DIA 2024 Global Annual Meeting: Full Schedule

2:15pm PDT

#136: In Vitro Diagnostic/Companion Diagnostics Developments in the US and Impact on Global Programs

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-536-L04-P; CME 1.00; RN 1.00

This session will present on the shifting regulatory landscape on diagnostics, including laboratory developed tests. Discussions will focus on a new proposed rule, the FDA’s oncology diagnostics pilot program, and global development implications.

Learning Objectives

Explain recent developments in the In Vitro Diagnostic/Companion Diagnostics (IVD/CDx) regulatory landscape in the US; Discuss regulatory implications of the proposed rule on LDTs; Evaluate the impact of FDA IVD initiatives on global drug development programs

Chair

Stephanie Choi, PhD

Speaker

Insights into FDA's Proposed Rule and LDT Initiatives
Cortez McBerry, PhD

New and Anticipated Trends in IVD and LDT Regulation
Laura DiAngelo, MPH

Impact of Changing IVD/LDT Landscape on Global Drug Development Programs
Megan Doyle, JD, MPH

Speakers

Stephanie Choi

Director, US Global Regulatory and Scientific Policy (GRASP), EMD Serono, United States

Stephanie Choi, Ph.D. is currently a Director in Global Regulatory and Scientific Policy at EMD Serono. Her current interests relate to regulatory policy in oncology, CDx, and RWE. Prior to EMD Serono, she worked as a regulatory strategist at Jazz Pharmaceuticals supporting early... Read More →

Laura DiAngelo

Research Director, AgencyIQ by POLITICO, United States

Laura DiAngelo is the Director of Regulatory Intelligence for POLITICO's AgencyIQ. She focuses primarily on regulatory intelligence issues impacting the medical device, diagnostics and digital health industries.

Megan Doyle

Associate Vice President, Assistant General Counsel - Diagnostics, Eli Lilly & Company, United States

Megan Doyle is an attorney and policy professional with 15 years of experience in the regulation of drugs, medical devices, combination products, and in vitro diagnostics. She received her law degree from Georgetown University Law Center and her master’s degree in public health... Read More →

Cortez McBerry

Partner, NDA Partners, United States

Monday June 17, 2024 2:15pm - 3:15pm PDT
Room 15AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

09: Regulatory, Session | 06: TranslationalDelivery Tech-PrecMedicine, Session

Format Session
Level Intermediate
Level Intermediate
Credit Type ACPE, CME, RN
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8:00am PDT

#307: Partnering with Regulatory Authorities to Unlock the Value in Digital Health Products

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-628-L04-P; CME 1.00; RN 1.00

Discussion of partnering with regulators to get novel digital health products through the approval processes. Learn insights from industry and regulators for creative, strategic, and flexible thinking on regulation of novel technologies.

Learning Objectives

Discuss the challenges of introducing novel digital technologies to FDA; Describe tactics to build better partnerships with regulators.

Chair

Rebecca Joy James, MBA, RAC

Speaker

Panelist
Anindita Saha

Panelist
James Wabby, MHS

Panelist
Adam Cargill, MS

Panelist
Wes Gerbig, PhD, MS

Speakers

Rebecca James

Director - Advisory, KPMG, LLC, United States

Rebecca is a Director in the Life Sciences consulting group at KPMG based out of Chicago, IL. She has over 14 years of experience in both consulting and industry roles with companies from pharmaceutical, medical device, and nutritional industries with an emphasis in Regulatory Affairs... Read More →

Adam Cargill

Director, QARACA, MediView XR, Inc., United States

Adam Cargill, MS RAC, is the Vice President of Quality, Regulatory, and Clinical for MediView XR. In his role he is accountable for the oversight of all regulatory, clinical, and quality functions. Responsibilities include overseeing the company’s global regulatory, clinical, and... Read More →

Wes Gerbig

Director, Global Regulatory Affairs, Drug Delivery and Digital Health, Eli Lilly and Company, United States

Anindita Saha

Associate Director Strategic Initiatives, Digital Health Center of Excellence, FDA, United States

Anindita (Annie) Saha is the Associate Director for Strategic Initiatives for the Digital Health Center of Excellence (DHCoE) at the Food and Drug Administration (FDA). She is leading strategic initiatives in moving care into the home, Artificial Intelligence, and international collaborations... Read More →

James Wabby

Global Head, Regulatory Affairs, Emerging Technologies and Combination Products, AbbVie, United States

James Wabby is the Global Head, Regulatory Affairs - (CoE) Emerging Technologies, Devices, and Combination Products at AbbVie in Irvine, California. He has 22 years of experience in increasing quality compliance and regulatory affairs responsibilities within the GxP regulated environment... Read More →

Wednesday June 19, 2024 8:00am - 9:00am PDT
Room 2 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

09: Regulatory, Session | 06: TranslationalDelivery Tech-PrecMedicine, Session

Format Session
Level Intermediate
Featured Topics Digital Technology
Level Intermediate
Feature Topics Digital Technology
Credit Type ACPE, CME, RN
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1:15pm PDT

#345: Regulatory Considerations in Trial Design for Cell and Gene Therapies

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-648-L04-P; CME 1.00; RN 1.00

Cell and gene therapies have enormous potential to address unmet medical need. The application of validated clinical trials design tools along with biomarkers to assess safety and endpoints can help address regulatory uncertainty.

Learning Objectives

Discuss regulatory considerations for cell and gene therapies including the use of data modeling in clinical trial design and the application of biomarkers both for safety assessment and measures of outcome; Discuss how to plan for meeting regulatory requirements and be able to incorporate these plans into your company’s drug development plans.

Chair

Kanwaljit Singh, MD, MBA, MPH

Speaker

Regulatory Considerations for Development of Pediatric Cell and Gene Therapies: FDA Update
Najat Bouchkouj, MD

Regulatory Consideration for Pediatric Cell and Gene Therapies - Industry Perspective
Paulla Dennis

Path from Bench-to-Bedside for a Cell and Gene Therapy Drug Product
Stephanie Cherqui, PhD

Speakers

Najat Bouchkouj

Associate Director for Pediatrics (Acting), Office of Clinical Evaluation, FDA, United States

Dr. Najat Bouchkouj is the Acting Associate Director for Pediatrics in the Office of Clinical Evaluation, OTP, CBER, FDA. Dr. Bouchkouj joined the FDA in 2016. She earned her medical degree from Damascus University, Syria and completed a residency in Pediatrics at the State University... Read More →

Stephanie Cherqui

Director, UC San Diego Gene Therapy Initiative, University of California San Diego, United States

Stephanie Cherqui is Professor in the Department of Pediatrics, Division of Genetics at the University of California San Diego. She is also the Director of the UC San Diego Gene Therapy Initiative. Her laboratory primarily centers on two research areas: the development of hematopoietic... Read More →

Paulla Dennis

Senior Director, Rare Diseases, Advanced Therapies, and Pediatrics, Fortrea, United States

• Paulla Dennis, Senior Director, is a leading member of the Rare Disease, Advanced Therapies, and Paediatric Team (RAPT) with over 20 years in the clinical research industry. Paulla has expertise in global phase I through IV pediatric and rare disease operational strategy and planning... Read More →

Kanwaljit Singh

Executive Director, International Neonatal Consortium, Critical Path Institute, United States

Wednesday June 19, 2024 1:15pm - 2:15pm PDT
Room 5AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

06: TranslationalDelivery Tech-PrecMedicine, Session | 09: Regulatory, Session | 02: ClinTrials -ClinOps, Session

Format Session
Level Intermediate
Featured Topics Cell and Gene Therapy
Level Intermediate
Feature Topics Cell and Gene Therapy
Credit Type ACPE, CME, RN
Tags Session

3:15pm PDT

#363: Implementing Changes To Drug-Device Combination Products Globally

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-663-L04-P; CME 1.00; RN 1.00

Industry and regulators will collaborate to discuss current challenges and future opportunities to streamline post approval changes to combination products.

Learning Objectives

Describe current regulatory frameworks for lifecycle management changes to combination products; Compare differences in expectations for submissions of post-approval changes globally; Discuss the utilization of harmonized guideline, ICH Q12, for management of post approval changes to combination products globally.

Chair

Chelsea O'Connell, MS, RAC

Speaker

FDA CBER Perspective on Postmarket Changes to CBER-Led Combination Products
Andrea Gray, PhD

Industry Perspective on the Latest ICH Q12 Training Module 8
Andrew Chang, PhD

Industry Perspective on Postmarket Changes to Combination Products: Global
Amy Wise, MBA

PMDA Update: Postmarket Changes to Combination Products in Japan
Keisuke Tanaka, PhD

Industry Perspective on Postmarket Changes to Combination Products: US
Lori-Anne Boville

Speakers

Chelsea O'Connell

Director, Global Regulatory and R&D Policy, Amgen, United States

Chelsea O’Connell, MS, RAC, joined Amgen in 2011 and is currently a Global Regulatory and R&D Policy Director, where she advances strategic regulatory policy goals by engaging with regulatory authorities, industry, professional associations, and other stakeholders across various... Read More →

Andrew Chang

Vice President, Quality and Regulatory Compliance, Novo Nordisk, United States

Dr. Andrew Chang is a multifaceted quality and CMC leader with 28 years well-rounded medical product regulatory and industry experiences. He is a board director for CASSS-Sharing Science Solutions and PDA, respectively. Andrew has served as a member of the planning committee for DIA... Read More →

Amy Wise

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

Amy Wise is an Associate Director Regulatory Affairs Device and Combination Products at AbbVie. Amy has been in the pharmaceutical industry for 25 years with 15 years in regulatory affairs, 5 years in quality and 5 years in pharmaceutical sciences. She has successfully provided the... Read More →

Andrea Gray

Biomedical Engineer Advisor, CBER, FDA , United States

Andrea Gray is a Biomedical Engineer Advisor in the Regulatory Operations Branch of the Division of Regulatory Operations and Programs (DROP) in the Office of Regulatory Operations (ORO), Center for Biologics Evaluation and Research (CBER). She specializes in regulatory review of... Read More →

Keisuke Tanaka

Reviewer, Pharmaceuticals and Medical Devices Agency (PMDA), Japan

Dr. Tanaka is Reviewer of the Office of Cellular and Tissue-based Products, PMDA. He received his Ph, D. from Osaka University in Bioorganic chemistry with emphasis in nucleic acid therapy. Since joining PMDA in 2021, he has worked in the Office of Cellular and Tissue-based Products... Read More →

Lori-Anne Boville

Group Director, Pharma Technical Regulatory, Device and Combination Products, Genentech, A Member of the Roche Group, United States

She is a Regulatory Affairs Expert in Biologics products, Medical Devices & Combination Products at Genentech. Lori has over 20 years of Biopharmaceutical product development, analytical testing, commercial quality, regulatory affairs and medical device experience. She has successfully... Read More →

Wednesday June 19, 2024 3:15pm - 4:15pm PDT
Room 1AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

09: Regulatory, Session | 06: TranslationalDelivery Tech-PrecMedicine, Session

Format Session
Level Intermediate
Featured Topics ICH, Regulator Perspectives
Level Intermediate
Feature Topics ICH,Regulator Perspectives
Credit Type ACPE, CME, RN
Tags Session

4:30pm PDT

#376: Challenges in Quality Control for Cell and Gene Therapy Development: Regulatory Perspectives and Best Practices

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-675-L04-P; CME 1.00; RN 1.00

This session will describe key challenges in quality assessment for cell and gene therapies, focusing on challenges related to raw materials; discuss regulatory perspectives; and present best practices to control and evaluate raw materials.

Learning Objectives

Identify the key current challenges in quality control for cell and gene therapy development; Explain global regulators’ perspectives on quality control, including raw material selection, control, and qualification; Discuss best practices, including standards and reference materials, to support the development and manufacture of cell and gene therapies.

Chair

Fouad Atouf, PhD

Speaker

Qualification and Selection of Raw Materials During Early Stage of Development
Mo Heidaran, PhD

Perspective on the Selection of Raw Materials for Cell Therapy Manufacturing
Haritha Vallabhaneni, PhD

Cell and Gene Therapy Products: Global Regulatory Perspective
Michael Day, PhD

Speakers

Fouad Atouf

Senior Vice President, Global Biologics, United States Pharmacopeia (USP), United States

Dr. Atouf has over 20 years’ experience in research, product development, characterization and quality assessment of biologics including cell and gene therapies (CGT). At USP, he heads the Biologics program and oversees standards development, stakeholder engagement and external... Read More →

Michael Day

Senior Director, Regulatory Science, VCLS, United States

As a Senior Director, Regulatory Science and Head of Cell and Gene Therapies at VCLS, Michael (Mike) is responsible for providing both regulatory strategy and CMC consulting services to clients for global product development ranging from small molecule drugs to biologics and advanced... Read More →

Mo Heidaran

Chief Regulatory Scientist, Cellx Inc., Consulting, United States

Dr. Mo Heidaran is currently Chief Regulatory Scientist at Cellx Inc. He previously worked as Head of Translational and Regulatory Strategy at GCTx (GC Therapeutics). He is a recognized expert in the development of cell and gene therapies with more than 9 years of experience at the... Read More →

Haritha Vallabhaneni

Biological Reviewer, Office of Cellular Therapy and Human Tissue CMC, CBER, FDA, United States

Dr. Vallabhaneni is a CMC Reviewer in the Division of Cell Therapy 1, CBER, FDA. She is involved in CMC review of regulatory applications involving cellular therapy products. She has extensive research experience in stem cells previously working on multiple research projects investigating... Read More →

Wednesday June 19, 2024 4:30pm - 5:30pm PDT
Room 6E San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

09: Regulatory, Session | 06: TranslationalDelivery Tech-PrecMedicine, Session | 10: RegCMC-Product Quality, Session

Format Session
Level Intermediate
Featured Topics Cell and Gene Therapy
Level Intermediate
Feature Topics Cell and Gene Therapy
Credit Type ACPE, CME, RN
Tags Session