DIA 2025 Global Annual Meeting: Full Schedule

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10:30am EDT

#322: Navigating the Challenges of Drug Delivery Using a Novel Device

Wednesday June 18, 2025 10:30am - 11:30am EDT

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-628-L04-P; CME 1.00; RN 1.00

Explore the evolving regulatory landscape of combination products for the delivery of cell and gene therapies. This session will provide essential insights into the current regulatory frameworks for drug delivery systems.

Learning Objectives

Explain the regulatory challenges that may exist for novel combination products; Identify regulatory strategies for resolving challenges.

Chair

John Lockwood

Speaker

Regulatory Considerations for the Next Generation of Drug Delivery Devices
Yoshiko Stowell, PhD, MS, PMP, RAC

Regulatory Considerations for the Next Generation of Drug Delivery Devices
Sarah Fairfield, MBA, RAC

Speakers

Sarah Fairfield

Associate Director, RA Device and Combination Products, AbbVie, United States

Sarah Fairfield is a dedicated and passionate regulatory professional with extensive expertise in medical devices and combination products. Currently, she serves as the Associate Director of Regulatory Affairs at AbbVie, Inc., where she supports global product development. She also... Read More →

John Lockwood

Sr. Director, Cencora Pharmalex, United States

John Lockwood, RAC, is the Senior Director of Medical Devices/IVDs for the Americas at Cencora PharmaLex, where he is responsible for managing and expanding Medical Device Services related to quality and regulatory. John has more than 25 years of experience in quality, regulatory... Read More →

Yoshiko Stowell

Vice President Regulatory Affairs, Kenai Therapeutics, United States

Yoshiko Stowell, PhD is VP Regulatory Affairs at Kenai Therapeutics. She has over 20 years of diverse experience in Regulatory Affairs (Clinical and CMC), R&D, and Project Management. She has experience in all states of development from proof of concepts to global Phase III Clinical... Read More →

Wednesday June 18, 2025 10:30am - 11:30am EDT
204ABC Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA

09: Regulatory, Session | 06: PersonalizedMed-ComboProd-Diagnostics, Session

Level Intermediate
Keyword Cell and Gene Therapy
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Feature Topics Cell and Gene Therapy
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1:45pm EDT

#338: Clinical Development of Orphan and Pediatric Drugs, Along with Regenerative Medicine Products in Japan

Wednesday June 18, 2025 1:45pm - 2:45pm EDT

204ABC

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-638-L04-P; CME 1.00; RN 1.00

Japan's regulatory authorities have enacted various measures to strengthen drug R&D and accelerate clinical development, particularly for regenerative medicine, pediatric, and orphan drugs, offering great prospects for biopharma/ biotech companies.

Learning Objectives

Discuss PMDA's efforts to address Japan's drug lag and promote an accelerated clinical development environment; Describe the trial landscape and analyze the challenges in developing Regenerative Medicine, Orphan, and Pediatric drugs in Japan; Develop strategies for Japan to engage in multi-regional trials, considering the unique aspects of conducting clinical studies in the country.

Chair

Edward C. Ian, MBA

Speaker

Industry Perspective
Sumati Nambiar, DrMed, MPH

Panelist
Teppei KIUCHI, MD, PhD, MPH

Speakers

Edward Ian

Head of Integrated Innovation Service Center, Mediscience Planning Inc., Japan

Edward Ian began his career as a lab. scientist and expanded his work into clinical development. His extensive experience with multinational companies in APAC and the US has made him a seasoned executive with expertise across a wide range of areas within the clinical research and... Read More →

Teppei KIUCHI

Associate Executive Director, Pharmaceuticals and Medical Devices Agency (PMDA), Japan

Teppei Kiuchi, M.D., MPH, PhD, is an associate executive director in the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan. In this role, Kiuchi is in charge of the review of regenerative medical products, Bio-CMC, vaccine and blood products. In his career Kiuchi has been... Read More →

Sumati Nambiar

Senior Director, Johnson and Johnson, United States

Dr. Nambiar is board certified in pediatrics and pediatric infectious diseases. She is a Fellow of the American Academy of Pediatrics and has over 20 years of experience in drug development and regulatory science. Currently, she is a Senior Director in the Child Health Innovation... Read More →

Wednesday June 18, 2025 1:45pm - 2:45pm EDT
204ABC Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA

02: ClinTrials-Ops, Session

Level Intermediate
Keyword Cell and Gene Therapy, Pediatrics
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Feature Topics Cell and Gene Therapy,Pediatrics
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1:45pm EDT

#349: Potency Measurements for Cellular and Gene Therapy Products

Wednesday June 18, 2025 1:45pm - 2:45pm EDT

143ABC

Component Type: Session
Level: Advanced
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-649-L04-P; CME 1.00; RN 1.00

This session will offer a comprehensive overview of the FDA’s expectations for potency testing, and insights into industry practices. It will explore how regulatory flexibility concerning potency can facilitate and accelerate the development process.

Learning Objectives

Describe the potency requirements for CGT products; Discuss the latest FDA’s guideline regarding potency testing and industry perspectives; Explain the Role of Surrogate Assays enhancing the overall potency assurance strategy; Examine the approaches adopted by sponsors to meet regulatory expectations.

Chair

Lesbeth Caridad Rodriguez, MS

Speaker

Potency matrix for a complex mechanism of action: case-study for a multi-component plasmid immunotherapy for prevention or delay of type 1 diabetes
David Campard, PhD, MSc

Comprehensive overview of the FDA’s expectations for potency testing, and insights into industry practices
Maria Amaya, PhD, MS

Developing a matrix approach for potency assessment in allogeneic cell therapy: a case study in standardization and predictive analytics
Simge Baloglu, PhD, MS

Speakers

Lesbeth Rodriguez

Director, Regulatory Affairs Policy and Science, Bayer, United States

Lesbeth Rodriguez, Director, Regulator Policy and Science at Bayer, is a regulatory policy leader specializing in advanced therapies and Chemistry, Manufacturing, and Controls (CMC) across all modalities. She represented PhRMA in the ICH Q13 Implementation Working Group and currently... Read More →

Maria Amaya

Lead External Advocacy, North America, Genentech, A Member of the Roche Group, United States

Maria Amaya is the Lead External Advocacy, North America in Quality Policy & Advocacy at Roche. In this position, Maria works within Roche/Genentech Global External Advocacy community to develop and deliver innovative quality and CGMP regulatory pathways, and collaborate with internal... Read More →

Simge Baloglu

SVP Analytical and Quality Control, Bluerock Therapeutics, United States

Simge Baloglu, PhD, is an Analytical Development and Quality Control leader with over 20 years of experience in biologics, gene and cell therapy, and vaccines. She has led analytical and CMC strategies from discovery through commercialization, regulatory approval, and lifecycle management... Read More →

David Campard

CMC RA Specialist, Novo Nordisk A/S, Denmark

David Campard is CMC Regulatory Affairs Specialist and leads multiple early development projects at Novo Nordisk for cell and gene therapy products (CGTPs). In this role, he set the regulatory strategy for CMC development of CGTPs in alignment with other areas (clinical, non-clinical... Read More →

Wednesday June 18, 2025 1:45pm - 2:45pm EDT
143ABC Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA

10: RegCMC-Product Quality, Session

Level Advanced
Keyword Cell and Gene Therapy
Level Advanced
format csv
Credit Type ACPE, CME, RN
Feature Topics Cell and Gene Therapy
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