12th Annual Clinical Trials in Oncology West Coast 2025

The West Coast's leading Clinical Trials in Oncology Conference showcasing the most efficient methods, strategies and solutions of running oncology trials.

14 - 15

May

2025
  • San Francisco Airport Marriott Waterfront, Burlingame, CA, USA
  • Complimentary
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Featured Speakers

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Edward Owen​

Therapeutic Area Director, Oncology, Early Clinical Development, Genentech

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Jennifer Willert​

Global Clinical Development Medical Director (CDMD), Novartis Cell and Gene/Hematology

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Lloryn Hubbard​

Director Clinical Trial Diversity and Patient Voice, Daiichi Sankyo

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Meghan McKenzie​

Director of Health Equity and Clinical Research, Chief Diversity Office, Genentech

Meghan McKenzie is a Director of Health Equity and Clinical Research in Genentech’s Chief Diversity 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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Keya Watkins​

SVP - Catalyst Oncology, Catalyst Clinical Research

Keya brings 25 years of experience in building and leading high-functioning teams in drug development inclusive of clinical operations, data sciences and trial support services. An executive in operational and commercial roles, she has extensive experience in implementing strategies and delivering excellence for complex, global Oncology trials.

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Cynthia C. Obiozor​

Oncology Clinical Research Medical Executive Director, Amgen

Physician life sciences and drug development strategist providing clinical insight and direct oversight of multi country clinical trials, expanded access protocols, diagnostics, and therapeutic collaborations in the oncology sector.

Notable Therapeutics:
SD-101,  Toll-like receptor 9 agonist, inducing inflammatory antitumor immune responses and has demonstrated clinical synergy with anti-PD-1 antibodies in PD-1 Ab-naïve and PD-1 Ab-refractory melanoma and in patients with anti-PD-1/PD-L1 naïve, recurrent/metastatic head and neck squamous cell carcinoma (HNSCC).

LUMAKRAS (soratasib), first in class KRAS G12C inhibitor indicated for the treatment of adult patients with KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC).

Notable Diagnostics:
Therascreen Qiagen RGQ PCR (an FDA-approved companion diagnostic (CDx) test to identify NSCLC patients harboring specific KRAS mutations in tumor DNA isolated from formalin-fixed paraffin-embedded (FFPE) NSCLC tumor tissue and that may be eligible for treatment with LUMAKRAS (soratasib).

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    2025 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.

    Company Website

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

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    Company Information

    Mercalis has a suite of Clinical Trial Support services designed to provide time and cost efficiencies.

    RxStudy Card – Pharmacy provides commercially available medications and supplies through retail and specialty pharmacies. This supply strategy reduces supply process steps, requires less employee time, eliminates supply waste, and has fewer risks resulting in an 80% reduction in labor and a 50% reduction in costs.

    RxStudy Card – Provider provides reimbursement for site sourced and administered medication and is essential for studies requiring biologics and oncolytics, which are more frequently being sourced directly by a provider and not through a pharmacy.

    RxStudy Card – Procurement is an innovative GLOBAL clinical trial supply process that more efficiently provides commercially available medications and supplies. RxStudy Card – Procurement leverages “in country” sourcing and distribution, provides study teams and sites a simple online ordering experience for “just in time” “as needed” delivery, in quantities specific to each site and patients need with direct to site shipments and real time order and shipment status.

    Company Website

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

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    Company Information

    Catalyst Oncology is a full-service, specialty clinical research organization (CRO) built to serve the global biotech industry. Backed by leading retention rates and a culture rooted in its core values, Catalyst Oncology provides customers with teams experienced across all functions, knowledgeable in complex drug classes and study designs, and with data-centric methodologies that help bring next-generation therapies to cancer patients.

    Company Website

    To learn more, please visit our website - catalystcr.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

    You need an Imaging Strategy that’s designed and customized for your oncology clinical trial. RadMD, a Medica Group Company, is your full service imaging core lab solution. Imaging endpoints are often used to support go/no-go decision-making in early phase trials. This is also a critical time to determine the development strategy for later study phases. https://www.rad-md.net/

    Company Website

    To learn more, please visit our website - www.rad-md.net

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    Company Information

    Scimega is a niche Canadian Oncology CRO with a singular focus on promoting and contributing to the successful conduct of cutting-edge oncology clinical trials in Canada. With a permanent, Lean-coached operations team our proven track record assisting mid-size and smaller US biotech/biopharma sponsors to undertake global oncology studies in Canada is bundled with 25 years of lessons learned!

    Company Website

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

    Adnexi is a tech-enabled principal investigator, site and key opinion leader (KOL) discovery solution for biopharma. Adnexi works with biopharma companies to improve trial site selection strategies, and achieve the inclusion of diverse patient populations. Our key solutions include:
    • TRIAL VERSITY: Diverse KOL discovery to find those KOLs and principal investigators that have the most access to diverse patient populations, including African American and Hispanic populations
    • BASE: Data-driven, algorithmic database of principal investigators for any disease based on massive data processing
    • AIM: Adnexi influence mapping. Survey-driven influence patterns for any disease with opinion data directly from physicians

    Company Website

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

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    Company Information

    Aixial Group is a well-established, oncology focused, global CRO. Aixial is recognized  for creative and proactive clinical expertise with an understanding and appreciation of the financial trust placed in their team by the sponsor to deliver results.

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    Company Information

    HeartcoR Solutions (HCS) is a leading Cardiac Safety Core Lab serving the Medical Device and Pharmaceutical Industries. HeartcoR has conducted 32 global IDE-PMA study projects since 2018 and has extensive understanding of Cardiac Safety execution to yield high study subject compliance in support of regulatory submissions.  HCS’ also serves Bio-Pharmaceutical companies conducting intensive QT and phase I-IV safety studies. The Company’s 50 employees hold a required certifications and our Electrophysiologist/Cardiologist analysis team are recognized experts in heart rhythm analysis. HeartcoR is based in Schaumburg Illinois, twenty minutes north of O’Hare Airport.

    Company Website

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

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    Company Information

    MMS Holdings (MMS) is an innovative, data focused CRO that supports the pharmaceutical and biotech industries with a proven, scientific approach to complex trial data and regulatory submission challenges. Strong industry experience, technology-enabled services, and a data-driven approach to drug development make MMS a valuable CRO partner, creating compelling submissions that meet rigorous regulatory standards. With a global footprint across four continents, MMS maintains a 97 percent customer satisfaction rating. For more information, visit www.mmsholdings.com

    Company Website

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

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    Company Information

    Biorasi is a global contract research organization (CRO) delivering fast and flexible solutions across clinical trials to maximize speed-to-market for its sponsors. As the leader in clinical trials for dermatology, neurology, and oncology, Biorasi sets new benchmarks for speed, agility, and quality in patient enrollment, decentralized trials, and data sciences.

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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

    Euromed Pharma deliver strategic services tailored to support companies in their quest to better healthcare. We support each industry player from drug development through the post-marketing phases. We offer solutions in CTS services, Clinical GMP Packaging, Labeling and Distribution, IMP management, Early Access and Named Patient Programs, Pharma Order to cash solutions, and Supply Chain & Logistics. We are present around the world with offices in Italy, Spain, Ireland, Germany, Singapore and the USA. Being one of the Petrone Group companies, Euromed Pharma is positioned at the forefront of innovation in pharmaceutical distribution.

    Company Website

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

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    Company Information

    IDDI optimizes the clinical development of drugs, biomarkers and IVD using a unique combination of advanced biostatistics and innovative data collection technology.

    IDDI covers the full spectrum of trial design, clinical data collection, management, analysis and reporting for Phase I- IV clinical trials.

    – IDDI’s services include: Clinical Development Plans, Protocol Development, Randomization (IWRS/IRT) with Drug Supply Management, EDC, Medical Coding, Data Management, Biostatistics, IDMC Support, Biomarker/Diagnostics Validation, Medical Writing.

    – IDDI’s therapeutic areas of expertise include oncology, ophthalmology, infectious diseases and cardiology.
    – Experience: 27+ years – 980+ trials (630+ in oncology) – 20 FDA/EMA approvals to-date
    – HQ in Belgium with offices in the USA ( Raleigh, NC, Boston, MA and San Francisco, CA).

    Company Website

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

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    Company Information

    Jumo Health develops age-appropriate, culturally sensitive, and relatable educational resources for patients and caregivers. We have experience serving diverse populations, covering more than 160 health topics across 75+ countries and 90+ languages – and we’re always expanding!

    Our multicultural offerings are designed to explain the latest in evidence-based literature using highly visual elements so that everyone can understand complex medical topics. We use familiar mediums to ensure this – from comic books and Pixar®-style animation, to virtual reality experiences and authentic documentary-style patient stories – all tailored based on age and audience.

    Jumo Health collaborates globally with more than 180 advocacy groups and community organizations to ensure an authentic patient experience is accurately represented.

    Company Website

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

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    Company Information

    LabConnect is the world’s most agile central laboratory solutions partner supporting clinical trials of all sizes and complexity. With modern operations and strategic alliances with world-leading laboratories, LabConnect is uniquely positioned to provide access to the latest innovation and automation. LabConnect is the trusted partner for biotechnology, pharmaceutical, and clinical research organizations.

     

    Follow LabConnect on LinkedIn

    Learn more at labconnect.com

    Company Website

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

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    Company Information

    Myonex provides tailored services and solutions to advance medicine through clinical to commercial stages with tailored drug sourcing and ancillary supply, to packaging, labeling, and distribution. With ten global locations, we offer flexible, efficient, and cost-effective support for clients across the pharmaceutical and biotech sectors.

     

    Company Website

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

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    Company Information

    Simply sourcing comparators – we offer a unique blend of small company flexibility and speed, backed with the large-scale buying power of the Orifarm Group, which is one of the largest pharmaceutical suppliers in Europe. With over €1.4B products sold in 2021 and more than 4,000 unique product lines sourced on a monthly basis, we have unparalleled access to “out of market” and manufacturer direct buying capability, both in the US and Europe.

    Company website: www.Orifarm-CTS.com

    Company Website

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

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    Company Information

    OWL Oncology Research is a Functional Service Provider (FSP), comprised of a global network of highly experienced independent contractors specializing in oncology and rare disease trials. We provide Clinical Operations Support Personnel such as CRAs, Project Managers, Clinical Trial Managers, and QC Oversight Monitors to build and grow your team as an alternative to the traditional CRO approach. We are committed to providing only the best contractors through our network, hand selected for their commitment to quality and excellence.

    Company Website

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

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      Why attend?

      The 12th Annual Clinical Trials in Oncology West Coast 2025 is back again!

      Our West Coast Oncology event is coming back for the 12th year in Burlingame, CA, USA on 14th-15th May 2025. Expanding with a significant range of hot topics on trial diversity, reframing complex oncology trials, patient centricity and decentralized trials; our 2025 event introduces a brand new second stream focusing on patient recruitment and engagement. 

      The conference program will cover a plethora of burning topics with top experts in the industry including, Genentech, Gilead, Johnson & Johnson, BeiGene and a Venture Capitalist to share how to secure investments for your oncology trial… so come and attend to hear vital insights and opinions that you want to hear!

      WHAT TO EXPECT FOR 2025?

      What do we have for 2025?

      We have introduced and dedicated a whole new stream on patient recruitment and engagement which focuses on harnessing strategizes, communication and latest trends in Oncology clinical trials. The event will include the top industry experts to share their latest struggles and successes.

       

      250+

      Attendees

      		20+

      Exhibitors

      		20+

      Speakers
      250+

      Attendees

      		20+

      Exhibitors
      20+

      Speakers

      Testimonials

      See What It's All About

      Agenda

      • 14 May 2025
      • 15 May 2025
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      Streams

      Stream one

      STREAM A: Clinical Operations

      Stream two

      STREAM B: Patient Recruitment and Engagement

      11 AM

      Improving clinical trial representation to increase access to trials

      • Sharing best practices for recruiting and integrating populations that are not well represented in oncology trials
      • Lessons from Advancing Inclusive Research Site Alliance collaborations
      • What strategies that pharma/biotech and vendor companies can design and support to help sites reach a more diverse patient population

      Speakers

      Meghan McKenzie
      Director of Health Equity and Clinical Research, Chief Diversity Office, Genentech

      11:30 AM

      The value of hope

      • Research and development initiatives have long acknowledged that patient participation in clinical research is driven by "hope for a cure" as a key incentive
      • Patient reported outcomes, subgroup analyses, "exit" interviews at study conclusions, help contextualize the value of trial data within a scientific, clinical, and humanistic framework
      • Within oncology indications particularly, selective patient targeting, innovative trial designs to accelerate approval, and assessments that reflect how patients "feel, function or survive" are highlighted as distinguishing characteristics.

      Speakers

      Jim Eamma
      Executive Director, Therapeutic Strategy, Oncology, Worldwide Clinical Trials

      12 PM

      PANEL DISCUSSION: Innovatively progressing patient-centric oncology trials in 2025

      • Strategies for advancing patient-centric trials in 2025, focusing on innovative approaches to enhance trial design and execution
      • Streamlining and improving patient involvement, communication, and the simplification of processes in trials to minimize patient burden
      • Sharing best practices to foster an engaged patient journey, ensuring patient retention throughout the trial process
      • Translating technology to tangible outcomes: What are the latest innovative technologies helping patients throughout the trial

      Speakers

      Sarah Schiltz
      Board Member, Cancer CAREpoint and Patient Advocate, National Cancer Institute
      Gay Crawford
      Founding Chair, Emeritus Member Patient and Family Advisory Council, Stanford Health Care South Bay Cancer Center
      Lloryn Hubbard
      Director Clinical Trial Diversity and Patient Voice, Daiichi Sankyo
      Meghan McKenzie
      Director of Health Equity and Clinical Research, Chief Diversity Office, Genentech

      12:30 PM

      TECHNOLOGY SPOTLIGHT: Enhancing patient centricity in oncology trials – A 360o site support model

      • Oncology trials are growing in complexity, both in design and execution.
      • Precision medicine is leading to hyper-fractionated patient populations in biomarker-driven studies.
      • Sponsors and CROs must evolve their operating models to enhance patient centricity in this shifting landscape.
      • This session presents a 360° Site Support model that puts patients at the center — with proven success in oncology trials.

      Speakers

      Bin Pan
      Executive Director, Operational Strategy, Ergomed

      12:45 PM

      Lunch and networking

      1:45 PM

      Clinical trial representation and how it intersects with patient-centric approaches and inclusive trial designs

      • The Need for Broad Representation: The importance of ensuring that clinical trials include a wide range of patient populations to improve the applicability and validity of results across all demographic groups. This approach helps reflect real-world conditions and ensures treatments are safe and effective for everyone.
      • Patient-Centric Trial Design: Focusing on designing trials with a patient-first approach, considering their needs, preferences, and challenges to improve engagement and outcomes.
      • Inclusive Trial Design: Exploring strategies for creating accessible trials, such as flexible locations, culturally sensitive recruitment, and remote monitoring, to ensure participation from diverse groups.
      • Intersectionality and Health Outcomes: Examining how diversity, patient-centric approaches, and inclusive design intersect to improve trial relevance, reduce healthcare disparities, and enhance the generalizability of results.

      Speakers

      Cynthia C. Obiozor
      Oncology Clinical Research Medical Executive Director, Amgen

      2:15 PM

      Reserved for event sponsor

      2:45 PM

      Transforming patient enrolment campaigns to make a meaningful impact on lifesaving research

      • Integrating the right biomarker to narrow relevant patient groups and optimize and personalize disease management
      • Engaging with the oncology community and advocacy groups to grow involvement of well-informed patients
      • Leveraging investigator expertise for pragmatic trial designs and patient identification
      • Building the evidence, from natural history to endpoint development, to support informed decisions by health authorities

      Speakers

      Zelanna Goldberg
      Chief Medical Officer, Replicate Bioscience

      3:15 PM

      Afternoon refreshments and networking

      3:45 PM

      PATIENT VOICE: My Story: How clinical trials have impacted my life (breast cancer at 31, lymphoma and eye disease)

      • Why clinical trials matter for patients
      • My Experience in Clinical Trials
      • Importance of media, personal stories, outreach
      • Lessons learned

      Speakers

      Gay Crawford
      Founding Chair, Emeritus Member Patient and Family Advisory Council, Stanford Health Care South Bay Cancer Center

      4:15 PM

      Reserved for event sponsor

      4:45 PM

      CLOSING KEYNOTE: Integrating patient perspectives to reduce patient burden and enhancing early oncology trial designs

      • Empowering study teams with methodologies to integrate patient perspectives in study protocols
      • Transformative case study on how patient insights reshaped an oncology trial

      Speakers

      Sarah Hamirani
      Portfolio Director, AbbVie

      5:15 PM

      Chairperson’s closing remarks

      END OF DAY 1 AND NETWORKING DRINKS

      8 AM

      Registration and refreshments

      8:20 AM

      Chairperson’s opening remarks

      Speakers

      Keya Watkins
      SVP - Catalyst Oncology, Catalyst Clinical Research

      8:30 AM

      KEYNOTE: 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
      Global Clinical Development Medical Director (CDMD), Novartis Cell and Gene/Hematology

      9 AM

      Joined at the Hip – Regulatory implications of the new Joint Clinical Assessment (JCA) regime

      • Understanding how we got here
      • Coordinating JCA in parallel to MAA
      • How to adapt your oncology strategy to JCA
      • What’s next for JCA

       

      Speakers

      Karen Benson
      Director, Regulatory Strategy Consulting, ICON

      9:30 AM

      PANEL DISCUSSION: Where is the oncology clinical trial industry headed in 2025?

      • Navigating new regulations around clinical trials smoothly and successfully
      • Predictions for how the global markets will impact US studies
      • The impact of artificial intelligence: how far can we expect to move forward in the next 12 months?
      • Patient centricity in clinical trials: how can burden be reduced in order to make trials easier for patients to participate in?

      Speakers

      Anthony Fermin
      Clinical Program Director, Genentech
      Keya Watkins
      SVP - Catalyst Oncology, Catalyst Clinical Research
      Jennifer Willert
      Global Clinical Development Medical Director (CDMD), Novartis Cell and Gene/Hematology
      Steve Warner
      Senior Vice President, Head of Translational Research & Medicine - Oncology, Sumitomo Pharma America

      10 AM

      Global virtual clinical trial supplies: The benefits of implementing a virtual supply strategy for commercially available medications and ancillary supplies

      • Optimize employ effort
      • Minimize waste and risk
      • Appreciate significant savings
      • Sustainably friendly

      Speakers

      Robbie Hill
      Director, Business Development, Mercalis

      10:30 AM

      Morning refreshments and networking sponsored Aixial

      11 AM

      New trial locations: Establishing an operational presence in new markets outside EU7

      • When the bandwidth for trials in certain places is limited, what are other regions that can host them?
      • Can we find new places to do studies?
      • Are there locations that replace Russia, Ukraine and Israel running trials are difficult?
      • A look at Asia Pacific, tapping into opportunity in new areas

      Speakers

      Faisal Rahman
      Senior Medical Director

      11:30 AM

      How to measurably increase operational efficiency in clinical trials

      • Identify and eliminate operational inefficiencies that cause bottlenecks in clinical trials
      • Organize, implement and maintain the coordination between investigators and study teams, sponsors, and other key operational partners to conserve resources and time to accelerate progress in cancer research
      • Implement continuous examination and optimization

      Speakers

      Julie Martin
      President & CEO, Scimega

      12 PM

      PANEL DISCUSSION: The pursuit of success: Driving your drug from the bench to bedside

      • Defining what do we do well and what could be improved – EU vs US focus
      • Planning and preparation within oncology drug trials – focus on phase 2/3
      • Choosing the right trial designs for rare disease studies
      • How to achieve a successful launch by building appropriate phase 3

      Seats available

      Speakers

      Keya Watkins
      SVP - Catalyst Oncology, Catalyst Clinical Research
      Dr. Kumar Gadamasetti
      CEO, Certum Bio

      12:30 PM

      Technology spotlight – Innovative Digital Opinion Leaders identification with Adnexi to improve trial awareness

      • Understand the reliance of both patients and doctors alike on online resources for trial and disease awareness.
      • Learn about a new technology solution to search for Digital Opinion Leaders sharing content online about the therapeutic area
      • Discover how to identify and track Digital Opinion Leaders across all social and online platforms
      • Plan how to engage Digital Opinion Leaders in trial awareness

      Speakers

      Sandra Shpilberg
      Co-Founder & CEO, Adnexi

      12:45 PM

      Lunch and networking

      1:45 PM

      Rethinking the paradigm and turning to RBQM for a risk-based, more targeted, and more efficient approach to clinical research in oncology

      • Knowing how to pick the right level of risk adjustment and critical to quality factors for your study
      • RBQM and vendors: how can we better work together to avoid common pitfalls and improve TMF quality
      • Why has there been a burdening resistance to adopting RBQM?
      • Understanding the latest regulation, ICH E6(R3), and how it’s designed to support better trial design, quality, patient safety and to better ensure compliance
      • How can RBQM help sponsors manage high clinical trial complexity?

      Speakers

      Catherine Caserza
      Director, Clinical Operations, Daichii Sankyo

      2:15 PM

      FIRESIDE CHAT: Solving challenges for operational excellence in early-phase oncology trials

      • Navigate new regulatory requirements and complex study designs with larger sample sizes and a broader global footprint
      • Implement country and site selection strategies that optimize FPI/LPI milestones
      • Manage the complexities of enrollment, cohort management, safety review, and trial logistics across multiple regions
      • Maintain a patient-centric approach to optimize study coordination and to benefit patients

      Speakers

      Keya Watkins
      SVP - Catalyst Oncology, Catalyst Clinical Research
      John McAdory
      Vice President, Clinical Operations, CG Oncology

      2:45 PM

      FDA regulations in decentralized clinical trials

      • An overview of the FDA's latest guidelines and requirements for DCTs, highlighting key aspects such as the integration of digital health technologies, remote monitoring, and the adherence to Good Clinical Practice (GCP) principles, as well as ensuring innovative trials maintain the highest standards of safety, efficacy, and data integrity.
      • Discussion of the FDA's collaborative efforts with other regulatory bodies, promoting harmonized standards and facilitating global acceptance of DCT methodologies.
      • Adhering to the FDA's comprehensive regulatory requirements so sponsors can navigate the complexities of DCTs and contribute to the evolution of clinical trials and the accelerated development of innovative medical treatments

      Speakers

      Wenjing Wang
      Associate Director - Associate Principal Scientist, Merck

      3:15 PM

      Afternoon refreshments and networking

      3:45 PM

      Functional precision oncology to increase clinical trial success rates

      • The Patient Selection Problem: Current biomarker-based strategies identify <30% of likely responders, leading to high failure rates and inefficient trial designs.
      • The SAGE Oncotest Advantage: A best-in-class ex vivo functional profiling platform that tests patient-derived tumor cells directly against the investigational drug to identify true responders.
      • Smarter Trial Design: Incorporating functional profiling to enrich responders into the study, thereby reducing required sample size while increasing clinical trial success rates

      Speakers

      Dr Chris Apfel
      CEO and Chairman, SageMedic Corp

      4:15 PM

      Reserved for event sponsor

      4:45 PM

      CLOSING KEYNOTE: Driving great decision making: A perspective from a finance fanboy

      • Perils of a less-optimal decision setup
      • Setting the stage for decision prep
      • Always bring them choices - scenarios for the win
      • Sticking the landing with clear decisions and documentation

      Speakers

      John Gouws
      VP Finance, Alumis

      5:15 PM

      Chairperson’s closing remarks

      Speakers

      Keya Watkins
      SVP - Catalyst Oncology, Catalyst Clinical Research

      END OF DAY 1 AND NETWORKING DRINKS

      8 AM

      Registration and refreshments

      8:50 AM

      Chairperson’s opening remarks

      Speakers

      Keya Watkins
      SVP - Catalyst Oncology, Catalyst Clinical Research

      9 AM

      Interactive Speaker-Hosted Roundtable Discussions

      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. Each discussion will be led by a table moderator and will focus on a different challenge within oncology clinical trials. Roundtables are an exciting, interactive way to build your personal network and learn from the experience and expertise of others.

      After 30 minutes, delegates will have the opportunity to swap and choose a different table, and each roundtable will run twice.

      1. Roundtable 1: Achieving successful integration of clinical operations, medical affairs, and clinical research groups to better develop protocols that support patient care and reduce patient, site and sponsor burden and to promote diversity
        Hosted by Luis A. Aguilar, Former VP, Business and Clinical Operations, Candel Therapeutics
      2. Roundtable 2: Measuring success by assessing the effectiveness of your patient enrollment strategy
        Hosted by Irene Soto, Clinical Operations Expert

      Speakers

      Luis A. Aguilar
      Vice President, Business and Clinical Operations, Candel Therapeutics
      Irene Soto
      Clinical Operations Expert

      10 AM

      Morning refreshments and networking

      10:30 AM

      KEYNOTE: How to align financial incentives between CROs and biotechs so that both sides win

      • Fine-tuning the partnership and incentivizing CROs to be more thoughtful in proposals
      • Reconsidering PM involvement and responsibilities
      • Encouraging data system investment
      • Building better budgets on the known

      Speakers

      Abhijit Ramachandran
      Director, Clinical Development Operations – Oncology, Corcept Therapeutics

      11 AM

      The Full Picture: RECIST PLUS

      Dr Shamsi will explore the evolution of oncology imaging, the limitations of RECIST 1.1, and how additional measurements can enhance early-phase decision-making and late-phase efficacy confirmation in clinical trials.

      • The evolution of oncology clinical trials since RECIST 1.1
      • The impact of immunotherapies, cell therapies, cancer vaccines, and ADCs
      • RECIST Plus – enhanced features that integrate volumetric and radiological parameters for a more comprehensive analysis

      Speakers

      Kohkan Shamsi, MD, PhD
      Co-founder, Vice President of Medical and Scientific Affairs, RadMD

      11:30 AM

      Clinical Trial Decarbonization: beginning our journey to NetZero

      • Measuring clinical trial carbon emission footprints
      • Identifying emissions hotspots and decarbonization initiatives
      • Aligning with key partners (e.g. CRO, Central Lab)
      • Incentivizing the organization

      Speakers

      Edward Owen
      Therapeutic Area Director, Oncology, Early Clinical Development, Genentech

      12 PM

      PANEL DISCUSSION: How innovation will shape the future of clinical research in oncology

      • Assessing the value of innovation in oncology trials: sharing best practice on engaging sites with new technology
      • Leveraging the latest technologies to enhance patient experience
      • Training sites and staff on new systems to maximize the benefits of the latest technology and streamline processes
      • Assessing the efficiency and success of pragmatic trials for more patient-centered approaches: do they work for oncology?

       

      Speakers

      Abhijit Ramachandran
      Director, Clinical Development Operations – Oncology, Corcept Therapeutics
      Edward Owen
      Therapeutic Area Director, Oncology, Early Clinical Development, Genentech
      Keya Watkins
      SVP - Catalyst Oncology, Catalyst Clinical Research
      Steve Warner
      Senior Vice President, Head of Translational Research & Medicine - Oncology, Sumitomo Pharma America

      12:30 PM

      Lunch and networking

      1:30 PM

      New alternate methods for clinical trials: Discussion of the use of human induced pluripotent stem cells for drug development

      Speakers

      Mukhtar Ahmed
      Director, Project & Portfolio Strategy, Greenstone Biosciences
      Rabindra Shivnaraine
      Director, Drug Discovery, Greenstone Biosciences

      2 PM

      PSI’s VISIONAL: Enhancing Feasibility & Enrollment Predictions with GenAI

      • GenAI-Driven Protocol & Enrollment Predictions: Explore how PSI integrates GenAI for protocol similarity searches and enrollment rate predictions, improving accuracy and efficiency in clinical trial planning.
      • Expanded Data for Global Feasibility Insights: Learn how VISIONAL™ incorporates three new data sources to enhance site performance analysis and offer insights across 56 countries, supporting better decision-making.
      • Faster Trial Planning & Budgeting: Discover how VISIONAL™ enables sponsors to quickly generate multi-country feasibility scenarios and budgets in under 30 minutes, streamlining the planning process.

      Speakers

      Emily McInturf
      Director, Feasibility, PSI CRO

      2:30 PM

      CARGO’s CAR-T related trials

      Speakers

      Cedric Dos Santos
      Former Vice President, Translational Medicine, CARGO Therapeutics

      3 PM

      Afternoon break, networking and prize draw

      3:30 PM

      The role of Medical Monitor in ensuring protocol compliance and patient safety in oncology clinical trials

      • Medical Monitors serve as the primary communication bridge between the study team, investigators, and regulatory bodies & play a critical role in ensuring protocol compliance and protecting patient safety in oncology trials.
      • Proactive oversight by a Medical Monitor assures trial integrity, regulatory adherence, and overall study success, making them a key pillar in the execution of high-quality clinical research.
      • Medical Monitors facilitate discussions on trial updates including emerging safety concerns, and protocol clarifications, ensuring smooth trial execution.
      • A Medical Monitor’s expertise in crisis management is crucial in responding to unexpected safety signals or high rates of SAEs, helping to guide decision-making for patient safety and trial continuation.

      Speakers

      Deepa Arora
      Director, AJNA Therapeutics

      4 PM

      The ongoing road to clinical trials from a startup perspective: bench to bedside with a novel pan-cancer target

      • Human endogenous retrovirus (HERV) sequences comprise 8% of the total human genome DNA, and they entered the genome between 10 and 50 million years ago
      • HERVs are unique tumor targets that are overexpressed in more than 80% of solid tumors, but not in normal tissues
      • SunnyBay Biotech has developed therapeutics targeting the HERV-K supergroup of HERVs
      • Our approach for moving novel HERV-K therapeutic antibody-drug conjugates (ADCs), which reduce tumor growth, inhibit metastasis, and prolong survival in murine models of breast and lung cancers, from the lab into the clinic will be discussed

      Speakers

      Gary Johanning
      CSO, SunnyBay Biotech
      Feng Wang-Johanning
      CEO, SunnyBay Biotech

      4:30 PM

      The clinical trial landscape of cell therapies in oncology

      • Cell therapies market landscape - current and future
      • Key industry trends
      • Industry forecast

      Speakers

      Tatiana Kolesnikova
      Director, Oncology and Hematology, GlobalData

      5 PM

      Chairperson’s closing remarks

      Speakers

      Keya Watkins
      SVP - Catalyst Oncology, Catalyst Clinical Research

      END OF CONFERENCE

      Speakers

      Select a speaker to learn more

      Back
      Edward Owen
      Therapeutic Area Director, Oncology, Early Clinical Development, Genentech

      Session Details:

      PANEL DISCUSSION: How innovation will shape the future of clinical research in oncology

      2025-05-15, 12:00 PM

      Session Details:

      Clinical Trial Decarbonization: beginning our journey to NetZero

      2025-05-15, 11:30 AM

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      Jennifer Willert
      Global Clinical Development Medical Director (CDMD), Novartis Cell and Gene/Hematology

      Session Details:

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

      2025-05-14, 8:30 AM

      Session Details:

      PANEL DISCUSSION: Where is the oncology clinical trial industry headed in 2025?

      2025-05-14, 9:30 AM

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      Dr. Kumar Gadamasetti
      CEO, Certum Bio

      Session Details:

      PANEL DISCUSSION: The pursuit of success: Driving your drug from the bench to bedside

      2025-05-14, 12:00 PM

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      Lloryn Hubbard
      Director Clinical Trial Diversity and Patient Voice, Daiichi Sankyo

      Session Details:

      PANEL DISCUSSION: Innovatively progressing patient-centric oncology trials in 2025

      2025-05-14, 12:00 PM

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      Cedric Dos Santos
      Former Vice President, Translational Medicine, CARGO Therapeutics

      Highly motivated Ph.D. research scientist with 9+ years of pre-clinical and translation research in the field of Hematology/Oncology, especially Acute Myeloid Leukemia (AML).

      Expert in normal/ malignant stem cells, signal transduction, biomarkers and drug discovery/drug development using small molecules or cancer immunotherapy both in vitro and in vivo. Strong ability to plan, develop, and execute pre-clinical studies for oncology drugs with excellent communication skills, presentation abilities and work ethic.
      Success driven team player able to work under pressure in order meet deadlines. Established collaborations with both academic and pharmaceutical companies.

      With an ambitious personality, my goal is to develop selective therapeutic strategies for targeting AML/cancer stem cells in order to start clinical trials and improve patients’ outcome. As a proof, one of my preclinical study led to a phase I/II clinical trial combining dasatinib with conventional chemotherapy aimed at improving outcomes in poor-risk AML patients that otherwise have low remission rates and high relapse rates (NCT01876953).

      Specialties: Hematological malignancies, especially AML, CML and MDS.
      Normal hematopoietic and leukemic stem cells isolation/characterization, signaling pathways, AML/MDS patient-derived xenograft model and syngeneic/GEMM AML mouse model.
      Pre-clinical, clinical and translational research.

      Session Details:

      CARGO’s CAR-T related trials

      2025-05-15, 2:30 PM

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      Catherine Caserza
      Director, Clinical Operations, Daichii Sankyo

      Session Details:

      Rethinking the paradigm and turning to RBQM for a risk-based, more targeted, and more efficient approach to clinical research in oncology

      2025-05-14, 1:45 PM

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      Wenjing Wang
      Associate Director - Associate Principal Scientist, Merck

      I am a seasoned regulatory affairs expert with nearly ten years of industry experience in medical devices, combination products and in vitro diagnostic devices. My latest experience includes regulatory registration for digital health technologies (DHTs) being utilized in decentralized clinical trials and DHTs being part of the combination product. I have master’s degrees in Biochemistry and Regulatory Affairs and a bachelor’s degree in biotechnology. I have extensive experience in global registrations including FDA, Health Canada, EMA, JMHW, NMPA, and other foreign agencies for various types of medical devices.

      Session Details:

      FDA regulations in decentralized clinical trials

      2025-05-14, 2:45 PM

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      Sarah Schiltz
      Board Member, Cancer CAREpoint and Patient Advocate, National Cancer Institute

      With over 30 years of experience in healthcare technology, I currently serve as a patient advocate and board member for organizations committed to driving positive change in healthcare and supporting those impacted by cancer. Previously, I held the position of marketing leader at Vocera Communications, a public company based in Silicon Valley. Following Vocera's acquisition by Stryker in February 2022, I provided advisory support during the transition throughout 2023.

      I dedicate my time and energy to enhancing the lives of cancer patients and the front-line caregivers who support them.

      'An experienced and passionate patient and caregiver advocate, helping improve the lives of those that have followed in her path on a cancer journey.  Motivational leader with record of success creating, executing, and managing programs that lead to immediate and long-term results. Experience building marketing divisions from the ground up, leading turnarounds for under-performing areas, and building consensus to advance adoption of services and technologies.'

      Session Details:

      PANEL DISCUSSION: Innovatively progressing patient-centric oncology trials in 2025

      2025-05-14, 12:00 PM

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      Abhijit Ramachandran
      Director, Clinical Development Operations – Oncology, Corcept Therapeutics

      Abhijit Ramachandran, Director of Clinical Operations at Corcept Therapeutics Inc. is an established versatile leader with deep experience in clinical trial operations management. Expertise in conducting and coordinating multi-center international clinical trials and managing cross-functional project teams. Highly skilled in liaising with Contract Research Organizations (CROs) and other suppliers to achieve program and company goals. Adept at managing the progress of clinical studies and ensuring adherence to study protocols, regulatory/internal SOPs, intended timelines, and budget. Solid experience with early and late-phase clinical studies, including orphan disease indications.

      Session Details:

      PANEL DISCUSSION: How innovation will shape the future of clinical research in oncology

      2025-05-15, 12:00 PM

      Session Details:

      KEYNOTE: How to align financial incentives between CROs and biotechs so that both sides win

      2025-05-15, 10:30 AM

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      Anthony Fermin
      Clinical Program Director, Genentech

      Clinical research professional with a pharmacy and nursing background experienced in managing clinical development studies in multiple therapeutic areas specializing in oncology in a fast-paced, cross-functional environment.

      Session Details:

      PANEL DISCUSSION: Where is the oncology clinical trial industry headed in 2025?

      2025-05-14, 9:30 AM

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      Meghan McKenzie
      Director of Health Equity and Clinical Research, Chief Diversity Office, Genentech

      Meghan McKenzie is a Director of Health Equity and Clinical Research in Genentech’s Chief Diversity 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: Innovatively progressing patient-centric oncology trials in 2025

      2025-05-14, 12:00 PM

      Session Details:

      Improving clinical trial representation to increase access to trials

      2025-05-14, 11:00 AM

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      Cynthia C. Obiozor
      Oncology Clinical Research Medical Executive Director, Amgen

      Physician life sciences and drug development strategist providing clinical insight and direct oversight of multi country clinical trials, expanded access protocols, diagnostics, and therapeutic collaborations in the oncology sector.

      Notable Therapeutics:
      SD-101,  Toll-like receptor 9 agonist, inducing inflammatory antitumor immune responses and has demonstrated clinical synergy with anti-PD-1 antibodies in PD-1 Ab-naïve and PD-1 Ab-refractory melanoma and in patients with anti-PD-1/PD-L1 naïve, recurrent/metastatic head and neck squamous cell carcinoma (HNSCC).

      LUMAKRAS (soratasib), first in class KRAS G12C inhibitor indicated for the treatment of adult patients with KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC).

      Notable Diagnostics:
      Therascreen Qiagen RGQ PCR (an FDA-approved companion diagnostic (CDx) test to identify NSCLC patients harboring specific KRAS mutations in tumor DNA isolated from formalin-fixed paraffin-embedded (FFPE) NSCLC tumor tissue and that may be eligible for treatment with LUMAKRAS (soratasib).

      Session Details:

      Clinical trial representation and how it intersects with patient-centric approaches and inclusive trial designs

      2025-05-14, 1:45 PM

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      Gay Crawford
      Founding Chair, Emeritus Member Patient and Family Advisory Council, Stanford Health Care South Bay Cancer Center

      A two-time cancer survivor, Crawford, a media professional amd a member of the Rotary Club of San Jose,  is most noted for “changing the landscape” of cancer care in Silicon Valley and California.  She served on the American Cancer Society’s National Extramural Grants programs a Stakeholder, helping to award some $100 million research dollars.  She is a founder of the second non-profit hospice in California; she found  an annual program serving 400 kids with cancer every year; she is the founder and firs president of  the Cancer Registry for the State of California, and an Emeritus member of Stanford Cancer Center South Bay’s Patient and Family Advisory Council.   Inn 2009,  she co-founded Cancer CAREpoint, which provides free non-medical services for cancer patients and families in the Bay Area and currently serves on their Advisory Sustaining Board.

      Crawford has many awards to her credit, including the National Ellen Stovall Award for Innovation in Cancer Care, (a national award for cancer patient advocacy). She was selected by KRON TV for their 2024  Remarkable Woman program; The Jefferson Award from KPIX TV CBS, in 2014 she was selected for the Citizen’s Award from Santa Clara County Medical Association; the Silicon Valley Business Journal named her a Woman of Influence in 2015 and she has received numerous honors from the American Cancer Society, where she is an honorary life member.

      Session Details:

      PANEL DISCUSSION: Innovatively progressing patient-centric oncology trials in 2025

      2025-05-14, 12:00 PM

      Session Details:

      PATIENT VOICE: My Story: How clinical trials have impacted my life (breast cancer at 31, lymphoma and eye disease)

      2025-05-14, 3:45 PM

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      Vicki Plaks
      Senior Scientific Director, Head of Cell Therapy, Oncology Translational Research, Johnson & Johnson
      Next speaker
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      Luis A. Aguilar
      Vice President, Business and Clinical Operations, Candel Therapeutics

      Session Details:

      Interactive Speaker-Hosted Roundtable Discussions

      2025-05-15, 9:00 AM

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      Gary Johanning
      CSO, SunnyBay Biotech

      Basic research on the role of viruses in the development of cancer. Studying how ancient endogenous retroviruses, which are present in all humans, become overexpressed in breast, ovarian, pancreatic and other cancers. Evaluating the efficacy of therapeutic antibodies and other therapies aimed at blocking human endogenous retrovirus expression in cancer cells.

      Session Details:

      The ongoing road to clinical trials from a startup perspective: bench to bedside with a novel pan-cancer target

      2025-05-15, 4:00 PM

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      Feng Wang-Johanning
      CEO, SunnyBay Biotech

      Session Details:

      The ongoing road to clinical trials from a startup perspective: bench to bedside with a novel pan-cancer target

      2025-05-15, 4:00 PM

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      Keya Watkins
      SVP - Catalyst Oncology, Catalyst Clinical Research

      Keya brings 25 years of experience in building and leading high-functioning teams in drug development inclusive of clinical operations, data sciences and trial support services. An executive in operational and commercial roles, she has extensive experience in implementing strategies and delivering excellence for complex, global Oncology trials.

      Session Details:

      Chairperson’s opening remarks

      2025-05-14, 8:20 AM

      Session Details:

      PANEL DISCUSSION: Where is the oncology clinical trial industry headed in 2025?

      2025-05-14, 9:30 AM

      Session Details:

      PANEL DISCUSSION: The pursuit of success: Driving your drug from the bench to bedside

      2025-05-14, 12:00 PM

      Session Details:

      FIRESIDE CHAT: Solving challenges for operational excellence in early-phase oncology trials

      2025-05-14, 2:15 PM

      Session Details:

      Chairperson’s opening remarks

      2025-05-15, 8:50 AM

      Session Details:

      PANEL DISCUSSION: How innovation will shape the future of clinical research in oncology

      2025-05-15, 12:00 PM

      Session Details:

      Chairperson’s closing remarks

      2025-05-14, 5:15 PM

      Session Details:

      Chairperson’s closing remarks

      2025-05-15, 5:00 PM

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      Julie Martin
      President & CEO, Scimega

      Julie Martin, MSc, Lean Certified, CEO is a 17-year industry veteran who has led Scimega as CEO for 5 years. Her passion for Scimega’s business and team stems from knowing its expert oncology clinical development services add distinct value to industry stakeholders at a time when it’s needed most. As CEO, Julie’s vision is to secure the company’s long-term success by leveraging her in-depth industry expertise and business acumen. She equates that success with setting a clear vision for the organization’s continued sense of purpose. Her leadership, and collaboration with the managing Board of Directors, combined ensure the business excellence upon which Scimega has built its reputation. Julie plays a vital role in promoting Scimega’s expertise and showcasing Canada’s attributes as a formidable partner in global oncology drug development with an evolving Lean methodology.

      Session Details:

      How to measurably increase operational efficiency in clinical trials

      2025-05-14, 11:30 AM

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      Kokhan Shamsi
      Director Medical & Scientific Affairs, RadMD
      Next speaker
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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:

      PSI’s VISIONAL: Enhancing Feasibility & Enrollment Predictions with GenAI

      2025-05-15, 2:00 PM

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      Sarah Hamirani
      Portfolio Director, AbbVie

      Accomplished leader with 20+ yrs. of clinical trial experience in oncology, respiratory, and metabolic diseases. Industry expert, consistently delivering programs with high integrity. Adept at influencing stakeholders. Spearheads innovation. Passionate about transforming patient and caregiver experience in clinical trials.A Diversity, Equity and Belonging champion- founder of inclusive research group in Phase I oncology trials at AbbVie and creator of affinity groups within the community.
      A suitcase-loathing adventurer. A Tiny Human’s Personal Assistant.

      Session Details:

      CLOSING KEYNOTE: Integrating patient perspectives to reduce patient burden and enhancing early oncology trial designs

      2025-05-14, 4:45 PM

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      Christian Apfel
      Chairman & CEO, SageMedic Corp
      • Chair, Life Science Committee, Keiretsu Forum
      • Mentor, Investor, and Board Member of Companies that create value and make the world a better place.
      Next speaker
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      Tatiana Kolesnikova
      Director, Oncology and Hematology, GlobalData

      Session Details:

      The clinical trial landscape of cell therapies in oncology

      2025-05-15, 4:30 PM

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      Mukhtar Ahmed
      Director, Project & Portfolio Strategy, Greenstone Biosciences

      Session Details:

      New alternate methods for clinical trials: Discussion of the use of human induced pluripotent stem cells for drug development

      2025-05-15, 1:30 PM

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      Rabindra Shivnaraine
      Director, Drug Discovery, Greenstone Biosciences

      Session Details:

      New alternate methods for clinical trials: Discussion of the use of human induced pluripotent stem cells for drug development

      2025-05-15, 1:30 PM

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      Sandra Shpilberg
      Co-Founder & CEO, Adnexi

      Sandra Shpilberg is the CEO & Co-founder of Adnexi, a software platform that helps biopharma identify the best trial sites (Site Intelligence), Key Opinion Leaders (KOL) and Digital Opinion Leaders (DOL) who can accelerate treatment development. Adnexi provides rapid, accurate, tech-enabled, customized, complete and continuously updating identification of trial sites, searching for prior experience that's relevant to your trials. Prior to Adnexi, Sandra was the CEO & Founder of Seeker Health, a successful patient finding platform that was acquired by Eversana. Prior to being an entrepreneur, Sandra held executive roles at biopharma companies including BioMarin and Johnson & Johnson.

      Session Details:

      Technology spotlight – Innovative Digital Opinion Leaders identification with Adnexi to improve trial awareness

      2025-05-14, 12:30 PM

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      John Gouws
      VP Finance, Alumis

      John is a results-driven leader with a genuine passion for turning business strategies into reality through financial planning and analysis across various industries. He has a knack for financial modeling, budgeting, strategic planning, and variance analysis, which helps me tackle complex challenges and support data-driven decision-making.

      Throughout his career, he's crafted and executed innovative financial strategies, streamlined processes, and led cost-saving initiatives that have significantly boosted operational efficiency and performance. He's managed multi-million-dollar budgets and steered investment strategies for complex project portfolios, making sure resources are used wisely to meet strategic goals.

      He's also committed to building and empowering high-performing teams. He's spearheaded organizational transformations, enhanced the scalability of financial operations, and created talent acquisition strategies and leadership programs to support diversity and inclusion.

      Session Details:

      CLOSING KEYNOTE: Driving great decision making: A perspective from a finance fanboy

      2025-05-14, 4:45 PM

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      Robbie Hill
      Director, Business Development, Mercalis

      Session Details:

      Global virtual clinical trial supplies: The benefits of implementing a virtual supply strategy for commercially available medications and ancillary supplies

      2025-05-14, 10:00 AM

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      Jim Eamma
      Executive Director, Therapeutic Strategy, Oncology, Worldwide Clinical Trials

      Jim Eamma’s experience in scientific and clinical research spans more than two decades and includes work in academic, clinical and CRO settings. Although oncology is his primary area of focus, he has also worked on clinical trials in other therapeutic areas. His intimate knowledge of studies at the level of the investigative site gives him the logistical and practical perspective needed for effective leadership and oversight. Today Jim will share more about Worldwide Clinical Trials and how the Worldwide team can help with your  oncology trials.

      Session Details:

      The value of hope

      2025-05-14, 11:30 AM

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      John McAdory
      Vice President, Clinical Operations, CG Oncology

      John McAdory, MHA has a strong background in clinical operations and project management in the healthcare industry. John is currently serving as the Vice President of Clinical Operations at CG Oncology (Cold Genesys).

      John has spent the last 20 years global clinical research specializing in the development novel oncolytic therapies. He has lead global clinical operation from clinical study design to submission of final study report including BLA filing. John has expertise in strategy development, risk management, project planning and execution and consistently achieving program goals. With a Six Sigma Green Belt, John specializes in identifying key area to find efficiency in clinical study conduct to save time and reduce cost. John previously held leadership and management positions at SillaJen, Inc, Janssen, Inc, and Amgen. John is a graduate of Hampton University with an BS in biology and has a Masters in Health Administration from the University of North Carolina, Chapel Hill.

      Session Details:

      FIRESIDE CHAT: Solving challenges for operational excellence in early-phase oncology trials

      2025-05-14, 2:15 PM

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      Irene Soto
      Clinical Operations Expert

      Ph.D. in biomedical engineering with 15+ years leading research and clinical trials. Extensive experience with international business operations and establishing collaborations. Excellent communication with scientific and lay audiences. Sound leadership skills in managing interdisciplinary teams across institutions with and without authority. Focus on problem-solving, conflict management, and creative solutions.

      Session Details:

      Interactive Speaker-Hosted Roundtable Discussions

      2025-05-15, 9:00 AM

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      Deepa Arora
      Director, AJNA Therapeutics

      Experienced Clinical Development and Drug Safety physician. Served in leadership positions in pharma companies for almost two decades, leading global clinical research and pharmacovigilance activities.

      Session Details:

      The role of Medical Monitor in ensuring protocol compliance and patient safety in oncology clinical trials

      2025-05-15, 3:30 PM

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      Karen Benson
      Director, Regulatory Strategy Consulting, ICON

      Karen Benson has over 20 years of experience in the pharmaceutical industry, serving in various roles including medical affairs and regulatory affairs.

      Throughout her career in regulatory affairs, Karen has worked across the various phases of development (PreIND, Phase 1 through Phase 4) and has experience in Oncology, Investigational New Drug Applications (INDs) and IND submissions, clinical trial applications (CTAs) and submissions, New Drug Applications (NDAs) and post market submissions.

      Session Details:

      Joined at the Hip – Regulatory implications of the new Joint Clinical Assessment (JCA) regime

      2025-05-14, 9:00 AM

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      Advisory Board

      Select a member to learn more

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      Cesare Spadoni

      Cesare is co-founder and Chief Operating Officer of Oncoheroes Biosciences Inc., a Boston-based biotech company focused on pediatric oncology drug development. Cesare has more than 20 years of experience in the drug development field, in both scientific and commercial roles. Previously, he held senior positions at AMRI, Aptuit Laurus, ThalesNano and Auxiliis. Cesare started his career as research scientist in a pharmaceutical company (Eisai, London) and in academia (Institute of Enzymology, Budapest).

      Following the death of his first daughter Laura to cancer, Cesare set up aPODD Foundation, a London-based charity focused on accelerating paediatric oncology drug development. As aPODD’s chairman he is actively involved on a pro-bono basis in drug repurposing projects, advocacy efforts and research collaborations.

      Cesare holds an MSc in Applied Molecular Biology and a PhD in Neurosciences from UCL, University of London, as well as an MBA from the Central European University, Budapest.

      Next
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      Frank Richard

      Frank Richard, MD, MBA is a seasoned medical doctor and has over 20 years of development experience in R&D. In his current role as VP Medical at Heidelberg Pharma AG, Germany, he is providing medical strategy and oversight for the preparation and conduct of phase I-III clinical studies using antibody-drug conjugates (ADCs). Additionally, he supports modelling &simulation activities to understand how to effectively use preclinical data from in vivo studies, mechanistic modeling, and bioanalysis to improve dose prediction and determine the optimal dose when introducing an ADC into clinical trials in various cancer indications.

      Frank has been working in the past in Immune-Oncology, Immunology& Respiratory, Rare Hematology Diseases and Iron Metabolism across big pharma and biotech.

      Frank holds a MD from Charité Medical University, Berlin, an MBA from University of Applied Sciences, Neu-Ulm, and is a board-certified Clinical Pharmacologist.

      Additionally, he exerts an unique expertise and interest in Bayesian Statistics and machine learning in Pharma and Biotech.

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      Stefano Ferrara

      Stefano Ferrara is a Clinical Development Expert and Director of Clinical Science at BeiGene, specializing in oncology clinical development with a focus on innovative cancer treatments. With over 20 years of leadership in global oncology clinical trials, he has played key roles at Celgene Corp, Novartis Pharma, and Sanofi-Aventis, specializing in GI, Lung, GU, and Pediatric cancers. Stefano is passionate about increasing accessibility to cancer treatment globally. He holds a strong commitment to humanitarian efforts as a supporter of Save the Children. Stefano brings his expertise in both science and advocacy to his role on the advisory board

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      Fatima Scipione

      Fatima serves as the Vice President of Global Patient Affairs at Blueprint Medicines, a global, fully integrated biopharmaceutical company that invents life-changing medicines. We seek to alleviate human suffering by solving important medical problems in two core focus areas: allergy/inflammation and oncology/hematology.

      In her role, Fatima leads transformative collaborations with external advocacy groups, empowering and educating those affected by systemic mastocytosis. She has led the launch of significant initiatives such as GRTY Health’s SM patient platform, MastoConnect (https://mastoconnect.com), and Colors of SM (https://www.colorsofsm.com/), in partnership with the advocacy community, and actively chairs the Equity, Diversity, and Inclusion (ED&I) patient committee, which looks to address the needs of marginalized and underrepresented communities.

      With over two decades of experience in the biopharma sector, Fatima is a dedicated and passionate advocate for patients. Celebrated by PharmaVoice 100 as one of the most inspiring leaders in patient advocacy, her work focuses on amplifying patient voices and harnessing the collective power of individuals to make a positive impact. Fatima is committed to enhancing patient engagement in the development of transformative medicines, ensuring that the patient perspective is integral to every stage of the process.

      She inspires her colleagues to foster a culture of purpose-driven advocacy, ensuring that patient welfare remains at the forefront of their mission. Beyond her professional role, Fatima is deeply involved in civic activities, continually dedicating herself to enhancing patient welfare and advocacy on a broader scale.

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      1800 Old Bayshore Highway Burlingame, California, USA, 94010

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      Conor Taylor

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      +44 (0) 20 7936 6870

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      Niki Khoshkbary

      Senior Conference Producer

      +44 204540 7545

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      Sunny Saikia

      VIP Delegate Manager

      SPONSORSHIP ENQUIRIES

      To enquire about sponsorship opportunities for the conference, please contact:

      Conor Taylor

      Sponsorship Sales Manager


      +44 (0)207 936 6870

      SPEAKER ENQUIRIES

      To enquire about speaking opportunities for the conference, please contact:

      Niki Khoshkbary

      Senior Conference Producer


      +44 204540 7545