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WHAT TO EXPECT FOR 2027?

As clinical trials continue to evolve, 2027 brings new challenges and opportunities across clinical operations, technology, regulation and patient engagement. OCT West Coast will bring the industry together to explore what is changing, what is working and what clinical trial teams need to be thinking about next.

Expect practical insights, honest discussions and real-world experiences from leaders across pharma, biotech and the wider clinical trial community. From navigating regulatory change and making the most of new technologies to improving trial efficiency, strengthening partnerships and putting patients at the center, the agenda will focus on the issues shaping clinical development today.

With a strong focus on collaboration and sharing practical experiences, OCT West Coast is an opportunity to connect with the region’s leading pharma and biotech companies, exchange ideas and explore new approaches to delivering smarter, more efficient and patient-focused clinical trials.

800+

Attendees

100+

Exhibitors

70+

Speakers

80%

Attendees at Director + Level
800+

Attendees

100+

Exhibitors
70+

Speakers

80%

Attendees at Director + Level

Testimonials

See What It's All About

Featured Speakers

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Gajanan Bhat​

Senior Vice President, Development Lead, TORL Biotherapeutics

A clinical research and development executive with over 20 years of experience in drug, device and imaging diagnostic agent development and a proven track record of successful execution of clinical development and post-marketing activities in early stage and pivotal clinical trials leading to NDA submissions, approvals and market launch. A result oriented team leader who provides directions to team and strategy for clinical development plan and execution to meet corporate objectives

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Niharika Kamat​

Vice President Clinical Operations, Sardocor

With a desire to create Patient Impact and to do the "hard things", I want to take on complex, challenging clinical programs while leading empowered, high performing teams to accomplish the Impossible. With close to 20 years’ experience in operationalizing strategic, global, Ph1 – Ph3 trials across various therapeutic areas and organizational sizes (large pharma to small biotech), I bring a strong skillset in Leadership, Cross-Functional Collaboration and building the Clinical department. I strive to represent the Patient voice as we design clinical trials balancing scientific goals with trial participant burden and to be the Sponsor of Choice to investigative sites and KOLs. Balancing operational and cost efficiencies with quality and inspection readiness are key areas of focus. I lead with integrity and empathy and enjoy cultivating ownership and excellence. Therapeutic Area Experience – Cardiovascular (AAV9 Gene Therapy, Medical Devices), Liver Diseases (Small Molecule, Hepatitis B, Hepatitis C), Hemophilia, Rare Disease

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Jennifer Willert​

Medical Director CART USOM, Novartis

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Meghan McKenzie​

Director, AIR Portfolio Alliance Lead, Population Science, Genentech

Meghan McKenzie is a Director of Health Equity and Clinical Research at Genentech, Inclusion and Belonging Office. She develops strategies to drive greater inclusion of underrepresented patient populations in clinical research and to advance health equity by working directly with sites in our Advancing Inclusive Research (AIR) Site Alliance and by gaining patient insights to change behavior and protocols.

Gaining patient, clinician and community insights early in program development is integral to developing what is important to patients and improving access to medicines and treatments for all patients, regardless of race, ethnicity, sexual orientation, gender identity, age, disability and socioeconomic status.

She has over 25 years of clinical development research experience working at the site, CRO and biotech level, and spanning multiple diseases, including oncology, ophthalmology, immunology, neurology, infectious and rare diseases.

Meghan received her Master’s Degree in Human Biology at San Francisco State University and her Bachelor’s Degree in Economics at University of North Carolina, Chapel Hill and has earned the Cornell University ‘Advanced D&I Certificate’ and the Columbia Business School ‘Certificate in Business Excellence

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Chitra Sharma​

Senior Vice President, Scribe Therapeutics

Chitra Sharma is a high-impact biotechnology executive with over 25 years of experience architecting product lifecycles from early-stage development through successful NDA/BLA approvals. A specialist in CMC and global Quality operations, she has pioneered regulatory and development strategies, working for industry titans including Genentech, Roche Bioscience, Cor Therapeutics and Vivus.
Currently, as SVP of Development at Scribe Therapeutics, she integrates breakthrough innovation with operational excellence.

Chitra’s expertise spans a sophisticated portfolio of CRISPR, Cell and Gene Therapy, Biologics and small molecules. Over 13 years as a founder and consultant, she served as a premier bridge between scientific discovery and commercial viability for both Fortune 500 firms and agile startups.
A pragmatic leader with deep technical mastery, Chitra is defined by her ability to scale global operations and build high-performing, compliant organizations that navigate the complexities of international drug development.

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Ndidi Rickert​

Senior Director, GxP Compliance, Kardigan Bio

A Kaizen-certified cross-functional leader with operations experience, I specialize in Global GxP Compliance, Audit Strategy and Execution and FDA BIMO, PAI, MHRA, EMA and Health Canada Inspections. I’ve helped bring life-saving therapies to market while fostering cultures of quality. A trusted change agent and co-creator of quality transformation initiatives, critical thinker, collaborator, embedding a culture of continuous improvement and regulatory excellence across complex, matrixed organizations. My work centers on aligning operational excellence with human impact because behind every system is a story, and behind every story is a life worth protecting. Passionate about Quality allyship, mentorship, learning and reinvesting in community.

I lead with purpose and heart, anchored in authenticity, I cultivate humane spaces where identity is honored and excellence, equity, and empathy co-exist.

My leadership is shaped by resilience, legacy, and the belief that stories bridge connection. Born in Sierra Leone, schooled in the UK, I now live in the US. As a perpetual incomer, I lead with commitment to equity, turning lived experience into systems that uplift.

Fun Facts: I grew up on the beaches of Sierra Leone | Myers-Briggs: INFJ | Sickle-Cell and Newborn Screening Advocate | STEM Mentor | Believer in Kindness

LinkedIn Bio: https://www.linkedin.com/in/ndidi-rickert-she-her-47197371/

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    2027 Sponsors Include:

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    Company Information

    ICON Biotech is a world leading healthcare intelligence and clinical research organisation, dedicated to the needs of small and mid-sized biopharma companies. We help biotech organisations meet their critical milestones and deliver data and evidence-based results to investors, large pharma partners and regulatory authorities. With over 8,000 staff working exclusively with biotech customers, we support over 500 biotech sponsors annually.

     

    ICON Biotech advances clinical research by offering highly focused, integrated outsourced services and solutions, delivered by tailored teams and management that understand the different pressures faced by biotechs in their drive to solve today’s challenges, without losing sight of their mission to deliver life-changing innovations tomorrow. To learn more, please visit www.iconplc.com/biotech

     

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    Company Information

    Novotech is a globally recognized full-service clinical research organization (CRO) and scientific advisory partner for biotech and small- to mid-sized pharmaceutical companies seeking to advance drug development. With deep therapeutic and regulatory expertise and an expansive global footprint across the Asia-Pacific region, North America, and Europe, Novotech offers clients an accelerated path to bring life-changing therapies to market.

    Company Website

    To learn more, please visit our website - www.novotech-cro.com

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    Company Information

    Biorce builds AI infrastructure for clinical trials. Our platform, Aika, accelerates how pharmaceutical companies, biotechs, and CROs design and execute clinical research—reducing protocol development time by at least 50% while eliminating costly amendments that delay patient access to life-saving treatments. Built on a foundation of 1 million clinical trials, Aika delivers evidence-based recommendations with complete regulatory transparency. Every decision auditable and defensible before agencies like the FDA and EMA.

    Company Website

    To learn more, please visit our website - https://www.biorce.com/

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    Company Information

    Caidya is a multi-therapeutic clinical research organization (CRO) serving innovators worldwide. Focused on delivery excellence and an elevated customer experience, Caidya offers a wide range of clinical services and vast therapeutic expertise, supporting its partners from pre-IND strategy, through clinical development to submission and post-marketing surveillance. Caidya leverages industry-leading and proprietary clinical technology to ensure trial transparency and data-driven decision-making. Formed in 2021 following the merger of leading CROs, dMed and Clinipace, Caidya has nearly 1,800 employees in 30+ countries throughout the world.

    Company Website

    To learn more, please visit our website - www.Caidya.com

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    Company Information

    EPS Corporation, an EPS Holdings Group Company, a Japanese headquartered company, is a comprehensive provider of clinical research outsourced services. Since 1991, the EPS Group has grown to over 7,800 staff providing quality R&D support to pharmaceutical, biotech, regenerative medicine, and medical device companies. EPS operates in Japan, China, South Korea, and Taiwan. With a business partner, we also support studies in other Asia-Pacific countries.

    Company Website

    To learn more, please visit our website - https://www.eps-holdings.co.jp/en/

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    Company Information

    Founded in 1997, Ergomed is a full service, global Phase I-IV clinical development and trial management service partner with leading expertise in developing oncology and rare disease drugs.  Our portfolio includes experience working with novel therapies, early phase development, immunotherapy, and adaptive trial designs. Ergomed embodies a patient-centric approach to recruitment and retention with access to global patients in vital geographical areas.  Ergomed’s proven delivery record, expertise, and true partnership means our sponsors can trust us to deliver their oncology trials whatever the challenge. We also offer an industry-leading suite of specialist pharmacovigilance (PV) solutions under the PrimeVigilance brand.

    Ergomed has supported and managed clinical development, trial management, pharmacovigilance, and medical information services for over 300 clients in more than 100 countries.

    We deliver a complete solution for oncology trials of all sizes and complexity. For more information about Ergomed, please visit: www.ergomedcro.com

    Company Website

    To learn more, please visit our website - www.ergomedcro.com

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    Company Information

    Fortrea is a leading global provider of clinical development and patient access solutions to the life sciences industry. We partner with emerging and large biopharmaceutical, medical device and diagnostic companies to drive healthcare innovation that accelerates life changing therapies to patients in need. Fortrea provides phase I-IV clinical trial management, clinical pharmacology, differentiated technology enabled trial solutions and post-approval services. Fortrea’s solutions leverage three decades of experience spanning more than 20 therapeutic areas. Our talented and diverse team of more than 19,000 people working in more than 90 countries is scaled to deliver focused and agile solutions to customers globally.

    Company Website

    To learn more, please visit our website - https://www.fortrea.com/

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    Company Information

    MRN is focused on the delivery of patient-centric clinical trials. Through our at-home, at-site and digital decentralized trials solutions we help our pharma and site partners design more flexible and accessible clinical trials allowing them to accelerate patient recruitment and enrollment and improve patient engagement and retention around the globe.

    Company Website

    To learn more, please visit our website - https://themrn.io/

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    Company Information

    MedPoint Digital develops intuitive, ICH-GCP compliant eClinical platforms for virtual investigator meetings, trial portals, interactive modules, and virtual clinical trials. Our digital solutions enable sites to be more productive, with online study training, study eBinders (eISF), digital study alerts and SUSARs, patient visit guides, and a wide range of study tools, available via web portals and mobile apps.

    Company Website

    To learn more, please visit our website - www.medpt.com

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    Company Information

    Parexel is among the world’s largest clinical research organizations (CROs), providing the full range of Phase I to IV clinical development services to help life-saving treatments reach patients faster. Leveraging the breadth of our clinical, regulatory and therapeutic expertise, our team of more than 21,000 global professionals collaborates with biopharmaceutical leaders, emerging innovators and sites to design and deliver clinical trials with patients in mind, increasing access and participation to make clinical research a care option for anyone, anywhere. We work With HeartTM every day to treat patients with dignity and continuously learn from their experiences, so every trial makes a difference.

    Company Website

    To learn more, please visit our website - https://www.parexel.com/

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    Company Information

    Premier Research International LLC (Premier) is a leading global CRO and consulting partner with expertise in driving a smarter, faster path to approval. Our integrated approach helps the life sciences industry turn breakthrough science into life-changing drugs, devices, and diagnostics by addressing trial complexity, overcoming development hurdles, and demonstrating product value. 

    Company Website

    To learn more, please visit our website - https://premier-research.com/

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    Company Information

    PSI is a privately-owned, full-service contract research organization (CRO), operating globally. PSI’s reputation on the market place is that of a no-nonsense CRO, capable of saving pharmaceutical sponsors millions of development dollars by consistently meeting clinical trial timelines. PSI’s global reach supports the operations of clinical trials across multiple countries.

    Company Website

    To learn more, please visit our website - http://www.psi-cro.com/

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    Company Information

    Trialbee is the leading global data and technology platform for patient matching and enrollment in clinical trials. Partnering with sponsors, CROs, sites, and software providers, Trialbee is achieving patient enrollment goals and driving diversity in clinical trials. We are the smartest way to match and enroll patients for your clinical trial.

    Company Website

    To learn more, please visit our website - trialbee.com

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    Company Information

    Precision medicine is in our blood, our cells, our genes, and our name. Precision for Medicine (PFM), the full-service global CRO, is purpose-built to accelerate clinical research and development processes to bring life-changing therapeutics to those who need them most. We integrate clinical operations excellence, laboratory expertise, and advanced data sciences to deliver on the promise of personalized therapy; translating research into real-world results and forever reimaging how to get there.

    Company Website

    To learn more, please visit our website - www.precisionformedicine.com

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    Company Information

    Trial Library is a mission-driven, AI-enabled health technology company dedicated to improving health equity in cancer care by expanding access to precision medicine through clinical trials. We work with community oncology sites, patients, and industry partners to accelerate enrollment and retention and ensure clinical research is accessible, navigable, and inclusive.

    Company Website

    To learn more, please visit our website - https://www.triallibrary.com/

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    Company Information

    P95 Julius Clinical is a global, science-led CRO delivering integrated clinical development and real-world evidence solutions across five continents. Combining deep expertise in infectious diseases, vaccines, neuroscience, and cardio-renal-metabolic research, we support both full-service and modular approaches across the entire development lifecycle and post-marketing phases for pharmaceutical, biotech, and public health partners. With regional hubs in Africa, Latin America, North America, Southeast Asia, and Europe, we operate with a team of 500 professionals and over 25 years of collective experience. Guided by flexibility, client focus, and excellence, we deliver solutions that make a meaningful impact on public health worldwide.

    URL: The therapeutically specialized CRO | Julius Clinical

     

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    Company Information

    IQVIA delivers AI‑powered clinical technologies that simplify trial operations, improve patient and site experiences, and accelerate clinical development. Our secure, SaaS‑based platforms use healthcare‑grade AI to streamline workflows, reduce administrative burden, and enable smarter, faster decision‑making across the clinical trial lifecycle.

    Company Website

    To learn more, please visit our website - https://www.iqvia.com/solutions/technologies

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    Company Information

    ACM Global Laboratories is one of the largest global independent central labs in the industry. ACM is certified by the College of American Pathologists (CAP) and the Substance Abuse and Mental Health Services Administration (SAMHSA). The company delivers high-quality laboratory testing and diagnostic lab services in support of both clinical trials research, toxicology and individual patient care. ACM provides a powerful combination of operational excellence, scientific expertise and unsurpassed global service to customers in more than 65 countries. ACM performs more than 20 million laboratory tests each year—spanning all medical disciplines including pathology, microbiology, molecular diagnostics, toxicology and more.

    Company Website

    To learn more, please visit our website - www.ACMGlobalLab.com

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    Company Information

    Founded in 2005, Inspire connects life sciences organizations with the voices that matter most—patients and caregivers. With 10 million unique annual visitors across over 3,000 disease states, Inspire leverages its engaged patient communities to accelerate clinical trial recruitment, uncover real-world evidence, deliver actionable market research, and provide targeted advertising solutions for health-focused audiences.  By bridging the gap between patients and life sciences, Inspire enables smarter decision-making and a deeper understanding of the communities it serves.

    Company Website

    To learn more, please visit our website - https://inspireresearch.com/

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    Company Information

    Advarra delivers the platform, insights, and expertise that make clinical trials more efficient and connected. We bring over 40 years of trusted IRB oversight, operational intelligence, and collaborative technology to the industry—streamlining study design, startup, and conduct for research sites, sponsors, and CROs worldwide. Learn more at www.advarra.com.

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      2026 Agenda

      • 11 Feb 2026
      • 12 Feb 2026
      Expand All

      Streams

      Stream one

      Stream A: Outsourcing & Clinical Operations

      Stream two

      Stream B: AI and Tech Transformation

      Stream three

      Stream C: Patient Centricity

      11 AM

      PATIENT ADVOCATE PERSPECTIVE: Improving support given to caregivers to reduce burden on patients’ families

      • Implementing support services for caregivers so they can provide information and early warnings of declining patient health
      • Educating caregivers so they are able to provide more compassionate care and more prepared to financially support
      • Maximizing efficiency and patient safety in cancer trials through caregiver engagement
      • Prioritizing caregiver involvement and embracing new ways to ensure they are fully supported

      Speakers

      Alan Balch
      CEO, Patient Advocate Foundation

      11:30 AM

      Decentralized and hybrid solutions giving sites and patients greater access to research

      • How decentralized and hybrid solutions can be used to increase patient access to clinical trials
      • In-home visits have benefits for participants, sites and sponsors
      • How to ensure uptake and adoption to drive global results
      • What's next for the hybrid trial model

      Speakers

      Irina Morris
      Senior Account Alliance Manager, MRN

      12 PM

      PANEL DISCUSSION: Effective collaboration in the trial ecosystem: How should pharma work with patient organizations and what are the best ways to engage with them?

      • Highlighting and overcoming the pitfalls of working with patient groups and how to facilitate the outreach to ensure everyone is onboard
      • Tackling lack of patient awareness: Improved methods of connecting community-based researchers with those in academic centers conducting trials
      • Elevating trial credibility by better working with networks globally to find patients and identify the best centers
      • Why patient advocacy groups are becoming gatekeepers for connecting sponsors and vendors
      • Making trials more patient-focused rather than disease focused

      Speakers

      Jenni Herber
      Associate Director, Clinical Operations, Kamau Therapeutics
      Bruce Morimoto
      Head of Drug Development, Fuku Biotech
      Alan Balch
      CEO, Patient Advocate Foundation
      Kenneth Wilson
      Senior Director, Operational Lead, Pfizer

      1 PM

      Lunch and networking break

      2 PM

      SITE PERSPECTIVE Beyond big centers: Unlocking the potential of community hospitals in oncology research

      • Site assessment: evaluating available clinical and research resources and performing a gap analysis
      • Centralized training for providers and research staff
      • Stepwise trial implementation with frequent monitoring
      • Shared resources from the academic center to support partner sites
      • Improving access to oncology clinical trials in community settings

      Speakers

      Wanda Truong
      Operations Manager, Helen Diller Family Comprehensive Cancer Center, University of California, San Francisco

      2:30 PM

      Why patient centricity must be built into outsourcing

      • Reframe patient centricity from “initiative” → “operating model”
      • Patient centricity is no longer a differentiator
        → It is a baseline expectation from regulators, investors, and patients
      • Yet most organizations still treat it as:
        • A set of tools
        • A functional workstream
        • Or a late-stage overlay
      • Patient centricity only scales when it is embedded into how we select, contract, govern, and operate with vendors
      • Outsourcing decisions shape: study design feasibility, site experience, patient burden, speed, quality, and retention
      • If patient centricity is not designed into outsourcing, it will not survive execution

      Speakers

      Rich Polgar
      Managing Director, Danforth Health

      3 PM

      Reaching underrepresented patients for trials in the current climate

      • Why inclusive research is a business and clinical imperative
      • How to continue the work in the current climate
      • Increasing focus on US enrollment
      • Five principles of data driven inclusive research

      Speakers

      Meghan McKenzie
      Director, AIR Portfolio Alliance Lead, Population Science, Genentech

      3:30 PM

      Afternoon refreshments and networking

      3:45 PM

      PRIZE DRAW

      Visit our exhibitors’ booths throughout the day and collect stamps in order to enter our Prize Draw and be in for a chance of winning Apple devices or Amazon giftcards. The Prize Draw will take place in the Exhibition Hall. Make sure you don’t miss out!

      4 PM

      Developing resilient clinical trials: Lessons learned in CAR-T for ped-young adult and adult oncology trials

      • Working with both cooperative groups and biotechs in a harmonious way
      • How to streamline processes and improve trial design
      • Avoiding pitfalls which can have lasting global impacts
      • Setting up trials for offsite patients and ensuring remote data can be obtained

      Speakers

      Jennifer Willert
      Medical Director CART USOM, Novartis

      4:30 PM

      CLOSING KEYNOTE: Effective inclusion of the patient and patient voice in clinical research

      • Integrating patient perspectives with those of healthcare professionals to create an effective and executable clinical trial
      • Redefining the patients’ role as active collaborators
      • Inclusion of the patient lived experience in clinical trial design, outcome measures, and trial success
      • Listening to patient priorities and fostering ongoing communication and transparency
      • Improving accessibility through digital tools, remote visits and flexible scheduling to help reduce patient burden

      Speakers

      Bruce Morimoto
      Head of Drug Development, Fuku Biotech

      5:30 PM

      Chair’s closing remarks

      Speakers

      Dale Posner
      Clinical Contracts, Calico Life Sciences

      END OF DAY 1 AND NETWORKING DRINKS

      Sponsored by EmVenio

      Join us in the atrium for a drinks reception

      11 AM

      The art of data integration: Biomarkers, AI, and the science of translational insight

      • Challenges of data silos and interoperability across research and clinical
      • Strategies for creating a cohesive data ecosystem that supports translational research
      • Case examples of successful data integration improving patient outcomes or accelerating drug development
      • Predictive and prognostic biomarker discovery through advanced analytics.
      • Regulatory and validation considerations for clinical implementation

      Speakers

      Shiya Song
      Senior Principal Computational Biologist, Amgen

      11:30 AM

      Driving AI transformation in clinical trial financial management

      • Discover how agentic AI streamlines and automates clinical trial financial workflows
      • Learn how team roles evolve—from doing to reviewing
      • Explore the key benefits of AI-driven payment processes in clinical trials
      • Understand how a platform approach unifies end-to-end financial management

      Speakers

      Zahiah (Zee Zee) Gueddar
      Senior Director Commercial Strategy, Clinical Trial Financial Suite, IQVIA Technologies

      12 PM

      PANEL DISCUSSION: How far can AI take us?

      • How AI, ML and predictive analytics are reshaping operations and redefining what CROs can deliver
      • A vision of what AI-powered research may look like in 2030
      • How to keep up with the fast-paced AI is developing whilst maintaining trial integrity
      • Ensuring AI use aligns with regulatory frameworks and safeguards patient trust
      • Promoting smarter trial designs using AI to optimize protocols and identify feasibility risks
      • AI, data and the changing role of the technology service provider

      Speakers

      Paulius Ojeras
      Vice President Clinical Operations, Perceive Biotherapeutics
      Revati Tatake
      Global Head of Pharma Research, Analysis and Competitive Intelligence, GlobalData Healthcare
      Travis Caudill
      VP Feasibility, Site Identification & Clinical Informatics, ICON

      12:30 PM

      Leverage the power of AI to optimize study site and CRA performance

      • Growing trial complexity increases site questions and strains CRA resources
      • RASPberry AI™ provides instant, accurate access to study-specific information
      • Rapid answers improve site performance and CRA productivity
      • Sponsors gain actionable insights into trial execution

      Speakers

      Tim Curry
      SVP, Account Development, MedPoint Digital

      1 PM

      Lunch and networking break

      2 PM

      Clinical development in the digital age

      • Regulatory landscape of drug and device approvals
      • Chronology of technological advances
      • Role of AI/ML in drug development
      • Artificial intelligence and ethics
      • Application of new technology/AI in various drug development – challenges and opportunities
      • Innovative methods and clinical trial considerations

      Speakers

      Gajanan Bhat
      Senior Vice President, Development Lead, TORL Biotherapeutics

      2:30 PM

      Balancing innovation with the reality of AI today

      • Understand the foundational requirements for AI
      • Differentiate between realistic and unrealistic expectations of AI and agents
      • Identify strategies for prioritizing AI use cases

      Speakers

      Noelle Saldana
      Head of Research Analytics (AI & ML), Fortrea

      3 PM

      Leveraging Machine Learning and Security Orchestration, Automation, and Response (SOAR) to combat cyber threats in clinical data operations

      • A look at how the digital transformation of clinical trials has created unprecedented cybersecurity challenges in protecting sensitive patient data and maintaining trial integrity
      • Examining how artificial intelligence and SOAR technologies are revolutionizing clinical data protection against sophisticated cyber threats, particularly Business Email Compromise (BEC) attacks
      • Demonstrating how AI-driven security solutions, integrated with SOAR platforms, can detect and respond to threats in real-time while maintaining GxP compliance
      • A practical framework for implementing AI-enhanced security measures in clinical data environments, including zero-trust architectures and automated response protocols for protecting electronic data capture
      • Gaining actionable insights into building robust cybersecurity frameworks that leverage AI capabilities to protect sensitive clinical data while ensuring regulatory compliance

      Speakers

      Jeff Malavasi
      Associate Director, Information Security and Data Compliance Clinical Data, Scholar Rock

      3:30 PM

      Afternoon refreshments and networking

      3:45 PM

      PRIZE DRAW

      Visit our exhibitors’ booths throughout the day and collect stamps in order to enter our Prize Draw and be in for a chance of winning Apple devices or Amazon giftcards. The Prize Draw will take place in the Exhibition Hall. Make sure you don’t miss out!

      4 PM

      Data on a budget: Building high impact evidence in resource constrained biotechs

      • Designing lean, focused studies to generate meaningful results
      • Leveraging strategic partnerships to stretch resources
      • Maximizing the value of every dataset through smart analysis and clear storytelling
      • Presenting compelling data to investors, partners and regulators with credibility and clarity

      Speakers

      Radha Duttagupta
      VP, Clinical Affairs, Nucleix

      4:30 PM

      AIKA: Revolutionizing clinical trial design and execution with intelligent automation

      • Transforming Protocol to Execution: How AIKA uses advanced AI to streamline protocol generation, enhance feasibility analysis, and reduce study start-up timelines.
      • Data-Driven Decision Support: Leveraging real-time operational insights and predictive analytics to improve trial performance and risk mitigation.
      • Scaling Clinical Operations: Practical examples of AIKA in action, from automated task orchestration to cross-functional collaboration that drives efficiency and quality.

      Speakers

      5 PM

      Chair’s closing remarks

      Speakers

      Revati Tatake
      Global Head of Pharma Research, Analysis and Competitive Intelligence, GlobalData Healthcare

      END OF DAY 1 AND NETWORKING DRINKS

      Sponsored by EmVenio

      Join us in the atrium for a drinks reception

      7:30 AM

      Registration & Refreshments

      8:10 AM

      Chair’s introductions

      Speakers

      Robert Loll
      Senior Vice President, Business Development and Strategic Planning, Praxis

      8:15 AM

      GlobalData opening remarks

      Speakers

      Revati Tatake
      Global Head of Pharma Research, Analysis and Competitive Intelligence, GlobalData Healthcare

      8:30 AM

      KEYNOTE: Demystifying Artificial Intelligence in clinical trials: Turning promise into practice

      • Overcoming the hype: Moving from pilot projects to real-world applications of AI in pharma
      • In a conservative and cautious industry, are we ready for AI?
      • Reskilling for the AI Age: Preparing today’s workforce for the future, equipped with data-centric skills
      • Unveiling but disparaging AI myths in clinical research

      Speakers

      Paulius Ojeras
      Vice President Clinical Operations, Perceive Biotherapeutics

      9 AM

      Is AI enough? Why smarter site identification still needs human-centred strategies

      • AI has accelerated site identification and feasibility through predictive analytics and historical data.
      • ICON’s OneSearch platform enables faster identification of high-performing sites.
      • AI alone cannot resolve all study start-up challenges.
      • Successful site selection requires human-centered strategies beyond capacity metrics.
      • Resource constraints and operational complexity make site success increasingly challenging.
      • This session explores how ICON’s approach has evolved over five years of AI-driven selection, combining technology with human-centred strategies.

      Speakers

      Travis Caudill
      VP Feasibility, Site Identification & Clinical Informatics, ICON

      9:30 AM

      PANEL DISCUSSION: Study start-up challenges in a competitive environment

      • Overcoming financial constraints when budgets are limited and resources tight
      • Fierce site competition: How start-ups can compete with established companies for sites
      • Utilizing effective planning to improve study and program efficiency without compromising patient safety
      • Agile and adaptable: Being prepared to adjust your strategy and approach as needed

      Speakers

      Rachel Yan
      Former Director, Clinical Operations, Allay Therapeutics
      Niharika Kamat
      Vice President Clinical Operations, Sardocor
      Robert Loll
      Senior Vice President, Business Development and Strategic Planning, Praxis
      Hala Borno
      Founder and CEO, Trial Library and Associate Clinical Professor, University of California, San Francisco

      10 AM

      The 2026 biotech landscape: Perspectives and projections

      • Trends observed during the JP Morgan Healthcare conference
      • Navigating geopolitical complexity, regulatory shifts, and a more selective funding environment

      Speakers

      Aditya Kotta
      VP Business Development, Novotech

      10:30 AM

      Morning refreshments and networking break

      11 AM

      Building resilient clinical trials: What the trial of tomorrow will look like

      • Future-facing models: What will define a ‘remarkable’ trial in the next decade?
      • Leveraging adaptive and decentralized trial designs to improve flexibility and speed
      • Empowering sites and CROs as partners to improve patient outcomes
      • Strengthening communication to avoid misaligned expectations in the face of global disruptions
      • Reducing costs and environmental impact while maintaining scientific integrity

      Speakers

      David Tsai
      Senior Director Clinical Operations, Terray Therapeutics

      11:30 AM

      Rare oncology isn’t just oncology, smaller: The necessary shift for operations and outsourcing teams

      • Shared operational foundations across rare oncology and other rare diseases
      • Rare oncology–specific differences you must plan for in conducting and outsourcing clinical research

       

      Speakers

      12 PM

      PANEL DISCUSSION: Big pharma vs. emerging biotechs: Different outsourcing strategies, shared challenges

      • Building flexibility into outsourcing partnerships for scalability
      • Cost, quality and efficiency trade-offs between different models
      • Identifying which model fits different phases of clinical development
      • What does transition look like to you and how feasible is it?

      Moderator: Anca Copaescu, CEO, Clinical Maestro

       

      Speakers

      Tsui Chern Cheah
      Senior Director, Strategic Sourcing & Procurement, Exelixis
      Anca Copaescu
      CEO & Founder, Clinical Maestro
      Rabindra Shivnaraine
      Director, Aerys Biosciences
      Chitra Sharma
      Senior Vice President, Scribe Therapeutics

      12:30 PM

      Breaking borders: Japan’s evolving landscape for global innovators

      • Japan’s pharmaceutical market transformation: addressing drug lag and drug loss
      • Regulatory and ecosystem reforms accelerating drug development in Japan
      • Key trends and organizations supporting pharmaceutical innovation
      • Strategic insights into Japan’s pharmaceutical business landscape
      • Japan as a gateway to expansion across the Asian pharmaceutical market

      Speakers

      Saya Toyoda
      Business Development Manager, EPS Corporation
      Katsura Kasahara
      Executive Professional, EPS Corporation

      1 PM

      Lunch and networking break

      2 PM

      Humanizing health authority inspections: Turning US BIMO/PAI scrutiny into first cycle approvals

      • Decoding what FDA BIMO/PAI inspectors actually look for and why
      • Designing inspection-ready systems that withstand real-world pressure
      • Data integrity and story coherence: The real drivers of first-cycle approvals
      • Communication choreography: Before, during, and after the inspection
      • Tailored guidance: Differentiating strategies for small biotechs vs. mid-size companies

      Speakers

      Ndidi Rickert
      Senior Director, GxP Compliance, Kardigan Bio

      2:30 PM

      Beginning with the end in mind: Building effective long-term follow-up strategies in complex therapy trials

      • Emphasize the critical role of LTFU in cell and gene therapy trials and why early planning matters
      • Outline key logistics and operations considerations (site readiness, patient tracking, communication pathways) that minimize follow-up costs and support successful LTFU models
      • Highlight the importance of early patient education and engagement and use of remote or virtual visits to improve retention and compliance
      • Share broad learnings from past programs where proactive LTFU planning facilitated compliance and improved cost predictability

      Speakers

      Veronica Irving
      Senior Project Manager, Oncology, Premier Research

      3 PM

      Cost optimization in outsourced clinical operations without compromising quality

      • Where sponsors overspend
      • Effective use of FSPs, near‑shore/off‑shore models
      • KPIs to track productivity and quality

      Speakers

      Niharika Kamat
      Vice President Clinical Operations, Sardocor

      3:30 PM

      Afternoon refreshments and networking

      3:45 PM

      PRIZE DRAW

      Visit our exhibitors’ booths throughout the day and collect stamps in order to enter our Prize Draw and be in for a chance of winning Apple devices or Amazon giftcards. The Prize Draw will take place in the Exhibition Hall. Make sure you don’t miss out!

      4 PM

      Sponsor’s oversight responsibilities on regulatory submissions for outsourced clinical trials – Integrating the Target Product Profile

      • Sponsor Accountability: Ultimate responsibility for regulatory submissions remains with the sponsor.
      • Target Product Profile Integration: Acts as a strategic anchor for submission quality and alignment.
      • Effective Oversight: Governance, communication, and risk management ensure compliance in outsourced settings.

      Speakers

      Hanna Cho
      Vice President, Global Regulatory Affairs, Biomea Fusion

      4:30 PM

      Meeting site challenges with stronger strategies

      • Addressing recent site performance concerns and rebuilding trust when site credibility is questioned
      • Identifying common gaps in oversight, governance to avoid actively monitoring site work
      • Understanding policies and competing with limited resources at sites
      • Enhancing site staff training, culture and accountability of clinical research

      Speakers

      Rachel Yan
      Former Director, Clinical Operations, Allay Therapeutics

      5 PM

      Chair’s closing remarks

      Speakers

      Robert Loll
      Senior Vice President, Business Development and Strategic Planning, Praxis

      END OF DAY 1 AND NETWORKING DRINKS

      Sponsored by EmVenio

      Join us in the atrium for a drinks reception

      Streams

      Stream one

      Stream A: Outsourcing & Clinical Operations

      Stream two

      Stream B: AI and Tech Transformation

      Stream three

      Stream C: Biotech Strategy

      8:50 AM

      Chair’s opening remarks

      Speakers

      Anthony Maida, Ph.D.
      Chief Clinical Officer - Translational Medicine, Oncotelic Therapeutics

      9 AM

      KEYNOTE PANEL DISCUSSION: Navigating the current geo-political landscape as a small biotech

      • Overviewing the current political landscape and understanding what the impact is on small biotech’s
      • Adapting to change by effectively navigating a small biotech though uncertainty
      • Understanding and leveraging new start-up opportunities by reviewing investment and marketing trends

      Speakers

      Justin Chickles
      CEO, Glycyx
      Manuel Lopez-Figueroa
      Chief Operating Officer, IMIDomics
      Anthony Maida, Ph.D.
      Chief Clinical Officer - Translational Medicine, Oncotelic Therapeutics

      9:30 AM

      Designed to deliver: Unlocking the value of bespoke outsourcing models

      • Move from siloed to integrated with a collaborative framework and culture
      • Build an agile operating model for immediate and long-term success
      • Unlock the value of strategic FSP: key examples of success

      Speakers

      Anne Baker
      General Manager, FSP, Parexel

      10 AM

      Patient advocacy and incorporating patient perspectives early on in a small biotech

      • Developing relationships with advocacy groups and patient communities from early stages
      • How does patient advocacy differ at biotechs vs large pharma?
      • Integrating patient insights into your study to ensure patients remain the priority throughout your trial

      Speakers

      Suyash Prasad
      President, Research and Development, Stealth Mode Biotech

      10:30 AM

      Outsourcing 101: How to effectively outsource when running a small biotech

      • Aligning in-house capacity to outsourcing needs to ensure your biotech sticks to budget
      • Understanding when it is time to outsource to ensure sufficient oversight and management of all vendors
      • Looking ahead to identify your biotech needs to integrate services seamlessly into current processes

      Speakers

      Brian Frenzel
      President, CEO, and Director, Tosk

      11 AM

      Morning refreshments and networking

      11:30 AM

      Managing Drug Development: A Biotech Company Perspective

      • Engaging right CROs/CDMOs
      • GXP compliance
      • Budget, timeline, and conflicts

      Speakers

      Laxminarayan Bhat, Ph.D.
      Founder, President, and Chief Executive Officer, Reviva Pharmaceuticals

      12 PM

      PANEL DISCUSSION: Managing and encouraging CRO relations effectively as a small biotech

      • Navigating CRO relations as a small biotech to ensure your trial is ran successfully
      • Communicating goals effectively to ensure your CRO understands and meets expectations
      • Encouraging collaboration to ensure your trial is a success for all parties involved

      Seats available

      Speakers

      Chris Adams
      Chief Executive Officer, Andarix
      Aditya Kotta
      VP Business Development, Novotech

      12:30 PM

      Embracing the unknown: Tips and tricks on how to grow your biotech

      • Building a network to support your biotech through challenges
      • Identifying weak points and understanding what you need to progress
      • Balancing trust and control when navigating the unknown to curb risk and accelerate progression

      Speakers

      Justin Chickles
      CEO, Glycyx

      1 PM

      Lunch and networking

      2 PM

      Navigating investor relations to secure funding as a small biotech

      • Overviewing the current investor landscape to enhance funding efforts effectively
      • Securing funding through effective communication and forecasting budgets
      • Understanding how to convey complex ideas clearly to streamline timelines effectively

      Speakers

      2:30 PM

      How to integrate technology effectively in your biotech to enhance clinical processes

      • Identifying how to use technology to enhance clinical processes
      • Curbing competition by integrating technology effectively into your biotech
      • Understanding when your biotech is at the right stage for technology integration

      Speakers

      Jennifer Johnston
      Ph.D., Cofounder and CEO, NysnoBio

      3:15 PM

      PRIZE DRAW

      Visit our exhibitors’ booths throughout the day and collect stamps in order to enter our Prize Draw and be in for a chance of winning Apple devices or Amazon giftcards. The Prize Draw will take place in the Exhibition Hall. Make sure you don’t miss out!

      8:50 AM

      Chair’s opening remarks

      Speakers

      David Tsai
      Senior Director Clinical Operations, Terray Therapeutics

      9 AM

      KEYNOTE: Making data-driven decisions: Effectively managing overwhelming amounts of data collected to ensure an ROI

      • How much data is good enough to make the decisions that we need?
      • Defining the role of real-world data in clinical research to assess the effectiveness of treatments
      • Prioritizing the timeliness of data to identify safety signals early and increase trial credibility: how are companies balancing their needs vs the requirements of the patients?
      • Ongoing debate for in-house vs external data managers: when is it best to outsource?

      Speakers

      Ting Ma
      Director, Clinical Data Science, Summit Therapeutics

      9:30 AM

      New approach to Site ID: Adding a semantic knowledge platform to a solid process foundation

      • Explores a “site ID in one click” roadmap that combines deep industry expertise with a first-of-its-kind semantic knowledge platform.
      • Demonstrates how 30 years of operational data, paired with external insights from 500k+ institutions and 3M sites, strengthens feasibility decision-making.
      • Shows how expertise-driven processes and advanced data integration reduce the industry’s 50% non-enrollment rate.
      • Highlights how this methodology enables sponsors to accelerate timelines, reduce costs, and improve overall trial efficiency.

      Speakers

      Emily McInturf
      Director, Feasibility, PSI CRO

      10 AM

      Making AI approachable

      • Move past the hype: Treat AI as a strategic enabler, not a technical hurdle.
      • Conversing with data: Use AI to interact with insights rather than just manage information.
      • Practical toolkit: Combine everyday assistants with specialized models for rapid document synthesis and cross-referencing.
      • Incremental adoption: Integrate AI capabilities gradually without overwhelming learning requirements.
      • Outcome: Empower teams to enhance expertise and decision-making with AI.

      Speakers

      Meraf Eyassu
      Executive Director of Clinical Operations, Terns Pharmaceuticals

      10:30 AM

      TECHNOLOGY SPOTLIGHT – Operationalizing AI in clinical trials

      • AI is poised to streamline the design, deployment, and monitoring of clinical trials.
      • Clinical ink has developed AI solutions for every trial stage, all within a robust governance framework for safety and compliance.

      Speakers

      Shane Johnson
      Senior Scientist, Clinical ink

      10:45 AM

      TECHNOLOGY SPOTLIGHT – Transforming clinical outsourcing: How outsourcing managers will become “Superhumans” with AI

      • Discuss AI use cases in procurement and clinical outsourcing
      • Explore AI in vendor management
      • Evaluate what's real and what is hype and why

      Speakers

      Anca Copaescu
      CEO & Founder, Clinical Maestro

      11 AM

      Morning refreshments and networking

      11:30 AM

      QUALITY ASSURANCE SPOTLIGHT: QA in an era of decentralized and data-driven clinical trials: A case study

      • Delivering future-ready QA practices aligned with FDA and ICH expectations
      • Unpacking corrective strategies: smarter monitoring, stronger oversight, and rapid CAPA
      • Exposing root causes: vendor gaps, device/data integration, and audit trail risks
      • Tackling real QA breakdowns in decentralized and tech-enabled studies

      Speakers

      Scott McCulloch
      Executive Director and Data Protection Officer (DPO)

      12 PM

      Tempus Ecosystem combines for smarter insight to precision medicine oncology trials

      • Utilize multi-omics data from next-generation sequencing to build a smarter, data-driven trial design.
      • Accelerate patient matching and enrollment through our extensive clinical trial site network.
      • Combine these capabilities in an integrated ecosystem to build a better, more efficient clinical trial.

      Speakers

      Arjun Ishwar
      Solutions Director, Omics, Tempus

      12:30 PM

      Why is biopharma industry talking about drug development in China? 

      • Drug development activity in China and key areas of enhanced activity
      • Clinical trials trends and the impact of geopolitical events on outsourcing
      • Is China a solution for early-phase clinical trials
      • Partnering and licensing activities from China

      Speakers

      Revati Tatake
      Global Head of Pharma Research, Analysis and Competitive Intelligence, GlobalData Healthcare

      1 PM

      Lunch and networking

      2 PM

      ACADEMIC SPOTLIGHT Hear how academic researchers are driving innovation in the field

      • Optimizing clinical research through effective technological integration
      • A case study from the University of Berkeley scientists on how they’ve successfully implemented technology in drug development

      Speakers

      Dr. Kartoosh Heydari
      Director, Cancer Research Laboratory FACS Core Facility, University of California Berkeley

      2:30 PM

      How to integrate technology effectively in your biotech to enhance clinical processes

      • Identifying how to use technology to enhance clinical processes
      • Curbing competition by integrating technology effectively into your biotech
      • Understanding when your biotech is at the right stage for technology integration

      Speakers

      Jennifer Johnston
      Ph.D., Cofounder and CEO, NysnoBio

      3 PM

      Afternoon refreshments, networking and prize draw

      3:15 PM

      PRIZE DRAW

      Visit our exhibitors’ booths throughout the day and collect stamps in order to enter our Prize Draw and be in for a chance of winning Apple devices or Amazon giftcards. The Prize Draw will take place in the Exhibition Hall. Make sure you don’t miss out!

      8 AM

      Registration and refreshments

      8:50 AM

      Chair’s opening remarks

      9 AM

      Translational execution at scale: The changing face of biomarker operations in modern drug development

      • Building biomarker operations functions that align with organizational scale and strategy
      • Optimizing vendor and central lab partnerships
      • Integrating biomarker data across translational and clinical pipelines
      • Preparing for the next evolution of biomarker-driven clinical trials

      Speakers

      Pedro Corpuz
      Director, Biomarker Operations, Alumis

      9:30 AM

      Navigating major inflection points from IND to approval: Indication clarity, regulatory strategy & quality-by-design to support the drug development journey

      • Define a clear indication and targeted patient population early by aligning the targeted product profile (TPP) with meaningful clinical outcomes and measurable endpoints.
      • Build a comprehensive development roadmap that anticipates key inflection points from IND through pivotal trials, ensuring evidence generation stays aligned with approval requirements.
      • Engage regulators early (e.g., Pre-IND meetings) to support gap analysis, de-risk development decisions, and refine a practical regulatory strategy.
      • Embed Quality by Design (QbD) principles from the start to protect data integrity, ensure fit-for-purpose operational execution, and improve inspection readiness.
      • Strengthen the likelihood of approval success by integrating indication clarity, regulatory alignment, and quality systems into a cohesive, proactive development approach.

      Speakers

      Adam Callahan, MS, MBA
      VP Global Therapeutic Area Head, Oncology & Hematology, Caidya

      10 AM

      Maintaining regulatory compliance across phases using adaptive clinical trials in Cell and Gene Therapy

      • Understanding regulatory expectations for adaptive clinical trial designs across all phases of development in cell and gene therapy, including current FDA and global guidance.
      • Learning how to design adaptive trials that maintain compliance and data integrity, with appropriate pre-specification, statistical rigor, and documentation strategies.
      • Identifying operational and regulatory challenges unique to adaptive trials, and explore best practices for real-time decision-making, monitoring, and regulator engagement.
      • Applying lessons learned from real-world cell and gene therapy case studies to balance innovation, speed, and patient safety while accelerating development.

      Speakers

      Chitra Sharma
      Senior Vice President, Scribe Therapeutics

      10:30 AM

      Strategies for success when every patient counts: enhancing retention and protocol compliance in ultra-rare and genetic disorders

      • In rare populations, every patient carries significant weight, making retention more critical than in most other therapeutic areas.
      • Because patient numbers are extremely limited, attrition cannot be absorbed—losing even a single participant can jeopardize the entire study.
      • Rare disease trials often focus heavily on recruitment, but retention is equally essential and frequently overlooked.
      • Collaboration with the Community is key
      • Case studies

      Speakers

      Kris O’Brien
      Director, Operational Strategy, Ergomed

      11 AM

      Morning refreshments and networking

      11:30 AM

      PANEL DISCUSSION: Sponsor, CRO, site collaboration: Aligning priorities across stakeholders

      • Outlining key differences in company budgets and pipelines
      • How to align financial incentives between CROs and pharma so that both sides win
      • Uniting in common challenges amongst all sponsors
      • Lessons learned from partnerships that improved performance
      • Balancing trust and transparency across the ecosystem
      • Patient safety, innovation and adaptability as shared goals

      Speakers

      Radha Duttagupta
      VP, Clinical Affairs, Nucleix
      Laurin Vincent
      Global Head, Enterprise Clinical Sourcing and Partnerships, Genentech
      Arla Yost
      Clinical Research Operations Director, Helen Diller Family Comprehensive Cancer Center, University of California
      Robert Loll
      Senior Vice President, Business Development and Strategic Planning, Praxis
      Dimitrios Mizantzidis
      Director of Product Marketing, IQVIA Technologies

      12:15 PM

      TECHNOLOGY SPOTLIGHT – Trial finder solutions – The evolving role of Patient Recruitment Platforms (PRPs) to Improve the last mile

      The last mile of patient recruitment—connecting interested patients to sites—often breaks down. This session explores how PRPs such as Trialbee’s Honey Platform™ strengthens that handoff through invisible, backend infrastructure that reduces missed connections and improves enrolment at scale.

      • Where patient-to-site handoffs fail
      • Why a single backend matters across studies and regions
      • How the Honey Platform improves conversion without changing the patient experience

      Speakers

      Michael Rosenberg
      Senior Director, Business Development, Trialbee

      12:30 PM

      Operational readiness: Aligning people, partners, and process for the first program

      • Creating a shared understanding of clinical development and operational fundamentals for teams rooted in discovery science
      • Leveraging external partners efficiently - CROs, consultants, vendors -especially when in-house experience is limited
      • Building lightweight processes that educate and empower, rather than overwhelm
      • Managing a “learning by doing” culture - iterative planning, open communication, and mentorship across disciplines

      Speakers

      Michelle Wong
      Vice President, Operations, Octant Bio
      Joanna Jay
      Head of Clinical Operations, Octant Bio

      1 PM

      Lunch and networking

      2 PM

      Deploying AI for generation and deployment within Roche’s Quality Programs

      Everyone talks about AI, but few are showing production use cases in Quality Management. In this session, Roche shares a practical look at their strategy for integrating GenAI into the Quality workflow. We will discuss the methodology behind using AI to enhance Risk-Based Quality Management (RBQM) and how we are leveraging unstructured data—like historical scribe notes—to modernize inspection readiness.

      • AI in RBQM: How AI supports the shift from reactive issue management to proactive risk identification, allowing teams to spot signals earlier in the trial lifecycle.
      • The "Mock Auditor" (Inspection Defense): A case study on analyzing unstructured data (such as scribe notes and deviation text) to predict auditor behavior and prepare teams for questioning.
      • The Trust Factor: Best practices for governance, validation, and maintaining a "Human-in-the-loop" when deploying GenAI in a GxP environment.

      Speakers

      Jennifer Hebert
      Director, Quality, Roche
      Shola Jhanji
      Quality Program Lead, Roche
      Chris Fratus
      RBQM Strategic Lead, Roche

      2:30 PM

      Metadata matters: How accurate TMF metadata elevates quality, KPIs, and oversight

      • Defining metadata to ensure accurate data points
      • System metadata configurations
      • Metadata outputs and analysis
      • Driving metadata and associated KPI outputs for better TMF outcomes

      Speakers

      Alexander Markiel
      Senior Director, Head of Clinical Systems and Trial Master File, Apogee Therapeutics

      3:15 PM

      PRIZE DRAW

      Visit our exhibitors’ booths throughout the day and collect stamps in order to enter our Prize Draw and be in for a chance of winning Apple devices or Amazon giftcards. The Prize Draw will take place in the Exhibition Hall. Make sure you don’t miss out!

      3:30 PM

      Speaker Hosted Round Tables

      Interactive roundtable sessions offer a unique opportunity to come together with your peers to share best practice and develop solutions to critical challenges facing the industry as a whole. Hosted by industry experts and each focused on a single issue, roundtables are an exciting, interactive way to build your personal network and learn from the experience and expertise of others. Each roundtable lasts for 30 minutes, delegates can select up to 2 roundtables.

      1. Roundtable 1 - Standing out in a sea of sponsors: Practical strategies for small biotechs working with large CROs
        Hosted by Rachel Yan, Former Director, Clinical Operations, Allay Therapeutics
      2. Roundtable 2 - Reinforcing the sponsor's pivotal role in ensuring trial integrity with the latest ICH GCP updates
        Hosted by Sharmaine Peterson, Associate Director, Clinical Quality Assurance, Zentalis
      3. Roundtable 3 - The show goes on: Supporting clinical trials during a time of war
        Hosted by Jasmine Washington, Head of Clinical Outsourcing and Contract Management, Cytokinetics
      4. Roundtable 4 - Using AI to accelerate data management and improve trial quality
        Hosted by Pietro Belligoli, Researcher, Former Roche and Constantin Weberpals, Machine Learning Research Collaborator, Stanford University
      5. Roundtable 5 - Mitigating risk: how to strategically plan and curb risk as a small biotech
        Hosted by Chris Adams, Chief Executive Officer, Andarix

      Speakers

      Rachel Yan
      Former Director, Clinical Operations, Allay Therapeutics
      Sharmaine Peterson
      Associate Director, Clinical Quality Assurance, Zentalis
      Jasmine Washington
      Associate Director, Cytokinetics
      Pietro Belligoli
      Researcher, Former Roche
      Constantin Weberpals
      Machine Learning Research Collaborator, Stanford
      Chris Adams
      Chief Executive Officer, Andarix

      4:30 PM

      Chair’s closing remarks and end of conference

      2026 Speakers

      Select a speaker to learn more

      Back
      Rachel Yan
      Former Director, Clinical Operations, Allay Therapeutics

      Experienced analytical professional with a versatile background in the biotechnology industry and clinical research site. Skilled in project management, quality compliance, protocol development, site management, clinical pharmacology and clinical trials in autoimmune, allergy, cardiovascular, nephrology, neuromuscular, pain and pediatrics.

      Session Details:

      PANEL DISCUSSION: Study start-up challenges in a competitive environment

      2026-02-11, 9:30 AM

      Session Details:

      Meeting site challenges with stronger strategies

      2026-02-11, 4:30 PM

      Session Details:

      Speaker Hosted Round Tables

      2026-02-12, 3:30 PM

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      Pedro Corpuz
      Director, Biomarker Operations, Alumis

      Alumis empowers innovative biomarker strategies under my leadership, where I oversee the full lifecycle of biospecimen management across clinical trials. With over three years at Alumis, I’ve spearheaded the creation of SOPs, directed biomarker sub-teams, and implemented multi-omics collection strategies to support autoimmune and immunology pipelines. Collaborative efforts with biomarker scientists, medical monitors, and bioinformaticians have driven operational success in translational and precision medicine initiatives. Over a decade of expertise in translational medicine and biospecimen operations underpins my commitment to advancing precision medicine. Past roles at Arcus Biosciences and Gilead Sciences honed my skills in clinical trial biosample management, biomarker planning, and vendor collaboration. My leadership fosters a culture of innovation and operational excellence, ensuring impactful contributions to clinical development and personalized healthcare solutions.

      Session Details:

      Translational execution at scale: The changing face of biomarker operations in modern drug development

      2026-02-12, 9:00 AM

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      Chris Adams
      Chief Executive Officer, Andarix

      Mr. Adams has been a founder or co-founder of life science and technology based companies in Massachusetts for the past several years. Mr. Adams has been instrumental in developing new proprietary therapeutic and medical device technologies and bringing the technologies to commercialization. The companies he has founded include, Compellis Pharmaceuticals, a developer of therapeutics to treat obesity and its co-morbidities, diabetes and hypertension and Mosaic Technologies, a venture backed MIT spin-out genomics company that developed patented technologies for genetic analysis and detection.

      Chris is the holder of more than 20 issued US and international patents for medical devices and pharmaceuticals.

      Session Details:

      PANEL DISCUSSION: Managing and encouraging CRO relations effectively as a small biotech

      2026-02-12, 12:00 PM

      Session Details:

      Speaker Hosted Round Tables

      2026-02-12, 3:30 PM

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      Hanna Cho
      Vice President, Global Regulatory Affairs, Biomea Fusion
      • Passionate about advancing biomedical innovation to improve human health.
      • VP Executive and Senior Leader within the biopharmaceutical industry.
      • Driving global regulatory and development strategies for drug development (clinical products), marketing applications, and lifecycle management (marketed products).
      • Proven success in bringing breakthrough therapies from development to approval:
      • Rubraca® (rucaparib), for ovarian cancer with germline or somatic BRCA mutations diagnosed by a companion diagnostic.
      • Voxzogo® (vosoritide), the first and only therapy approved for achondroplasia (rare disease), the most common form of dwarfism.
      • Scientific foundation: Key inventor of two FDA approved drugs:
      • Zelboraf® (Vemurafenib, the first personalized/precision medicine targeting melanoma).
      • Prezista® (Darunavir, targeting HIV infection).
      • Committed to making a difference through teamwork and science.

      Session Details:

      Sponsor’s oversight responsibilities on regulatory submissions for outsourced clinical trials – Integrating the Target Product Profile

      2026-02-11, 4:00 PM

      View In Agenda
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      Tsui Chern Cheah
      Senior Director, Strategic Sourcing & Procurement, Exelixis

      Session Details:

      PANEL DISCUSSION: Big pharma vs. emerging biotechs: Different outsourcing strategies, shared challenges

      2026-02-11, 12:00 PM

      View In Agenda
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      Bruce Morimoto
      Head of Drug Development, Fuku Biotech

      Dr Morimoto has over 25 years of industry experience leading project teams in the development of innovative medicines for neurodegenerative diseases including Parkinson’s, Alzheimer’s, ALS and frontotemporal dementias.  Previously, Bruce held leadership roles at Alkahest, Celerion, Cerecin and Allon Therapeutics, and works closely with the Michael J Fox Foundation, chairing one of their scientific review panels.  He is an advisor to several biotech companies.  Bruce started his career on the faculty in the Chemistry Department at Purdue University.  Bruce earned his doctorate in biochemistry from UCLA and completed a postdoctoral fellowship at the University of California Berkeley.

      Session Details:

      PANEL DISCUSSION: Effective collaboration in the trial ecosystem: How should pharma work with patient organizations and what are the best ways to engage with them?

      2026-02-11, 12:00 PM

      Session Details:

      CLOSING KEYNOTE: Effective inclusion of the patient and patient voice in clinical research

      2026-02-11, 4:30 PM

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      Laurin Vincent
      Global Head, Enterprise Clinical Sourcing and Partnerships, Genentech

      We simply can’t make amazing discoveries and address patient's needs alone. We need to work together: collaborate, being agile, bring in partners, innovate and co-create. Delving in and solving problems, coaching, ensuring quality, optimizing our relationships and bringing the bold and authentic voice to the table is what I do best. I create vibrant and motivated teams enabling meaningful organizational transformation while building strategic relationships.

      In my extensive clinical experience, I have built and transformed functions, simplified clinical processes and systems, lead quality programs, managed complex supplier partnerships, negotiated high profile contracts and implemented fit for purpose global governance frameworks. I’ve managed various projects around clinical technologies with an eye to quality, CRO/supplier optimization and supplier oversight. I’ve led global teams that were highly productive, engaged and impactful in achieving the organization’s goals.

      I care deeply for making work meaningful and fun for my colleagues, teams, partners and the organization. I do this through collaborating, being agile, simplifying, creating a sense of community and bringing forth bold ideas.

      Session Details:

      PANEL DISCUSSION: Sponsor, CRO, site collaboration: Aligning priorities across stakeholders

      2026-02-12, 11:30 AM

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      Meghan McKenzie
      Director, AIR Portfolio Alliance Lead, Population Science, Genentech

      Meghan McKenzie is a Director of Health Equity and Clinical Research at Genentech, Inclusion and Belonging Office. She develops strategies to drive greater inclusion of underrepresented patient populations in clinical research and to advance health equity by working directly with sites in our Advancing Inclusive Research (AIR) Site Alliance and by gaining patient insights to change behavior and protocols.

      Gaining patient, clinician and community insights early in program development is integral to developing what is important to patients and improving access to medicines and treatments for all patients, regardless of race, ethnicity, sexual orientation, gender identity, age, disability and socioeconomic status.

      She has over 25 years of clinical development research experience working at the site, CRO and biotech level, and spanning multiple diseases, including oncology, ophthalmology, immunology, neurology, infectious and rare diseases.

      Meghan received her Master’s Degree in Human Biology at San Francisco State University and her Bachelor’s Degree in Economics at University of North Carolina, Chapel Hill and has earned the Cornell University ‘Advanced D&I Certificate’ and the Columbia Business School ‘Certificate in Business Excellence

      Session Details:

      Reaching underrepresented patients for trials in the current climate

      2026-02-11, 3:00 PM

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      Revati Tatake
      Global Head of Pharma Research, Analysis and Competitive Intelligence, GlobalData Healthcare

      Revati Tatake, PhD, is the Global Head of Pharma Research, Analysis and Competitive Intelligence at GlobalData Healthcare.  Revati has over 25 years of multidisciplinary experience in academic research and the healthcare industry, both on the client and agency sides of the business. Previously she worked as a VP of Databases and Analytics at GlobalData, where she made significant contributions to Pharma Intelligence Center. Before joining GlobalData, Revati worked at Citeline/Informa, where she was involved in competitive intelligence and analytics of clinical trials and drugs in the areas of Autoimmune/Inflammation, Central Nervous System, and Ophthalmology.  Earlier, Revati worked at Boehringer Ingelheim Pharmaceuticals for over 12 years as Senior Scientist to Senior Principal Scientist, where she led drug discovery projects involving traditional high-throughput screening, as well as innovative approaches for gene and cell therapies. She also worked at Boehringer Ingelheim as a Director of Competitive Intelligence for projects in cardiometabolic space and research beyond borders. She is a co-inventor on many issued US patents related cell and gene therapies and has several publications in peer reviewed scientific journals. Revati holds a PhD in Tumor Immunology from the Tata Cancer Research Institute in Mumbai, India. She did her postdoctoral fellowship at the University of Connecticut Health Center and Boehringer Ingelheim.

      Session Details:

      PANEL DISCUSSION: How far can AI take us?

      2026-02-11, 12:00 PM

      Session Details:

      Chair’s closing remarks

      2026-02-11, 5:00 PM

      Session Details:

      Why is biopharma industry talking about drug development in China? 

      2026-02-12, 12:30 PM

      Session Details:

      GlobalData opening remarks

      2026-02-11, 8:15 AM

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      Justin Chickles
      CEO, Glycyx

      Session Details:

      KEYNOTE PANEL DISCUSSION: Navigating the current geo-political landscape as a small biotech

      2026-02-12, 9:00 AM

      Session Details:

      Embracing the unknown: Tips and tricks on how to grow your biotech

      2026-02-12, 12:30 PM

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      Manuel Lopez-Figueroa
      Chief Operating Officer, IMIDomics

      Session Details:

      KEYNOTE PANEL DISCUSSION: Navigating the current geo-political landscape as a small biotech

      2026-02-12, 9:00 AM

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      Jenni Herber
      Associate Director, Clinical Operations, Kamau Therapeutics

      Session Details:

      PANEL DISCUSSION: Effective collaboration in the trial ecosystem: How should pharma work with patient organizations and what are the best ways to engage with them?

      2026-02-11, 12:00 PM

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      Jennifer Willert
      Medical Director CART USOM, Novartis

      Session Details:

      Developing resilient clinical trials: Lessons learned in CAR-T for ped-young adult and adult oncology trials

      2026-02-11, 4:00 PM

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      Radha Duttagupta
      VP, Clinical Affairs, Nucleix

      Energetic, hands-on leader, with broad experiences bridging IVD Product Development/commercialization and Clinical Trial design, operation and registrational activities. Successful commercial tests include CytoScan™ XON (Exon level CN detection), CytoScan™ Optima (Prenatal CN detection), Cytoscan® Dx (first-to-market FDA approved whole genome CN assay). Experienced in the entire product life-cycle with strong command of R&D, Manufacturing and Clinical Validation. Successful in balancing internal and external stake-holders and tying strategic goals with tactical execution. Passionate about people, teams and a culture of innovation. Experienced in : US and CE-IVD registrations, Observational Trials, Clinical Trial Management, LDT/IVD Product Development, Design Control/documentations, analytical and clinical validation, Commercialization, GLP, GCP, GMP compliance, Manufacturing Transfer, Reagent Development/Kitting , Laboratory Operations, Lead Internal/External collaborations, Technology Assessment/IP generation, Design of Experiments (DOE), Microarray analysis, Sequencing, Cell-free DNA analysis.

      Session Details:

      PANEL DISCUSSION: Sponsor, CRO, site collaboration: Aligning priorities across stakeholders

      2026-02-12, 11:30 AM

      Session Details:

      Data on a budget: Building high impact evidence in resource constrained biotechs

      2026-02-11, 4:00 PM

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      Jennifer Johnston
      Ph.D., Cofounder and CEO, NysnoBio

      Session Details:

      How to integrate technology effectively in your biotech to enhance clinical processes

      2026-02-12, 2:30 PM

      Session Details:

      How to integrate technology effectively in your biotech to enhance clinical processes

      2026-02-12, 2:30 PM

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      Joanna Jay
      Head of Clinical Operations, Octant Bio

      Session Details:

      Operational readiness: Aligning people, partners, and process for the first program

      2026-02-12, 12:30 PM

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      Michelle Wong
      Vice President, Operations, Octant Bio

      I was a corporate attorney with a marketing and sales background in highly-regulated industries (pharma/biotech). Regardless of industry or function, focus on client needs and delivering superlative business results are the hallmarks of my work. As an attorney in the Financial Services and Investment Management practice at Dechert LLP, I helped the boards and managers of various investment vehicles navigate complex compliance and business matters arising from operating in a dynamic regulatory environment. In my sales and marketing career in pharma/biotech, I developed business tools for reaching customers, built enduring and high-value customer relationships and delivered record-beating business results in a competitive market.

      Session Details:

      Operational readiness: Aligning people, partners, and process for the first program

      2026-02-12, 12:30 PM

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      Alan Balch
      CEO, Patient Advocate Foundation

      Dr. Balch has 23 years of executive leadership in the nonprofit sector spanning multiple areas both nationally and internationally including access and affordability, health equity, prevention and early detection, and patient-centered research. He earned his PhD in environmental studies with a concentration in political economy in 2003 from the University of California, Santa Cruz; his master’s degree in environmental sciences in 1997 from the University of Texas in San Antonio; his bachelor’s degree in biology in 1994 from Trinity University in San Antonio.

      Session Details:

      PATIENT ADVOCATE PERSPECTIVE: Improving support given to caregivers to reduce burden on patients’ families

      2026-02-11, 11:00 AM

      Session Details:

      PANEL DISCUSSION: Effective collaboration in the trial ecosystem: How should pharma work with patient organizations and what are the best ways to engage with them?

      2026-02-11, 12:00 PM

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      Paulius Ojeras
      Vice President Clinical Operations, Perceive Biotherapeutics

      Session Details:

      KEYNOTE: Demystifying Artificial Intelligence in clinical trials: Turning promise into practice

      2026-02-11, 8:30 AM

      Session Details:

      PANEL DISCUSSION: How far can AI take us?

      2026-02-11, 12:00 PM

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      Scott McCulloch
      Executive Director and Data Protection Officer (DPO)

      Session Details:

      QUALITY ASSURANCE SPOTLIGHT: QA in an era of decentralized and data-driven clinical trials: A case study

      2026-02-12, 11:30 AM

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      Kenneth Wilson
      Senior Director, Operational Lead, Pfizer

      Ken is a highly motivated and collaborative leader in the BioPharma industry with over three decades of experience in the CRO and sponsor sectors.  Proven track record of project management, line management, strategic planning, operational execution, business unit management and business development. Skilled in managing high-value partnerships with other sponsors and vendors, leading business growth, negotiating complex contracts and budgets, generating revenue increases in the CRO sector through innovative solutions and sourcing models, and delivering results across a broad range of clinical development programs and business models with key areas of expertise in: Strategic Partnership/Alliance Management, Management of Full-Service CROs, Ancillary Vendor and HCP Outsourcing and Contracting, End-to-End Project Management and Line Management.

       

      Session Details:

      PANEL DISCUSSION: Effective collaboration in the trial ecosystem: How should pharma work with patient organizations and what are the best ways to engage with them?

      2026-02-11, 12:00 PM

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      Jennifer Hebert
      Director, Quality, Roche

      Session Details:

      Deploying AI for generation and deployment within Roche’s Quality Programs

      2026-02-12, 2:00 PM

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      Kathleen Purcell
      Senior Director, Head of QA (GCP) Programs, Roche

      Innovative and Collaborative Compliance Leader with expertise and proven success in developing business strategy and establishing quality management framework for start-up compliance departments in large established pharmaceutical companies. -Healthcare Compliance, Rx&D Code of Ethical Practices and HCP value transfer -GCP compliance, auditing, regulatory inspection support, CAPA -Training (facillitation, instructional design, LMS management, curricula development) -Procedural Document Management (SOP creation, Documentum, Process Mapping)

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      Jeff Malavasi
      Associate Director, Information Security and Data Compliance Clinical Data, Scholar Rock

      Dedicated security professional with a diverse history of working in healthcare, education, nonprofit and SaaS environments. Skilled in Microsoft 365 architecture, IAM/IGA and business process automation. Current MSc candidate in Computing Security at Rochester Institute of Technology.

      Session Details:

      Leveraging Machine Learning and Security Orchestration, Automation, and Response (SOAR) to combat cyber threats in clinical data operations

      2026-02-11, 3:00 PM

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      Ting Ma
      Director, Clinical Data Science, Summit Therapeutics

      Clinical data expert with a track record of working effectively in the biotechnology industry. A seasoned data engineering leader with a focus on solving clinical data challenges. Skilled in building scalable clinical data pipelines. Proficient in R, SAS, Python, SQL, Machine Learning, and Data Analysis. Strong clinical data professional graduated from Stanford University.

      Session Details:

      KEYNOTE: Making data-driven decisions: Effectively managing overwhelming amounts of data collected to ensure an ROI

      2026-02-12, 9:00 AM

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      Meraf Eyassu
      Executive Director of Clinical Operations, Terns Pharmaceuticals

      Meraf Eyassu is a Executive Director of Clinical Operations at Terns Pharmaceuticals. Meraf has over 20 years experience working in biotech, health and the pharmaceutical industry. She has managed and overseen large global clinical trials in various therapeutic areas and multiple phases of development.

      Session Details:

      Making AI approachable

      2026-02-12, 10:00 AM

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      Gajanan Bhat
      Senior Vice President, Development Lead, TORL Biotherapeutics

      A clinical research and development executive with over 20 years of experience in drug, device and imaging diagnostic agent development and a proven track record of successful execution of clinical development and post-marketing activities in early stage and pivotal clinical trials leading to NDA submissions, approvals and market launch. A result oriented team leader who provides directions to team and strategy for clinical development plan and execution to meet corporate objectives

      Session Details:

      Clinical development in the digital age

      2026-02-11, 2:00 PM

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      Brian Frenzel
      President, CEO, and Director, Tosk

      Silicon Valley entrepreneur, board member, and private investor. Extensive experience in founding and financing new companies and improving performance of existing companies.

      Have previously served as CEO, Chairman, COO and/or CFO of four successful start-up companies that achieved an exit for investors, either through M&A or IPO. Functional areas of expertise include: general management, product development, fundraising, licensing, finance, marketing strategy, and governance.

      Specialties: Managing the start-up and high growth process, research and product development strategy, team-building, and M&A / IPO preparation and implementation.

      Session Details:

      Outsourcing 101: How to effectively outsource when running a small biotech

      2026-02-12, 10:30 AM

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      Dr. Kartoosh Heydari
      Director, Cancer Research Laboratory FACS Core Facility, University of California Berkeley

      Session Details:

      ACADEMIC SPOTLIGHT Hear how academic researchers are driving innovation in the field

      2026-02-12, 2:00 PM

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      Sharmaine Peterson
      Associate Director, Clinical Quality Assurance, Zentalis

      Session Details:

      Speaker Hosted Round Tables

      2026-02-12, 3:30 PM

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      Niharika Kamat
      Vice President Clinical Operations, Sardocor

      With a desire to create Patient Impact and to do the "hard things", I want to take on complex, challenging clinical programs while leading empowered, high performing teams to accomplish the Impossible. With close to 20 years’ experience in operationalizing strategic, global, Ph1 – Ph3 trials across various therapeutic areas and organizational sizes (large pharma to small biotech), I bring a strong skillset in Leadership, Cross-Functional Collaboration and building the Clinical department. I strive to represent the Patient voice as we design clinical trials balancing scientific goals with trial participant burden and to be the Sponsor of Choice to investigative sites and KOLs. Balancing operational and cost efficiencies with quality and inspection readiness are key areas of focus. I lead with integrity and empathy and enjoy cultivating ownership and excellence. Therapeutic Area Experience – Cardiovascular (AAV9 Gene Therapy, Medical Devices), Liver Diseases (Small Molecule, Hepatitis B, Hepatitis C), Hemophilia, Rare Disease

      Session Details:

      PANEL DISCUSSION: Study start-up challenges in a competitive environment

      2026-02-11, 9:30 AM

      Session Details:

      Cost optimization in outsourced clinical operations without compromising quality

      2026-02-11, 3:00 PM

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      Robert Loll
      Senior Vice President, Business Development and Strategic Planning, Praxis

      Robert Loll is the SVP of Business Development & Strategic Planning at Praxis, a full service patient recruitment & retention agency that specializes in optimizing study enrollment for research studies with award-winning creative and superior execution.  Designing and deploying effective patient recruitment campaign strategies since 2004, Robert’s clinical background includes 16+ years providing patient care for top collegiate, Olympic and disabled athletes around the world and working for outpatient rehabilitation companies including Baxter, Caremark and NovaCare.  Robert is an Advisory Board member for The Center for Information and Study on Clinical Research Participation (CISCRP), an independent non-profit organization dedicated to educating and informing the public and patients about clinical research.

      Session Details:

      Chair’s introductions

      2026-02-11, 8:10 AM

      Session Details:

      PANEL DISCUSSION: Study start-up challenges in a competitive environment

      2026-02-11, 9:30 AM

      Session Details:

      Chair’s closing remarks

      2026-02-11, 5:00 PM

      Session Details:

      PANEL DISCUSSION: Sponsor, CRO, site collaboration: Aligning priorities across stakeholders

      2026-02-12, 11:30 AM

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      Arla Yost
      Clinical Research Operations Director, Helen Diller Family Comprehensive Cancer Center, University of California

      Arla holds an MSc in Interdisciplinary Oncology and is both CCRP and PMP certified. She has worked in healthcare and oncology for over 15 years, with the last 9 years spent focused on clinical research operations at UCSF’s NCI-designated Comprehensive Cancer Center.

      Session Details:

      PANEL DISCUSSION: Sponsor, CRO, site collaboration: Aligning priorities across stakeholders

      2026-02-12, 11:30 AM

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      Emily McInturf
      Director, Feasibility, PSI CRO

      Emily McInturf, Director of Feasibility, has worked in the clinical research industry for the past 15 years. As a leader within PSI’s global feasibility team, Emily specializes in strategy development across multiple therapeutic areas – focusing on aligning a study’s design with top enrolling investigators in the right countries.

      Using PSI’s INTELIA platform, a machine-learning-powered system for data-driven feasibility and enrollment forecast, Emily models and compares hundreds of country and site combinations, their budgets and probability of success, ultimately recommending the most optimal enrollment scenario in line with each sponsor’s key objectives. As a director, Emily provides oversight for global feasibility and site identification activities for both pre- and post-award opportunities and projects.

      Session Details:

      New approach to Site ID: Adding a semantic knowledge platform to a solid process foundation

      2026-02-12, 9:30 AM

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      Aditya Kotta
      VP Business Development, Novotech

      Aditya Kotta is the VP of Business Development for Novotech. He has been with the company since 2018. He has 14 years of experience in the clinical trial industry, working in both Clinical Operations and Business Development. He holds degrees in Biomedical Engineering from Johns Hopkins University and Medical Science from Boston University.

      Session Details:

      The 2026 biotech landscape: Perspectives and projections

      2026-02-11, 10:00 AM

      Session Details:

      PANEL DISCUSSION: Managing and encouraging CRO relations effectively as a small biotech

      2026-02-12, 12:00 PM

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      Anca Copaescu
      CEO & Founder, Clinical Maestro

      Anca Copaescu is the founder and CEO of Clinical Maestro®, bringing more than 20 years of experience in clinical operations and outsourcing. She is dedicated to helping life sciences organizations move from reactive oversight to proactive, intelligence-driven outsourcing by connecting data, operational context and human expertise. Through Clinical Maestro, Anca advances smarter sourcing strategies, continuous vendor governance, stronger performance management and greater inspection readiness. Her work focuses on translating technology and AI into practical capabilities that help clinical teams anticipate risk, strengthen compliance and make faster, better-informed outsourcing decisions.

      Session Details:

      PANEL DISCUSSION: Big pharma vs. emerging biotechs: Different outsourcing strategies, shared challenges

      2026-02-11, 12:00 PM

      Session Details:

      TECHNOLOGY SPOTLIGHT – Transforming clinical outsourcing: How outsourcing managers will become “Superhumans” with AI

      2026-02-12, 10:45 AM

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      Katsura Kasahara
      Executive Professional, EPS Corporation

      Katsura Kasahara is currently serving as an Executive Professional in the Global Business Development Division at EPS Corporation since 2021. In this role, Katsu strengthens the bridge between Japan and  international pharmaceutical development projects. This role leverages over 30 years of experience in pharmaceutical development and licensing within the industry.

      Katsu's extensive career spans numerous countries and regions, working with both Japanese pharmaceutical companies, Ono Pharmaceutical and Shionogi, as well as global mega-pharma, Eli Lilly. From the Japan base, Katsu managed pharmaceutical development not only in Japan but also in East Asia and Singapore. Additionally, Katsu has spent approximately 15 years stationed in the UK and the US, leading European expansion from the UK and overseeing US operations, including successful FDA approvals.

      Katsu's knowledge and experience in pharmaceutical development and business are underpinned by a strong foundation in medicinal chemistry. Katsu holds a Master's degree in Pharmacy and is a licensed pharmacist.

      Session Details:

      Breaking borders: Japan’s evolving landscape for global innovators

      2026-02-11, 12:30 PM

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      Saya Toyoda
      Business Development Manager, EPS Corporation

      Session Details:

      Breaking borders: Japan’s evolving landscape for global innovators

      2026-02-11, 12:30 PM

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      Zahiah (Zee Zee) Gueddar
      Senior Director Commercial Strategy, Clinical Trial Financial Suite, IQVIA Technologies

      Zahiah (Zee Zee) Gueddar leverages over 17 years of diverse industry expertise encompassing delivery, finance, operational effectiveness, and the commercial sector. Zee Zee offers invaluable insight into the challenges encountered by sponsors, CRO’s, sites and patients. In her role leading IQVIA’s Financial Technology offerings, she serves as an innovative partner for clients seeking transformative outcomes and growth opportunities. Known as a strategic thinker and problem solver, Zee Zee is responsible for driving growth and differentiation, product go-to market & ensuring innovative and competitive offerings. Zee Zee is based in Southern California and is a graduate of San Diego State University.

      Session Details:

      Driving AI transformation in clinical trial financial management

      2026-02-11, 11:30 AM

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      Shola Jhanji
      Quality Program Lead, Roche

      Session Details:

      Deploying AI for generation and deployment within Roche’s Quality Programs

      2026-02-12, 2:00 PM

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      Chris Fratus
      RBQM Strategic Lead, Roche

      Dynamic and experienced leader with a proven track record of guiding teams and managing complex projects to achieve strategic objectives in both local and global settings. Excels at identifying and resolving challenges, designing sustainable solutions, and maintaining high standards while ensuring alignment with organizational goals. Demonstrated expertise in strategic planning, project and change management, and problem-solving, with a strong focus on driving continuous improvement and delivering impactful results.

      Session Details:

      Deploying AI for generation and deployment within Roche’s Quality Programs

      2026-02-12, 2:00 PM

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      Shiya Song
      Senior Principal Computational Biologist, Amgen

      A passionate and experienced Computational Biologist (Ph.D. Bioinformatics, M.S. Statistics - University of Michigan), I specialize in pioneering algorithm development for DNA consumer products and applying advanced statistical modeling to clinical biomarker data for immuno-oncology programs. My technical skills span population & statistical genetics, cancer genomics, statistical inference, and machine/deep learning. In industry, I've successfully led multidisciplinary teams with 10+ reports to architect and implement cutting-edge biomarker platforms—from automated data ingestion to live longitudinal visualizations and advanced machine learning models for safety and efficacy endpoint—and have directed critical biomarker analyses (e.g., for BiTEs) to inform pharmacodynamics, mechanism of actions, patient stratification, mitigate risks, and advance drug development.

      Session Details:

      The art of data integration: Biomarkers, AI, and the science of translational insight

      2026-02-11, 11:00 AM

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      Adam Callahan, MS, MBA
      VP Global Therapeutic Area Head, Oncology & Hematology, Caidya

      Adam Callahan is VP Global Therapeutic Area Head, Oncology & Hematology at Caidya. Adam brings nearly 30 years of experience and a strong record of building high-performing, global teams that drive clinical programs for regulatory approval and commercialization of therapies. Adam leads a team of medical, scientific, and clinical development experts who engage early and often to help refine sponsor strategies, improve targeting, and accelerate delivery.

      Adam’s teams also bring an adeptness in molecule-to-market strategies and operational excellence. Adam’s operational acumen ensures Caidya’s ability to provide development strategies while delivering exceptional experiences for our clients.

      Session Details:

      Navigating major inflection points from IND to approval: Indication clarity, regulatory strategy & quality-by-design to support the drug development journey

      2026-02-12, 9:30 AM

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      Shane Johnson
      Senior Scientist, Clinical ink

      Dr. Shane Johnson is a Senior Scientist at Clinical ink with a background in neuroscience and 9 years of experience in machine learning, biomarkers, and digital health technology. Dr. Johnson is interested in leveraging emerging connected device data streams and AI to improve clinical trials and patient outcomes.

      Session Details:

      TECHNOLOGY SPOTLIGHT – Operationalizing AI in clinical trials

      2026-02-12, 10:30 AM

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      Wanda Truong
      Operations Manager, Helen Diller Family Comprehensive Cancer Center, University of California, San Francisco

      Session Details:

      SITE PERSPECTIVE Beyond big centers: Unlocking the potential of community hospitals in oncology research

      2026-02-11, 2:00 PM

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      Tim Curry
      SVP, Account Development, MedPoint Digital

      Tim Curry joined MedPoint Digital in 2006 and in his current role leads an elite team focused on strategic global program development. Tim has extensive experience consulting with biopharma clients on effective applications across a broad suite of digital platforms and services. Tim holds an MBA from the University of Chicago.

      Session Details:

      Leverage the power of AI to optimize study site and CRA performance

      2026-02-11, 12:30 PM

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      Kris O’Brien
      Director, Operational Strategy, Ergomed

      Kris has nearly four decades of experience in the clinical research industry, spanning roles in contract research organizations (CROs), pharmaceutical companies, and academia. Throughout her career, she has worked across a wide range of therapeutic areas, with a strong focus on rare diseases.

      As a subject matter expert in rare disease research, Kris has spent significant time collaborating with patient advocacy organizations and patient-led support groups to ensure that the voices of those living with rare conditions are meaningfully represented in every study opportunity. She integrates patient feedback into strategic study insights, driving successful enrollment and retention.

      With a long and successful background in clinical operations, Kris brings a comprehensive understanding of all aspects of study execution. She combines this operational expertise with a deep passion for patient-centric research, ensuring success from study inception through completion.

      Session Details:

      Strategies for success when every patient counts: enhancing retention and protocol compliance in ultra-rare and genetic disorders

      2026-02-12, 10:30 AM

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      Noelle Saldana
      Head of Research Analytics (AI & ML), Fortrea

      Noelle Saldana is Head of Research Analytics (AI & ML) for the AI/ML Innovation Studio at Fortrea, enabling clinical trial transformations with AI. With over 15 years of experience at the intersection of data science, AI, and strategic leadership, Noelle has driven transformative initiatives across startups, nonprofits, and Fortune 500 companies. Her work spans embedding intelligent insights into cloud-native applications and driving pragmatic, collaborative approaches to AI adoption. She holds an A.B. in Applied Mathematics and Physical Anthropology from Washington University in St. Louis and an M.S. in Applied Mathematics from Cal Poly Pomona.

      Session Details:

      Balancing innovation with the reality of AI today

      2026-02-11, 2:30 PM

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      Chitra Sharma
      Senior Vice President, Scribe Therapeutics

      Chitra Sharma is a high-impact biotechnology executive with over 25 years of experience architecting product lifecycles from early-stage development through successful NDA/BLA approvals. A specialist in CMC and global Quality operations, she has pioneered regulatory and development strategies, working for industry titans including Genentech, Roche Bioscience, Cor Therapeutics and Vivus.
      Currently, as SVP of Development at Scribe Therapeutics, she integrates breakthrough innovation with operational excellence.

      Chitra’s expertise spans a sophisticated portfolio of CRISPR, Cell and Gene Therapy, Biologics and small molecules. Over 13 years as a founder and consultant, she served as a premier bridge between scientific discovery and commercial viability for both Fortune 500 firms and agile startups.
      A pragmatic leader with deep technical mastery, Chitra is defined by her ability to scale global operations and build high-performing, compliant organizations that navigate the complexities of international drug development.

      Session Details:

      PANEL DISCUSSION: Big pharma vs. emerging biotechs: Different outsourcing strategies, shared challenges

      2026-02-11, 12:00 PM

      Session Details:

      Maintaining regulatory compliance across phases using adaptive clinical trials in Cell and Gene Therapy

      2026-02-12, 10:00 AM

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      Travis Caudill
      VP Feasibility, Site Identification & Clinical Informatics, ICON

      In my role, I am responsible for leading ICON’s country and site selection strategy ensuring that every project ICON undertakes benefits from a data-driven approach, optimized to reflect customer priorities, and with a probability of success calibrated to each customer’s risk preferences.

      I started my journey working for a local health insurance company supporting actuarial (claims data) analysis, and then joined a local CRO to help them develop a data-driven site identification strategy to support their late phase studies.  Since then I’ve held a number of Feasibility, Site Identification, and Study Start-up focused roles across midsize and large CROs.

      I’m an expert in trial modelling and leveraging artificial intelligence to inform country and site selection. I have really enjoyed helping to develop ICON’s OneSearch platform as well as leading initiatives to deliver next-generation scenario planning capabilities.  As we work to bring the best of both organizations together I’m excited about exploring new opportunities to excite and delight our customers through data-driven delivery.

      Session Details:

      Is AI enough? Why smarter site identification still needs human-centred strategies

      2026-02-11, 9:00 AM

      Session Details:

      PANEL DISCUSSION: How far can AI take us?

      2026-02-11, 12:00 PM

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      Jasmine Washington
      Associate Director, Cytokinetics

      Session Details:

      Speaker Hosted Round Tables

      2026-02-12, 3:30 PM

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      Todd McGrath
      Chief Operations Officer, MRN

      Todd McGrath has over 19 years’ experience in the clinical trial and life science industry across pharmaceutical and biotech companies.

      Today, Todd is MRN’s Chief Operating Officer. In this role he oversees all global operations for the company. Todd’s leadership has been instrumental to MRN’s pharma clients, guiding them through operational challenges to finding hybrid trial success and opportunities to maximize their return on investment. Todd’s passion for making trials more accessible and less burdensome for patients and their families, continues to drive MRN’s vision of allowing more people to participate in trials and getting drugs to the market and patients, faster.

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      Hala Borno
      Founder and CEO, Trial Library and Associate Clinical Professor, University of California, San Francisco

      Hala Borno, MD is a physician scientist, Associate Professor of Medicine at the University of California San Francisco, Founder, and Chief Executive Officer of Trial Library, an AI-enabled research platform with a mission to advance access to precision medicine.

      Dr. Borno has published 100+ peer-reviewed papers and previously served as co-Medical Director of the Genitourinary Medical Oncology Clinic at the Helen Diller Family Comprehensive Cancer Center (HDFCCC) at UCSF. At HDFCCC, Dr. Borno served on the executive leadership committee for the Prostate Cancer Program and the Liaison to the Office of Community Engagement. She has also served as a member of the American Society of Clinical Oncology Social Determinants of Health working group, and GU committee for NRG oncology. She previously served as the Vice Chair of the Health Disparities Committee for Alliance for Clinical Trials in Oncology and co-led the Recruitment Science Research Hub at HDFCCC.

      Dr. Borno graduated with honors in biochemistry and received her medical degree from the University of North Carolina at Chapel Hill where she was a recipient of a merit scholarship. She completed her internal medicine residency and medical oncology fellowship training at UCSF. She served as chief oncology fellow at UCSF and was a National Institute on Aging T32 research fellow in the Division of Geriatrics. Dr. Borno's research has been featured in peer-reviewed journals such JAMA Oncology, Cancer, and Nature. She continues to serve on expert panels for the development of guidelines in the management of advanced prostate cancer. Her work has been covered by national news outlets such as NPR, Washington Post, CBS News, Bloomberg News, and STAT News.

      Session Details:

      PANEL DISCUSSION: Study start-up challenges in a competitive environment

      2026-02-11, 9:30 AM

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      Arjun Ishwar
      Solutions Director, Omics, Tempus

      Passionate and accomplished technical and commercial leader in the genomics space with a track record of success in rapidly increasing revenue, driving operational efficiency and delighting customers.

      Session Details:

      Tempus Ecosystem combines for smarter insight to precision medicine oncology trials

      2026-02-12, 12:00 PM

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      Michael Rosenberg
      Senior Director, Business Development, Trialbee

      Michael Rosenberg, based in LA, is an experienced leader with deep expertise in patient recruitment and clinical trial enrollment strategy. As Senior Director at Trialbee, he works closely with sponsors, CROs, and study teams to design and execute recruitment approaches that improve patient access and trial feasibility. Michael brings over a decade of direct hands-on experience across the patient recruitment lifecycle, with a strong focus on translating operational challenges into practical, data-driven solutions. His background spans recruitment strategy, study support, and cross-functional collaboration within the clinical research ecosystem.

      Session Details:

      TECHNOLOGY SPOTLIGHT – Trial finder solutions – The evolving role of Patient Recruitment Platforms (PRPs) to Improve the last mile

      2026-02-12, 12:15 PM

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      Constantin Weberpals
      Machine Learning Research Collaborator, Stanford

      Constantin Weberpals is a researcher focused on applying artificial intelligence to clinical research and operations. With a background in information systems and machine learning, his work has explored machine-learning-based biomarkers and AI for clinical trial operations at Stanford University. He also worked at McKinsey & Company, advising biopharma on improving operational efficiency through technology.

      Session Details:

      Speaker Hosted Round Tables

      2026-02-12, 3:30 PM

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      Pietro Belligoli
      Researcher, Former Roche

      Session Details:

      Speaker Hosted Round Tables

      2026-02-12, 3:30 PM

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      Rich Polgar
      Managing Director, Danforth Health

      Steering the helm for biotechs at Danforth Advisors, my strategic procurement proficiency shapes the landscape of clinical development. With a laser focus on sourcing strategy and risk mitigation, my contribution has been pivotal in advising organizations through critical transitions, including mergers and acquisitions. The expertise I honed while advising on operational growth strategies and variabilizing workforces underscores my current mission to optimize our clients' partnerships and exit strategies.

      My tenure as a Senior Director at Danforth Advisors cultivated a deep understanding of clinical sourcing, from preclinical and translational stages to real-world evidence and late-phase data analysis. This comprehensive background facilitates my current role, where I'm committed to advancing sourcing of trials & digital health through robust supplier and stakeholder engagement, thereby empowering the acceleration of our clients' portfolio growth and fostering strategic partnerships.

      Session Details:

      Why patient centricity must be built into outsourcing

      2026-02-11, 2:30 PM

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      David Tsai
      Senior Director Clinical Operations, Terray Therapeutics

      Life sciences is about pushing scientific boundaries to impact as many lives as possible. My work is grounded in one belief: we are all patients at the end of the day. The moment we forget this truth, we lose sight of our core purpose.

      Because the patients we are fighting for aren't strangers: they're our family, loved ones, and ourselves.

      My career is built on the foundations of clinical research, optimizing internal and external partnerships and relationships, all around pushing breakthrough therapies to reach the ones who need it most.

      I started as a clinical research coordinator at UC Davis enrolling patients in hematology, oncology, and rare disease trials. Those patients are the unsung heroes — offering their time to offer hope to future patients — and they taught me that every decision in clinical development matters more than we realize.

      Since then, I've built a deliberately non-traditional career path that's bridged the clinical site, sponsor, and nearly all stages of drug development. I jump into extended roles where needed — clinops, program management, regulatory strategy, program team leadership — because that's how you learn to solve any problem that comes up.

      I specialize in rescuing stalled clinical trials — identifying what's broken, creating and executing critical action plans, and getting programs back on track fast. More recently I've been focused on novel therapeutic modalities where no regulatory playbook exists and you're building the plane while flying it.

      As a speaker and advisor, I help others think about the problems that haven’t surfaced yet and creatively build solutions — but the work I'm most proud of is the personal 1:1 time spent coaching and helping people across academia, biotech, pharma, and even complete strangers who've become close friends.

      Let's remember, at the end of the day, we are all patients. So let's do right by us.

      Session Details:

      Building resilient clinical trials: What the trial of tomorrow will look like

      2026-02-11, 11:00 AM

      Session Details:

      Chair’s opening remarks

      2026-02-12, 8:50 AM

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      Anne Baker
      General Manager, FSP, Parexel
      • More than 30 years of industry experience, including 18 years in FSP
      • Anne brings extensive expertise in clinical operations leadership and strategic solutions
      • Began her clinical research career in New Zealand as a study coordinator/research nurse. Later joining GSK then Parexel as a CRA. Relocated to US with Parexel accumulating 11 yrs in study oversight. Held roles with RPS, PRA and ICON FSP strategic solutions. Recently returned to Parexel as an FSP expert.

      Session Details:

      Designed to deliver: Unlocking the value of bespoke outsourcing models

      2026-02-12, 9:30 AM

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      Advisory Board

      Select a member to learn more

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      Dr Alison McMorn
      Head of Clinical Strategy and Development, LifeArc

      Dr. McMorn is an experienced clinical development researcher with over 25 years of industry experience and has a strong focus in CNS and paediatric drug development. She has worked for both Pharmaceutical Companies and Contract Research Organisations including holding positions at SAR Monitoring Services Ltd, Mundipharma International Ltd and Shire Development Inc. Starting her career at SAR as a Clinical Research Associate (CRA) she subsequently moved to Mundipharma where she was responsible for initiating the first paediatric clinical research program for the company. At Shire Dr. McMorn led, planned and managed global paediatric and adult clinical development programs for a wide variety of indications including psychiatry, pain, gastrointestinal and hepatology across all phases of development (Phase 0 to Phase 4). In addition she was responsible for harmonizing Clinical Trial Administrator (CTA) working practices across all regions for the company. In 2015 Dr. McMorn joined AMO Pharma Ltd, a virtual pharmaceutical company focused predominantly on paediatric neurodevelopmental rare diseases, as VP of Clinical Development. She holds an undergraduate degree in Pharmacology and a PhD in Psychology from the University of Leeds, UK.

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      Behtash Bahador
      Senior Director, Community Engagement & Partnerships, Center for Information & Study on Clinical Research Participation (CISCRP)

      Behtash Bahador is the Senior Director of Community Engagement & Partnerships at the non-profit organization CISCRP, and holds a Master of Science in Health Communication from the Tufts University School of Medicine. Since 2014, he has collaborated with a range of stakeholder groups to establish and implement patient- and public-centric initiatives across the life-cycle of drug and treatment development. This has included supporting the development of regulatory and cross-disciplinary best practice guidelines, operationalizing key elements of evidence-based public health programing into research engagement activities, and always keeping the needs of patients, participants and the public at the forefront of his work.

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      Kathleen Cohen
      Vice President, Clinical Development, Marinus Pharmaceuticals

      Kathleen Frenia Cohen is Vice President and Head of Clinical Development Operations at Marinus Pharmaceuticals.  Prior to joining Marinus, she spent 20+ years at PRA Health Sciences in a variety of project management and operational oversite roles. Kathleen graduated from the University of the Science in Philadelphia with a PharmD and completed a post-doctoral fellowship in Pharmacoeconomics and Outcomes Research from Rutgers College of Pharmacy. Kathleen resides in Media, PA.

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      Aditya Kotta
      VP Business Development, Novotech

      Aditya Kotta is the VP of Business Development for Novotech. He has been with the company since 2018. He has 14 years of experience in the clinical trial industry, working in both Clinical Operations and Business Development. He holds degrees in Biomedical Engineering from Johns Hopkins University and Medical Science from Boston University.

      Session Details:

      The 2026 biotech landscape: Perspectives and projections

      2026-02-11, 10:00 AM

      Session Details:

      PANEL DISCUSSION: Managing and encouraging CRO relations effectively as a small biotech

      2026-02-12, 12:00 PM

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      Martin Rodriguez
      Consumer Safety & Evidence Global Quality & Excellence Head, Opella

      Senior executive Leader in Life Science (Biochemist) and Lean/Six Sigma Green-belt certified, with more than 20 year of experience in clinical operations, Operational Excellence (i.e., operational strategy, performance management, process optimization, risk management, Quality-by-Design and team performance), clinical quality, and Service Providers / Outsourcing management.

      I developed, reengineered, automated, and optimized business processes with a risk-based and approach to produce high quality outputs and to ensure regulatory compliance. I led the development, implementation and monitoring of different operational and quality strategies and models including Outsourcing as well as new/ innovative clinical capabilities to fulfill consumers/ patients needs .

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      Rosalie Filling
      Vice President, Senior Global Head R&D Operations, Keenova

      In her over 25 years of experience, Rosalie “Rosie” Filling has transformed R&D operations in every company she has worked for, developing clear-cut strategies to help advance clinical trials with high-quality operational execution and scientific excellence.

       

      Rosie is the Vice President, Senior Global Head R&D Operations Endo International plc. She is part of the global R&D leadership team and is charged with the coordination and implementation of clinical development strategies for the company’s research and development. She provides strategic direction and oversight of the R&D Operations team, which includes clinical operations, data management, biostatistics, medical writing, clinical supplies, trial master file/inspection readiness and business operations. This integrated team handles the execution of all aspects related to Endo’s clinical trials. Endo has active research and development programs in men’s health, orthopedics, and endocrinology. Beyond these therapeutic areas, the company also has focused development in the areas of sterile injectables and complex generic products.

       

      Rosie’s main focus at all times is on the end users—the patients. Bringing new and, at times, life-saving medications to patients drives Rosie’s sense of purpose.

       

      Rosie joined Endo from Lupin Pharmaceuticals in Blue Bell, PA where she was Senior Director, Head of Clinical Operations, and built the clinical operations organization to support the US and Global R&D Organization. Prior to Lupin, Rosie spent nearly five years at Teva in Frazer, PA where she was the US site head of Clinical Operations and was responsible for the successful delivery of Inhalation, Women’s Health, and Cardiovascular clinical trials. Earlier in her career, Rosie held various roles at Eisai, MGI Pharma and PPD.

       

      Rosie earned her B.S. in Biology with a minor in Chemistry from the University of Pittsburgh.

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      Edwin van Vulpen
      Executive Director and Head of Clinical Business Development Euro-Asia
      Next

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      Nick McCudden


      +61 280 978 126

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      Karina Gomez


       

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