DIA 2024 Global Annual Meeting

Component Type: Session
Level: Intermediate

Steve Jobs. Elon Musk. Innovators who create new things or solve problems in new ways. But how do you be creative? How can a team come up with new development plans, trial designs, or enrollment strategies? Learn decision science’s proven process.

Learning Objectives

Recognize decision science mindset (expand versus contract, alternative versus value focused); Identify framing and re-framing techniques; Identify and clarify value criteria; Demonstrate value criteria to systematically develop creative solutions.

Chair

Tyler Ludlow, MBA

Speaker

Creativity and Innovation within Clinical Drug Development
Candice Junge, PhD

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: Basic

Join our beginner-friendly Chat GPT workshop! Designed to provide both an overview and hands-on experience, this session will delve into the fundamentals of ChatGPT technology. From understanding its underlying principles to practical applications, participants will gain insight into AI-driven conversations. Through interactive demonstrations and guided exercises, attendees will get firsthand experience in leveraging ChatGPT's capabilities. Whether you're new to AI or seeking practical insights, this session promises to equip you with valuable knowledge and skills

Learning Objectives

Describe the basics of artificial intelligence, large language models, and ChatGPT; Identify with using hands-on experience by interacting with ChatGPT through guided exercises; Discuss best practices for interacting with the technology as well get an overview of ethical considerations and potential limitations of ChatGPT technology; Assess the impact its already creating in pharma R&D, and what are the use cases that you can get started with.

Chair

Ankush Chandna, MSc

Speaker

Facilitator
Anjali Shah, PharmD

Facilitator
Ankush Chandna, MSc

Component Type: Workshop
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-570-L04-P; CME 1.00; RN 1.00

This workshop will discuss how to combine FDA medical queries (FMQs) and standardized MedDRA queries with study data, as well as how to compare them through interactive figures and tables. It will also discuss how to interpret the algorithmic FMQs.

Learning Objectives

Describe how to apply the FDA Medical Queries (FMQs) Excel file and the Standardized Medical Queries (SMQs)ASCII files to a given study trial by combining it with study data; Create interactive figures and tables to analyze the medical queries for a study and compare them for FMQs and SMQs.

Chair

Rebecca Lyzinski, MS

Speaker

How to Compare FDA Medical Queries and Standardized MedDRA Queries with Interactive Graphics
Rebecca Lyzinski, MS

How to Compare FDA Medical Queries and Standardized MedDRA Queries with Interactive Graphics
Scott Proestel, DrMed, MD

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

This workshop will discuss best practices and essential skills for leading without authority. Attendees with go through a real-world case study for leading a cross functional team through a long-term project without formal authority. This workshop will delve into essential strategies for fostering alignment, cultivating open communication, promoting agility, and successfully navigating barriers within organizations.

Learning Objectives

Discuss best practices and develop the essential skills needed for leading without authority in a cross functional team environment; Describe influencing stakeholders, negotiation tactics, and relationship building..

Chair

Mica Elizalde, RAC

Speaker

Facilitator
Connie Pascual, MSc

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: 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: Workshop
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-658-L04-P; CME 1.00; RN 1.00

Recruiting pediatric patients is a challenge and one of the solutions is to carefully design the study in an hybrid way to borrow adult data for pediatric study using innovative statistical techniques. The workshop discusses the recruitment challenges involved and then attendees will play a role of providing their thoughts on pediatric recruitment challenges. The workshop explains how well a study can be designed in an innovative way with appropriately utilizing the statistical techniques with case study to overcome recruitment challenges.

Learning Objectives

Discuss how to borrow historical adult data for pediatric study where recruiting pediatric patients is a huge challenging task.

Chair

Rajesh Kumar Gajendran, SR, MSc

Component Type: Workshop
Level: Intermediate

The interactive workshop will provide an opportunity for participants to discuss common barriers that hinder effective communication in cross-cultural, diverse teams. Discussion will draw from the management, psychology, and drug development literature to help contextualize communication and feedback giving.

Learning Objectives

Identify and discuss common interactions and patterns that can hinder effective communication in diverse and cross-cultural teams in drug development; Describe common pitfalls and fallacies related to feedback and learn how to avoid them; Identify evidence-based solutions on how to reduce barriers to communication.

Chair

Jennifer Kim, PhD

Speaker

Empirical Perspective: What the Research on Team Communication in Drug Development Reveals
Emily Botto

Learning and Development Perspective: Best Practices for Training and Implementation
Tamei Elliott, MS

Case Perspective: Learnings from the Field
Christine Mayer-Nicolai, PharmD

Component Type: Workshop
Level: Basic

Unlock the secrets of workplace success! Learn to harness the strengths of each generation and build a cohesive and successful team. Don't miss out on the opportunity to learn valuable insights and strategies for managing a diverse workforce.

Learning Objectives

Explore the unique characteristics and differences among different generations in the workplace; Discuss practical ideas on how to effectively manage and create a harmonious and productive work environment; Describe how to dispel the myths and stereotype of each generation.

Chair

Tywnia Brewton

Speaker

Facilitator
Leslie Sam