Logistics Solutions for Direct-to-Patient Clinical Trials
A joint seminar by World Courier, MRN and PAREXEL
Wednesday 29th March 2017
09:00-16:00 CET - World Courier facility Rüsselsheim
Lise-Meitner-Str. 8, Gewerbepark Blauer See, 65428 Rüsselsheim (Frankfurt area), Germany
Direct-to-Patient (DtP) approaches to clinical trials are experiencing unprecedented and sustained growth. DtP models can bring certain medical procedures and protocols to a patient’s home. This brings superb opportunities, including improved patient recruitment and retention, as well as additional challenges around patient confidentiality and the variety of regulatory landscapes from country to country. Many companies involved in conducting studies, providing patient care, supporting clinical trial supply chains and even the regulators themselves are in the process of determining best practices for DtP.
This educational seminar is for industry professionals whether they have some experience, a growing interest in or even are just curious about DtP. The interactive format will consider how the various entities involved, including sponsors, CROs, sites, pharmacies, clinical packaging companies, central laboratories, home care providers and couriers can all work together to address the various challenges with a shared goal of broadening patient participation in clinical trials and enhancing the patient experience.
KEY LEARNING OBJECTIVES
- Understand how to identify and mitigate risks through collaboration, advance planning and clearly defining roles and responsibilities
- Gain insights into what specific challenges can occur with direct-to-patient projects and how these might be mitigated
- Learn about practical approaches to the evolving regulatory landscape that is driving direct-to-patient service models
- Understand what regulatory components need to be considered, and how this may differ by country
09:00 Welcome / Introduction: Objectives & Goals (Mike Sweeney, World Courier)
10:00 A Holistic View of DtP Project Management (Andrea Zobel, PAREXEL)
From treatment area and requirements to protocol design, patient recruitment and managing the many challenges around supply chain management, when is DTP the right fit for your study and how can such projects be most effectively managed?
10:30 Coffee break
10:45 Workshop 1 (Andrea Zobel and Corinna Schwarzkopf, PAREXEL)
Part 1: A Patient’s Perspective - What are the obstacles preventing patients from participating in clinical trials and what solutions can help overcome these challenges?
Part 2: Patient Confidentiality - When implementing a DtP approach, confidential patient information must be shared with multiple parties. What are the risks and how are they best mitigated?
12:45 The Evolution of DTP (David Spillett, World Courier)
From commercial drug lifesaving programs to a rapidly growing clinical trials demand, DtP models have evolved significantly during the past few years and the path forward points to continued growth and new challenges
13:15 Utilizing Home Trial Support to Improve Patient Recruitment & Retention Challenges (Stuart Redding and Paul Bodfish, MRN)
What types of studies or scenarios require Home Trial Support, what treatment services can be conducted in the home, how can Home Trial Support providers work seamlessly with and complement investigator sites and how do home treatments enhance the patient experience?
13:45 Workshop 2 - Interactive Home Trial Support Discussion (Stuart Redding and Paul Bodfish, MRN)
- Clinical Trial Home Trial Support Case Studies
- What are the potential challenges of implementing Home Trial Support projects within your organization?
- Open discussion / Q&A
14:45 Coffee break
15:00 Panel Discussion (MRN, PAREXEL and World Courier)
DTP & Regulatory Considerations and Other Topics of Interest
15:45 Closing Remarks (Mike Sweeney, World Courier)
The event is free of charge and lunch will be served at the venue.
For questions please contact:
Susanne Martin: +49 (0) 40 2263341-0
ABOUT THE SPEAKERS
Vice President, Corporate Services
Medical Research Network Limited
Paul is responsible for the oversight, maintenance and development of MRN’s Quality Management System. A key component of this is to ensure that MRN project teams understand the potential regulatory and legal hurdles that Home Trial Support in global clinical trials brings, and how these can be mitigated and resolved. Paul is one of the original founders of MRN in 2006 and also currently has responsibility for the Training and Contracts & Proposals teams. Paul has over 20 years’ experience in clinical trials having previously spent 12 years at PAREXEL in addition to working for Proctor & Gamble and the Imperial Cancer Research Fund.
VP Business Development
Medical Research Network Limited
Stuart has over 20 years’ experience in the pharmaceutical industry, successfully delivering clinical trials, with a focus on patient recruitment & retention. Stuart has worked across many disciplines, including data management, clinical operations, project management, feasibility, budget & proposal development, business development & marketing. Stuart worked with both Sponsors (American Cyanamid, Novo Nordisk) & CRO-s (MDS Harris, Chiltern), before joining MRN in 2006 as one of the founders & Head of Project Management. Stuart currently has responsibility for global business development & marketing, with a focus on educating customers in how to utilise Home Trial Support for successful clinical trial completion.
Senior Manager Clinical Trial Material Strategic Sourcing & Product Development
PAREXEL International Limited
Corinna Schwarzkopf joined PAREXEL in 2007 as a Clinical Logistics Manager. In her initial years with the company, Corinna planned and setup clinical logistics for internationally conducted clinical trials. By the time she graduated from operational level to a line manager in the Clinical Logistics Department responsible for education and mentoring of staff working on drug and ancillary supplies logistics for clinical trials. In the past four years Corinna has taken on the expert role for sourcing of depot and courier services, purchase of drug and ancillary supplies as well as rental of equipment from third party suppliers worldwide. Recently she joined the Product Development team and oversees and organizes now the implementation of innovation in the Logistics business globally (e.g. Just in Time labelling, demand forecasting, direct to patient logistics).
Corinna holds a natural science doctors degree in Biochemistry from the Martin Luther University in Halle a. Saale / Germany and a German teacher’s examination for secondary schools.
Key Account Director
World Courier (UK) Limited
David is a pharmaceutical services professional with over 15 years' experience in the provision of GXP compliant services. He is considered a subject matter expert in the context of Clinical Trial Supplies and is one of the few GMP/GDP specialists whose experience includes the administration of investigational products in a clinical setting. David is currently Key Account Director at World Courier where he is often called upon to assist in solving the supply chain challenges associated with novel therapies. He has previously worked as a Clinical Supplies Lead for Penn Pharma where he managed pharmaceutical development and supply chain projects for a variety of small, medium and large pharmaceutical companies. David holds a post graduate diploma in clinical research gained whilst working as a Research Physiologist at Simbec Research Ltd.
Senior Director, Global Service Development
World Courier Management Inc.
Mike is responsible for the development and standardization of World Courier’s services across 50+ countries, with specific focus on offerings such as direct-to-patient and cell and gene therapy. Since joining World Courier in 1992, Mike assumed a number of positions within US operations, customer service, compliance and clinical trials. He progressed to senior roles, including director of US customer service/operations, director of new service development and director of regional accounts prior to transitioning into a global IT leadership position and into his current role in mid-2015.
Senior Director, Product Management, Clinical Trial Supplies and Logistics
PAREXEL International Limited
Andrea Zobel initially joined PAREXEL in 2004 as Clinical Logistics Manager - Head of Clinical Trial Supply. Andrea significantly contributed to building up the Clinical Trial Supply services, including the expansion of a global depot network. She rejoined PAREXEL for a second time in 2015 in the capacity of Global Senior Director Portfolio Management. Andrea has recently taken on the responsibility for the definition and implementation of new product and services for PAREXEL’s Clinical Trial Supplies and Logistics business globally.
Her scientific career includes 12 years’ research in gene technology, pharmacology and preclinical development, both in academic research and in biotech companies.