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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
TBD
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
TBD
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
  16: Community-Rounds, Session |   07: ProjectManagement-StrategicPlanning, Session

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
TBD
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
TBD
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
  09: Regulatory, Session |   07: ProjectManagement-StrategicPlanning, Session

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
TBD
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
  07: ProjectManagement-StrategicPlanning, Session |   16: Community-Rounds, Session
 
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    Advanced Analytics
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    Patient Experience
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Virtual
  • 00: Plenary
  • 01: ClinSafety-PV
  • 02: ClinTrials-Ops
  • 03: Data-Tech
  • 04: MedAffairs-SciComm
  • 05: Patient-Impact-Product-Dev
  • 06: PersonalizedMed-ComboProd-Diagnostics
  • 07: ProjectManagement-StrategicPlanning
  • 08: RD-Quality-Compliance
  • 09: Regulatory
  • 10: RegCMC-Product Quality
  • 11: Statistics-Data Science
  • 12: ProfDevelopment
  • 13: Spotlight
  • 14: DIAmond
  • 15: Content-Hubs
  • 16: Community-Rounds
  • 17: Posters
  • 18: InnovationTheaters
  • 20: Short-Courses
  • Level
  • Advanced
  • Basic
  • Intermediate
  • Keyword
  • Advanced Analytics
  • Artificial Intelligence (AI)
  • Bioethics
  • Biomarkers
  • Cell and Gene Therapy
  • Clinical Trial Design
  • Diagnostics
  • Digital Technology
  • Global Perspectives
  • Non-CE
  • Patient Experience
  • Payers
  • Pediatrics
  • Rare Disease
  • Real-World Data (RWD) / Real-World Evidence (RWE)
  • Regulator Perspectives
  • Regulatory Collaboration
  • Regulatory Convergence and Harmonization
  • Regulatory Reliance
  • Student Programming