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Tuesday, June 21 • 11:00am - 12:00pm
#222: Patient-Focused Drug Development: Reflecting on a Decade of Insights

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Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Application UAN: 0286-0000-22-558-L04-P ; CME 1.00; RN 1.00

This session will explain how to apply principles of patient-focused drug development to cross-disciplinary functions within research and development and in regulatory strategy and reflect on best practices both in eliciting patient input and in translating it.

Learning Objectives

Identify and apply best practices in employing methods to capture patient experience data; Identify the importance of applying patient insights throughout the drug development and regulatory decision-making approaches through examples.

Chair

Kristina Bowyer

Speaker

Patient-Focused Drug Development Meetings and Beyond: Lessons Learned and Future Opportunities for Engaging FDA
James Valentine, JD, MHS

Obtaining Input From People With Kidney Diseases to Design and Evaluate New Drugs and Devices
Mark David Lim, PhD

Patient Perspective
Isabelle Lousada, MA



Speakers
avatar for Kristina Bowyer

Kristina Bowyer

Vice President, Patient Advocacy & Engagement, Ionis Pharmaceuticals, Inc., United States
Kristina Bowyer joined Ionis in 1992 and currently serves as the Vice President of Patient Centric Drug Development. She founded Ionis’ Patient Advocacy program 2012 to ensure that the patient perspective is incorporated into every aspect of drug development. Kristina’s expertise... Read More →
avatar for Isabelle Lousada

Isabelle Lousada

Chief Executive Officer and President, Amyloidosis Research Consortium, United States
As a former patient, Lousada has spent 20 years dedicated to patient advocacy, accelerating drug development, and promoting awareness of rare diseases. Lousada founded the Amyloidosis Research Consortium (ARC) in 2015. ARC is a patient-focused nonprofit, harnessing the power of collaboration... Read More →
avatar for Mark D Lim, PhD

Mark D Lim, PhD

Vice President for Research, Discovery, and Innovation, American Society of Nephrology , United States
Mark D. Lim is Vice President of Research, Discovery, and Innovation at the American Society of Nephrology. The department aims to sustain the growth of innovations for people with kidney diseases, building on KidneyX, a partnership with US HHS that incentivizes entrepreneurs, and... Read More →
avatar for James Valentine

James Valentine

Attorney, Hyman, Phelps & McNamara, PC, United States
James Valentine, JD, MHS is an attorney at Hyman, Phelps & McNamara where he assists medical product industry and patient advocacy organization clients in a wide range of regulatory matters, including new drug and biologic development and approval issues. Mr. Valentine has been central... Read More →


Tuesday June 21, 2022 11:00am - 12:00pm CDT
Room 183 A McCormick Place 2301 South Indiana Avenue Gate 40 Chicago, IL 60616
  05: Patient Engagement, Session