Clinical Operations in Oncology Trials East Coast 2023

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 19-07-2022, 8:50 am OPENING KEYNOTE: Disruption in Oncology trials: new technology and themes in 2022 19-07-2022, 9:00 am Chairperson’s opening remarks 20-07-2022, 8:50 am View In Agenda

Biography: Fatima is passionate about elevating the patient voice on a global scale.   She believes that understanding patient experiences and challenges is essential to speeding up the development of life-changing medicines. Further, she advocates in support of patients gaining the skills, courage, and knowledge to navigate through a cancer diagnosis, to make informed decisions, and to ensure they can advocate for and achieve the best care possible.   This fierce passion and commitment to putting the needs of patients first is evident in her decades-long career where she is recognized as an influential global advocate thought leader focused on patient centered research, policy, access, and regulatory impact.   She has held multiple senior management positions in healthcare and is a respected member of the biopharma and cancer communities. Fatima has contributed to numerous publications in partnership with the advocacy community and key academic researchers to advance patient-centered care, as well as being included in the PharmaVOICE 100 in 2014 and receiving the Trailblazer Brand Champion Award from PM3670 in 2015

Session Details: PANEL: Reducing the burden of clinical trials on oncology patients 19-07-2022, 11:30 am View In Agenda

Biography: Leticia has over 20 years of industry experience managing several research projects and clinical studies in various roles. She started her career in Pharma at Biogen, working collaboratively in an integrated monoclonal antibody research team and then moving to development in clinical operations, where she managed numerous phase I-III clinical trials in diverse therapeutic areas including, gastroenterology, immunology, neurology, and neuropathic pain.   She continued her career at Merck/EMD Serono where she served as a Clinical Research Scientist providing strategic and operational expertise in the planning and conduct of Phase I-III clinical studies in oncology and immuno-oncology, contributing to the BLA submission of BAVENCIO®, which led to the FDA accelerated approval in merkel cell carcinoma and in urothelial carcinoma. Later she served as a Chief of Staff to the Head of Development in Oncology, where she partnered with executive sponsors to identify and promote projects that are of strategic importance to the company and translating the function strategy into operational plans.   In 2020 Leticia joined Black Diamond Therapeutics, a biotech company addressing the significant unmet need for novel precision oncology therapies for patients with genetically defined cancers. Leticia’s efforts have been widely recognized by promotion to Executive Director of Clinical Operations where she is responsible for ensuring that clinical stage programs achieve objectives within established timelines, budget, and quality standards, while fostering a highly collaborative culture and serving as a leadership role model.   Leticia earned her Bachelor’s Degree in Biomedical Laboratory and Clinical Sciences from the School of Medicine at Boston University, followed by a Master’s Degree in Regulatory Affairs and Health Policy from the Massachusetts College of Pharmacy and Health Sciences in Boston.

Session Details: PANEL: Reducing the burden of clinical trials on oncology patients 19-07-2022, 11:30 am PANEL: Incorporating decentralized approaches into your oncology trial: what works, and what doesn’t? 20-07-2022, 11:00 am FIRESIDE CHAT: Handling the long term impact of COVID on oncology clinical trials 20-07-2022, 1:30 pm View In Agenda

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Session Details: Growing an Early Development pipeline by 300% in 2 years, leveraging T and NK cell immunology, maintaining innovation and a collaborative culture 19-07-2022, 12:45 pm View In Agenda

Biography: Tamieka Lauz Hunter joined Relay Therapeutics 1.5  years ago. Having worked for a multitude of pharmaceutical, biotechnology and CRO organizations over 12 years with primary therapeutic expertise in clinical execution of oncology programs. Her passion lies in precision medicine and bringing novel therapeutic options to patients with unmet need. Tamieka acquired a MSHS: Clinical Research Administration at George Washington University School of Medicine.

Session Details: PANEL: Reducing the burden of clinical trials on oncology patients 19-07-2022, 11:30 am Recruitment and retention strategies in clinical trials 19-07-2022, 2:15 pm View In Agenda

Biography: Robert Buka is a Product Director for the Acorn AI Intelligent Trials portfolio. He leads Acorn's Study Feasibility product, which helps pharmaceutical sponsors and CROs use historical data and predictive algorithms to properly plan and execute their clinical trials to achieve study accrual targets. Robert has over 9 years of technology industry experience leading data science teams and delivering digital transformation projects. Robert studied Biology and Statistics at the University of Pennsylvania.

Session Details: AI Powered Enrollment Forecasting and Real Time Industry Insights 19-07-2022, 9:30 am 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 19-07-2022, 12:15 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 20-07-2022, 11:30 am View In Agenda

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Biography: Yolanda is the Vice-President of Clinical Operations at Accutar Biotechnology. She brings along 17 years of experience in Clinical Development, with focus on both Clinical Operations and Clinical Project Management. Her areas of expertise include strategic operations planning at the compound-level; first-in-human study planning & adaptive execution in therapeutic areas of oncology and ophthalmology. Leadership with cross-functional teams has included the development and implementation of governance and operational strategy, optimizing processes and building dynamic teams to exceed business objectives. Prior to joining Accutar, she held various positions at Bayer in the US and a number of countries within Asia. This attributes to her extensive knowledge of bridging-strategy between the two continents.

Session Details: PROBLEM-SOLVING ROUNDTABLE DISCUSSIONS 20-07-2022, 9:00 am View In Agenda

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Mr. Adams has been a founder or co-founder of life science and technology based companies in Massachusetts for the past several years. Mr. Adams has been instrumental in developing new proprietary therapeutic and medical device technologies and bringing the technologies to commercialization. The companies he has founded include, Compellis Pharmaceuticals, a developer of therapeutics to treat obesity and its co-morbidities, diabetes and hypertension and Mosaic Technologies, a venture backed MIT spin-out genomics company that developed patented technologies for genetic analysis and detection. Chris is the holder of more than 20 issued US and international patents for medical devices and pharmaceuticals.

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Biography: Dawn has over 20 years of experience in the pharmaceutical industry. She have worked within every level of clinical data management, from Data Coordinator to Senior Director where she participated in or had oversight for more than 250 clinical trials. During her time in the industry, she has provided consultation to organizations on clinical trial conduct, best practices in Data Management and data capture as well as developed standardized libraries and templates to support the adoption of CDISC standards. She is an active member of SCDM as a GCDMP SME, course designer and webinar presenter as well as Co-Chair of the annual conference (2018-2021) and serves on the SCDM Board of Trustees. Dawn is involved as a member of the CDISC-CDASH core team, Diabetes sub-team, CDASH CFAST Expanded Leadership Team and former Co-Chair of the CRF Library project. Dawn currently holds the position of Vice President, BD Operations, where she supports business development as a Clinical Subject Matter Expert for both software and data services as well as overseeing the Proposals and Solution Consulting departments.

Session Details: Data-Driven Operations and Oversight with elluminate 19-07-2022, 3:45 pm View In Agenda

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: KEYNOTE: Participating in a clinical study as a cancer patient 19-07-2022, 10:00 am View In Agenda

Biography: Michael Breen, PhD, is the Senior Director of Infectious Diseases and Oncology at GlobalData in Boston. He has over eight years of experience in market analysis, business intelligence, and providing strategic insight for the pharmaceutical industry. Prior to his current role, he was a Senior Analyst for Decision Resources Group, where he gained extensive experience writing in-depth reports and developing forecasts for a variety of indications, including rare and infectious diseases and vaccines. Michael has a BA in biology and biochemistry from Hunter College, and a PhD in biochemistry from Boston University School of Medicine.

Session Details: Clinical development landscape of immune-oncology agents 20-07-2022, 3:00 pm 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: Integrative approach to biomarker-driven patient enrolment in oncology and rare diseases clinical research 19-07-2022, 2:45 pm View In Agenda

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Session Details: Building confidence in wearable intelligence and digital biomarkers as novel endpoints in oncology trials 19-07-2022, 3:15 pm View In Agenda

Biography: As co-founder and Chief Operating Officer, Rob Hummel is responsible for global operations at Suvoda. His leadership is fundamental to the delivery of high-quality products, outstanding client services, and overall company growth. He maintains oversight of the sales and professional services teams worldwide and has led significant team growth while exceeding customer satisfaction targets year over year. Prior to Suvoda, Rob held leadership positions with NextDoc Corporation and Clarix/Phase Forward, where he was instrumental in delivering life sciences solutions for clients ranging from small biotechnology firms to large, global pharmaceutical companies and CROs. Rob holds a B.S. in biology from Lafayette College.

Session Details: Flexible by Design: Tools to Manage Uncertainty & Complexity in Early Phase Oncology Trials 19-07-2022, 10:30 am PANEL: Incorporating decentralized approaches into your oncology trial: what works, and what doesn’t? 20-07-2022, 11:00 am View In Agenda

Biography: Jeffrey DiPaolo, MD is the Manager, Oncology Medical Affairs at Clario. He is board certified in Diagnostic Radiology and Neuroradiology with extensive experience in oncology. In his current role, Dr. DiPaolo focuses on trial read design and sales support for the Oncology Medical Affairs team. Previously, he was the Co-founding Partner of Open MRI of Wall (NJ) and Partner/Radiologist at PPRG (NJ). Dr. DiPaolo has specialized in diagnostic radiology, neuroradiology and radiology and holds an emeritus position at Ocean University Medical Center, part of Hackensack Meridian Health. Dr. DiPaolo was a Neuroradiology Fellow at the University of Michigan and received his medical degree from Sidney Kimmel Medical College at Thomas Jefferson University. He practiced for more than 20 years and has over 35 years of experience in the field of medicine.

Session Details: Strategies for successful oncology recurrence trials 19-07-2022, 5:00 pm View In Agenda

Biography: Kelly Franchetti is a Sr. Vice President and Global Head of Patient Insights and Strategy at YPrime. A highly experienced registered nurse who continues to spend time with patients directly, her diverse background comprises patient advocacy and clinical research. Kelly has over 25 years of experience in obtaining and discerning the patient and caregiver experience as well as developing strong relationships with advocacy groups on a global scale. She has extensive experience in multiple therapeutic areas such as oncology, cardiovascular, endocrinology, orthopedics, infectious disease, neurology, pediatrics, and critical care. This depth and breadth of experience translate into a keen understanding of how patients think regarding their treatment giving her a singular perspective on the best way to approach patients with their treatment options, and an understanding that proves invaluable to her pharmaceutical and clinical research stakeholders.

Session Details: Advancing Technology in Oncology Clinical Trials and What the Patients Want You to Know 20-07-2022, 2:00 pm View In Agenda