DIA 2025 Global Annual Meeting: Full Schedule

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10:30am EDT

#323: 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

151B

Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-629-L04-P; CME 1.00; RN 1.00

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

Initiatives of Medical Institutions - Introduction to High-Quality Trials Using Networks
Kenichi Nakamura, MD, PhD, MBA

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

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

Speakers

Akihiro Ishiguro

Head of PMDA, Washington D.C. Office, Pharmaceuticals and Medical Devices Agency (PMDA), Japan

Dr. Akihiro Ishiguro, PhD is the Head of Pharmaceuticals and Medical Devices Agency (PMDA) Washington D.C. Office. His work at PMDA began in 2004 when PMDA was established, allowing him to experience the contribution of post marketing drug safety, new drug review, review management... Read More →

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.

Kenichi Nakamura

Chief, Department of International Clinical Development, National Cancer Center Hospital, Japan

Dr. Nakamura is Chief of International Clinical Development at the National Cancer Center Hospital. After earning his MD from Kyoto University in 1999 and completing surgical training, he joined NCC to manage JCOG, Japan’s largest cancer clinical trial group. Since 2015, he has... Read More →

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
151B Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA

07: ProjectManagement-StrategicPlanning, Forum

Level Intermediate
Keyword Rare Disease, Global Perspectives
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Feature Topics Rare Disease,Global Perspectives
Tags Forum

4:00pm EDT

#366: FDA Rare Disease Town Hall

Wednesday June 18, 2025 4:00pm - 5:00pm EDT

146BC

Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-662-L04-P; CME 1.00; RN 1.00

This annual town hall provides a forum for senior FDA officials to reflect on key trends and discuss opportunities in rare disease drug development and review. Officials answer moderated and audience burning questions facing the work that they do.

Learning Objectives

Describe new FDA programs and initiatives intended to help facilitate development of drugs for rare diseases; Evaluate opportunities for sponsors and patient stakeholders to engage with regulators; Identify current trends in challenges and opportunities facing orphan drug development.

Chair

James Valentine, JD, MHS

Speaker

Perspectives on Rare Immunology & Inflammation Product Development
Nikolay Nikolov, MD

Perspectives on Rare Neuroscience Product Development
Teresa Buracchio, MD

Speakers

Teresa Buracchio

Director, Office of Neuroscience, OND, CDER, FDA, United States

Teresa Buracchio, MD, is Director of the Office of Neuroscience in the Center for Drug Evaluation and Research, Food and Drug Administration (FDA). She oversees the review of new drug programs for neurologic and psychiatric diseases. Dr. Buracchio joined FDA in 2013. Dr. Buracchio... Read More →

Nikolay Nikolov

Director, Office of Immunology and Inflammation, OND, CDER, FDA, United States

Dr. Nikolay P. Nikolov is a board-certified Internist and Rheumatologist and is currently the Director of the Office of Immunology and Inflammation, CDER. During rheumatology fellowship at NIAMS, NIH, he studied cellular and molecular mechanisms of autoimmunity. Then, at the Sjögren's... Read More →

James Valentine

Director, Hyman, Phelps & McNamara, PC, United States

James Valentine, JD, MHS is an attorney at Hyman, Phelps & McNamara where he assists medical product industry and patient advocacy organization clients in a wide range of regulatory matters, including new drug and biologic development and approval issues. Mr. Valentine has been central... Read More →

Wednesday June 18, 2025 4:00pm - 5:00pm EDT
146BC Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA

09: Regulatory, Forum | 02: ClinTrials-Ops, Forum

Level Intermediate
Keyword Rare Disease, Student Programming
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Feature Topics Rare Disease,Student Programming
Tags Forum

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