DIA 2024 Global Annual Meeting: Full Schedule

7:00am PDT

DIA Annual Meeting Orientation

Component Type: Session

First time at the DIA Annual Meeting? We encourage you to attend the Annual Meeting Orientation to learn how to make the most of your time at the meeting and meet fellow first-timers.

Chair

Susan Benedetti

Speakers

Susan Benedetti

Senior Project Manager, Annual Meeting, DIA, United States

Monday June 17, 2024 7:00am - 8:00am PDT
Content Hub Sails Pav San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

17: Networking Opportunities, Session

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12:00pm PDT

#117 CH: Rare Diseases Multistakeholder Collaboration Towards Regulatory Endorsed Innovative Clinical Development Approach

Component Type: Workshop
Level: Intermediate

ERDERA focuses on accelerating rare diseases drug development by combining real-world data processing, Patient Centered Outcome measures integration, a streamlined gene editing and technology transfer platforms, and innovative clinical trials designs.

Learning Objectives

Identify innovative methodologies, technologies and tools for innovative therapy development; Prepare a collaboration with an innovative Rare Disease research Ecosystem and recall its funding opportunities.

Chair

Solange Corriol-Rohou, DrMed, MD, PhD

Speaker

Facilitator
Alexandre Betourne, PharmD, PhD

Speakers

Alexandre Betourne

Executive Director, Critical Path Institute, United States

Alexandre Bétourné, PhD, PharmD, is Executive Director for the Rare Disease Cures Accelerator-Data and Analytics Platform initiative. Dr. Bétourné holds both a PhD and a PharmD from the University of Toulouse in France. Before joining C-Path, he worked with a team of senior U.S... Read More →

Solange Corriol-Rohou

Senior Director, Global Regulatory Affairs & Policy, R&D, Europe, AstraZeneca , France

Pulmonologist and immuno-allergist by training, Solange joined AstraZeneca R&D in 2004 and is currently Sr. Global Policy Director, with responsibilities in the Respiratory/Infection, Oncology and Vaccine/Immune therapies franchises. Over the past 20 years, moving from the French... Read More →

Monday June 17, 2024 12:00pm - 12:30pm PDT
Content Hub Sails Pav San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

15: Content Hubs, Workshop | 02: ClinTrials -ClinOps, Workshop

Level Intermediate
Level Intermediate
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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
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1:30pm PDT

#126 CH: AI Enhanced Contact Center: Risks to Consider for Medical and Patient Information Exchange

Component Type: Workshop
Level: Basic

The use of AI is highly praised, but risks must be addressed to protect the public (patients) from unethical influence, incorrect information, and privacy breaches.

Learning Objectives

Discuss examples of AI use in Medical Information contact center; Describe the risks associated with AI use and its impact on the public (patients).

Chair

Valerie Huh, PharmD, MBA

Speakers

Valerie Huh

Associate Director, Global Innovation and Implementation, Propharma Group, United States

Valerie Huh brings over 20 years of expertise in the pharmaceutical, healthcare, and education sectors. She holds a Pharm.D and an MBA, and she is passionate about leveraging advanced technology and new ways of working to improve operational efficiency. In her current role, she is... Read More →

Monday June 17, 2024 1:30pm - 2:00pm PDT
Content Hub Sails Pav San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

04: MedAffairs-SciComm, Workshop | 15: Content Hubs, Workshop

Level Basic
Level Basic
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11:00am PDT

#231 CH: Quality in Focus: Diethylene and Ethylene Glycol Challenges

Component Type: Workshop
Level: Intermediate

Participants will delve into the US FDA's regulatory guidance, exploring the testing protocols for high-risk drug components and explore the essential requirements and recommended practices to ensure product safety and compliance.

Learning Objectives

Recognize key factors contributing to diethylene glycol (DEG) and ethylene glycol (EG) contamination; Examine the US FDA's regulatory guidance, delving into the testing procedures for high-risk drug components contaminated with DEG and EG; Explore requirements and recommended practices for manufacturers, repackagers, preparers, and distributors.

Chair

Chaitanya Koduri

Speakers

Chaitanya Koduri

Director, International Government and Regulatory Engagement, US Pharmacopeia, United States

Tuesday June 18, 2024 11:00am - 11:30am PDT
Content Hub Sails Pav San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

15: Content Hubs, Workshop | 09: Regulatory, Workshop

Level Intermediate
Level Intermediate
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12:30pm PDT

#241 CH: Practical (and Real) AI and Advanced Automation in New Product Planning and Clinical Development

Component Type: Workshop
Level: Basic

Realizing the value of AI and Advanced Automation tools is no longer hypothetical - real value is being created by the thoughtful application of these tools. We will explore pragmatic examples and opportunities within this working session.

Learning Objectives

Create a pragmatic approach for developing and implementing AI and Advanced Automation tools within their organizations; Describe how to develop a plan, implement and calculate and measure ROI for such tools.

Chair

Bryan Katz, MBA

Speakers

Bryan Katz

Chief Strategy Officer, Propharma Group, United States

Tuesday June 18, 2024 12:30pm - 1:00pm PDT
Content Hub Sails Pav San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

15: Content Hubs, Workshop | 02: ClinTrials -ClinOps, Workshop

Level Basic
Level Basic
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2:30pm PDT

#259.1 IS: Arnold Venture Innovation Session: Better Drug Information for Payers, Physicians, and Patients

Component Type: Session

Shared decision-making between patients and their healthcare providers about their treatments is important, and these complex decisions can be facilitated by presenting knowledge in an intuitive manner about the benefit/risk of various therapies based on the insights learned during the clinical investigation. This session will critically consider scientific issues related to communicating drug information advances expeditiously and safely.

Chair

Arnold Ventures

Speaker

Speaker
Rita F. Redberg, MD, MSc, FACC

Speaker
Steven Woloshin

Speakers

Rita Redberg

Director, Women's Cardiovascular Services; Professor of Medicine, UCSF Medical Center, United States

Dr. Redberg is a general Cardiologist and interested in preventive cardiology. Her research interests are in our use of medical procedures and devices. She studies the regulatory process for medical devices and the strength of evidence that supports them, particularly high-risk devices... Read More →

Steven Woloshin

Professor, Dartmouth Institute, United States

Dr. Steven Woloshin is co-director of the Center for Medicine and Media at The Dartmouth Institute and a general internist. He and Lisa Schwartz co-created the drug facts box, drug-benefit and harm-data summaries shown in clinical trials to improve consumer decision-making. The FDA's... Read More →

Arnold Ventures

United States

Tuesday June 18, 2024 2:30pm - 3:00pm PDT
Content Hub Sails Pav San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

17: Networking Opportunities, Session

Featured Topics Patient Focused
Feature Topics Patient Focused
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11:15am PDT

#331 CH: Emerging Standards for Novel Excipients

Component Type: Workshop
Level: Intermediate

Participants will delve into the challenges of applying novel excipients to pharmaceutical formulations and conducting safety assessment, while also gaining insights into the crucial regulatory requirements needed to ensure product compliance and safety.
Moreover, the rationale behind the development of emerging standards, their potential impact, and the ways in which they can contribute to elevating the standard of excellence with novel excipients will be presented. Attendees will also learn about emerging standard approaches that will help remove the current barriers to using novel excipients in new therapeutics/advanced formulations.

Learning Objectives

Explore challenges of using novel excipients in drug formulations; Gain insights into emerging standard approaches and possible pathways for novel excipients development.

Chair

Tong (Jenny) Liu, PhD

Speakers

Tong (Jenny) Liu

Principal Scientist, US Pharmacopeia, United States

Jenny holds a PhD in Chemistry from Boston University and has more than 20 years of experience in analytical method development and validation for pharmaceutical products. After postdoctoral research at Rutgers university (New Jersey) and work at AustarPharma and Catalent Pharma Solutions... Read More →

Wednesday June 19, 2024 11:15am - 11:45am PDT
Content Hub Sails Pav San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

15: Content Hubs, Workshop | 10: RegCMC-Product Quality, Workshop

Level Intermediate
Level Intermediate
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11:45am PDT

#332 CH: Informing Clinical Trials with Patient Feedback Through Simulations: An Innovative Methodology

Component Type: Workshop
Level: Intermediate

Clinical trial simulations are a valuable and insightful methodology in understanding the patient experience during a clinical trial. Discussion will focus on strategies in operationalizing clinical trial simulations to inform clinical trial design.

Learning Objectives

Discuss how to derive and operationalize insights from patients and caregivers from clinical trial simulations; Explain strategies on how insights can impact clinical trial design and operation.

Chair

Wesley D Peters, MS

Speakers

Wesley Peters

Research Specialist II, Patient Experience, Evidera/Thermo Fisher Scientific, United States

Wes Peters is a public health professional with over 7 years of experience in the Life Science industry. Wes received his Master of Science in Public Health (MSPH) from the Johns Hopkins Bloomberg School of Public Health with a focus in Health Education and Health Communication. Currently... Read More →

Wednesday June 19, 2024 11:45am - 12:15pm PDT
Content Hub Sails Pav San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

15: Content Hubs, Workshop | 05: Patient-Focused Drug Dev, Workshop

Level Intermediate
Level Intermediate
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12:30pm PDT

#333 CH: Real-World Evidence (RWE) for Regulatory and Health Technology Assessment (HTA) Decision Making – Where are we?

Component Type: Workshop
Level: Intermediate

While the use of Real-World Data (RWD) in the post-marketing surveillance setting has increased in recent years, RWD use for decision-making in the pre-licensing is currently the focus of all stakeholders through various initiatives, including at the global level.

Learning Objectives

Discuss the value and importance of various multi-stakeholder collaborations to agree what and how real-world data (RWD) can be collected in order to generate real-world evidence (RWE) to support and optimise drug development; Understand the initiatives and recommendations on the use of RWE to inform decisions by healthcare systems (HTA/payers and regulators).

Chair

Solange Corriol-Rohou, DrMed, MD, PhD

Speaker

Facilitator
David Sidney Ross, MBA, MSc, PMP, RAC

Speakers

Solange Corriol-Rohou

Senior Director, Global Regulatory Affairs & Policy, R&D, Europe, AstraZeneca , France

David Ross

Senior Director, Regulatory Data and Submissions, AstraZeneca, United States

David Ross has led enterprise projects at AstraZeneca and Abbott Labs. He implemented enterprise solutions at AZ for cross-functional CSR Initiative, led the PQ/CMC pilot for AZ, developed roles for Early Clinical Authoring and leads Clinical Study Start up improvements in alignment... Read More →

Wednesday June 19, 2024 12:30pm - 1:00pm PDT
Content Hub Sails Pav San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

15: Content Hubs, Workshop | 12: Value-Access, Workshop

Level Intermediate
Level Intermediate
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2:30pm PDT

#358 CH: RBQM (Risk-Based Quality Management): What Topics Should be Discussed with Whom in the Room?

Component Type: Workshop
Level: Intermediate

Critical-to-Quality (CtQ) factors are key to determining which protocol-related processes and variables matter. These should be defined cross-functionally during risk assessment and built into all functional plans to have a common focus and approach.

Learning Objectives

Define Critical-to-Quality (CtQ) variables; Streamline CtQ to all functional plans for common approach; Understand the benefits from reduced SDR/SDV by focusing on CtQ as variables that matter.

Chair

Terry Katz, MS

Speakers

Terry Katz

Senior Director, Biostatistics and DM Planning and Functional Excellence, Daiichi Sankyo, United States

Terry Katz is Sr Dir of Biostatistics and DM Planning and Functional Excellence at Daiichi Sankyo. Previously he was Head of Global Data Management and Statistics at Merck Animal Health, Head of Biometrics at ImClone Systems, Senior Manager of Analysis & Reporting for PRA, and a Statistician... Read More →

Wednesday June 19, 2024 2:30pm - 3:00pm PDT
Content Hub Sails Pav San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

15: Content Hubs, Workshop | 02: ClinTrials -ClinOps, Workshop

Level Intermediate
Level Intermediate
Tags Workshop