Clinical trial start-up delays are a persistent challenge in oncology drug development, often leading to increased oversight costs, delayed patient enrollment and prolonged time to market.
Inefficiencies in start-up time can add months to trial timelines, impacting both financial and competitive positioning. In this webinar, the expert speakers will discuss the key factors contributing to trial start-up inefficiencies and explore data-driven strategies to mitigate these delays.
By initiating key operational activities ahead of regulatory submission, sponsors can shorten the time between the FDA’s “May Proceed” letter and site activation—saving up to over four months in start-up timelines. They will cover the following key topics:
- Common bottlenecks in clinical trial start-up and their financial impact
- Importance of early site engagement and balancing site selection between community and research institutions
- Best practices for vendor identification and contract execution before investigational new drug (IND) submission
- Role of preemptive regulatory document preparation in streamlining site activation
- Case studies highlighting how a proactive approach has led to faster enrollment and cost savings
With a growing emphasis on efficiency in clinical trials, it is essential for sponsors to rethink their approach to trial start-up. This session will provide actionable insights to help optimize early-stage trial operations, reduce delays and accelerate patient enrollment.
Join this webinar to learn how proactive planning can significantly reduce clinical trial start-up timelines and enhance overall study efficiency.
Speakers
Jennifer Keppler, Vice President, Translational Medicine, Translational Drug Development (TD2)
Jennifer Keppler has more than 20 years of experience in translational research, clinical trials and regulatory strategy across academic, industry and CRO settings. Prior to joining TD2 as Vice President of Translational Medicine, she was the Chief Operating Officer and acting Vice President of Clinical Development for ImaginAb, where she oversaw the preclinical translation, as well as clinical and regulatory strategy, for biologic-based drug products.
Over the course of her career, she has overseen investigational new drug (IND) filings from phase I through phase II for both small and large molecules. Ms. Keppler has a Master of Business Administration from the University of Southern California. She also holds a Bachelor of Science in Marketing from the University of Phoenix and an Associate of Science in Nuclear Medicine Technology. Ms. Keppler is an author of numerous scientific papers about clinical PET/radiopharmaceuticals and diagnostic imaging.
Message Presenter
April Coburn, Director, Site Services, Translational Drug Development (TD2)
April Coburn has over 19 years’ experience in clinical research, working in a myriad of roles including Medical Writing, TMF Services, Clinical Operations, Global Study Start-Up, Global Site Relationships, Business Development, and Site Services. April has been responsible for leading large global teams, implementing key initiatives to streamline start-up and feasibility, and overseeing the creation and development of site alliance structures to promote site and CRO collaboration. Bringing life-changing drugs to patients and furthering research through continued education and development of new therapies continues to be her passion and motivation in this important industry.
Message Presenter
Nick Conde, Translational Program Manager, Translational Drug Development (TD2)
Nick Conde serves as Program Manager in Translational Research at TD2 and is responsible for the coordination of IND-enabling research and development efforts in oncology. This includes cross-functional management supporting all aspects of drug development necessary to support successful IND submissions with FDA.
He has over 11 years of experience in the pharmaceutical industry, with over 7 years of direct experience in drug development supporting Phase I FIH oncology trials across a variety of technologies. He holds a Bachelor of Science degree from the University of Illinois at Urbana Champaign.
Message PresenterWho Should Attend?
This webinar will appeal to those working in the following areas or having the following job titles:
- Clinical Operations and Clinical Trial Managers
- Directors and VPs of Clinical Development
- Regulatory Affairs Professionals
- Clinical Site Engagement and Feasibility Teams
- Oncology Drug Developers and Biotech Executives
What You Will Learn
Attendees will learn about:
- How trial start-up inefficiencies impact both cost and enrollment timelines
- Best practices for optimizing site engagement and vendor selection before regulatory approval
- How aligning trial start-up activities with investigational new drug (IND) submission can shorten timelines by over four months
- Real-world examples of strategies that have led to faster site activation and patient enrollment
Xtalks Partner
Translational Drug Development (TD2)
As a contract research organization (CRO) specializing in oncology and precision medicine, Translational Drug Development (TD2) collaborates with innovative biotech and pharmaceutical companies to expedite the delivery of treatments for rare cancers to patients. TD2 offers exclusive access to its Oncology Ecosystem, which includes services for clinical trial management, regulatory support, and preclinical studies. This comprehensive support aims to maximize the success of your research.
Related Webinars
You Must Login To Register for this Free Webinar
Already have an account? LOGIN HERE. If you don’t have an account you need to create a free account.
Create Account