DIA 2024 Global Annual Meeting: Full Schedule

11:00am PDT

#107: Cloud-Driven Transformation: Empowering Pharma Industry and Regulators

Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-521-L04-P; CME 1.00; RN 1.00

This forum will identify how cloud-based technologies may be utilized to promote interactive and collaborative regulatory review (applicant-regulator; inter-regulator) both regionally and internationally. Speakers will discuss several regulatory use cases and initiatives that are leveraging these technologies to modernize data exchange and regulatory review.

Learning Objectives

Illustrate how cloud-based technologies may promote interactive and collaborative regulatory review (applicant-regulator; inter-regulator) both regionally and internationally discussion of several regulatory and scientific use cases opportunities leveraging cloud-based solutions; Discuss relevant PDUFA VII provisions and FDA’s public-private partnerships and European Medicines Agency initiatives in advancing regulatory science through the application of cloud technology.

Chair

Vada A. Perkins, DrSc, MSc

Speaker

US FDA/Industry Regulatory Cloud Research Collaboration: Project PRISM (PrecisionFDA Regulatory Information Service Module)
Vada A. Perkins, DrSc, MSc

FDA Update
Ginny Hussong

PRISM Use Case: ICH M11 Protocol
Ron Fitzmartin, PhD, MBA

Cloud-Driven Transformation: Enabling the Ambition of a Global Pharmaceutical Quality Knowledge Management Capability
Hilmar Hamann, PhD

Speakers

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 →

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 →

Hilmar Hamann

Head of Information Management, European Medicines Agency, Netherlands

Dr. Hilmar Hamann is the Head of Information Management at the European Medicines Agency where he focuses on transforming technology capabilities for the Network of Regulatory Agencies in the EU and its stakeholders to become an all-digital, efficient and data-driven Network of the... Read More →

Virginia Hussong

Branch Chief, Data Standards, CBER, FDA, United States

Ginny serves as Chief of CBER's Data Standards Branch, where she leads a multidisciplinary team that advances standards such as eCTD, CDISC, IDMP, ICSR, SPL and related terminologies. In addition, conducts technical validation of clinical study data, leads related reviewer training... Read More →

Monday June 17, 2024 11:00am - 12:00pm PDT
Room 6B San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

03: Data-Tech, Forum

Format Forum
Level Intermediate
Featured Topics Digital Technology, Regulatory Collaboration
Level Intermediate
Feature Topics Digital Technology,Regulatory Collaboration
Credit Type ACPE, CME, RN
Tags Forum

12:45pm PDT

#122 CH: Digital Transformation: More Than Just Technology - Understanding How to Make it a Reality

Component Type: Workshop
Level: Intermediate

The industry has invested heavily in digital transformation initiatives over the past decade. Despite the promise shown by new technology (e.g. GenAI), many processes are still manual and require significant resourcing. Solutions will be discussed.

Chair

Louise Lind Skov, PhD

Speaker

Spreaker
Waheed Jowiya, PhD

Speakers

Waheed Jowiya

Digitalisation Strategy Lead, Novo Nordisk A/S, Denmark

Waheed is a Digitalisation Strategy Lead at Novo Nordisk. In his role at Novo Nordisk, Waheed has been instrumental in shaping the digitalisation strategy for the company's content creation initiatives. Waheed has played a crucial role in developing the strategy for scaling and deployment... Read More →

Louise Lind Skov

Head of Content Digitalisation, Novo Nordisk A/S, Denmark

Louise is Head of Content Digitalisation at Novo Nordisk. In her current role at Novo Nordisk, Louise plays a pivotal role in advancing the way clinical and regulatory documents are managed and processed. Leading the digital transformation effort, she heads the development of innovative... Read More →

Monday June 17, 2024 12:45pm - 1:15pm PDT
Content Hub Sails Pav San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

15: Content Hubs, Workshop | 03: Data-Tech, Workshop

Level Intermediate
Level Intermediate
Tags Workshop

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

Support of Digital Protocol Initiatives
Chris Decker, MS

The Value of Data: A Regulatory Perspective
Ana Zanoletty Perez

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

Speakers

Ron Fitzmartin

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

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

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

2:15pm PDT

#131: Innovative Approaches to the Design of Pediatric Development Programs: What’s New in the Use of Pediatric Extrapolation

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-531-L04-P; CME 1.00; RN 1.00

The ICH E11A guidance advances use of pediatric extrapolation in three areas: (1) role of exposure-response; (2) statistical implications of using external data; and (3) extrapolation of safety. After an overview, these three areas will be explored.

Learning Objectives

Define pediatric extrapolation and three components of extrapolation concept; Describe role of exposure-response in supporting data extrapolation from reference to target pediatric population; Examine the impact of extrapolation on false positive rate of a pediatric clinical trial; Outline impact of pediatric extrapolation on generation of safety data in the target pediatric population.

Chair

Robert "Skip" Nelson, MD, PhD

Speaker

FDA Update on ICH E11A EWG on Pediartic Extrapolation
Lynne Yao, MD

Industry Update
Forrest Williamson, PhD, MS

Industry Update on ICH E11A EWG on Pediatric Extrapolation
Brenda Cirincione, PhD, MS

Speakers

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 →

Brenda Cirincione

Vice President, Clinical and Quantitative Pharmacology, Vertex, United States

Brenda Cirincione has over 20 years of research experience in Clinical Pharmacology and Pharmacometrics. She received a PhD in pharmaceutical sciences and a MA in statistics from the University of Buffalo, State University of New York, and has experience working in businesses across... Read More →

Forrest Williamson

Director of Pediatrics, Statistical Innovation Center, Eli Lilly and Company, United States

Forrest Williamson is a Director of Pediatrics within the Global Statistical Sciences organization at Eli Lilly and Company, serves as Adjunct Assistant Clinical Professor of Medicine at the Indiana University School of Medicine, and has Professional Statistician accreditation from... Read More →

Lynne Yao

Director, Division of Pediatric and Maternal Health, Office of New Drugs, CDER, FDA, United States

Lynne Yao, M.D., is the Director, Division of Pediatrics and Maternal Health in the Office of New Drugs, Center for Drug Evaluation and Research. The Division of Pediatrics and Maternal Health oversees quality initiatives which promote and necessitate the study of drug and biological... Read More →

Monday June 17, 2024 2:15pm - 3:15pm PDT
Room 14AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

03: Data-Tech, Session | 11: Statistics-Data Science, Session | 02: ClinTrials -ClinOps, Session

Format Session
Level Intermediate
Featured Topics Special Populations
Level Intermediate
Feature Topics Special Populations
Credit Type ACPE, CME, RN
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3:30pm PDT

#147: Data and Technology Influence on ICH Initiatives: M4Q(r2)/Q12 and Global Harmonization

Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-546-L04-P; CME 1.00; RN 1.00

Join industry leaders in this interactive forum to discuss the development of ICH initiatives ICH Q12 and ICH M4Q(r2), how they will impact the product approval lifecycle, and the technology that will manage these processes and the data.

Learning Objectives

Describe important initiatives that will have a direct impact on the pharmaceutical product approval lifecycle; Identify how the initiatives will influence changes in our industry for patient-product access and faster approvals; Discuss how technology and data has a major role in bringing these initiatives to reality.

Chair

Brooke Casselberry, MS, RAC

Speaker

Panelist
Andrew Chang, PhD

Panelist
Ciby Joseph Abraham, PhD

Panelist
Alexander Gaffney, MS, RAC

Panelist
Lawrence Yu, PhD

Speakers

Ciby Abraham

Senior Director and Group Manager, Project and Product Leadership, AstraZeneca, United States

Ciby Abraham is a Senior Director and Group Manager, Project and Product Leadership in CMC Regulatory Affairs at AstraZeneca. Prior to his role with AstraZeneca, Ciby worked at the for several years FDA as a Team Leader. In addition, Ciby worked in the industry as a formulator, analytical... Read More →

Brooke Casselberry

Vice President, Advisory and Delivery, Epista Life Sciences, United States

Brooke is known for her pivotal roles in collaborating with Sponsor Companies, Health Authorities, and Technology Developers. She has maintained focus on leveraging cutting-edge technologies as a catalyst for regulatory advancements, optimization, and collaboration for global go-to-market... 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 →

Alexander Gaffney

Executive Director, Regulatory Policy And Intelligence, AgencyIQ by POLITICO, United States

Alexander Gaffney is the Executive Director of Regulatory Policy and Intelligence for POLITICO's AgencyIQ, where he leads a team of more than a dozen regulatory intelligence professionals. Alexander has worked in regulatory for more than a decade, including at the Regulatory Affairs... Read More →

Lawrence Yu

Director, Office of New Drug Products, OPQ, CDER, FDA, United States

Lawrence X. Yu, Ph.D., is the Director, Office of New Drug Products, Food and Drug Administration and Rapporteur, ICH M4Q(R2) Expert Working Group. Dr. Yu is also an adjunct Professor at the University of Michigan. Dr. Yu is an Associate Editor of the AAPS Journal. Dr. Yu has authored/co-authored... Read More →

Monday June 17, 2024 3:30pm - 4:30pm PDT
Room 6B San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

03: Data-Tech, Forum

Format Forum
Level Intermediate
Featured Topics ICH, Digital Technology
Level Intermediate
Feature Topics ICH,Digital Technology
Credit Type ACPE, CME, RN
Tags Forum

8:00am PDT

#204: Wearable Sensors and Digital Health Technologies for Tracking Neurological and Neuromuscular Disorders

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-559-L04-P; CME 1.00; RN 1.00

Neurological disorders are complex and multifaceted, with symptoms that can vary widely. Wearable sensors and digital health technologies enable objective collection of data at the patients' home, providing unprecedented ways for tracking diseases.

This session will include presentations from several NIH-funded and Investigator-initiated studies focused on collecting digital measures of disease progression, including in patients with progressive supranuclear palsy, Parkinson disease, Alzheimer’s and ALS, and their potential impact on clinical trials and care for individuals with neurological disorders.

Learning Objectives

Demonstrate innovative wearable sensors and digital technologies capable of accurately detecting and monitoring neurological disease symptoms; Identify methods for seamlessly integrating wearable sensors with existing healthcare systems to ensure continuity of care.

Chair

Ashkan Vaziri, PhD

Speaker

NIH Update
Yuan Luo, PhD

Academic Update
Bijan Najafi, PhD, MSc

Industry Update
Sharon Tamir

Industry Update
Ashkan Vaziri, PhD

Speakers

Ashkan Vaziri

Co-founder and CEO, Biosensics LLC, United States

Dr. Vaziri is a Founder and CEO of BioSensics, a biomedical firm focused on the development of wearable sensors and digital health platforms for clinical trials and research. Dr. Vaziri’s work presents a unique combination of academic research, product development, and small business... Read More →

Yuan Luo

Program Director, AD/ADRD Biomarkers, Division of Neuroscience, National Institute on Aging, NIH, United States

Dr. Yuan Luo is a Program Director of the Clinical Interventions and Diagnostics Branch in the Division of Neuroscience at National Institute on Aging, NIH. She oversees the Division’s technology portfolio, such as using wearable, sensors technology for early detection, monitoring... Read More →

Bijan Najafi

Professor of Surgery; Director, Clinical Research, Baylor College of Medicine, United States

Dr. Bijan Najafi, Professor of Surgery at Baylor College of Medicine, specializes in digital health and biotechnologies. He's the Director of Clinical Research in Vascular Surgery and Co-Director of Center to Stream Healthcare in Place (C2SHIP). Recognized by Tucson Local Media in... Read More →

Sharon Tamir

Digital Healthcare Innovation, Business and Research Strategy, MT-Pharma, United States

Sharon Tamir, Leading the Digital Healthcare Innovation team at MT-Pharma since Jan2023. Prior to that she worked as a VP Program Leader of the Neuro-oncology and the Myelofibrosis programs at Karyopharm Therapeutics. Sharon Brings over a decade of experience in drug development... Read More →

Tuesday June 18, 2024 8:00am - 9:00am PDT
Room 5AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

03: Data-Tech, Session

Format Session
Level Intermediate
Featured Topics Digital Technology
Level Intermediate
Feature Topics Digital Technology
Credit Type ACPE, CME, RN
Tags Session

8:00am PDT

#205: Data Standards SOS: Reducing Burnout and Navigating Through Fatigue - Part 1

Component Type: Workshop
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-560-L04-P; CME 1.00; RN 1.00

At the DIA 2023 a round table on data standards and harmonization discussed “standards fatigue” related to data standards, reference models, consortia, industry groups, and their impact on the industry. We intend to address this topic in a two-part workshop.

Learning Objectives

Identify various data standards and harmonization efforts across pharma and biotech industries; Discuss challenges and business impact related to the understanding, implementation, and maintenance of data standards initiatives in light of digital transformation efforts; Describe approaches to identify overlapping/competing initiatives and develop synergistic approaches to reduce fatigue.

Chair

Venkatraman Balasubramanian, PhD, MBA

Speaker

Facilitator
Sridevi Nagarajan, PhD

Facilitator
Norman Schmuff, PhD

Facilitator
Hilmar Hamann, PhD

Facilitator
Cesar Vinces

Facilitator
Vanni Carapetian, MPH

Facilitator
Heiner Oberkampf, PhD

Speakers

Venkatraman Balasubramanian

SVP and Global Head, Industry Solutions - Healthcare and Life Sciences, Orion Innovation, United States

V. “Bala” Balasubramanian is Senior Vice President and Global Head, Industry Solutions Group for Healthcare and Life Sciences at Orion, a global digital transformation products, solutions and services firm. Bala has over three decades of IT and digital transformation experience... Read More →

Vanni Carapetian

Director, Regulatory Data, Genentech, A Member of the Roche Group, United States

Vanni brings nearly 20 years of life sciences and technology expertise drawn from team and leadership roles at Roche, J&J, and Amgen. Their experience spans clinical development, manufacturing, and regulatory and their principal interest lies in setting and executing strategies that... Read More →

Hilmar Hamann

Head of Information Management, European Medicines Agency, Netherlands

Sridevi Nagarajan

Head, Digital Regulatory Strategy, AstraZeneca , United Kingdom

Bringing over two decades of experience, Sridevi Nagarajan is a seasoned strategic portfolio management professional is deeply rooted in data-driven approaches. The expertise lies in successfully steering digital transformations within the Pharmaceutical and Public Health sectors... Read More →

Heiner Oberkampf

CEO, ACCURIDS, Germany

Heiner Oberkampf is the CEO and Co-founder of ACCURIDS, which is a software for collaborative data standards implementation, that helps pharma companies, e.g., in the implementation of IDMP standards through a federated product data graph. With a group of pharma companies, he has... Read More →

Norman Schmuff

Associate Director for Science, OPMA, OPQ, FDA, United States

Norman R. Schmuff joined the FDA in 1990. For more than 20 years, he has participated in ICH as a member of several Expert Working Groups. He was the Rapporteur for the M4 CTD (eCTD) – Quality Implementation Working Group. He is involved in many FDA electronic submission initiatives... Read More →

Cesar Vinces

EU Interim and International Policy Lead, Accumulus Synergy, United States

Cesar serves as Interim EU & International Policy Lead at Accumulus Synergy within Regulatory Innovation. He engages with industry experts, national regulators, and global organizations to foster policy changes and develop strategies that enhance regulatory frameworks, promoting industry... Read More →

Tuesday June 18, 2024 8:00am - 9:00am PDT
Room 2 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

03: Data-Tech, Workshop

Format Workshop
Level Intermediate
Featured Topics Regulatory Collaboration
Level Intermediate
Feature Topics Regulatory Collaboration
Credit Type ACPE, CME, RN
Tags Workshop

10:00am PDT

#223: Challenges in Exceeding the Quality of Existing Endpoints and Approaches Using Digital Tools

Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-574-L04-P; CME 1.00; RN 1.00

This forum will discuss how novel technologies provide the means to measure new endpoints and can assess existing endpoints in new ways. Regulatory models are needed to encourage the acceptance of these novel approaches.

Learning Objectives

Identify a clear understanding of regulatory frameworks surrounding digital endpoints; Describe the challenges that may arise when a new tool can measure endpoints more effectively than existing tools; Discuss how to build regulator confidence in novel endpoints and tools.

Chair

Rob Berlin, JD, MPH

Speaker

FDA Perspective
Jeffrey Nahum Siegel, DrMed, MD

Industry Perspective
Julie Tai, PhD

Industry Perspective
Lauren Oliva, PharmD, RPh

Industry Perspective
Rasika Kalamegham, PhD

Speakers

Rob Berlin

Head, US Regulatory Policy, GlaxoSmithKline, United States

Rob Berlin is Head of U.S. Regulatory Policy at GlaxoSmithKline (GSK). Rob leads a team focused on driving U.S. regulatory policy, advocacy, and intelligence activities, to ensure optimal advancement and lifecycle management of GSK’s product portfolio. Rob came to GSK from the FDA... Read More →

Rasika Kalamegham

Head, US Regulatory Policy, Genentech, A Member of the Roche Group, United States

Rasika Kalamegham, Ph.D, is Head of U.S. Regulatory Policy at Genentech. She oversees all FDA related policy work related to the pipeline and serves as the principal representative to Congressional and advocacy relations for regulatory policy. She plays an active role in many trade... Read More →

Lauren Oliva

US Lead, Global Regulatory Policy, Biogen, United States

Lauren Oliva is US lead for Global Regulatory Policy at Biogen. She oversees the development and execution of R&D’s policy roadmap to advance Biogen’s neuroscience and rare disease portfolio. She is passionate about patient centric drug development and the impact of multi-stakeholder... Read More →

Jeffrey Siegel

Director, Office of Drug Evaluation Sciences, OND, CDER, FDA, United States

Jeffrey Siegel is the Director of the Office of Drug Evaluation Sciences (ODES) in the Office of New Drugs (OND), CDER, FDA. ODES oversees Clinical Outcome Assessments, Biomarker Qualification, Research and Bioinformatics in OND. Dr Siegel has over 20 years of experience in research... Read More →

Julie Tai

Director, GRA, Precision Medicine and Digital Health, GlaxoSmithKline, United States

Tuesday June 18, 2024 10:00am - 11:00am PDT
Room 6B San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

03: Data-Tech, Forum

Format Forum
Level Intermediate
Featured Topics Digital Technology
Level Intermediate
Feature Topics Digital Technology
Credit Type ACPE, CME, RN
Tags Forum

10:00am PDT

#224: Data Standards SOS: Reducing Burnout and Navigating through Fatigue - Part 2

Component Type: Workshop
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-575-L04-P; CME 1.00; RN 1.00

At the DIA 2023 a round table on data standards and harmonization discussed “standards fatigue” related to data standards, reference models, consortia, industry groups, and their impact on the industry. We intend to address this topic in a two-part workshop.

Learning Objectives

Identify various data standards and harmonization efforts across pharma and biotech industries; Discuss challenges and business impact related to the understanding, implementation, and maintenance of data standards initiatives in light of digital transformation efforts; Describe approaches to identify overlapping/competing initiatives and develop synergistic approaches to reduce fatigue.

Chair

Venkatraman Balasubramanian, PhD, MBA

Speaker

Facilitator
Sridevi Nagarajan, PhD

Facilitator
Heiner Oberkampf, PhD

Facilitator
Vanni Carapetian, MPH

Facilitator
Hilmar Hamann, PhD

Facilitator
Norman Schmuff, PhD

Facilitator
Cesar Vinces

Speakers

Venkatraman Balasubramanian

SVP and Global Head, Industry Solutions - Healthcare and Life Sciences, Orion Innovation, United States

Vanni Carapetian

Director, Regulatory Data, Genentech, A Member of the Roche Group, United States

Hilmar Hamann

Head of Information Management, European Medicines Agency, Netherlands

Sridevi Nagarajan

Head, Digital Regulatory Strategy, AstraZeneca , United Kingdom

Heiner Oberkampf

CEO, ACCURIDS, Germany

Norman Schmuff

Associate Director for Science, OPMA, OPQ, FDA, United States

Cesar Vinces

EU Interim and International Policy Lead, Accumulus Synergy, United States

Tuesday June 18, 2024 10:00am - 11:00am PDT
Room 2 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

03: Data-Tech, Workshop

Format Workshop
Level Intermediate
Featured Topics Regulatory Collaboration
Level Intermediate
Feature Topics Regulatory Collaboration
Credit Type ACPE, CME, RN
Tags Workshop

1:15pm PDT

#247: Bridging Randomized Clinical Trials and Real-World Data Utilizing Data Linkage and Tokenization

Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-585-L04-P; CME 1.00; RN 1.00

Data linkage is a methodology to capture data from patients before, during, and after a clinical trial. The panel will discuss the challenges of conducting randomized clinical trials (RCTs) linked with real-world data (RWD), and will emphasize the data linkage methodologies and current needs.

Learning Objectives

Describe the methodology of data linkage, a relatively new method to collect individual patient data before, during, and after a clinical trial outside the randomized clinical trial (RCT) setting; Discuss challenges for different stakeholders involved in utilization of real-world evidence (RWE) and more specifically data linkage, including industry, regulators, and payers/HTA.

Chair

Aaron Kamauu, MD, MPH, MS

Speaker

Panelist
Francesco Pignatti, MD

Panelist
Kajsa Kvist

Panelist
Brian Bradbury, DrSc, MA

Panelist
Akshay Vashist

Speakers

Brian Bradbury

Vice President, Center for Observational Research, Amgen, United States

Brian D. Bradbury is Vice President and Head of the Center for Observational Research (CfOR) at Amgen, Inc. He leads a global team of epidemiologists, data scientists, programmers and operations professionals who generate real-world evidence (RWE) to support the development and continuous... Read More →

Aaron Kamauu

CEO, Navidence LLC, United States

Dr. Aaron Kamauu (MD, MS Biomedical Informatics, MPH, University of Utah School of Medicine) is the CEO at Navidence. He is a physician entrepreneur and an industry-leading advisor in the Real-World Data (RWD) space, specifically focusing on leveraging real-world healthcare data to... Read More →

Kajsa Kvist

Scientific Vice President, Novo Nordisk, Denmark

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 →

Akshay Vashist

Exec Dir, Otsuka Pharmaceutical Development & Commercialization, United States

Tuesday June 18, 2024 1:15pm - 2:15pm PDT
Room 14AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

03: Data-Tech, Forum

Format Forum
Level Intermediate
Featured Topics Real-World Data (RWD)- Real-World Evidence (RWE)
Level Intermediate
Feature Topics Real-World Data (RWD)- Real-World Evidence (RWE)
Credit Type ACPE, CME, RN
Tags Forum

1:15pm PDT

#248: The Evolving Role of Artificial Intelligence in the Medicinal Product Lifecycle

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-586-L04-P; CME 1.00; RN 1.00

This session will provide perspectives from stakeholders on successes and limitations from practical examples and discuss principles and best practices for maximizing the potential while managing the risks moving forward.

Learning Objectives

Describe the current state of the use of artificial intelligence (AI) in the medicinal product lifecycle including its opportunities and challenges; Discuss principles and best practices to maximize potential of AI while managing risks.

Chair

Hilmar Hamann, PhD

Speaker

EMA Update
Lorenzo De Angelis, PhD

Industry Update
Carlyn Crisostomo, MBA

Industry Update
Alexandra (Zan) Cha, PhD, MA

Industry Update
Timothe Menard, PharmD, MSc

Speakers

Lorenzo De Angelis

Platform Architect, European Medicines Agency, Netherlands

Lorenzo De Angelis studied Physics in Sapienza University of Rome, where he graduated cum laude in July 2014. He then moved to the Netherlands, where he obtained his physics PhD in December 2018, with a thesis entitled "The Singular Optics of Random Light". Afterwards, he joined the... Read More →

Alexandra (Zan) Cha

Principal, Chief Technology Office, Booz Allen Hamilton, United States

Zan brings 20+ years of experience in health AI / analytics, and IT /product / ops management, applied to medical devices, pharmaceuticals, supply chain, clinical trials, insurance tech, chronic disease management, and population health & wellness. She is currently focused on advancing... Read More →

Carlyn Crisostomo

Vice President, Head of R&D AI Strategy and Execution (RAISE), Amgen, United States

Hilmar Hamann

Head of Information Management, European Medicines Agency, Netherlands

Timothe Menard

Global Head, Quality Excellence Digital | Bioethics Coach (Data Ethics), F. Hoffmann-La Roche Ltd, Switzerland

Started in drug safety at Merck KGaA, joined Roche as a GCP/PV auditor. Transitioned to analytics; now heads Quality Excellence Digital. Focuses on digital & analytics for core quality deliverables. Co-founded the Inter coMPany quALity Analytics consortium to drive data/quality policy... Read More →

Tuesday June 18, 2024 1:15pm - 2:15pm PDT
Room 6F San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

03: Data-Tech, Session | 09: Regulatory, Session

Format Session
Level Intermediate
Featured Topics Artificial Intelligence (AI), Regulator Perspectives
Level Intermediate
Feature Topics Artificial Intelligence (AI),Regulator Perspectives
Credit Type ACPE, CME, RN
Tags Session

3:15pm PDT

#266: Exploiting Real-World Data From Social Media in Patient-Focused Drug Development

Component Type: Session
Level: Basic
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-692-L04-P; CME 1.00; RN 1.00

Social media is an important new source of real-world data (RWD) for patient-focused drug development. This session will present a review of considerations from an industry and regulators perspectives when listening to social media from patients.

Learning Objectives

Summarize the work done by group of experts from companies’ members; Discuss the challenges and opportunities of exploiting real-world data (RWD) from social media listening for R&D purposes and regulatory submissions; Propose best practices.

Chair

Thierry H Escudier, MSc

Speaker

Industry Update
Sarah Lyons

Academic Update
Philipp Cimiano, PhD

Industry Update
Vishakha Sharma, PhD

Speakers

Philipp Cimiano

Head of Semantic Computing Group, Director, Joint AI Center, Bielefeld University, Germany

Philipp is an expert in Artificial Intelligence and Natural Language Processing. He graduated in computer science and obtained his PhD and habilitation from KIT. Since 2009, he is full professor for computer science at Bielefeld University. He leads the Semantic Computing group and... Read More →

Thierry Escudier

Chairman, Strategic Consulting, DCRIPT, France

Leader in Clinical Research, with more than 30 year’s experience in Corporate R&D pharma organizations , Thierry has been promoting patient engagement strategy across the Industry. Thierry is now acting as an independent consultant providing strategic consulting and is very much... Read More →

Sarah Lyons

Vice President, Data Transformation and AI Platforms, DTA and AI, IQVIA, Canada

Sarah Lyons is a Vice President responsible for IQVIA’s Data Transformation & AI Platforms serving healthcare and life science organizations globally with capabilities spanning privacy-enhancing technologies, natural language processing, and AI-enabled language solutions. In addition... Read More →

Vishakha Sharma

Senior Principal Data Scientist, Roche, United States

Vishakha Sharma, senior principal data scientist at Roche Diagnostics Information Solutions, leads NLP and ML initiatives, improving navify product portfolio for enhanced patient care. Vishakha has authored over 50 peer-reviewed publications and given 20+ invited talks. She serves... Read More →

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

03: Data-Tech, Session

Level Basic
Featured Topics Real-World Data (RWD)- Real-World Evidence (RWE)
Level Basic
Feature Topics Real-World Data (RWD)- Real-World Evidence (RWE)
Credit Type ACPE, CME, RN
Tags Session

3:15pm PDT

#270: Something Borrowed Something New for Effective Project Management: Adopting Different Thinking Approaches and New Technologies in Life Science Project Management

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Application UAN: 0286-0000-24-602-L04-P; CME 1.00; PDU 1.00 PMI 2166XALVLX; RN 1.00

Many project management methodologies, alternative thinking approach and new technologies can be applied to life science project management and bring many benefits. In this session, the adoption of Design Thinking and Generative AI, two of the emerging topics in health care industry, into life science project management will be discussed. The session will also demonstrate, with case studies, the possibilities of implementing new thinking approach for effective project management, team leading and efficient business process development. We will also examine practical applications of Generative AI in project management from optimizing scheduling, resource planning, and risk management. Reflecting on the current adoption efforts, this session provides a platform to explore possibilities to leverage new thinking and technologies to enhance life science project management.

Learning Objectives

Critique how many project management methodologies, thinking approaches, and new technologies can be applied to life science projects, and they may bring various benefits into the practice; Implement applicable methodologies and protocol new technologies in real-world practice.

Chair

Char Leung

Speaker

Industry Update
Rune Bergendorff, MSc

Speakers

Char Leung

Director, Development Program Management, Genmab, United States

Char Leung is a Director, Development Program Management at Genmab where she leads the operationalization of drug development strategies. Prior to Genmab, Char spent 9 years at Janssen R&D managing biologics discovery and development projects with increasing responsibilities. Char... Read More →

Rune Bergendorff

Partner, International Life Sciences, Implement Consulting Group, Denmark

Rune Bergendorff, Partner at Implement Consulting, boasts two decades of consultancy experience spanning Europe and the US. Educated in IT and business, his focus is centered on delivering sustainable digital transformations that drive business impact and value. Over the past 15 years... Read More →

Tuesday June 18, 2024 3:15pm - 4:15pm PDT
Room 8 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

03: Data-Tech, Session | 07: ProjectManagement-StrategicPlanning, Session

Format Session
Level Intermediate
Featured Topics Artificial Intelligence (AI)
Level Intermediate
Feature Topics Artificial Intelligence (AI)
Credit Type ACPE, CME, PMI, RN
Tags Session

3:15pm PDT

#267: Evolution of Electronic Product Information in LATAM: Challenges and Opportunities to Improve the Value of Healthcare

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-599-L04-P; CME 1.00; RN 1.00

This session provides a comprehensive overview of the status/evolution of the concept of electronic product information (ePI) in LATAM from multiple perspectives, including industry, international regulatory bodies, and various stakeholders involving patients and healthcare professionals (HCPs). It also reviews some of the relevant initiatives undertaken in Low to Medium income countries and their benefits and potential.

Learning Objectives

Identify the impact of electronic product information (ePI) hybrid pilots and regulatory framework evolution in LATAM countries; Discuss relevant initiatives undertaken in Low to medium income countries; Examine industry motivations and challenges in implementing ePI pilots; Describe the evolving landscape (efforts of HA's based on international standard for ePI, regulatory advancements made to ensure an optimal experience for patients/ HCPs, implications of these challenges on healthcare.

Chair

Leonardo Semprun Semprun, RPh

Speaker

Electonic Product Information Regulatory Evolution in Brazil
Nélio Cézar de Aquino, SR, MSc

Electronic Product Information in Low to Middle Income Countries
Rutendo Kuwana, RPh

Industry Outlook in Brazil: Exploring eLabeling Perspectives
Rosana M. Mastellaro, PharmD, RPh

Considerations for Implementation and Adoption of Digital Labels
Maria Cristina Mota Pina, MBA

Speakers

Leonardo Semprun

Global Regulatory Policy Lead-LatAm, MSD, Panama

Leonardo Semprún is currently Senior Director, Global Regulatory Policy at MSD. In this role, Leonardo is responsible to define and execute a regional regulatory policy plan that addresses current and future needs, while also advocating for and anticipating regulatory change with... Read More →

Nélio Cézar de Aquino

General Manager of Medicines, ANVISA, Brazil

Nélio Cézar de Aquino is the General Manager of Medicines at the Brazilian Health Regulatory Agency (Anvisa). He has held various positions at Anvisa, including General Manager of Information Technology, Ports, Airports, Borders, and Customs Warehouses, Public Quality Control Laboratories... Read More →

Rutendo Kuwana

Team Lead, Incidents and Substandard/Falsified Medical Products, World Health Organization (WHO), Switzerland

Rutendo is leading the Incidents and Substandard/Falsified (ISF) medical products team at the World Health Organization (WHO) since June 2021. The ISF team is part of the Regulation and Safety (REG) Unit of the Regulation and Prequalification (RPQ) department that is within the Access... Read More →

Rosana Mastellaro

Director, Technical Regulatory Affairs and Innovation, Sindusfarma, Brazil

Pharmacist, She is currently Director of Technical Regulatory Affairs and Inovation at Sindusfarma. She has worked for 17 years in the pharmaceutical industry. Specialist in Project Management. She acts in defense of the pharmaceutical industrial sector and coordinates regulatory... Read More →

Maria Cristina Mota Pina

Head, Regulatory Policy for Emerging Markets -Japan and Australia, AbbVie, United States

Cristina is currently Director at AbbVie where she coordinates regulatory policy and intelligence activities for the Emerging Markets. Cristina worked for Boehringer Ingelheim for 13 years in different roles including Quality, Validation and Regulatory Affairs. Cristina attended Universidad... Read More →

Tuesday June 18, 2024 3:15pm - 4:15pm PDT
Room 11AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

09: Regulatory, Session | 03: Data-Tech, Session

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

4:30pm PDT

#281: Harnessing Real-World Evidence in Regulatory Decision-Making: Update on DARWIN EU, Use of Real-World Evidence in New Applications in the EU

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-613-L04-P; CME 1.00; RN 1.00

A rapidly changing landscape has led to an increased use of real-world evidence (RWE) in regulatory decision making, as a complement to randomized clinical trials (RCTs), impacting how medicines are developed and assessed. The session will present where we are and discuss the exciting future ahead.

Learning Objectives

Describe how real-world data (RWD) is being leveraged to generate real-world evidence (RWE) in support of regulatory assessment and decision-making processes in Europe; Discuss the progress of DARWIN EU, and a high-level overview of the use of RWE in recent applications in EU and see how the generation of meaningful evidence can support safer and more effective treatments for patients.

Chair

Steffen Thirstrup, MD, PhD

Speaker

EMA Update
Sabine Haubenreisser, PhD, MSc

Industry Update
Laura T. Pizzi, PharmD, MPH

Patient Update
Dave deBronkart

Industry Update
Brian Bradbury, DrSc, MA

Speakers

Brian Bradbury

Vice President, Center for Observational Research, Amgen, United States

Dave deBronkart

Patient Advocate, E-Patient Dave, LLC, United States

"e-Patient Dave" deBronkart is a cancer survivor and former high tech marketer, a founding member of the HL7 FHIR Patient Empowerment Workgroup, the BMJ patient advisory panel, and the Society for Participatory Medicine. He was the Mayo Clinic’s 2015 Visiting Professor in Internal... Read More →

Sabine Haubenreisser

Principal Scientific Administrator, Stakeholders and Communication Division, European Medicines Agency, Netherlands

Sabine Haubenreisser is a pharmacologist with special interest in scientific cooperation and regulatory convergence to the benefit of public health, through engagement with external stakeholders, the European network of experts and international partners and regulators. She has held... Read More →

Laura Pizzi

Chief Science Officer, ISPOR, United States

Motiur Rahman

Senior Epidemiologist, Real World Evidence Analytics, OMP, CDER, FDA, United States

Motiur Rahman is a Senior Epidemiologist at Real-World Evidence (RWE) Analytics in the Office of Medical Policy, Center for Drug Evaluation and Research (CDER), US Food and Drug Administration (FDA). His responsibilities include developing guidance, improving internal Agency processes... Read More →

Steffen Thirstrup

Chief Medical Officer, European Medicines Agency, Netherlands

Steffen Thirstrup is a medical doctor and board certified specialist in clinical pharmacology and therapeutics. He holds a PhD in pharmacology and has a long background in clinical internal medicine. He is an adjunct professor at the Faculty of Health Sciences, University of Copenhagen... Read More →

Tuesday June 18, 2024 4:30pm - 5:30pm PDT
Room 6B San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

03: Data-Tech, Session

Format Session
Level Intermediate
Featured Topics Real-World Data (RWD)- Real-World Evidence (RWE), Regulator Perspectives
Level Intermediate
Feature Topics Real-World Data (RWD)- Real-World Evidence (RWE),Regulator Perspectives
Credit Type ACPE, CME, RN
Tags Session

4:30pm PDT

#279: Accelerating Innovation Through Design: Integrating Real-World Data into Clinical Trials

Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-611-L04-P; CME 1.00; RN 1.00

In this forum, speakers from regulatory, industry, and research organizations will discuss methodological considerations and evaluate various innovative use cases in different settings that integrate real-world data (RWD) in clinical designs.

Learning Objectives

Discuss global regulatory guidance, frameworks, and best practices for real-world data (RWD) in innovative hybrid study designs for regulatory purposes; Describe innovative approaches and statistical methods for integrating RWD and clinical trial data for clinical decision-making; Appraise use cases where RWD have been used in hybrid study designs to support clinical and regulatory development.

Chair

Rachele Hendricks-Sturrup, DrSc, MA, MSc

Speaker

Panelist
Mehmet Burcu, PhD, MS

Panelist
Christina Mack, PhD, MPH

Panelist
Catherine C. Lerro, PhD, MPH

Speakers

Rachele Hendricks-Sturrup

Research Director, Real-World Evidence, Duke-Robert J. Margolis, MD, Center for Health Policy, United States

Rachele Hendricks-Sturrup, DHSc, joins Duke-Margolis as the Research Director leading the Center’s Real-World Evidence (RWE) portfolio, including managing its RWE Collaborative. She is a scientist/researcher, health policy and industry professional, journalist, and academician within... Read More →

Mehmet Burcu

Senior Director, Epidemiology, Merck & Co., Inc., United States

Dr. Mehmet Burcu is a Senior Director in the Department of Epidemiology at Merck & Co., Inc., Rahway, NJ, United States. He currently leads a team of epidemiologists to support clinical development and regulatory decision making in Oncology. He has expertise in large, automated database... Read More →

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 →

Christina Mack

Chief Scientific Officer, Real-World Solutions, IQVIA, United States

Christina Mack is Chief Scientific Officer of IQVIA real world solutions. An epidemiologist and engineer by training, she is responsible for driving scientific and technical innovation that directly impacts patient health. Recognized as a 2023 PharmaVoice100 Honoree, she’s committed... Read More →

Tuesday June 18, 2024 4:30pm - 5:30pm PDT
Room 6F San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

05: Patient-Focused Drug Dev, Forum | 03: Data-Tech, Forum | 11: Statistics-Data Science, Forum | 02: ClinTrials -ClinOps, Forum

Format Session
Level Intermediate
Featured Topics Real-World Data (RWD)- Real-World Evidence (RWE)
Level Intermediate
Feature Topics Real-World Data (RWD)- Real-World Evidence (RWE)
Credit Type ACPE, CME, RN
Tags Forum

8:00am PDT

#303: How Common Data Models Can Address the Challenges in the Use of Clinical Trial and Real-World Data for Evidence Generation

Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-624-L04-P; CME 1.00; RN 1.00

This panel will discuss different types of data models that exist and their strengths and weaknesses in relation to real-world data (RWD) and interoperability.

Learning Objectives

Recognize the different types of data models that exist and their strengths and weaknesses in relation to real-world data (RWD) and interoperability; Discuss the appropriate data models for primary and secondary data and how clinical data managers can potentially help RWD and trial data to meet the evidentiary requirements for regulatory decision-making.

Chair

Jesper Kjær, MS

Speaker

Panelist
Davera Gabriel, RN

Panelist
Jonathan Stuart Chainey

Panelist
Stacy Tegan

Speakers

Jonathan Chainey

Executive Director, Global Head, Data Standards and Governance, Data Sciences, Roche, United States

Jonathan Chainey is an Executive Director and Global Head, Data Standards and Governance within Data Sciences, Product Development at Roche. He leads a global team accountable for the cross-functional governance and adoption of Roche’s CDISC-aligned global data standards across... Read More →

Davera Gabriel

Director of Client Success, Evidentli USA LLC, United States

Davera Gabriel, RN FHL7 FAMIA is the Director of Client Success at Evidentli USA. Widely recognized as one of the world's leaders in accelerating the evolution of healthcare data standards in translational research. She has lead data alignment efforts in groundbreaking, multi-site... Read More →

Jesper Kjaer

Global Director for Public, Private Partnerships, Strat Ops, Global Med Affairs, Novo Nordisk, Denmark

Global Director for Public, Private Partnerships at Novo Nordisk, Global Medical Affaris. Former Director of Data Analytics Centre at the Danish Medicines Agency and co-chair of HMA / EMA Big Data Steering Group. 20 years for life science experience in academia and industry. Been... Read More →

Stacy Tegan

Program Director, Transcelerate Biopharma, Inc., United States

Stacy Tegan is a Program Director at TransCelerate Biopharma, Inc., a non-profit organization with a mission to collaborate across the biopharmaceutical R&D community. In her current role she oversees projects to enable information sharing and harmonization across the clinical development... Read More →

Wednesday June 19, 2024 8:00am - 9:00am PDT
Room 6D San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

03: Data-Tech, Forum

Format Forum
Level Intermediate
Featured Topics Real-World Data (RWD)- Real-World Evidence (RWE)
Level Intermediate
Feature Topics Real-World Data (RWD)- Real-World Evidence (RWE)
Credit Type ACPE, CME, RN
Tags Forum

8:00am PDT

#304: Synergizing Large Language Models and Digital Health Technology for Healthcare Transformation

Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-625-L04-P; CME 1.00; RN 1.00

This discussion will dive into large language models (LLMs) impact on healthcare, their integration with digital health technology, and ethical/regulatory implications.

Learning Objectives

Describe how digital health technologies (DHTs) and generative artificial intelliegence (AI), including large language models (LLMs) are applied to healthcare context; Examine the various integration points between LLMs and DHT and discover how these technologies can work synergistically to revolutionize patient care, telemedicine, remote, and disease progression.

Chair

Jagdeep Podichetty, PhD, MS

Speaker

Panelist
Qi Liu, PhD

Panelist
Jie Shen, PhD, MBA

Panelist
Sakshi Sardar, PhD

Panelist
Emily Lewis, MS

Speakers

Jagdeep Podichetty

Senior Director of Predictive Analytics, Critical Path Institute, United States

Dr. Jagdeep Podichetty is the Senior Director of Predictive Analytics in the Quantitative Medicine Program at the Critical Path Institute, where he is developing quantitative solutions such as disease progression models, survival models, clinical trial simulation, and artificial intelligence... Read More →

Emily Lewis

Artificial Intelligence and Innovation Lead, Neurology, UCB, United States

Emily Lewis is a trailblazing innovator and leader in the realm of digital health and AI. With nearly two decades of experience, she has made significant contributions to the development and adoption of cutting-edge digital health solutions. Her passion for using technology to improve... Read More →

Qi Liu

Assoc Director for Innovation and Partnerships, OCP, OTS, CDER, FDA, United States

Dr. Qi Liu is the Associate Director for Innovation & Partnership in the Office of Clinical Pharmacology (OCP)/ Office of Translational Sciences, CDER, FDA. She has helped developing OCP’s portfolio on AI, real world evidence and digital health technologies. Qi leads OCP Innovative... Read More →

Sakshi Sardar

Senior Director, Digital and Precision Medicine, Critical Path Institute, United States

Sakshi Sardar is a Senior Director for Digital and Precision Medicine within Quantitative Medicine at the Critical Path Institute. Her focus is on driving the development of essential components for utilizing digital health technologies (DHTs) to meet evidentiary requirements for... Read More →

Jie Shen

Director, Digital Science, AbbVie, United States

Jie Shen is a data science leader with a track record of building innovative solutions for drug discovery and development. Currently he is a Director of Digital Science at AbbVie, leading the digital health technology development, validation, and data analytics. Prior to his current... Read More →

Wednesday June 19, 2024 8:00am - 9:00am PDT
Room 6E San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

03: Data-Tech, Forum

Format Forum
Level Intermediate
Featured Topics Artificial Intelligence (AI), Digital Technology
Level Intermediate
Feature Topics Artificial Intelligence (AI),Digital Technology
Credit Type ACPE, CME, RN
Tags Forum

10:00am PDT

#319: Unlocking the Potential of IDMP for Global Exchange of Medicinal Products Data

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-637-L04-P; CME 1.00; RN 1.00

This session will discuss how the ISO IDMP standards have a pivotal role in enhancing global pharmacovigilance and improving visibility in the product supply chain. The collaborative efforts of the Global IDMP Working Group reflect the need to advance this critical endeavor.

Learning Objectives

Define IDMP standards and explain their benefits when globally implemented; Describe the role of the unique global IDMP identifiers in data exchange of medicinal product information; Discuss the impact of global IDMP identifiers on different use cases in the medicinal product life cycle, for example, pharmacovigilance and drug shortages, supply chain integrity.

Chair

Malin Kristina Fladvad, PhD, MSc

Speaker

Unlocking the Potential of IDMP: Global Use Cases
Ron Fitzmartin, PhD, MBA

Unlocking the Potential of IDMP for Global Exchange of Medicinal Products Data
Hilmar Hamann, PhD

Speakers

Malin Fladvad

Portfolio Officer, Uppsala Monitoring Centre, Sweden

Malin Fladvad is a Portfolio officer at Uppsala Monitoring Centre (UMC). In this position she is responsible for the WHODrug Product Portfolio which dictionaries and applications are used in clinical trials and safety monitoring worldwide. Malin is also engaged in various efforts... Read More →

Ron Fitzmartin

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

Hilmar Hamann

Head of Information Management, European Medicines Agency, Netherlands

Wednesday June 19, 2024 10:00am - 11:00am PDT
Room 5AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

01: ClinSafety-PV, Session | 03: Data-Tech, Session

Format Forum
Level Intermediate
Level Intermediate
Credit Type ACPE, CME, RN
Tags Session

11:00am PDT

#329 RT: Roundtable Discussion: The Evolving Role of Artificial Intelligence in the Medicinal Product Lifecycle

Component Type: Session

Join the Regulatory Affairs Community for a follow up round table discussion tied to session: The Evolving Role of Artificial Intelligence in the Medicinal Product Lifecycle (Tuesday, June 18 | 1:15PM - 2:15 PM PDT). Space is limited.

Chair

Brooke Casselberry, MS, RAC

Speakers

Brooke Casselberry

Vice President, Advisory and Delivery, Epista Life Sciences, United States

Wednesday June 19, 2024 11:00am - 12:00pm PDT
Ballroom 20 A/ Zone 1 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

16: Community Rounds, Session | 03: Data-Tech, Session | 09: Regulatory, Session

Tags Session

1:15pm PDT

#348: Challenges and Solutions to Building the Right Patient-Centered Evidence to Support Fit-For-Purpose Sensor-Based Outcomes

Component Type: Workshop
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-651-L04-P; CME 1.00; RN 1.00

Challenge areas for developing patient-centered sensor-based outcomes (SBOs) will be identified, along with solutions and key considerations using real-world examples of SBO development.

Learning Objectives

Describe key challenges to leveraging the patient-focused drug development (PFDD) guidance series to develop fit-for-purpose, patient-centered sensor-based outcomes (SBOs, eg, wearables) to support medical product development and decision making; Identify potential solutions to inform development of fit-for-purpose, patient-centered SBOs.

Chair

Katelyn R Keyloun, PharmD, MS

Speaker

Sensor-Based Outcome Measure Development: Challenge Areas for Concept Elicitation and Interpretation of Endpoints
Bill Byrom, PhD

FDA Update
Michelle Campbell, PhD

EMA Update
Steffen Thirstrup, MD, PhD

Speakers

Katelyn Keyloun

Director, R&D Digital and Data Strategy, AbbVie, United States

Kate has spent the last 10 years in the HEOR space, supporting evidence generation and the intersection of Patient Centered Outcomes Research and Digital Health. She started her career researching a cure for malaria, which fostered her strong desire to study medicine and gain a 360... Read More →

Bill Byrom

Vice President, Product Intelligence and Positioning; Principal, eCOA Science, Signant Health , United Kingdom

Bill is an eCOA scientist and VP of product intelligence and positioning at Signant Health. He has worked in the Pharmaceutical industry for over 30 years and is the author of over 70 publications and two industry textbooks on ePRO. His recent scientific work includes the use of wearable... 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 →

Steffen Thirstrup

Chief Medical Officer, European Medicines Agency, Netherlands

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

05: Patient-Focused Drug Dev, Workshop | 03: Data-Tech, Workshop

Format Workshop
Level Intermediate
Featured Topics Patient Focused
Level Intermediate
Feature Topics Patient Focused
Credit Type ACPE, CME, RN
Tags Workshop

1:15pm PDT

#347: Artificial Intelligence in the Drug Development Lifecycle: Opportunities and Challenges in Regulatory Operations

Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-650-L04-P; CME 1.00; RN 1.00

This panel will discuss opportunities and challenges of leveraging artificial intelligence (AI) in the drug development lifecycle, especially in regulatory operations. The panel will include representation from regulatory, and industry.

Learning Objectives

Identify the impact of artificial intelligence (AI) in the drug development lifecycle from health authorities' and, industry's perspectives; Recognize opportunities for the regulators and industry to leverage rapid advancement of AI to the drug development lifecycle; Discuss challenges to implement changes from policy, technology, standard, data security in regulatory operations.

Chair

Ethan Chen, MBA, MS, PMP

Speaker

The Evolving Role of Artificial Intelligence in the Medicinal Product Lifecycle
Hilmar Hamann, PhD

Panelist
Tala Fakhouri, PhD, MPH

Panelist
Nicole Mahoney, PhD

Speakers

Ethan Chen

Director, Division of Data Management Services and Solutions, OBI, OSP, CDER, FDA, United States

Ethan Chen provides overall leadership to CDER in streamlining electronic and traditional submissions and delivering solutions to enable rapid adoption of emerging electronic data standards. Since joining the FDA in 2012, Mr. Chen has led several critical initiatives as the CDER Informatics... Read More →

Tala Fakhouri

Associate Director for Policy Analysis, Office of Medical Policy, CDER, FDA, United States

Hilmar Hamann

Head of Information Management, European Medicines Agency, Netherlands

Nicole Mahoney

Executive Director US Regulatory Policy & Intelligence, Novartis Pharmaceuticals Corporation, United States

Nicole Mahoney is an Executive Director for Regulatory Policy at Novartis, and global regulatory policy lead for data and digital technologies, including real-world evidence and artificial intelligence. Prior to Novartis, she led Regulatory Policy at Flatiron Health, helping support... Read More →

Wednesday June 19, 2024 1:15pm - 2:15pm PDT
Room 6B San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

09: Regulatory, Forum | 03: Data-Tech, Forum

Format Forum
Level Intermediate
Featured Topics Artificial Intelligence (AI), Regulator Perspectives
Level Intermediate
Feature Topics Artificial Intelligence (AI),Regulator Perspectives
Credit Type ACPE, CME, RN
Tags Forum

2:15pm PDT

#357 RT: Roundtable Discussion: Leveraging Cloud-Based Technologies to Accelerate Reliance and Convergence - An Industry and Regulatory Agency Experience

Component Type: Session

Join the Digital Acceleration Community for a follow up round table discussion tied to session: Leveraging Cloud-Based Technologies to Accelerate Reliance and Convergence - An Industry and Regulatory Agency Experience (Wednesday, June 19 | 10:00AM - 11:00AM PDT). Space is limited.

Chair

Cesar Vinces

Speakers

Cesar Vinces

EU Interim and International Policy Lead, Accumulus Synergy, United States

Wednesday June 19, 2024 2:15pm - 3:15pm PDT
Ballroom 20 BC/ Zone 2 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

16: Community Rounds, Session | 09: Regulatory, Session | 03: Data-Tech, Session

Tags Session

3:15pm PDT

#362: Streamlining Processes and Data Exchange Across R&D Functions to Improve Performance and Facilitate Automation

Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-662-L04-P; CME 1.00; RN 1.00

In this interactive forum, panelists share how they are working across R&D to improve processes and data flows, govern their data, move toward more data-driven processes, and facilitate the use of artificial intelligence (AI) and advanced technologies.

Learning Objectives

Identify how sponsor companies are optimizing their business processes and getting more value from their data across R&D; Discuss approaches for process optimization, data governance and standardization; Describe ways to move towards data-driven business processes and how to enable greater automation and business efficiency across product development.

Chair

Cary Smithson, MBA

Speaker

Panelist
Linda Chong, MBA

Panelist
Rayna Venook, PhD

Speakers

Cary Smithson

Senior Director, Business Transformation & Systems Management, Cencora Pharmalex, United States

Cary Smithson is the Senior Director, Business Transformation and Systems Management at PharmaLex and has over 30 years of experience helping life science Regulatory, Clinical and Quality organizations drive increased productivity, streamline information management and enhance regulatory... Read More →

Linda Chong

Director, Regulatory Information Management, Daiichi Sankyo, United States

Linda Chong has overall 20 years of experience within the Pharmaceutical industry specifically Regulatory Information Management, Global Submission Management, and Data Governance including organization change management. She is currently the Director of Regulatory Information Management... Read More →

Rayna Venook

Team Lead, Pharma Development Regulatory, Genentech, A Member of the Roche Group, United States

Rayna Venook is a Team Lead within the Regulatory Information Management organization at Roche. In this capacity, she focuses on facilitating the development and delivery of solutions to enhance data interoperability to enable integrated solutions across Roche. She has 17 years of... Read More →

Wednesday June 19, 2024 3:15pm - 4:15pm PDT
Room 11AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

03: Data-Tech, Forum

Format Forum
Level Intermediate
Featured Topics Artificial Intelligence (AI)
Level Intermediate
Feature Topics Artificial Intelligence (AI)
Credit Type ACPE, CME, RN
Tags Forum

3:15pm PDT

#360: More than Meets the Eye: AI’s Potential to Identify Skin Manifestations of Internal Disease in Patients of Color

Component Type: Session
Level: Basic
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-660-L04-P; CME 1.00; RN 1.00

Unlocking AI's potential to facilitate diversity in clinical trials demands inclusive images capturing skin manifestations of internal diseases across races and ethnicities. Join our panel to learn more about inclusive innovation in AI solutions.

Learning Objectives

Discuss the importance of photographs and images in AI algorithms to identify internal diseases impacting patients of color and how that supports clinical trial enrollment; Identify the questions to ask of AI solution providers to ensure imagery is inclusive; Describe what’s being done to improve imagery in AI learning to drive clinical trial diversity.

Chair

Pamela Simpkins, MBA

Speaker

Patient Update
Tricha Shivas, MS

Industry Update
Lionel Phillips, MBA

Industry Update
Brian H Johnson

Speakers

Pamela Simpkins

Managing Partner, Mezzopointe. LLC, United States

Biopharma R&D executive with 26+ years in the industry and nearly a decade as an institutional investor. Expert in R&D Finance with a proven track record in accelerating development of key pipeline assets to achieve regulatory approval and market authorization. Built, led and sold... Read More →

Brian Johnson

Vice President, R&D Technology, Takeda, United States

Lionel Phillips

President, Inside Edge Consulting, United States

Tricha Shivas

Chief of Staff and Strategy, Foundation For Sarcoidosis Research, United States

Tricha Shivas joined the Foundation for Sarcoidosis Research (FSR) in December of 2020. As the Chief of Staff and Strategy, she works with various stakeholders including individuals living with sarcoidosis. Through her career she has built strong stakeholder relations, created comprehensive... Read More →

Wednesday June 19, 2024 3:15pm - 4:15pm PDT
Room 6B San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

03: Data-Tech, Session | 11: Statistics-Data Science, Session | 02: ClinTrials -ClinOps, Session

Format Session
Level Basic
Featured Topics Artificial Intelligence (AI), Decentralized Clinical Trials (DCTs)
Level Basic
Feature Topics Artificial Intelligence (AI),Decentralized Clinical Trials (DCTs)
Credit Type ACPE, CME, RN
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3:15pm PDT

#361: Recruitment Optimization in Clinical Trials: Looking Towards an Adaptive Future

Component Type: Session
Level: Basic
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-661-L04-P; CME 1.00; RN 1.00

Recruitment is a significant building block of clinical trials and also one of the greatest challenges, often having a direct influence on trial success or failure. In-efficiencies associated with patient recruitment may lead to prolonged trial durations, increased costs, and delays in bringing effective treatments to market. This session will explore methods for predicting the effect of different recruitment patterns on trial progression, outcomes and likelihood of the trial to meet its goals and present newly available technologies and trial design measures for successfully advancing recruitment.

Learning Objectives

Describe the considerations of recruitment rate optimization in clinical trials and adaptive trials in particular; Discuss the available technologies and methodologies for optimizing recruitment via dedicated software, patient advocacies, databases and registries and the evaluation of trade-offs between trial duration and sample size requirements within a variety of adaptive trial designs as compared with standard fixed designs.

Chair

Raviv Pryluk, PhD

Speaker

Time is Life: Leveraging Innovation in Clinical Trials for Rapid Recruitment
Tanya Russell, PhD, MS, RPh

Potential for Leveraging AI/ML in Pre-Trial Recruitment Modelling
Jenny Higley, MS

Demystifying Site Engagement: Leveraging an Omnichannel Approach with Data-Driven Clinical Analytics
Sanghita Bhattacharya, PhD

Optimizing Clinical Trial Site Selection: Balancing Recruitment Efficiency and Population Diversity
Raviv Pryluk, PhD

Speakers

Raviv Pryluk

PhaseV, United States

Raviv is the co-founder & CEO of PhaseV, a technology company that leverages causal-ML and advanced software capabilities to support advanced & innovative clinical trials. Raviv holds a B.Sc. and M.Sc. in engineering from the Technion (Cum Laude) and Ph.D. in computational neuroscience... Read More →

Sanghita Bhattacharya

Associate Director Data Science , Feasibility and Analytics, Clinical Operations, Johnson & Johnson Innovative Medicine, United States

Sanghita leads the DS strategy and Pathway for clinical trial feasibility for Cardiovascular Metabolism and Pulmonary Hypertension Therapeutic Areas in Janssen R&D Data Science. Sanghita has been within the healthcare sector for 14 years, with experience in both MedTech as well as... Read More →

Jenny Higley

Director, Head of Feasibility CoE, Biogen, United States

Jenny has 20 years of clinical research experience and is currently the Director of the Feasibility Center of Excellence at Biogen, where she has worked for the past four years. Jenny’s career also includes CRO and ARO experience from IQVIA, Syneos Health, and the Duke Clinical... Read More →

Tanya Russell

Vice President, Integration Lead, Pfizer Inc, United States

Tanya Russell recently moved into a new role as Vice President, CD&O Integration Lead supporting the R&D integration of Seagen and Pfizer into one Pfizer Oncology department. For the last 3+ years, Tanya was Pfizer’s Oncology and Rare Disease Clinical Operations Head with accountability... Read More →

Wednesday June 19, 2024 3:15pm - 4:15pm PDT
Room 6D San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

11: Statistics-Data Science, Session | 03: Data-Tech, Session | 02: ClinTrials -ClinOps, Session

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

4:30pm PDT

#372: Leveraging Cloud-Based Technologies to Accelerate Reliance and Convergence: An Industry and Regulatory Agency Experience

Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-671-L04-P; CME 1.00; RN 1.00

This forum will discuss regulatory activities and technology to enable global convergence and reliance for post-approval changes (PAC). Diverse panelists will share examples of efficient collaboration and information exchange to reduce the PAC process cycle times.

Learning Objectives

Recognize the importance of global collaboration to support sovereign decision making; Discuss how building in reliance practices into cloud-based solutions could accelerate the post-approve changes (PAC) process globally; Explain how cloud solutions support transparency, trust, regulatory convergence, and information exchange, and collaboration to increase patient access to therapies.

Chair

Dominique Lagrave, PharmD

Speaker

Panelist
Samvel Azatyan, MD, PhD

Panelist
David Mukanga, PhD, MPH

Panelist
Susanne Ausborn, PhD

Panelist
Cynthia Ban

Speakers

Dominique Lagrave

Senior Vice President of Regulatory Innovation, Accumulus Synergy, United States

Dominique has over 25 years of International Regulatory Affairs experience with the last 20 years spent in Global Regulatory Operations leadership role. Past experiences include work at Galderma, Novo Nordisk, Liquent-Parexel and Dendreon. Dominique joined Accumulus as SVP of Regulatory... Read More →

Susanne Ausborn

Global Head International Regulatory Policy, Roche, Switzerland

Susanne Ausborn has more than 20 years of experience in technical regulatory affairs and regulatory policy, being currently Global Head International Regulatory Policy in Roche. M.Sci. in Analytical Chemistry and PhD in Biophysical Chemistry, Susanne is a strong advocate for global... Read More →

Samvel Azatyan

Team Lead, Regulatory Convergence and Networks (RCN/REG), World Health Organization (WHO), Switzerland

Dr Samvel Azatyan is a Paediatrician with a PhD in clinical pharmacology and medical products regulation. Over his more than 24 years at WHO, he has had a wide range of leadership roles associated with the regulation of medical products, including supporting regulatory collaboration... Read More →

Cynthia Ban

Global Head, Regulatory Affairs CMC, Vaccines, Sanofi, Canada

Cynthia Ban is the Global Head Regulatory CMC & Devices for Vaccines at Sanofi. Senior Global Leader in the pharmaceutical industry specializing in Regulatory Affairs. Worked for small biotech and large multinational companies. Led and developed teams across multiple geographies and... Read More →

David Mukanga

Deputy Director, Africa Regulatory Systems, Bill & Melinda Gates Foundation, United States

Dr. David Mukanga is Deputy Director Africa Regulatory Systems at the Bill & Melinda Gates Foundation, where he leads the foundation’s Africa regulatory systems optimization portfolio, and the linkage between regulatory systems and health care services. In this role, David supports... Read More →

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

03: Data-Tech, Forum

Format Forum
Level Intermediate
Featured Topics Digital Technology, Regulatory Collaboration, Regulatory Reliance
Level Intermediate
Feature Topics Digital Technology,Regulatory Collaboration,Regulatory Reliance
Credit Type ACPE, CME, RN
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8:00am PDT

#403: Achieving Diversity in Clinical Research Using Digital Health Technologies

Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Application UAN: 0286-0000-24-679-L04-P; CME 1.00; RN 1.00

This session will explore, from three complementary perspectives, how to improve diversity in clinical research by actively addressing accessibility, equity, and inclusion throughout the design and implementation of digital health technologies.

Learning Objectives

Summarize the current state and define industry goals related to diversity, equity, and inclusion (DEI) in clinical research; Outline the role of digital solutions in achieving these diversity, equity, and inclusion goals in clinical research; Apply core principles for digital design and implementation with case studies.

Chair

Lindsay Hughes, PhD, MS

Speaker

Panelist
Silas Buchanan

Speakers

Lindsay Hughes

Principal, Patient Experience Solutions and Patient Centered Solutions, IQVIA, United States

Dr. Hughes is a scientist and leader with nearly 20 years of experience in behavioral and life sciences, focusing particularly on the role of access to information in human behavior and health outcomes. She is a former advisor to national governments on stigma in healthcare and clinical... Read More →

Silas Buchanan

Chief Executive Officer, Institute for eHealth Equity, United States

Thursday June 20, 2024 8:00am - 9:00am PDT
Room 5AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

05: Patient-Focused Drug Dev, Forum | 03: Data-Tech, Forum

Format Forum
Level Intermediate
Featured Topics Digital Technology, Diversity Equity and Inclusion (DEI)
Level Intermediate
Feature Topics Digital Technology,Diversity Equity and Inclusion (DEI)
Credit Type ACPE, CME, RN
Tags Forum

9:15am PDT

#411: Generative AI-Driven Clinical Data Management: A Myth or a Reality?

Component Type: Session
Level: Advanced
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-686-L04-P; CME 1.00; RN 1.00

This session will discuss use of generative AI to transform clinical data operations across the clinical trials lifecycle across use cases such as integration, summarization, translation, content generation, and knowledge extraction. The use of generative AI will be discussed for applications such as smart data review and edit checks, workflow automation, and real-time data transformation.

Learning Objectives

Discuss the challenges associated with existing clinical data platforms; Identify specific uses cases where such challenges exist in study startup, study conduct, and study closeouts; Describe how generative AI will transform the clinical data platform to operate seamlessly driving faster patient recruitment and efficient site selection or trial conduct.

Chair

Lichen Shen

Speaker

Creating Production Grade (Gen)AI-Powered Software for Clinical Trials
Lichen Shen

Industry Update
Sharmin Nasrullah, MS

Speakers

Sharmin Nasrullah

General Manager, Life Sciences, Clinical, Salesforce, United States

Lichen Shen

Senior Director of Product R&D, Medidata, United States

Lichen imagines a world without diseases and monsters. He innovates in commercial tech, national defense intelligence, and life sciences industry. One of his current roles is co-leading the (Generative) AI Platform as a Service and the next generation clinical trial data platform... Read More →

Thursday June 20, 2024 9:15am - 10:15am PDT
Room 6D San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

03: Data-Tech, Session

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