Discover how to redesign R&D policies with women in mind. Join experts to explore why women’s inclusion in clinical trials matters, what changes are needed, and how stakeholders can drive impact. Together, let's shape a more inclusive future for research.
Learning Objectives
Recognize the historical underrepresentation of women in clinical trials, its healthcare impact, and the role of initiatives in addressing gender disparities; Identify key policy changes and strategies for including gender considerations into clinical trial design; Describe ways to develop actionable approaches to foster cross-sector collaboration among industry, regulatory bodies, government, and research institutions to advance gender diversity in clinical research.
Ms.Federer is an independent board member for public and private companies, and is a globally recognized leader in digital transformation and health technologies. Previously, she was the Chief Digital Officer for one of the world’s largest life sciences companies, leading the enterprise-wide... Read More →
Partner, Healthcare and Life Sciences Practices, Kearney, United Kingdom
More than a decade of experience in Strategy Consulting across sectors, with 8+ years across value chains in Pharmaceuticals, MedTech and Life Sciences. Focused on helping biopharma Research & Development (R&D) leaders bring superior treatments to patients more quickly by transforming... Read More →
Director, Strategic Initiatives, National Academy of Medicine, United States
Melissa Laitner is Director of Strategic Initiatives and Special Assistant to the President at the National Academy of Medicine, where she leads initiatives addressing critical domestic and global health policy challenges and directs cross-cutting projects on biomedical innovation... Read More →
National A.N.G.E.L. Lead, Tigerlily Foundation, United States
Dr. Neosho C. Ponder is an accomplished educator, passionate advocate, and impactful speaker originally from Kansas City, Missouri. As the Marketing and Communications Officer at the National Council of the Churches of Christ in the USA (NCC), she brings her extensive background in... Read More →
Vice President & Global Head Health Equity & Population Science, Genentech, United States
Dr. Nicole Richie, Ph.D. is the Vice President and Global Head of Health Impact & Population Science at Genentech, Roche responsible for leading the product development vision and developing strategies to broaden scientifically driven representation of understudied populations in... Read More →
Tuesday June 17, 2025 8:30am - 9:30am EDT 146BCWalter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
Turnover in the clinical research industry hovers at 27%. Given the high stress, high turnover nature of the industry, the need for stress reduction tools is critical. In this session you will learn techniques to implement for yourself and teams.
Learning Objectives
Identify a simple way to immediately reduce stress in less than 2 minutes; Practice a technique to increase energy, clarity and decision making; Complete a guided non-sleep deep rest practice to calm, soothe and restore.
Founder, CEO, Clinical Research Pro, United States
Jess Thompson brings over 15 years of clinical research experience across labs, sites, CROs, and pharma. She founded Clinical Research Pro to empower professionals through education, development, and career growth. Under her leadership, Clinical Research Pro fosters a supportive community... Read More →
Executive Vice President, SOGLIA, SOGLIA - Entrada Ventures Group, United States
Leanne is the EVP at Soglia. As a Patient Experience Organization, or PXO, we are driven to reimagine the way patients interact with pharmaceutical companies throughout their treatment journey. With over 25 years of experience in clinical research and coaching, Leanne brings a unique... Read More →
Tuesday June 17, 2025 10:30am - 11:30am EDT 206Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
Tufts CSDD and DIA collaborated on a research study with a working group of 16 biopharmaceutical companies and CROs examining the current use of artificial intelligence (AI) and machine learning (ML) to support clinical research.
Learning Objectives
Describe the level of adoption of artificial intelligence (AI) and machine learning (ML) across biopharmaceutical companies and contract research organizations and the top activities where AI/ML is being implemented and utilized; Discuss the impact of AI/ ML on time savings, investment, and deployment of organizational resources.
Chair
Mary Jo Lamberti, PhD, MA
Speaker
Panelist Mukul Virmani, Esq, MS
Use Case Examples within Clinical Development Emily Carter, MBA
Director, Data Science & Analytics, AbbVie, United States
Emily leads the Data Science & Analytics Trial Execution teams in R&D at AbbVie. Her teams’ focus is on enhancing the efficiency and quality of end-to-end trial execution through comprehensive data analysis and insights across RBQM, Feasibility & RWD, Medical & Safety, Trial Diversity... Read More →
Director of Sponsored Research, Research Associate Professor, Tufts Center for the Study of Drug Development, United States
Mary Jo Lamberti is on the faculty at Tufts University and is Director of Sponsored Research at Tufts Center for the Study of Drug Development (CSDD). She is a global expert on benchmarking drug development operating practices. Her research focuses on a variety of areas including... Read More →
Luciana Petcu is a Senior Manager in Takeda’s Emerging Priorities & Innovation (EP&I) team within the R&D Global Development organization. She leads cross-functional initiatives that drive innovation, operational excellence, and cultural transformation in clinical trial operations... Read More →
Director, Clinical Data Science, AI Research Center, Gilead, United States
Strategic and visionary leader with over a decade of experience driving innovation in clinical data science, AI/ML analytics, and operational excellence within global pharmaceutical and CRO settings. Demonstrated expertise in managing high-performing teams, delivering transformational... Read More →
Tuesday June 17, 2025 1:45pm - 2:45pm EDT 207BWalter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
The ability to find, access, understand, and apply healthcare-related information (health literacy) plays a large role in global health outcomes. This session reviews health literacy and strategies to increase health literacy in a digital age.
Learning Objectives
Discuss the basics of health literacy and how they relate to health outcomes; Explain ways to apply new strategies for communicating healthcare information to a broad audience with a range of health literacy levels; Utilize digital tools to achieve strategic goals around healthcare information dissemination.
Founder and Principal, Apath Nexus Consulting, United States
Founder of Apath Nexus, Lindsay provides strategic regulatory guidance and intelligence to support innovation and compliance with FDA and select international frameworks. He has worked with pharmaceutical and biotechnology companies, patient groups, and trade associations to align... Read More →
Associate Director, Development Unit Lead, Patient Centricity and Engagement, Biogen, Inc., United States
Anna Osinski is an Associate Director, Development Unit Lead in Biogen’s Patient Centricity and Engagement team. Anna has more than 17 years of experience in clinical trial recruitment and currently oversees patient engagement strategy for trials in Movement Disorders, MS & Immunology... Read More →
Principal Medical Writer and Consultant, Whitsell Innovations, Inc., United States
Chantelle holds a PhD in Medical and Molecular Genetics from Oregon Health & Science University and completed postdoctoral training at the University of North Carolina (UNC) at Chapel Hill prior to transitioning into a medical writer role at Whitsell Innovations, Inc. (WI), where... Read More →
Tuesday June 17, 2025 4:00pm - 5:00pm EDT 151AWalter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
Regulatory decisions are often a widely discussed topic, but have you considered how a breadth of experience in the career journeys of regulators positively influences decision making within regulatory bodies? Join us to hear from our panel about the impact of their varied career paths in the critical work that they do. This is your opportunity to hear directly from regulators from the UK, Canada & Brazil about what they do, how they got there and what they have experienced and learnt along the way!
Learning Objectives
Recognize how breadth of experience within regulators supports medicines development for patients and society; Identify how skills developed in one sector (e.g., industry, academia, healthcare) can contribute to the skills needed in another (e.g., regulators).
Chair
Paula Walker, MA
Speaker
Panelist Marcelo Moreira, MS
ANVISA Career Pathway: Impact to Medicines Development Bianca Zimon, LLM
MHRA Career Pathway: Impact to Medicines Development Mandy Kaur Budwal-Jagait, MSc
Head of GCP, Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom
Mandy Budwal-Jagait is the Head of GCP and Lead Senior GCP inspector with the MHRA. She joined the Agency in April 2014 as a GCP Inspector and became GPvP Operations Manager in 2020, responsible for the Pharmacovigilance Inspection programme. In 2022, Mandy became the Head of GCP... Read More →
Global Head of Risk Based Quality Management, Roche Products Ltd., United Kingdom
Paula is the Global Head of RBQM at Roche, having started with the company with a Quality Policy focus. Formerly Head of Compliance (GCP/PV/GLP) at the MHRA and Acting Head of Inspectorate, having started in 2009 as a GCP Inspector; spending 13.5 years at the Regulator. Paula has... Read More →
Advisor to the International Affairs Office at the Brazilian Health Regulatory Agency (Anvisa). Specialist in Health Regulation and Constitutional Law, with extensive experience in health regulation and enforcement, as well as in bilateral and multilateral negotiations, international... Read More →
Pharmacist. At Anvisa, serving as General Manager of Biological Products, Radiopharmaceuticals, Blood, Tissues, Cells, Organs, and Advanced Therapy Products.
Tuesday June 17, 2025 4:00pm - 5:00pm EDT 206Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
