Loading…
Type: 07: ProjectManagement-StrategicPlanning clear filter
Tuesday, June 10
 

1:00pm EDT

22P: Accelerating Breakthroughs: Project Management Strategies in Drug Development
Tuesday June 10, 2025 1:00pm - 4:00pm EDT
Component Type: Tutorial
CE: ACPE 2.75 Application UAN: 0286-0000-25-503-L04-P; CME 2.75; IACET 2.75; PDU 2.75 PMI 2166LKA26P; RN 2.75

Pre-registration required and is an additional fee. *Please note: Short Courses are stand-alone events. Registration for the main conference, forum, etc. are not mandatory. Already registered? Log in to DIA's My Account My Events. This Short Course will be offered virtually – Join from anywhere!This short course provides a focused, in-depth exploration of how established project management frameworks, tools, and best practices can be applied specifically to the drug development process. Participants will begin by examining a range of methodologies—such as Agile, Waterfall, and hybrid approaches—to understand which strategies work best for managing the multifaceted challenges of clinical trials. Through guided instruction, attendees will learn how to adapt these methodologies to meet stringent regulatory requirements, handle complex demands, and maintain stringent quality standards. In addition to foundational methodologies, this course delves into practical tools and templates that streamline project planning, risk management, and communication. These tools help teams navigate the intricate timelines associated with bringing a drug to market, enabling participants to anticipate and mitigate risks before they become obstacles. By learning to identify common bottlenecks and implement effective contingency plans, attendees can keep projects on schedule and budget, ensuring that new therapies reach patients faster. A central component of the course focuses on enhancing cross-functional collaboration. Participants will learn strategies to improve communication among scientific, clinical, regulatory, and operational teams, ensuring that everyone shares a common understanding of project goals and responsibilities. This improved alignment not only accelerates decision-making but also fosters a more cohesive and productive working environment. To reinforce these concepts, the course provides real-world examples and case studies to give participants hands-on experience in applying project management principles, evaluating risk, adjusting timelines, and coordinating team efforts in real-world scenarios. In addition, advanced tools and techniques are introduced, equipping learners with cutting-edge resources that support informed decision-making and efficiency throughout the drug development lifecycle. By the end of this program, participants will have gained a practical, customizable toolkit they can immediately apply in their daily work. Participants will emerge with greater confidence in managing complex drug development and clinical research projects, ultimately improving trial outcomes and accelerating the delivery of innovative therapies to the patients who need them. Receive $50 off your Global Annual Meeting total purchase by registering for two or more Short Courses. Purchases must be made at the same time to receive the discount. Discounts will be reflected on the last page of the cart. Registered attendees for this virtual Short Course will receive access to the course recording for 2 full months post-course! This allows you to remain flexible with your schedule and not worry if you need to step out momentarily. Have a conflict with the dates of the course, but are interested in the content? Register anyway and you will receive access to the recording!

Who should attend?

Professionals working in or interested in drug development who seek to improve their project management knowledge and skillset. Roles that would benefit from this course include project managers, clinical research associates, data managers, regulatory specialists, and clinical operations staff, amongst others, who aim to streamline processes and deliver projects on time and on budget to accelerate the development of new therapies.

Learning Objectives

  • Identify key project management methodologies and tools to improve efficiency in drug development
  • Discuss drug development timelines by learning strategies to manage risks, streamline timelines, and overcome bottlenecks
  • Apply Cross-Functional Collaboration to ensure smoother project execution and faster delivery of therapies


Speakers
avatar for Melody Keel

Melody Keel

Founder, CEO and Consultant, The Research Associate Group, Inc., United States
Melody Keel is a transformative clinical operations strategist and Founder/CEO of The Research Associate Group, pioneering a people-first approach to clinical trial excellence. With nearly two decades of experience across rare diseases, oncology, and CNS, she developed the proprietary... Read More →
avatar for Jessica Thompson

Jessica Thompson

Founder, CEO, Clinical Research Pro, United States
Jess Thompson brings over 15 years of clinical research experience across labs, sites, CROs, and pharma. She founded Clinical Research Pro to empower professionals through education, development, and career growth. Under her leadership, Clinical Research Pro fosters a supportive community... Read More →
Tuesday June 10, 2025 1:00pm - 4:00pm EDT
Virtual Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
 
Monday, June 16
 

12:10pm EDT

CH: Leading Teams Through Organizational Change and Layoffs - Best Practices for Change Management
Monday June 16, 2025 12:10pm - 12:40pm EDT
Component Type: Workshop
Level: Advanced

Learn best practices for leading teams through change and layoffs with confidence and empathy. Gain strategies to communicate effectively, maintain morale, and ensure business continuity. Leave with actionable insights to navigate transition.

Learning Objectives

Identify key change management strategies to lead teams effectively through organizational change and layoffs. Demonstrate effective communication techniques to maintain trust, morale, and engagement during transitions. Develop action plans to support employees, minimize disruption, and ensure business continuity.

Chair

Vidya Narayanaswamy, MBA, MSc

Monday June 16, 2025 12:10pm - 12:40pm EDT
TBD Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA

2:15pm EDT

Models of Collaborations to Advance Regulatory Science: Lessons Learned
Monday June 16, 2025 2:15pm - 3:15pm EDT
Component Type: Session
Level: Advanced

Regulatory science is a rapidly evolving field with emerging technologies. This session explores collaborative models in drug development and highlights lessons-learned and factors for effective collaborations in advancing regulatory science.

Learning Objectives

Discuss models and management of collaborative partnerships to advance novel therapies for patients; Describe strategies to help optimize cross-functional team engagement and multidisciplinary interactions.

Chair

Huong Huynh, PhD

Speaker

Panelist
Liang Zhao, PhD

Panelist
Carla Rodriguez-Watson, PhD, MPH

Panelist
Allison Cuff Shimooka, MBA


Speakers
avatar for Huong Huynh

Huong Huynh

Director of Regulatory Science, Critical Path Institute, United States
avatar for Carla Rodriguez-Watson

Carla Rodriguez-Watson

Reagan-Udall Foundation for the FDA, United States
Dr. Carla Rodriguez-Watson is the Scientific Director of the Innovation in Medical Evidence Development and Surveillance (IMEDS) program at the Reagan-Udall Foundation for the FDA. The Foudation’s mission is to advance FDA’s mission to modernize product development, accelerate... Read More →
avatar for Allison Cuff Shimooka

Allison Cuff Shimooka

Chief Operating Officer, TransCelerate Biopharma Inc, United States
Allison is Chief Operating Officer of TransCelerate BioPharma Inc. In this role, Allison is responsible for shaping and delivering on TransCelerate’s strategic vision: to advance collaboration in driving efficient, effective and high-quality delivery of new medicines through the... Read More →
LZ

Liang Zhao

Director for Global Regulatory Science and Innovation, University of California San Francisco, United States
Dr. Liang Zhao has been serving as Director of the Division of Quantitative Methods and Modeling (DQMM), Office of Research and Standards (ORS) in Office of Generic Drugs, CDER since 2015. He initially joined FDA as a clinical pharmacology reviewer in the Office of Clinical Pharmacology... Read More →
Monday June 16, 2025 2:15pm - 3:15pm EDT
TBD Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  07: ProjectManagement-StrategicPlanning, Session

3:45pm EDT

Spinning Plates and Juggling Chainsaws: Mastering the Art of Complex Project Management
Monday June 16, 2025 3:45pm - 4:45pm EDT
Component Type: Session
Level: Intermediate

Explore strategies for high complexity projects, focusing on collaborations, regulatory submissions and asset integration. Gain insights on stakeholder management, risk mitigation, strategic planning to turn potential chaos into streamlined success.

Learning Objectives

Discuss challenging biopharmaceutical collaborations and efficient integration of assets; Identify effective strategies for managing complex regulatory submissions in the pharmaceutical industry; Recognize ways to assess risks and develop contingency plans for project timelines and budgets; State how to apply multiple stakeholder management techniques to ensure alignment and informed decision-making across governances.

Chair

Matthew Curin, PharmD

Speaker

Speaker
Andrea Jux


Speakers
avatar for Matthew Curin

Matthew Curin

Sr. Dir, Head of Program Management, Therapeutic Dermatology, Galderma, United States
Matt has been working in the pharmaceutical industry for more than 25 years, spending the first 8 years in clinical manufacturing before moving into project management in 2007. Since then, Matt has provided project, program, and portfolio management leadership in clinical development... Read More →
AJ

Andrea Jux

Senior Director, Development Program Management, Genmab US, Inc., United States
Accomplished Leader with 3 decades of experience in the pharmaceutical industry, focusing on strategic initiatives, operational excellence and regulatory compliance. Adept at leading cross-functional teams and forging partnerships to execute complex projects. Passionate about optimizing... Read More →
Monday June 16, 2025 3:45pm - 4:45pm EDT
TBD Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
 
Tuesday, June 17
 

10:30am EDT

Transforming the Project Management Role to Meet the Emerging Needs in Pharma: Extending Scope from R&D Focus to Launch Projects
Tuesday June 17, 2025 10:30am - 11:30am EDT
Component Type: Session
Level: Intermediate

This pilot expanded Project Manager (PM) from R&D to encompass launch activities, enhancing cross-functional collaboration and planning, stakeholder communication and alignment with country organizations. A PM covering the entire value chain drives project success.

Learning Objectives

Assess the impact of end-to-end coverage of projects, including commercialization, on project value; Integrate critical components of launch planning, including R&D, marketing, access, and medical tactics; Develop skills to enhance cross-functional collaboration among R&D and global and local commercial teams to improve project outcomes.

Chair

Andreas Sutter, PhD, MPharm, RPh

Speaker

Industry Perspective
Jo Ann Kerwin

Industry Perspective
Stacy Hurt, MBA, MHA


Speakers
avatar for Jo Kerwin

Jo Kerwin

Senior Director Strategic Planning &. Operations, Jo Ann Kerwin, United States
Experienced global pharmaceutical senior director with over 30 years of pharma experience spanning early research, clinical operations, project, program, portfolio management and medical affairs. A solutionner who provides analytical and critical thinking skills to drive innovation... Read More →
avatar for Stacy Hurt, MBA, MHA

Stacy Hurt, MBA, MHA

Chief Patient Officer, Parexel , United States
Stacy is a globally recognized advocate in patient communities, ensuring patients/caregivers voice their experience & feedback at early stages to improve drug development. She promotes clinical research accessibility for people with disabilities, for equal access to better treatments... Read More →
avatar for Andreas Sutter

Andreas Sutter

Senior Program Management Leader, Bayer AG, Germany
Andreas Sutter is a senior program management leader in the pharmaceutical industry, with expertise spanning from early research to product launches. He focuses on implementing R&D and commercialization strategies for oncology, especially radioligand therapies. His experience includes... Read More →
Tuesday June 17, 2025 10:30am - 11:30am EDT
TBD Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  07: ProjectManagement-StrategicPlanning, Session

1:45pm EDT

Guerrilla Strategic Delivery
Tuesday June 17, 2025 1:45pm - 2:45pm EDT
Component Type: Session
Level: Intermediate

Traditional project management methodologies often burden teams with unnecessary complexity, slowing progress and stifling innovation. Guerilla Strategic Delivery explores bold, adaptive, and pragmatic approaches to project execution that cut through the noise and deliver real results. This session will challenge outdated frameworks, offering fresh strategies that meet teams where they are—maximizing efficiency, flexibility, and impact without the bureaucratic bloat. Whether you're leading a startup, managing cross-functional teams, or driving change within a large organization, you'll leave with actionable insights to streamline delivery and achieve strategic success on your terms.

Learning Objectives

Implement adaptive strategies to enhance project delivery by prioritizing impact over rigid processes; Optimize workflows by streamlining complexity while ensuring strategic alignment and accountability; Facilitate team empowerment by balancing structure and support with minimal bureaucracy; Apply innovative techniques to accelerate decision-making and improve problem-solving efficiency.

Chair

Sajida Roberson, MBA, MPH

Speaker

Short-Cycle Strategy: Adaptive Execution for High-Impact Delivery
Marina Kobiashvili

Breaking the Waterfall: A Pragmatic Agile Approach in Drug Development Perspective - Applying Agile Principles in a Traditionally Rigid Lifecycle
Sean Ogle

Panelist
Jennifer Trevor, PhD, MS


Speakers
MK

Marina Kobiashvili

Independent Consultant, United States
SO

Sean Ogle

Senior Consultant, SEI Inc., United States
avatar for Sajida Roberson

Sajida Roberson

Business Transformation, Independent Consultant, United States
Meet Sajida Roberson, a dynamic consultant blending strategic leadership with hands-on expertise to drive impactful business transformations. With a proven track record in global pharmaceutical companies, Sajida seamlessly transitioned from corporate strategy roles to independent... Read More →
avatar for Jennifer Trevor

Jennifer Trevor

Director-Global Category Lead- Development, Astellas, United States
Jen Trevor, PhD, combines scientific expertise with business acumen, driving innovation in pharma. With a PhD in Chemistry from the University of Illinois at Chicago, Jen began her career in biosensor research at Argonne National Laboratory and as a Forensic Chemist at the DEA. She... Read More →
Tuesday June 17, 2025 1:45pm - 2:45pm EDT
TBD Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  07: ProjectManagement-StrategicPlanning, Session

4:00pm EDT

Delivering Effective Business Transformations and How to Apply them to Drug Development
Tuesday June 17, 2025 4:00pm - 5:00pm EDT
Component Type: Session
Level: Intermediate

Significant business transformations can be critical to achieve organizational vision and goals in an evolving landscape. In this session we will discuss how to effectively plan, execute and monitor significant business transformations.

Learning Objectives

Discuss the importance of business transformations in defining future-states and driving organizations forward; Explain how to effectively plan, execute and monitor business transformations; Describe how to apply business transformations to drug development.

Chair

Ashar Choudhry, MBA

Speakers
AC

Ashar Choudhry

Executive Director, Enterprise Operational Excellence, Bristol Myers Squibb, United States
Tuesday June 17, 2025 4:00pm - 5:00pm EDT
TBD Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  07: ProjectManagement-StrategicPlanning, Session
 
Wednesday, June 18
 

10:30am EDT

Why Does Drug Loss Occur? Challenges to be Addressed for Patients, and Japan's Contribution to Globalized Drug Development
Wednesday June 18, 2025 10:30am - 11:30am EDT
Component Type: Forum
Level: Intermediate

This forum will address need for a global development strategy aimed at enhancing patient access to new drugs and maximizing business opportunities in Japan. The panelists will consist of members from pharma industry associations, agency and academia

Learning Objectives

Discuss maximizing value of innovative products for the global market including Japan; Apply learnings to clinical development strategy to expand target patients and market effectively; Describe need to enhance access to innovative drugs for children and patients with rare diseases; Discuss influencing regulators, industry, and trial sites to improve the local environment and reduce burdens in global simultaneous development.

Chair

Toshiharu Sano, RPh

Speaker

Changes in Japan's Pharmaceutical Regulations and Clinical Environment
Akihiro Ishiguro, PhD

Initiatives of Medical Institutions - Introduction to High-Quality Trials Using Networks
Kenichi Nakamura, DrMed

What is Drug Lag and Loss: Challenges for Globalization in Japan
Nobutaka Kobayashi, MPharm


Speakers
AI

Akihiro Ishiguro

Deputy Review Director, Office of New Drug III, Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Dr. Akihiro Ishiguro is the Director of the Review Planning Division, Office of Review Management, Pharmaceuticals and Medical Devices Agency (PMDA). His professional experience includes new drug review and post marketing drug safety. He had the opportunity to join projects to develop... Read More →
NK

Nobutaka Kobayashi

Deputy Director, Mitsubishi Tanabe Pharma Corporation, Japan
Kobayashi was engaged in medicinal chemistry as a research scientist in the pharmaceutical company for 13 years. After that, he was engaged in medical policy, drug price application, and management planning for 13 years.
avatar for Kenichi Nakamura

Kenichi Nakamura

Director, Department of International Clinical Development, National Cancer Center Hospital, Japan
Dr. Nakamura is the Director of the Department of International Clinical Development at the National Cancer Center Hospital. He completed his degree at Kyoto University in 1999. After spending seven years training as a general surgeon, he joined the National Cancer Center to participate... Read More →
avatar for Toshiharu Sano

Toshiharu Sano

Associate Vice President, MSD, Japan
Toshiharu Sano has over 30 years of experience in pharmaceutical industry and has broad experiences in Clinical Research, R&D planning and Business Operations for Clinical Development in Japan. He also worked as several initiative’s leads and change manager through his career in... Read More →
Wednesday June 18, 2025 10:30am - 11:30am EDT
TBD Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  07: ProjectManagement-StrategicPlanning, Forum

12:00pm EDT

Roundtable Discussion: Transforming the Project Management Role to Meet the Emerging Needs in Pharma - Extending Scope from R&D Focus to Launch Projects
Wednesday June 18, 2025 12:00pm - 1:00pm EDT
Component Type: Session

Join the Project Management Community for a follow up round table discussion tied to session: Transforming the Project Management Role to Meet the Emerging Needs in Pharma - Extending Scope from R&D Focus to Launch Projects (Tuesday, June 17 | 10:30am - 11:30am EDT). Space is limited.

Learning Objectives

Identify ways to apply concepts and techniques from the session.

Chair

Nancy Linda Styple

Speakers
avatar for Nancy Styple

Nancy Styple

Project Management Leader, Bayer AG, United States
Nancy has been excited to work in Program Management for over 20 years and is a strong advocate for the work that Project Managers and Project Leaders deliver along the value chain in drug development. Nancy starting as a bench research scientist in biotech and has experience in multiple... Read More →
Wednesday June 18, 2025 12:00pm - 1:00pm EDT
TBD Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA

1:45pm EDT

Portfolio Management in Pharma: Strategies and Insights from Large, Medium, and Small Pharma Organizations
Wednesday June 18, 2025 1:45pm - 2:45pm EDT
Component Type: Forum
Level: Intermediate

This panel discussion explores the diverse strategies employed by organizations in managing their portfolio across the value chain. Experts will discuss how systems, tools, benchmarks and visualizations are utilized to enhance decision-making.

Learning Objectives

Describe the different Portfolio Management approaches used across the pharmaceutical value chain in organizations of varying size; Outline success factors for effective Portfolio Management within your own organization.

Chair

Erin Mulrooney, MSc, PMP

Speaker

Biotech Perspective
Christine Mears, MA

Rare Disease Industry Perspective
Katie Bloom

Large Pharma Industry Perspective
Rosa Tarng, MA


Speakers
avatar for Katie Bloom

Katie Bloom

Executive Director, Co-Head of PMO, Program Management Office, Ultragenyx, United States
Katie Bloom, Executive Director of Program and Portfolio Management with over 25 years of industry experience. Currently, she co-leads the Program Management Office at Ultragenyx. Ultragenyx is a biopharmaceutical company committed to bringing novel products to patients for the treatment... Read More →
CM

Christine Mears

Executive Director, Portfolio Management, Generate BioMedicines, United States
avatar for Erin Mulrooney

Erin Mulrooney

Director, Portfolio Management, Daiichi Sankyo, Inc, United States
Erin Mulrooney is a Director of Portfolio Management in the Global Project Management and Leadership group at Daiichi Sankyo. There she is responsible for portfolio prioritization and reporting to enable data-driven decision making. Before joining Daiichi Sankyo in August 2024, Erin... Read More →
avatar for Rosa Tarng

Rosa Tarng

Translational Program Management, Takeda, United States
Rosa Tarng is a program management professional with ~20 years of industry experience. Rosa is currently the Head of Oncology Translational Program Management at Takeda where she has also held roles in Cell Therapy Program Operations and Oncology Research Program Management. Prior... Read More →
Wednesday June 18, 2025 1:45pm - 2:45pm EDT
TBD Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  07: ProjectManagement-StrategicPlanning, Forum

1:45pm EDT

Innovative Operating Models in Regulatory Affairs Driving Value, Efficiency, and Success
Wednesday June 18, 2025 1:45pm - 2:45pm EDT
Component Type: Session
Level: Advanced

Operating models and company’s culture can affect an organization’s value and efficiency. This session will delve into Regulatory Affairs operating models, including opportunities and challenges, providing best practices for your organization.

Learning Objectives

Compare operating models being used by regulatory affairs organizations that are driving greater value, efficiency, and career empowerment; Discuss successes and challenges with different operating models.

Chair

Anton Mihic, MSc

Speaker

Panelist
Donna Boyce, MS, RAC

Panelist
Lisa Ruiz, PhD, MBA

Panelist
Alison Maloney, PhD, MBA, MS


Speakers
avatar for Donna Boyce

Donna Boyce

Head and Senior Vice President of Global Regulatory Sciences, Pfizer Inc, United States
Donna Boyce is Senior Vice President of Global Regulatory Sciences and a member of the Pfizer Research and Development (PRD) Leadership Team. She joined Pfizer in May 2013 as the Vice President, Global Regulatory Affairs, Vaccine. In her current role, Donna is responsible for the... Read More →
avatar for Alison Maloney

Alison Maloney

Head of Regulatory Affairs North America, Bayer , United States
Alison Maloney is currently Head of Regulatory Affairs North America for Bayer Pharmaceuticals. Prior to this role, she was the Head of Regulatory Affairs for Bayer Radiology and Consumer Health North America. Alison has also held Canadian positions as the Head of Regulatory Affairs... Read More →
AM

Anton Mihic

Partner, McKinsey & Company, United States
Anton is a management consultant serving clients in McKinsey’s Life Science R&D practice across global PharmaCos, innovative Biotechs, CROs and Private Equity portfolio companies. Anton leads McKinsey’s global Regulatory Affairs, Safety and R&D Quality service line, and focuses... Read More →
avatar for Lisa Ruiz

Lisa Ruiz

VP, Regulatory Affairs Operations, CMC & Device, Abbvie, United States
Lisa Ruiz is a Regulatory Affairs executive leader with over 30 years in the pharmaceutical industry and broad experience in regulatory having held strategic roles across therapeutic areas, functions and geographies. She is currently the Vice President of Regulatory Affairs Operations... Read More →
Wednesday June 18, 2025 1:45pm - 2:45pm EDT
TBD Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA

2:55pm EDT

Roundtable Discussion: Portfolio Management in Pharma - Strategies and Insights from Large, Medium and Small Pharma
Wednesday June 18, 2025 2:55pm - 3:55pm EDT
Component Type: Session

Join the Project Management Community for a follow up round table discussion tied to session: Portfolio Management in Pharma - Strategies and Insights from Large, Medium and Small Pharma (Wednesday, June 18 | 1:45pm - 2:45pm EDT). Space is limited.

Learning Objectives

Identify ways to apply concepts and techniques from the session.

Chair

Erin Mulrooney, MSc, PMP

Speakers
avatar for Erin Mulrooney

Erin Mulrooney

Director, Portfolio Management, Daiichi Sankyo, Inc, United States
Erin Mulrooney is a Director of Portfolio Management in the Global Project Management and Leadership group at Daiichi Sankyo. There she is responsible for portfolio prioritization and reporting to enable data-driven decision making. Before joining Daiichi Sankyo in August 2024, Erin... Read More →
Wednesday June 18, 2025 2:55pm - 3:55pm EDT
TBD Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
 
  • Filter By Date
    Jun 9 - 19, 2025
    June 2025
    SunMonTueWedThuFriSat
    1234567
    891011121314
    15161718192021
    22232425262728
    2930 
  • Filter By Venue
  • Filter By Type
  • Level
  • Keyword
  • Timezone

Share Modal

Share this link via

Or copy link

Filter sessions
Apply filters to sessions.