Jasminemay Barcelon, MSc, is an Analyst of Oncology and Hematology at GlobalData in the UK. Jasminemay graduated from the University of California, Los Angeles in Physiological Sciences / Pre-Medicine with three years' experience as a physician partner in obstetrics and gynecology and gynecology oncology publishing case studies on vaginal sarcoma in pregnancy and treatment of gestational trophoblastic neoplasia. She was concurrently a lead clinical trial coordinator for four Phase III clinical trials at UCLA gaining a breadth of knowledge on clinical trial design, patient monitoring, and regulatory reporting.  She holds a Master of Science in Cancer & Molecular and Cellular Biology from the Bart's Cancer Institute with research focused on targeting chemoresistance in high-grade serous ovarian cancer. Jasminemay is passionate about data-driven insights and developing strategies to target unmet needs in oncology.

Christine Von Raesfeld (she/her), founder and CEO of People with Empathy (PwE), is a pillar of patient advocacy and allyship in the rare and chronic disease community. Through the lens of her lived experiences in health care, she has become a champion for patient voices, diversity and inclusion in clinical research, and equitable patient–sponsor partnerships.

Christine has brought her unique perspective and honed expertise as a featured speaker for numerous conferences on topics ranging from clinical trial recruitment to data and digital rights, from a true patient perspective. She serves as an e-patient scholar with Stanford Medicine X and a Technical Expert Panelist with the Centers for Medicare & Medicaid Services (CMS), among other roles. Wherever possible, Christine generates momentum toward progress around her patient advocacy interests, and she has become a thought leader worldwide, stimulating dialog on a range of topics relevant to patients, clinicians, and industry as moderator and host of People with Empathy: The Inside Track on Clubhouse.

After being diagnosed with a meningioma and p1RCC (a rare kidney cancer) in 2014, Bill co-founded rarekidneycancer.org with Dr. James Hsieh in 2016.  In 2018 and 2020, with Pete Kane, he brought together 17 teams of more than 100 researchers who used his medical data to determine “genes of interest” related to his disease.  He applied ensemble reasoning to evaluate the results of these hackathons (which Bill calls “gamified tumor boards” ) to discover better ways to do cancer research.  Bill is currently automating these “gamified tumor boards” using Large Language Models (LLMs).  Bill is also involved in several patient organizations and is a CDMRP reviewer.

Prior to rarekidneycancer.org, Bill worked with Sabrina Paseman to use non-invasive Blood fluorescence to detect iron deficiency anemia (Patent 8,306,594) and with Katherine Paseman to expand Pulse oximetry technology to do non-invasive measurement of Hemoglobin and Hematocrit.  

Bill’s 50 year career in AI started at age 18, when he worked with Howie Johnson at Rice University using n-grams (like chatGPT) to do classical music composition.  He continued his music work at MIT in Steve Ward’s lab exploring generative grammars and constraints.  He then applied his Symbolic AI knowledge to Electrical Design Automation as the 16th employee at Daisy Systems. Bill next founded Atherton Technology (which failed) and then Calico Commerce (which IPOed), where he repurposed his music composition system to do sales configuration over the internet (Patent 5,745,765).  After Bill took Calico public, he retired and, as discussed above, has dedicated his time to rarekidneycancer.org, patient advocacy and working with his daughters on non-invasive blood analysis.

Jason Keenan, MS, CIP is the UCSF IRB Associate Director of Full Committee Reviews. In his 10 years at the UCSF IRB, Jason has been part of the review of dozens of oncology clinical trials. In the past two years, the UCSF IRB streamlined the review process for oncology clinical trials, resulting in faster times to approval. The presentation will cover the steps the IRB took to accomplish this goal.

Kathy Benton is a seasoned professional with 20 years of experience in clinical research. Her clinical research journey started in 2004 as a Regulatory Coordinator/Study Coordinator at Oregon Health & Science University, working in the Women’s Healthcare and General Surgery.  In 2011, Kathy became a CRA and worked at various CRO’s for over 10 years. In 2022, Kathy moved to the Site Engagement role, dedicated to Eli Lilly and in 2023, moved to Takeda as a Study Site Engagement Lead. She is passionate in fostering relationships with external and internal partners to ensure  sites have a positive trial experience.

Being able to strategically lead and oversee global complex clinical trials, coach and guide my team, collaborate with external and internal stakeholders, collaborate with the vendors, foresee risks and implement timely mitigation measures, continue to be agile to change management, ability to navigate through fluid/challenging situations, while being inclusive, respectful and empathetic, is what makes me a leader.

Clear decision making, effective communication, tailoring to the audience, funneling the right level of information upwards and cascading the guidance downwards, identifying process gaps and building efficiency where/as needed, keeping my team motivated and fostering a positive/growth mindset and lastly being able to wear multiple hats, with the final goal to make a positive impact to the lives of patient’s globally is what makes me a Clinical Trials Leader.

Harit Nandani has 12+ years of experience in clinical trials data and technology leadership for both diagnostics and therapeutic trials. He specializes in clinical trial data management and analysis, configuring systems for population-scale studies, and using analytics tools to monitor projects. Currently, he is the Director of Clinical Data Management at GRAIL, overseeing data and systems for trials in the UK and US supporting early cancer detection diagnostics development. He has worked on projects enrolling over 300,000 participants, leading to the development of the Galleri test, which has detected over 50 types of cancer and has been named one of TIME Magazine's best inventions and The Atlantic's 10 most promising breakthroughs of 2022. Prior to GRAIL, Harit led late-stage pivotal trials in Oncology at Gilead Sciences and worked in various clinical research roles at a CRO and a small biopharmaceutical development company.

Dr. Chris Apfel is the founder and CEO of SageMedic Corp., an early-stage clinical diagnostics company to assist oncologists in selecting the most effective treatment for their patients. Dr. Apfel is also the Chair of Life Sciences at the Keiretsu Angel Investment Forum, where he invests in life-science companies that have the potential to positively impact patients with serious conditions. Prior to starting SageMedic, he was an Associate Professor at UCSF. Dr. Apfel is an internationally known authority on designing, conducting, and publishing highest quality clinical trials with thousands of patients that have changed medical practice with over 100 peer-reviewed publications. Dr. Apfel is a California licensed physician with 20+ years of clinical experience in anesthesiology, critical care medicine, and emergency medicine. He received his medical degree (MD) and his doctoral degree (PhD equivalent) from Justus-Liebig-Universität Giessen, Germany, and his Master of Business Administration (MBA) from the Wharton School of Business, University of Pennsylvania, PA

AVenture Capitalist and Private Equity Investor, identified/evaluated investment opportunities by analyzing market trends, conducting due diligence, and assessing the companies' financial viability and growth potential. Furthermore, thrived on identifying untapped opportunities, disrupting traditional business models, and spearheading change that positively impacts the bottom lines; and have consistently driven revenue growth, expanded market share, and enhanced overall business performance by leveraging emerging technologies and implementing forward-thinking strategies. As a collaborative leader, they fostered a culture of excellence, encouraging team members to think creatively and take ownership of their projects.

Cameron McClure, Associate Director of Clinical Trial Diversity within Global Clinical Operations, BeiGene

Cameron McClure is an Associate Director of Clinical Trial Diversity within Global Clinical Operations at BeiGene. Prior to this role he has had several leadership positions within Clinical Business Operations overseeing site contracts, budgets, payments, and a team of Business and Data Analysts.  Cameron has worked in Academia for institutions such as Stanford University and Emory University in Clinical Research Finance and began his career at Morehouse School of Medicine as a Clinical Research Coordinator. He is an agile project manager, a leader, and a visionary with a focus on process improvement through innovation.  He currently resides in Long Beach, CA with his family and enjoys traveling, music production, and learning.

Arla Yost, Clinical Research Operations Director, Helen Diller Family Comprehensive Cancer Center, UCSF

Arla holds an MSc in Interdisciplinary Oncology and is both CCRP and PMP certified. She has worked in healthcare and oncology for almost 15 years, with the last 7 years spent focused on clinical research operations at UCSF’s NCI-designated Comprehensive Cancer Center.

Chief Medical Officer at ASC Therapeutics, a biopharma company focusing on gene editing and gene therapy for Hemophilia A and MSUD, and allogeneic cell therapy for Graft-vs-Host Disease in hematologic malignancies. Holding a tenured Professorship of Immunology at the University of Leon, Spain. Received PhD from the University of Wuerzburg, Germany and MD from the University of Salamanca, Spain
Author and co-author of over 100 peer-reviewed publications, including Nature, Lancet, Journal of Immunology and Journal of Experimental Medicine, books and medical articles and member of several scientific and medical societies.

Chuanbo is currently the Senior Director, Head of Clinical Development at Freenome, Inc. Prior to this, he has worked on the clinical research and development of pharmaceutical, medical device and IVD products in a few companies, including Glaxo, Abbott, GRAIL, etc. In the current role, he leads the department of high caliber clinical research professionals with multi-disciplinary functions and expertise focusing on design, launch and conduct of large scale clinical studies to support early cancer screening products using blood samples.

Passionate about leadership and talent development, optimization and innovation in healthcare.

With over 25 years of comprehensive clinical development expertise spanning biotech companies, CROs, and academic research sites, I have contributed to advance novel therapies across diverse therapeutic areas such as oncology, immunology, virology, etc. in global Phase 1-4 programs, driving regulatory submissions, and achieving approvals for significant HIV therapies at Gilead Sciences.  I’ve held various Clinical Operations leadership roles at Amgen, Gilead, and currently at Profound Bio as Executive Director heading Clinical Operations department.

Dr. Radha Duttagupta brings over 15 years of experience in test development, trial strategy and pre- and post-market studies for LDT/RUO/IVD products in the clinical diagnostic industry. Currently serving as the Vice President of Clinical Affairs at Nucleix, she is helping drive the clinical strategy around the development of a lung cancer screening test.

Prior to Nucleix, Radha served as Director of Clinical Operations and Clinical Development at Karius driving the clinical validity, utility and publication strategy for the Karius® Test (liquid biopsy for infectious diseases) in immunocompromised patients suspected with pneumonia. Radha has held previous positions at Cepheid (Danaher) leading clinical trials in the ID portfolio including Xpert® Xpress MVP, Xpert® MTB/XDR (molecular DST for Extreme Drug Resistance TB) and Affymetrix (part of Thermofisher Scientific) in product and clinical development of pre and post-natal tests for copy number (CN) detection spanning CytoScan™ XON, CytoScan™ Optima and CytoScan™ Dr. Radha has a Ph.D in Biochemistry and Molecular Genetics from Rutgers University and University of Medicine and Dentistry of New Jersey (UMDNJ), Robert Wood Johnson Medical School, New Jersey and was a post-doctoral fellow in the Transcriptome group at Affymetrix.

Emily McInturf, Director Feasibility, has worked in the clinical research industry for the past 15 years. As a leader within PSI’s global feasibility team, Emily specializes in strategy development across multiple therapeutic areas – focusing on aligning a study’s design with top enrolling investigators in the right countries.

Using PSI’s INTELIA platform, a machine-learning-powered system for data-driven feasibility and enrollment forecast, Emily models and compares hundreds of country and site combinations, their budgets and probability of success, ultimately recommending the most optimal enrollment scenario in line with each sponsor’s key objectives.

As a Director, Emily provides oversight for global feasibility and site identification activities for both pre- and post-award opportunities and projects.

Chantalle Willie, B.Sc., CCRP, CIPP-C, Lean Certified, Associate Director Feasibility & Client Success, since 2019 she leads feasibility activities at Scimega using a data-driven approach and nurtures longstanding site network relations. Chantalle is an experienced Clinical Trial Specialist with a history of working in oncology research in various capacities, including site management, contracts, budgets, feasibility, and start-up. Also, a key member of the Scimega business development team, Chantalle received her B.Sc. from Western University with a Major in Medical Sciences, and her Lean Certification from the Lean Six Sigma Company, Canada. Chantalle is a certified Information Privacy Professional – Canada through the IAPP, and a member of the Society of Clinical Research Associates (SOCRA).

Leslie brings a 360^o perspective on clinical trials from her 20+ years of experience in the industry from academia to biotech, phase I unit to SMO oversight, and into the CRO world where she is currently a member of the ICON Biotech Oncology TA Leadership Team. She is passionate about partnering with biotech to model complementary supports for trial execution custom to each organization’s needs and ensuring equitable access to trials for all patients. Leslie holds a Master of Science in Biotechnology from The Johns Hopkins University and is the chair of ICON’s global Disability Awareness Network (DAWN) community group.

• BSc in biology from Saint Andrew’s Presbyterian College, US. MSc in Biology from Texas Christian University
• Oncology project-management specialist with almost 25 years of experience in academic, clinical site, and contract research organization (CRO) settings.
• Experience in all phases of reseach (Phase I-III) including Phase IV across multiple study designs such as basket and umbrella studies, 3+3 dose escalation, expansion, accelerated titration, modified toxicity-probability interval, and Bayesian logistic-regression model

As a Solution Consultant, Jason works with Sponsor organizations to understand their challenges and come up with creative solutions leveraging the elluminate platform. Jason has lead design & development for several products ranging from a Data Management Workbench, Data Integrations, Clinical Operations Platform, Clinical Analytics, and Risk Based Quality Management.  Jason has been in the clinical trials industry for over 15 years and his prior experience includes, global central laboratory, eCOA design, process improvement, and building an automated workforce.

Tom has worked in the life sciences industry for over 26 years, with the first 10 as a pharmaceutical representative and marketing product manager for Bertek, Merck and GSK.

Tom joined Mercalis 16 years ago, created the RxStudy Card offering in 2009 and for the past 14 years has been focused on changing the paradigm of the traditional clinical trial supply process to one of greater efficiency through the RxStudy Card.

Bob Bauer is Executive Director of Operational Strategy at Precision for Medicine.   He is a 23-year clinical operations professional with extensive tenures in both the pharmaceutical sponsor and contract research organization (CRO) sectors. His diverse experience spans across all phases of clinical research, encompassing a wide range of study designs and therapeutic indications. Bob has played key roles in several programs involving rare and challenging to recruit populations and has implemented creative and cost-effective approaches to ensure successful patient engagement and recruitment.

Nissa Ashenbramer, Senior Project Manager, Oncology & Hematology
Nissa Ashenbramer brings over 25 years of industry expertise to her role as a Senior Project Manager. Her primary focus has been in oncology, with 15 years dedicated to project management and an additional ten years as a Clinical Research Associate (CRA).

Having engaged on both the pharmaceutical and CRO fronts, Nissa has a strong emphasis on early-phase I and II oncology studies, especially in advanced solid tumors. Throughout her career, she has also made significant contributions to oncology indications in Phases III and IV.

In addition to her primary role, Nissa has taken on various responsibilities, such as a clinicaltrials.gov administrator, Investigator Sponsored Trial facilitator, and Independent Response Review moderator. Her expertise further extends to budget negotiations, IRB submission specializations, and her role as a CTMS Super User. Passionate about nurturing talent, Nissa takes pride in mentoring both Project Managers and CRAs.