Clinical Operations in Oncology Trials West Coast 2023

The West Coast's top event to discover and discuss the most efficient methods of running oncology trials

  • Burlingame, CA, United States
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WHAT TO EXPECT FOR 2023?

A FANTASTIC NETWORK OF YOUR PEERS AND COLLEAGUES. Clinical Operations in Oncology is the meeting place for leading pharmaceutical companies and up and coming biotechnology institutes. Discover how to excel in oncology operations and clinical supply strategy as well as form key connections for long-term success for your clinical trial.

200+

Attendees

20+

Exhibitors

15+

Speakers

80%

Attendees at Director+ level

200+

Attendees

20+

Exhibitors

15+

Speakers

80%

Attendees at Director+ level

See What It's All About

2022 Agenda

  • 5 Apr 2022
  • 6 Apr 2022
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7:30 AM

Registration and refreshments

8:20 AM

Chairperson’s opening remarks

8:30 AM

OPENING KEYNOTE: Disruption in oncology clinical trials: new technology and themes in 2022

  • During this opening keynote, Len Rosenberg will be setting the scene for oncology trials in 2022: what's new, and what's changed? Hear Len's thoughts on topics including:
  • Are sponsors fully embracing change and technology?
  • Decentralized approaches for oncology trials: what works, and what doesn't?
  • Beyond the obvious: where are opportunities for innovation being overlooked?

9 AM

AI powered enrollment forecasting and real time study tracking against industry

  • How well are you able to forecast enrollment and track external factors that can impact the performance of your ongoing study? In this session you will learn how Medidata Acorn AI's Intelligent Trials solution leverages performance data from 27,000+ clinical trials including 8M patients in 33k facilities spanning 145+ countries to:
  • Keep trials on track with real time monitoring of performance against similar trials and changing industry conditions
  • Use predictive models to significantly enhance enrollment forecasting and reforecasting, enabling more proactive responses
  • Include trial insights in user workflows supporting the iterative nature of trials while also supporting access via data feeds

9:30 AM

EXPERT INSIGHTS: Designing a decentralized oncology trial: strategies for success

  • Understanding the regulatory environment for planning a decentralized trial
  • Designing a trial to maximize recruitment potential and ensure you have enough patients enrolled
  • Selecting partners to work with to make your trial a success

10 AM

Flexible by design: tools to manage uncertainty and complexity in early phase oncology trials

  • Examine common challenges in early phase oncology trials that can be mitigated with technology tools
  • Explore functionality that can help manage the uncertainty in trial duration, treatment variability and protocol amendments
  • Discuss how an early phase oncology trial case study leveraged IRT functionality to address the protocol complexities

10:30 AM

Morning refreshments and networking

11 AM

PANEL: The ongoing challenge of patient recruitment: what’s new for oncology studies in 2022?

  • Achieving patient diversity in oncology studies: what to consider
  • Sourcing patients and the impact of social media on finding participants for your trial
  • Recruiting up to target and beyond: what should you be aiming for?
  • Spreading awareness and making sure eligible patients are aware of your trial
  • The impact of COVID-19 on recruitment and retention: what new challenges are there?
  • PANELLISTS:
  • Mary Syto, Director, Clinical Science, Bristol Myers Squibb
  • Dr. Chris Apfel, MD, PhD, MBA, Chairman and CEO, SageMedic Corp

11:30 AM

Building effective site relationships: a solid case

Julie Martin, CEO of Scimega Research builds a solid case for effective site relationship 'how to' for the long term to ensure the best possible outcomes for oncology clinical trial sponsors and the cancer patients participating in their cutting-edge trials. Key insights include strategies to:

  • Expedite suitable site identification using hard data sets
  • Best practices to meet and surpass enrollment targets
  • Achieve patient eligibility review efficiency
  • Optimize site engagement to attain maximum effectiveness for quality, timely data entry and query resolution

Julie Martin, Chief Executive Officer, Scimega Research

12 PM

FIRESIDE CHAT: Fear of the unknown: modern clinical data challenges in oncology

  • Managing clinical trials with COVID restrictions: considerations from study startup and execution to data management
  • Heterogeneity of site structure: who is truly responsible for data?
  • Adaptive EDC platform
  • What's next for oncology trials?

12:30 PM

Holistic approach to oncology clinical research in the era of personalized medicine

  • Precision For Medicine (PFM) in the oncology clinical research arena: what we know, where we are and where we want to be
  • PFM after COVID-19 pandemic: partnership model to create an innovative environment in clinical research
  • Anticipating the future: pfm fluid and integrative approach to biomarker-driven patient enrolment in oncology clinical research

1 PM

Lunch and networking

2 PM

MINI WORKSHOP: Establishing and maintaining investigators engagement in a competitive oncology clinical trial landscape

Led by a moderator, this session aims to generate discussion from the audience around maintaining investigator engagement. Participants will have fifteen minutes to discuss the topic with the person sitting next to them before submitting ideas, which can be anonymous, via Slido. These will then appear on the screen and the audience will have the opportunity to upvote their favourites, which the moderator will then discuss.

2:30 PM

Image assessments in early phase oncology trials and imaging risks that can affect your trial: imaging data insurance policy for better decision-making

  • 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. Many clinical development teams find themselves questioning:
  • What imaging biomarkers should we target?
  • What endpoints and criteria best suit the compound?
  • Are central reads necessary for all subjects?
  • Should we just collect and hold images? if so, what decision tree do we use to pull the trigger on central reads?
  • What supporting clinical data should be collected?
  • What types of radiology support do we need?

3 PM

Operational considerations for protocol development to support study success

  • The value of the operations perspective
  • How to calculate and communicate burden on patients and sites to stakeholders
  • How to predict and evaluate possible enrollment hurdles
  • Strategies to minimize risk of protocol deviations

3:30 PM

Afternoon refreshments and networking

4 PM

Regulatory insights: understanding FDA accelerated approval processes

  • Submitting for FDA approval when limited data sets are available: what do you need to consider?
  • What can sponsors and CROs do to ensure confirmatory trials sure up early results
  • Surrogate measures vs hard endpoints: which option is most effective?

4:30 PM

A gateway to efficiency: oncology adaptive design

  • What is adaptive design?
  • Advantages of utilizing an adaptive design in oncology trials
  • How does this adaptive design differ from the traditional approach?
  • What to expect, from a CRO and sponsor perspective, with an adaptive design approach to clinical trials?

5 PM

Managing academic partnerships with oncology start-ups

  • Establishing a partnership with an academic institution as an initial path forward for an oncology start-up: how are these partnerships initiated and maintained?
  • Study management and transfer of obligations to academic partners: best practices and lessons learned
  • Maintaining relationships with participating sites: perspectives from the site and the sponsor

5:30 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 45 minutes, delegates will have the opportunity to swap and choose a different table, and each roundtable will run twice.

ROUNDTABLE 1: Putting your patient first: making your oncology study as patient-centric as possible

Prasun Mishra, Chief Executive Officer, Agility Pharmaceuticals

ROUNDTABLE 2: Establishing your target product profile early on: best practice and considerations

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

ROUNDTABLE 3: Pragmatic solutions to challenges in the conduct of oncology trials

Len Rosenberg, Head, Clinical Operations, Beat AML

ROUNDTABLE 4: Reducing the burden of clinical trials on cancer patients

Devin Trejo, Director, Global Product Development, Oncology Early Development, Pfizer

10:30 AM

Morning refreshments and networking

11 AM

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

  • Trends and themes for 2022: what's on the horizon?
  • Handling social distancing and pandemic measures when patients are visiting sites or hospitals
  • How CROs are working with patients to manage the situation alongside the emergence of new variants and lockdown measures
  • New technology and innovation in the wake of the pandemic: what are the positive outcomes for oncology clinical studies?
  • The impact of recent staff shortages on clinical trials: handling delays and setbacks due to internal human resources
  • With many therapeutic areas now looking to decentralization, is this possible (and desirable) for oncology clinical trials?

11:45 AM

Strategies for successful oncology recurrence trials

This presentation will address successful strategies for oncology recurrence trials including review of operational and read recommendations to help you improve efficiency and quality for your recurrence studies.

12:15 PM

Data-driven operations and oversight with elluminate

  • Learn how elluminate delivers:
  • Operational analytics including enrollment, protocol compliance and safety
  • Risk-based analyses and insights with elluminate RBQM
  • Operational knowledge for data-driven development with elluminate CTMS
  • Centralized issue management across roles in operations, data and medical review
  • Sample tracking, data forecasting and financial performance indicators

12:45 PM

Lunch and networking

1:45 PM

Successfully navigating and making the most of your interactive response systems

  • Choosing which IRT platform is best for your oncology trial: what should you consider?
  • Using IRT technology effectively to improve the patient experience
  • How IRT can support drug supply for oncology trials with an undefined end of study treatment

2:15 PM

How ongoing COVID-19 infections are affecting oncology clinical trials

  • Omicron variant impact is different than others
  • Perpetually understaffed at clinical sites as well as CROs
  • Missing key person can cause impactful delay(s)
  • Regulatory delays at certain FDA sections

2:45 PM

Reducing the burden of clinical trials on cancer patients

  • Incorporating e-consent and remote elements into your oncology study
  • Making no decision about the patient without the patient: ensuring you incorporate the patient voice into your study design
  • Looking at access to clinical trials and how better understanding of patient needs can lead to higher enrolment in studies

3:15 PM

Chairperson’s closing remarks

END OF CONFERENCE

2022 Speakers

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RICK PATT
Co-Founder And Principal, RadMD

Dr. Patt is Co-Founder and Principal in RadMD. He has a broad prior experience in medical imaging: this includes research and development of contrast agents: design and manage site and central reviews and trained reviewers for over 300 oncology trials; and has expertise in cardiovascular device, infectious disease, and pulmonary fibrosis trials. He has performed blinded reads and adjudications in a variety of trial types. He has held positions as both an academic and private practice radiologist. After his fellowship at Georgetown University and the National Institutes of Health (NIH), he served as Chief of Body MRI, then Director of MRI, at Georgetown University Medical Center, where he was both an investigator and blinded reader in numerous pharmaceutical and medical device clinical trials. He subsequently joined Berlex Labs as Associate Director, followed by Director of Medical Imaging Clinical Development. where he managed an experienced team in all phases of clinical development of radiological contrast agents. Dr. Patt also served as Medical Director for HealthHelp, a radiology management services organization. He founded Foresight Consulting, working with pharmaceutical and medical device companies on the utilization of medical imaging into clinical development programs. He has numerous publications, has served on an NCI Advisory Panel, is a reviewer for major radiology journals, and has been an invited lecturer across the US and Europe on the use of medical imaging in clinical trials.

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JEF BENBANASTE
VP Of Product, Medidata Acorn AI Intelligent Trials

Jef Benbanaste has led the launch and commercialization of multiple analytical SaaS solutions at Medidata and currently leads Intelligent Trials. Jef has over 16 years of experience improving business processes and decision-making through the use of technology and analytics. Prior to joining Medidata, Jef led projects at the global insurance company AIG which applied predictive modeling and machine learning techniques to improve risk segmentation and shape business unit strategies. Before that, he was in technology consulting at Deloitte. Jef has a MBA from MIT and a BS from the University of Virginia.

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ESTHER MAHILLO
Vice President, Operational Strategy, Precision For Medicine

Dr. Mahillo has 28+ years of experience in the clinical research arena, 25 of them in oncology global trials. Her areas of expertise are inmuno-oncology, including cancer vaccines, advanced therapies, genetically modified organisms and other immuno therapies. She has an in-depth knowledge on oncology networks and advocacy groups, with which she cooperates since 1999. Dr. Mahillo is a professor/magister in several Master programs administered at different Universities (Universidad Alcalá de Henares, Universidad CEU San Pablo, CESIF). She has authored of 3 books, 20 scientific articles, and 24 contributions to scientific congresses. Dr. Mahillo was awarded the first prize of the Spanish Society of Medical Oncology (SEOM) in 2015 for her project “Y Seguiré” (will keep on moving), for the promotion of clinical research. Dr. Mahillo obtained her PhD with a research on the role of multicatalytic proteinase (proteasome) as an oncology intracellular target, research line that ended up with the development of bortezomib, a proteasome inhibitor approved for the treatment of multiple myeloma patients.

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BAO DINH
Associate Director, Clinical Data Management, Ascendis Pharma
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TED RILEY
Director, Regulatory Practice Operations, Halloran Consulting Group
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HEIDI COSSENTINE
Study Lead, Clinical Operations, Oncology, Corcept Therapeutics
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ANWAR MAHMOOD
Associate Director, Technical Operations, Exelixis
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RAVI KIRON
Head, BioPharma External Innovation, EMD Serono,

Dr. Ravi Kiron based in California, USA is an experienced pharma/biotech executive with decades of experience in discovery R&D through late-stage clinical development, intellectual property and regulatory, technology & business development, M&A, strategy and product commercialization, negotiating and executing partnerships by leveraging his extensive global business development networks in CVMD, Oncology, CNS, Wound Healing, Microbiome and Diagnostics. He was a tenure-track faculty member at Cornell University Medical College and adjunct faculty at University of Rhode Island. Dr. Kiron served in various operational & management roles at Pfizer Inc., and J&J/ALZA, in Cardiovascular R&D, Oncology clinical development (Tarceva), strategic business development and M&A (acquisition of WLA, PHA & other biotech). Dr. Kiron has consulted for several dozen global biotech & pharma companies, founded and led multiple companies/new ventures, served as an Entrepreneur In Residence (EIR) at SRI Ventures, ShangPharma Innovation and advises company and non-profit boards. ​Currently, Dr. Kiron is Head, BioPharma External Innovation at the Merck KGaA/EMD Serono’s Silicon Valley Innovation Hub in Menlo Park, California and is exploring cutting edge game changing technologies (Artificial Intelligence & Machine Learning, Microbiome, Electroceuticals etc.) to have an impact on pharma/biotech research, product development and launches.

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DR ELISE BROWNELL
Executive Vice President Of Operations And Project Management, Amarantus BioScience

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

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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.

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MARY SYTO
Director, Clinical Scientists, Early Clinical Development, 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).

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DR SOUHIL ZAIM
Vice President, Medical And Scientific Affairs, Medical Imaging, Clario
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LEN ROSENBERG
Head Of Clinical Operations, BAML, LLC A Division Of The Leukemia & Lymphoma Society

Dr. Rosenberg is a 30 plus year executive with proven experience in driving operational excellence at all levels within the pharmaceutical, biotechnology, eclinical and contract research organization sectors. With his diverse background which includes executive management, clinical and regulatory operations, business development, eclinical technology solutions and new product/licensing evaluations, he brings tremendous hands on insights to optimizing the drug development cycle, from the early start-up stage to global product registration across many key therapeutic areas including CNS and oncology. Dr. Rosenberg is Managing Partner of eP2Consulting, Inc. since 2001. He also currently serves as Head, Clinical Operations at Beat AML, LLC, a division of The Leukemia & Lymphoma Society. Dr. Rosenberg received his Ph.D., from the Kellogg Pharmaceutical Clinical Scientist Program, University of Minnesota, College of Pharmacy and his Bachelor of Science, Pharmacy, from the Philadelphia College of Pharmacy and Science. Contact Information: 4 Quail Court, Mount Laurel, NJ 08054 (c: 609-923-9443)

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KELLY SNOW
Head Of Strategic Initiatives, Suvoda

As head of strategic initiatives and a member of the executive leadership team at Suvoda, Kelly is responsible for driving strategic growth across the organization. Prior to this, Kelly spent 4 years as VP of Product Management and Marketing at Suvoda, where she led the strategic direction of the product suite and external communications. She has spent her career in professional services and product development teams, working with Top 10 Pharma companies in e-clinical focused organizations including Phase Forward and Oracle, as well as B2C technology companies. Kelly holds a bachelor's degree in Interdisciplinary Studies in Bioethics focusing on Neuroscience and Philosophy, a certificate in Conceptual Foundations of Medicine, and a minor in Italian Literature and Language from the University of Pittsburgh.

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DARSHITA PATEL
Director, Clinical Operations, Iovance Therapeutics
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GABRIEL LUCIANO
Executive Director, Clinical Operations, Corvus Pharmaceuticals,

Mr. Luciano joined Corvus Pharmaceuticals in 2018 and has served as Vice President of Clinical Operations since 2021. He was Senior Director of Clinical Operations at Pharmacyclics from 2012 to 2017 where he was responsible for the development, implementation and maintenance of the Clinical Operations infrastructure, as well as the GCP inspection hosting platform and processes, and regulatory authority marketing approval inspection hosting. From 2008 to 2011, he was Senior Clinical Trial Manager at Seattle Genetics where he was responsible for the oversight of multiple oncology clinical trials, as well as support for the development of the Clinical Operations infrastructure and regulatory authority marketing approval inspection hosting. From 1990 to 2008 he held various Clinical Operations positions at Abgenix, Pharmacyclics, Quintiles, Covance and Syntex. Mr. Luciano earned a B.A. in Psychology and Biology from the University of California at Santa Cruz.

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PRASUN MISHRA
Chief Executive Officer, Agility Pharmaceuticals

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

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DEVIN TREJO
Director, Global Product Development , Pfizer
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JULIANNE FEOLA
PhD, Director, Clinical Operations, GT Biopharma
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JOSHUA ONDATJE
Executive Director, Project Management, Oncology, Worldwide Clinical Trials
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TONY TRAN, PHD
Clinical Scientist, Clinical Development, Ascendis Pharma
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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.

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GAVIN CHOY
Chief Clinical Development Officer, GT Biopharma
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CHRIS APFEL
CEO, SageMedic Corp
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