Agenda for Day 2 – Friday, September 11, 2026 - ET (Eastern Time, GMT-05:00)
Fundamentals for newcomers to clinical trial transparency & disclosure.
Understand the landscape of data disclosure, key stakeholders, and why transparency matters across the clinical trial lifecycles
Navigate major regulations and requirements across FDA, EMA, MHRA, Health Canada, and other jurisdictions
Master core concepts including anonymization, redaction, plain language summaries, data sharing and common compliance pitfalls
- Rehana Blunt - Senior Manager, Clinical Trials Disclosure, Amgen
An interactive workshop designed for senior disclosure professionals and industry veterans.
Prepare for emerging regulatory landscapes including EHDS, expanding Asian markets, and evolving transparency requirements across jurisdictions
Master disclosure approaches for challenging scenarios including adaptive trials, decentralized/hybrid studies, novel modalities, and multi-sponsor collaborations
Build scalable strategies and technology roadmaps that future-proof your disclosure program as complexity and portfolio size increase
- Tom Chmielewski - Senior Director, Disclosure & Transparency, Jazz Pharmaceuticals
Explore how AI enhances rather than replaces medical writing expertise.
- Address the reality: Why AI cannot replace strategic value, clinical judgement, and expertise that medical writers provide
Evaluate current AI tools, their appropriate applications, and where human expertise remains essential for quality and compliance
Redefine the evolving medical writer role from tactical execution to strategic oversight, with expanded skills and career opportunities in an AI-enabled environment
- Shirisha Kanthala - Director of Trial Disclosure, Incyte
- Sujata Shah - Senior Director, Medical Writing Delivery & Excellence, Moderna
Explore how leading organizations are repositioning medical writers from tactical executors to strategic partners in disclosure planning and patient communication
Examine organizational models that integrate medical writers earlier in trial planning, involve them in cross-functional decision-making, and recognize their expertise
Learn strategies for career development, professional recognition, and creating pathways for medical writers to influence transparency strategies and patient-facing communications
- Shirisha Kanthala - Director of Trial Disclosure, Incyte
Challenge the “handoff model” between regulatory writing and disclosure and examine why it creates misalignment, inefficiencies, and avoidable rework
Expose the hidden cost of disconnected teams by exploring how inconsistencies across protocols, study reports, and public disclosures arise, and how to prevent them upstream
Rethink the role of medical writers in transparency by positioning clinical team writers and disclosure specialists as a unified function with shared accountability for clear, consistent communication
- Sujata Shah - Senior Director, Medical Writing Delivery & Excellence, Moderna
- Oanh Stephan - Executive Director, Head of Global Medical Writing, BeOne Medicines
- Linda LaMarre - Director, Medical Writing, Daiichi Sankyo
Learn how Cytokinetics established a Health Literacy Council to improve the clarity, accessibility and consistency of patient-facing materials across the organization
Explore how Clinical Trial Transparency and Patient Advocacy partner to incorporate patient preferences and feedback into Plain Language Summaries, publication summaries, informed consent forms and other patient communications
Discover practical lessons for implementing health literacy principles and patient-centered review processes that enhance understanding, trust and engagement
- Marina Peele - Associate Director, Clinical Trial Transparency, Cytokinetics
- Addie Lucas - Associate Director of Patient Advocacy & Engagement, Cytokinetics
- Learn how Bristol Myers Squibb developed Video Plain Language Summaries (PLS) of Clinical Trial Results as an additional way for patients and the public to engage with clinical trial results.
Discover how approved written PLS content can be transformed into standardized video summaries through an AI-enabled workflow that maintains scientific integrity, governance, traceability, and human oversight.
Explore how automation shifted teams from video production activities to reviewer and editor roles, enabling patient-centered communication to scale without a proportional increase in headcount.
Gain insights into accessibility-focused design, lessons learned implementing Video PLS in a resource-constrained environment, and how this work may help us better understand the impact of communication format on patient engagement and access to clinical trial results
- Nikki Moolman - Senior Manager, Clinical Trial Results, Bristol Myers Squibb
Understand Malaysia’s regulatory pathway for clinical trial authorization and how disclosure obligations are embedded across the trial lifecycle
Explore registration and results reporting requirements for sponsors conducting trials in Malaysia, including timelines and submission expectations
- Tee Khim Boon, PhD - Senior Principal Assistant Director, National Pharmacy Regulatory Agency (NPRA),MOH
Understand NLM’s current expectations for registration and results reporting, including how quality of reporting is evaluated; obtain information about determinations of non-compliance made independent of NLM
Explore how the Protocol Registration and Results System (PRS) is being modernized, including guided tutorials and system improvements designed to support higher‑quality data entry
Learn how delayed results reporting fits into a modernized oversight model, including NIH and FDA considerations and what disclosure teams need to document
- Stacey Arnold - Results Team Subject Matter Expert, National Institutes of Health (NIH)
April 2026 policy changes, including new expectations for returning individual and summary‑level results to participants
How UK transparency requirements diverge from EU approaches
Clarifying sponsor vs site responsibilities in participant communications
- Clive Collett - Head of Policy and Engagement, Health Research Authority (HRA)
- Stephen Lam - Business Manager (Clinical Investigations and Trials), Medicines and Healthcare products Regulatory Agency (MHRA)
Examine how Commercially Confidential Information (CCI) can be identified and planned for early in a drug program, beginning at protocol development and initial regulatory submissions
Contrast proactive, early‑stage CCI approaches with late‑stage redaction and disclosure decisions at the program level
Understand how managing CCI during document authoring reduces downstream rework and supports more consistent, defensible disclosure outcomes
Discuss the impact of company size on CCI management strategy, risk tolerance, and stakeholder engagement
- Laura Dodd - Associate Director of Clinical Trial Transparency & Disclosure, Kura Oncology
- Whitney Graves - Director, Clinical Trial Transparency & Disclosure, Immunome
Explore the full journey of patient-facing materials from development to real-world access, including how organizations can ensure patients actually find, understand and use the information provided
Apply plain language and health literacy principles that strengthen clarity, trust and usability across diverse patient populations while supporting consistent communication throughout the trial lifecycle
Develop intentional and repeatable distribution strategies that incorporate data-driven insights, partnerships and measurable outcomes to demonstrate meaningful patient engagement
- Kimbra Edwards - Senior Director, Health Communication Services, Center for Information and Study on Clinical Research Participation (CISCRP)
Review how evolving regulatory expectations and good clinical practice standards are reshaping informed consent requirements and what this means for how sponsors design and communicate consent documents
Explore the tension between legal completeness and genuine participant comprehension and how plain language principles can bridge the gap
Determine practical approaches for designing consent processes that build meaningful trust and informed participation across trial populations
- Rachel Ennis - Director, Head of Informed Consent Medical Writing, Merck
Explore how Bristol Myers Squibb's PAIR (Protocol Amendment Impact Review) automates protocol amendment impact assessments, eliminating manual bottlenecks, compliance risks, and inconsistent interpretation across global trial teams
Discover how PAIR integrates with ClinicalTrials.gov APIs to generate same-day impact assessments with 100% coverage and compliance, removing dependency on manual Global Trial Lead input
Gain insights into technical implementation, governance framework, measurable outcomes, and practical lessons from deploying agentic AI to transform clinical trial transparency operations at enterprise scale
- Anna McGlade - Clinical Trials Registration Lead, Bristol Myers Squibb
Examine where full CTIS implementation is creating real operational friction for sponsors managing multi-country trials across member states
Explore transparency obligations that sit outside the CTIS framework, including Switzerland’s 2025 provisions and the emerging EHDS secondary use requirements
Develop practical approaches for closing compliance gaps where CTIS coverage is incomplete or misaligned with broader global disclosure obligations
Explore emerging trends and anticipated changes in clinical trial disclosure for 2027 and beyond, including regulatory evolution, technology advancement, and shifting stakeholder expectations
Examine open questions facing the industry such as diversity in trials without enforcement mandates, decentralized trial implications, and AI regulation acceleration
Gain forward-looking perspectives from diverse industry voices to help organizations prepare strategically for the next phase of clinical transparency
- Elizabeth Brown - Executive Director, Disclosure & Health Literacy, Merck