DIA 2024 Global Annual Meeting: Full Schedule

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

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

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 →

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

#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

#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 80 publications and two industry textbooks on ePRO. Bill serves on 2 ISPOR task forces, the C-Path working... 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

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 →

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