Since 2017, the FDA’s Oncology Center of Excellence (OCE) has created more than 300 research and educational outreach projects and programs focused on advancing the design, analysis, and regulations surrounding oncology drug development. As development continues to rapidly evolve, these projects and programs are intended to promote more effective and safer products, more accessible and efficient trials, and better patient outcomes.
These emerging programs will likely impact your drug development efforts, potentially requiring lengthened timelines, greater enrollment, and increased costs. In this webinar, Worldwide Clinical Trials’ clinical research methodology and oncology strategy experts will present the OCE’s most imperative initiatives. You’ll walk away with an understanding of multiple evolving projects at the OCE and how they impact your oncology program.
Key topics:
- The FDA Oncology Center of Excellence special projects and programs
- A focus on new dose optimization requirements through Project Optimus from a medical, scientific, and operational perspective
- Growing requirements for diversity, equity, and inclusion among oncology clinical research
- Innovative trial designs, methods of analysis, and operational strategies to fulfill regulatory requirements
Speakers
Matt Cooper, PhD, Executive Director, Therapeutic Strategy Lead, Oncology, Worldwide Clinical Trials
Matt has 25 years of experience in the life science industry conducting clinical trials across all phases. His experience spans roles at sponsors, sites, and the NHS, and he has extensive experience in site management and expanded use of oncology therapies. He is passionate about building effective relationships between industry stakeholders to drive innovation and patient access.
Message Presenter
Matthew Confeld, PharmD, PhD, Assistant Director, Clinical Research Methodology, Worldwide Clinical Trials
Matthew has 10+ years of experience in pharmaceutical science. His experience spans preclinical drug development of environment responsive nanoparticles for various solid tumor indications, serves as a translational advisor to a National Institute of Health center of biologic research in pancreatic cancer, and has extensive experience in pharmacy including clinical pharmacogenomics for a large healthcare system and specialty pharmacy management. He provides consulting-like services to sponsors across phases of development from preclinical through NDA.
Message PresenterWho Should Attend?
This webinar will benefit Vice Presidents, Directors, Managers, Department Heads, Scientists and Researchers working at pharmaceutical and biotechnology companies.
Relevant areas:
- Clinical affairs
- Clinical R&D
- Clinical research
- Clinical operations
- Medical affairs
- Oncology
- Project management
- Regulatory affairs
- Strategic planning
What You Will Learn
- The FDA Oncology Center of Excellence special projects and programs
- A focus on new dose optimization requirements through Project Optimus from a medical, scientific and operational perspective
- Growing requirements for diversity, equity and inclusion among oncology clinical research
- Innovative trial designs, methods of analysis and operational strategies to fulfill regulatory requirements
Xtalks Partner
Worldwide Clinical Trials
Worldwide Clinical Trials (Worldwide) is a leading global contract research organization (CRO) that works in partnership with biotechnology and pharmaceutical companies to create customized solutions that advance new medications, from discovery to reality. Our full-service clinical development capabilities include bioanalytical laboratory services and Phase I-IV clinical trials, as well as post-approval and real-world evidence studies – all powered by our talented and accessible team of clinicians, scientists, and researchers who bring their first-hand expertise to each clinical program.
At Worldwide, we understand that each customer and project are unique, so we take a collaborative and personalized approach to identify and meet specific needs and goals. Anchored in our company’s scientific heritage, we are therapeutically focused on cardiovascular, metabolic, neuroscience, oncology, and rare diseases. We apply this deep therapeutic knowledge to develop flexible plans and quickly solve problems in the rapidly evolving clinical development landscape.
Our team of 3,000+ professionals spans 60+ countries, and believes that through collaboration, and a culture that embraces diversity, equity, inclusion, and belonging (DEI&B), everyone plays an important role in making a world of difference for patients and their caregivers. We are united in cause with our customers to improve the lives of patients through new, innovative therapies.
For more information, please visit www.worldwide.com or connect with us on LinkedIn.
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