Archives: Agenda

• Managing increasing regulatory divergence across the US, Europe, and emerging global trial regions
• Understanding the operational impact of evolving FDA expectations and Project Optimus requirements on oncology development programs
• Do sponsors know where the gaps are in the latest ICH-GCP E6(R3) and how can AI help conduct gap analyses across SOPs and study documents
• Assessing the current state of European harmonization, including ongoing challenges around submissions, approvals, and operational consistency across markets

Moderator: Keya Watkins, President – Oncology, Worldwide Clinical Trials

As oncology development grows more complex, CRO partnerships have become central to how programs scale, execute, and deliver. Yet in practice, these relationships are often more nuanced than the traditional value proposition suggests.

In this candid discussion, we’ll explore CRO partnerships from a biotech perspective – examining where they fall short, and what it takes to make them work in real-world settings.

• The strategic upside of CRO partnerships, including scaling with specialized operational and regulatory expertise
• Where partnerships break down, from misaligned expectations to gaps in execution, communication, and accountability
• When a single, integrated CRO model is most effective — and when a more tailored, multi-CRO approach better supports program needs
• What stronger partnerships look like in practice, with a focus on alignment, transparency, and shared ownership of outcomes

How strategic collaboration can accelerate innovation:

• Moving from transactional execution to consultative partnership
• How CROs can become strategic problem solvers, not just service providers
• Building trust transparency and shared accountability

• The factors/barriers for why patients don’t readily participate in clinical trials and how to address them
• Why targeted culturally humble communication is necessary for “marketing” clinical trials
• The benefits of navigation to retain patients
• Success story examples

Best 3 LinkedIn posts from day 1 with hashtag #CTO and @Clinical Trials in Oncology Event Series tagged will win a prize in day 2 morning’s prize draw during chair’s opening remarks. Deadline end of drinks reception day 1. You must be present to win!

Faraz Siddiqui is an experienced healthcare attorney who negotiates clinical research agreements on behalf of Memorial Sloan Kettering with pharmaceutical companies and CROs. His session will cover:

• How Sponsors can collaborate with sites on innovations to accelerate trial activation, in an environment of limited budgets and high study volume.
• Implementation of site-driven legal innovations to streamline contract negotiation frameworks.
• Case Study of MSK’s Early Drug Development (EDD)’s cross-functional pilot (regulatory, legal, operations, finance) to address bottlenecks and improve efficiency in study activation

• Why tissue biopsies are sometimes essential in clinical trials for novel therapeutics
• Question-based framework to align tissue collection and analysis with clinical trial objectives and timelines
• Emerging biomarker technologies including digital pathology, artificial intelligence, and multiplex spatial biology