethe-University, Frankfurt, Germany and an MBA from the University of Bradford, UK. He has more than 27 years of experience in health care: 4 years of academic research in pharmacology, more than 7 years in the pharmaceutical industry (clinical research, international marketing, drug information), more than 12 years as President, CEO and Managing Director in patient organizations. He was serving as a patient-representative at the Federal Joint Committee (G-BA), the central steering body in the German health-care system for almost 11 years. He held multiple volunteer positions at national and European level in the board of patient-organisations.  In 2015, Andreas established admedicum^® that helps companies and health-care providers aligning their products and services with the needs of the patients along the life-cycle from early development over clinical development and market-access to commercialization.

Session Details: Patient engagement supporting recruitment in an ATMP-Clinical Trial 15-07-2020, 10:10 am View In Agenda

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Megan brings nearly 23 years of industry experience across a broad range of therapeutic areas, including oncology, infectious disease, pain and respiratory with a focus on project management and clinical operations at both pharma and CROs.  She has experience with several types of agents with a specific interest in advancing cellular immunotherapeutics.  Megan recently presented at the ISCT Commercialization Series on start-up considerations for global expansion of cell therapy trials and previously presented a webinar entitled ‘Operational Excellence in Immuno-Oncology Clinical Trials’.  As a member of Precision’s Adoptive Cell Therapy working group, she works with scientific, medical and clinical operations experts to stay abreast of recent developments in this evolving space as well as assist in the standardization of forms, templates and trainings to promote consistency in execution of these trials at Precision.

Session Details: Using Data Sciences to Drive Innovations in Clinical Trials 15-07-2020, 10:30 am 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: Clinical Analytics for Safety Assessment 15-07-2020, 10:40 am View In Agenda

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Session Details: Building better partnerships for biotechs without major pipelines or R&D budgets 15-07-2020, 11:10 am View In Agenda

Biography: Tom has worked in the life sciences industry for over 20 years, initially as a pharmaceutical representative and then as a pharmaceutical product manager. Over the past 10 years Tom has become an expert in providing sponsors and CRO’s with an innovative clinical supply process that is patient centric, saves clinical operations and supply management teams time and saves sponsors money.

Session Details: Discover Real World Innovation in Oncology Clinical Trial Supplies 15-07-2020, 11:30 am View In Agenda

Biography: Bryant has enjoyed nearly 25 years in clinical research domain, mostly comprised of industry leadership in clinical data management and clinical operations. Most notably, he developed and led a global team of clinical data managers in the successful delivery of high quality data in Oncology, Hemophilia and Ophthalmology submissions. Bryant has led workstreams in the identification of innovative and transformative process and tools for future clinical data environments. Immediately prior to joining Medidata, he supported departments in clinical data standards and HEOR research. Bryant is currently the Director, Data Science and Analytics Portfolio where he ensures seamless coordination and oversight between commercialization, marketing, strategy and corporate development operations for Data Science products and solutions.

Session Details: Making Precision Medicine a Reality in Clinical Development, Discovery and Beyond 15-07-2020, 11:40 am View In Agenda

Biography: Aditi Khurana, is a Senior Manager of Project Management with Jazz Pharmaceuticals, Palo Alto, CA. She is a Project Management Professional (PMP) and is certified in Global Regulatory affairs (RAC). She holds a Bachelors in Neuroscience from University of California Los Angeles, and a Master of Business Administration from University of Illinois Urbana-Champaign. She has 11 years of combined experience working initially in the biomarker identification, companion diagnostics & assay development space as an ASCP licensed Clinical Cytogenetics and Molecular Biologist, and later in project management roles leading planning for clinical development and regulatory submissions deliverables. Key areas of focus include study concept development, IND and BLA submission planning, decision frameworks and developing strategic roadmaps for global product success. Early in her career, she worked as a clinical bench scientist and supported validation of lab developed tests for solid tumor panels for lung, breast, and gastroesophageal tissue, several Heme-Onc indications such as AML, ALL, NHL and MM, molecular sequencing panels, and liquid biopsy tests. These tests were used to confirm diagnostic, prognostic and predictive elements of the disease and/or therapy. In her free time she enjoys non-fiction reading, dabbling in poetry, volunteering for professional organizations, pursuing philanthropic initiatives or just chasing her curiosity into new avenues.

Session Details: Navigating the Oncology Landscape- A Regulatory Perspective 15-07-2020, 12:10 pm View In Agenda

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Session Details: Immuno-oncology: will we meet its challenges? 15-07-2020, 12:00 pm View In Agenda

Biography: Amanda Paley is the Senior Director Clinical Development Strategy at AiCure and works with industry sponsors conducting phase I - IV studies. In her role Amanda works closely with sponsors to determine how to best align artificial intelligence technologies to support medication adherence, data quality, and collection of novel digital endpoints in their trials and enable new approaches to making data-driven decisions across their portfolio. Previously, she led the Enrollment Strategy and Protocol Analytics group at Acurian, where her team developed clinical trial patient recruitment strategies. She holds a psychology degree from Boston University and began her career in clinical research working as a study coordinator in multiple therapeutic areas at Boston University School of Medicine and the University of Texas Health Science Center.

Session Details: The Dose for the Right Patient in Oncology Trials 15-07-2020, 12:30 pm View In Agenda