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Choosing the Right Partner to Build a Successful Direct-to-Patient (DTP) Clinical Trial Framework

WEBINAR DETAILS

Date: June 5, 2017 (60 minutes)

Featured Speakers:

  • Mia Kobuta, Manager, Logistics Client Services, Sharp Clinical Services Inc.
  • Will Plyler, Manager, Business Development – Clinical Research Services, McKesson Specialty Pharmacy Solutions

Patient enrollment is one of the most critical variables in a successful clinical trial. For drug therapies that are focused on an elderly patient population and the critically ill, sponsors and contract research organizations are increasingly turning to direct-to-patient (DTP) distribution strategies for their clinical trial design. In certain situations, DTP trials can reduce the patients’ need to travel to the clinical site and can potentially contribute to improved patient recruitment and retention over traditional drug distribution strategies.

DTP trials are fast becoming a key clinical trial solution within certain patient populations and trials. Choosing a provider with comprehensive capabilities, the necessary infrastructure, a broad background of experience and a culture of problem-solving flexibility can help to both accelerate your study and reduce study costs.

In this webinar, you will learn:

  • How DTP trials can potentially contribute to the improvement of patient enrollment, retention and overall patient satisfaction
  • What to look for in a partner to manufacture, package and distribute clinical drug supplies for DTP studies
  • The regulatory landscape for DTP trials

In this presentation, we’ll examine the key aspects of a DTP program and how it works — protocol development, clinical manufacturing/packaging, fulfillment/distribution, logistics/tracking and maintaining compliance — with an eye to determining the trials for which it might work and choosing the best partner to support your clinical trial.

In many ways, your clinical manufacturer and packaging partner is a key link to a successful DTP program. By choosing a company with a comprehensive range of services, you’ll be able to manage your entire supply chain, including packaging and labeling of the investigational product and clinical support services, with a single provider and under one roof. A clinical manufacturer and packager with experience in conducting DTP studies will help you develop an appropriate protocol and distribution strategy, which can both mitigate risks and drive better outcomes.

For a DTP trial, it’s important that your partner has manufacturing, packaging, and clinical support services. They should be able to design, assemble and label patient kits in a customized fashion in order to satisfy your clinical trial needs. Furthermore, your CMO should work to develop an optimal carrier and distribution approach that is customized based on your drug’s temperature requirements, the size of the individual kits, the nature of the material and the frequency of dispatches to the patient’s home.

Keywords: Clinical Trial, Clinical Manufacturing

    ABOUT OUR SPEAKERS

    Mia Kobuta, Manager, Logistics Client Services, Sharp Clinical Services Inc.


    Mia oversees the logistics project management and global depot teams within Sharp Clinical Services. Her prior roles with Sharp have included Logistics Project Coordinator as well as Global Depot Manager. She has been responsible for helping to build out Sharp’s global depot network as well as assuring the highest of quality standards through routine audits of Sharp’s depot network.

    She is a native of Ukraine and is fluent in three languages. Mia is focused on providing her clients with critical insight; necessary to offer a proactive approach to meet their goals. She is well versed on international import and export regulations and is excited about the opportunity to discuss Direct to Patient strategies with you.

    In addition to attending National Technical University in Lviv City in Ukraine, she is also certified as a Lead Auditor (TPECS) ISO 9001:2015 as well as a subject matter expert for dangerous goods handling.

    Will Plyler, Manager, Business Development – Clinical Research Services, McKesson Specialty Pharmacy Solutions


    Will joined the McKesson Specialty Health team in April of 2016 through its acquisition of Biologics, Inc. and now leads multiple new business opportunities for our Clinical Research Services division. This includes supporting biopharma manufacturers, NCI NCTN Network Groups, and academic cancer centers launch new clinical trials. He has 8 years of experience forming strategic relationships and working with sponsors to design drug distribution models to optimize healthcare outcomes.

    Will earned his Bachelor of Arts degree in Economics from the University of North Carolina at Chapel Hill, and holds a Masters in Business Administration from North Carolina State University

    THIS PROGRAM IS INTENDED FOR

    VPs, Directors, Managers of:

    • Clinical Supply Chain
    • Clinical Logistics
    • Clinical Operations
    • Clinical Outsourcing
    • Project Management
    • Vendor Management
    OUR XTALKS PARTNER FOR THIS EVENT
     

    Sharp Clinical Services - A Fully Integrated, End-to-End Clinical Manufacturing and Packaging Company

    As a division of UDG plc., a global healthcare services company with a market cap of over €1 billion, Sharp Clinical Services is committed to helping our customers achieve clinical trial success. Our customized and tailored approach to your program is what makes Sharp different than the other clinical trial manufacturers and packagers in the industry. Our global project management process links our sites in Phoenixville, PA and Crickhowell, UK and is focused on a tailored and flexible approach to your clinical trial through dedicated project management. At Sharp we are committed to serving our customers with the highest levels of excellence with on time delivery rates of 99.9% and a global depot network of over 30 depots in every major region of the world. Our Clinical services include:

    • Analytical & Research
    • Formulation Development
    • In House Label Design & Printing
    • Clinical Manufacturing
    • Packaging & Labeling
    • IRT
    • Storage & Distribution

    To learn more about Sharp please call Joe Scollins, US Sales & Marketing Director, at 484-896-8545

    Biologics, Inc. - A Full-Solution Distribution Partner

    Biologics’ Clinical Research Services division supports drug manufacturers, academic cancer centers, and NCI network groups with clinical trial drug distribution and logistics services. As costs associated with clinical trials increase, along with the increasing demand to provide high-quality, adaptive clinical trial protocols, efficiency and transparency in all aspects of a trial are critical. Biologics proposes distribution, with full solution services and protocol support programs. This will reduce administrative costs, drug waste and increase patient compliance. Our sponsors will gain greater efficiencies through reduced cost redundancies and improved consistency and integrity of data.

    • Enhance service offerings by providing complex protocol solutions with industry leading customer and performance metrics for:
      • Just in Time delivery for randomized, double-blind clinical trials
      • Dose-specific, patient-specific dispensing models
      • Direct-to-Patient delivery
      • REMS compliant distribution for post-market studies
      • Patient adherence programs

    • Relieve study site anxiety of receiving and maintaining inventory through Biologics JIT delivery
    • Maintain a dedicated multidisciplinary team to rapidly address all trial stakeholders’ questions and concerns – Study Sponsors, Vendors, Participating Study Sites
    • Provide longitudinal data visibility/consistency of performance as channel management partner
    • Serve as a dedicated partner to ensure operational excellence with complex clinical trial protocols and adaptive trial designs
     
     

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