DIA 2018 Global Annual Meeting

Component Type: Forum
Level: Basic
CE: ACPE 1.25 Knowledge UAN: 0286-0000-18-526-L04-P; CME 1.25; IACET 1.25; RN 1.25

Using a multi-disciplinary approach, we will take a dynamic look at the experience of those involved in patient engagement, across stakeholder groups representing different regions, to understand how we have collectively moved the needle. As organizations have embarked upon efforts and implemented initiatives, we will provide a bird’s eye view of the impact of patient engagement across various stakeholders.

Learning Objectives

Describe how patient engagement has evolved across stakeholder groups in the past few years; Discuss the impact of collective approaches on patient engagement in medicines development lifecycle; Apply key learnings from collective approaches in their own efforts; Describe recent achievements in patient engagement and identify remaining challenges.

Chair

Lode Dewulf

Speaker

Panelist
David Gray

Panelist
Sarah Krug

Panelist
Pamela Tenaerts

Panelist
Lisa Cone

Component Type: Forum
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-18-527-L04-P; CME 1.25; IACET 1.25; RN 1.25

This session provides a look at how regulators, companies, and patients can work together to discuss the benefits and risks of emerging products that can lead to better patient outcomes.

Learning Objectives

Describe how regulators incorporate patient preferences into benefit/risk assessment; Identify how international efforts are building methodology for patient preferences and input into development, using case study examples.

Chair

Deborah E. Collyar

Speaker

Benefit- Risk Communication: Lessons from Patients
Dinah Duarte

PREFERing to Advocate for Patient Preferences
Rebecca A. Noel, DrPH

Component Type: Forum
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-18-543-L04-P; CME 1.25; IACET 1.25; RN 1.25

This interactive session will convene three distinct patient advocacy groups (PAGs) who will discuss how their unique business models are being used to build long-term relationships with sponsors. The session will also describe how PAGs resource, fund and execute interactions and collaborations with sponsors and discuss opportunities, challenges and solutions arising from the business side of patient engagement, such as maintaining independence, understanding potential conflicts of interest and ensuring transparency

Learning Objectives

Identify three distinct patient advocacy group (PAG) business models being used to build long-term relationships with sponsors; Describe how PAGs resource, fund and execute interactions and collaborations with sponsors; Discuss opportunities, challenges and solutions arising from the business side of patient engagement, such as maintaining independence and ensuring transparency.

Chair

Kristin Voorhees, MA

Speaker

The Business of Patient Engagement
Alice Bast

Necessary Relationships: The Effect of Pharmaceutical Relationships on Rare Disease Patient Advocacy Organizations
Katie Jensen, MPA

A Day in the Life: Making Patient Engagement Real
Suzanne Schrandt, JD

Component Type: Forum
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-18-559-L04-P; CME 1.25; IACET 1.25; RN 1.25

This will discuss the FDA's history of including patient's voice in the regulatory process and current or new efforts that may be more advanced. How has their view of patient engagement changed? Evolution of the Patient Representative Program and Patient Engagement Advisory Council, for example. Engage in dialogue with the FDA and provide considerations for next steps, including from sponsor and patient.

Learning Objectives

Describe current and upcoming FDA efforts to advance the incorporation of patient input into medical product development and FDA’s regulatory decision-making; Discuss regulatory and methodological considerations that must be addressed in order to realize the full potential for patient input to support medical product development and evaluation.

Chair

Pujita Vaidya, MPH

Speaker

How FDA Involves Patients and Advocates
Andrea Furia-Helms, MPH

Partnering for Patients: A Regulatory Framework to Advance Patient-Focused Drug Development
Eleonora Ford, PhD

Panelist
Theresa Mullin, PhD

Panelist
Anindita Saha

Panelist
Telba Irony, PhD

Component Type: Forum
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-18-577-L04-P; CME 1.25; IACET 1.25; RN 1.25

This forum will review lessons learned from the Patient-Focused Drug Development meetings held to date, including externally-led meetings, and provide patient perspectives on their experiences and what has changed in their field as a result. Representation will include both rare, life threatening and chronic disease communities, as well as FDA.

Learning Objectives

Appraise recent examples of FDA’s current efforts to incorporate the patient perspective into regulatory decision-making; Discuss implementation of patient engagement provisions in 21st Century Cures Act and PDUFA VI; Evaluate current proposals of methods collecting patient experience data.

Chair

James E. Valentine

Speaker

FDA Perspective on the Value and Potential of PFDD
Theresa Mullin, PhD

Experience From an FDA-Led PFDD Meeting - NTM Case Study
Amy Leitman, JD

Experience From an Externally-Led PFDD Meeting; TSC Case Study
Steven L. Roberds, PhD

Component Type: Forum
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-18-594-L04-P; CME 1.25; IACET 1.25; RN 1.25

A look at experiences and lessons learned from the autoimmune and neurology fields.

Learning Objectives

Identify common challenges and pitfalls in recruiting underserved patients for research activities; Discuss best practices for recruiting and engaging with diverse groups of patients in activities such as patient insights research and clinical trials; Apply effective models of collaboration and education to address challenges around engaging underrepresented groups in research.

Chair

Hollie Schmidt, MS

Speaker

Strengthening the Bridge Between Diverse Patient Populations and the Clinical Trial Journey
Yaritza Peña

Best Practices for Patient Insights Research: Engaging a Diverse Population
Kelly Franchetti, BSN, RN

Strength in Diversity: How a Multi-Stakeholder Partnership Network is Addressing Minority Underrepresentation in MS Research
Hollie Schmidt, MS

Component Type: Forum
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-18-645-L04-P; CME 1.25; IACET 1.25; RN 1.25

As the industry continues to evolve and incorporate the patient’s voice into drug development - ultimately toward the stage of regular and continuous integrative collaboration - this session will discuss how it’s essential to openly assess and discuss common topics and challenges that may impact the long-term sustainability of patient engagement.

Learning Objectives

Identify the needs of private payers when defining the value of healthcare treatments and interventions; Describe the legal, regulatory, and compliance considerations that biopharmaceutical companies must address to develop and execute sustainable, ethical and compliant patient engagement initiatives; Evaluate methodologies that biopharmaceutical companies are using to measure internal changes related to regularly, efficiently, and successfully implementing patient-centric solutions.

Chair

Katherine Capperella

Speaker

Industry Perspective
Rebecca A. Vermeulen, RPh

Patient Perspective
Jayne C. Gershkowitz

Legal Perspective
Patrik Florencio, JD

Payer Perspective
Samuel R. Nussbaum, MD

Component Type: Forum
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-18-680-L04-P; CME 1.25; IACET 1.25; RN 1.25

This forum will identify a sponsor that uses a Patient Leadership Council to regularly and continuously receive patient input, a patient group that has a collaborative relationship with a sponsor to continuously share patient insights, a sponsor that has seen landscape change and can share the impact and a healthcare provider (HCP) to discuss their historical collaboration with sponsors to collect and share patient insights.

Learning Objectives

Identify how healthcare providers have historically collaborated to share patient insights and how can they help advance patient engagement; Discuss how medical science liaisons engage with the healthcare providers to develop meaningful scientific exchanges while generating insights about patients; Discuss processes that help develop a comprehensive patient engagement program, and present experiences with patient communities.

Chair

Nadina Jose, MD

Speaker

Panelist
Fatima C. Scipione

Panelist
Alexandra Malinowski, PharmD

Example of Best Practice in Protocol Design Review
Ellen Coleman, MPH, MS

Panelist
Mark Summers

Panelist
Kristin Smedley