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

Delivering a Data-Driven ICH M11 Clinical Protocol Template
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 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

2:15pm PDT

#134: Shifting Medical Writing Value Propositions with the Use of Technology Tools

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-534-L04-P; CME 1.00; RN 1.00

The life science industry constantly faces the business challenge of delivering safe and effective medicines to patients faster while reducing costs. Accelerated delivery of clinical documents has led to an increased workload for medical writers, which is only exacerbated by the competitive recruitment of talent and the expectation of “perfect” document delivery. These drivers and advancements in automation and AI are transforming medical writing. In addition to articulating their value proposition, writers and their managers will have to adapt to this technical transformation and level-up their skills. This panel will focus on providing both strategic and tactical considerations for medical writing teams. We will highlight the importance of communicating our role as content strategists, finding early adopters, developing training for multiple learning styles, building a support network, and surviving the change management process.

Learning Objectives

Discuss how the medical writing role is evolving in the face of technology; Outline the new skillset(s) that medical writers will need and how these change the value proposition of medical writing; Discuss strategies for engaging and training teams through this evolution.

Chair

Robin Whitsell

Speaker

Barbenheimer: Medical Writing Can Evolve and Still Be Great in the Face of Technology
Robin Whitsell

SOS! Tech Tools in Medical Writing Communicating your value in the AI age
Kayla Williams

Taking the Robot out of the Medical Writer: A Change Management Approach
Joanne Hilton, PhD, MBA

Speakers

Robin Whitsell

President, Whitsell Innovations, Inc., United States

Founder and president of Whitsell Innovations, Inc., a medical writing firm headquartered in Chapel Hill, NC, Ms. Whitsell has over 25 years of experience, specializing in global submission strategy, regulatory medical writing, emerging technologies, and data visualization. Prior... Read More →

Joanne Hilton

Executive Director, Medical Writing, GlaxoSmithKline, United Kingdom

Joanne Hilton joined GSK in July 2023 as Executive Director, Medical Writing. With over 20 years' experience in medical communications, she has a track record of building capabilities, driving strategic growth, delivering operational excellence and leading innovation. Her recent focus... Read More →

Kayla Williams

Director and Head, Oncology Medical Writing, Takeda, United States

This year, Kayla Williams celebrates 25 years in clinical and regulatory medical writing. She is interested in all aspects of the field, from trial design to registration and beyond, and believes medical writers and simple, intuitive writing processes are key to maximizing the joy... Read More →

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

04: MedAffairs-SciComm, Session

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

2:15pm PDT

#130: Interactive Safety Graphics in the Regulatory Decision-Making Process

Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-530-L04-P; CME 1.00; RN 1.00

Different visionary options may lead to a different look and feel to clincial study reports (CSRs) and submissions:

Broader use of interactive displays in submissions

Sponsor provides interactive package(s)

Regulators/sponsors use their own interactive package(s)

Let’s continue the discussion on how best to collaborate on interactive safety review strategy and development.

Learning Objectives

Identify the impact of interactive displays on submission content and the review process including the clinical study report (CSR) and trial data submission, use of review software, and answering information requests.

Chair

Greg Ball, PhD

Speaker

Panelist
Scott Proestel, DrMed, MD

Panelist
Y. Veronica Pei, MD, MEd, MPH

Panelist
Glen Wright Colopy, PhD, MSc

Panelist
David Nahamya

Speakers

Greg Ball

Safety Data Scientist, ASAPprocess, United States

Greg served in the Navy and taught HS math and physics before earning his PhD in biostatistics from the University of Texas. He co-led a crossfunctional company initiative at Merck to develop and implement the Aggregate Safety Assessment Planning (ASAP) process. His research on blinded... Read More →

Glen Colopy

Head of Data Science and Statistics, Wildfell Software, United States

Glen Wright Colopy is the Head of Data Science & Statistics at Wildfell, a startup specializing in custom software and data science solutions for the biotech and life science industries. Glen's day-to-day work is as a hands-on full stack data science contributor, focused on helping... Read More →

David Nahamya

Secretary to the Authority, Uganda National Drug Authority, Uganda

David was born in 1967 to Mr. and Mrs. Kihumuro; Ntungamo District, Western Uganda. He is known for being an influential person for positive change and leads with confidence. David is a graduate of MSc. Pharmaceutical Sciences - University of Havana; has PGD in Management - Uganda... Read More →

Y. Veronica Pei

Acting Associate Director, Biomedical Informatics and Regulatory Review Science, FDA, United States

Dr. Veronica Pei is a board-certified emergency physician and a commissioned officer in the U.S. Public Health Service currently serving as Associate Director (Acting) of Biomedical Informatics and Regulatory Review Science team in the Office of New Drugs (OND), FDA. In this role... Read More →

Scott Proestel

Senior Medical Officer, ODES, OND, CDER, FDA, FDA, United States

Scott Proestel, MD, is a Senior Medical Officer on the Biomedical Informatics and Regulatory Review Science Team at the US FDA’s Center for Drug Evaluation and Research. He completed his internal medicine training at Johns Hopkins Hospital and obtained his medical degree from Columbia... Read More →

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

11: Statistics-Data Science, Forum | 01: ClinSafety-PV, Forum

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

3:30pm PDT

#144: Paradigm Shift in Adverse Event Report Management and Sharing: The Case, The Need, and Possible Ways Forward

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-543-L04-P; CME 1.00; RN 1.00

The current paradigm of repeated safety report transmission to multiple regulators results in greater noise, duplicative effort, more lag time, and diverted focus from protecting patients and building trust through a shared proactive safety science. Might international collaboration evolve in this era of real-world evidence to no longer require such continual circulation of the same adverse event reports? Might newer technologies be leveraged for a more effective modern system? What are the options and the issues that would need to be considered to realize this future state? A panel of regulators and international stakeholders will discuss the issues.

Learning Objectives

Identify the issue and extent of international replication of safety reports; Discuss the possibility of leveraging modern processes or technical solutions (e.g., blockchain or decentralized networks) to enable more effective international collaboration; Determine how to move this agenda forward by focusing on patient safety in light of challenges and opportunities.

Chair

Andrew Bate, PhD, MA

Speaker

Paradigm Shift in Adverse Event Report Management and Sharing: Industry Update
Mayur A Patel, PharmD

Regulatory Perspective on AE Report Management and Sharing and Future Directions
Phil Tregunno

Speakers

Andrew Bate

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

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

Mayur Patel

Vice President, Oncology Therapy Area, Global Patient Safety, AstraZeneca, United States

Mayur Patel is an experienced drug developer and pharmacovigilance professional with over 25 years in biopharmaceutical industry. Currently, Dr. Patel is the Vice President Global Patient Safety in the Oncology Therapy Area at AstraZeneca based in the US. Over his career, he has managed... Read More →

Phil Tregunno

Deputy Director - Patient Safety Monitoring, Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom

Phil is the Deputy Director of Patient Safety Monitoring within MHRA’s Safety & Surveillance function and has over twenty years of experience working in pharmacovigilance. Prior to his current role Phil spent fourteen years leading and developing the pharmacovigilance system, including... Read More →

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

01: ClinSafety-PV, Session

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

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

3:30pm PDT

#156: Data Insight Generation: Leveraging Data Visualization in Study Planning, Monitoring, Exploration, Reporting, and Submission

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-555-L04-P; CME 1.00; RN 1.00

In this session, we will present various interactive graphics and new concept meetings that can be used to provide informative data insights and to enhance clinical trials execution from planning, monitoring, reporting, and regulatory submission.

Learning Objectives

Identify information of interest in an interactive way, which can greatly enhance clinical trials execution from planning, monitoring, reporting, and regulatory submission; Describe how to generate additional, broader, and deeper insights in helping accelerate the understanding of the clinical trial data, and further drive the understanding of disease development and patient journey.

Chair

Erya Huang, PhD

Speaker

Industry Update
Melvin Slaighter Munsaka, PhD, MEd, MS

Industry Update
Neetu Sangari, PhD, MEd, MS

Industry Update
Matthew Kumar, MSc

Speakers

Erya Huang

Associate Director Statistics, Bayer AG, United States

Dr. Huang is the Associate Director at Bayer U.S. LLC. She has many years of experiences working on global drug developments and registrations. She is also the main contact person of the data visualization app center in Bayer North America since 2016, being passionate about introducing... Read More →

Matthew Kumar

Associate Director, Lead Computational Scientist, Bayer, Canada

Matthew Kumar is a Lead Computational Scientist at Bayer within the Oncology Digitalization and Computational Sciences group, located in Mississauga, Ontario, Canada. Matthew brings with him over 10 years’ experience as a data scientist and statistician, spanning multiple areas... Read More →

Melvin Munsaka

Senior Director, Head Safety Statistics, AbbVie, United States

Melvin S. Munsaka is a Senior Director and Head of the Safety Statistics at AbbVie in the Statistical Sciences and Analytics Department. He has a PhD in Mathematical Statistics from Queen’s University in Canada. He has been in the industry for more than 25 years. He co-leads the... Read More →

Neetu Sangari

President/CEO, Pragya Tech Leaders, United States

Dr. Neetu Sangari is an influential Data Analytics Pharma leader, contributing to the Pharma industry, driving change, simplification, and delivering value through innovation. She has over 18 years of Progressive experience in the Pharmaceutical Industry, Clinical Research Organizations... Read More →

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

11: Statistics-Data Science, 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

#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

Advancing the National Plan to Address AD/ADRD
Yuan Luo, PhD

Digital Health Revolution: Wearable Sensors for Cognitive Frailty Monitoring
Bijan Najafi, PhD, MSc

Remote Disease Monitoring Platforms for ALS
Sharon Tamir

A Multi-Modal Digital Health Solution for Remote Monitoring of Disease Symptoms in Neurological Disorders
Ashkan Vaziri, PhD

Speakers

Ashkan Vaziri

Founder and CEO, Biosensics, 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

#210: Digital Biomarkers as Clinical Endpoints: The Road to Regulatory Acceptability

Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-565-L04-P; CME 1.00; RN 1.00

This forum will review the current regulatory paradigms for the use of digital biomarkers as endpoints in clinical trials in the US and EU. A panel of experts will discuss validation pathways and compare regulatory approaches between regions.

Learning Objectives

Describe the V3 process (verification, analytical validation, clinical validation) for validating digital health technologies as fit-for-purpose in a clinical trial; Identify validation pathways in the US and EU; Discuss outstanding challenges to the use of digital health technologies for remote data capture in clinical trials.

Chair

Lina AlJuburi, PharmD, MSc

Speaker

Enhancing Clinical Research in Europe: Navigating the Regulatory Landscape
Max Wegner, PharmD, RPh

Panelist
Anindita Saha

Industry Perspective
Steve Berman, MPH

Industry Update
Gul Erdemli, MD, PhD

Speakers

Lina AlJuburi

Head, Global Regulatory Science and Policy - North America, Sanofi, United States

A background in pharmacy and an interest in drug development and regulation led me to the US FDA where I spent several years within CDER, Office of New Drugs. By far the hardest decision, in 2012, I transitioned to the private sector in the field of Regulatory Science and Policy... Read More →

Steve Berman

Deputy Vice President, Science and Regulatory Affairs, BIO, United States

Steve Berman serves as Deputy VP of Science and Regulatory Strategy for the Biotechnology Innovation Organization (BIO). Steve joined BIO after serving as a Director, Translational Regulatory Affairs, at AstraZeneca. Steve joined AZ after eight years at FDA, working in both CDER and... Read More →

Gul Erdemli

Global Program Regulatory Director, Novartis Pharmaceuticals Corporation, United States

Gül Erdemli is a Global Program Regulatory Director at Novartis Regulatory Affairs Early Development. She is a drug development leader with more than 15 years industry experience from target identification to clinical development. She has an MD degree from Hacettepe University, Medical... Read More →

Anindita Saha

Associate Director Strategic Initiatives, Digital Health Center of Excellence, FDA, United States

Anindita (Annie) Saha is the Associate Director for Strategic Initiatives for the Digital Health Center of Excellence (DHCoE) at the Food and Drug Administration (FDA). She is leading strategic initiatives in moving care into the home, Artificial Intelligence, and international collaborations... Read More →

Max Wegner

Head Regulatory Affairs, Bayer AG, Germany

After studying pharmacy at the University of Bonn, Max Wegner commenced his PhD in pharmacology at Bayer and started in Regulatory Affairs as a Dossier Manager in 1996 in Wuppertal. Since then, Max has been employed in various functions within Product Development at Bayer and also... Read More →

Tuesday June 18, 2024 8:00am - 9:00am PDT
Room 6B San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

09: Regulatory, 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

#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

#225: Regulatory Guidance and Papers on Technology Innovations

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-576-L04-P; CME 1.00; RN 1.00

This session will describe and identify emerging technology innovations and health authority papers, guidance, and discussion on their use in regulatory filings and development. The session will discuss emerging artificial intelligence (AI) trends, structured content authoring, and structured data including their development, use, risks, and potential future in pharmaceutical development. Attendees will hear from industry experts on the topics and their potential implementation and impacts to the field.

Learning Objectives

Describe and identify emerging technology innovations and health authority papers, guidance, and discussion on their use in regulatory filings and development; Discuss emerging artificial intelligence (AI) trends, structured content authoring, and structured data including their development, use, risks, and potential future in pharmaceutical development; Describe potential implementation and impacts to the field.

Chair

David Meats

Speaker

AI and Technology Trends and Regulation Introduction
David Meats

Regulation Guidance and Concensus Papers
Madhavi Gidh-Jain, PhD

Regulation Guidance
Louise Lind Skov, PhD

Speakers

David Meats

Director, Regulatory Services Management, Certara, United States

David Meats is a Director of Regulatory Services and Medical Affairs at Certara. He has been a medical writer and manager for 23 years working in oncology, immuno-oncology, endocrinology, musculoskeletal, cardiac, hepatic, renal, and infectious disease therapeutic areas on nearly... Read More →

Madhavi Gidh-Jain

Global Medical Writing and Document Management Head, Sanofi, United States

Madhavi Gidh-Jain is the Global Head of Medical Writing and Document Management for all therapeutic areas and regions at Sanofi. Madhavi has more than 20 years of experience in designing, writing, and reviewing medical and regulatory documents for pharmaceuticals, biologics, devices... 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 →

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

04: MedAffairs-SciComm, Session

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

1:15pm PDT

#252: Ensuring Inspection Readiness for Clinical Trials Using Decentralized Clinical Trial Design Features

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-590-L04-P; CME 1.00; RN 1.00

The speakers will discuss regulatory and industry perspectives on sponsor and investigator responsibilities when incorporating decentralized clinical trials features in a trial to ensure trial participant safety, data reliability and quality and inspection readiness.

Learning Objectives

Describe various design features of decentralized clinical trials (DCT), including use of digital health technologies for remote data capture; Discuss what sponsors should do upfront in the planning and during the conduct of the trial and where the risks to data integrity lie in trials incorporating DCT features; Discuss the core elements of an FDA inspection; Identify steps to ensure inspection readiness for clinical investigators and sponsors.

Chair

Cara Alfaro, PharmD

Speaker

FDA Update
Cara Alfaro, PharmD

Industry Update
Jonathan Andrus, MS

Panelist
Kassa Ayalew, MD, MPH

Speakers

Cara Alfaro

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

Dr. Alfaro received her B.S. in pharmacy from Purdue University and her Pharm.D. from the Ohio State University. She completed a residency and research fellowship in psychiatric pharmacy at the University of Texas Health Science Center at San Antonio. In 1998, she joined NIH as a... Read More →

Jonathan Andrus

Co-CEO, CRIO, United States

Mr. Andrus brings over 25 years of executive management, operational, quality, and business experience to CRIO. Most recently he served as Chief Strategy Officer for Clinical Ink. Prior to that, he served as Senior Vice President for BioClinica (now Clario), where he led the e-clinical... Read More →

Kassa Ayalew

Director, DCCE, OSI, Office of Compliance, CDER, FDA, United States

Dr. Kassa Ayalew is Division Director for the Division of Clinical Compliance Evaluation in the Office of Scientific Investigation at Center for Drug Evaluation and Research in FDA. Dr. Ayalew oversees the review of integrity of efficacy and safety data submitted to the FDA and the... Read More →

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

02: ClinTrials -ClinOps, Session | 08: RD Quality-Compliance, Session

Format Session
Level Intermediate
Featured Topics Decentralized Clinical Trials (DCTs), Digital Technology
Level Intermediate
Feature Topics Decentralized Clinical Trials (DCTs),Digital Technology
Credit Type ACPE, CME, RN
Tags Session

1:15pm PDT

#253: Platform Technology Designation: Opportunities and Challenges for Implementation

Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-591-L04-P; CME 1.00; RN 1.00

This forum will review the key components of the new FDA Platform Technologies Designation program. A panel of experts will provide their perspectives on the proposal and discuss opportunities and challenges related to its implementation.

Learning Objectives

Describe the key attributes of the proposed Platform Technology Designation Program as described by the anticipated FDA draft guidance; Discuss stakeholder perspectives about the new designation program; Describe anticipated opportunities and challenges related to its implementation.

Chair

Andrea Doyle

Speaker

Panelist
Rachael Anatol

Panelist
Evdokia Korakianiti, PhD, MSc

Panelist
Monica Veldman

Speakers

Rachael Anatol

Deputy Super Office Director, Office of Therapeutic Products, CBER, FDA, United States

Andrea Doyle

Head, Global Regulatory Affairs, Neurology, Sanofi, United States

Evdokia Korakianiti

Head of Quality and Safety of Medicines, European Medicines Agency, Netherlands

Evdokia has joined the Agency in 2002. Since 2020, she is leading the Quality and Safety Department, which ensures that patients take medicine that are safe, are of the best possible quality and are manufactured in compliance with EU and international standards. She leads the Agency’s... Read More →

Monica Veldman

Director, Global Regulatory Policy, Alliance for Regenerative Medicine, United States

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

09: Regulatory, Forum

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

1:15pm PDT

#256: Successful Strategies for Leading and Influencing Without Authority in an Evolving Digital Landscape

Component Type: Workshop
Level: Intermediate

This workshop will discuss best practices and essential skills for leading without authority. Attendees with go through a real-world case study for leading a cross functional team through a long-term project without formal authority. This workshop will delve into essential strategies for fostering alignment, cultivating open communication, promoting agility, and successfully navigating barriers within organizations.

Learning Objectives

Discuss best practices and develop the essential skills needed for leading without authority in a cross functional team environment; Describe influencing stakeholders, negotiation tactics, and relationship building..

Chair

Mica Elizalde, RAC

Speaker

Facilitator
Connie Pascual, MSc

Speakers

Mica Elizalde

Sr. Principal Scientist, Regulatory Digital Health, Merck & Co., Inc., United States

Connie Pascual

Principal Scientist, Regulatory Digital Health, Merck & Co., Inc., United States

Connie is currently a Director of Regulatory Affairs (Digital Health) at Merck. She has worked in the medical device industry in Regulatory Affairs for over 14 years focused on digital health technologies. She has successfully managed, led, and authored domestic and international... Read More →

Tuesday June 18, 2024 1:15pm - 2:15pm PDT
Room 8 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

13: ProfDevelopment, Workshop

Format Workshop
Level Intermediate
Featured Topics Digital Technology
Level Intermediate
Feature Topics Digital Technology
Tags Workshop

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

8:00am PDT

#307: Partnering with Regulatory Authorities to Unlock the Value in Digital Health Products

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-628-L04-P; CME 1.00; RN 1.00

Discussion of partnering with regulators to get novel digital health products through the approval processes. Learn insights from industry and regulators for creative, strategic, and flexible thinking on regulation of novel technologies.

Learning Objectives

Discuss the challenges of introducing novel digital technologies to FDA; Describe tactics to build better partnerships with regulators.

Chair

Rebecca Joy James, MBA, RAC

Speaker

Panelist
Anindita Saha

Panelist
James Wabby, MHS

Panelist
Adam Cargill, MS

Panelist
Wes Gerbig, PhD, MS

Speakers

Rebecca James

Director - Advisory, KPMG, LLC, United States

Rebecca is a Director in the Life Sciences consulting group at KPMG based out of Chicago, IL. She has over 14 years of experience in both consulting and industry roles with companies from pharmaceutical, medical device, and nutritional industries with an emphasis in Regulatory Affairs... Read More →

Adam Cargill

Director, QARACA, MediView XR, Inc., United States

Adam Cargill, MS RAC, is the Vice President of Quality, Regulatory, and Clinical for MediView XR. In his role he is accountable for the oversight of all regulatory, clinical, and quality functions. Responsibilities include overseeing the company’s global regulatory, clinical, and... Read More →

Wes Gerbig

Director, Global Regulatory Affairs, Drug Delivery and Digital Health, Eli Lilly and Company, United States

Wes Gerbig has been in the pharmaceutical and medical device industry for over 20 years. By background he is an electrical and software engineer. Wes holds a PhD in Global Leadership, an MS in Engineering Management, BS in Engineering and is licensed to practice engineering in the... Read More →

Anindita Saha

Associate Director Strategic Initiatives, Digital Health Center of Excellence, FDA, United States

James Wabby

Global Head, Regulatory Affairs, Emerging Technologies and Combination Products, AbbVie, United States

James Wabby is the Global Head, Regulatory Affairs - (CoE) Emerging Technologies, Devices, and Combination Products at AbbVie in Irvine, California. He has 22 years of experience in increasing quality compliance and regulatory affairs responsibilities within the GxP regulated environment... Read More →

Wednesday June 19, 2024 8:00am - 9:00am PDT
Room 2 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

09: Regulatory, Session | 06: TranslationalDelivery Tech-PrecMedicine, Session

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

1:15pm PDT

#344: Leveraging Point of Care Technologies for Near Real Time, Interactive Safety Surveillance: Opportunities and Challenges

Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-647-L04-P; CME 1.00; RN 1.00

Forum will summarize a study that demonstrated the ability of healthcare provides (HCPs) and pharmacovigilance (PV) staff to have near real-time adverse event communications. Panelists will discuss opportunities and challenges for extending this new, potentially transformative capability.

Learning Objectives

Discuss how digital technologies can facilitate the near real time, interactive exchange of adverse drug information between healthcare providers (HCPs) and pharmacovigilance (PV) experts in a trusted, compliant, and transparent manner; Identify the opportunities and challenges with such an approach.

Chair

Gregory Powell, PharmD, MBA

Speaker

MHRA Update
Phil Tregunno

Patient Update
Dave deBronkart

Physician/EHR update
Auren Weinberg, MD, MBA

Speakers

Gregory Powell

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

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

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 →

Phil Tregunno

Deputy Director - Patient Safety Monitoring, Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom

Auren Weinberg

Chief Medical Officer, Veradigm, United States

Wednesday June 19, 2024 1:15pm - 2:15pm PDT
Room 14AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

01: ClinSafety-PV, Forum

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

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
Susanne Ausborn, PhD

Panelist
David Mukanga, PhD, MPH

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
Tags Forum

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

Speaker
Stephanie Ueng

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

Silas Buchanan is the Founder and CEO of OurHealthyCommunity. Silas is an experienced underserved-community engagement strategist, dedicated to building equitable partnerships and crafting web-based ecosystems that solve for known, outreach and engagement failure points. Silas has... Read More →

Stephanie Ueng

Strategy Director, Roche, 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