DIA 2024 Global Annual Meeting: Full Schedule

11:00am PDT

#105: The Intersection of Science, Ethics, and Participant Collaboration in Pediatric Rare Disease Product Development

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-519-L04-P; CME 1.00; RN 1.00

Experts in pediatric rare disease product development, pediatric ethics and patients/advocates discuss designing studies to best benefit the patient, and how patients/caregivers assess risks and benefits in early phase trials.

Learning Objectives

Discuss the ethical and scientific considerations for designing studies for rare diseases that impact children, including the level of evidence needed to initiate early phase trials; Discuss how patients and caregivers weigh the risks of early-phase studies against the benefits of a potential treatment for their rare disease, especially when there are limited to no other options.

Chair

Donna Snyder, MD

Speaker

Ethical Considerations for Including Children in Rare Disease Trials
Donna Snyder, MD

Update from ORPURM/DRDMG
Mehul Desai, MD

Patient Perspective
Mark Dant

Patient Perspective
Ryan Dant

Speakers

Donna Snyder

Executive Physician, WCG, United States

Donna Snyder, MD, MBE is the Executive Physician of WCG where she contributes subject matter expertise and operational guidance across WCG to ensure that research will be conducted to the highest ethical standards. Prior to WCG, Dr. Snyder served as the leader and Senior Pediatric... Read More →

Mark Dant

Volunteer Executive Director, The Ryan Foundation, The Ryan Foundation for Rare Disease Research, United States

Mark is the Founder and Volunteer Executive Director of the Ryan Foundation and is the former Board Chair of the of the EveryLife Foundation for Rare Diseases. Mark and his family founded the Ryan Foundation in 1992 shortly after their only child Ryan was diagnosed with MPS I. Since... Read More →

Ryan Dant

Patient Advocate, The Ryan Foundation for Rare Disease Research, United States

Ryan Dant is a long-time patient advocate diagnosed at the age of three with Mucopolysaccharidosis type 1 (MPS 1), a rare lysosomal storage disorder. When doctor’s predicted Ryan’s life to be cut short due to the disease, Ryan’s parents, Mark and Jeanne, spearheaded the funding... Read More →

Mehul Desai

Medical Reviewer, ORDPURM/DRDMG, OND, CDER, FDA, United States

Mehul Desai M.D. is a medical officer in the Division of Rare Diseases and Medical Genetics (DRDMG), Office of New Drugs (OND), Center for Drug Evaluation Research (CDER), with the US Food and Drug Administration (FDA). Dr. Desai has clinical development experience in both the pharmaceutical... Read More →

Monday June 17, 2024 11:00am - 12:00pm PDT
Room 17AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

05: Patient-Focused Drug Dev, Session | 09: Regulatory, Session | 02: ClinTrials -ClinOps, Session

Format Session
Level Intermediate
Featured Topics Ethics, Rare Disease, Special Populations
Level Intermediate
Feature Topics Ethics,Rare Disease,Special Populations
Credit Type ACPE, CME, RN
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2:15pm PDT

#133: ICH M11 Protocol Template: A Global Solution for Global Drug Development

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-533-L04-P; CME 1.00; RN 1.00

This session will highlight the latest developments of the ICH M11 Clinical Protocol Template including guidelines,protocol template, and technical specification and how these documents will facilitate more efficient and effective trials.

Learning Objectives

Describe the M11 ICH deliverables and the latest developments on ICH M11 guideline, protocol template and technical specification; Describe the types trials and phase that the template encompasses; Discuss the technical specification as a technical representation of the template to facilitate electronic exchange.

Chair

Ron Fitzmartin, PhD, MBA

Speaker

Global Synergy: Enhancing Patient Outcomes and Advancing Clinical Research Through International Protocol HarmonizationT
Vada A. Perkins, DrSc, MSc

The Value of Data: A Regulatory Perspective
Ana Zanoletty Perez

Support of Digital Protocol Initiatives
Chris Decker, MS

Speakers

Ron Fitzmartin

Senior Informatics Advisor, Office of Regulatory Operations, CBER, FDA, United States

Ron Fitzmartin is Senior Informatics Advisor, Office of Regulatory Operations, Center for Biologics Evaluation and Research, Food and Drug Administration. In this role Ron provides policy and strategy consultation and support on a wide range of topics focused on electronic regulatory... Read More →

Chris Decker

President and Chief Executive Officer, CDISC, United States

Chris is recognized industry wide as a leading technology and standards expert for designing, developing, and implementing complex process and technology solutions. He brings years of experience serving in various executive-level positions across software development, clinical research... Read More →

Ana Zanoletty Perez

Head of Clinical Trials Transformation workstream, European Medicines Agency, Netherlands

Ana qualified as a pharmacist and following various roles managing clinical trials for the biopharmaceutical industry joined EMA in 2006. At EMA she spent her initial years coordinating initial marketing authorisation procedures, and later transitioned into the management of post-authorisation... Read More →

Vada Perkins

Vice President, Global Head of Regulatory Intelligence & Policy, Boehringer Ingelheim, United States

Vada A. Perkins is Vice President. Global Head of Regulatory Policy & Intelligence for Boehringer Ingelheim. He is a former FDA Senior Advisor for Regulatory Science with international regulatory policy and strategy expertise in promoting convergence for the assessment of medicinal... Read More →

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

03: Data-Tech, Session

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

3:30pm PDT

#152: Innovative Alternative Approaches to Evaluating GCP During the COVID-19 Public Health Emergency and Beyond

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-551-L04-P; CME 1.00; RN 1.00

This session discusses regulator and industry experience with the use of alternative tools to evaluate GCP compliance during the COVID-19 public health emergency and post-pandemic.

Learning Objectives

Discuss the alternative, innovative, risk-based approaches regulators used to evaluate GCP compliance during the COVID-19 public health emergency; Describe the application of these tools in the post-pandemic environment; Explain industry’s perspective on and experiences with regulators' use of alternative approaches to GCP evaluations.

Chair

Emily Gebbia, JD

Speaker

FDA Update
Ling Yang, MD, PhD, FAAFP

Beyond the Pandemic, Sustaining Approaches to GCP Compliance
Paula Walker, MA

Health Canada Update
Jennifer Evans

Speakers

Paula Walker

Global Head of Risk Based Quality Management, Roche Products Ltd., United Kingdom

Paula is the Global Head of RBQM at Roche, having started with the company with a Quality Policy focus. Formerly Head of Compliance (GCP/PV/GLP) at the MHRA and Acting Head of Inspectorate, having started in 2009 as a GCP Inspector; spending 13.5 years at the Regulator. Paula has... Read More →

Jennifer Evans

Compliance Specialist, Health Canada, Canada

Jennifer Evans obtained her degree in Biochemistry from the University of Victoria, in British Columbia, Canada. She worked in the pharmaceutical and biotechnology industries in research, clinical and quality roles for 14 years prior to joining Health Canada in 2012 as a regulatory... Read More →

Emily Gebbia

Associate Director for Regulatory Development, OSI, OC, CDER, FDA, United States

Emily Gebbia is the Associate Director of Regulatory Development in the Office of Scientific Investigations (OSI) in CDER’s Office Compliance at the U.S. FDA. Emily provides strategic leadership and subject matter expertise for OSI’s policy efforts, including the development of... Read More →

Ling Yang

Senior Physician, OSI, OC, CDER, FDA, United States

Ling Yang is a senior physician in the Office of Scientific Investigations in FDA’s Center for Drug Evaluation and Research. She has worked at FDA for over 15 years and has extensive experience in GCP compliance evaluation, clinical review and FDA regulation of new drugs, generic... Read More →

Monday June 17, 2024 3:30pm - 4:30pm PDT
Room 17AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

08: RD Quality-Compliance, Session

Format Session
Level Intermediate
Featured Topics Regulator Perspectives
Level Intermediate
Feature Topics Regulator Perspectives
Credit Type ACPE, CME, RN
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8:00am PDT

#213: Beyond Traditional Trials: Real-World Data for External Controls, with Focus on Cancer Drug Applications

Component Type: Session
Level: Advanced
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-568-L04-P; CME 1.00; RN 1.00

Advanced cancers pose a dilemma between evidentiary requirements and speedy access to innovative agents. We present the results of a survey with regulators and discuss factors that influence acceptability of real-world data and possible optimal submission strategies.

Learning Objectives

Describe the challenges of drug development with evidence using external controls; Discuss regulators’ attitudes about real-world evidence and opportunities for addressing the challenges; Identify strategies using real-world evidence to maximize impact on the regulatory decision.

Chair

Francesco Pignatti, MD

Speaker

Real-World Data to Support Benefit-Risk Assessment: Regulatory Perspective
Douwe Postmus, PhD, MSc

External Comparators Using Real-World Data: Results of a Simulation Study
Gerd Rippin, DrSc

The Role and Impact of Real-World Data in Cancer Drug Applications
Catherine C. Lerro, PhD, MPH

Speakers

Catherine Lerro

Senior Pharmacoepidemiologist, Oncology Center of Excellence, FDA, United States

Dr. Lerro is a senior pharmacoepidemiologist in the Oncology Center of Excellence at the US FDA. Prior to joining the FDA, she trained at the National Cancer Institute in the Division of Cancer Epidemiology and Genetics. She holds a doctorate degree and masters in public health from... Read More →

Francesco Pignatti

Scientific Adviser for Oncology, European Medicines Agency, Netherlands

Francesco Pignatti graduated as Medical Doctor at the University of Rome La Sapienza, Italy. In 1995 he became Research Fellow at the EORTC Data Center in Brussels, Belgium In 1997 he obtained a Master of Science degree in Biostatistics from the University of Limburg, Belgium. In... Read More →

Douwe Postmus

Assistant Professor & Seconded National Expert, University Medical Center Groningen & EMA, Netherlands

Dr Douwe Postmus is employed as an assistant professor at the Department of Epidemiology of the University Medical Center Groningen, The Netherlands. His research focuses on applying quantitative modeling techniques to decision making problems in health care, including regulatory... Read More →

Gerd Rippin

Senior Director, Biostatistics, Real-World Solutions, IQVIA, Germany

Dr. Gerd Rippin is a trained statistician, receiving his statistics degree in 1995 from the University of Dortmund, Germany (equivalent to BSc and MSc), and his Dr. of Sciences (equivalent to PhD) in 1999 from the University of Mainz, Germany. Dr. Rippin has worked as a medical statistician... Read More →

Tuesday June 18, 2024 8:00am - 9:00am PDT
Room 17AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

11: Statistics-Data Science, Session

Format Session
Level Advanced
Featured Topics Regulator Perspectives, Real-World Data (RWD)- Real-World Evidence (RWE)
Level Advanced
Feature Topics Regulator Perspectives,Real-World Data (RWD)- Real-World Evidence (RWE)
Credit Type ACPE, CME, RN
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10:00am PDT

#227: How to Ensure Compliance in a Changing Regulatory Environment: A Regulators Perspective

Component Type: Session
Level: Advanced
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-578-L04-P; CME 1.00; RN 1.00

Hear the thoughts of regulators regarding how they see the future direction of travel for GCP Inspections. Learn about changes to compliance strategies and collaboration initiatives which are underway or in the pipeline.

Learning Objectives

Describe challenges currently faced by regulators regarding clinical trial inspections; Discuss strategies being developed by Health Authorities including future initiatives, direction of travel, and collaborative relationships.

Chair

Jason Wakelin-Smith

Speaker

FDA Update
Emily Gebbia, JD

Speakers

Emily Gebbia

Associate Director for Regulatory Development, OSI, OC, CDER, FDA, United States

Junko Sato

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

Dr. Sato joined the Pharmaceuticals and Medical Devices Agency (PMDA) in 1998, and she is currently the Associate Executive Director. She has work experiences in new drug review for 11 yrs, risk management for 3 yrs, and international area for 11 yrs. She also worked in U.S. FDA as... Read More →

Jason Wakelin-Smith

Expert GCP Inspector and Head of Compliance Expert Circle, Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom

Jason Wakelin-Smith joined the MHRA in November 2006 as a GCP Inspector becoming a Senior GCP & GLP Inspector in 2015, a Lead Senior GCP & GLP Inspector in 2017 and the Expert Inspector for GCP in April 2022. Jason has a broad range of experience within the MHRA compliance teams having... Read More →

Tuesday June 18, 2024 10:00am - 11:00am PDT
Room 17AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

08: RD Quality-Compliance, Session

Format Session
Level Advanced
Featured Topics Regulator Perspectives
Level Advanced
Feature Topics Regulator Perspectives
Credit Type ACPE, CME, RN
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1:15pm PDT

#244: Evidence Generation to Support Regulatory Decision-Making: Shift of the Trend over Time

Component Type: Session
Level: Basic
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-582-L04-P; CME 1.00; RN 1.00

This session will discuss the recent shifts in evidence-based regulatory decision-making, to include types of evidence used to support decisions. Future requirements for evidence generation to support regulatory decision-making will be considered.

Learning Objectives

Describe the need for evidence generation to support regulatory decision-making; Discuss the changing evidence landscape supporting regulatory decision-making; Identify what is needed in the future.

Chair

Saad Shakir, DrMed, MD, FFPM, FISPE, FRCP

Speaker

The Changing Trends in the Evidence Supporting Major Regulatory Decisions (Products Withdrawals) in Europe
Saad Shakir, DrMed, MD, FFPM, FISPE, FRCP

Quantitative Measurement of the Public Health Impact of Medicines Withdrawals and Suspensions in Europe
Samantha Lane, MSc

Industry Update
Andrew Bate, PhD, MA

Industry Update
Jeremy Jokinen, PhD, MS

Speakers

Saad Shakir

Director, Drug Safety Research Unit, United Kingdom

Saad Shakir is a pharmacoepidemiologist and drug safety physician. He has worked in the fields of pharmacovigilance, pharmacoepidemiology and risk management for 30 years, initially at the UK Regulatory Authority, then the international pharmaceutical industry and as the Director... Read More →

Andrew Bate

Vice President, Head of Safety Innovation and Analytics, GlaxoSmithKline, United Kingdom

Andrew is VP and Head of Safety Innovation & Analytics at GSK and a member of the Global Safety Leadership team. Previously Andrew was in the Epidemiology Leadership team at Pfizer for a decade. Prior to joining Pfizer, Andrew was at the Uppsala Monitoring Centre for more than 12... Read More →

Jeremy Jokinen

Vice President and Head, Safety Evidence and Sciences, Bristol-Myers Squibb Company, United States

Jeremy Jokinen is the Vice President and Head, Safety Evidence and Sciences at Bristol Myers Squibb. In this role, he leads a global team of risk management, epidemiology, and safety science experts responsible for insights, evidence generation, and risk minimization programs ensuring... Read More →

Samantha Lane

Head of Research, Centre of Pharmacovigilance Sciences, Drug Safety Research Unit, United Kingdom

Samantha Lane is a Senior Research Fellow and the Head of Research for the Centre of Pharmacovigilance Sciences at the Drug Safety Research Unit. Samantha leads study design and statistical analysis and has experience with the CPRD electronic health records database. She has a background... Read More →

Tuesday June 18, 2024 1:15pm - 2:15pm PDT
Room 17AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

01: ClinSafety-PV, Session

Format Session
Level Basic
Level Basic
Credit Type ACPE, CME, RN
Tags Session

3:15pm PDT

#273: How to Provide Necessary Medicinal Products to Children?

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-605-L04-P; CME 1.00; RN 1.00

In this session, speakers share the efficacy of exsiting pediatric regulation and discuss future collaboration to promote pediatric drug development worldwide

Learning Objectives

Describe the pediatric regulation of Japan and ASEAN; Discuss collaboration to promote pediatric drug development in these countries.

Chair

Junko Sato, PhD

Speaker

PMDA Update
Michiyo Sakiyama, MD

Industry Upate
Robert "Skip" Nelson, MD, PhD

FDA Update
Gerold Wharton

Speakers

Junko Sato

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

Robert Nelson

Senior Director, Pediatric Drug Development (CHILD), Johnson & Johnson, United States

Robert “Skip” Nelson, MD, MDiv, PhD. is currently Senior Director, Pediatric Product Development in the Child Health Innovation Leadership Department (CHILD) at Johnson & Johnson. Previously, he was the Deputy Director and Senior Pediatric Ethicist in the Office of Pediatric Therapeutics... Read More →

Michiyo Sakiyama

Associate Senior Scientist for Clinical Medicine, Office of Vaccines and Blood, Pharmaceuticals and Medical Devices Agency (PMDA), Japan

Michiyo Sakiyama, MD is an Associate Senior Scientist for Clinical Medicine of the office of Vaccines and Blood Products at the Pharmaceuticals and Medical Devices Agency (PMDA). She is a pediatrician and currently involved in reviewing vaccines against infectious diseases, blood... Read More →

Gerold Wharton

Program Analyst, Office of Clinical Policy and Programs, OC, FDA, United States

Tuesday June 18, 2024 3:15pm - 4:15pm PDT
Room 17AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

09: Regulatory, Session

Format Session
Level Intermediate
Featured Topics Special Populations
Level Intermediate
Feature Topics Special Populations
Credit Type ACPE, CME, RN
Tags Session

4:30pm PDT

#289: Post-COVID cGMP Inspections by Global Regulatory Authorities

Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-620-L04-P; CME 1.00; RN 1.00

Unfold real-world post-COVID inspections at global pharmaceutical manufacturing facilities, gaining insights into successes and disappointments within them. Appreciate perspectives on post-COVID inspections from FDA, EMA, Anvisa, and NMPA inspectors.

Learning Objectives

Recognize key advances and innovations that regulatory authorities and manufacturing facilities have adopted post-COVID in cGMP inspections;. Identify ongoing challenges that regulatory authorities and manufacturing facilities face in maintaining compliance and ensuring product quality in the post-COVID landscape and their implications in future pharmaceutical developments.

Chair

Lan Mu, PhD, RAC

Speaker

Industry Update
Karthik Iyer, MS

Panelist
Erica Franca Costa, RPh

Case Studies
Chiang Syin

Speakers

Lan Mu

Senior Vice President, Bio-Thera Solutions, United States

Dr. Lan Mu has over 25 years of experience in drug discovery, development, and global registration in various therapeutic areas. She was a principal research investigator at Sanofi prior to earning the Regulatory Affairs Certification (RAC). Subsequently, she held roles of increasing... Read More →

Erica Franca Costa

Health Regulation Specialist, ANVISA, Brazil

Pharmacist, Health Regulation Specialist, Senior GMP Inspector. She has been a member of the Brazilian National Health Surveillance Agency (ANVISA) since 2005, carrying out, among other activities, BPF inspections, medicine and cosmetic products registration, regulatory convergence... Read More →

Karthik Iyer

Director, Global Quality, Merck & Co., Inc., United States

Karthik is currently an associate director for Data and Analysis in the Office of Surveillance. Prior agency roles included CMC reviewer (Office of Process and Facilities), Acting Branch Chief ( Office of Surveillance) and Senior Policy Advisor (Office of Manufacturing and Product... Read More →

Chiang Syin

President, Meadows Biosolutions LLC, United States

Tuesday June 18, 2024 4:30pm - 5:30pm PDT
Room 17AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

10: RegCMC-Product Quality, Forum

Format Forum
Level Intermediate
Featured Topics Regulator Perspectives
Level Intermediate
Feature Topics Regulator Perspectives
Credit Type ACPE, CME, RN
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1:15pm PDT

#351: Revolutionizing Quality Management: Harnessing the Power of AI for Enhanced Decision Making and Continuous Improvement

Component Type: Session
Level: Basic
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-654-L04-P; CME 1.00; RN 1.00

This session explores four use cases of AI's potential to revolutionize quality management (QM) decision making and enhance organizational processes. Discover how AI is being implemented within QM and AI's role in identifying trends and driving improvement initiatives.

Learning Objectives

Describe the role of AI for quality management (QM) decision making, with a focus on advanced data analysis and pattern recognition, quality risk management, inspection readiness and drive continuous improvement initiatives; Identify practical use cases of AI in enterprise QMS, metadata extraction, risk assessment, and knowledge management systems, showcasing the benefits of AI integration.

Chair

Oliver Fink, MS

Speaker

AI Embedded Capabilities in an Enterprise Quality Management System
Michael Pelosi, MA, MBA, MSc

Augmenting Quality Assurance Activities with AI
Oeystein Kjoersvik, MS, MSc

AI Use Cases in Regulatory Monitoring
Haleh Valian, PhD

Speakers

Oliver Fink

Head Learning, Processes and Digitalization, Boehringer Ingelheim Pharma Gmbh & Co. KG, Germany

Oeystein Kjoersvik

Technology Auditor and Quality Projects Lead, Merck Sharp & Dohme LLC, United States

Oeystein Kjoersvik is currently a Technology Auditor and Quality Projects lead at Merck, one of his focuses is AI within QA. Oeystein also served as a Machine Learning SME for TransCelerate's Intelligent Automation team. Prior to his current role, he held the role of Product Owner... Read More →

Michael Pelosi

Director, Quality Analytics, Astellas, United States

Haleh Valian

Head of Decision Quality Analytics and Innovation, Biogen, United States

Haleh is the Biogen's Head of R&D Decision, Quality Analytics and innovations. She has more than 21 years of expertise utilizing advanced analytics to solve challenging business problems relating to process optimization in a variety of industries, including pharma, healthcare, and... Read More →

Wednesday June 19, 2024 1:15pm - 2:15pm PDT
Room 17AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

08: RD Quality-Compliance, Session

Format Session
Level Basic
Featured Topics Artificial Intelligence (AI), Risk Management
Level Basic
Feature Topics Artificial Intelligence (AI),Risk Management
Credit Type ACPE, CME, RN
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