Optimizing Early Phase Clinical Trials to Minimize Risk and Improve Decision-Making

Join an IQVIA webinar, Accelerating Molecule Advancement: Optimizing Early-Phase Clinical Trials With Adaptive Designs, where industry experts will explore how sponsors and CROs can overcome rising costs, regulatory shifts, and global uncertainties by leveraging innovative trial methodologies. Discover how customized adaptive designs, hybrid approaches, and AI powered analytics are transforming early-phase research—enabling faster, safer go/no go decisions and streamlining the transition from first in human to later phase studies. Attendees will gain actionable insights into building strong foundations, accessing global site networks, and integrating delivery models to bring critical treatments to patients more quickly and efficiently.

Register Free: https://www.appliedclinicaltrialsonline.com/act_w/molecule

Event overview:

In today’s rapidly evolving drug development landscape, early-phase clinical trials face mounting pressures: rising costs, shifting regulatory frameworks, geopolitical uncertainties, and heightened investor scrutiny. Yet, these challenges also open the door to transformative opportunities and “out of the box” thinking.

This webinar will explore how sponsors and CRO partners can leverage innovative trial methodologies — including customized adaptive designs, hybrid approaches, and model informed drug development (MIDD)— to generate high-quality data faster, make more informed go/no go decisions, and safely accelerate molecule progression.

Key discussion points will include:

• The changing landscape of early-phase trials: navigating cost pressures, regulatory shifts, and global uncertainties.
• Adaptive and hybrid trial designs: understanding disease process and novel drug targets, consolidating phases, integrating healthy volunteers and patient populations, and enabling faster and safe proof‑of‑concept decisions.
• Foundational pillars for success: specialized expertise, flexible customized adaptive design strategies, global site access and tested recruitment infrastructure, and integrated delivery models.
• Global site networks: how strategically placed, safe and experienced, therapeutically aligned sites enhance patient recruitment, efficiency, and quality.
• Seamless early‑phase to late-phase transition: ensuring continuity, preserving institutional knowledge, removing white space, and streamlining data ecosystems.

Three key take-aways

• Understand how customized adaptive and hybrid trial designs can consolidate phases, integrate diverse populations, and enable faster, safer go/no‑go decisions.
• Learn why specialized expertise, robust site networks, and advanced analytics are essential for navigating complex protocols and accelerating molecule advancement.
• Recognize how a seamless early‑phase to late-phase delivery model preserves institutional knowledge, streamlines data ecosystems, and reduces downstream costs—ultimately bringing treatments to patients faster.
  

Speakers:

Elizabeth Allen, PhD
Vice President, Early Phase Development Center of Excellence, Scientific Strategy
IQVIA

Elizabeth (Liz) Allen, PhD, is vice president of early clinical development at IQVIA and specializes in complex adaptive Phase 1 designs and serves on the Global Medical and Scientific Review Group. She has over 35 years of experience in clinical pharmacology, 30 years at IQVIA, and more than 40 publications. Allen previously held a visiting professorship position at King’s College London.

Raymond Cook, MD
Vice President, Medical Strategy, Early Phase Development
IQVIA

Raymond Cook, MD, is vice president of medical strategy for early phase development. Cook is responsible for oversight of the Early Phase Center of Excellence, which provides early-phase clinical design and strategy to support sponsors in the development and implementation of their early clinical development plan. He has 20 years combined clinical practice and industry research experience. He spent 7 years in academia as an assistant professor in the Department of Otolaryngology-Head and Neck Surgery and Facial Plastic and Reconstructive Surgery at the University of North Carolina. He joined IQVIA Biotech in 2012. Cook has extensive experience in protocol development through clinical study report (CSR), investigational new drug (IND), investigational device exemption (IDE), and new drug application (NDA) filings, experience with clinical end points committees, steering committees, DSMB, abstract contributions, and the development of strategic partnerships.

Daphne Tsitoura, MD,PhD
Vice President, Therapeutic Strategy
IQVIA

Daphne C. Tsitoura, MD, PhD, is a biopharmaceutical leader with over 20 years of experience shaping clinical and preclinical drug development. She has designed 40+ proof‑of‑concept studies and led phase III programs resulting in four marketed therapies. Her expertise spans immunology, respiratory, dermatology, and rare diseases, supported by medical and doctoral training from Athens University, Imperial College London, and Stanford University.

Register Free: https://www.appliedclinicaltrialsonline.com/act_w/molecule