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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Why attend?

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

See What It's All About

2023 Agenda

  • 25 Apr 2022
  • 26 Apr 2022
Expand All

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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Plan Your Visit

Venue

San Francisco Airport Marriott Waterfront

San Francisco Airport Marriott Waterfront 1800 Old Bayshore Highway Burlingame, California USA 94010

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SPONSORSHIP ENQUIRIES

Conor Taylor

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+44 (0) 20 7936 6870

SPEAKING OPPORTUNITIES

Louisa Manning

Program Director

+44 (0) 20 7936 6870

MARKETING ENQUIRIES

Moona Popal

Marketing Manager

SPONSORSHIP ENQUIRIES

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

Conor Taylor

Sponsorship Sales Manager


+44 (0)207 936 6870

SPEAKER ENQUIRES

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

Douglas Webber

Program Director


+44 (0)207 866 9411