With over 14 years of experience in biopharmaceuticals and healthcare software, I am the co-founder and Chief Operating Officer of IgniteData, a company pioneering the automation of clinical trial data collection. At the forefront of our innovation is Archer, a virtual research assistant that seamlessly integrates electronic health records (EHR) with electronic data capture (EDC) systems, eliminating duplication, reducing errors, and accelerating study timelines. I have co-authored multiple peer-reviewed publications exploring the value and complexities of using real-world data in clinical research and am a frequent public speaker, advocating for the transformation of clinical trials through data-driven technologies. My work is grounded in a passion for improving patient outcomes, driving operational efficiency, and fostering collaboration between sponsors, healthcare providers, and technology partners. Through IgniteData, our mission is to make clinical trials more efficient, accessible, and reliable, ensuring that the future of clinical research is faster, smarter, and more connected.

Seasoned pharmaceutical professional with 20+ years of experience specializing in healthcare data integration, clinical analytics, and competitive intelligence. Leverages deep pharmaceutical knowledge and advanced analytics capabilities to transform complex data into actionable business insights

Manfred Mäder is VP Global Device & Packaging Development in TRD (Technical Research and Development) at Novartis.

Prior to this, he held the position Head of Global Compliance & Audit for Devices & Combination Products overseeing all Alcon, Pharma, and Sandoz sites producing this type of products and Global QA Head of Technical Research and Development at Novartis Pharma starting in February 2011.

Prior to this position he was Senior VP of Quality Management & Regulatory Affairs, at Ypsomed, a company producing Medical Devices and Combination Products starting in 2007. Previously, he was responsible for Quality Assurance Management at Sanofi-Aventis for the Frankfurt Injectables site. Before then, being based in Kansas City/ US, he had a global responsibility for Quality and Regulatory for one of the Aventis Blockbuster products. Prior to that, he held several positions in QA and QC.

By training he is pharmacist and holds a doctorate in pharmaceutical analytics and statistics by the University of Wuerzburg/ Germany.

Lotte Bjerre Knudsen is a Danish national, born in 1964 in a small town near Copenhagen. She holds a degree in biotechnology from the Technical University of Denmark, and a Doctoral degree in Scientific Medicine from the University of Copenhagen, Denmark. Lotte has been with Novo Nordisk since her university graduation in 1989 and has since then held several positions within the company and is today Chief Scientific Advisor in Research & Early Development and heads up IDEA (Innovation and Data Experimentation Advancement). She has deep experience across the entire value chain of drug discovery and development and has published extensively. Lotte is an inventor on many patents, all fully owned by Novo Nordisk. She has been part of representing Novo Nordisk in five FDA Advisory committees. Lotte has received numerous awards. Most recently, she was the recipient the Paul Langerhans Award from the German Diabetes Association and a co-recipient of the American Association for the Advancement of Science Mani Bhaumik Breakthrough of the Year Award, the Lasker Foundation Lasker-DeBakey Clinical Award and the Breakthrough Prize in Life Sciences.

Terry Oehler, DPM has been practicing podiatry in the Denver metro area more than 25 years. Dr Oehler recently developed Colorado Clinical Research chasing his passion for clinical research.  He has more than 27 years of experience in practicing podiatry and surgery.  He graduated from Iowa State University with a BS in Biology with emphasis in pre-med and Des Moines University with a Doctorate in Podiatric Medicine before completing a 2 year surgical residency program.

Shrenik Mehta is a Senior Principal Scientist at Genentech, where he leads efforts in biologics formulation and drug delivery technology development. With extensive expertise in sustained delivery of biologics, he has pioneered innovative technologies for ocular and subcutaneous administration. His work also encompasses the development of ultra-high concentration formulations and factors impacting subcutaneous bioavailability, significantly advancing the field of subcutaneous biologics delivery. Shrenik earned his PhD in Pharmacology from Baylor College of Medicine, providing him with a robust foundation in drug development. He is excited to share his insights on "Accomplishing Sustained Release and Long Acting Delivery" as a panelist at the PODD Conference.

TBA

Kris Blouch is a leader in oncology with 20 years of experience across academia, pharmaceutical and biotech industries. Blouch is passionate about creating an intentional clinical trial experience for participants. She currently serves as the Senior Director, Patient Recruitment & Retention Strategy at Exelixis, where she leads a team overseeing global informed consent processes, HCP & patient-facing engagement materials and digital platforms, and a standing patient council, while driving strategies to meet enrollment and retention goals across all studies.

Previously, Blouch held roles in Translational Medicine and Clinical Development at GSK, where she led the development and launch of an innovative clinical trial allowing for real-time data return and trial matching to participants, in addition to a large cross-Pharma consortium. Her expertise in oncology spans pre-clinical research, GMP manufacturing of CAR-macrophages, translational medicine, clinical biomarkers, disease strategy, clinical development, and clinical operations.

Dr Rashmi Thakur is Director of GPS (global product strategy) Business Development and CMC strategy in the Portfolio Strategy and Integration group at Bristol Myers Squibb. She provides guidance for evaluating in-licensing/ co-development opportunities, M&As, collaborating closely with Search and Evaluation, R&D, Commercial, and Finance teams.

She recently served as a key interface in the due diligence and post-agreement integration of BioNTech-BMS deal for co- development and co-commercialization of BioNTech’s investigational bispecific antibody across numerous solid tumor types.

With over two decades of experience in the pharmaceutical industry, Rashmi brings deep expertise in drug development and cross-border collaboration. Rashmi joined BMS in 2023 as a cross-functional matrix team lead for multiple programs. She also spearheaded the initiative to develop a delivery device strategy playbook.

Prior to BMS, she spent 15 years at Johnson & Johnson Innovative Medicine, where she held roles in formulation development, MS&T and CMC/Value chain leadership. She led projects in continuous manufacturing, oligonucleotide development, and completed an international assignment in Asia focused on CRO management. Earlier in her career, she held scientific roles at McNeil Consumer (now Kenvue), Hoffmann-La Roche, and marketing roles at Alkem labs and Wyeth.

Rashmi holds a PhD in Pharmaceutical Sciences from Rutgers University and an MBA with a marketing focus from the University of Mumbai.

Dr Elly Barry is a board-certified pediatrician and pediatric hematologist/oncologist with over 15 years of experience in drug development. Prior to joining Day One in 2021, she was Global Clinical Lead for Pediatric Oncology at Pfizer, as well as Head of Pfizer’s Pediatric Oncology Leadership Team where she oversaw more than 10 pediatric oncology clinical programs.

She has also held previous roles at Genzyme and Millenium/Takeda focused on the development of oncology therapeutics in adults. Dr Barry serves on the Industry Advisory Council for CureSearch and is a member of the ACCELERATE Platform Steering Committee. She is also a co-chair of the Children’s Oncology Group Industry Relations Council.

Dr Barry is a graduate of the pediatric hematology/oncology fellowship program at the Dana Farber Cancer Institute and Children’s Hospital Boston, and the pediatric residency program at Tufts. She received her MD at Yale University School of Medicine and also obtained a Masters in Medical Science degree from Harvard Medical School.

Roger Liu has over 30 years in industry and possesses a track record of commercializing and launching combination products supporting key pharmaceutical franchises. He has cultivated a reputation as an innovator, collaborator and partner advocate for delivery technology developers and manufacturers.

Roger currently serves as Director-Combination products and leads the technology scouting, feasibility, and delivery system integration efforts within AbbVie, matching external innovation with internal drug product assets. He has particular focus and passion on making things easier and more intuitive for the patient while managing expectations for the corporation on strategies, timelines, and execution.

Roger's history includes patents, papers, and experience through roles at AstraZeneca, West, Biogen, Amgen and Lilly. He is a recipient of AbbVie’s Chairman's Award, the highest honor at AbbVie. Roger holds a BS in Mechanical Engineering from the University of Illinois at Urbana-Champaign and an MBA from the Kelley School of Business at Indiana University.