Operation TrialBlazer Leveraging New and Anticipated US Policy Changes in Early Development

Operation TrialBlazer is reshaping US clinical development. See what it means for your strategy

Register Free: https://www.appliedclinicaltrialsonline.com/act_w/Operation-TrialBlazer

Event overview:

The US Department of Health and Human Services (HHS) launched Operation TrialBlazer to strengthen US leadership in clinical research by reducing development barriers, accelerating early-phase studies, modernizing regulatory pathways, improving patient participation, and encouraging sponsors to conduct development programs within the United States. Key initiatives include expedited investigational new drug (IND) pathways, streamlined phase 1 requirements, increased adoption of innovative trial designs, enhanced use of real-world data, and modernization of clinical trial infrastructure. This webinar will explore the evolving regulatory and operational landscape and discuss the practical implications for biopharmaceutical sponsors and drug developers.

Key Learning Objectives:

• Understand what Operation TrialBlazer means for biopharmaceutical development in the United States
• Learn how regulatory modernization may accelerate study start-up and early-phase execution
• Determine actions sponsors can take now to leverage new pathways, trial models, and data approaches

Who Should Attend:

• Clinical operations leaders (Director, Executive Director, VP, SVP, and Head of) at large and midsize biopharma companies
• Clinical operations and development executives at emerging biopharma (EBP) companies, including C-suite leaders who oversee trials
• Senior decision-makers responsible for trial execution, CRO and vendor oversight, and clinical outsourcing strategy

Speakers:

Raymond Cook, MD
VP, Early Clinical Development Center of Excellence
IQVIA

Raymond Cook, MD, is vice president, Medical Strategy for Early Phase Development, at IQVIA. Dr Cook oversees 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 plans. He has 20 years of combined clinical practice and industry research experience, including 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. He 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; clinical end point committees; steering committees; data and safety monitoring boards (DSMBs); abstract contributions; and the development of strategic partnerships.

Brad Smith, PhD
VP, Clinical Strategies
IQVIA

Brad Smith, PhD, is a recognized leader in the development and implementation of biomarkers, companion diagnostics, and emerging technologies, with extensive experience spanning laboratory research, clinical development, and patient care applications. Dr Smith brings a proven track record of advancing innovative diagnostic solutions and translating scientific discoveries into real-world health care impact.

He previously held leadership roles in laboratory management and corporate development at Cell Signaling Technology, as well as assay development and laboratory leadership positions at Santa Cruz Biotechnology. He earned BS and MS degrees from the University of California, followed by a PhD from Stanford University. He completed postdoctoral research at both the University of California, San Francisco (UCSF) and Stanford University.

Thyagarajan (Rajan) Sourirajan, BPharm
Senior Director, CMC Regulatory Strategy, DDRS, IQVIA; Head of CMC Centre of Excellence
IQVIA

With nearly 30 years of experience in chemistry, manufacturing, and controls (CMC) regulatory affairs, Rajan Sourirajan, BPharm, has led global regulatory strategies and submissions for biologics, cell and gene therapies, and small molecules across US Food and Drug Administration (FDA), European Medicines Agency (EMA), Health Canada, and Asia-Pacific markets. Previously a lead CMC evaluator with Singapore's Health Sciences Authority, Sourirajan also held leadership roles at Pfizer and LabCorp/Covance, providing strategic drug development and regulatory consulting for more than a decade.

Marshall Scicchitano, MS
Senior Director, Head of Nonclinical Center of Excellence
IQVIA

Marshall Scicchitano, MS, is a nonclinical drug development expert with more than 25 years of experience supporting therapeutics from discovery through approval. He brings deep expertise in toxicology, pharmacology, pharmacokinetics (PK), and regulatory strategy across multiple therapeutic areas and modalities, helping development teams identify safety risks early and advance programs with greater confidence.

Lori Ehrlich, MD, PhD
Regulatory Strategy Lead, Hematology-Oncology Center of Excellence
IQVIA

Lori Ehrlich, MD, PhD, is regulatory strategy lead for IQVIA's Hematology-Oncology Center of Excellence. She brings 11 years of US Food and Drug Administration (FDA) experience as a clinical reviewer and deputy director in hematologic malignancies. Board certified in pediatric hematology/oncology, Dr Ehrlich advises pharmaceutical and biotechnology companies on regulatory considerations across clinical development, including FDA and European Medicines Agency (EMA) interactions and submissions for hematologic malignancies and benign hematology.

Register Free: https://www.appliedclinicaltrialsonline.com/act_w/Operation-TrialBlazer