Clinical Operations in Oncology Trials West Coast 2022

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

Session Details: Regulatory insights: understanding FDA accelerated approval processes 05-04-2022, 4:00 pm PROBLEM-SOLVING ROUNDTABLE DISCUSSIONS 06-04-2022, 9:00 am View In Agenda

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Session Details: FIRESIDE CHAT: Fear of the unknown: modern clinical data challenges in oncology 05-04-2022, 12:00 pm View In Agenda

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Session Details: FIRESIDE CHAT: Fear of the unknown: modern clinical data challenges in oncology 05-04-2022, 12:00 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: Chairperson’s opening remarks 05-04-2022, 8:20 am OPENING KEYNOTE: Disruption in oncology clinical trials: new technology and themes in 2022 05-04-2022, 8:30 am PANEL: The ongoing challenge of patient recruitment: what’s new for oncology studies in 2022? 05-04-2022, 11:00 am Chairperson’s closing remarks 05-04-2022, 5:30 pm Chairperson’s opening remarks 06-04-2022, 8:50 am PROBLEM-SOLVING ROUNDTABLE DISCUSSIONS 06-04-2022, 9:00 am PANEL: Looking at new trends and themes for oncology clinical trials in the wake of the pandemic: what’s new, and what’s changed? 06-04-2022, 11:00 am Chairperson’s closing remarks 06-04-2022, 3:15 pm 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: PANEL: The ongoing challenge of patient recruitment: what’s new for oncology studies in 2022? 05-04-2022, 11:00 am View In Agenda

Biography: Mr. Luciano joined Corvus Pharmaceuticals in 2018 and has served as Vice President of Clinical Operations since 2021. He was Senior Director of Clinical Operations at Pharmacyclics from 2012 to 2017 where he was responsible for the development, implementation and maintenance of the Clinical Operations infrastructure, as well as the GCP inspection hosting platform and processes, and regulatory authority marketing approval inspection hosting. From 2008 to 2011, he was Senior Clinical Trial Manager at Seattle Genetics where he was responsible for the oversight of multiple oncology clinical trials, as well as support for the development of the Clinical Operations infrastructure and regulatory authority marketing approval inspection hosting. From 1990 to 2008 he held various Clinical Operations positions at Abgenix, Pharmacyclics, Quintiles, Covance and Syntex. Mr. Luciano earned a B.A. in Psychology and Biology from the University of California at Santa Cruz.

Session Details: MINI WORKSHOP: Establishing and maintaining investigators engagement in a competitive oncology clinical trial landscape 05-04-2022, 2:00 pm View In Agenda

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Session Details: Successfully navigating and making the most of your interactive response systems 06-04-2022, 1:45 pm View In Agenda

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Session Details: EXPERT INSIGHTS: Designing a decentralized oncology trial: strategies for success 05-04-2022, 9:30 am View In Agenda

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Session Details: Managing academic partnerships with oncology start-ups 05-04-2022, 5:00 pm View In Agenda

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Session Details: PANEL: Looking at new trends and themes for oncology clinical trials in the wake of the pandemic: what’s new, and what’s changed? 06-04-2022, 11:00 am View In Agenda

Biography: Dr. Ravi Kiron based in California, USA is an experienced pharma/biotech executive with decades of experience in discovery R&D through late-stage clinical development, intellectual property and regulatory, technology & business development, M&A, strategy and product commercialization, negotiating and executing partnerships by leveraging his extensive global business development networks in CVMD, Oncology, CNS, Wound Healing, Microbiome and Diagnostics. He was a tenure-track faculty member at Cornell University Medical College and adjunct faculty at University of Rhode Island. Dr. Kiron served in various operational & management roles at Pfizer Inc., and J&J/ALZA, in Cardiovascular R&D, Oncology clinical development (Tarceva), strategic business development and M&A (acquisition of WLA, PHA & other biotech).  Dr. Kiron has consulted for several dozen global biotech & pharma companies, founded and led multiple companies/new ventures, served as an Entrepreneur In Residence (EIR) at SRI Ventures, ShangPharma Innovation and advises company and non-profit boards. ​ Currently, Dr. Kiron is Head, BioPharma External Innovation at the Merck KGaA/EMD Serono’s Silicon Valley Innovation Hub in Menlo Park, California and is exploring cutting edge game changing technologies (Artificial Intelligence & Machine Learning, Microbiome, Electroceuticals etc.) to have an impact on pharma/biotech research, product development and launches.

Session Details: PANEL: Looking at new trends and themes for oncology clinical trials in the wake of the pandemic: what’s new, and what’s changed? 06-04-2022, 11:00 am View In Agenda

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Session Details: PROBLEM-SOLVING ROUNDTABLE DISCUSSIONS 06-04-2022, 9:00 am Reducing the burden of clinical trials on cancer patients 06-04-2022, 2:45 pm View In Agenda

Biography: Elise Brownell, PhD. has spent the last 35 years in the bio/pharmaceutical arena where she has played key roles in Discovery, Development and Opportunity Assessment to drive innovation. After completing her doctorate at Yale University, Elise’s career started at SUNY Stony Brook. She continued her interest in comparative molecular biology during her tenure at Frederick Cancer Research Facility and expanded her facility with molecular genetics while in various functions at Bayer Healthcare. Her efforts were widely recognized by promotion to Director, Project Management, where she led global cross-functional teams. Elise also became a member of the founding team of a venture-backed spin out (Aerovance, Inc), where she became head of project management. Dr. Brownell serves in Interim Executive capacities for a number of emergent and highly innovative companies in the Life Science sector, and as a mentor to the entrepreneurs who run them. Elise received her MS, MPhil and PhD from Yale University, and her BS from Allegheny College

Session Details: PROBLEM-SOLVING ROUNDTABLE DISCUSSIONS 06-04-2022, 9:00 am View In Agenda

Biography: As a Solutions Consultant with eClinical Solutions, Dan serves as a subject matter expert for the elluminate Clinical Data Cloud, the foundation of digital trials. Dan is responsible for presenting the robust data management solutions made possible with elluminate, and can customize product demonstrations to address specific customer needs.

Session Details: Data-driven operations and oversight with elluminate 06-04-2022, 12:15 pm View In Agenda

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Session Details: PANEL: The ongoing challenge of patient recruitment: what’s new for oncology studies in 2022? 05-04-2022, 11:00 am View In Agenda

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Session Details: Operational considerations for protocol development to support study success 05-04-2022, 3:00 pm View In Agenda

Biography: As head of strategic initiatives and a member of the executive leadership team at Suvoda, Kelly is responsible for driving strategic growth across the organization. Prior to this, Kelly spent 4 years as VP of Product Management and Marketing at Suvoda, where she led the strategic direction of the product suite and external communications. She has spent her career in professional services and product development teams, working with Top 10 Pharma companies in e-clinical focused organizations including Phase Forward and Oracle, as well as B2C technology companies. Kelly holds a bachelor's degree in Interdisciplinary Studies in Bioethics focusing on Neuroscience and Philosophy, a certificate in Conceptual Foundations of Medicine, and a minor in Italian Literature and Language from the University of Pittsburgh.

Session Details: Flexible by design: tools to manage uncertainty and complexity in early phase oncology trials 05-04-2022, 10:00 am PANEL: Looking at new trends and themes for oncology clinical trials in the wake of the pandemic: what’s new, and what’s changed? 06-04-2022, 11:00 am View In Agenda

Biography: Jef Benbanaste has led the launch and commercialization of multiple analytical SaaS solutions at Medidata and currently leads Intelligent Trials. Jef has over 16 years of experience improving business processes and decision-making through the use of technology and analytics. Prior to joining Medidata, Jef led projects at the global insurance company AIG which applied predictive modeling and machine learning techniques to improve risk segmentation and shape business unit strategies. Before that, he was in technology consulting at Deloitte. Jef has a MBA from MIT and a BS from the University of Virginia.

Session Details: AI powered enrollment forecasting and real time study tracking against industry 05-04-2022, 9:00 am PANEL: Looking at new trends and themes for oncology clinical trials in the wake of the pandemic: what’s new, and what’s changed? 06-04-2022, 11:00 am View In Agenda

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Session Details: A gateway to efficiency: oncology adaptive design 05-04-2022, 4:30 pm View In Agenda

Biography: Julie Martin - CEO & co-Owner joined Scimega 9 years ago. Having worked for 2 other CROs before, her passion for Scimega’s business and team stems from knowing its expert oncology clinical development services add distinct value to industry stakeholders at a time when it’s needed most. As CEO, Julie’s vision is to secure the company’s long-term success by leveraging her in-depth industry expertise & business acumen. She equates that success with setting a clear vision for the organization’s continued sense of purpose. Her leadership & collaboration with the managing Board of Directors combined ensure the business excellence upon which Scimega has built its reputation. Julie plays a vital role in promoting Scimega’s expertise and showcasing Canada’s attributes as a formidable partner in global oncology drug development.

Session Details: Building effective site relationships: a solid case 05-04-2022, 11:30 am View In Agenda

Biography: Dr. Mahillo has 28+ years of experience in the clinical research arena, 25 of them in oncology global trials. Her areas of expertise are inmuno-oncology, including cancer vaccines, advanced therapies, genetically modified organisms and other immuno therapies. She has an in-depth knowledge on oncology networks and advocacy groups, with which she cooperates since 1999. Dr. Mahillo is a professor/magister in several Master programs administered at different Universities (Universidad Alcalá de Henares, Universidad CEU San Pablo, CESIF). She has authored of 3 books, 20 scientific articles, and 24 contributions to scientific congresses. Dr. Mahillo was awarded the first prize of the Spanish Society of Medical Oncology (SEOM) in 2015 for her project “Y Seguiré” (will keep on moving), for the promotion of clinical research. Dr. Mahillo obtained her PhD with a research on the role of multicatalytic proteinase (proteasome) as an oncology intracellular target, research line that ended up with the development of bortezomib, a proteasome inhibitor approved for the treatment of multiple myeloma patients.

Session Details: Holistic approach to oncology clinical research in the era of personalized medicine 05-04-2022, 12:30 pm View In Agenda

Biography: Dr. Patt is Co-Founder and Principal in RadMD. He has a broad prior experience in medical imaging: this includes research and development of contrast agents: design and manage site and central reviews and trained reviewers for over 300 oncology trials; and has expertise in cardiovascular device, infectious disease, and pulmonary fibrosis trials. He has performed blinded reads and adjudications in a variety of trial types. He has held positions as both an academic and private practice radiologist. After his fellowship at Georgetown University and the National Institutes of Health (NIH), he served as Chief of Body MRI, then Director of MRI, at Georgetown University Medical Center, where he was both an investigator and blinded reader in numerous pharmaceutical and medical device clinical trials. He subsequently joined Berlex Labs as Associate Director, followed by Director of Medical Imaging Clinical Development. where he managed an experienced team in all phases of clinical development of radiological contrast agents. Dr. Patt also served as Medical Director for HealthHelp, a radiology management services organization. He founded Foresight Consulting, working with pharmaceutical and medical device companies on the utilization of medical imaging into clinical development programs. He has numerous publications, has served on an NCI Advisory Panel, is a reviewer for major radiology journals, and has been an invited lecturer across the US and Europe on the use of medical imaging in clinical trials.

Session Details: Image assessments in early phase oncology trials and imaging risks that can affect your trial: imaging data insurance policy for better decision-making 05-04-2022, 2:30 pm View In Agenda

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Session Details: Strategies for successful oncology recurrence trials 06-04-2022, 11:45 am View In Agenda

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Session Details: How ongoing COVID-19 infections are affecting oncology clinical trials 06-04-2022, 2:15 pm View In Agenda