Clinical Operations in Oncology Trials West Coast 2023

The West Coast's leading event showcasing the most efficient methods of running oncology trials.

25 - 26

April

2023
  • San Francisco Airport Marriott Waterfront, Burlingame, California
  • Complimentary
  • Why attend?
  • 2023 Agenda
  • 2023 Speakers
  • Plan Your Visit
  • Sponsors
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Featured Speakers

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Oscar Segurado​

Chief Medical Officer, ASC Therapeutics

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Bao Dinh​

Associate Director, Clinical Data Management, Ascendis Pharma

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Arla Yost​

Clinical Research Operations Director, University of California

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Dorothy Nguyen​

Vice President of Clinical Development, AmMax Bio

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Gary Albert​

Director, Clinical Operations, Patient Recruitment and Trial Management, Formerly Turning Point Therapeutics

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Lixia Wang​

Senior Vice President, Data Science, Vaxxinity

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Blake Morrison​

Vice President, Head of Global Medical and Scientific Affairs, Sumitomo Pharma Oncology

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    2023 Sponsors Include:

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    Company Information

    Labcorp is a leading global life sciences company that provides vital information to help doctors, hospitals, pharmaceutical companies, researchers and patients make clear and confident decisions. Through our unparalleled diagnostics and drug development capabilities, we provide insights and accelerate innovations to improve health and improve live. Learn more about and Labcorp at www.Labcorp.com or follow us on LinkedIn and Twitter @Labcorp.

    Company Website

    To learn more , please visit our website - medtech.labcorp.com

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    Company Website

    To learn more , please visit our website - http://www.ppdi.com/Services/PPD-Biotech

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    Company Information

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

    Company Website

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

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    Company Information

    ProTrials Research, Inc., is a full-service clinical research organization (CRO) and woman-owned business headquartered in San Jose, CA, with clinical operations personnel located throughout North America and across the world. ProTrials works with sponsors in the pharmaceutical, biotechnology and medical device industries to deliver high-quality clinical development services in a wide range of therapeutic areas. Founded in 1996, ProTrials has been successfully supporting clinical research for over 25 years.

    Company Website

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

    Interested in Learning More About the ‘Canadian’ Opportunity?

    Scimega is a niche Canadian oncology CRO acting in Canada for the conduct of global cutting-edge oncology trials sponsored by small to mid-size biotechs.

    In the face of an ever-changing clinical trial landscape our robust operations design guarantees sponsors the quickest global site start-up and fastest patient recruitment with assured premium quality data.
    Skilled in collaborative vendor teaming, our oncology experts work with your team to devise innovative solutions specific to the unique challenges of your oncology clinical trial.
    24 years of unparalleled Canadian oncology experience means our operational KPIs consistently surpass global industry norms.
    Explore an Expansion with Us!

    Company Website

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

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    Company Information

    Viedoc designs engaging software for the life science industry. By accelerating clinical trials on all levels, our solutions support major pharmaceutical, biotech, and medical device companies, as well as renowned research institutions worldwide. Headquartered in Uppsala, Sweden, Viedoc also has offi ces in America, France, Japan, Vietnam, and China. Since our inception in 2003, over 1 million patients in more than 75 countries have participated in studies powered by Viedoc. www.viedoc.com

    Company Website

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

    eClinical Solutions is a leading global provider of cloud-based enterprise software and software-driven clinical data services. The elluminate® Clinical Data Cloud provides life sciences companies with greater control of their clinical trial data with one platform for all data sources, from aggregation through to standardization, visualization, and preparation for submission. elluminate software and data driven services have been used by more than 100 life sciences companies on over 500 clinical trials to reduce cycle time and improve data quality. For more information, visit www.eclinicalsol.com, or contact us at info@clinicalsol.com.

    Company Website

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

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    Company Information

    ClinDatrix, Inc., a CRO, helps pharmaceutical, biotechnology and medical device innovators with clinical projects ranging from Phase I studies to multinational pivotal Phase III trials and post-marketing studies. Our high-caliber project management, clinical monitoring, medical safety, data management, biostatistics, regulatory affairs and quality assurance capabilities make us a valued partner.

    Company Website

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

    Suvoda is a global clinical trial technology company specializing in highly complex, life-sustaining studies in therapeutic areas like oncology, CNS, and rare disease. Suvoda empowers clinical trial professionals to manage the most urgent moments in the most urgent trials through IRT, eConsent, and eCOA solutions delivered on a single platform.

    Company Website

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

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    Company Information

    Translational Drug Development (TD2) is a world-class oncology drug development organization specializing in the development of new oncology medicines. TD2 offers fully integrated precision oncology clinical development solutions that combine the highest standards in clinical trials management, disruptive imaging, biomarker strategies, and unparalleled access to real-time patient data.

    Company Website

    To learn more , please visit our website - www.td2inc.com

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    Company Information

    TrialCard Incorporated is a full-service life sciences commercialization partner that provides comprehensive solutions that span the entire biopharmaceutical value chain. In addition to a foundation of fully integrated, digitally enabled patient support services, its broader offerings include everything from late-stage clinical trial management to post-marketing HCP engagement services and proprietary data-as-a-service payer intelligence and insights. Founded in 2000, TrialCard provides commercialization needs for more than 160 life science customers and has connected over 35 million patients with more than $18 billion in branded drug savings to date. The company is headquartered in Morrisville, North Carolina.

    Company Website

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

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    Company Information

    Veramed is a pioneering CRO redefining intelligent healthcare decision-making through end-to-end biometrics that brings people, innovation, and technology together with world-class governance to accelerate evidence generation and advance patient health. With skilled Statisticians and Programmers uniquely matched and scaled to client needs, we produce exceptional deliverables swiftly using a blend of skill, rigorous governance, and automation to optimize the speed and success of clinical research from design and submission to launch and commercialization.

    Company Website

    To learn more , please visit our website - www.veramed.co.uk

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    Company Information

    Vial is a next-generation CRO that leverages the nationwide Vial site network to ensure faster, higher-quality trial outcomes for sponsors. Additionally, our tech-enabled trial management system, streamlined study startup processes, centralized pre-screening call center, and unparalleled approach to patient recruitment will successfully deliver a superior CRO experience.

    Company Website

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

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      Why attend?

      Arena International are delighted to announce Clinical Operations in Oncology West Coast for our in-person event on the 25th and 26th April 2023! For the 10th Annual event our West Coast oncology conference is expanding and will now consist of two streams which will give our attendees the ability to choose which sessions they want to attend.

      The 2023 program will cover a plethora of topics that have been plaguing the industry in recent years. This includes such issues as; patient enrolment and engagement, managing site relationships, funding issues and many more.

      WHAT TO EXPECT FOR 2023?

      This year the event has grown to include the dedicated technology and data management stream which will focus on reviewing the latest innovations in clinical trials. The event will bring together hundreds of 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

      2023 Agenda

      • 25 Apr 2022
      • 26 Apr 2022
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      Streams

      Stream one

      Clinical Operations in Oncology Trials

      Stream two

      Technology & Innovation

      11 AM

      Precision Clinical Trials In The Era Of Big Data, Artificial Intelligence, and Precision Medicine

      • Exploring the innovations in modern clinical trials that have made a difference in precision medicine.
      • In the modernising world of AI how much impact can we expect that to have on clinical trials.
      • Identifying the future of Precision trials and highlighting the big players in the field.

      Speakers

      11:30 AM

      Early Phase Oncology Imaging Endpoints: Optimize the opportunity and avoid the risks

      • Early phase imaging presents an opportunity to understand the nuances of your compound
      • Learn budget-friendly strategies to collect and assess radiology results in a phase 1 study
      • Know the risks of site-based imaging assessments
      • Which imaging endpoint best reflects immune-oncology compounds' efficacy?

      Speakers

      2 PM

      Best practices for safety and data review committees for early oncology studies

      • Real ways of managing the essential committees that you need to work with.
      • Tips and tricks of realizing which type of companies are essential to work with and how to work with them.

      Speakers

      4:30 PM

      Workshop: How to create an essential product target profile for drug development

      • An interactive session designed to give a key skillset to those looking to enhance their skills in drug development.

      Speakers

      8:15 AM

      Registration and refreshments

      8:20 AM

      Chairperson’s opening remarks

      8:30 AM

      OPENING PANEL: Tackling the current industry trends in patient enrolment for oncology trials.

      • How we as an industry can work together to enhance enrolment.
      • Analysing current trends in enrolment and sharing advice to increase trial uptake.
      • Looking into the future and working together to build trust in the industry.

      Speakers

      9 AM

      Oncology Trial Success: Knowledge gained from 2020-2022

      • Preparing for the unexpected – Lessons learned from 2Q20
      • Thinking outside the box – Awareness of capabilities is the key to success
      • Strength within – Strategies for effectively leveraging the experience of your teams
      • It’s a brave new world – The landscape of oncology trials going forward

      Speakers

      9:30 AM

      Expanding early phase oncology trials outside of the US

      • The pros and cons of internationalizing your trial at an early stage.
      • Choosing which countries to expand your trials into, how to know which is best for you.
      • Exploring the viability of other countries thanks to advances in data integrity.
      • Site availability issues particularly following loss of sites due to geopolitical issues.

      Speakers

      10 AM

      Advancing Oncology Clinical Trials Option to Patients in the Local Community Setting

      • Leveraging strategic site partnerships with local community hospitals
      • Expanding the advanced clinical trial offering and awareness
      • Easing the financial burden of local clinical trials vs travel to large hospitals for additional options
      • Patient and Care Family Story

      Speakers

      10:30 AM

      Morning refreshments and networking

      11 AM

      How are today’s patients coping with modernized trials?

      • A firsthand insight onto what it is like participating in a trial.
      • Which key things helped make my time simpler on a trial.
      • How even minor things from the protocol can have a huge impact on patients.

      Speakers

      11:30 AM

      Getting Hard Feasibility Data: How To Do It

      • How do you access current, hard feasibility data?
      • Does your CRO have a stable, permanent clinical team with trial legacy capability and expertise in your domain?
      • Are your sites and vendors audit proof?
      • Does your CRO act like a SMO with a dedicated site network?
      • Are you confident your CRO has the capacity to achieve your study milestones on or before deadline?
      • Is your CRO independent, and well-rounded in regard to systems, with a collaborative vendor team of specialized expertise to support your program?

      Speakers

      12 PM

      PANEL: Exploring modern innovation in oncology trials, have trials become over complicated with options?

      • Highlighting the key changes in oncology in recent years.
      • What do technological advancements actually offer for those running a trial.
      • Discussing the uses of hybrid trials and what successes have been had.

      Speakers

      12:30 PM

      Running Up That Hill: Accelerate Cycle Times & Reach Patients Faster with elluminate

      Learn how the elluminate Clinical Data Cloud and Biometrics Services deliver

      • Operational insights across numerous data sources that provides definitive answers and analytics on enrollment, protocol compliance and safety
      • Improved study oversight with a holistic view of risk across all data sources
      • 50 out-of-the-box visualizations to support supports cross-study analysis for deeper insights with self-service access to clinical and operational analytics
      • Increased productivity across data management, medical monitoring, clinical operations, clinical programming and statistical analysis roles

      Speakers

      1 PM

      Lunch and networking

      2 PM

      PANEL: Reducing the patient burden, what we as an industry can do to help.

      • Can we utilize parts of decentralized trials to help patients or do they actually make things worse.
      • How to work with sites to ensure that we create patient friendly protocols.
      • Sharing experiences from previous trials to learn together for the good of the patient.

      Speakers

      2:30 PM

      Closing the divide, how to work with supply as clin ops when it comes to study design

      • The essentials of communication with your CMC team when designing a study to ensure its success.
      • Highlighting the current issues in supply and what to expect in the near future.
      • Tips and tricks for a strong overall clinical team.

      Speakers

      3 PM

      TRIAL DIVERSITY: Tech-Enabled Selection of Clinical Trial Sites with Diverse Patient Populations

      • FDA now requires Phase 3 trials to submit a Diversity Plan; learn about what should be included
      • Learn about an effective, tech-enabled solution to identify clinical trial sites with the most diverse patient populations
      • Translate data into Diversity Plan enrollment targets for your clinical trial and an action plan for site selection and activation

      Speakers

      3:15 PM

      Afternoon refreshments and networking

      3:45 PM

      PANEL: Working in partnership with clinical sites to improve the accuracy and efficiency of your trial

      • Highlighting the common issues of an oncology trial from a site perspective
      • How to work with sites to reduce turnover and burnout.
      • Best practices to support sites to reduce the overall burden on them.
      • Designing protocols with sites to ensure ease of use.

      Speakers

      4:30 PM

      Drive Oncology Trial Execution with the Right Tools, Resources, and Experience

      • Over the last decade, novel oncology treatments across multiple therapeutic classes have driven better patient outcomes
      • A proliferation of oncology focused biotechs and therapies in development resulted in a highly competitive field focused on many of the same therapeutic targets.
      • In addition, the number of ongoing and recruiting oncology clinical trials has slowed patient enrollment and made site identification more difficult.
      • To avoid clinical trial delays it is critical to identify research experienced investigators and sites that treat protocol-specific patient populations.

      Speakers

      5 PM

      Chairperson’s closing remarks

      END OF DAY 1 AND NETWORKING DRINKS

      8:15 AM

      Registration and refreshments

      8:50 AM

      Chairperson’s opening remarks

      9 AM

      PROBLEM-SOLVING ROUNDTABLE DISCUSSIONS

      During the roundtable discussion session, the conference hall will be divided into four ‘zones’. Delegates can choose which zone they would like to join. Each zone will be led by a table moderator and will focus on a different challenge within clinical operations in oncology trials. After 30 minutes, delegates will have the opportunity to swap and choose a different table, and each roundtable will run twice.

      ROUNDTABLE 1: Reducing the patient burden, what practices can we adopt to ensure we remain patient focused.

      ROUNDTABLE 2: Diversity and inclusion in oncology trials: why is this so important, and how can we achieve this?

      ROUNDTABLE 3: Working on protocol design for the long run, discussing best practices for modern trials.

      Joe Shan, Executive Director, Clinical Development Operations , MEI Pharma

      ROUNDTABLE 4: How to work with sites to get them to prioritise your study.

      Iris Sison, Senior Director, Head of Clinical Operations ,IGM Biosciences

      Speakers

      10:15 AM

      Morning refreshments and networking

      10:45 AM

      Innovative approaches to oncology clinical study designs and operations after the pandemic disruptions

      • Defining the key changes driven by the pandemic
      • Patient focus and decentralization in oncology trials:
      • Looking into the future, what to consider when planning early phase trials

      Speakers

      11:15 AM

      Designing and Operationalizing Trials that Increase Patient Diversity Across Study Phases

      • Trial Design and Startup Considerations
      • Enrollment and Retention Tactics
      • Patient Advocacy and Community Strategy

      Speakers

      11:45 AM

      Preparing for the Unexpected in Early Phase Trials

      • Discussing the key problem areas that can go wrong in early phases of clinical trials
      • Negotiations with CRO’s when you have contradicting expectations of a trial
      • Diverting resources in the most efficient way when something unexpected happens

      Speakers

      12 PM

      Lunch, Networking & Apple Prize Draw

      1:30 PM

      A Survey of Colleagues: Identifying how have shifts in available tech impacted clinical trial and work success in recent years

      • Highlighting the key areas in which the industry is thriving and struggling with new tech
      • Comparing Oncology studies with alternative indications in a variety of factors
      • Discussing impacts on quality of work as a sponsor in the industry

      Speakers

      2 PM

      The clinical development landscape of cell therapies in oncology

      • Clinical trial landscape of pipeline drugs
      • Overview of currently marketed drugs and future projections
      • Analysis of hematological versus solid cancers
      • Overview of the most promising technologies by market size, including CAR-T and CAR-NK cells, TCRs, and others

      Speakers

      3 PM

      Chairperson’s closing remarks

      END OF CONFERENCE

      2023 Speakers

      Select a speaker to learn more

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      Ekatherina Goryachikov
      VP and Head of Clinical Operations, Adicet Bio

      Session Details:

      Expanding early phase oncology trials outside of the US

      2023-04-25, 9:30 AM

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      Oscar Segurado
      Chief Medical Officer, ASC Therapeutics

      Session Details:

      Innovative approaches to oncology clinical study designs and operations after the pandemic disruptions

      2023-04-26, 10:45 AM

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      Bao Dinh
      Associate Director, Clinical Data Management, Ascendis Pharma
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      Arla Yost
      Clinical Research Operations Director, University of California

      Session Details:

      OPENING PANEL: Tackling the current industry trends in patient enrolment for oncology trials.

      2023-04-25, 8:30 AM

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      Luis A. Aguilar
      VP, Business and Clinical Operations, Candel Therapeutics

      Session Details:

      OPENING PANEL: Tackling the current industry trends in patient enrolment for oncology trials.

      2023-04-25, 8:30 AM

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      Joe Coffie
      Sr. Clinical Operations Professional, Imago BioSciences

      Session Details:

      PANEL: Working in partnership with clinical sites to improve the accuracy and efficiency of your trial

      2023-04-25, 3:45 PM

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      Joe Shan
      MPH, Executive Director, Clinical Development Operations, MEI Pharma

      Session Details:

      PROBLEM-SOLVING ROUNDTABLE DISCUSSIONS

      2023-04-26, 9:00 AM

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      Dorothy Nguyen
      Vice President of Clinical Development, AmMax Bio

      Session Details:

      PANEL: Exploring modern innovation in oncology trials, have trials become over complicated with options?

      2023-04-25, 12:00 PM

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      Gary Albert
      Director, Clinical Operations, Patient Recruitment and Trial Management, Formerly Turning Point Therapeutics

      Session Details:

      OPENING PANEL: Tackling the current industry trends in patient enrolment for oncology trials.

      2023-04-25, 8:30 AM

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      Lixia Wang
      Senior Vice President, Data Science, Vaxxinity

      Session Details:

      Best practices for safety and data review committees for early oncology studies

      2023-04-25, 2:00 PM

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      Umar Hayat
      Vice President, CMC and Supply Chain, Union Therapeutics

      Umar Hayat, Ph.D. is VP of CMC and Supply Chain at Union Therapeutics and has more than two decades of experience in pharmaceutical development, manufacturing and supply chain. He held senior level positions with Relypsa (acquired by Galenica for 1.52B US$), Anacor (acquired by Pfizer for 5.2B US$) and Transcept Pharmaceuticals (revers merger with Paratek). He played a pivotal role in the development and commercialization of Veltassa® (USA and EU), a treatment for hyperkalemia, Intermezzo® for MOTN insomnia, Kerydin® for onychomycosis, and Eucrisa® for atopic dermatitis. Dr. Hayat is managing partner of Revive Pharm USA. He is also a co-founder of U&D Pharma and working on Replyte Gel, a treatment for anogenital warts. Dr. Hayat received his Ph.D. in process engineering from INP-Toulouse, France and Post-Doctoral Fellowship from Ecole Polytechnique de Montreal, Canada. He received M.Sc. Chemistry degree from Punjab University, Institute of Chemistry

      Session Details:

      Closing the divide, how to work with supply as clin ops when it comes to study design

      2023-04-25, 2:30 PM

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      Prasun Mishra
      Founding Partner, World Investors and Entrepreneurs Society

      Dr Mishra (Ex Genentech, Ex NCI, Ex NIH) is the founding president and CEO of the American
      Association for Precision Medicine ( and chair of ACT AAPM’s Coronavirus Taskforce He
      is leading research efforts focused on preventing curing chronic diseases not only treating
      the sick but also providing knowledge/tools to individuals to live longer, healthier lives

      He is also the founder and CEO of Agility Pharmaceuticals, a pharmaceutical company
      committed to revolutionizing drug discovery development through technology, big data,
      robotics, and artificial intelligence He is a serial entrepreneur who founded his first company
      after graduating high school, and his second company during his Ph D Since then, he has
      accumulated a wealth of experience by building, investing, and advising numerous other
      companies He is an investor, co founder/ board member of a few corporations, focused on
      accelerating drug discovery/ development, data analytics, robotics, mental health, and digital
      health He is also the founder of AAPM Angels and Investors AAi an investment group focused
      on investing in drug discovery, diagnostics, precision medicine, technology healthcare
      companies He is also the founding investor and advisor to Barcelona Ventures and serves as an
      advisor to a 100 M private equity fund

      Widely recognized as a thought leader in the field of ‘technology and healthcare’, Dr Mishra has
      keynoted, chaired, curated, and organized numerous successful international conferences He
      served as a Scientist and Principal Investigator at the pharma giant Genentech, Roche Where
      he participated in several drug discovery project teams Moreover, his passion for drug
      development and precision medicine has led to the identification of new drug targets,
      biomarkers, companion diagnostics, and several drugs/ combinations in the clinic

      His research work has been recognized globally by over 40 prestigious awards and honors Due
      to his unique perspective selfless service, he is a highly respected sought after mentor to
      many The companies that he has advised have raised multimillion dollars Notably, he serves
      as a mentor and advisor to several VC funds and startup accelerators, including IndieBio
      HIMSS/Health 2 0 ’s Project Zygote, MedLabs ZGC Capital, J&J JLabs UCSF Innovation Venture,
      UCSF Invent Fund, and California Life Sciences’s FAST program, to help grow California’s life
      sciences innovation ecosystem

      Session Details:

      Precision Clinical Trials In The Era Of Big Data, Artificial Intelligence, and Precision Medicine

      2023-04-25, 11:00 AM

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      Joan Chambers
      CEO, Greater Gift

      Session Details:

      PANEL: Reducing the patient burden, what we as an industry can do to help.

      2023-04-25, 2:00 PM

      Session Details:

      PANEL: Working in partnership with clinical sites to improve the accuracy and efficiency of your trial

      2023-04-25, 3:45 PM

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      Allyson Gunsallus
      Associate Director, BridgeBio

      Session Details:

      A Survey of Colleagues: Identifying how have shifts in available tech impacted clinical trial and work success in recent years

      2023-04-26, 1:30 PM

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      Mary Syto
      Senior Director, Clinical Science, Bristol Myers Squibb

      Experienced Clinical Research Scientist with 20+ years of experience in pharmaceutical drug discovery and development in CRO and industry settings. Most recent clinical development experience in multiple sclerosis space leading to the successful marketing authorization of Zeposia (ozanimod) in the US and Europe. Therapeutic areas: Dermatology, Gastroenterology, Immunology/Inflammation, Neurology, and Oncology (Hematology and Solid Tumors).

      Session Details:

      PANEL: Reducing the patient burden, what we as an industry can do to help.

      2023-04-25, 2:00 PM

      Session Details:

      PANEL: Looking at new trends and themes for oncology clinical trials in the wake of the pandemic: what’s new, and what’s changed?

      2023-04-25, 11:00 AM

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      Dr Elise Brownell
      Executive Vice President, Portfolio and Project Management, Vivacitas Oncology

      Elise Brownell, PhD. has spent the last 35 years in the bio/pharmaceutical arena where she has played key roles in Discovery, Development and Opportunity Assessment to drive innovation.

      After completing her doctorate at Yale University, Elise’s career started at SUNY Stony Brook. She continued her interest in comparative molecular biology during her tenure at Frederick Cancer Research Facility and expanded her facility with molecular genetics while in various functions at Bayer Healthcare. Her efforts were widely recognized by promotion to Director, Project Management, where she led global cross-functional teams. Elise also became a member of the founding team of a venture-backed spin out (Aerovance, Inc), where she became head of project management.

      Dr. Brownell serves in Interim Executive capacities for a number of emergent and highly innovative companies in the Life Science sector, and as a mentor to the entrepreneurs who run them.

      Elise received her MS, MPhil and PhD from Yale University, and her BS from Allegheny College

      Session Details:

      Workshop: How to create an essential product target profile for drug development

      2023-04-25, 4:30 PM

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      Catherine Caserza
      Director, Clinical Operations, Daichii Sankyo

      Session Details:

      How are today’s patients coping with modernized trials?

      2023-04-25, 11:00 AM

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      John Tomaro
      Vice President, Clinical Operations, BoltBiotherapeutics

      Session Details:

      Preparing for the Unexpected in Early Phase Trials

      2023-04-26, 11:45 AM

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      Anthony Maida
      Chief Clinical Officer, Sapu BioScience

      Session Details:

      PANEL: Working in partnership with clinical sites to improve the accuracy and efficiency of your trial

      2023-04-25, 3:45 PM

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      Iris Sison
      Senior Director Clinical Operations Oncology

      Iris Sison is the Director, Head of Clinical Operations at IGM Biosciences, Inc. She has over 15 years of experience with a variety of leadership and technical roles from the site level, CRO to big and small biotech settings. She has experience in clinical trial management across therapeutic areas in Phase I-IV with a strong emphasis on Phase I oncology in Solid Tumors and Hematology Oncology. Iris has led numerous study teams in operationalizing complex multicenter global studies through innovative study design and development. Over the course of her career, she has played a key role in the development of a number of successful new drugs to market e.g. Avastin, Lucentis, Herceptin, Zelboraf, Keytruda, and Ibrance.

      Her experience at the site level, CRO and clinical trial management gives her a unique perspective and knowledge for patients, sites and CROs. This insight gives her an understanding of the operational challenges that would need to be managed efficiently and effectively in order to conduct a successful multi-centered global clinical trial. Iris is very passionate about delivering high quality results and continue to strive to be innovative in order to improve the speed and efficiency of drug development and eventually treat and find cures for patients with cancer and other debilitating diseases.

      Session Details:

      PROBLEM-SOLVING ROUNDTABLE DISCUSSIONS

      2023-04-26, 9:00 AM

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      Laura Accettola
      Vice President, Hematology/Oncology, Therapeutic Unit Head, PPD, part of Thermo Fisher Scientific

      Laura currently serves as Vice President and Therapeutic Unit Head for Hematology and Oncology at PPD, part of Thermo Fisher Scientific. In this role she holds responsibilities for the strategic direction, business operations, and operational delivery for hematology and oncology Ph I-III clinical trials.

       

      Laura brings with her more than 25 years from the pharma and biotech side with broad multinational experience across the product development lifecycle which includes global development, clinical operations, medical affairs, and value and access. Laura is passionate about improving the patient experience on clinical trials and delivering medicines in the most accessible ways.

      Session Details:

      Designing and Operationalizing Trials that Increase Patient Diversity Across Study Phases

      2023-04-26, 11:15 AM

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      Jeffery Pettit-Williams
      Principal Project Manager, Patient Diversity, PPD

      Session Details:

      Designing and Operationalizing Trials that Increase Patient Diversity Across Study Phases

      2023-04-26, 11:15 AM

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      Laura M. Currie
      Senior Clinical Research Associate

      Session Details:

      Oncology Trial Success: Knowledge gained from 2020-2022

      2023-04-25, 9:00 AM

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      Julie Martin
      Chief Executive Officer, Scimega

      Julie Martin - CEO & co-Owner joined Scimega 9 years ago. Having worked for 2 other CROs before, 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 & business acumen. She equates that success with setting a clear vision for the organization’s continued sense of purpose. Her leadership & 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.

      Session Details:

      Getting Hard Feasibility Data: How To Do It

      2023-04-25, 11:30 AM

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      Kohkan Shamsi
      MD, PhD: Co-founder and Principal, RadMD

      Session Details:

      Early Phase Oncology Imaging Endpoints: Optimize the opportunity and avoid the risks

      2023-04-25, 11:30 AM

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      Dan McGann
      Solutions Consultant, eClinical Solutions

      As a Solutions Consultant with eClinical Solutions, Dan serves as a subject matter expert for the elluminate Clinical Data Cloud, the foundation of digital trials. Dan is responsible for presenting the robust data management solutions made possible with elluminate, and can customize product demonstrations to address specific customer needs.

      Session Details:

      Running Up That Hill: Accelerate Cycle Times & Reach Patients Faster with elluminate

      2023-04-25, 12:30 PM

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      Sandra Shpilberg
      Co-Founder & CEO, Adnexi

      Session Details:

      TRIAL DIVERSITY: Tech-Enabled Selection of Clinical Trial Sites with Diverse Patient Populations

      2023-04-25, 3:00 PM

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      Andy Kinley
      Vice President, Innovation and Clinical Science, Precision For Medicine

      Session Details:

      Drive Oncology Trial Execution with the Right Tools, Resources, and Experience

      2023-04-25, 4:30 PM

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      Sakis Paliouras
      Associate Director, Oncology and Hematology, US, GlobalData

      Session Details:

      The clinical development landscape of cell therapies in oncology

      2023-04-26, 2:00 PM

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      Harit Nandani
      Director, Clinical Data Management, GRAIL, Inc.

      Harit Nandani has 12+ years of experience in clinical trials data and technology leadership for both diagnostics and therapeutic trials. He specializes in clinical trial data management and analysis, configuring systems for population-scale studies, and using analytics tools to monitor projects. Currently, he is the Director of Clinical Data Management at GRAIL, overseeing data and systems for trials in the UK and US supporting early cancer detection diagnostics development. He has worked on projects enrolling over 300,000 participants, leading to the development of the Galleri test, which has detected over 50 types of cancer and has been named one of TIME Magazine's best inventions and The Atlantic's 10 most promising breakthroughs of 2022. Prior to GRAIL, Harit led late-stage pivotal trials in Oncology at Gilead Sciences and worked in various clinical research roles at a CRO and a small biopharmaceutical development company.

      Session Details:

      PANEL: Exploring modern innovation in oncology trials, have trials become over complicated with options?

      2023-04-25, 12:00 PM

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      Sarah Anderson
      Executive Director, Oncology Strategy Lead Worldwide Clinical Trials

      Sarah R. Anderson is an Executive Director, Oncology Strategy Lead at Worldwide Clinical Trials.  Ms. Anderson has dedicated the past 17 years to building and advancing innovative oncology clinical trial concepts through development execution. Her passion is leading therapeutic strategy development along with a strategic thoughtfulness on advancing clinical trial options to patients in a local community setting.

      Session Details:

      Advancing Oncology Clinical Trials Option to Patients in the Local Community Setting

      2023-04-25, 10:00 AM

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