Joshua Cox has been honing his data management expertise in the drug development industry for nearly 20 years.  After breaking into the industry and gaining exposure to diverse therapeutic areas and development approaches with a CRO, Joshua has focused the last 15-years in sponsor driven early phase oncology.  He has enjoyed opportunities with bio-tech start-ups as well as established big pharma companies, each engagement adding valuable knowledge and experience to his skillset.  Joshua has led the development of data management departments by conceiving and implementing fit for purpose and results-driven technologies and processes always with an eye toward innovation and efficiency.  Now pursuing leadership opportunities outside the confines of traditional data management, Joshua is eager and excited to be a part of teams pursuing novel solutions to known challenges as well as employing cutting edge strategies and technologies to elevate the already high standards we expect and ultimately get the best medicines to the patients in need.

Dan Solis is a recognized expert in FDA import operations and is the Assistant Commissioner for ORA’s Office of Import Operations. Prior to this position he was the Division Director for the Division of West Coast Imports since February 9, 2018. He started his career with FDA in 1998. Prior to working in FDA, Mr. Solis worked in the Bioresearch field focusing on Medical Device and Drug Application Products after graduating from the University California of Irvine and the University of La Verne. Mr. Solis has held many positions within FDA that includes working at the FDA lab in Irvine, Ca. as a Microbiologist, HQ position within the Division of Import Operations in Rockville, MD, working as an Import Compliance Officer and working in the FDA Los Angeles District Office as a Director of Import Operations Branch.

Jonathan Chainey is an Executive Director and Global Head, Data Standards & Governance within Data Sciences, Product Development at Roche. He leads a global team accountable for the cross-functional governance and adoption of Roche’s CDISC-aligned global data standards across all Roche sponsored early & late phase clinical trials.  He is currently serving on CDISC’s board of directors and is chair of CDISC’s Technical Advisory Committee.

Over the past 25 years Jonathan has worked within the biopharmaceutical industry in the U.K., Switzerland, and United States. in a range of disciplines including pre-clinical pharmacological research (Ciba-Geigy), clinical data management (Parexel), statistical programming & analysis (Pfizer, Novartis), applications development (Pfizer, Roche), and process analysis, data standards & governance (Roche).

Jonathan has a scientific background and education including a BSc (Hons) Pharmacology, University of Bath, U.K. He is a British citizen and currently located in the San Francisco Bay Area, California.

Dr. Hyunjae Ryan Kim is currently the leader of a team at Gilead Sciences, which specializes in oncology genomics analytics. He is responsible for developing multimodal AI algorithms and applications used in clinical development for oncology. Additionally, he researches how to improve cancer treatment using deep learning and multi-omics data integration by modulating tumor microenvironments.

Dr. Kim previously held the associate director of pediatric oncology bioinformatics position at the Texas Children’s Cancer Center at Baylor College of Medicine (BCM). Before joining BCM, he was a senior computational biologist at the Memorial Sloan Kettering Cancer Center. Dr. Kim and his team developed routine genomic profiling systems (MSK-IMPACT) and matching treatment options for all patients in MSKCC. He also served as research faculty at the Rockefeller University, where he built systems to decipher epigenetic codes and transcriptional controls from multi-omics data with C. David Allis and Thomas Tuschl. Dr. Kim completed his postdoctoral training in Systems Biology at Columbia University Medical Center.

I started my career at Everest Clinical Research in CDM. I later joined Gilead's CDM team focusing on infectious disease therapeutic area. I transitioned to commercial (sales analytics) for almost 3 years to better understand the lifecycle of drug post approval. I decided to return to CDM and joined Biomarin to better understand rare diseases. Post Biomarin, I spent some time at Nektar before landing the position at Denali, focusing on rare disease trials again.

Kimberly Barnholt has been a healthcare leader in various roles spanning from academic research, to disruptive start-up, to global pharmaceutical company. In all roles, she has focused on bridging science, data, and operational disciplines to challenge the status quo and transform how we can deliver more impact for our patients. At Genentech, she has served as a Program Leader for cross-industry collaborations and cross-R&D data ecosystem transformation. Currently, Dr. Barnholt is leading an Evidence Generation team of data strategists and clinical innovation and technology leaders to integrate new approaches to clinical trials.

Edward joined the UCSF Office of Research as its Director of the Human Research Protection Program (HRPP) in May 2020. In this role, he oversees the UCSF HRPP, which is comprised of the Institutional Review Board (IRB) and its committees, the Quality Improvement Unit, and the Human Gamete, Embryo and Stem Cell Research (GESCR) Committee. Edward has a background in strategic planning and business plan implementation for clinical research activities; experience building and directing clinical and research programs at Academic Medical Centers; and familiarity with creating de novo core clinical research support services. He has served as co-investigator on the NIH Clinical Network for Contraceptive Research grant, clinical site investigator for an NIH-funded grant studying Antiphospholipid Pregnancy Loss, and co-investigator on a March of Dimes program grant on risk factors for prematurity. More recently, Edward was a Strategic Advisor for Clinical and Translational Research Programs at the Stanford University Center for Clinical & Translational Research & Education. He has also served as the Director of Clinical Research Operations for the Tufts Clinical and Translational Science Institute, a consult lead for the Johns Hopkins University/Tufts University Trial Innovation Center, as well as an Assistant Professor in the Department of Medicine at Tufts University School of Medicine.

Satha Thillaiampalam has been leading various responsibilities within the biopharmaceutical industry. Throughout his twenty-year career as a Biostatistician and Statistical Programmer, he has led numerous strategic initiatives involving cross functional teams to continuously improve systems, processes, and governance. In his current role, he leads the processes and infrastructure activities for oncology biostatistics department within Lilly. His key interests are optimizing operational efficiency and developing high performing systems by leveraging advancements in technology and standards.

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

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.