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: Recruiting and Hiring, Preparing a Workforce, Evolving a Workforce and its Company
Carlos Orantes, MBA

Case Study: Creating a Culture of Belonging Inside Out
Karen J Wood

Component Type: Forum
Level: Basic

This forum is designed to inspire, provide insights for robust career planning, and targeted for anyone interested in further development regardless of the stage of their career. Join industry and executive leaders as they answer your career questions.

Learning Objectives

Describe how to approach career planning with a focus on experiences, transferrable skills, and cross-training; Discuss how to use mentoring relationships as a career catapult; Differentiate development from promotion/advancement and use that in career planning; Identify how to mentally deal with uncertainty and benefit from lateral moves and from keeping an open mind.

Chair

Leslie Sam

Speaker

Panelist
David Fryrear, MS

Panelist
Jeremy Jokinen, PhD, MS

Panelist
Paula Walker, MA

Panelist
Niam Vora, PharmD

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

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: Session
Level: Intermediate
CE: ACPE 1.00 Application UAN: 0286-0000-24-602-L04-P; CME 1.00; PDU 1.00 PMI 2166XALVLX; RN 1.00

Many project management methodologies, alternative thinking approach and new technologies can be applied to life science project management and bring many benefits. In this session, the adoption of Design Thinking and Generative AI, two of the emerging topics in health care industry, into life science project management will be discussed. The session will also demonstrate, with case studies, the possibilities of implementing new thinking approach for effective project management, team leading and efficient business process development. We will also examine practical applications of Generative AI in project management from optimizing scheduling, resource planning, and risk management. Reflecting on the current adoption efforts, this session provides a platform to explore possibilities to leverage new thinking and technologies to enhance life science project management.

Learning Objectives

Critique how many project management methodologies, thinking approaches, and new technologies can be applied to life science projects, and they may bring various benefits into the practice; Implement applicable methodologies and protocol new technologies in real-world practice.

Chair

Char Leung

Speaker

Industry Update
Rune Bergendorff, MSc

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-621-L04-P; CME 1.00; RN 1.00

This session will provide an overview of today’s biosimilars landscape, explore trends in uptake, describe innovative programs from industry disruptors, and report perspectives from key stakeholders through their primary market research.

Learning Objectives

Summarize results of current payer and provider research on barriers to biosimilar coverage and adoption, with a focus on product interchangeability; Describe the challenges and solutions of real-world data (RWD) and real-world evidence (RWE) in decision-making; Identify a framework for operational readiness in biosimilar management.

Chair

Charlie Dragovich, RPh

Speaker

Industry Update
Chara Reid, PharmD, RPh

Industry Update
Catherine Lockhart, PharmD, PhD, MS

Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Application UAN: 0286-0000-24-629-L04-P; CME 1.00; RN 1.00

Join us as we delve into the cutting-edge realm of risk-based quality management (RBQM) and learn how quality briefs revolutionize compliance reporting both internally and for externally for regulators. Discover how quality briefs offer proactive transparency at the time of filing, incorporating ICH E8/E6(R3) expectations, and focusing on highest risk critical to quality (CtQ) areas. Gain insights from real-world case studies of multi-company implementations, and uncover strategies to collaborate across functions for swift product delivery while maintaining stringent quality standards. Explore how quality briefs drive a paradigm shift in quality management, moving from gatekeeping at the end of the process to proactive involvement from the start, in line with ICH E6 R3 and E8 R1 quality by design principles. Learn how to craft the GCP compliance story of your product's development, with each CtQ factor assessed for compliance status at filing, supported by evidence and data analytics insights. Dive into the 'How' of implementation, with practical guidance for companies keen on adopting this transformative approach, including updates on Health Authority engagement.

Learning Objectives

Critique the methodology behind implementing the outcomes-based approach of quality briefs in risk-based quality management (RBQM), illustrating how it demonstrates the compliance status of critical to quality (CtQ) factors; Design effective cross-functional communication strategies within a company to facilitate the implementation of changes required for adopting quality briefs, emphasizing collaboration; Identify the key challenges and successes derived from real-world insights.

Chair

Paula Walker, MA

Speaker

Panelist
Cheryl Grandinetti, PharmD

Panelist
Jennifer Emerson, PhD, MPH, RN, PMP

Panelist
Jamie Bridges, MPH

Panelist
Alissa Mun, MS

Component Type: Session
Level: Basic
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-638-L04-P; CME 1.00; RN 1.00

Join us for a candid tour of three journeys toward integrating AI into key use cases. We share real-world metrics, best practices, and lessons learned as our teams evolve from traditional document development to effective digital solutions. This session focuses on practical ways in which medical writing organizations are using AI technologies to enable new ways of working, achieve business value, and get drugs to market faster.

Learning Objectives

Compare approaches to incorporating artificial intelligence (AI) in key use cases; Identify potential solutions to challenges within your organization; Appraise your organization’s plans for AI implementation.

Chair

Regina Lynn Preciado

Speaker

Evolution of Technology and Exploring Use of Generative AI in Medical Writing
Madhavi Gidh-Jain, PhD

Using GenAI to Write First Draft of Clinical Study Reports
John Henry April, III, MA

Evolve or Perish: Embracing Automation in Medical Writing
Waheed Jowiya, 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

Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Application UAN: 0286-0000-24-680-L04-P; CME 1.00; RN 1.00

Medical affairs and clinical development enhance the scientific credibility of the company (and its products) with established and emerging clinical investigators These collaborations may also improve study recruitment techniques.

Learning Objectives

Design new activities which require participation from both medical affairs and clinical development; Demonstrate how the medical affairs team can provide real-world data to help inform study designs and execution; Critique case studies of successful collaborations.

Chair

J. Lynn Bass, PharmD, RPh

Speaker

Industry Update
J. Lynn Bass, PharmD, RPh

Industry Update
Rebecca A. Vermeulen, RPh

Industry Update
Sonja Hokett, PharmD, MS, MSc