18th Annual Outsourcing in Clinical Trials West Coast 2026

Creating a collaborative environment where pharma & biotech leaders can find solutions to current challenges through innovations and partnerships

11 - 12

February

2026
  • Hyatt Regency San Francisco Airport, Burlingame, CA, USA
  • Complimentary
  • Agenda
  • Advisory Board
  • Speakers
  • Plan Your Visit
  • Event Gallery
  • Sponsors
  • Media Centre
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Featured Speakers

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Amrita Pati​

Executive Director, Computational Biology, Amgen

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Kelly Bryant​

Chief Operating Officer, Adjuvia Therapeutics

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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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Chris Saunders​

Executive Director, Head of Development Outsourcing, Jade Biosciences

My career has been built on the belief that we achieve more when we come together. My purpose is to connect people and organizations through a robust Strategic Sourcing and Supplier Relationship Management approach. Leading, solving problems, building relationships, coaching, and bringing bold ideas to the table is what I do best.

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Jennifer Willert​

Medical Director CART USOM, Novartis

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    2026 Sponsors Include:

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    Company Information

    ARENSIA Exploratory Medicine, a German-based company, is a leader in “first-in-patient” Phase IB and II/Proof-of-Concept clinical trials across a wide range of disease areas. With 14 proprietary research clinics and cutting-edge Phase I infrastructure, ARENSIA accelerates the early detection of efficacy signals for new therapies at an unparalleled speed. Its streamlined, highly efficient approach reduces patient recruitment time and costs by over 50% compared to conventional trial sites, which are often overcrowded and understaffed. This exceptional performance has resulted in a 93% repeat business rate and robust growth through collaborations with top pharmaceutical companies, biotechs, and global CROs. Headquartered in Düsseldorf, ARENSIA operates with a team of 600 professionals across 8 countries.

    Company Website

    To learn more, please visit our website - http://www.arensia-em.com/

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    Company Information

    ICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organisations. We develop new innovations, drive emerging therapies forward and improve patient lives. With headquarters in Dublin, Ireland, ICON employed approximately 41,150 employees in 113 locations in 53 countries as at September 30, 2022.

    Company Website

    To learn more, please visit our website - https://www.iconplc.com/sectors/biotech

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    Company Information

    Clario is a leading provider of endpoint data solutions that generate high-quality clinical evidence for our pharmaceutical, biotech, and medical device partners. We offer comprehensive evidence generation solutions that combine eCOA, cardiac solutions, medical imaging, precision motion, and respiratory endpoints. Since our founding more than 50 years ago, Clario has delivered deep scientific expertise and broad endpoint technologies to help transform lives around the world. Our endpoint data solutions have supported clinical trials over 26,000 times in more than 100 countries. Our global team of science, technology, and operational experts have supported over 60% of all FDA drug approvals since 2012.

    Company Website

    To learn more, please visit our website - www.Clario.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

    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

    IQVIA Technologies help you transform your clinical trials and improve patient safety with SaaS-based applications and tech-enabled services designed to streamline processes, improve workflows, and effectively engage and inform patients. The Orchestrated Clinical Trials (OCT) platform eases the burden on your sites and makes it easier and more appealing for patients to enroll and remain engaged, produces faster trials to database lock, and speeds time to market. For more information visit www.iqvia.com/oct or email us at OrchestrateYourTrials@iqvia.com

     

    Company Website

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

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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

    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

    PCM Trials has been at the forefront of decentralized clinical research since 2008, leading mobile visits and recently introducing community-based research sites. We are driving the shift to patient-centric clinical trials, giving individuals the flexibility to engage in research studies in ways that work best for them. Our approach expands opportunities for participation, resulting in greater patient diversity, reduced patient dropout, and faster study results.

    Company Website

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

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    Company Information

    Premier Research is a leading clinical development service provider that helps highly innovative biotech and specialty pharma companies transform breakthrough ideas into reality. The company has a wealth of experience in the execution of global, regional and local clinical development programs with a special focus on addressing unmet needs in areas such as analgesia, CNS, oncology, pediatric, and rare disease.

    Company Website

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

    Worldwide is changing how the world experiences CROs – in the best possible way. From early phase, bioanalytical sciences, late phase, post-approval and real-world evidence, Worldwide Clinical Trials provides full-service drug development services for central nervous system, cardiovascular, metabolic, general medicine, oncology and rare disease therapies.

    Company Website

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

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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

    Advance Research Associates is a premier provider of biostatistical and data management services to the pharmaceutical, biotech, and medical device industries. Since 1996, ARA has supported 700+ clinical trials worldwide across all therapeutic areas. Our collaborative approach helps maximize efficiency and agility by acting as an experienced member of your team.

    Company Website

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

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    Company Information

    Advanced Clinical is a global clinical research services organization, providing CRO, FSP, Strategic Resourcing and Consulting Services for biopharmaceutical and medical device organizations. Our company is committed to improving all lives touched by clinical research and we address the hopes of patients and healthcare professionals with industry-leading services and technology in life sciences.  Visit our website to learn more about how we deliver a Better Clinical Experience.

    Company Website

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

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    Company Information

    Advarra breaks the silos that impede clinical research, aligning patients, sites, sponsors, and CROs in a connected ecosystem to accelerate trials. Advarra is number one in research review services, a leader in site and sponsor technology, and is trusted by the top 50 global biopharma sponsors, top 20 CROs, and 50,000 site investigators worldwide. Advarra solutions enable collaboration, transparency, and speed to optimize trial operations, ensure patient safety and engagement, and reimagine clinical research while improving compliance.

    For more information, visit – www.advarra.com

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    Company Website

    To learn more, please visit our website - http://aicure.com/

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    Company Information

    Allucent is on a mission to help bring new therapies to light by solving the distinct challenges of small and mid-sized biotech companies. We’re a global provider of comprehensive drug development solutions, including consulting, clinical operations, biometrics, and clinical pharmacology across a variety of therapeutic areas. With more than 30 years of experience in over 60 countries, our individualized partnership approach provides experience-driven insights and expertise to assist clients in successfully navigating the complexities of delivering novel treatments to patients.

    Company Website

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

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    Company Information

    Almac Group is a global leader in providing a range of expert services and support across the drug development lifecycle.

    We are trusted experts in R&D, diagnostic services, API manufacture, formulation development, clinical trial supply services and technologies through to commercial-scale manufacture and distribution.

    We are recognised as an industry leader in client service, providing understanding, experience and knowledge to our clients as we work together to advance human health.

    Almac is trusted by the leading global biopharma companies to provide crucial services across their drug development projects. In the last 5 years alone, we have contributed to over 50% of all FDA approved New Molecular Entities (NMEs) and are currently supporting 30% of EU approved /pre-registered Gene therapy products.

    A privately owned organisation, Almac has grown organically over the past five decades, employing over 7,700 highly skilled employees across 18 facilities in Europe, North America, and Asia. Learn more about us at https://www.almacgroup.com/

    Company Website

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

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    Company Information

    Altasciences is a forward-thinking, mid-size contract research organization offering pharmaceutical and biotechnology companies of all sizes a proven, flexible approach to preclinical and early phase clinical studies, from lead candidate selection to proof of concept. For over 25 years, Altasciences has been integrating into clients’ projects to help support educated, faster, and more complete early drug development decisions. Altasciences’ full-service solutions include preclinical safety testing, clinical pharmacology, bioanalysis, program management, medical writing, biostatistics, data management and more, all of which can be tailored to specific sponsor requirements. Altasciences… helping sponsors get better drugs to the people who need them, faster.

    Company Website

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

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      WHAT TO EXPECT FOR 2026?

      With regulations ever changing and the innovative advancements of technology rapidly growing, this conference will address the everyday and perspective challenges faced when working within the clinical trial space. New for 2026, is our Biotech Strategy stream, focusing on the challenges and strategies in drug development from a small biotech perspective.

      This conference will bring industry professionals together to share knowledge, with a focus on collaboration, advancing clinical development and concentrating on clinical operations, innovation, technology and of course, patient centricity.

      This is a unique opportunity to network and share knowledge with the region’s leading pharmaceutical firms and biotechs, to discuss operationally efficient, specifically targeted clinical trials. The 2026 program boasts 4 full streams complete with key content.

      Stream A: Outsourcing & Clinical Operations

      Stream B: AI and Tech Transformation

      Stream C Day 1: Patient Centricity

      Stream C Day 2: Biotech Strategy (NEW)

      400+

      Attendees

      		30+

      Exhibitors

      		30+

      Speakers

      		80%

      Attendees at Director + Level
      400+

      Attendees

      		30+

      Exhibitors
      30+

      Speakers

      		80%

      Attendees at Director + Level

      Testimonials

      See What It's All About

      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

      Reserved for event sponsor

      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 becoming gatekeepers for connecting sponsors and vendors
      • Making trials more patient-focused rather than disease focused

      Speakers

      Michelle Finegan
      Senior Director, Patient Advocacy and Strategic Alliances, Neurelis
      Jenni Herber
      Associate Director, Clinical Operations, Kamau Therapeutics
      Bruce Morimoto
      Head of Drug Development, Fuku Biotech

      12:30 PM

      Reserved for event sponsor

      1 PM

      Lunch and networking break

      2 PM

      Reaching underrepresented patients for trials in the current climate

      Speakers

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

      2:30 PM

      Reserved for event sponsor

      3 PM

      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

      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

      Reserved for event sponsor

      5 PM

      CLOSING KEYNOTE: Innovative recruitment tactics in the digital age

      • Adopting responsible digital practice while still driving efficiency and innovation
      • Building trust with patients through transparent communication and informed consent
      • Rethinking patient recruitment with AI, what are the ethics we need to consider?
      • How to pinpoint and mitigate the recruitment challenges upfront to avoid impact to study milestones
      • Applying digital outreach (social media, HER data) to identify and engage diverse populations
      • Building culturally sensitive recruitment campaigns to promote inclusion

      5:30 PM

      Chair’s closing remarks

      END OF DAY 1 AND NETWORKING DRINKS

      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

      Amrita Pati
      Executive Director, Computational Biology, Amgen

      11:30 AM

      Reserved for 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

      Seats available

      Speakers

      Paulius Ojeras
      Vice President Clinical Operations, Perceive Biotherapeutics
      Meghan McKenzie
      Director, AIR Portfolio Alliance Lead, Population Science, Genentech

      12:30 PM

      Reserved for event sponsor

      1 PM

      Lunch and networking break

      2 PM

      Clinical development in the digital age

      Speakers

      Gajanan Bhat
      Senior Vice President, Development Lead, TORL Biotherapeutics

      2:30 PM

      Reserved for event sponsor

      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

      Session reserved for Annette Bugno, Associate Director Clinical Records, Corcept Therapeutics

      Speakers

      Annette Bugno
      Associate Director Clinical Records, Corcept Therapeutics

      4:30 PM

      Reserved for event sponsor

      5 PM

      CLOSING KEYNOTE: 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

      5:30 PM

      Chair’s closing remarks

      END OF DAY 1 AND NETWORKING DRINKS

      7:30 AM

      Registration & Refreshments

      8:20 AM

      Chair’s 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

      Reserved for 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

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

      Speakers

      Revati Tatake
      Global Head of Pharma Research, Analysis and Competitive Intelligence, GlobalData Healthcare
      Euodia Jonathan
      Associate Director, Clinical Operations, OncoNano Medicine
      Rachel Yan
      Director, Clinical Operations, Allay Therapeutics

      10 AM

      Reserved for 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

      Shreya Badhrinarayanan
      Global Development Lead, Clinical Development Oncology & Hematology, Pfizer

      11:30 AM

      Reserved for Worldwide Clinical Trials

      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?

      Seats available

      Speakers

      Tsui Chern Cheah
      Director, Strategic Sourcing & Procurement, Exelixis
      Chris Saunders
      Executive Director, Head of Development Outsourcing, Jade Biosciences

      12:30 PM

      Reserved for event sponsor

      1 PM

      Lunch and networking break

      2 PM

      Overcoming funding challenges to get your drug to market as quickly and safely as possible

      • Implementing an improved strategy of pipeline focusing on market, time and investment in clinical trials
      • Aligning the reimbursement ecosystem to be operationally efficient
      • Optimizing the funding infrastructure to avoid bankruptcy or being bought out
      • Taking control of finances to deliver seamless trials and getting products approved
      • How is clinical data being presented to investors and shareholders and how does it affect the way they perceive the budgets
      • Bringing in major venture capitalist who work in early stages of clinical trials

      Speakers

      Kim Potter
      Director of Clinical Operations, Alume Biosciences

      2:30 PM

      Reserved for event sponsor

      3 PM

      Mergers, acquisitions and industry consolidation: What it means for sponsors?

      • Sharing perspectives on how CRO consolidation impacts vendor selection, pricing and long-term outsourcing strategies
      • Addressing CRO consolidation risks: How to protect clinical trials
      • Do the consolidated companies support the needs of all types of sponsors across all the stages of clinical drug development?
      • How ongoing consolidation may prove to be a successful strategy for the industry

      Speakers

      Chris Saunders
      Executive Director, Head of Development Outsourcing, Jade Biosciences

      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

      Session reserved for Niharika Kamat, Vice President Clinical Operations, Sardocor

      Speakers

      Niharika Kamat
      Vice President Clinical Operations, Sardocor

      4:30 PM

      Reserved for event sponsor

      5 PM

      CLOSING KEYNOTE: 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
      Director, Clinical Operations, Allay Therapeutics

      5:30 PM

      Chair’s closing remarks

      END OF DAY 1 AND NETWORKING DRINKS

      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

      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

      Bruno Larida
      Chief Business Officer, Omios Biologics
      Justin Chickles
      CEO, Glycyx
      Manuel Lopez-Figueroa
      Chief Operating Officer, IMIDomics

      9:30 AM

      Reserved for event sponsor

      10 AM

      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

      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

      CASE STUDY: What does it take to start up a biotech company from scratch?

      • An overview of common challenges and how to overcome these
      • Securing initial funding: navigating opportunities available to raise capital
      • Overcoming early stage hurdles
      • Building strategic partnerships to support your biotech

      Speakers

      Chris Adams
      Chief Executive Officer, Andarix

      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

      12:30 PM

      Effectively navigating FDA submissions as a small biotech to reduce timelines

      • Identifying what is needed for a submission and strategizing effective plans to gain data in a timely manner
      • Looking ahead to determine regulatory complications and devise risk mitigation plans to curb roadblocks
      • Understanding when to employ a CRO and how they can streamline regulatory processes and minimize delays

      Speakers

      Kelly Bryant
      Chief Operating Officer, Adjuvia Therapeutics

      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

      Bruno Larida
      Chief Business Officer, Omios Biologics

      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

      Joshua Cox
      Vice President, Clinical Data & Analytics Capabilities, Eli Lilly and Company

      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, Summit Therapeutics

      9:30 AM

      Reserved for event sponsor

      10 AM

      Making AI approachable

      Speakers

      Meraf Eyassu
      Executive Director of Clinical Operations, Terns Pharmaceuticals

      10:30 AM

      Reserved for event sponsor

      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), Recode Therapeutics

      12 PM

      Reserved for event sponsor

      12:30 PM

      PANEL DISCUSSION: Using data and information from electronic medical records in order to shorten patient recruitment timelines

      • What are the benefits of electronic medical records and how can they enhance patient recruitment processes?
      • Navigating challenges and overcoming hurdles when using electronic medical records
      • Using electronic medical records in conjunction with other methods of identifying and screening patients in order to shorten timelines and reduce overall costs

      Seats available

      Speakers

      Radha Duttagupta
      VP, Clinical Affairs, Nucleix

      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

      Turning inspection fears into readiness action in an uncertain regulatory environment

      • Building a well-developed infrastructure early on in the trial to avoiding working retrospectively
      • Safeguarding years of investment by ensuring careful planning and preparation
      • How AI can help sponsors stay TMF inspection-ready
      • Hear from companies doing it right

      Speakers

      Christian Hummel
      Regulatory Affairs Manager, ReacX Pharmaceuticals

      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

      Speakers

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

      9 AM

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

      Speakers

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

      9:30 AM

      Reserved for event sponsor

      10 AM

      Sponsor’s oversight responsibilities on regulatory submissions for outsourced clinical trials

      Speakers

      Hanna Cho
      Vice President, Global Regulatory Affairs, Biomea Fusion

      10:30 AM

      Reserved for event sponsor

      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

      Seats available

      Speakers

      Radha Duttagupta
      VP, Clinical Affairs, Nucleix
      Laurin Vincent
      Global Head, Enterprise Clinical Sourcing and Partnerships, Genentech

      12 PM

      Reserved for event sponsor

      12:30 PM

      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

      1 PM

      Lunch and networking

      2 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

      2:30 PM

      Session reserved for Revati Tatake

      Speakers

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

      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.

      RT 1 Revolutionizing healthcare: Incorporating new technologies to reduce the burden on sites, sponsors and CROs
      RT 2 Acknowledging the value that patients can bring to every stage of the drug development pathway
      RT 3 Navigating vendor selection: Reducing the noise of all the competing tools and services
      RT 4 Mitigating risk: how to strategically plan and curb risk as a small biotech
      RT 5 Balancing limited funds while ensuring patient centricity as a small biotech
      RT 6 Aligning ideas with investor expectations for effective pitching and successfully secure funding

      4:30 PM

      Chair’s closing remarks and end of conference

      Speakers

      Select a speaker to learn more

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      Kelly Bryant
      Chief Operating Officer, Adjuvia Therapeutics

      Session Details:

      Effectively navigating FDA submissions as a small biotech to reduce timelines

      2026-02-12, 12:30 PM

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      Rachel Yan
      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:

      CLOSING KEYNOTE: Meeting site challenges with stronger strategies

      2026-02-11, 5:00 PM

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      Kim Potter
      Director of Clinical Operations, Alume Biosciences

      I contribute to protocol development, protocol medical writing, conceptual development per FDA guidance, background research, QC/QA, compilation of TMF, and briefing and supporting documents. I am experienced in writing/reviewing ICFs, CSRs, NTF/MTF, IRB material, data tables, data spreadsheets, and briefing documents. I am responsible for the development and execution of clinical study plans and budget analysis. I am skilled in MS Office, SAS and SPSS, EDC, public speaking, and team building.

      Session Details:

      Overcoming funding challenges to get your drug to market as quickly and safely as possible

      2026-02-11, 2:00 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, 12:30 PM

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      Amrita Pati
      Executive Director, Computational Biology, Amgen

      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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      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:

      CASE STUDY: What does it take to start up a biotech company from scratch?

      2026-02-12, 11:30 AM

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      Sage Callaway
      Associate Director, Clinical Business Operations, Oncology, Ascendis Pharma

      Experienced Professional with a demonstrated history of working in the biotechnology industry. Skilled in Medical Devices, Biotechnology, Management, Cell Culture, and U.S. Food and Drug Administration (FDA). Strong healthcare services professional with a Masters of Science focused in Biological Science with an emphasis in Therapeutic Science and Pharmaceutical Business from Dominican University of California.

      Next speaker
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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

      2026-02-12, 10:00 AM

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      Tsui Chern Cheah
      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

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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:

      Effective inclusion of the patient and patient voice in clinical research

      2026-02-11, 3:00 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:

      PANEL DISCUSSION: How far can AI take us?

      2026-02-11, 12:00 PM

      Session Details:

      Reaching underrepresented patients for trials in the current climate

      2026-02-11, 2:00 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:

      Chair’s opening remarks

      2026-02-11, 8:20 AM

      Session Details:

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

      2026-02-11, 9:30 AM

      Session Details:

      Session reserved for Revati Tatake

      2026-02-12, 2:30 PM

      Session Details:

      Chair’s opening remarks

      2026-02-12, 8:50 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, 10:00 AM

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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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      Chris Saunders
      Executive Director, Head of Development Outsourcing, Jade Biosciences

      My career has been built on the belief that we achieve more when we come together. My purpose is to connect people and organizations through a robust Strategic Sourcing and Supplier Relationship Management approach. Leading, solving problems, building relationships, coaching, and bringing bold ideas to the table is what I do best.

      Session Details:

      Mergers, acquisitions and industry consolidation: What it means for sponsors?

      2026-02-11, 3:00 PM

      Session Details:

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

      2026-02-11, 12:00 PM

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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:

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

      2026-02-11, 5:00 PM

      Session Details:

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

      2026-02-12, 11:30 AM

      Session Details:

      PANEL DISCUSSION: Using data and information from electronic medical records in order to shorten patient recruitment timelines

      2026-02-12, 12:30 PM

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      Michelle Finegan
      Senior Director, Patient Advocacy and Strategic Alliances, Neurelis

      I have diverse experience in the pharmaceutical and medical device fields in patient advocacy as well as coaching pharma and STEM clients in communication and leadership skills.

      I am passionate about patient advocacy and being the voice of the patient. I have held active and influential roles in advocacy, Key Opinion Leaders (KOL) relationships, marketing and senior management. My experience in both the commercial and patient advocacy side of business makes me:

      • Nimble in fast-paced, dynamic, regulated environments
      • Strong leadership skills with the ability to build high performance teams
      • Identify synergies and collaborations that support opportunities for the company with various stakeholders
      • Teamwork with the ability to work cross-functionally and communicate with a myriad of internal and external stakeholders

      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 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

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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, 2:00 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, 2:00 PM

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      Bruno Larida
      Chief Business Officer, Omios Biologics

      Session Details:

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

      2026-02-12, 9:00 AM

      Session Details:

      Navigating investor relations to secure funding as a small biotech

      2026-02-12, 2:00 PM

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      Alan Balch
      CEO, Patient Advocate Foundation

      Session Details:

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

      2026-02-11, 11:00 AM

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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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      Shreya Badhrinarayanan
      Global Development Lead, Clinical Development Oncology & Hematology, Pfizer

      Shreya Badhrinarayanan, MD, FRSPH, is the Global Development Lead for Clinical Development, Oncology & Hematology at Pfizer. She leads clinical programs advancing antibody-drug conjugates (ADCs), bispecific antibodies, small molecules, and immuno-oncology (IO) biologics, driving innovative treatments in cancer care. Previously at Genentech, a Roche subsidiary, she provided strategic direction for the development of new Immuno-Oncology drugs by leading cross-functional teams and conducting medical monitoring of clinical trials. Earlier in her career, she served as a Physician with the National Health Service (NHS) in the UK, where she made significant contributions to clinical and research initiatives. Thriving in the field of medical leadership and management, Dr. Badhrinarayanan received the Edward Jenner Award from the NHS Leadership Academy. To further her passion for teaching, she served as an Honorary Lecturer in Medical Education and Simulation at the University of Adelaide Medical School, Australia. Her wide range of interests varies from AI in health care to D&I initiatives that have been embodied through her contributions to print and media as well as at conferences across the globe. In addition, she is the editor/reviewer of numerous high-impact journals, including the British Medical Journal. For her work and commitment towards public health, Dr. Badhrinarayanan was elected as a Fellow of the Royal Society of Public Health, UK. She received her medical degree from University of Sussex Medical School, UK, with numerous accolades.

      Session Details:

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

      2026-02-11, 11:00 AM

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      Christian Hummel
      Regulatory Affairs Manager, ReacX Pharmaceuticals

      Session Details:

      Turning inspection fears into readiness action in an uncertain regulatory environment

      2026-02-12, 2:30 PM

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      Scott McCulloch
      Executive Director and Data Protection Officer (DPO), Recode Therapeutics

      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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      Jennifer Hebert
      Director, Quality, Roche

      Session Details:

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

      2026-02-12, 9:00 AM

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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)

      Session Details:

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

      2026-02-12, 9:00 AM

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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, 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
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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:

      Session reserved for Niharika Kamat, Vice President Clinical Operations, Sardocor

      2026-02-11, 4:00 PM

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      Annette Bugno
      Associate Director Clinical Records, Corcept Therapeutics

      Developing and maintaining the TMF across functions. Adapting processes to fit business needs and ensuring measurable KPIs to ensure completeness, quality, and timeliness of the TMF.

      Session Details:

      Session reserved for Annette Bugno, Associate Director Clinical Records, Corcept Therapeutics

      2026-02-11, 4:00 PM

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      Advisory Board

      Select a member to learn more

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      Dr Alison McMorn
      PH.D – VP, CLINICAL DEVELOPMENT, AMO PHARMA LTD

      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, 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
      Head of Business Development, Novotech

      Aditya is the Regional Director of Business Development at Novotech, the Asia Pacific specialist CRO. He has extensive experience helping sponsor companies make their trials a reality across a range of projects from first in human to phase iv.

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

      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, Endo Pharmaceuticals

      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
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