DIA 2024 Global Annual Meeting: Full Schedule

11:00am PDT

#108: Risk Management in Advanced Device Technology Development

Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-522-L04-P; CME 1.00; RN 1.00

This panel will discuss innovative medical products due to their contribution to advancing medical care and are thus expected to have major impact in the coming years. Risk management pertaining to future technologies will be critical as product become more patient centric.

Learning Objectives

Analyze latest expectations and challenges utilizing an integrated risk management approach for combination products; Discuss the importance of an integrated risk management approach to increase product understanding earlier within the product development phase.

Chair

James Wabby, MHS

Speaker

Panelist
Kimberly Trautman, MS

Panelist
Donna Rycroft, BSN

Panelist
Olivia Wong, MBA

Speakers

Kimberly Trautman

Managing Director, Trautman International Services, United States

Experienced Medical Devices, IVD and Combination Product Expert with over 40 years of experience, including 24 years working at the U.S. FDA CDRH. Author of the 1996 Medical Device Quality System regulation and member of the authoring group for Combination Product GMPs in Part 4... 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 →

Donna Rycroft

Director, Study Risk Management, AbbVie, United States

Strategic Leader in Clinical Development with 11 years expertise in Risk-based Quality Management (RBQM) leading the development, implementation and change management of RBQM models and supporting systems at AbbVie and Allergan. Currently leading a team of Study Risk Leads supporting... Read More →

Olivia Wong

Director, Quality, Combination Products, Gilead, United States

Olivia Wong is the Director of Quality, Combination Products at Gilead Sciences in Foster City, CA. She has 22 years of industry experience in medical devices and combination products, where she has provided quality engineering expertise throughout the product lifecycle, including... Read More →

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

01: ClinSafety-PV, Forum | 06: TranslationalDelivery Tech-PrecMedicine, Forum

Format Forum
Level Intermediate
Featured Topics Risk Management
Level Intermediate
Feature Topics Risk Management
Credit Type ACPE, CME, RN
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2:15pm PDT

#138: Having the End in Mind When Building Quality into Clinical Trials: A Regulatory and Industry Perspective

Component Type: Session
Level: Advanced
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-538-L04-P; CME 1.00; RN 1.00

This session will discuss regulatory and industry perspectives on building quality into clinical trials by providing updates to agency policy of risk-based monitoring (RBM), quality risk management (QRM), and quality-by-design (QbD) (e.g., ICH E6R3, ICH E8R1, draft and final guidances), including case examples.

Learning Objectives

Discuss the importance of building quality into clinical trials; Identify a study’s critical quality (CTQ) factors and the importance of involving all stakeholders in their identification; Describe FDA’s expectations for implementing quality-risk management and developing and executing risk-based monitoring plans to focus on CTQ factors with inspection case examples of sponsors, CROs, service providers and clinical investigators.

Chair

Kenneth Getz, MBA

Speaker

Speaker
Linda B Sullivan, MBA

FDA Update
Elena Boley, MD, MBA, FACP

Industry Update
Michael Torok, PhD

Speakers

Kenneth Getz

Tufts Center for the Study of Drug Development, Center For the Study of Drug Development, United States

Ken Getz is the Executive Director and a Professor at the Tufts Center for the Study of Drug Development, Tufts University School of Medicine. He is also the chairman of CISCRP – a nonprofit organization that he founded to educate and raise public and patient awareness of the clinical... Read More →

Elena Boley

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

Dr. Boley is a senior physician in the Good Clinical Practice Assessment Branch of the Division of Clinical Compliance Evaluation (DCCE)/Office of Scientific Investigations (OSI) in CDER/FDA. She provides regulatory and scientific oversight for CDER-assigned bioresearch monitoring... Read More →

Linda Sullivan

Senior Fellow, Tufts Center For the Study of Drug Development, United States

Ms Sullivan is a Senior Fellow at the Tufts Center for the Study of Drug Development. She has more than 30 years of experience working in the Healthcare and Clinical Research industries helping organizations optimize processes to improve financial and quality outcomes. She founded... Read More →

Michael Torok

Vice President, Global Head of Quality Assurance Programs, Genentech, A Member of the Roche Group, United States

Michael Torok, Ph.D. is the Global Head of Quality Assurance Programs at Genentech/Roche. He is energized and driven by the mission of positioning Quality to be an accelerant in developing new therapeutics, rather than a guardrail or "policemen". To enable this shift, cross-functional... Read More →

Monday June 17, 2024 2:15pm - 3:15pm PDT
Room 6D San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

08: RD Quality-Compliance, Session

Format Session
Level Advanced
Featured Topics ICH, Risk Management
Level Advanced
Feature Topics ICH,Risk Management
Credit Type ACPE, CME, RN
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2:15pm PDT

#137: Options to Consider When Balancing Risk, Timelines, Cost, and Patient Centricity While Meeting Project Optimus Guidelines

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-537-L04-P; CME 1.00; PDU 1.00 PMI 2166YE3LVS; RN 1.00

Review principles of FDA's Project Optimus and discuss the impact on oncology clinical development strategies. Scenario analysis with risk management is needed to balance project cost, timelines, patient centricity and health equity approaches.

Learning Objectives

Describe the essential points of FDA's Project Optimus Guidance and how it may impact drug development; Discuss how project managers and oncology development teams gain insight into options to consider in order to balance cost, timelines, and risk during dose finding/dose optimization in new molecular entities and new indications.

Chair

Nancy Linda Styple

Speaker

Patient Update
Julia Maues, MA

Industry Update
Gary Wilkinson, PhD

Project Management Considerations for Project Optimus
Nancy Linda Styple

Speakers

Nancy Styple

Project Management Leader, Bayer AG, United States

Nancy has been excited to work in Program Management for over 20 years and is a strong advocate for the work that Project Managers and Project Leaders deliver along the value chain in drug development. Nancy starting as a bench research scientist in biotech and has experience in multiple... Read More →

Julia Maues

Patient Advocate, Patient-Centered Dosing Initiative, United States

Julia Maues spearheads the Patient-Centered Dosing Initiative (PCDI), challenging conventional cancer drug dosing practices and prioritizing patient well-being alongside efficacy. She is co-founder of GRASP (Guiding Researchers and Advocates to Scientific Partnerships), an organization... Read More →

Gary Wilkinson

Director of Clinical Pharmacology, Ryvu Therapeutics, Poland

Monday June 17, 2024 2:15pm - 3:15pm PDT
Room 1AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

09: Regulatory, Session | 05: Patient-Focused Drug Dev, Session | 07: ProjectManagement-StrategicPlanning, Session

Format Session
Level Intermediate
Featured Topics Risk Management
Level Intermediate
Feature Topics Risk Management
Credit Type ACPE, CME, PMI, RN
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3:15pm PDT

#263: Risk Management Planning- Some Twenty Years Later: Where we Started, How Far we have Come and a Modern Path Forward

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-595-L04-P; CME 1.00; RN 1.00

This session provides an opportunity to pause and reflect on how far we have come and discuss areas for future focus, innovation, and key influential drivers for change from a scientific, technological and patient-centric perspective.

Learning Objectives

Describe the evolution in the use of risk management principles in the context of patient safety; Discuss the role of real-time information and collaboration/engagement as the catalyst for action in risk management; Identify current limitations and challenges; List specific case examples from a public health and patient safety perspective; Discuss opportunities for future innovations.

Chair

Rania Mouchantaf, PhD

Speaker

FDA Update
Gerald Dal Pan, MD, MHS

MHRA Update
Alison Cave, PhD

Effectiveness of Interventions: Successes and Challenges
Yola Moride, PhD, FISPE

Industry Update
Mamiko Kasho

EMA Update
Priya Bahri, PhD, RPh

Speakers

Priya Bahri

Senior Lead (Pharmacovigilance and Risk Management Guidance and Policy), European Medicines Agency, Netherlands

Priya Bahri, RPh, PostGradDipEpi, PhD, at EMA since 1996, is now EMA's Lead Pharmacovigilance and Risk Management Guidance and Policy. In this role, she also instigates research and regulatory frameworks for risk communication, stakeholder engagement for pharmacovigilance and implementation... Read More →

Alison Cave

Chief Safety Officer, Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom

Dr Cave joined the Medicines and Healthcare products Regulatory Agency (MHRA) in July 2021 as the Chief Safety Officer with responsibility for the safety of medicines and devices in the UK. She holds a BSc Honours degree and PhD from the University of London and has significant academic... Read More →

Mamiko Kasho

Executive Director, Global PV Management Dept., Global Safety HQs, Eisai Co., Ltd., Japan

Mamiko Kasho is Executive Director of Global Pharmacovigilance Management in Global Safety HQ of Eisai Co., Ltd, and has been involved in global PV area since she joined the company in 2007. Mamiko has been responsible for PV agreements with licensing partners for 15 years and at... Read More →

Yola Moride

President, YolaRX Consultants, Canada

Prof. Yola Moride has a strong track record of methodological expertise in pharmacoepidemiology and therapeutic risk management. She is Research Professor at Rutgers University and President of YolaRX Consultants. She received a PhD in Epidemiology from McGill University and a Post-doctoral... Read More →

Rania Mouchantaf

A/Executive Director, Marketed Pharmaceuticals Bureau, MHPD, Health Canada, Canada

Dr. Rania Mouchantaf is A/Executive Director at the Marketed Health Products Directorate at Health Canada with over 17 years of experience in the area of pharmacovigilance. Before entering the public service she worked in the private sector, however her interest in pharmacovigilance... Read More →

Gerald Dal Pan

Director, Office of Surveillance and Epidemiology, CDER, FDA, United States

Gerald J. Dal Pan, MD, MHS currently serves as the Director of the Office of Surveillance and Epidemiology in FDA’s Center for Drug Evaluation and Research, where since 2005 he has been responsible for the Center’s programs in adverse event surveillance and analysis, pharmacoepidemiology... Read More →

Tuesday June 18, 2024 3:15pm - 4:15pm PDT
Room 6B San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

01: ClinSafety-PV, Session

Format Session
Level Intermediate
Featured Topics Risk Management, Patient Focused
Level Intermediate
Feature Topics Risk Management,Patient Focused
Credit Type ACPE, CME, RN
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3:15pm PDT

#271: How Will the Increasing use of Real-World Evidence for Regulatory Decision-Making Impact QA Strategies and GCP Inspections?

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-603-L04-P; CME 1.00; RN 1.00

This session will bring regulators and industry quality experts together to explore how quality management systems can be developed to meet the challenges real-world evidence presents to QA activities and regulatory inspection expectations.

Learning Objectives

Evaluate quality challenges associated with the use of real-world evidence as part of regulatory studies; Discuss how to apply proportionate risk-based quality assurance activities which meet regulatory expectations.

Chair

Andrew Gray, PhD

Speaker

FDA Update
L'Oreal Walker

FDA Update
Lee H. Pai-Scherf, MD

Industry Perspective
Abi Seifert, MBA

Speakers

Andrew Gray

Director, QA Clinical Therapeutic Area Head, Johnson & Johnson, United Kingdom

Andrew is a member of Johnson and Johnson's R&D Quality organisation where he has responsibility for risk-based audit strategies across the company’s clinical therapeutic areas. With an active interest in the use of RWE for regulatory decision making, Andrew was responsible for... Read More →

Lee Pai-Scherf

Senior Physician, GCP Assessment Branch, DCCE, OSI, OC, CDER, FDA, United States

Lee H. Pai-Scherf, MD, Senior Physician, OSI, Office of Compliance, CDER, FDA Dr. Pai-Scherf is a Senior Physician in the Good Clinical Practice Assessment Branch of the Division of Clinical Compliance Evaluation /Office of Scientific Investigations in CDER/FDA. She provides regulatory... Read More →

Abi Seifert

Global Head Country Development Quality, Novartis , United States

Abi has worked in the Pharma industry for over 25 years, serving in clinical development in both QA and operational roles. Her career started in clinical study monitoring and GCP auditing and evolved into roles that defined strategy around project management, process excellence and... Read More →

L'Oreal Walker

Supervisory Consumer Safety, OBIMO, ORA, FDA, United States

L'Oreal Walker is a seasoned professional with over two decades of experience in regulatory compliance and oversight. Currently serving as a Supervisory Investigator in the Office of Bioresearch Monitoring West Division within the Office of Regulatory Affairs at the FDA, L'Oreal leads... Read More →

Tuesday June 18, 2024 3:15pm - 4:15pm PDT
Room 16AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

08: RD Quality-Compliance, Session

Format Session
Level Intermediate
Featured Topics Risk Management, Real-World Data (RWD)- Real-World Evidence (RWE)
Level Intermediate
Feature Topics Risk Management,Real-World Data (RWD)- Real-World Evidence (RWE)
Credit Type ACPE, CME, RN
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8:00am PDT

#301: Risk Minimization in the EU: New Guidance, New Collaborations

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-622-L04-P; CME 1.00; RN 1.00

Risk minimization is a key area of pharmacovigilance.This session presents revised EU guidance and discusses multidisciplinary and multistakeholder approaches to implementation.

Learning Objectives

Summarize new EU-regulatory guidance on risk minimization measures and its implications for stakeholders; Recognize underpinning rationales and concepts from implementation science, engagement frameworks, mixed methods and digital opportunities; Identify successful collaborations across stakeholders for implementing risk minimization measures in healthcare.

Chair

Priya Bahri, PhD, RPh

Speaker

Industry Update
Meredith Smith, PhD, MPA, FISPE

Patient Update
Regina Mariam Kamoga, MPA

Speakers

Priya Bahri

Senior Lead (Pharmacovigilance and Risk Management Guidance and Policy), European Medicines Agency, Netherlands

Regina Mariam Kamoga

Executive Director, Community Health And Information Network ( CHAIN), Uganda

She is passionate about patient centered healthcare and patient safety and her work puts emphasis on patient, family, community engagement and empowerment at the grassroots level. One of her key roles is as a WHO Patient Safety champion and she is a member of the WHO’s Patients... Read More →

Meredith Smith

Senior Director, Implementation Science Pillar Lead, Evidera, Inc, United States

Meredith Smith, PhD, MPA, FISPE is Senior Director and Head, Implementation Science team within the Patient-Centered Research group at Evidera, Inc., PPD, a part of Thermo Fisher Scientific. She is a behavioral scientist and health services researcher by training with over 20 years... Read More →

Wednesday June 19, 2024 8:00am - 9:00am PDT
Room 11AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

01: ClinSafety-PV, Session

Format Session
Level Intermediate
Featured Topics Risk Management, Regulator Perspectives
Level Intermediate
Feature Topics Risk Management,Regulator Perspectives
Credit Type ACPE, CME, RN
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10:00am PDT

#317: Unlocking the Potential of Pharmacogenomics for Reducing the Burden of Adverse Drug Reactions

Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-635-L04-P; CME 1.00; RN 1.00

This session will explore current progress in pharmacogenomics; the barriers and opportunities it represents for drug safety from the perspective of medicines regulators, industry, the scientific community, healthcare professionals, and patients.

Learning Objectives

Discuss the importance of pharmacogenomics for introducing better risk mitigation strategies; Appraise progress being made in this field internationally; Recognize opportunities for introduction of pharmacogenomic research in your organization.

Chair

Alison Cave, PhD

Speaker

From Post-Marketing Reports of Side Effects to Pharmacogenomic Research: Can we Reduce the Burden of ADRs?
Alison Cave, PhD

Patient Perspective
Christine Von Raesfeld

Industry Perspective
Gregory Powell, PharmD, MBA

Academic Perspective
Kathleen M. Giacomini, PhD

Speakers

Alison Cave

Chief Safety Officer, Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom

Kathleen Giacomini

Dean, School of Pharmacy, Professor and Principal Investigator, University of California San Francisco, United States

Kathleen M. Giacomini, Ph.D. Kathy Giacomini, a professor in the School of Pharmacy at the University of California, San Francisco, is a leader in the field of membrane transporters with a focus on genetic polymorphisms. She cloned, characterized and discovered the endogenous role... Read More →

Gregory Powell

Senior Director, Safety and Clinical Innovation, GlaxoSmithKline, United States

Greg Powell is the Senior Director of Safety and Clinical Innovation at GlaxoSmithKline. He completed his PharmD at the University of Florida, his MBA at East Carolina University, and his BS in Pharmacy at the University of North Carolina. He has over twenty years of experience practicing... Read More →

Christine Von Raesfeld

Founder/SME, Patient Experience, The Light Collective, United States

Christine is a pillar of patient advocacy and allyship in the rare and chronic disease community. She is a champion for patient voices, diversity and inclusion in clinical research, and equitable patient-sponsor partnerships. As a patient, Christine has assisted in initiatives including... Read More →

Wednesday June 19, 2024 10:00am - 11:00am PDT
Room 6B San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

01: ClinSafety-PV, Forum

Format Forum
Level Intermediate
Featured Topics Risk Management, Regulator Perspectives
Level Intermediate
Feature Topics Risk Management,Regulator Perspectives
Credit Type ACPE, CME, RN
Tags Forum

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

Knowledge Management System with AI Based Recommender Service
Oliver Fink, MS

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, Czech Republic

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

Mike is the Astellas lead for strategy, implementation and integration of analytics and digital transformation capabilities and services across the Quality Assurance function.

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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1:15pm PDT

#353: ICH M15 Model Informed Drug Development: Steps Toward Harmonized Guidance

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-656-L04-P; CME 1.00; RN 1.00

Model Informed Drug Development (MIDD) can enhance the efficiency of drug development and regulatory decision-making. The ICH M15 guideline aims to enable the further integration and consistent use of MIDD. This session will cover the draft guideline in greater detail.

Learning Objectives

Discuss the draft guideline and what may be new to drug developers and the regulatory community, including the concept of a risk-based assessment, the value of multidisciplinary team alignment on MIDD strategy, and early alignment with regulators; Identify current approaches, best practices, and future opportunities to enhance development and decision-making.

Chair

Erin Greene, JD

Speaker

Industry Perspective
Malidi Ahamadi

Regulatory Perspective
Hao Zhu, PhD

Industry Perspective
Mark C. Peterson, PhD

Speakers

Erin Greene

US Lead, Global Regulatory Policy and Innovation, Takeda, United States

Experienced leader in Global Regulatory Policy and Intelligence with a demonstrated history of working in the pharmaceutical and healthcare industries. Graduated from American University, Washington College of Law with an emphasis on FDA regulation and health law and policy.

Malidi Ahamadi

US Head, Modeling and Simulation, Sanofi, United States

Mark Peterson

Senior Director, Modeling and Simulation, Vertex Pharmaceuticals, United States

Dr. Mark C. Peterson works at Vertex Pharmaceuticals as a Senior Director in Clinical & Quantitative Pharmacology. Prior to that, he was at Pfizer (9 years), Biogen (2 years) and Amgen (8 years). Dr. Peterson received a Bachelor of Sciences in Pharmacy (1992) and a Doctorate in Pharmaceutical... Read More →

Hao Zhu

Division Director, Division of Pharmacometrics, OCP, OTS, CDER, FDA, United States

Wednesday June 19, 2024 1:15pm - 2:15pm PDT
Room 16AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

09: Regulatory, Session

Format Session
Level Intermediate
Featured Topics ICH, Risk Management
Level Intermediate
Feature Topics ICH,Risk Management
Credit Type ACPE, CME, RN
Tags Session

3:15pm PDT

#366: The Intersection of Patient-Experience Data and Benefit-Risk Analysis

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-666-L04-P; CME 1.00; RN 1.00

This session will explore how patient experience data (PED) can be used to inform benefit-risk analysis. The panel will include discussion on regulators’ views and incorporation of PED and successful case examples.

Learning Objectives

Describe the role patient experience data (PED) plays in benefit-risk analysis; Identify how to develop PED in a way that can inform regulatory decision-making; Discuss if and how new diversity and inclusion regulations will impact the development of PED and regulators’ interpretation of benefit-risk.

Chair

Allison Martin, MS
Victoria DiBiaso, BSN, MPH, RN

Speaker

The Intersection of Patient-Experience Data and Benefit-Risk Analysis: FDA Update
Michelle Campbell, PhD

The Intersection of Patient-Experience Data and Benefit-Risk Analysis: EMA Update
Francesco Pignatti, MD

The Intersection of Patient-Experience Data and Benefit-Risk Analysis: patient Update
Hollie Schmidt, MS

Speakers

Allison Martin

Director, Regulatory Science and Policy, North America, Sanofi, United States

As a Director on Sanofi’s Regulatory Science and Policy North America team, Allison is responsible for advancing regulatory science and strategically engaging in regulatory policy efforts. In this role, Ms. Martin collaborates with internal and external stakeholders to identify... Read More →

Michelle Campbell

Associate Director, Stakeholder Engagement and Clinical Outcomes, ON, OND, CDER, FDA, United States

Michelle Campbell is the Associate Director for Stakeholder Engagement and Clinical Outcomes in the Office of Neuroscience, Office of New Drugs (OND), Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration (FDA). Dr. Campbell joined FDA in 2014 and was previously... Read More →

Victoria DiBiaso

Global Head, Patient Informed Development and Health Value Translation, Sanofi, France

Vicky has 25+ years of clinical research experience. She holds a Master of Public Health, is a nurse by training. Her work has been published in The Wall Street Journal, she has been recognized as one of the Top 20 Industry Innovators, through integrating patient communities into... 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 →

Hollie Schmidt

Vice President of Scientific Operations, Accelerated Cure Project, United States

Hollie Schmidt is the VP of Scientific Operations at the Accelerated Cure Project, a research-focused patient advocacy organization for MS. She has planned, developed, and directed numerous initiatives aimed at creating research resources and bridging different stakeholder communities... Read More →

Wednesday June 19, 2024 3:15pm - 4:15pm PDT
Room 5AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

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

Format Session
Level Intermediate
Featured Topics Diversity Equity and Inclusion (DEI), Patient Focused, Risk Management
Level Intermediate
Feature Topics Diversity Equity and Inclusion (DEI),Patient Focused,Risk Management
Credit Type ACPE, CME, RN
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