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Type: 04: MedAffairs-SciComm clear filter
Monday, June 15
 

2:30pm EDT

#435: AI Competency Framework for Medical Writers: Essential Skills to Enhance Medical Writing AI Expertise
Monday June 15, 2026 2:30pm - 3:30pm EDT
105AB
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-26-531-L04-P; CME 1.00; RN 1.00

This session will describe essential AI-related skills for medical writers to leverage AI responsibly for greater efficiency while ensuring compliance and scientific integrity. The speakers will discuss how medical writers are becoming AI stewards.

Learning Objectives

Define the knowledge, skills, and behaviors medical writers need to responsibly and effectively integrate AI technologies in medical writing while meeting quality and compliance standards; Discuss how the medical writer’s role in scientific communications is changing with the use of generative AI.

Chair

Eileen Girten, MS

Speaker

Panelist
Mary Ost, PHD, MS

Panelist
Jeanette Towles, MA, RAC


Speakers
avatar for Eileen Girten

Eileen Girten

Medical Writing Therapeutic Area Lead, Pfizer, United States
Eileen M. Girten serves as the Medical Writing Therapeutic Area Lead at Pfizer and brings nearly 17 years of medical writing experience spanning publications and regulatory documentation. She holds a Bachelor of Arts in Chemistry from Rosemont College, a Master of Science in Psychology... Read More →
avatar for Mary Ost

Mary Ost

Director, AI-assisted Operations, Regulatory Medical Writing, Johnson & Johnson , United States
Mary Ost, PhD, is Director of AI-assisted Operations for Regulatory Medical Writing at Johnson & Johnson Innovative Medicine, with 30 years of experience across the pharma and CRO spaces. As AI-assisted Operations Lead, Mary has defined strategy and led solution deployment for AI-driven... Read More →
avatar for Jeanette Towles

Jeanette Towles

CEO, Synterex, United States
Jeanette Towles, MA, RAC is the Founder and CEO of Synterex, Inc., a clinical and regulatory consulting firm pioneering the digital transformation of regulatory science in life sciences and healthcare. Under her leadership, Synterex is developing a digital regulatory ecosystem—a... Read More →
Monday June 15, 2026 2:30pm - 3:30pm EDT
105AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  04: MedAffairs-SciComm, Session
  • Audience Intermediate
  • Area Artificial Intelligence
  • Level Intermediate
  • format csv
  • Credit Type ACPE, CME, RN
  • Interest Area Medical Affairs & Scientific Communication,Health Technology & AI
  • Feature Topics Artificial Intelligence
  • Tags Session
 
Tuesday, June 16
 

4:15pm EDT

#552: Optimizing the Content Ecosystem Through Lean Authoring: A Framework to Meet Regulatory Expectations and Prepare to Automate
Tuesday June 16, 2026 4:15pm - 5:15pm EDT
105AB
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-26-587-L04-P; CME 1.00; RN 1.00

This session explores how lean authoring streamlines clinical regulatory documents, debunks myths about reviewer preferences, and offers practical strategies and case studies to improve authoring and better serve both teams and regulators.

Learning Objectives

Identify common misconceptions around regulatory reviewer preferences and practices in reviewing CSRs and Module 2 documents; Explain how to prepare well-informed and effective arguments to persuade cross-functional authoring teams to create leaner, more concise, user-focused, and automation-ready documents; Recognize how and when to implement successful change management practices at your own organization

Chair

Lauren Geary, PHD

Speaker

Panelist
Inger Oedum Nielsen, PHD, MS


Speakers
LG

Lauren Geary

Senior Director, GSC, Regulatory Writing and Submission Capabilities, Eli Lilly and Company, United States
As the Sr. Director of Regulatory Capabilities and Submissions at Eli Lilly, I am responsible for ensuring functional proficiency in regulatory medical writing. Leveraging my medical training at the USC Keck School of Medicine, and regulatory training and experience in clinical trial... Read More →
avatar for Inger Nielsen

Inger Nielsen

Associate Director, Novo Nordisk A/S, Denmark
Inger Ødum Nielsen is Associate Director in Content Innovation and Management, Clinical Reporting at Novo Nordisk, where she leads a team focused on driving digital transformation in clinical reporting. She has a strong track record of operationalising digital tools into the line... Read More →
Tuesday June 16, 2026 4:15pm - 5:15pm EDT
105AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  04: MedAffairs-SciComm, Session |   08: RegPolicy-Strategy-GlobalCollaboration, Session |   06: ProfDevelop-Program-PortfolioMgmt, Session
  • Audience Intermediate
  • Level Intermediate
  • format csv
  • Credit Type ACPE, CME, RN
  • Interest Area Medical Affairs & Scientific Communication,Regulatory
  • Tags Session
 
Wednesday, June 17
 

1:45pm EDT

#624: Optimizing Protocol Data Collection to Reduce Site and Patient Participation Burden
Wednesday June 17, 2026 1:45pm - 2:45pm EDT
108B
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Application UAN: 0286-0000-26-613-L04-P; CME 1.00; RN 1.00

This session presents results of a recent TransCelerate–Tufts CSDD study highlighting trends, benchmarking protocol data collection practices, and offering new, practical strategies to simplify protocol designs and reduce participant and site burden.

Learning Objectives

Analyze new benchmarks on the distribution of protocol data across core, standard, and non-core endpoints; Identify procedures associated with non-core and non-essential endpoints and their contribution to patient and site burden; Discuss strategies to evaluate protocol data collection, simplify design and lower participation burden.

Chair

Kenneth Getz, MBA

Speaker

New Benchmarks on Clinical Trial Data Collection Practices and their Impact
Kenneth Getz, MBA

Frameworks and Tools Guiding Optimization of Protocol Data Collection
Jackie Cole, MS


Speakers
JC

Jackie Cole

Director, Design and Innovation, Clinical Operations, Gilead Sciences, United States
Jackie Cole is a clinical development innovator with more than two decades of experience across clinical operations and site engagement. At Gilead, she serves as Director of Design & Innovation, driving enterprise-wide innovation strategies that reshape how trials are designed and... Read More →
avatar for Kenneth Getz

Kenneth Getz

Tufts Center for the Study of Drug Development, Tufts University School of Medicine, United States
Ken Getz is the Executive Director and a Professor at the Tufts Center for the Study of Drug Development, Tufts University School of Medicine. He is also the chairman of CISCRP – a nonprofit organization that he founded to educate and raise public and patient awareness of the clinical... Read More →
Wednesday June 17, 2026 1:45pm - 2:45pm EDT
108B The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  02: ClinicalTrialOps-Innovation, Session |   03: Data-Tech-AI, Session |   04: MedAffairs-SciComm, Session
  • Audience Intermediate
  • Level Intermediate
  • format csv
  • Credit Type ACPE, CME, RN
  • Interest Area Clinical Development & Operations,Data Management & Data Standards
  • Tags Session

1:45pm EDT

#628: Beyond the Keyboard: Elevating Regulatory Writing with a Business Mindset
Wednesday June 17, 2026 1:45pm - 2:45pm EDT
105AB
Component Type: Session
Level: Advanced
CE: ACPE 1.00 Knowledge UAN: 0286-0000-26-619-L04-P; CME 1.00; RN 1.00

This session provides a framework and tools to adopt a business mindset, helping regulatory writing leaders and teams shift from document/submission execution to strategic influence.

Learning Objectives

Discuss building a business mindset; Identify practical methods to incorporate business thinking into day-to-day decision-making; Recognize how to apply frameworks to evaluate team influence and cross-functional collaboration.

Chair

Robin Whitsell

Speaker

Panelist
Tatyana Wanderer, PHD

Panelist
Angela Russell Winnier, PHD


Speakers
avatar for Tatyana Wanderer

Tatyana Wanderer

Executive Director, Head of Medical Writing and CTD, Moderna, United States
With over 10 years of experience in the pharmaceutical industry, Dr. Wanderer brings innovative thinking and lean process-focused approach. As the Head of Medical Writing at Syros Pharmaceuticals, Tatyana leverages experience in both biotech/pharma side and the vendor side. On the... Read More →
avatar for Tatyana Wanderer

Tatyana Wanderer

Executive Director, Head of Medical Writing and CTTD, Moderna, United States
Tatyana Wanderer, PhD, is Head of Medical Writing and Clinical Trial Transparency & Disclosure at Moderna, where she leads global teams focused on delivering high-quality clinical documentation and advancing transparency. With nearly two decades of experience across regulatory writing... Read More →
avatar for Robin Whitsell

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 →
avatar for Angela Winnier

Angela Winnier

Executive Director of Medical Writing, Pfizer, United States
Angela Winnier joined Pfizer in 2018 and is Executive Director of Medical Writing and the therapeutic area lead for internal medicine and inflammation/immunology. In addition to her pipeline support, Angela serves as technology lead for medical writing, providing strategic and operational... Read More →
Wednesday June 17, 2026 1:45pm - 2:45pm EDT
105AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  04: MedAffairs-SciComm, Session
  • Audience Advanced
  • Level Advanced
  • format csv
  • Credit Type ACPE, CME, RN
  • Tags Session

1:45pm EDT

#634: Access Unlocked: Collaborative Strategies for Navigating Regulatory and Payor Landscapes
Wednesday June 17, 2026 1:45pm - 2:45pm EDT
115AB
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-26-623-L04-P; CME 1.00; RN 1.00

Aligning regulatory and payor expectations is critical in the evolving healthcare landscape. Regulatory Affairs, Medical Affairs, and Market Access functions are collaborating within this complex ecosystem to ensure sustained patient access to medicines.

Learning Objectives

Examine the dynamic collaboration between Regulatory Affairs, Medical Affairs, and Market Access to effectively address current regulatory and payor requirements; Describe advancements in drug development that ensure clinical trials align with regulatory frameworks and coverage decisions.

Chair

Alison Maloney, MBA, MS

Speaker

An Academic Perspective
Sean D. Sullivan, PHD

A Medical Perspective
Emma Lee

A Regulatory Perspective
Todd Paporello, PHARMD, MBA


Speakers
EL

Emma Lee

Executive Director and Head, US Medical Affairs Patient Access and Quality, Gilead Sciences, United States
avatar for Alison Maloney

Alison Maloney

Head of Regulatory Affairs North America, Bayer , United States
Alison Maloney is currently Head of Regulatory Affairs North America for Bayer Pharmaceuticals. Prior to this role, she was the Head of Regulatory Affairs for Bayer Radiology and Consumer Health North America. Alison has also held Canadian positions as the Head of Regulatory Affairs... Read More →
avatar for Todd Paporello

Todd Paporello

Vice President, Global Head of Regulatory Affairs, Specialty Care, Sanofi, United States
Todd Paporello is the Vice President & Global Head of Regulatory Affairs Specialty Care at Sanofi. Before joining Sanofi, he held leadership positions of increasing responsibility within regulatory affairs at Bayer, Roche, Genentech, Merck, and Schering-Plough. Todd holds pharmacy... Read More →
SS

Sean Sullivan

Prof. of Pharmacy, Public Hlth, University of Washington, United States
Wednesday June 17, 2026 1:45pm - 2:45pm EDT
115AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  08: RegPolicy-Strategy-GlobalCollaboration, Session |   04: MedAffairs-SciComm, Session

4:00pm EDT

#648: Medical Affairs: Drivers of Scientific Impact and Strategic Value in Healthcare
Wednesday June 17, 2026 4:00pm - 5:00pm EDT
105AB
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-26-634-L04-P; CME 1.00; RN 1.00

Discover how Medical Affairs drives strategic value across the drug lifecycle through scientific leadership, data-driven insights, and digital fluency to improve patient outcomes.

Learning Objectives

Discuss Medical Affairs’ evolving role in driving scientific credibility and impact; Describe how digital fluency, data analytics, and AI transform it into a tech-enabled function; Identify best practices and leadership insights for advancing capabilities in a patient-centric, data-driven ecosystem.

Chair

Ranjini Prithviraj, PMP

Speaker

Panelist
Donna A. Holder, PHARMD

Panelist
Alexander Condoleon

Panelist
Sarah Jarvis, MBA


Speakers
AC

Alexander Condoleon

Chief Medical Affairs Officer, Medical Engagements & Impact, Pfizer, United States
avatar for Donna Holder

Donna Holder

Principal, HDMA Advisory, United States
Donna Holder has over 30+ yrs experience in the pharma. She now serves as an advisor to Medical Affairs organizations within the pharmaceutical industry. She was recently the Executive Director & Head of Digital Strategy and Innovation in Global Oncology Medical Affairs at Daiichi... Read More →
avatar for Sarah Jarvis

Sarah Jarvis

Global Medical & Evidence Lead, ZS Associates, United States
Sarah Jarvis leads our Global Medical & Evidence consulting space at ZS. Based now in San Francisco, California, Sarah has worked in the lifesciences industry for over 25 years and has focused exclusively on working with medical affairs clients for the past 20+ years at ZS. ZS has... Read More →
RP

Ranjini Prithviraj

Director, Global Medical Affairs, Publication Management, Regeneron Pharmaceuticals, United States
Wednesday June 17, 2026 4:00pm - 5:00pm EDT
105AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  04: MedAffairs-SciComm, Session
 
Thursday, June 18
 

8:00am EDT

#702: Cross-Functional Agentic End-to-End Dossier Preparation: Where are we Today and Progress Towards Realizing the Vision
Thursday June 18, 2026 8:00am - 9:00am EDT
109AB
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-26-644-L04-P; CME 1.00; RN 1.00

As pharma companies set increasingly bold ambitions for productivity, technology is more crucial than ever. This session presents a vision for how productivity can be boosted end-to-end with Agentic AI, with humans working alongside agents.

Learning Objectives

Describe recent trends in regulatory submission preparation acceleration, including role of technology; Discuss a vision for how Agentic AI can underpin each step of submission dossier preparation.

Chair

Anton Mihic, MSC

Speaker

Agentic AI for statistical programming and rapid biostatistical analysis
Ralf Raschke

Panel discussion: Learnings from AI-enabled clinical and regulatory decision making
Jennings Xu

Panel discussion: Learnings from AI-enabled regulatory submissions
Cassie Gregson

Panel discussion: Learnings from AI-enabled end-to-end dossier generation
Andrea Doyle


Speakers
AD

Andrea Doyle

Global Regulatory Affairs NA Head, Sanofi, United States
Andrea Doyle is Global Regulatory Affairs Head of Region North America (NA) and Global Advertising and Promotion at Sanofi. She provides oversight and regulatory expertise to optimize development programs and leads Global Advertising and promotion to deliver dynamic solutions to support... Read More →
CG

Cassie Gregson

VP Head of AI Enterprise Process & Innovation Center, AstraZeneca, United States
avatar for Anton Mihic

Anton Mihic

Partner, McKinsey & Company, United States
Anton is a management consultant serving clients in McKinsey’s Life Science R&D practice across global PharmaCos, innovative Biotechs, CROs and Private Equity portfolio companies. Anton leads McKinsey’s global Regulatory Affairs, Safety and R&D Quality service line, and focuses... Read More →
RR

Ralf Raschke

Senior Expert, McKinsey & Company, United States
JX

Jennings Xu

Senior Director, Data Science & Digital Health, Johnson & Johnson Innovative Medicine, United States
Jennings Xu is Senior Director of Data Science at Johnson & Johnson, where he leads R&D Generative AI strategy, partners with Global Regulatory Affairs on end-to-end AI-enabled acceleration, and heads Asia-Pacific R&D Data Science. He oversees multidisciplinary teams across discovery... Read More →
Thursday June 18, 2026 8:00am - 9:00am EDT
109AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  03: Data-Tech-AI, Session |   04: MedAffairs-SciComm, Session |   08: RegPolicy-Strategy-GlobalCollaboration, Session
  • Audience Intermediate
  • Area Artificial Intelligence
  • Level Intermediate
  • format csv
  • Credit Type ACPE, CME, RN
  • Interest Area Health Technology & AI,Medical Affairs & Scientific Communication
  • Feature Topics Artificial Intelligence
  • Tags Session
 
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DIA 2026 Global Annual Meeting
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  • 00: Plenary
  • 01: ClinSafety-PV-RM
  • 02: ClinicalTrialOps-Innovation
  • 03: Data-Tech-AI
  • 04: MedAffairs-SciComm
  • 05: PersonalizedMed-ComboProd-Diagnostics
  • 06: ProfDevelop-Program-PortfolioMgmt
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  • Patient-Centered Design and Experience
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  • Therapeutic Pathways
  • Trust and Responsible Innovation