SOURCE: Xtalks

Xtalks Webinars

February 05, 2016 07:00 ET

Early-Stage Considerations for Maximizing Success in Initial Oncology Clinical Trials, a New Webinar Presented by Premier Research

TORONTO, ON--(Marketwired - February 05, 2016) - The live broadcast taking place on Wednesday, February 24, 2016 at 11am EST (4pm GMT), will highlight the many aspects a company must consider in planning and executing a trial, and how a CRO can help throughout the process.

When a company has received funding for a first-in-man oncology trial of a novel compound, the circumstances are typical: limited budget, uncomfortable timeline, a scarcity of skilled clinical trial professionals, and limited knowledge of short-term clinical strategy. And one can recognize that the success of the compound -- and possibly the company -- depends on the outcome of this trial.

To complicate matters, the target is a newly validated mutated receptor present in only 15 percent of pancreatic cancer patients, with no diagnostic test yet approved. One is also using an antibody-like molecule with the unique property of not only inhibiting the receptors' activity, but also stimulating a potent immune response. Neither the class of drug nor the target has ever been tested in a clinical trial. In addition, much of the preclinical data suggests it will synergize with unapproved newer molecules that are now in later-stage trials.

It's reassuring to know that almost 25 percent of drugs now used to treat patients are targeted and novel and had similar beginnings. Companies are at the very forefront of personalized medicine, and many are co-developing, at a very early stage, biomarkers and diagnostic kits to define those patients who will best respond to the therapy -- or yield non-invasive information about whether patients are getting the desired pharmacodynamic effect from the drug.

There are many highly skilled people and organizations to help plan and execute such studies. Some contract research organizations specialize in exactly this type of situation and can help one meet their objectives, ideally getting involved immediately after -- if not before -- one meets critical funding milestones. They will want to adopt a one-team approach and an agreed-on definition of attainable objectives, combined with proper planning and execution of a high-quality, timely trial. This will improve the likelihood of meeting study objectives and establish continuity that aids in development of more advanced trials.

Join experts from Premier Research Paul Hallenbeck, Executive Director of Drug Development Strategy in Oncology, and Luke Gill, Executive Director of Clinical Development Planning, for an information session as they discuss:

  • Developing a strategy
    • Determining one's short and long term strategies
    • Beginning with the end in mind and using a strategies planning tool called Target Product Profile
  • Translational medicine considerations
    • How to maximize the potential for developing a predictive biomarker
    • PK, PD
  • Defining the objectives of the initial trial
    • Go/no-go criteria
    • Objectives and adaptive designs in early oncology trials
    • Proof of concept, mechanism, efficacy, target
    • Safety, clinical endpoints
  • Operational considerations
  • Choosing the right CRO for one's company

For more information about this complimentary event or to register, visit:

About Premier Research

Premier Research is a leading contract research organization serving the needs of biotechnology, pharmaceutical, and medical device companies worldwide. The company has a wealth of experience in the execution of global, regional, and local clinical development programs, with a special focus on addressing unmet needs in areas such as analgesia, CNS, rare diseases, medical device and diagnostics, and pediatric research. Premier Research operates in 84 countries and employs more than 1,000 professionals, including a strong international network of clinical monitors and project managers, regulatory, data management, statistical, scientific, and medical experts. With its mission to improve productivity in clinical development, the company aligns itself with the mission of its customers to bring new medical treatments to patients promptly, accurately, and cost-effectively.

To learn more about Premier Research visit:

About Xtalks

Xtalks, powered by Honeycomb Worldwide Inc., is a leading provider of educational webinars to the global Life Sciences community. Every year thousands of industry practitioners (from pharmaceutical & biotech companies, private & academic research institutions, healthcare centers, etc.) turn to Xtalks for access to quality content. Xtalks helps Life Science professionals stay current with industry developments, trends and regulations. Xtalks webinars also provide perspectives on key issues from top industry thought leaders and service providers.

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