DIA 2026 Global Annual Meeting: Full Schedule

11:00am EDT

#404: Evidence-Based Insights Informing Participant Compensation Strategies

Monday June 15, 2026 11:00am - 12:15pm EDT

Component Type: Session
Level: Advanced
CE: ACPE 1.25 Knowledge UAN: 0286-0000-26-512-L04-P; CME 1.25; RN 1.25

This session presents findings from a DIA–Tufts CSDD study examining how participant compensation strategies vary across trial phases and therapeutic areas and their impact on recruitment, retention, and enrollment outcomes, with implications for protocol design and trial execution

Learning Objectives

Describe how participant compensation strategies vary by trial phase and therapeutic area; Assess evidence linking compensation practices to recruitment, retention, and enrollment outcomes; Apply study insights to support consistent, ethical, and effective compensation decisions in protocol design and trial execution.

Chair

Kenneth Getz, MBA

Speaker

Panelist
Lindsay McNair, MD, MPH, MS

Panelist
Sabina Kineen

Panelist
Brittany Niland

Panelist
Elizabeth Smith Morris

Speakers

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 →

Sabina Kineen

Lived Experience Expert, Fabry Support & Information Group, United States

Sabina Kineen is a dedicated patient advocate and speaker with a passion for equitable access to clinical trials and healthcare. As both a patient and caregiver, she brings a unique, lived perspective that drives her work in health literacy, patient engagement, and reducing disparities... Read More →

Lindsay McNair

Principal Consultant, Equipoise Consulting, United States

Lindsay McNair, MD, MPH, MSB is Principal Consultant at Equipoise Consulting. She was previously the Chief Medical Officer for WCG. In this role she oversaw WCG IRB, and provided consultation to institutions and biopharma companies on a wide range of issues related to clinical protocol... Read More →

Elizabeth Smith Morris

Director, Product Management, Patient Engagement, Suvoda, United States

Brittany Niland

Senior Director- Patient Engagement, Recruitment, Diversity & Retention, Eli Lilly and Company, United States

Brittany Niland is Senior Director of Patient Engagement, Recruitment, Diversity & Retention, leading global, patient-centered recruitment and retention strategies across the Oncology portfolio. She focuses on expanding equitable access to clinical trials, accelerating enrollment... Read More →

Monday June 15, 2026 11:00am - 12:15pm EDT
108B The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA

02: ClinicalTrialOps-Innovation, Session

Audience Advanced
Area Patient-Centered Design and Experience, Therapeutic Pathways
Level Advanced
format csv
Credit Type ACPE, CME, RN
Interest Area Clinical Development & Operations,Clinical Development & Operations
Feature Topics Patient-Centered Design and Experience,Therapeutic Pathways
Tags Session

1:30pm EDT

#427 CH: Develop Regulatory CMC Strategies to Mitigate Global Drug Shortages Risks for Marketed Drug Products

Monday June 15, 2026 1:30pm - 2:00pm EDT

Content Hub

Component Type: Workshop
Level: Advanced

Develop proactive Regulatory CMC strategies to mitigate and prevent drug shortage risks for marketed products

Learning Objectives

Benchmark key drivers for assessing supply- and demand-related risks that may lead to drug shortages. Develop proactive Regulatory CMC strategies to mitigate and prevent drug shortage risks for marketed products. Apply risk-based decision making to strengthen global supply continuity and regulatory compliance.

Monday June 15, 2026 1:30pm - 2:00pm EDT
Content Hub The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA

12: Content-Hubs, Workshop

Audience Advanced
Level Advanced
format csv
Tags Workshop

2:30pm EDT

#437: Opportunity, Caution or Reluctance: Global Trends for Regulating AI in Pharmaceutical Manufacturing

Monday June 15, 2026 2:30pm - 3:30pm EDT

118C

Component Type: Session
Level: Advanced
CE: ACPE 1.00 Application UAN: 0286-0000-26-533-L04-P; CME 1.00; RN 1.00

Artificial intelligence is revolutionizing drug manufacturing, yet regulations are still catching up. With key guidance from the EU and US in development, a proactive and collaborative approach is needed for global regulatory alignment, ensuring AI i

Learning Objectives

Identify and summarize regulatory trends specific to AI use in Manufacturing; Distinguish AI use in manufacturing from use in product development.

Chair

Gert Thurau, PHD

Speaker

PMDA regulatory perspectives on AI in Manufacturing
Yoshihiro Matsuda, DrMed

Case Study Industry applications of AI
Thomas O'Connor, PHD

FDA regulatory perspectives on AI in Manufacturing
Tina Kiang, PHD

Speakers

Tina Kiang

Director, Division of Regulation and Guidance, OPPQ, OPQ, CDER, FDA, United States

Tina Kiang, Ph.D. currently serves as the Director of the Division of Regulation and Guidance in OPQ/OPPQ. She has over 20 years of combined regulatory and leadership experience at the FDA. Tina has led and supervised the development and finalization of guidance and regulations on... Read More →

Yoshihiro Matsuda

Senior Scientist (for Quality), Pharmacist, Pharmaceuticals and Medical Devices Agency (PMDA), Japan

Dr. Matsuda is a pharmacist and a Principal Senior Scientist for Quality at the Pharmaceuticals and Medical Devices Agency (PMDA), Japan. He received his Bachelor of Pharmaceutical Sciences from Toho University in 1997 and his Master’s degree from Toyama Medical and Pharmaceutical... Read More →

Thomas O'Connor

Director Process Analytics, GSK, United States

Tom is a director for process analytics at GSK. His team develops models to accelerate process development and increase the robustness of commercial manufacturing. Tom joined GSK from the FDA where he was the deputy director of the Office of Pharmaceutical Quality Research in the... Read More →

Gert Thurau

Head of CMC Regulatory Policy for Manufacturing Technology Innovation in, F. Hoffmann-La Roche Ltd, Switzerland

Dr. Gert Thurau is the Head of Manufacturing Technology and Innovation Advocacy in the CMC Reg PTR Policy team at Hoffmann- La Roche in Basel, Switzerland. His responsibility includes the regulatory advocacy for the adoption of advanced technologies in GMP manufacturing – covering... Read More →

Monday June 15, 2026 2:30pm - 3:30pm EDT
118C The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA

07: RegCMC-Product Quality, Session | 03: Data-Tech-AI, Session

Audience Advanced
Area Artificial Intelligence
Level Advanced
format csv
Credit Type ACPE, CME, RN
Interest Area Quality Assurance / Control & CMC,Health Technology & AI
Feature Topics Artificial Intelligence
Tags Session

2:30pm EDT

#439.1: From Lag to Lead: Accelerating Global Innovative Medicines Through China’s NMPA

Monday June 15, 2026 2:30pm - 3:30pm EDT

203AB

Component Type: Session
Level: Advanced

China is reshaping global drug development and regulatory strategy. This session equips MNC regulatory leaders with decision framework, actionable strategies, pathway insights, and case studies to optimize China integration and global approvals.

Learning Objectives

Assess China’s evolving regulatory landscape to inform global portfolio strategy; Examine National Medical Products Administration (NMPA) regulatory pathways to optimize timelines and market entry; Apply decision frameworks and practical approaches to integrate China into global programs while balancing global alignment, local requirements, and execution risk.

Chair

Wenny Du, MBA, RAC

Speaker

Global Strategy and Challenges
Todd Paporello, PHARMD, MBA

China Strategy and Solution
Wei Zhang

Panel Discussion
Xiaoyuan Chen, MD

Industry Case Studies
Wenny Du, MBA, RAC

Speakers

Xiaoyuan Chen

Professor, Tsinghua University School of Basic Medicine, China

Researcher Chen Xiaoyuan graduated with a bachelor's degree in clinical medicine in 1996 and a master's degree in clinical pharmacology in 2002. In 2010, he received a doctorate in pharmacology from Shanghai Jiaotong University. In 2002, he joined the drug evaluation center of the... Read More →

Wenny Du

Sr. Director, Global Regulatory Lead, Amgen Inc., United States

Wenny Du, MS, MBA, RAC, serves as Senior Director and Global Regulatory Lead (GRL) for Oncology at Amgen Inc., where she leads global regulatory teams to shape and execute strategies that enable worldwide innovative medicine approvals. With over 25 years of biopharmaceutical industry... Read More →

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 →

Wei Zhang

SVP, Head of Medicine, Greater China, Boehringer Ingelheim, China

Monday June 15, 2026 2:30pm - 3:30pm EDT
203AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA

08: RegPolicy-Strategy-GlobalCollaboration, Session

Audience Advanced
Level Advanced
format csv
Tags Session

2:30pm EDT

#439: Early Intervention in Slowly Progressing Chronic Diseases: Navigating Regulatory and Reimbursement Uncertainty

Monday June 15, 2026 2:30pm - 3:30pm EDT

115AB

Component Type: Session
Level: Advanced
CE: ACPE 1.00 Application UAN: 0286-0000-26-536-L04-P; CME 1.00; RN 1.00

Global interest in early intervention for chronic diseases is driving regulatory innovation, but evidence and reimbursement barriers remain. This forum will highlight how global agencies and payers are adopting harmonized, patient-focused approaches.

Learning Objectives

Analyze global regulatory and reimbursement challenges associated with decision-making for early treatment of chronic diseases; Assess existing gaps and opportunities within US and EU regulatory and reimbursement frameworks to advance in this area.

Chair

Simon Bennett, MS

Speaker

Regulatory challenges facing the development of treatments for chronic neurological disorders
Steffen Thirstrup, MD, PHD

Panelist
Julian Beach, MBA

Patient Perspective
Mindy Cameron

Speakers

Julian Beach

Interim Executive Director, Healthcare Quality and Access, Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom

Julian oversees the portfolio that is designed to ensure the quality and access of products to the UK market - this includes scientific advice, licensing assessment, marketing authorisations for all innovative and established medicines. A committed professional with over 15 years... Read More →

Simon Bennett

Director, EU Regulatory Policy, Biogen, United Kingdom

As Director of European Regulatory Policy at Biogen, Simon is responsible for developing and leading Biogen’s European regulatory policy agenda and associated activities in key areas. Simon started at Biogen in 2003 in clinical development before moving into Regulatory Sciences... Read More →

Mindy Cameron

Patient Advocate, Advocacyworks, United States

Mindy Cameron's evolution as a rare disease patient expert started over 20 years ago when her second son was diagnosed with Duchenne muscular dystrophy. Through her work with non-profit, research, and industry organizations, Mindy has become a recognized voice for patients living... Read More →

Steffen Thirstrup

Chief Medical Officer, European Medicines Agency, Netherlands

Dr. Steffen Thirstrup, MD, PhD, has been Chief Medical Officer at the European Medicines Agency (EMA) since June 2022. A specialist in clinical pharmacology, he has held leadership roles at the Danish Medicines Agency, served as a CHMP member at EMA, and co-chaired the European Commission’s... Read More →

Monday June 15, 2026 2:30pm - 3:30pm EDT
115AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA

08: RegPolicy-Strategy-GlobalCollaboration, Session

Audience Advanced
Area Therapeutic Pathways, Global Alignment in Practice
Level Advanced
format csv
Credit Type ACPE, CME, RN
Interest Area Value & Access,Regulatory
Feature Topics Therapeutic Pathways,Global Alignment in Practice
Tags Session

4:00pm EDT

#451: Race/Ethnicity, Ancestry, and Clinical Phenotype Real-World Data to Precisely Anticipate Treatment Effectiveness and Patient Outcomes

Monday June 15, 2026 4:00pm - 5:00pm EDT

116

Component Type: Session
Level: Advanced
CE: ACPE 1.00 Knowledge UAN: 0286-0000-26-546-L04-P; CME 1.00; RN 1.00

Real-world data that encompass race, ethnicity, or ancestry and clinical phenotypes are growing increasingly sophisticated in utility. This panel will discuss why precision medicine is ripe for new and ongoing exploration in regulatory contexts.

Learning Objectives

Describe precision medicine approaches involving clinical phenotype RWD in context with race, ethnicity, ancestry data, that can be instrumental to address unmet patient and health system needs; Discuss how regulators have reacted to precision medicine-based research approaches in context with race, ethnicity, ancestry information, inclusive of research design modifications made along the way.

Chair

Rachele Hendricks-Sturrup, MA

Speaker

Panelist
Carla Rodriguez-Watson, MPH

TBD
Lysel Brignoli, MS

Speakers

Lysel Brignoli

Associate Principal, RWE, Oracle Life Sciences, France

Lysel Brignoli is an expert in Real-World Evidence and epidemiologic research, with over a decade of experience designing and leading studies that generate insights for healthcare decision-making. Her work focuses on innovative study designs, patient registries, and the integration... Read More →

Rachele Hendricks-Sturrup

Research Director, Real-World Evidence, Duke-Margolis Institute For Health Policy (DMI), United States

Dr. Rachele Hendricks-Sturrup is the Research Director of Real-World Evidence (RWE) at the Duke-Margolis Institute for Health Policy in Washington, DC, strategically leading and managing the Institute's RWE Collaborative and RWE policy research portfolio and education. As an engagement... Read More →

Carla Rodriguez-Watson

Director of Research, Reagan-Udall Foundation for the FDA, United States

Dr. Rodriguez-Watson is focused on continuously developing and enhancing a portfolio of work that leverages real-world data and experiences to inform and conduct clinical and post-market drug safety and effectiveness studies to improve population health. Key projects bring together... Read More →

Monday June 15, 2026 4:00pm - 5:00pm EDT
116 The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA

05: PersonalizedMed-ComboProd-Diagnostics, Session | 03: Data-Tech-AI, Session | 10: Stats-EvidenceGeneration-RWE, Session

Audience Advanced
Level Advanced
format csv
Credit Type ACPE, CME, RN
Interest Area Biostatistics
Tags Session

10:15am EDT

#507: Paying Fair: Regulatory and Ethical Challenges in Research Participant Compensation

Tuesday June 16, 2026 10:15am - 11:30am EDT

107AB

Component Type: Session
Level: Advanced
CE: ACPE 1.25 Application UAN: 0286-0000-26-557-L04-P; CME 1.25; RN 1.25

We will share case examples and trends from 24,000 records, analyze ethical challenges involved in paying participants, and discuss how protective policies or administrative practices can result in unjust treatment.

Learning Objectives

Explain the ethical considerations that govern payment to research participants; Evaluate the potential for institutional and administrative policies to inadvertently create unjust treatment of research participants; Apply the Belmont Principles of Beneficence and Justice to real-world cases involving payment to research participants and propose strategies for ethical decision-making.

Chair

Kelly Fitzgerald, PHD

Speaker

Panelist
Karla Childers, MS

Panelist
Wenora Johnson

Panelist
Sam Whitaker

Panelist
Robin Kuprewicz, MA

Speakers

Karla Childers

Vice President, Bioethics, Policy & Partnerships, Johnson & Johnson, United States

Karla Childers is Vice President, Bioethics, Policy & Partnerships in the Johnson & Johnson Office of the Chief Medical Officer. Her primary responsibility is leading and coordinating various bioethics-based, science policy projects since 2013. Her longest running responsibility has... Read More →

Kelly FitzGerald

Executive IRB Chair and Vice President of IBC Affairs, WCG , United States

Kelly FitzGerald is the IRB Executive Chair and Vice President of IBC Affairs at WCG IRB where she oversees the operation of both the IRB and several hundred institutional IBCs. Kelly is a certified IRB professional and holds a B.S. in Chemical Engineering from the University of New... Read More →

Wenora Johnson

Administrative Support & Research/Patient Advocate, United States

Robin Kuprewicz

Clinical Trials Director, Georgetown University, United States

Robin Kuprewicz is the Clinical Trials Director for the Georgetown University Huntington's Disease Care, Education and Research Center. She holds a Masters in Medical Anthropology and has ten years of experience in clinical trials. She has helped Huntington's Disease participants... Read More →

Sam Whitaker

Founder & CEO, Mural Health, United States

Tuesday June 16, 2026 10:15am - 11:30am EDT
107AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA

02: ClinicalTrialOps-Innovation, Session

Audience Advanced
Area Ethics, Trust and Responsible Innovation, Patient-Centered Design and Experience
Level Advanced
format csv
Credit Type ACPE, CME, RN
Interest Area Clinical Safety & Pharmacovigilance,Patient Engagement
Feature Topics Ethics, Trust and Responsible Innovation,Patient-Centered Design and Experience
Tags Session

1:45pm EDT

#528: Suffix or Superfluous? Evaluating FDA’s Biologics Naming Convention

Tuesday June 16, 2026 1:45pm - 3:00pm EDT

118AB

Component Type: Session
Level: Advanced
CE: ACPE 1.25 Knowledge UAN: 0286-0000-26-569-L04-P; CME 1.25; RN 1.25

This session explores pharmacovigilance for biosimilars, focusing on how FDA’s suffix-based naming and surveillance are implemented in practice. Panelists from FDA, academia, and industry will discuss suffix-related challenges and future directions.

Learning Objectives

Describe the FDA’s nonproprietary naming convention for biological products and its intended role in pharmacovigilance; Analyze empirical evidence from FAERS to evaluate how suffix reporting impacts pharmacovigilance activities; Assess the role of naming conventions in broader active surveillance systems, such as the Sentinel System, and their implications for biosimilar safety monitoring.

Chair

Stacey Ricci, DRSC

Speaker

TBD
Mary Jo Carden, JD

TBD
Judith Maro, MS

TBD
Mariana Socal, MD, PHD, MS

Speakers

Mary Jo Carden

Carden Associates, United States

Mary Jo Carden is President of Carden & Associates. She previously served as Head of Policy at Sandoz, Inc., Vice President of Government and Pharmacy Affairs at AMCP. She has also served as Director of Regulatory Affairs at Medco Health Solutions, in various government affairs capacities... Read More →

Judith Maro

Associate Professor, Department of Population Medicine, Harvard Medical School, United States

Dr. Maro is an Associate Professor in the Department of Population Medicine at Harvard Medical School and the Harvard Pilgrim Health Care Institute. She received her doctorate in Engineering Systems at the Massachusetts Institute of Technology (MIT). She is a site principal investigator... Read More →

Stacey Ricci

Director, Scientific Review Staff, OTBB, CDER, FDA, United States

As Director of the Scientific Review Staff in the Office of Therapeutic Biologics and Biosimilars (U.S.FDA/CDER), Dr. Ricci leads a team of scientists, clinicians, pharmacists, and project managers who oversee the review of biosimilar products at all stages of development, advance... Read More →

Mariana Socal

Associate Professor, Johns Hopkins Bloomberg School of Public Health, United States

Dr. Socal is an associate professor at the Johns Hopkins Bloomberg School of Public Health. Prof. Socal researches ways to improve access and affordability of prescription drugs, including generics and biosimilars, gene therapies, insulins, and the global pharmaceutical supply chain... Read More →

Tuesday June 16, 2026 1:45pm - 3:00pm EDT
118AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA

01: ClinSafety-PV-RM, Session

Audience Advanced
Level Advanced
format csv
Credit Type ACPE, CME, RN
Interest Area Clinical Safety & Pharmacovigilance
Tags Session

1:45pm EDT

#529: Early Outcomes and Strategic Learnings from the DIA Obesity Consortium’s Initial Collaborative Phase

Tuesday June 16, 2026 1:45pm - 3:00pm EDT

108A

Component Type: Session
Level: Advanced
CE: ACPE 1.25 Knowledge UAN: 0286-0000-26-654-L04-P; CME 1.25; RN 1.25

This session summarizes the work of the DIA Obesity Consortium with focus on the agreements that have been reached about which are the endpoints that should be included in Phase 3 clinical trials for the development of obesity drugs. The work is a result of the discussions among 10 companies, FDA, EMA, and many other advisors from patient advocacy organizations across the Americas and Europe.

Learning Objectives

Identify key clinically meaningful endpoints used in GLP-1 trials; Describe current opportunities and challenges in obesity drug development; Explain how the public private partnership led by Drug Information Association is advancing trial endpoint alignment.

Chair

Maria Vassileva, PHD

Speaker

Panelist
Katherin Ruiz

Panelist
Alison Matsui, MPH

Panelist
Brad Jordan, PHD

Panelist
Jingyu (Julia) Luan, PHD

Speakers

Brad Jordan

Associate Vice President, Regulatory Policy and Strategy, Eli Lilly and Company, United States

Brad Jordan is the Associate Vice President of Regulatory Policy and Strategy at Eli Lilly, where he is responsible for the regulatory policy strategy for Lilly’s cardiometabolic and immunology therapeutic areas.

Jingyu (Julia) Luan

Executive Regulatory Science Director, AstraZeneca, United States

Dr. Luan is currently the Executive Regulatory Science Director at AstraZeneca (AZ), where she oversees all regulatory aspects of obesity and diabetes drug development and supports the research, development, and commercialization efforts in these disease areas. She also leads the... Read More →

Alison Matsui

Senior Principal PCOR Scientist, Genentech, A Member of the Roche Group, United States

Katherin Ruiz

Consultant, Global Scientific Communications, Eli Lilly and Company, United States

Maria Vassileva

Chief Science and Regulatory Officer, DIA, United States

Dr. Vassileva has decades of experience with managing complex multi-stakeholder biomedical research programs. She spent most of her career in the nonprofit sector, leading the Science Team at the Arthritis Foundation, and working at the Foundation for NIH and the American Association... Read More →

Tuesday June 16, 2026 1:45pm - 3:00pm EDT
108A The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA

02: ClinicalTrialOps-Innovation, Session

Audience Advanced
Area Therapeutic Pathways
Level Advanced
format csv
Credit Type ACPE, CME, RN
Interest Area Clinical Development & Operations
Feature Topics Therapeutic Pathways
Tags Session

1:45pm EDT

#531: Tolerability in Immuno-Oncology: Patient Experience as a Core Element of Clinical Trials

Tuesday June 16, 2026 1:45pm - 3:00pm EDT

107AB

Component Type: Session
Level: Advanced
CE: ACPE 1.25 Knowledge UAN: 0286-0000-26-571-L04-P; CME 1.25; RN 1.25

Update on a DIA study advancing patient experience data to assess tolerability in immuno-oncology trials, highlighting conceptual model progress and stakeholder insights for regulatory decisions.

Learning Objectives

Describe recent developments from the DIA study integrating patient experience into immuno-oncology tolerability assessments; Examine findings from literature and KOL interviews; Identify strategies for operationalizing a multidimensional tolerability framework; Recognize multistakeholder perspectives to support trial design, data collection, and benefit–risk evaluation.

Chair

Devin Peipert, PHD

Speaker

Panelist
Efrat Dotan, MD

Panelist
Maria Paula Bautista Acelas, MSC

Panelist
Lia Ridout

Speakers

Maria Paula Bautista Acelas

Scientific Program Manager, Research Partnerships, DIA, United States

Maria Paula offers expert guidance in scientific content development and project management for DIA’s global research partnerships, meetings, and programs. She is dedicated to advancing impactful, patient-centric scientific content that generates evidence to support the integration... Read More →

Efrat Dotan

Executive Medical Director, Ann B Barshinger Cancer Institute, Lancaster General, Penn Center for Cancer Care Innovation, United States

Devin Peipert

Professor of Health Outcomes Measurement, University of Birmingham, United Kingdom

Prof Peipert holds a 125th Anniversary Chair in the Department of Applied Health Sciences at the University of Birmingham, where he is affiliated with the Centre for Patient Reported Outcomes Research (CPROR) and the Birmingham Health Partners Centre for Regulatory Science and Innovation... Read More →

Lia Ridout

Patient Advocate, -, United States

Lia Ridout is a passionate survivor advocate in the lung cancer community. Diagnosed with stage 3b ALK+ non-small cell lung cancer in 2017, despite having no known risk factors, she became dedicated to advocating for patients. In recent years, she has expanded her focus to include... Read More →

Angela Rylands

Global Head of Patient Centred Outcomes, Kyowa Kirin, United Kingdom

Tuesday June 16, 2026 1:45pm - 3:00pm EDT
107AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA

02: ClinicalTrialOps-Innovation, Session

Audience Advanced
Area Therapeutic Pathways, Patient-Centered Design and Experience
Level Advanced
format csv
Credit Type ACPE, CME, RN
Interest Area Clinical Development & Operations,Patient Engagement
Feature Topics Therapeutic Pathways,Patient-Centered Design and Experience
Tags Session

1:45pm EDT

#543: Global Regulatory Perspectives on Bayesian Design and Analysis Informing Regulatory Decision Making

Tuesday June 16, 2026 1:45pm - 3:00pm EDT

116

Component Type: Forum
Level: Advanced
CE: ACPE 1.25 Knowledge UAN: 0286-0000-26-581-L04-P; CME 1.25; RN 1.25

Bayesian statistical methods are gaining increasing importance in drug development, with growing regulatory recognition across major global health authorities. Recent developments highlight this momentum: the U.S. Food and Drug Administration (FDA) released a draft guidance in early 2026 on the use of Bayesian methodology in clinical trials, while China’s Center for Drug Evaluation (CDE) issued a draft guidance in 2026 focused on Bayesian approaches for external data borrowing. In parallel, the European Medicines Agency (EMA) has published a concept paper and is currently seeking public consultation (Q1–Q2 2026) as a first step toward developing formal guidance. This session brings together key contributors to these regulatory initiatives to provide a unique, cross-regional perspective on the evolving role of Bayesian design and analysis in informing regulatory decision-making. Speakers will present the scope, principles, and current thinking reflected in their respective documents, as well as discuss areas of alignment, divergence, and ongoing uncertainty across regions. Given that all three agencies are actively shaping their positions, this session offers a timely opportunity for dialogue between regulators and industry. Through case examples and panel discussion, participants will gain insight into how Bayesian methods are being evaluated in practice, including considerations for trial design, external data integration, and evidentiary standards. The session will also highlight opportunities for stakeholder engagement, particularly in the context of EMA’s ongoing public consultation. Attendees will leave with a clearer understanding of global regulatory expectations and practical strategies for incorporating Bayesian approaches into drug development programs in a rapidly evolving regulatory landscape.

Learning Objectives

Summarize key elements of recent FDA (2026) and CDE (2026) draft guidances and EMA concept paper on Bayesian methods; Compare regulatory perspectives and areas of alignment and divergence across regions; Explain applications of Bayesian approaches in clinical trial design, analysis, and regulatory decision-making; Identify current expectations, implementation challenges, and opportunities for industry engagement in shaping future guidance.

Chair

May F Mo, MBA, MS

Speaker

Panelist
Juan Jose Abellan

Panelist
Andrew Thomson, PHD, MA, MSC

Speakers

Juan Jose Abellan

Statistician, Data Analytics and Methods Task Force, European Medicines Agency, Netherlands

May Mo

Associate Vice President, Biostatistics, Amgen, United States

May Mo is an Associate Vice President of Biostatistics and the Head of Design and Innovation (D&I) group within the Center of Design and Analysis (CfDA) at Amgen. In her role, she leads an internal platform organization with specialized statistical expertise in areas such as Innovative... Read More →

Andrew Thomson

Consultant, Regnitio, Netherlands

Dr Thomson is a consultant providing expert advice on clinical trial design, analysis and interpretation. He spent over 18 years as a regulator in the EU system, where he held a variety of quantitative roles, initially at the UK regulator, MHRA and subsequently at EMA. In his time... Read More →

Tuesday June 16, 2026 1:45pm - 3:00pm EDT
116 The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA

10: Stats-EvidenceGeneration-RWE, Forum | 02: ClinicalTrialOps-Innovation, Forum

Audience Advanced
Area Global Alignment in Practice
Level Advanced
format csv
Credit Type ACPE, CME, RN
Interest Area Clinical Development & Operations
Feature Topics Global Alignment in Practice
Tags Forum

4:15pm EDT

#554: Reverse Pitches: How Pharma Actually Buys

Tuesday June 16, 2026 4:15pm - 5:15pm EDT

103A

Component Type: Session
Level: Advanced

Founders pitch to pharma expecting a straightforward evaluation, but pharma doesn't buy the way VCs do. Led by Whale Tank judges and biopharma thought leaders, this session flips the script—showing how pharma actually evaluates, negotiates, and commits to partnerships with innovative companies.

Learning Objectives

Identify the hidden criteria and decision-makers that determine whether a pharma deal moves forward; Understand MSAs, compliance requirements, and relationship dynamics that shape biopharma partnerships; Recognize common deal-stoppers and structure early conversations to align with how pharma actually evaluates and buys.

Chair

Ligia Kilinski Kilinski Cevasco

Speaker

Panelist
Mindy Gruba

Speakers

Ligia Kilinski Cevasco

BioPharma Consultant, Ligia Kilinski-Cevasco, Inc., United States

Mindy Gruba

Associate Director, Clinical Trial Digital Health, Moderna, United States

Tuesday June 16, 2026 4:15pm - 5:15pm EDT
103A The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA

06: ProfDevelop-Program-PortfolioMgmt, Session | 08: RegPolicy-Strategy-GlobalCollaboration, Session | 18: Lift-Series, Session

Audience Advanced
Area Biotech-ClinTech-Pathway
Level Advanced
format csv
Interest Area Biotechnology & Investors
Feature Topics Biotech-ClinTech-Pathway
Tags Session

10:15am EDT

#604: Counting the Cost: Translating Participant Burden into Fair Compensation

Wednesday June 17, 2026 10:15am - 11:30am EDT

108B

Component Type: Workshop
Level: Advanced
CE: ACPE 1.25 Application UAN: 0286-0000-26-599-L04-P; CME 1.25; RN 1.25

This interactive workshop moves beyond analysis to implementation—translating burden into cost and exploring fair compensation models to advance equity, access, and the participation experience

Learning Objectives

Examine how participant burdens translate into measurable costs and affect recruitment and retention; Apply fairness-based frameworks that align compensation with lived experience; Evaluate ethical, regulatory, and policy considerations to guide implementation models that improve equity and strengthen science through representative participation

Chair

Lani Hashimoto

Speaker

Panelist
Donna Libretti Cooke, JD

Panelist
Bernadette Tosti

Panelist
T.J. Sharpe, PMP

Panelist
Shay Webb

Speakers

Donna Libretti Cooke

Chief Impact Officer & Owner, ImpactSphere Clinical, LLC, United States

Donna Libretti Cooke, JD is Chief Impact Officer and Owner of ImpactSphere Clinical, LLC, advising pharma sponsors, CROs, and start-up vendors on participant payment strategy and clinical trial operations. She co-developed the Whole-Person Participant Support™ framework and led... Read More →

Lani Hashimoto

Consultant, Patient Experience, Hashimoto Consulting Services, United States

Dedicated to connecting patients to research, Lani's lived experience as a trial participant & as a caregiver further inspired her professional pursuits. She credits the Cystic Fibrosis Foundation as a key influence in her passion for patient experience & the importance of patient... Read More →

T.J. Sharpe

Patient Engagement Expert, Sharpe Patient Insights, United States

T.J. Sharpe is a keynote speaker, writer, and patient engagement leader who partners with life sciences companies and healthcare organizations to integrate meaningful patient perspectives into clinical research and healthcare innovation. He develops and leads patient engagement programs... Read More →

Bernadette Tosti

Partner, BGT Partners LLC, United States

Bernadette Tosti brings nearly 10 years of healthcare marketing, clinical trial recruitment and retention, and digital recruitment technology experience to her role at Quintiles. During her tenure at Quintiles, she has helped develop innovative technology solutions for recruitment... Read More →

Shay Webb

Global Clinical Trials Operation, Emerging Talent Rotation, Merck & Co., Inc., United States

Wednesday June 17, 2026 10:15am - 11:30am EDT
108B The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA

02: ClinicalTrialOps-Innovation, Workshop

Audience Advanced
Area Ethics, Trust and Responsible Innovation, Patient-Centered Design and Experience
Level Advanced
format csv
Credit Type ACPE, CME, RN
Interest Area Patient Engagement,Value & Access
Feature Topics Ethics, Trust and Responsible Innovation,Patient-Centered Design and Experience
Tags Workshop

10:15am EDT

#603.1: Case Studies on AI-Enabled and Analytical Practices and Solutions Reducing Site and Participant Burden in Clinical Trials

Wednesday June 17, 2026 10:15am - 11:30am EDT

108A

Component Type: Session
Level: Advanced
CE: ACPE 1.25 Application UAN: 0286-0000-26-598-L04-P; CME 1.25; RN 1.25

In this session, sponsor companies present use cases on strategies and solutions deployed (e.g., digitized protocols and AI-enabled tool) to simplify protocol design and reduce participant and site burden.

Learning Objectives

Discuss case examples profiling solutions and practices that sponsors have implemented to measure and reduce participant and site burden in clinical trials; Identify key factors driving burden in clinical trials; Describe approaches and experience with digitized protocol designs and AI-enabled protocol planning and design solutions.

Chair

Abigail Dirks, MS

Speaker

Panelist
Stephanie Christopher, MA

Panelist
Katrina Mateo, PHD, MPH

Speakers

Stephanie Christopher

Patient Engagement and Advocacy Lead, Pfizer, United States

Stephanie Christopher is a Patient Engagement and Advocacy Lead at Pfizer, where she supports clinical research teams to bring patient perspectives into the design and implementation of clinical trials and recruitment strategies. In this role, she supports Pfizer’s Breast, Genitourinary... Read More →

Abigail Dirks

Senior Data Scientist, Tufts Center for the Study of Drug Development, United States

Abigail Dirks is a Senior Data Scientist at the Tufts Center for the Study of Drug Development (Tufts CSDD) where she specializes in analyzing large datasets pertaining to all aspects of industry-funded drug development performance including protocol design complexity, investigative... Read More →

Katrina Mateo

Associate Director, Development Innovation, Regeneron Pharmaceuticals, United States

Katrina F. Mateo, PhD MPH, is a public health researcher, interventionist, and strategist bringing evidence-based, human-centered solutions to complex challenges. She leverages qualitative/mixed-method research methodology, human-centered design thinking, systems-thinking, behavioral... Read More →

Wednesday June 17, 2026 10:15am - 11:30am EDT
108A The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA

02: ClinicalTrialOps-Innovation, Session | 03: Data-Tech-AI, Session

Audience Advanced
Area Artificial Intelligence, Digital Enablement and Modernization
Level Advanced
format csv
Credit Type ACPE, CME, RN
Interest Area Health Technology & AI
Feature Topics Artificial Intelligence,Digital Enablement and Modernization
Tags Session

10:15am EDT

#601: Inside the Investor’s Mind: How Today’s Biotech Investors Choose Where to Place Their Bets

Wednesday June 17, 2026 10:15am - 11:30am EDT

103A

Component Type: Session
Level: Advanced

This session takes participants inside the investor’s mind in today’s complex funding environment. Investors and financial leaders will discuss how they evaluate pipelines, platforms, and partnerships, where they look for differentiated deal flow, how valuation frameworks are changing, and what ultimately convinces them to lean in—or pass.

Learning Objectives

Explain how current biotech investors evaluate pipelines, platforms, and partnerships in today’s funding climate; Describe how valuation frameworks, risk appetite, and evidence expectations are evolving across stages and modalities; Identify what ultimately convinces investors to engage, lean in, or pass and how companies can position themselves accordingly.

Chair

Raju Kucherlapati

Speaker

Panelist
Jay Roberts, MBA

Panelist
Sahirzeeshan Ali

Panelist
Mey Boukenna, MD, PHD

Speakers

Sahirzeeshan Ali

Founder and General Partner, Modi Ventures, United States

Sahir Ali is the founder of Modi Ventures, a venture capital firm at the forefront of investing in the convergence of biology and technology. With a focus on scientific superintelligence and the engineering of life, he has backed breakthrough companies advancing AI-driven drug discovery... Read More →

Mey Boukenna

Partner, Life Sciences & Healthcare Investments, PagsGroup, United States

Mey Boukenna, M.D., Ph.D., leads Biotechnology and Healthcare Investments at PagsGroup, Steve Pagliuca’s family office. She transitioned to investments after starting her career in medicine and research at the University of Bern, Switzerland. There, she conducted a few years of... Read More →

Raju Kucherlapati

Paul C. Cabot Professor of Genetics and Professor of Medicine, Harvard Medical School, United States

Since 2001 Dr. Kucherlapati is the Paul C. Cabot Professor of Genetics and Professor of Medicine at Harvard Medical School and was the first Scientific Director of the Harvard Medical School-Partners HealthCare Center for Genetics and Genomics (HPCGG). He was a co-founder of several... Read More →

Jay Roberts

Partner, Ventac Partners, United States

Senior strategic executive in the biopharma industry for over 30 yrs. Serving as an Executive Advisor for Life365, a next generation AI platform connecting patients and providers. Also serves as a Partner with Ventac Partners, a global venture catalyst in life sciences and a Venture... Read More →

Wednesday June 17, 2026 10:15am - 11:30am EDT
103A The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA

05: PersonalizedMed-ComboProd-Diagnostics, Session | 06: ProfDevelop-Program-PortfolioMgmt, Session | 18: Lift-Series, Session

Audience Advanced
Area Biotech-ClinTech-Pathway
Level Advanced
format csv
Feature Topics Biotech-ClinTech-Pathway
Tags Session

10:15am EDT

#608: Can You Complete Your Submission in 10 Weeks?

Wednesday June 17, 2026 10:15am - 11:30am EDT

202AB

Component Type: Workshop
Level: Advanced
CE: ACPE 1.25 Knowledge UAN: 0286-0000-26-605-L04-P; CME 1.25; PDU 1.25 PMI 2166B0UIY1 ; RN 1.25

Drug development teams are being expected to deliver marketing applications in record time, despite increased complexity. This workshop is designed to give participants first-hand experience in such a submission.

Learning Objectives

Recognize key factors that must be identified proactively to ensure creation of a submission timeline that is both expedited and feasible; Diagnose the critical path and rate-limiting components in the plan, and learn ways of mitigating the risks of those components; Demonstrate the ability to adjust to changes and embrace scenario-planning when faced with uncertainty.

Chair

Steve Sibley, MS

Speaker

Can You Complete Your Submission in 10 weeks!
Sharon Wolfe-Schwartz, MS

Speakers

Steve Sibley

Vice President, Global Submissions and Submissions Leadership, Certara, United States

With a career spanning more than 30 years in the pharmaceutical industry, Mr. Sibley has extensive experience across regulatory writing, consulting, and regulatory project leadership roles. He has successfully supported projects from discovery through approval and life cycle management... Read More →

Steve Sibley

Vice President, Global Submissions and Submissions Leadership, Veristat LLC, United States

Sharon Wolfe-Schwartz

Executive Director, Regulatory Medical Writing, Harmony Biosciences Management, Inc., United States

Wednesday June 17, 2026 10:15am - 11:30am EDT
202AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA

06: ProfDevelop-Program-PortfolioMgmt, Workshop | 08: RegPolicy-Strategy-GlobalCollaboration, Workshop | 04: MedAffairs-SciComm, Workshop

Audience Advanced
Area Artificial Intelligence
Level Advanced
format csv
Credit Type ACPE, CME, PMI, RN
Feature Topics Artificial Intelligence
Tags Workshop

1:45pm EDT

#626: Navigating the Regulatory Labyrinth: How Well Do Language Models Read the Fine Print?

Wednesday June 17, 2026 1:45pm - 2:45pm EDT

107AB

Component Type: Session
Level: Advanced
CE: ACPE 1.00 Knowledge UAN: 0286-0000-26-616-L04-P; CME 1.00; RN 1.00

Comprehensive benchmarking of four major LLMs across 100 FDA approval packages identifies optimal models for regulatory tasks. Study provides critical insights on accuracy, limitations, and implementation strategies for regulatory AI adoption.

Learning Objectives

Identify which LLM models demonstrated highest accuracy of generative AI for extracting critical regulatory data from FDA approval packages; Recognize key limitations and failure modes when using LLMs for regulatory intelligence, including hallucination rates and performance degradation patterns; Apply evidence-based benchmarking to select an LLM

Chair

Sam Kay, RAC

Speaker

Navigating the Regulatory Labyrinth: How Well Do Language Models Read the Fine Print?
Cameron Kieffer, PHD

Navigating the Regulatory Labyrinth: How Well Do Language Models Read the Fine Print?
Jeff MacDonald, PHARMD

Navigating the Regulatory Labyrinth: How Well Do Language Models Read the Fine Print?
Aleksandr Merenkov

Speakers

skay8

VP of Pharmaceutical Strategy, Basil Systems, United States

Sam Kay is Vice President of Pharma at Basil Systems, where he leads AI-powered regulatory intelligence solutions for global pharmaceutical companies. A recognized authority in the field, Sam co-authored Chapter 6 of Regulatory Intelligence Reimagined (RAPS) and teaches Regulatory... Read More →

Cameron Kieffer

Director, Global Regulatory Intelligence and Policy Research, Takeda, United States

Jeff MacDonald

Associate Director, Global Regulatory Policy and Intelligence, BeOne Medicines, United States

Aleksandr Merenkov

Associate Director, Global Regulatory Intelligence, Genmab US, Inc., United States

Wednesday June 17, 2026 1:45pm - 2:45pm EDT
107AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA

03: Data-Tech-AI, Session

Audience Advanced
Area Artificial Intelligence
Level Advanced
format csv
Credit Type ACPE, CME, RN
Feature Topics Artificial Intelligence
Tags Session

1:45pm EDT

#627: Patient-Directed Data Sharing: Enabling Innovations While Including Patients in Decisions about Secondary Data Use

Wednesday June 17, 2026 1:45pm - 2:45pm EDT

111AB

Component Type: Forum
Level: Advanced
CE: ACPE 1.00 Knowledge UAN: 0286-0000-26-615-L04-P; CME 1.00; RN 1.00

We’ll review the history, laws, and policies of the current data sharing environment. We’ll discuss ethical considerations for why the typical approach to consent and deidentification of data hinder trust and innovation. We’ll give a case study of pa

Learning Objectives

Describe the history of data sharing and the laws and policies that have informed it; Discuss the ethical considerations for shifting our mindset about data access permissions; Apply a patient-directed mindset to data access to unlock innovation and improve data utility

Chair

Karla Childers, MS

Speaker

Panelist
Mary Gray, PHD

Panelist
Aaron Leibtag

Panelist
Sarah Chamberlin

Speakers

Sarah Chamberlin

Founder and Chief Program Officer, flok, United States

Sarah Chamberlin is Founder & Chief Program Officer of flok Health, a nonprofit advancing care and research for inherited metabolic disorders. She is a leader in patient-directed research and participatory data models, building community-powered data infrastructure that centers patient... Read More →

Karla Childers

Vice President, Bioethics, Policy & Partnerships, Johnson & Johnson, United States

Mary Gray

Senior Principal Researcher, Microsoft Research, United States

Mary L. Gray is a Senior Principal Researcher at Microsoft Research and a leading scholar of the social and ethical dimensions of data-driven AI systems. Trained as an anthropologist, her research examines how digital infrastructures shape labor, identity, and human rights. She leads... Read More →

Aaron Leibtag

CEO, Pentavere, Canada

Wednesday June 17, 2026 1:45pm - 2:45pm EDT
111AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA

03: Data-Tech-AI, Forum | 02: ClinicalTrialOps-Innovation, Forum

Audience Advanced
Area Ethics, Trust and Responsible Innovation
Level Advanced
format csv
Credit Type ACPE, CME, RN
Interest Area Data Management & Data Standards,Patient Engagement
Feature Topics Ethics, Trust and Responsible Innovation
Tags Forum

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

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 →

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 →

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 →

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

8:00am EDT

#704: The View from the Top: What is the Future of Medical Writing?

Thursday June 18, 2026 8:00am - 9:00am EDT

105AB

Component Type: Forum
Level: Advanced
CE: ACPE 1.00 Knowledge UAN: 0286-0000-26-646-L04-P; CME 1.00; RN 1.00

Senior regulatory writing leaders from top pharma companies will share a candid, strategic view of how medical/regulatory writing is evolving over the next 3–5 years. The panel will explore how technology (including AI and structured content), new regulatory pathways, and shifting operating models are redefining writer responsibilities, team structures, and the value writers bring to development programs. Attendees will leave with clear insights on future-ready skills and practical steps to position regulatory writing as a critical driver of regulatory and clinical success.

Learning Objectives

Describe leadership-level forecasts for the medical/regulatory writing function over the next 3–5 years, including key forces driving change; Identify how top pharma organizations are redefining the role and value of regulatory writers; Explain the implications of technology adoption on writer responsibilities, quality oversight, and team structures.

Chair

Robin Whitsell

Speaker

Panelist
Elizabeth Brown, MS, PMP

Panelist
Krista Crenshaw, MS

Panelist
Nancy Tam, MS

Panelist
Joanne Hilton, MBA

Speakers

Elizabeth Brown

Executive Director, Clinical & Regulatory Strategic Communications, Merck & Co., Inc., United States

Elizabeth Brown is the Executive Director, Head of Clinical Transparency Communications at Merck & Co, Inc., where she oversees clinical trial registration and results disclosure, as well as health literacy deliverables (ICF/PLS). She has led people, projects, and initiatives in biopharma... Read More →

Krista Crenshaw

Sr. Director, Clinical Content Operations, Alcon, United States

Krista is the Senior Director of Clinical Content Operations at Alcon, leading a global organization of medical writers, QC specialists, and publications leads responsible for clinical trial documentation, regulatory submissions, and publications for devices and pharmaceuticals. With... Read More →

Joanne Hilton

VP, Global Medical Writing, GlaxoSmithKline, United Kingdom

Joanne Hilton has over 25 years’ experience in medical communications across regulatory affairs, clinical development and medical affairs in large pharma as well as boutique agencies. She has a track record of building capabilities globally, delivering strategic growth, talent management... Read More →

Nancy Tam

Vice President and Head of Medical Writing, Pfizer, United States

Nancy Tam is the Head of Medical Writing at Pfizer and has more than 20 years of experience as a medical writing professional in the biopharmaceutical industry. Nancy is passionate about the role of medical writers in clinical development and has been involved in a wide range of transformation... Read More →