Archives: Agenda

• Start with what matters but allow imagination in how you define “what matters”
• Design for a moving target by embracing uncertainty as a creative tool, not a risk to avoid
• Execute with discipline but treat operational constraints as a spark for innovation
• Making the right choices at the right Time: Look to employ clear, patient-anchored frameworks to advance, pause, or pivot programs at critical inflection points
• Keep patients at the center because nothing generates creativity like unmet human

• Synthetic populations and AI-simulated control arms are already reducing reliance on traditional randomization
• Real-time, adaptive approval models could replace rigid phase boundaries
• Continuous post-market learning may become as important as pre-market proof
• Decision-making authority shifts as AI accelerates evidence generation beyond human-paced review cycles

• Integrating patient insights early in protocol and endpoint design
• Partnering with advocacy organizations to reach diverse and underrepresented populations
• Aligning patient engagement strategies with regulatory and ethical expectations
• Measuring the impact of patient-centric approaches on trial outcomes

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

• Recognizing how the geographic concentration of oncology trials can limit the global relevance of regulatory evidence
• Understanding the role of genomic and epigenomic variation across ancestries in driving treatment response and toxicity
• Identifying how environmental and contextual factors interact with biology to influence therapeutic outcomes
• Evaluating how conventional eligibility criteria may exclude biologically relevant patient populations
• Learning the principles of ancestry-aware eligibility design as a scientifically rigorous approach to trial inclusion
• Assessing how eligibility reform can improve the predictive validity of clinical trial data for regulators and sponsors
• Applying ancestry-aware trial design concepts to support equitable, efficient, and globally applicable drug approvals

• Integrating the right biomarker to narrow relevant patient groups and optimize and personalize disease management
• Engaging with the oncology community and advocacy groups to grow involvement of well-informed patients
• Leveraging investigator expertise for pragmatic trial designs and patient identification
• Building the evidence, from natural history to endpoint development, to support informed decisions by health authorities
• Modernizing criteria: Moving beyond traditional cut-offs to include underrepresented populations safely

Moderator: Ricki Fairley, Chief Executive Officer, Touch, The Black Breast Cancer Alliance