DrugInfoAssn

11/27/2025

We are pleased to announce that the early-bird registration deadline has been extended until December 2.

On Wednesday, December 17, DIA will host two focused educational sessions to help you quickly catch up on essential updates in gene therapy and advanced spatial analysis.

Session 1 (9:30–10:10)
“Assessment of Shedding for Gene Therapy Products Using Viral Vectors”
Speaker: Dr. Teruhide Yamaguchi, Kanazawa Institute of Technology

The public comment period closed in May, and official guidance on “shedding assessment” is expected soon. Dr. Yamaguchi, who helped draft the document, will explain its key points in 40 minutes:

What needs to be assessed, and by when?
How does this differ from Cartagena Law evaluations?
If you work with viral vectors, fresh information is critical. Attend in person and you may ask questions directly.

Session 2 (13:10–13:40)
“Capturing Drug Candidate Mechanisms in Spatial Context: New Frontiers in Single-Cell and Spatial Analysis”
Speaker: Dr. Toru Uchiyama, National Center for Child Health and Development

From single-cell to spatial—drug discovery is entering a new era. Advances in next-generation sequencing (NGS) are revolutionary. As research accelerates from bulk → single-cell → spatial analysis, Dr. Uchiyama will cover:

Why is spatial analysis a game-changer?
What insights emerge from combining cell location and gene expression?
How far has its application to AAV gene therapy progressed?
In just 30 minutes, broaden your perspective on drug discovery.

December 17 will be a day to accelerate your knowledge update. Don’t miss this chance to gain fresh insights and new perspectives. We look forward to your participation!
An on-demand recording will be available at a later date. Please consider this option as well.

10th DIA Cell and Gene Therapy Products Symposium in Japan:
https://ow.ly/IRXl50XxE8A

11/20/2025

Program Now Available! Highlights of the session‼
Take advantage of our Early Bird Team Rate – register today and save!

We would like to introduce one of Sessions as below.

Session ４: Realizing the True Value of the Conditional and Time Limited Approval System

Highlight sessions at the 10th Anniversary Symposium!

Closing Day 2 is " Realizing the True Value of the Conditional and Time Limited Approval System" which is a perfect theme to conclude the symposium.

Join us to hear real experiences regarding two products approved under this system and one that was not. Plus, in-depth discussions between the PMDA and industry experts. – Only at DIA!

✅ What were the reasons and background behind the approvals and non-approval?

✅What are the remaining challenges of the system and its future prospects for the system to realize its true value?

This is a must-see session for anyone considering the future of regenerative medicine products. Don’t miss this valuable opportunity!

SESSION CHAIR:

Akihiro Kume (RPM Co., Ltd.)
Mizuho Nonaka (Sumitomo Pharma Co.,Ltd.)

SPEAKERS:

Atsushi Nishikawa (Pharmaceuticals and Medical Devices Agency (PMDA))
Kazumi Sawaguchi, PhD (SanBio Company Limited)
Makiko Okada (Chugai Pharmaceutical Co., Ltd.)
Kazuhisa Senshu (Terumo Corporation)

10th DIA Cell and Gene Therapy Products Symposium in Japan:

https://ow.ly/reeA50Xu5yP

11/13/2025

Program Now Available: 10th DIA Cell and Gene Therapy Products Symposium in Japan

[Session Highlight]
Stable Manufacturing of Cellular Therapeutic Products: Towards Consistent Manufacturing Processes Throughout the Product Lifecycle
This session aims to ensure consistent manufacturing across the product lifecycle by explaining and discussing current support measures. The Ministry of Economy, Trade and Industry will first introduce initiatives in regenerative medicine, including promoting the use of CDMOs (Contract Development and Manufacturing Organizations) for pharmaceutical development. Pharmaceutical companies will then share scenarios and challenges in applying core technologies. The ISO/TC 276 Mirror Committee will present an overview and practical use of standards—particularly JIS Q 2101: Cell Manufacturing Process Management System, published in February 2025. Finally, a panel discussion with experts from PMDA and leading CDMOs will explore the adequacy of these support measures.

SESSION CHAIR:
◾ Maki Tanaka Maki Tanaka (Takara Bio Inc.)
◾ Ikuo Kawauchi (FUFIFILM Holdings Corporation)

SPEAKERS:
◾ Shoki Nishio (Ministry of Economy, Trade and Industry(METI))
◾ Mika Yoshimatsu (T Cell Nouveau Inc.)
◾ Ryutaro Hirasawa, PhD (Daiichi Sankyo Co., Ltd.)
◾ Ikuo Kawauchi (FUFIFILM Holdings Corporation)
◾ Ryuji Kato (Tokai National Higher Education and Research System, Nagoya University)

PANELISTS:
◾ Kenichiro Maeda (Pharmaceuticals and Medical Devices Agency (PMDA))
◾ Junichi Mineno (Takara Bio Inc.)

Take advantage of our early bird team rate – register today and save: https://ow.ly/OFK250XqRGX.

11/11/2025

Take advantage of our early bird team rate – register today and save!
Clinical Data Management (CDM) is undergoing a remarkable transformation. With the rise of Digital Transformation (DX) and Artificial Intelligence (AI), the ways we collect, process, and analyze data are evolving rapidly. The use of Real-World Data (RWD) is expanding, and Post-Marketing Surveillance (PMS) is demanding more agile and strategic approaches from CDM professionals. Meanwhile, regulatory frameworks like ICH-GCP continue to evolve, adding new layers of complexity and opportunity.
In this dynamic landscape, the core mission of CDM - ensuring the reliability and integrity of clinical data - remains as vital as ever. As we embrace innovation, we must also ask: “What core values must we preserve while navigating change?”.

Join us at the 29th DIA Japan Annual Workshop for Clinical Data Management to explore this essential question. Through interactive sessions, panel discussions, and Q&A, we’ll dive into key topics including DX and AI, RWD, regulatory adaptation, PMS, quality management, and workforce development.

Hear from experts across industry, government, and academia, and gain insights that bridge real-world practice with future-forward thinking.

Whether you're a professional, leader, educator, regulator, or researcher, this workshop offers a unique opportunity to connect, learn, and co-create practical knowledge for the future of CDM.

🔗 Learn more and register: https://ow.ly/lAzz50XpYE4.

11/06/2025

From foundational programs to advanced training, DIA eLearning makes professional growth flexible, accessible, and built for your schedule. Learn at your pace, on your time. Explore eLearning Programs → https://ow.ly/azfR50XnIJk

eLearning Modules

11/05/2025

🚀 Programme Now Available - 10th DIA Cell and Gene Therapy Products Symposium in Japan
Don’t miss your chance to save - register early with our early bird team rate today!

🔬 Session Spotlight: Establishing a Mature Ecosystem for New Modalities - Lessons Learned from Success Cases
This session highlights gene and cell therapies, addressing key opportunities and challenges in maturing a modality-driven ecosystem that enables clinical implementation and commercialization. Drawing insights from startups and academia, we will explore cross-sector perspectives. Regulatory updates and support initiatives by public sectors will be shared, touching on survey results from the Ministry of Health, Labour and Welfare’s Project for Promoting the Development of Infrastructure for the Practical Implementation of Gene Therapy. A panel discussion will follow, using speakers’ insights to examine gaps in development speed between Japan and overseas. The session will also consider how to leverage public support for business value maximization including global collaboration.

Session Chairs:
◾ Sumimasa Nagai, MD, PhD (Kyoto University Hospital)
◾ Akihiro Kume, MD, PhD (RPM Co., Ltd.)

Speakers:
◾ Kenji Nonaka (Orizuru Therapeutics, Inc.)
◾ Daniel Ring (AviadoBio Ltd.)
◾ Hitoshi Kuboniwa, PhD (Renz Oku Biologics Co., Ltd.)
◾ Hideyuki Hakui (MHLW, Japan)
◾ Megumi Haga, PhD (AMED)

Learn more & register: https://ow.ly/j9hR50XnjPj.

10/20/2025

Conferences come and go, but your visibility should not. Get continuous exposure to key decision-makers in life sciences with a DIA Marketplace listing. Stay connected, stay seen. Explore the Marketplace → https://eu1.hubs.ly/H0n-QX70

10/20/2025

United by Science. Driven by Patients.

The wait is over, the DIA 2026 Global Annual Meeting Pre-Sale is officially live!
Save 10% off the Early Bird rate — our lowest price of the year — when you register before December 1.
This is your chance to use your 2025 budget to secure your seat at the meeting that brings together the entire life sciences ecosystem, from biotech innovators and pharma leaders to regulators, patients, and investors.
This year’s event has evolved like never before:
🔹 Daily Opening Plenary Sessions
🔹 Focused Themes on Therapeutics, Innovation & Biotech, and AI in Medicine
🔹 The FDA Town Hall, where the future of science meets policy

Don’t wait, the Pre-Sale ends December 1!

https://eu1.hubs.ly/H0nYjrd0

10/16/2025

(Sponsored) We’re looking forward to welcoming Shashi Shankar, CEO and co-founder of Novellia (https://eu1.hubs.ly/H0nTW6H0) to the DIA Real-World Evidence Conference this week.

Join his session on October 17th at 11:00am PT to learn how AI is helping biopharma teams unify 15+ years of fragmented patient data to accelerate adoption, improve safety, and enable smarter decisions across the therapeutic lifecycle.

10/14/2025

Two premier DIA events are coming to North Bethesda, MD this winter—don’t miss your chance to connect, learn, and lead!
🔹 Global Pharmacovigilance and Risk Management Strategies Conference
🗓️ January 26–28, 2026
Explore the latest in global drug safety, risk management, and PV innovation.
Early Bird Rates Expire October 31 → https://eu1.hubs.ly/H0nR1zH0

🔹 Regulatory Submissions, Information, and Document Management Forum
🗓️ February 2–4, 2026
Discover best practices and technology advancements driving regulatory excellence.
Early Bird Rates Expire October 31 → https://eu1.hubs.ly/H0nR1w00

Register now and secure your spot at these must-attend DIA events.

10/14/2025

Excited to welcome Shashi Shankar, CEO of to this week! Learn how AI is helping Biopharma teams unify 15+ years of patient data to drive smarter, faster decisions.

10/14/2025

(Sponsored) We’re looking forward to welcoming Shashi Shankar, CEO and co-founder of Novellia (https://eu1.hubs.ly/H0nQJYN0) to the DIA Real-World Evidence Conference this week.

Join his session on October 17th at 11:00am PT to learn how AI is helping biopharma teams unify 15+ years of fragmented patient data to accelerate adoption, improve safety, and enable smarter decisions across the therapeutic lifecycle.