DIA 2024 Global Annual Meeting

Component Type: Session
Level: Basic

It is well understood that diversity in the workplace contributes to innovation and improved business outcomes. Interweaving diversity, equity, and Inclusion (DEI) strategies into the work of an organization can improve performance and create thriving workplace cultures. Building such a culture translates into a sense of belonging that inspires employees across the pharmaceutical industry to be more engaged, considering their organization a great place to work and committing to the company mission. While most companies include DEI in their strategic plans, there remains a disconnect between having DEI as a company priority and the actual cultivation of an inclusive workplace. DEI efforts at many companies are limited to only passive learning (e.g., online modules and training) and a shift to a more engaging, fit-for-purpose approach is needed. In this session, we will share case studies of ongoing diversity, equity, and inclusion (DEI) workplace initiatives and we will delve into concrete action plans to translate DEI company priorities.

Learning Objectives

Describe existing diversity, equity, and inclusion (DEI) policies within the workplace to identify strengths and gaps; Discuss DEI initiatives that foster a culture of belonging in the workplace.

Chair

Ruth Milena Gómez Vargas, MS

Speaker

Case Study: Medical Writing Inclusion, Diversity, and Equity Alliance
Ruth Milena Gómez Vargas, MS

The Big Picture: Inclusive Workplaces Benefit Patients
Xoli Belgrave, MSc

Case Study
Carlos Orantes, MBA

Case Study
Karen J Wood

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-532-L04-P; CME 1.00; RN 1.00

Evidence shows that improving diversity in clinical trials requires early planning. The session presents a cost analysis and case examples from an expert panel on the impact of incorporating patient diversity tactics and resources early in the process.

Learning Objectives

Discuss how to quantify the cost and resources required to execute tactics that increase clinical trial diversity; Explain how the exclusion of patient diversity tactics in budget planning impacts diversity and overall study milestones; Identify considerations that can influence leadership decision-making around diversity during the budget planning process.

Chair

Lloryn Hubbard

Speaker

Industry Update
Ryan Brown, MPA

Industry Update
Steve T. Satek, MBA

Industry Update
Monica Eason

Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-545-L04-P; CME 1.00; RN 1.00

This forum will include discussion among multiple sponsors sharing their first-hand, cross-therapeutic area experience on notable trends and challenges they have faced in preparing these early diversity plan submissions. Panelists will also address how they plan to adapt to more expansive categories enumerated within diversity action plan guidance and share reflections on recently released FDA guidances on this topic (i.e. diversity action plans, post market approaches to obtain data on underrepresented populations, collection of race and ethnicity data). Additionally, panelists will discuss what policy deliverables and clarifications they would like to see reflected in the final guidances. The panel will also include FDA’s perspective and reflections from 2 years of diversity plan submissions as well as any considerations as we look to the future.

Learning Objectives

Describe best practices and regulatory feedback on diversity plan submissions.; Compare the perspectives of both FDA and sponsors about the current landscape of trial diversity-related guidances, including the latest diversity action plan guidance.; Discuss how by using an interactive audience feature where we seek others’ experience compiling and feedback from the FDA on diversity plan submissions.

Chair

Dylan Bechtle, MS

Speaker

Industry Update
Andrea Doyle

Industry Update
Del Smith, PhD, MS

Industry Update
Stacy Holdsworth, PharmD

FDA Update
Tamy Kim, PharmD

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-550-L04-P; CME 1.00; PDU 1.00 PMI 2166LI6KQZ; RN 1.00

Embark on a transformative journey to unlock leadership superpowers! Discover the secrets to excel, empower, and inspire. Challenge perceptions and unleash your inner leadership superhero with engaging discussions, and real-world examples.

Learning Objectives

Discuss compassionate leadership's impact on culture and success; Describe how to empower teams for self-organization and ownership; Identify how to cultivate a culture of continuous learning and foster team connection, diversity, and inclusion; Determine how to nurture growth for team members' personal and professional thriving.

Chair

Vidya Narayanaswamy, MBA, MSc

Speaker

Elevate Leadership: Harnessing the Five Superpowers
Vidya Narayanaswamy, MBA, MSc

Elevate Leadership: Harnessing the Five Superpowers
Sushma D.A. Hallock, MBA

Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Application UAN: 0286-0000-24-577-L04-P; CME 1.00; RN 1.00

This forum will describe strategies for patient engagement to help design patient experience studies (PED). Case studies will illustrate the critical impact of patient engagement on the design of PED studies.

Learning Objectives

Examine the critical role that patient engagement can have on the success of patient experience studies; Implement strategies to overcome challenges associated with patient engagement in hard-to-reach populations.

Chair

Ellen Janssen, PhD

Speaker

Lessons Learned from Publicly Funded Patient Engagement Activities
Caroline Vass, PhD

Industry-Led Case Study
Bennett Levitan, MD, PhD

Industry Update
Brett Hauber, PhD, MA

FDA Update
Robyn Bent, MS, RN

Patient Advocacy Perspective
Bellinda King-Kallimanis, PhD, MSc

Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-580-L04-P; CME 1.00; RN 1.00

Minority access to clinical trials is an ongoing challenge. Community Health Centers (CHCs) can support linking these populations to studies. This session shares results from a national CHC survey that informs about needs and perceptions that can help increase participation.

Learning Objectives

Describe how to distinguish Community Health Centers (CHCs) from other types of healthcare organizations; Discuss results from a grant that surveyed 40 CHCs nationwide about their perceptions and needs related to clinical trials; Evaluate options for CHCs to be involved with supporting clinical trial and diverse enrollment.

Chair

Pete Fronte, MBA

Speaker

Industry Update
Karen Correa, PhD

Community Health Care Update
James Schultz, MD, MBA, FAAFP

Patient Update
Mario DuCre

Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-589-L04-P; CME 1.00; RN 1.00

This forum will present the considerations in global development strategy to approach to broader market including Japan for maximizing worldwide patient access and business opportunity. The panelists are from pharma and biotech.

Learning Objectives

Describe how to maximize the value of innovative products for the global market and benefit patients worldwide; Discuss how to apply the learnings to the clinical development strategy to expand target market effectively considering patient access to innovative drugs; Identify how to influence to regulators, industry, and trial sites to improve local environment to reduce hurdles and enhance global simultaneous development.

Chair

Eri Sekine

Speaker

Panelist
Leyna Mulholland, PharmD, PhD, MS

Panelist
Toshiharu Sano, RPh

Panelist
Xiaojun (Wendy) Yan, MD, MBA

Component Type: Workshop
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-600-L04-P; CME 1.00; RN 1.00

This workshop will assist attendees with ways to properly accommodate medically complex and/or rare disease patients through providing accessibility tools and solutions. Soft skills and “person first” language will be discussed.

Learning Objectives

Identify how to expand the definition of diversity; Describe how to have conversations with patients about disabilities; Explore solutions and recommendations for no/low-cost actions you can take to make your facility as accessible as possible for a variety of disabilities; Define resources for support and training for site staff.

Chair

Stacy Hurt, MBA, MHA

Speaker

Facilitator
Carlos Orantes, MBA

Facilitator
Cecile Gonzalez-Cerimele

Facilitator
Mindy Cameron

Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-634-L04-P; CME 1.00; RN 1.00

There is a critical need for innovation in women’s health, particularly maternal health. What will it take to improve care in this area? How can innovative regulatory, reimbursement and access policies encourage novel approaches to women’s health?

Learning Objectives

Identify areas of women’s health which face barriers preventing innovation; Describe disparities in women’s/maternal health and existing regulatory, payment and access policies intended to improve outcomes; Evaluate the types of policy changes needed to encourage innovation

Chair

Nancy Bradish Myers, Esq, JD

Speaker

Panelist
Lynne Yao, MD

Panelist
Tara Croft, MBA

Panelist
Sandy Milligan, JD, MD

Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-636-L04-P; CME 1.00; RN 1.00

This forum will address industry challenges in the recruitment and retention of underserved populations in clinical research, and explores how regulators, physicians, sponsors and others can work together to develop solutions to tackle health equity.

Learning Objectives

Identify a proposal for addressing underrepresentation of underserved populations in Europe; Describe regulatory and industry perspectives in addressing recruitment and retention challenges for multi-regional clinical trials; Discuss best practices that can help shape inclusivity of clinical trials across borders.

Chair

Ambily Banerjee, PhD

Speaker

The EU Perspective and the Role of ACT EU
Ana Zanoletty Perez

Evolving FDA Perspective Based on Learningd from DAP Submissions on What Diversity Looks Like
M. Khair ElZarrad, PhD, MPH

Industry Perspective of Community Engagement in Europe: A Case Study
Monique Adams, PhD, MS

CT Network One-Pager v2
Nicholas Brooke, MBA

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-641-L04-P; CME 1.00; PDU 1.00 PMI 2166PJJJ85; RN 1.00

90% of trials are performed in higher-income countries. In this session, the audience will learn directly from stakeholders about establishing infrastructure in low and/or middle income countries (LMICs) and how building capacity can improve quality of care and outcomes for patients.

Learning Objectives

Describe global research expertise and identifying gaps on a local level; Identify approaches to translate local research expertise to global research excellence; Recognize successful strategies for long-term sustainability and growth.

Chair

Muhammad Ali Hameed, CPA, MBA

Speaker

Facilitator
Twanna L Davis, MBA

Facilitator
Jeanine Condo Condo

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-666-L04-P; CME 1.00; RN 1.00

This session will explore how patient experience data (PED) can be used to inform benefit-risk analysis. The panel will include discussion on regulators’ views and incorporation of PED and successful case examples.

Learning Objectives

Describe the role patient experience data (PED) plays in benefit-risk analysis; Identify how to develop PED in a way that can inform regulatory decision-making; Discuss if and how new diversity and inclusion regulations will impact the development of PED and regulators’ interpretation of benefit-risk.

Chair

Allison Martin, MS
Victoria DiBiaso, BSN, MPH, RN

Speaker

The Intersection of Patient-Experience Data and Benefit-Risk Analysis: FDA Update
Michelle Campbell, PhD

The Intersection of Patient-Experience Data and Benefit-Risk Analysis: EMA Update
Francesco Pignatti, MD

The Intersection of Patient-Experience Data and Benefit-Risk Analysis: Industry Update
Jill Yersak

The Intersection of Patient-Experience Data and Benefit-Risk Analysis: patient Update
Hollie Schmidt, MS

Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-665-L04-P; CME 1.00; RN 1.00

Adequate enrollment of underrepresented groups continues to be a challenge in a complex, global regulatory and research ecosystem. Review and assess evolving expectations and processes in the US, Canada, and other regulatory systems, what has been implemented, what adjustments have been made, what has worked, and what hurdles or differences remain.

Learning Objectives

Describe the background and underlying requirements to FDA’s and other health authorities’ diversity and inclusion policies and guidance; Discuss how different stakeholders have implemented and reacted to implementation of new and evolving policies; Identify areas where views or expectations diverge; Discuss and describe what has worked, what has not; Identify how this area might change in future.

Chair

Alexis Miller, JD

Speaker

FDA Update
Karen Hicks, DrMed

Health Canada Update
Alysha Croker, PhD

UK Update
Naho Yamazaki, PhD

Patient Update
Loriana Hernandez-Aldama

Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Application UAN: 0286-0000-24-679-L04-P; CME 1.00; RN 1.00

This session will explore, from three complementary perspectives, how to improve diversity in clinical research by actively addressing accessibility, equity, and inclusion throughout the design and implementation of digital health technologies.

Learning Objectives

Summarize the current state and define industry goals related to diversity, equity, and inclusion (DEI) in clinical research; Outline the role of digital solutions in achieving these diversity, equity, and inclusion goals in clinical research; Apply core principles for digital design and implementation with case studies.

Chair

Lindsay Hughes, PhD, MS

Speaker

Panelist
Silas Buchanan

Component Type: Session
Level: Basic
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-685-L04-P; CME 1.00; RN 1.00

The session will share findings from a recent mixed-method study that examined the different types of racial microaggressions patients experience while participating in clinical trials and how these interactions affect their experience.

Learning Objectives

Describe findings from a recent study examining common forms of racial discrimination experienced by patients in clinical trials; Discuss the impact that these interactions can have on patient-reported outcomes, including patient trust and willingness to participate in another study at that site or location; Discuss evidence-based solutions that can reduce exclusion in clinical trials.

Chair

Jennifer Kim, PhD

Speaker

How Microaggressions Can Impact the Patient Experience in Clinical Trials
Sharon Rivera Sanchez

Research Perspective: The Science of Exclusion in Clinical Trials
Ruby Madison Ford, MPH

Amplifying the Patient Voice: Incorporating the Patient Experience
Perla Nunes

Industry Update
Rodney Winley

Industry Update
Elizabeth Rosenkrands-Lange, MPH, MS