Busting the myths of decentralized trials

The truth about depot-to-patient shipments

  • Free

Why attend?

The decentralized trials approach isn’t a new concept. It allows patients to receive most – if not all – of their treatment at home rather than at a clinical site. Many are the benefits of this patient-centric model. However, although more than 75% of clinical trials professionals report that at least some of their activities have already been decentralized due to the COVID-19 outbreak, many still hesitate to switch, raising concerns about regulations, IMP integrity, data protection and patient care.

On December 14th, 2021, Andrea Zobel, Senior Director Personalized Supply Chain at World Courier, will delve into decentralized trials logistics and setting up a best-in-class central dispensing model ensuring compliance, integrity, end-to-end visibility, and safety.

She will be joined by industry experts from the International Society for Pharmaceutical Engineering (ISPE)’s Direct-to-Patient task force to discuss the most common concerns and myths raised around the central dispensing model.

Register now to attend the live event and receive a copy of the recording to listen on-demand. The session will be followed by a live Q&A with the speakers.

* Source: Decentralized Clinical Trials in 2020: A Global Survey, PharmaIntelligence Informa

Key Learning Objectives

  • Understand the decentralized trials approach and the central dispensing model
  • Clarify any doubts and misconceptions about the efficiency and compliance of decentralized trials
  • Hear about successful case studies from industry experts
  • Ask questions live to decentralized trials experts

Target Audience

  • Clinical Operations Manager
  • Operations Manager
  • Director Clinical Supply
  • Head of Global Procurement
  • Supply Chain Manager
  • Lab Manager
  • Senior Strategic Sourcing Manager
  • Logistics Manager

Speakers

Select a speaker to learn more

Andrea Zobel, PhD
Senior Director, Personalized Supply Chain World Courier

Andrea leads the Cell and Gene Therapy and Direct-to-Patient service lines, with a focus on defining strategy, driving growth and solving operational and process challenges which arise from the complexity of these shipments. With a wealth of expertise and experience gained across academia, pharmaceutical services and clinical trials logistics, Andrea has served in a number of senior leadership roles in research and development, clinical trial supply chain as well as product and project management before joining our team in 2021.
In parallel, Andrea is an active member of the ISPE (International Society for Pharmaceutical Engineering), author for the PDA (Parentarel Drug Association), HBA (Healthcare Business Women Association) and the female manager network of the VBU (Verband der Biotechnologieunternehmen).

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Mark Saxon, PA-C, MBA
Senior Vice President, Operations Clinical trials, Matrix Medical Network

With more than 25 years’ experience in healthcare both as provider and executive, Mark is adept in clinical trials, population health, all aspects virtual/telehealth, and operations. With Matrix Medical Network, Mark, as SVP of operations Clinical Trials , has been able to develop and execute decentralized clinical trials service line that brings the trials to the patients.
As part of the Mercy Virtual team, Mark was responsible for all 14 Mercy Virtual services, overseeing operational leaders and working in tandem with clinical counterparts in support of one team inside of Mercy. This led to first virtual Joint Commission Certification.

Before joining this team in 2014, Mark served as both a strategic administrator and Chief Physician assistant for a number of cardiothoracic surgery practices.

Mark also has been an adjunct instructor for the Saint Louis University physician assistant program, an advanced cardiovascular life support trainer, and a paramedic crew chief.

As a member of the Army National Guard, Mark saw active duty as a nuclear biological chemical specialist in the Persian Gulf War and provided relief for Mississippi River flood victims.

He earned his bachelor’s degree in biology from Truman University – Missouri, a bachelor’s degree in physician assistant from the Medical University of South Carolina – Charleston, and his master’s degree in business administration from Lindenwood University in St. Charles, Missouri.

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Lisa Falzone
Principal Clinical Supply Manager, Bayer US

Lisa is a Principal Clinical Supply Manager at Bayer specializing in the supply of cold chain investigational products. Lisa is also responsible for operationalizing a global Direct-to-Patient process at Bayer. In addition, she is an active member of ISPE (International Society of Pharmaceutical Engineers) and GCSG (Global Clinical Supply Group) where she leads groups supporting the implementation of Direct-to-Patient.

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Alexander Pytlarz
President of Operations, Infuserve America

Alexander Pytlarz is a pharmacist and President of Operations for Infuserve America in Saint Petersburg, Florida. He has responsibilities for and works closely with all aspects of the quality department, compliance team, and corporate operations at Infuserve America. His daily and yearly goals focus on maintaining and improving current operations and achieving annual operational growth.
Alexander is a graduate of the University of Pittsburgh, School of Pharmacy. Before joining Infuserve, he has worked in, owned, and operated both compounding and long-term care pharmacies.

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