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Tuesday, June 26 • 2:00pm - 3:00pm
#260: Optimizing Clinical Development With Adaptive Trial Designs

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Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-18-595-L04-P; CME 1.00; IACET 1.00; RN 1.00

Early-phase adaptive clinical trials combine multiple clinical objectives into one study to deliver high-quality data and substantial time and cost savings compared to a traditional approach involving several single-purpose studies. A biopharmaceutical developer needs to design a clinical strategy from product inception to regulatory approval that is tailored to meet clinical and regulatory expectations and is time- and cost-effective. This roadmap must detail the strategies for general clinical development, study design and operational execution and focus on a target product profile (TPP) that provides the product development team with valuable and measurable deliverables as well as the objectives for and guidance on the clinical development plan. The importance of having an in-depth understanding of adaptive clinical trial design and logistics is critical.

This interactive session will provide the framework for scientifically robust and efficient early-phase clinical drug development. Working with cross-functional teams and developing appropriate operational infrastructure for all stakeholders, including drug developers, clinical research organizations (CROs) and investigator sites, will also be highlighted.

Learning Objectives

Identify strategies to reduce timelines and reduce unnecessary human exposure while increasing potential for successful outcomes; Describe how to leverage accruing data to constantly fine tune the clinical trial and decision making; Identify multiple clinical objectives by thoughtful planning and management to be efficient and cost effective.

Chair

Stanley C McDermott

Speaker

Adaptive Trial Designs for Early Phase Clinical Development
Jignesh Patel, PhD

The Range of Flexibility Being Shown in Clinical Trial Designs at the FDA in Oncology With Emphasis on Adaptive Trials
Mark Thornton, MD, PhD, MPH



Speakers
avatar for Stanley McDermott

Stanley McDermott

Managing Director, Clinical Research, Cardinal Health Regulatory Sciences
Dr. McDermott has responsibilities for clinical research consultants providing clinical strategy, design and operations services. He also leads clinical development programs. He has experience with clinical development strategy, planning, execution and reporting; clinical trial design... Read More →
JP

Jignesh Patel

Senior Director, Data Services, Clinical Pharmacology and PK, Early Dev Services, PRA Health Sciences
Clinical Pharmacologist, leading the Quantitative Clinical Pharmacology department in PRA-Early Development Services, US. ~15 years of drug development research and PK/PD advisory experience: design and execution of clinical pharmacology and pharmacokinetic development and submissions... Read More →
MT

Mark Thornton

Senior Clinical Consultant, Biologics Consulting
Mark Thornton, MD, MPH, PhD brings 25 years of FDA and industry experience. He has gained or granted approval of 4 BLAs and his specialties are immuno- and molecularly target-based oncology therapies and companion diagnostics. Dr. Thornton has expertise in Regulatory strategies such... Read More →


Tuesday June 26, 2018 2:00pm - 3:00pm
Room 156ABC Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA