DIA 2024 Global Annual Meeting

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-537-L04-P; CME 1.00; PDU 1.00 PMI 2166YE3LVS; RN 1.00

Review principles of FDA's Project Optimus and discuss the impact on oncology clinical development strategies. Scenario analysis with risk management is needed to balance project cost, timelines, patient centricity and health equity approaches.

Learning Objectives

Describe the essential points of FDA's Project Optimus Guidance and how it may impact drug development; Discuss how project managers and oncology development teams gain insight into options to consider in order to balance cost, timelines, and risk during dose finding/dose optimization in new molecular entities and new indications.

Chair

Nancy Linda Styple

Speaker

Patient Update
Julia Maues, MA

Industry Update
Gary Wilkinson, PhD

Project Management Considerations for Project Optimus
Nancy Linda Styple

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: 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: Session
Level: Intermediate

Join the Professional Education, Training & Development/Project Management Community for a follow up round table discussion tied to session: Be Creative and Innovative - A Simple Step-by-Step Decision Science Based Process for You and Your Team (June 17 | 3:30-4:30PM PDT). Space is limited.

Learning Objectives

identify ways to apply concepts and techniques from the session

Chair

Tyler Ludlow, MBA

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: 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: 0286-0000-24-641-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: Basic
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-649-L04-P; CME 1.00; RN 1.00

The clinical research workforce crisis threatens to undermine the entire drug development ecosystem. This session will discuss the glaring disconnect between the visionary discourse on how to revolutionize the clinical research enterprise and the sober recognition that operationalization of any such vision rests on the shoulders of a workforce that’s in dire straits. It will feature a variety of industry leaders who will frame the issue and share lessons, solutions, and workforce development models that can be emulated globally to help build the next generation of clinical researchers--diverse and research ready.

Learning Objectives

Discuss the extent of the clinical research workforce crisis, including a diminishing pool of experienced clinical research professionals a ‘war for talent’ that is driving high and unsustainable turnover; Identify factors contributing to this crisis; Describe promising steps that can help with future workforce development.

Chair

Susan Landis

Speaker

Panelist Speaker
Marlena Jackson

Industry Update
Jimmy Bechtel, MBA

Speaker
Doug Peddicord, PhD

Academic Update
Jonathan Watanabe, PharmD, PhD

Panelist
Martine Dehlinger-Kremer, 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: 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