Managing a Successful Direct-to-Patient Trial Using Interactive Response Technology

As the industry strengthens its focus on patient centricity, Direct-to-Patient clinical trials have emerged as a popular trial design that have the potential to increase patient recruitment and retention. However, despite its popularity, the Direct-to-Patient model hasn’t been fully adopted by many sponsors due to the complexity of regulations, potential cost implications and a multitude of other factors.

Interactive Response Technology plays a crucial role in the success of a Direct-to-Patient trial. Because drug supplies are being managed and shipped from distribution facilities directly to patients’ homes, a sponsor must have a high-quality system in place to accurately track the chain of custody, ensure patient-blinding and handle other logistical challenges.

In this webinar, participants will hear from an expert at a leading biotherapeutics company, which is experienced with running Direct-to-Patient trials using Interactive Response Technology in the cardiopulmonary space for the past five years. The speaker will discuss the benefits and challenges faced when implementing a Direct-to-Patient trial, the reasons why they chose to run this trial type and the considerations to make when choosing to implement an Interactive Response Technology system using this model. Participants will learn about how the right Interactive Response Technology system can equip study teams to successfully handle the multiple layers of complexity within a Direct-to-Patient trial and how this trial design could be utilized more widely in the future.

Speakers

Lisa Killi, Director of Clinical Supplies Management, Bellerophon

After earning her MBA from Rutgers University, Lisa Killi entered the clinical supply arena at Bristol-Myers Squibb. Lisa moved to Sanofi where she was responsible for managing post-marketing clinical supply projects, and played a lead role in the validation and implementation of key clinical supply management systems and the establishment of internal clinical supply packaging, labelling and distribution facilities. Currently, Lisa is the Director of Clinical Supplies Management at Bellerophon Therapeutics, and oversees the cradle to grave clinical supply chain for global device/drug supply programs that employ Direct-to-Patient distribution to address the unique nature of the products and patient populations. She is responsible for the development, implementation and oversight of all Bellerophon clinical supply management strategies, procedures, Interactive Response Technology and mobile application solutions.

Message Presenter

Chris Petruzela, Design Consultant Group Lead, Suvoda

As a Design Consultant Group Lead at Suvoda, Chris Petruzela specializes in defining the behavior of Interactive Response Technology systems customized to manage drug supply and treatment assignment at a study-specific level as well as providing guidance in requirements gathering and system design to colleagues. Along with his extensive project management experience, Chris has experience in designing Interactive Response Technologysystems to meet the needs of Direct-to-Patient clinical trials. Chris is a graduate of Lehigh University with a Bachelor of Science in Computer Science Engineering.

Message Presenter