Clinical Operations in Oncology Virtual Conference 2021

Biography: An entrepreneur and CEO with more than two decades of experience in the medical cannabis, biotechnology, pharmaceutical, nutraceutical, and medical device industries, Christina’s dedication to revolutionizing patient care is unprecedented. Through her roles as CEO, Spectral Analytics Precision Tele-Monitoring, Founder and CEO of Affinity Bio Partners, Board President and CEO of Affinity Patient Advocacy, and CEO & Co-Founder of AI Health Outcomes, Christina has been involved with revolutionary projects and global clinical studies that positively impact patients. As a clinical research pioneer, contracts negotiator, Opinion Columnist for CEO WorldBiz, and host of the I Am Christina DiArcangelo show, she has utilized the tools at her disposal to champion patient care and provide best-in-class patient advocacy services. For Christina, patient care comes first.

Session Details: PATIENT SNIPPET STORY: Participating in a clinical trial: what can be improved from a patient perspective? 01-12-2021, 9:00 am View In Agenda

Biography: Dr Mishra (Ex Genentech, Ex NCI, Ex NIH) is the founding president and CEO of the American Association for Precision Medicine ( and chair of ACT AAPM’s Coronavirus Taskforce He is leading research efforts focused on preventing curing chronic diseases not only treating the sick but also providing knowledge/tools to individuals to live longer, healthier lives He is also the founder and CEO of Agility Pharmaceuticals, a pharmaceutical company committed to revolutionizing drug discovery development through technology, big data, robotics, and artificial intelligence He is a serial entrepreneur who founded his first company after graduating high school, and his second company during his Ph D Since then, he has accumulated a wealth of experience by building, investing, and advising numerous other companies He is an investor, co founder/ board member of a few corporations, focused on accelerating drug discovery/ development, data analytics, robotics, mental health, and digital health He is also the founder of AAPM Angels and Investors AAi an investment group focused on investing in drug discovery, diagnostics, precision medicine, technology healthcare companies He is also the founding investor and advisor to Barcelona Ventures and serves as an advisor to a 100 M private equity fund Widely recognized as a thought leader in the field of ‘technology and healthcare’, Dr Mishra has keynoted, chaired, curated, and organized numerous successful international conferences He served as a Scientist and Principal Investigator at the pharma giant Genentech, Roche Where he participated in several drug discovery project teams Moreover, his passion for drug development and precision medicine has led to the identification of new drug targets, biomarkers, companion diagnostics, and several drugs/ combinations in the clinic His research work has been recognized globally by over 40 prestigious awards and honors Due to his unique perspective selfless service, he is a highly respected sought after mentor to many The companies that he has advised have raised multimillion dollars Notably, he serves as a mentor and advisor to several VC funds and startup accelerators, including IndieBio HIMSS/Health 2 0 ’s Project Zygote, MedLabs ZGC Capital, J&J JLabs UCSF Innovation Venture, UCSF Invent Fund, and California Life Sciences’s FAST program, to help grow California’s life sciences innovation ecosystem

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Session Details: CASE STUDY: Targeted personalized cancer therapy: the holy grail of cancer treatment 01-12-2021, 4:30 pm View In Agenda

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Session Details: FIRESIDE CHAT: Fear of unknown: overcoming challenges in data management in early phase oncology trial 01-12-2021, 3:30 pm 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: OPEN PANEL DISCUSSION: Unpacking decentralized trials: what remote elements can be incorporated into oncology trials? 01-12-2021, 1:30 pm View In Agenda

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Session Details: Cytokine Release Syndrome and Neurotoxicity Considerations for CAR T Therapeutic Studies 01-12-2021, 9:00 am View In Agenda

Biography: Ahmad Namvargolian co-founded Care Access in 2015 which quickly grew into one of the most trusted clinical research companies in the US. Namvargolian’s one core mission for Care Access is to remove barriers in clinical research for sponsors, physicians, and patients; making clinical research accessible to all. This mission was put to test in 2020 when COVID-19 swept through the world causing shutdowns of businesses and clinics. Under Namvargolian’s leadership, Care Access expanded its unique industry solutions and delivered on the largest and most complex decentralized trial to date, taking clinical research directly to patients by deploying “Jump Teams” anywhere in the country and creating pop-up research infrastructure on demand. Having established over 150 “pop-up” sites, Care Access has enrolled over 4,000 patients and conducted over 60,000 home visits. Prior to Care Access, Namvargolian was a research scientist and earned his Master’s Degree in Public Policy from University of Chicago and Bachelor of Science degree in Bioengineering and Material Science from UC Berkeley.

Session Details: OPEN PANEL DISCUSSION: Unpacking decentralized trials: what remote elements can be incorporated into oncology trials? 01-12-2021, 1:30 pm View In Agenda

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Session Details: CASE STUDY: An SME performing a multi-site trial: overcoming challenges under the (post-) pandemic era 01-12-2021, 12:00 pm View In Agenda

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Session Details: CASE STUDY: An SME performing a multi-site trial: overcoming challenges under the (post-) pandemic era 01-12-2021, 12:00 pm View In Agenda

Biography: Bonnie Bain, PhD, is the Global Head and EVP of Healthcare Operations and Strategy. Bonnie has over 20 years’ experience in the healthcare sector and a proven track record of developing innovative solutions on both the client and agency sides of the business. Bonnie was GlobalData Healthcare’s first Western analyst, and under her leadership, the company launched a number of premium syndicated reports, analytical tools, and databases in the pharmaceuticals and medical devices space. Prior to GlobalData, Bonnie was Vice President and Global Research & Analysis Director for Informa’s Pharma Division, which includes Datamonitor Healthcare, Scrip Group, and Business Insight. Bonnie also worked for several years at Decision Resources as an Analyst and Project Manager. On the client side of the industry, Bonnie worked for several years as a Senior Manager in Marketing Strategy and Analytics at Boston Scientific, where her work contributed to the successful commercialization of the first ever Access and Visualization Platform at the company. Bonnie has a PhD in Biochemistry and Molecular Biology from Purdue University and completed a Post-Doctoral Fellowship in Molecular Pharmacology at the University Of Miami School Of Medicine. She also has a graduate certificate in Applied Management Principles from Purdue University Krannert School of Management.

Session Details: Embracing disruption in pharma: is COVID-19 a catalyst for lasting change? 01-12-2021, 1:00 pm View In Agenda

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Session Details: Chair’s opening remarks 01-12-2021, 8:55 am OPEN PANEL DISCUSSION: Unpacking decentralized trials: what remote elements can be incorporated into oncology trials? 01-12-2021, 1:30 pm View In Agenda

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Session Details: Regulatory spotlight: pathways for expedited drug approvals in oncology 01-12-2021, 2:30 pm View In Agenda

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Session Details: Building an effective site-sponsor connection and making the trials easier on sites and patients 01-12-2021, 2:00 pm View In Agenda

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Session Details: Building an effective site-sponsor connection and making the trials easier on sites and patients 01-12-2021, 2:00 pm View In Agenda

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Session Details: Building an effective site-sponsor connection and making the trials easier on sites and patients 01-12-2021, 2:00 pm View In Agenda

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Session Details: The role of the ‘virtual’ patient in oncology trials 01-12-2021, 11:00 am View In Agenda

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Session Details: What is fuelling the rapid rise of oncology clinical development in China? 01-12-2021, 9:30 am What is fuelling the rapid rise of oncology clinical development in China? 01-12-2021, 10:45 am View In Agenda

Biography: Cesare has more than 20 years of experience in the drug development field, in both scientific and commercial roles. He is co-founder and Chief Operating Officer of Oncoheroes Biosciences Inc., a Boston-based biotech company exclusively focused on paediatric oncology drug development. Prior to that he held senior positions at AMRI, Aptuit Laurus, ThalesNano and Auxiliis BV. Cesare started his career as research scientist in a pharmaceutical company (Eisai, London) and in academia (Institute of Enzymology, Budapest). Following the death of his first daughter Laura to cancer, Cesare set up aPODD Foundation, a London-based charity focused on accelerating paediatric oncology drug development. As aPODD’s chairman and trustee he is actively involved on a pro-bono basis in drug repurposing projects, advocacy efforts and research collaborations with other childhood cancer charities. Cesare holds an MSc in Applied Molecular Biology and a PhD in Neurosciences from UCL, University of London, as well as an MBA from the Central European University, Budapest.

Session Details: FIRESIDE CHAT: Drug development for pediatric cancers: what additional hurdles need to be overcome when working with children? 01-12-2021, 1:30 pm View In Agenda

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Biography: Clare has been doing clinical trials in clinical operations and project management for the more than 18 years. Her first 15 years were with the CROs. She started off her career in LabCorp (formerly known as Covance) as a CRA who manages sponsor studies in Singapore and Malaysia. Later on, she joined PPD and over the years, she  became the regional head for Singapore, Malaysia, Vietnam and Indonesia. Clare then returned to LapCorp and headed the Early Clinical Development team in Asia Pacific to run Immuno-Oncology, Rare Diseases and Epidemiology studies in the region. Clare is now with Tessa Therapeutics, working on cell therapy studies, focusing on CAR-T treatment.

Session Details: CRO oversight for gene and cell therapy studies: 01-12-2021, 10:00 am View In Agenda

Biography: Mary Jo Lamberti is a faculty member at Tufts Medical School and Associate Director of Sponsored Research at Tufts CSDD at Tufts University School of Medicine. She has extensive experience on benchmarking drug development operating practices. Her research focuses on a variety of areas including outsourcing and partnerships, clinical supplies, investigative site initiation and management, patient recruitment and retention, and the use of technologies and digital solutions in clinical trials. She has been a frequent speaker at global industry conferences and has published extensively. She holds a B.A. from Wellesley College and a Ph.D. from Boston University.

Session Details: STUDY RESULTS: Clinical research professionals and the shift to remote work during the COVID-19 pandemic 01-12-2021, 12:30 pm View In Agenda

Biography: Maria Florez is involved in research looking at the impact of digital transformation in clinical research and organizational strategies and practices driving improvement in development operations and economics. Maria has been a researcher and strategist in the healthcare sector for 15 years. She has held positions at Cleveland Clinic and at New York-Presbyterian Hospital of Columbia and Cornell Universities and has published articles in trade and peer-reviewed journals. She holds a B.S. in economics and an M.A. in international economics from The Fletcher School of Law and Diplomacy at Tufts University.

Session Details: STUDY RESULTS: Clinical research professionals and the shift to remote work during the COVID-19 pandemic 01-12-2021, 12:30 pm View In Agenda

Biography: As the Director of Clinical Research, Latoya Lashley oversees the operational management and compliance of the Neely Center for Clinical Cancer Research (NCCCR) at Tufts Medical Center. Her work includes supervising clinical research staff, as well as developing and maintaining partnerships with industry sponsors, hospital collaborators, and clinical trial network professionals. The NCCCR participates in over 120 active clinical trials including cooperative group, federally-funded, investigator-initiated and industry-sponsored trials. The NCCCR is the core facility of the Tufts Medical Center Cancer Center dedicated to promoting oncology and hematology clinical research in compliance with local, federal, and sponsor/funding agency clinical trial policies. Over the previous twelve years, Ms. Lashley has worked with a range of stakeholders as a Clinical Research Coordinator, Project Manager, and Clinical Research Manager with a focus in pediatric oncology at the Dana-Farber/ Boston Children’s Cancer and Blood Disorders Center. Ms. Lashley holds a Master in Public Health from Boston University School of Public Health and is a Certified Clinical Research Professional since 2016.

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Biography: Quinn leads her team in navigating Axiom's clients throughout their entire project lifecycle based on their study needs, from Fusion eClinical Suite configuration to database lock and closeout activity. Quinn’s team is dedicated to executing well-planned processes to offer clients the best possible experience. Her passion lays with developing strategy, processes, and people as we continue to grow.

Session Details: To the front of the line: how to navigate site selection and start-up with specific tailoring to small biotech and pharma 01-12-2021, 12:00 pm View In Agenda

Biography: Jas has over 17 years of CRO experience; primarily in small to mid-size biotech companies within oncology. She has managed numerous oncology clinical trials from Phase I to Phase 3, including solid and liquid tumors. Jas is currently responsible and accountable for the clinical management department overseeing the entire life cycle of a project, from feasibilities and site selection, initiation, enrollment/treatment, and final TMF handover. She is a collaborative leader, and her strengths are providing realistic solutions to oncology clinical trials.

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Session Details: Decentralized trials in oncology: execution today and forecast for tomorrow 01-12-2021, 11:30 am View In Agenda

Biography: Joss is Executive Director and Head of Strategy & Partnerships at THREAD Research, a leading provider of Decentralized Clinical Trial technologies for life sciences. In his role, Joss oversees all aspects of THREAD’s corporate strategy and establishes strategic relationships with third parties to develop collaborative solutions that integrate with THREAD’s decentralized clinical trial (DCT) platform. These partnerships help drive THREAD’s mission of creating a single comprehensive experience for decentralized research to make studies more inclusive and more efficient. Prior to THREAD, Joss was a leader in IQVIA’s Real World Solutions group, driving innovation in clinical research through the application of real-world data to optimize clinical trial planning and design external control arms.

Session Details: Best practices for oncology DCT adoption 01-12-2021, 10:30 am Reserved for 01-12-2021, 9:30 am View In Agenda

Biography: Tatiana Eidus, biophysicist by training, has over a decade of experience in clinical development. Holding positions at CROs and global pharma companies, Tatiana has accumulated wide expertise in operational aspects of initiating and managing Phase I-III trials across Europe and US. Drawn by ARENSIA’s team spirit and its mission to accelerate drug development process and enable patient´s access to novel medicines faster, Tatiana joined ARENSIA’s US office in Cambridge, MA in 2015. In her current role as Director Corporate Development, Tatiana is responsible for cross-functional coordination of setting up of new clinical programs and overseeing the trials throughout their execution.

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