Archives: Agenda

• Big pharma is a battleship in a speedboat world. FSP outsourcing offers the agility to cut through traditional development timelines and chart a faster course to patients.
• In this presentation, Parexel will share how they partnered with Bristol Myers Squibb (BMS) to make a strategic shift, transitioning from a predominantly full-service outsourcing model to a functional service provider model. This involved redefining traditional roles, innovating tasks and responsibilities, and talent redeployment in support of pipeline priorities.
• The presenters will discuss the strategic considerations and benefits of this transition, demonstrating how through a collaborative partnership, they worked to enhance BMS’ clinical trial operations, creating resource efficiencies, increasing agility, and optimizing clinical operations across their global portfolio. This presentation will offer valuable insights for companies seeking to adapt their outsourcing strategies to meet the demands of today’s complex and rapidly changing drug development environment.

• Harnessing Apple Watch technology: key features for detecting heart arrhythmias
• What the evidence says: insights from published cardiovascular studies
• From wrist to research: smart distribution models for clinical trial success
• Making it work: tackling operational and data management hurdles for clinical trial success

• Uncovering the invisible: a 20-year analysis of medically underrepresented populations in clinical trials
• Benchmarking against the US census reveals structural gaps and needs
• Adopt a six-pillar architecture to embed equity from the ground up

• What is realistic, what isn’t, and how can you stay ahead of the curve?
• How biotech and pharma differ when it comes to technology and innovation: as a biotech, where should your priorities lie?
• Staying ahead of competitors when funding and resources are limited for technology investment
• Leveraging agility and flexibility to adopt technology quickly
• Balancing innovation with risk management and scalable development

MODERATOR Jay Russak, Former Senior Director, Clinical Operations, Keros Therapeutics

• Streamlining feasibility, site selection and qualification processes to minimize delays
• Leveraging technology to manage documents, workflows and communication
• Identifying common bottlenecks and strategies to overcome them proactively
• Aligning sponsor, CRO and site teams to ensure clarity from day one

• How to build a strong CRO onboarding plan that sets your study up for success
• Making your kickoff meeting count: aligning teams, timelines, and expectations
• Fast-tracking your study start-up — from project plan to site activation
• Anticipating and mitigating early risks to protect your study timelines

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. Roundtables will take place in the Stream A conference room.

ROUNDTABLE 1: Navigating biological material regulations

Sean D. Smith, Biological Threat Exclusion Coordinator (BTEC), US Customs and Border Protection

ROUNDTABLE 2: Keeping patients at the heart of your clinical trial

Behtash Bahador, Senior Director, Community Engagement & Partnerships, CISCRP

ROUNDTABLE 3: Fostering a positive relationship with your CRO and vendor partners

Liza Micioni, Director, Clinical Operations, Tris Pharma

ROUNDTABLE 4: Negotiation tips for emerging startups