About C3 Summit
C3 Summit (Conversations on Clinical Content) is a premier clinical and life sciences summit that provides a platform for sponsors, CROs, and biotech professionals to share knowledge, gain industry insights, and build connections. Known for its casual yet highly informative format, the clinical summit features time-efficient, well-curated discussions designed for senior leaders in Pharma, Medical Device, Biotech, and Contract Research Organizations (CROs).
This year in San Francisco, the C3 Summit panels will take place in the afternoon and feature topics across compliance, agentic AI, clinical operations, and more. See the agenda below for more details.
Enhance your TMF Operations at the TMF Experience
Prior to C3 Summit panels in the afternoon, we invite your TMF colleagues to join us in the morning for a hands-on, interactive forum featuring expert-led sessions on oversight best practices, Veeva Vault optimization, cross-functional collaboration, and building a stronger TMF culture. Hear from industry leaders as they share practical strategies for navigating ICH E6 R3, managing vendors, and driving inspection readiness across your TMF operations.
Why Attend C3 Summit?
NETWORKING
Connect with industry peers in the life sciences community, spend time with familiar colleagues, and make new connections.
KNOWLEDGE SHARING
Acquire new approaches by hearing strategies and experiences from peers sharing successes and lessons learned.
PRACTICAL TAKEAWAYS
Return to your teams with pragmatic insights that can be directly applied to existing strategies and processes.
CONVENIENCE
Enjoy an afternoon of efficient, insight-packed panels followed by a happy hour in an experience celebrated for its concise format.
ONE-OF-A-KIND EVENT
Experience the synergy that only one of TransPerfect’s world class events can provide—where every discussion and new connection contributes to an energy that cannot be replicated.
Interested in seeing C3 Summit San Francisco 2023 panel discussions?
Watch our 2023 sessions, which focused on diversity and inclusivity in patient recruitment, training and development, AI in clinical trials, and more.
Speakers
Agenda
Agenda
8:45 – 10:00 AM
Check-in
10:00 – 10:15 AM
Opening Remarks
10:15 – 11:00 AM
What ICH E6 R3 Means for Your TMF
The release of ICH E6 R3 marks a shift toward risk-based, participant-centered trial execution. In this opening session, TMF experts break down the core changes and what they mean for your operations. Hear how organizations are updating their oversight models, adjusting TMF processes, and aligning technology with the new expectations. You will also learn how early adopters are responding across TMF ownership, quality review, and system adoption. Walk away with a clearer view of how to translate guidance into real-world TMF improvements.
Ben Rogers, LMK’s Manager of TMF Education and Employee Development, is responsible for LMK’s TMF University, including the delivery of accredited TMF University courses and the thorough evaluation of student competency assessments. He also oversees LMK’s Corporate Training & Education Program where he leads the development of training content and resources for LMK staff and clients. He has extensive experience in the clinical research industry and has worked in nearly every facet of TMF, from Document Technician to Senior Manager of Site Management Services and TMF.
Laurel-Ann Schrader is a resident TMF subject matter expert. She is a Certified TMF Manager with 21+ years' experience. Her expertise includes TMF inspection readiness, preparation, and support; best practices for clinical document processes, procedures, and cross-functional culture; eTMF implementation and management; and the real-world application of the TMF Reference Model. She previously worked in clinical operations at Ardea Biosciences, ICON, BioPharm Systems, and Amylin Pharmaceuticals. Laurel is an active participant and contributor to the TMF Reference Model working groups and is a thought leader in the TMF industry.
Janice has over 15 years of experience in clinical research (pharmaceutical, biotech and CRO), providing direction and leadership in the clinical operations and document management areas. Her experience includes strategic planning and oversight of TMF services such as eTMF implementation, process development, business/technology alignment, TMF management, content migration, audit and regulatory inspection readiness, risk management, CAPA implementation, KPI/metrics development, line management, resource and budget planning, and cross-functional team leadership. Her results driven approach and continuous improvement mindset are proven for client's success.
Erin O’Boyle is Senior Vice President of Clinical Operations at Rezolute, Inc. with more than 25 years of experience managing studies from start-up through BLA submission and approval. She has worked internationally across adult and pediatric populations, supporting protocols for both large disease indications and ultra-rare conditions.
Erin is passionate about clear communication and alignment among study stakeholders, knowing that bringing a new product to market takes more than a village.
Erin is passionate about clear communication and alignment among study stakeholders, knowing that bringing a new product to market takes more than a village.
11:00 – 11:15 AM
Break
11:15 – 11:45 AM
Unlocking the Full Potential of Your eTMF System
A well-designed eTMF should work for your teams, not against them. In this session, Janice del Rosario and Chrystal Payne share practical strategies to tailor eTMF workflows that align with real operational needs, drive user adoption, and strengthen sponsor–CRO collaboration. They will explore how oversight and metrics reveal TMF health, what pitfalls to avoid during setup and implementation, and how consistent metadata use and accountability keep teams inspection ready. Attendees will gain insight into creating flexible, intuitive systems that support every stage of the trial.
Janice has over 15 years of experience in clinical research (pharmaceutical, biotech and CRO), providing direction and leadership in the clinical operations and document management areas. Her experience includes strategic planning and oversight of TMF services such as eTMF implementation, process development, business/technology alignment, TMF management, content migration, audit and regulatory inspection readiness, risk management, CAPA implementation, KPI/metrics development, line management, resource and budget planning, and cross-functional team leadership. Her results driven approach and continuous improvement mindset are proven for client's success.
Chrystal Payne has worked in the pharmaceutical industry for more than 23 years and currently serves as Manager of the Trial Master File at Structure Therapeutics. Prior to this role, she was Clinical Trial Manager at SFJ Pharmaceutical with a focus on the Trial Master File.
Chrystal began her career in the early 2000s at Chiron Corporation and has since managed teams, implemented TMF systems, and contributed across a wide range of therapeutic indications.
Chrystal began her career in the early 2000s at Chiron Corporation and has since managed teams, implemented TMF systems, and contributed across a wide range of therapeutic indications.
11:45 AM – 12:15 PM
One TMF, One Team - Collaboration Built to Last
A Trial Master File is only as strong as the team behind it. In this closing session, learn how sponsors, CROs, and partners can work together more effectively to build a truly collaborative TMF environment. From clarifying roles and responsibilities to fostering transparent communication and shared accountability, this session offers real strategies to improve cross-functional alignment. Learn how to shift from isolated efforts to unified TMF ownership and walk away with practical steps to support partnership-driven success.
Laurel-Ann Schrader is a resident TMF subject matter expert. She is a Certified TMF Manager with 21+ years' experience. Her expertise includes TMF inspection readiness, preparation, and support; best practices for clinical document processes, procedures, and cross-functional culture; eTMF implementation and management; and the real-world application of the TMF Reference Model. She previously worked in clinical operations at Ardea Biosciences, ICON, BioPharm Systems, and Amylin Pharmaceuticals. Laurel is an active participant and contributor to the TMF Reference Model working groups and is a thought leader in the TMF industry.
Laurie came to TransPerfect 3 years ago from the CRO space, working the previous 14 years at Worldwide Clinical Trials in the TMF Mgmt. group and has experience with several eTMF systems (which included TI as the CRO’s System Admin). Laurie worked on over 500 studies across all therapeutic areas and phases I-IV, pre- and post-marketing, First in Human, and Post-Marketing/Evidence studies. She strongly values the relationship between functions and systems and ensuring everyone is following the quality requirements and best practices to ensure delivery of inspection ready TMFs and positive audit/inspection results. Quality is everyone’s responsibility.
12:15 – 12:30 PM
Ask US Anything!
Wrap up the TMF track with an open Q&A featuring all speakers. This is your opportunity to ask follow-up questions about the sessions, dive deeper into TMF topics, and learn more about the TMF services discussed throughout the morning. Whether you’re seeking clarity, recommendations, or next steps, this interactive discussion will help you leave with confidence and actionable insights.
12:30 – 1:30 PM
Networking Lunch
12:30 – 1:30 PM
Networking Lunch and Check-In
1:30 – 2:00 PM
Regulatory-Ready Patient Engagement: Aligning Advocacy with Compliance
Embedding the patient voice is a core expectation in drug development, yet translating it into regulatory-ready action can still be too ambiguous and cause compliance headaches. This session will bring together regulatory experts with experience in navigating the complexities of working with advocacy groups, gathering patient experience data, and integrating diverse perspectives into trial design. The panelists will share real-world examples on balancing advocacy, diversity, and compliance to ensure engagement strategies that are impactful for patients and credible (and compliant) with regulators.
Cindy Alvarez is a regulatory affairs professional with two decades of global drug development experience in oncology, oncolytic immunotherapies, and neurodegenerative diseases. She has led early- and late-stage filings worldwide, holds a US Regulatory Affairs Certification (RAC), and earned degrees in Biological Sciences and Regulatory Affairs. Cindy is passionate about mentorship and lifelong learning.
Vanessa Cahee is a Biotech Clinical Research Consultant specializing in Clinical Trial Diversity and Clinical Operations. With nearly 25 years in biopharma, including roles at Genentech, Amgen, Onyx, OncoMed, and Myovant, she has led pivotal studies supporting approvals of Kyprolis and Myfembree. She has also co-authored a DIA Global Forum series and speaks internationally on guidance for representative clinical trials.
Laura O’Donnell is a high-engagement leader with more than 20 years of experience in clinical operations and a passion for improving the patient and site experience. As Head of Global Site Engagement at GSK, she harnesses the Site Voice of the Customer to remove friction and make clinical research faster, better, and more human.
Beginning her career in bench science with a focus on immunology, Laura advanced through biotech and pharma leadership roles, specializing in trial optimization and strategic site partnerships. She has built a US Study Start-Up unit, led site-centered innovation initiatives, launched a global site feedback program, and developed a flexible partnership model.
Beginning her career in bench science with a focus on immunology, Laura advanced through biotech and pharma leadership roles, specializing in trial optimization and strategic site partnerships. She has built a US Study Start-Up unit, led site-centered innovation initiatives, launched a global site feedback program, and developed a flexible partnership model.
2:00 – 2:30 PM
Managing a Compliance Program Under the New Executive Administration
With a new executive administration comes new priorities, policies, and enforcement approaches that can cause chaos even in the most established of compliance programs. In this session, legal and compliance leaders will share practical advice for anticipating regulatory shifts, recalibrating risk management, and keeping programs agile in the face of uncertainty.
Marty Hoffman is a legal and compliance leader with over 25 years of experience building compliance programs in highly regulated industries, including healthcare, life sciences, technology, and government. A former US Air Force JAG, Marty has held numerous legal and compliance leadership roles, spending much of his career in healthcare before entering the tech space five years ago.
Kari Loeser is an experienced Chief Compliance Officer with extensive legal and compliance expertise
across large, mid-size, small, and pre-commercial organizations. As a senior executive, she advises on
areas including Board of Director Committee accountability, sales and marketing business conduct and
practices, promotional review, medical review, publications, medical affairs, corporate compliance
programs for life science companies, auditing, monitoring, investigations, corrective actions, policies,
and training. Kari has also served as Chief Privacy Officer at her two most recent companies. She is a
licensed attorney in Illinois and registered in-house counsel in California.
across large, mid-size, small, and pre-commercial organizations. As a senior executive, she advises on
areas including Board of Director Committee accountability, sales and marketing business conduct and
practices, promotional review, medical review, publications, medical affairs, corporate compliance
programs for life science companies, auditing, monitoring, investigations, corrective actions, policies,
and training. Kari has also served as Chief Privacy Officer at her two most recent companies. She is a
licensed attorney in Illinois and registered in-house counsel in California.
Paul Pitts is a partner at Reed Smith LLP and serves as the managing partner of the firm’s San
Francisco office. He represents health care providers and life sciences companies in regulatory
matters and business transactions, with a particular focus on compliance with federal and state
fraud and abuse laws.
Francisco office. He represents health care providers and life sciences companies in regulatory
matters and business transactions, with a particular focus on compliance with federal and state
fraud and abuse laws.
2:30 – 2:45 PM
Break
2:45 – 3:15 PM
Launch Success: How AI and Centralization Are Redefining Commercial Excellence
Life sciences companies are transforming how they launch medical products globally—centralizing content production, connecting translation workflows, and finding ways to embed AI throughout their processes. This panel brings together leaders across pharma and biotech sponsors to explore how intelligent systems are redefining commercial excellence, from content creation to performance measurement, and what it takes to build scalable, compliant, and true global launch success.
Shane Madden brings more than 14 years of experience helping global brands transform how they launch, scale, and measure success in markets worldwide. At TransPerfect Digital, he leads teams that partner with top organizations in pharma, financial services, entertainment, and technology to deliver measurable impact through data and creativity.
In the life sciences sector, Shane focuses on helping companies achieve Launch Success by integrating AI, digital engagement, and personalization into commercialization strategies. His work has supported leading brands including Citi, J&J, SC Johnson, and Novartis.
In the life sciences sector, Shane focuses on helping companies achieve Launch Success by integrating AI, digital engagement, and personalization into commercialization strategies. His work has supported leading brands including Citi, J&J, SC Johnson, and Novartis.
Devin Gray brings over a decade of expertise in optimizing translation workflows, website architecture, and content data structures. Skilled in Drupal, Sitecore, and Adobe Experience Manager, he has implemented processes that cut turnaround times and costs while leading cross-functional teams and onboarding nearly 200 employees to standardized practices.
Amanda Marvel is a senior marketing, advertising, and operations executive with a proven track record of leading award-winning teams, delivering high-impact global campaigns, and driving operational excellence across in-house agencies. Since 2023, Amanda has served as Senior Director of Global Marketing Operations at Gilead Sciences, where she leads content production globally.
Prior to joining Gilead, Amanda spent nearly 15 years at Intel, most recently as Marketing Director, where she led global product campaigns and launch creative that elevated brand visibility and business performance. Her experience spans B2B, B2C, B2I, and HCP audiences across the tech and healthcare sectors, consistently delivering strategies that connect, inspire, and perform.
Prior to joining Gilead, Amanda spent nearly 15 years at Intel, most recently as Marketing Director, where she led global product campaigns and launch creative that elevated brand visibility and business performance. Her experience spans B2B, B2C, B2I, and HCP audiences across the tech and healthcare sectors, consistently delivering strategies that connect, inspire, and perform.
Vik Kapoor is the Head of AI Products and Platforms, based in San Diego. In this role, he leads a digital team focused on transforming innovative AI capabilities from experimentation to enterprise scale.
With more than 20 years of experience, Vik has led numerous transformational technology initiatives across data, analytics, and AI. He is known for fostering a culture of innovation and delivering enterprise-wide programs that drive measurable value for the organization.
With more than 20 years of experience, Vik has led numerous transformational technology initiatives across data, analytics, and AI. He is known for fostering a culture of innovation and delivering enterprise-wide programs that drive measurable value for the organization.
3:15 – 4:00 PM
AI Across the Trial Lifecycle — Lessons Learned from Design to Delivery
AI is no longer the “future of clinical trials.” It’s happening right now, and affecting all facets of clinical research across the product lifecycle. With experts across clinical operations, medical strategy, patient equity, and regulatory affairs, this panel will feature examples and insights into where AI has been successful, where it falls short, and how it’s continuing to change the clinical landscape. Regardless of whether you’re looking to improve design feasibility, simplify processes across global teams, expand your diversity efforts, or speed up study approvals, you’ll hear pragmatic takes with fresh ideas for using AI in your daily work.
David Tsai began his clinical research career at UC Davis Medical Center, conducting pivotal trials and serving on an SCD advisory board. Moving to the sponsor side, he built strong site and CRO partnerships to rescue underperforming trials. His expertise spans hematology/oncology, with current focus on CRISPR-based genetic medicines at Scribe Therapeutics.
Sage Calloway brings 15+ years of industry experience, following earlier careers as an adjunct professor, chef, actor, and model.
Meghan McKenzie develops strategies to increase inclusion of underrepresented patient populations in clinical research, working with sites in the Advancing Inclusive Research (AIR) Site Alliance and shaping best practices through site and patient insights. She brings over 25 years of experience across multiple therapeutic areas and holds advanced credentials in human biology and economics.
4:00 – 5:30 PM
Networking Cocktail Reception
FAQs
Is this event free?
Yes, there is no registration fee associated with this event. However, spots are limited and you will receive a confirmation email once your seat is confirmed.
Will travel and hotel be provided?
No, TransPerfect will not be covering any travel or hotel costs incurred to attend the event.
Who is the event for?
C3 Summit brings together two focused programs in one day. The morning sessions feature the TMF Experience, designed for TMF leaders driving compliance, oversight, and collaboration across the Trial Master File. The afternoon sessions make up the C3 Summit, geared toward executives, directors, and senior managers across Pharma, Medical Device, Biotech, and Contract Research Organizations. Spaces are limited and will be prioritized accordingly, with eligibility subject to approval by the TransPerfect Life Sciences team.
