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.

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.

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.

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.

Laurie Herraiz has a diverse background in clinical research in academic medical centers, having started her career as an NIH-funded clinical trialist at the University of California San Francisco (UCSF). She transitioned into the field of human subjects regulations and compliance, where she eventually served as the Director of the Human Research Protections Program and the Institutional Review Board. Her expertise spans clinical trial operations, regulations, and privacy law, while her current work incorporates community engagement with data governance. With her extensive knowledge and leadership, she finds great professional satisfaction in helping investigators navigate the complex regulatory landscape and bridging the gap between participants and researchers.

Derek is the Senior Director of Business Enablement at Saama and has over 14 years of experience in clinical research, with strong focus in biometrics, programming, systems implementation & integration, and software development. Prior to joining Saama, Derek spent his career in the CRO & software development spaces, where he supported Data Management and Biometrics activities in multiple roles. An enthusiastic advocate for change & innovation, he helps drive the adoption of new processes & tools in CDM and CDS.

Innovative leader with 20 years of clinical research and healthcare experience, specializing in acquisition, management, and transformation of clinical biospecimen and digital health assessment data. Collaborative creator of tech-enabled solutions for the pharmaceutical industry. Accomplished, analytical director possessing strong interpersonal and communication skills with experience in managing multi-functional teams at both a strategic and tactical level. Key strengths include driving transformational change, strategic planning and execution, spearheading business process improvement initiatives, and building high-performing organizations. Built and introduced countless strategies within R&D to achieve efficiencies and resolve process and application gaps. Experienced in operations oversight and guidance, including resource and financial projections and prioritization.

Davy Baele is Team Leader, CDM Programming with over 15 years of experience with CDISC SDTM submissions. Prior to joining IDDI more than 10 years ago, he gained lots of expertise in the field as Data Integration Specialist and Project Manager for legacy SDTM data conversion projects whilst also being a member of the CDISC SDS and define.xml team in 2012-2013. At IDDI, Davy was able to develop, implement, and optimize SDTM processes and tools. As a Team Leader he is very grateful to have a motivated team of CDM Programming Specialists that share his passion and positive attitude to continuously improve robustness and efficiency on the daily CRO deliverables.

Dawn has over 25 years of experience in the pharmaceutical industry. She has 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 former Co-Chair of the annual conference (2018-2021) and currently 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 Biometrics services as well as overseeing the Proposals and Solution Consulting departments.

Kelsey Buhler has been a Product Specialist at Viedoc Technologies since 2021, and specializes in providing technical demos, support, and project management for Viedoc study builds. Prior to her role at Viedoc, she has 7 years combined experience as a Data Manager/Project Manager at a Medical Device CRO, a Data Entry Specialist, and a Clinical Subjects Associate, where she would obtain consent from subjects in clinical trials. All these experiences drive her passion for user-friendly Electronic Data Capture (EDC) systems that increase efficiencies for the subjects, site, and all other study users.

Wendy has 25+ years experience in the life sciences industry with a career spanning academic research, preclinical drug discovery, and clinical trials, culminating in a focus and passion for delivering technology solutions that help bring treatments to patients faster.  Wendy is currently part of the product strategy leadership team for IQVIA Clinical Data Analytics Suite (CDAS), providing both SaaS solutions for the market as well as IQVIA’s internal CRO needs.  As part of the CDAS team, Wendy is responsible for strategy, product management leadership, and Go to Market activities.

Dan Solis is a recognized expert in FDA’s 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. He brought leadership to the Office of Import Operations in March 2020, during the Covid-19 pandemic and became permanent Assistant Commissioner in November 2020.

Started with the FDA in 2009 as a Consumer Safety Officer in the San Francisco District Office (Alameda, CA) and focused primarily on imported FDA regulated products including Field Work, Entry Review, FSVP (Foreign Supplier Verification Program), and Special Operations. Have also conducted GMP inspections of Foods, Seafood HACCP, and Dietary Supplement manufacturers. Also worked in the South San Francisco Resident Post from 2013 to 2019 and currently stationed in the San Francisco District Office. Promoted to Import Specialist in 2023.