DIA 2024 Global Annual Meeting

Component Type: Workshop
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-527-L04-P; CME 1.00; RN 1.00

This workshop is a deep discovery of the potential and impact of master protocol for clinical development programs. These conversations are essential in challenging traditional clinical trials as a path forward for innovation in clinical research.

Learning Objectives

Recognize the history and basics of clinical research as it relates to master protocols; Compare and contrast master protocols to traditional (fixed sample size) and adaptive trial designs; Describe important methodological principles of master protocols and simulation-guided design; Discuss key benefits of master protocols for stakeholders of clinical development programs.

Chair

Muhammad Ali Hameed, CPA, MBA

Speaker

Facilitator
Jay Park, PhD, MSc

Facilitator
J. Kyle Wathen, PhD, MS

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-534-L04-P; CME 1.00; RN 1.00

The explosion of technology and expectations for its use are transforming medical writing. In addition to articulating their value proposition, writers and their managers will have to adapt to this transformation and level-up their skills, in the face of ever-evolving technology and technical challenges. This panel will focus on providing both strategic and tactical considerations for medical writing teams. We will highlight the importance of finding early adopters, developing training for multiple learning styles, building a support network, and surviving the change management process.

Learning Objectives

Discuss how the medical writing role is evolving in the face of technology; Outline the new skillset(s) that medical writers will need and how these change the value proposition of medical writing; Discuss strategies for engaging and training teams through this evolution.

Chair

Robin Whitsell

Speaker

Industry Update
Joanne Hilton, PhD, MBA

Industry Update
Kayla Williams

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: Workshop
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-560-L04-P; CME 1.00; RN 1.00

At the DIA 2023 a round table on data standards and harmonization discussed “standards fatigue” related to data standards, reference models, consortia, industry groups, and their impact on the industry. We intend to address this topic in a two-part workshop.

Learning Objectives

Identify various data standards and harmonization efforts across pharma and biotech industries; Discuss challenges and business impact related to the understanding, implementation, and maintenance of data standards initiatives in light of digital transformation efforts; Describe approaches to identify overlapping/competing initiatives and develop synergistic approaches to reduce fatigue.

Chair

Venkatraman Balasubramanian, PhD, MBA

Speaker

Facilitator
Sridevi Nagarajan, PhD

Facilitator
Norman Schmuff, PhD

Facilitator
Hilmar Hamann, PhD

Facilitator
Cesar Vinces

Facilitator
Vanni Carapetian, MPH

Facilitator
Heiner Oberkampf, PhD

Component Type: Workshop
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-575-L04-P; CME 1.00; RN 1.00

At the DIA 2023 a round table on data standards and harmonization discussed “standards fatigue” related to data standards, reference models, consortia, industry groups, and their impact on the industry. We intend to address this topic in a two-part workshop.

Learning Objectives

Identify various data standards and harmonization efforts across pharma and biotech industries; Discuss challenges and business impact related to the understanding, implementation, and maintenance of data standards initiatives in light of digital transformation efforts; Describe approaches to identify overlapping/competing initiatives and develop synergistic approaches to reduce fatigue.

Chair

Venkatraman Balasubramanian, PhD, MBA

Speaker

Facilitator
Sridevi Nagarajan, PhD

Facilitator
Heiner Oberkampf, PhD

Facilitator
Vanni Carapetian, MPH

Facilitator
Hilmar Hamann, PhD

Facilitator
Norman Schmuff, PhD

Facilitator
Cesar Vinces

Component Type: Workshop
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-588-L04-P; CME 1.00; RN 1.00

Increasingly, biopharmas are integrating patient engagement across their corporations in ways that address shared priorities with patient communities. Additionally, they are also increasing the transparency related to delivering on these commitments, including but not limited to, the percent of clinical trials that are informed by patients. This workshop will discuss approaches taken by various companies, the role of advocates, and their perspectives on the importance of achieving meaningful patient engagement, along with the steps necessary to achieve the goals.

Learning Objectives

Describe how to bring together key stakeholders to evaluate how, and where, patient engagement can be fully integrated to address what matters most to patients; Describe how to move beyond patients informing select clinical trials to 100% of a portfolio; Identify how to align resources, capabilities and change management needs to deliver on the vision; Discuss how to communicate and monitor the impact of engagement strategies.

Chair

Victoria DiBiaso, BSN, MPH, RN

Speaker

Implementable Approaches to Fully Integrating Patient Engagement Across an Entire Company: Including all Clinical Trials
Tracey Robertson, MBA

Patient Perspective
Hollie Schmidt, MS

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: Session
Level: Basic
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-615-L04-P; CME 1.00; PDU 1.00 PMI 2166M3MMI2; RN 1.00

The session will provide an overview of projct management (PM) in discovery and early development and contrast to the application of PM skills in later stages. The session will include best practices for driving impact with discovery and early development functional areas.

Learning Objectives

Describe the value of project management (PM) on discovery teams and early in the drug development lifecycle; Compare adaptations for PM in discovery versus development in both large pharma and smaller biotech settings; Discuss best practices for driving impact with discovery and early development functional areas.

Chair

Elizabeth Somers, MS

Speaker

The Value of Project Management in Driving Drug Discovery Success - Small Company Perspective
Stuart Ince, PhD

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-628-L04-P; CME 1.00; RN 1.00

Discussion of partnering with regulators to get novel digital health products through the approval processes. Learn insights from industry and regulators for creative, strategic, and flexible thinking on regulation of novel technologies.

Learning Objectives

Discuss the challenges of introducing novel digital technologies to FDA; Describe tactics to build better partnerships with regulators.

Chair

Rebecca Joy James, MBA, RAC

Speaker

Panelist
Anindita Saha

Panelist
James Wabby, MHS

Panelist
Adam Cargill, MS

Panelist
Wes Gerbig, PhD, MS

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: Workshop
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-651-L04-P; CME 1.00; RN 1.00

Challenge areas for developing patient-centered sensor-based outcomes (SBOs) will be identified, along with solutions and key considerations using real-world examples of SBO development.

Learning Objectives

Describe key challenges to leveraging the patient-focused drug development (PFDD) guidance series to develop fit-for-purpose, patient-centered sensor-based outcomes (SBOs, eg, wearables) to support medical product development and decision making; Identify potential solutions to inform development of fit-for-purpose, patient-centered SBOs.

Chair

Katelyn R Keyloun, PharmD, MS

Speaker

Sensor-Based Outcome Measure Development: Challenge Areas for Concept Elicitation and Interpretation of Endpoints
Bill Byrom, PhD

FDA Update
Michelle Campbell, PhD

EMA Update
Steffen Thirstrup, MD, PhD

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-664-L04-P; CME 1.00; PDU 1.00 PMI 216658O27Z; RN 1.00

In this session, we will provide an overview of lifecycle management for an asset from patent filing to loss of exclusivity. Critical success factors require early planning, rigorous prioritization, organizational alignment, cross-functional buy-in and collaboration, and retention of enterprise memory over the long lifecycle of an asset. Program managers will gain insight into their unique role as champions of process and people, ensuring therapies reach patients faster. Proven strategies from case study examples will outline key decision points at each stage of product development, identify tools for strengthening cross-functional team planning, ensure quality oversight, and enhance successful delivery of the product lifecycle strategy.

Learning Objectives

Identify the concept of pharmaceutical lifecycle management and its role in bringing lifesaving therapies to patients efficiently; Discuss the challenges of pharmaceutical lifecycle management, such as siloed department planning and lack of resources; Describe the role of project management in ensuring continuity of lifecycle management and the execution of the product strategy.

Chair

Susan Carino, MBA, MS, PMP, RAC

Speaker

Unlocking Success: Mastering the Pharmaceutical Asset Lifecycle Journey: Industry Update
Aditi Khurana, MBA, PMP, RAC

Component Type: Forum
Level: Intermediate

Curious about who shapes the decisions behind medicines approval and inspection? Wondering about the diversity in backgrounds and perspectives within regulatory agencies? Join us for an insightful session delving into the critical role of diversity in medicines development and regulatory decision-making. Ever pondered if your skills could transition you from being regulated to a regulator, or vice versa? Explore how transferable skills can bridge the gap between industry and regulatory roles, fostering diverse thinking essential for patient-centric outcomes. Discover career pathways in both sectors and learn how breadth of experience in seemingly unrelated roles can enrich regulatory processes, including patient advocacy. Don't miss this opportunity to uncover the less trodden path between regulators, the regulated, and patient advocacy. Join us to pave the way for a more inclusive and impactful medicines development landscape.

Learning Objectives

Recognize transferable skills from industry to regulatory roles, fostering diversity crucial for innovation; Assess the panelists' career trajectories transitioning between sectors, gaining strategies for professional growth; Identify the patient advocacy's role, understand how similar transferable skills are utilized to support patient-centric approaches.

Chair

Paula Walker, MA

Speaker

Panelist
Sophie Radicke, MSc

Panelist
Patroula Smpokou, MD

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-687-L04-P; CME 1.00; PDU 1.00 PMI 21664WZFGG; RN 1.00

Through strong sponsorship, stakeholder management, and communication practices, many companies have been more effective at bringing innovation and new learnings from external organizations and consortia back into their respective companies.

Learning Objectives

Recognize how dedicating resources can enable your organization to enhance talent and innovation, increase value, and maximize your investment in consortia participation; Discuss the application of best practices around communicating new solutions/tools and events to the right internal stakeholders to maximize uptake; Describe building a coalition of internal champions to support collaboration.

Chair

John Richard Dobbins, MEd

Speaker

Industry Update
Sarah McKay Tremethick

Industry Update
Toni Spears, BSN

Industry Update
John Z. Sun, PhD, MBA, PMP