Clinical Operations in Oncology Trials East Coast 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?

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 and 1M+ study sites to:

• Use predictive models to significantly enhance enrollment forecasting and reforecasting, enabling more proactive responses
• Keep trials on track with real time monitoring of performance against similar trials and changing industry conditions
• Include industry patient diversity benchmarks within specific indications to drive real improvements in clinical trial recruitment

• An overview of participating in a clinical trial from a patient’s perspective: what do trial sponsors overlook?
• Understanding the experience of enrolling in a trial as a patient, from becoming aware of the study through to clinic visits
• The importance of regular communication with patients
• Making participation as easy as possible for your patients: what do patients really want?

• Considering your patient during the study design phase: working closely with patients and advocacy groups in order to achieve this
• Understanding patient accessibility needs: are decentralized and hybrid approaches the way forward?
• Ensuring potential patient participants are aware of your trial: maximizing the reach of your recruitment campaigns
• Making “no decision about the patient without the patient”: what this means for your clinical trial

• Identifying patients for your study: ensuring your recruitment campaign reaches the maximum number of patients
• Does e-consent and incorporating remote elements ease the burden on patients and increase recruitment?
• The role of social media and how to optimize online campaigns to recruit patients
• Using data to modify inclusion and exclusion criteria when identifying participants

• Selection of regions/sites to support enrolment targets
• Methods of engaging patients for enhanced recruitment
• Retention options and impact of availability of options based on global footprint of trials

A look at the future and how to leverage lessons learned in 2020 and 2021 to. Implement key operations process and adaptations to help US sponsors optimally navigate the new normal in clinical trial operations in Canada and other geographic areas.

• Strengthen and promote a positive company culture, productive teamwork through transition, continuous knowledge-sharing & keeping employee turnover low
• Nurture oncology site relations while tracking and adapting to changed & changing site research capacities
• Ensure on-time and compliant treatments through proactive prevention & mitigation risks
• Meet project milestones through all circumstances
• Be audit/inspection-ready I the new reality

• With new variants and ever changing restrictions, what COVID-related considerations should you take into account when designing an oncology trial?
• Running a clinical trial with social distancing in place: what measures are likely to be long term?
• The importance of working closely with CROs, vendors, sites and patients to mitigate the impact of COVID on oncology trials
• Risk management and how pandemic-handling measures will affect processes in the long term

• An overview of Andarix’s technology to target lung and pancreatic cancer
• Developing personalized cancer treatments: challenges and opportunities
• Shipping products from lab to patient: what is required?
• Results from Phase 1 studies and plans for Phase 2
• Identifying national and international partners to make trials a success

Operational oversight within outsourced models has become increasingly complex for teams who are tasked with managing trials amid a rapidly changing landscape of partners, technologies, and global regulations. The elluminate Clinical Data Cloud provides one source of truth for clinical and operational data to manage trials across sources. Learn how elluminate delivers:

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

• Outlining smart guide lines for a risk-based data strategy
• Defining and ensuring smart data collection

• Why has oncology been slower to adopt decentralization in clinical trials?
• What elements of decentralization could be incorporated into oncology?
• Understanding your patient: is decentralization the most desirable approach for your patient?
• Regulatory considerations when running a decentralized trial in oncology
• Decentralization as a method of increasing recruitment and improving retention: does this work in oncology?

During the roundtable discussion session, the conference hall will be divided into three ‘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: Funding your oncology study as a small to medium sized biotech: getting buy in from investors

ROUNDTABLE 2: Challenges and opportunities of decentralization in oncology studies

ROUNDTABLE 3: Putting your patient first: making your oncology study as patient-centric as possible

Yolanda Wan, Vice President, Clinical Operations, Accutar

ROUNDTABLE 4: Considerations and best practice for maintaining a strong site-sponsor relationship

Diana Hummel, Associate Director, Clinical Operations, Relay Therapeutics

• An overview of Tufts CSDD’s global study on remote working in clinical research, in collaboration with the Bill and Melinda Gates Medical Research Institute
• The impact of remote working on productivity in the execution of clinical research
• General preparedness and responsiveness of research organizations
• Assessing the overall positive and negative effects of working remotely for clinical research professionals

Pending confirmation:

Mary Jo Lamberti, PhD, Research Assistant Professor, Director of Sponsored Research, Tufts Center for the Study of Drug Development

Maria Florez, M.A., Research Consultant, Tufts Center for the Study of Drug Development

• An overview of Sanofi Genzyme’s oncology pipeline and understanding its specific operational requirements
• Facilitating cross-team support and ensuring resource optimization
• Ensuring data safety and efficacy

• Why Quality is so important in drug development and clinical trial execution
• Balancing new and evolving automation with critical thinking
• Understanding end to end development – from first in human to post approval trials
• Reducing risk with comprehensive study specific training

• Weighing up important considerations for choosing a CRO
• Overseeing vendors and CROs at different stages of your trial: what do you need to be doing?
• Aligning vendor and sponsor teams under one shared goal to deliver your oncology trial smoothly and efficiently

• The clinical trials landscape of immune-oncology drugs in the pipeline
• Overview of currently marketed drugs and future projections
• Key opinion leader (KOLs) insight on the current treatment options, pipeline drugs, unmet needs, and the most promising R&D strategies