Archives: Agenda

• Paediatric oncology trials pose unique challenges
• International clinical trial networks have traditionally driven the clinical development of new agents for pediatric patients
• Partnership opportunities for study protocol preparation and patient selection: the case for basket trials
• Regulatory implications and the case for “fit-for-filing” studies
• Examples of collaborative approaches

Speaker Hosted Roundtables
Interactive roundtable sessions offer a unique opportunity to come together with your peers to share best practice and develop solutions to critical challenges facing the industry.

Hosted by industry experts and each focused on a single issue, roundtables are an exciting, interactive way to build your personal network and learn from the experience and expertise of others.

Each roundtable session lasts for 30 minutes, and delegates may attend up to 2 roundtables.

RT 1: Discussing AI strategies, benefits and challenges: experiences and future planning
Frank Richard, Vice President Medical, Heidelberg Pharma

RT 2: Collaborating between sponsor, CROs and sites effectively to increase efficiency
Marta Perez-Noguera, Director Clinical Operations EU, Luzsana

RT 3:Considering project plans in clinical trials: why are they so important?
Cornelia Baumgartner, Head of Clinical Operations,  T-CURX

• Examine the oncology clinical trial journey from patient and site perspectives, identifying current stressors and opportunities to solve challenges
• Dive in on specific practices and technologies that can remove friction from the trial experience for patients and reduce workloads for sites
• Identify future innovation spaces to streamline the trial experience and how that can lead to better care for patients and better trial outcomes for sponsors

• Finding the right balance between the needs of sponsor company and vendor to ensure right fit
• Negotiating contracts: getting the right deal
• Dealing with change orders and managing the budget
• Forging partnerships and relationships to enhance contract negotiations and communication

This session explores the pivotal milestones in clinical trial regulation from the 1930s onward, highlighting key changes that shaped today’s standards in patient safety, ethical considerations, and scientific rigor. Participants will gain insights into how regulations evolved in response to historical events and scientific advancements, providing a comprehensive understanding of the frameworks that ensure ethical practices and patient protection in clinical trials today.

• The early days: Establishing regulatory foundations following critical incidents in the 1930s and 1940s
• Nuremberg Code (1947) and Declaration of Helsinki (1964): Milestones in ethical standards
• FDA regulations and the Belmont Report (1979): Shaping patient protection in clinical trials
• ICH-GCP guidelines (1996): Introducing a unified standard for international trials

In this captivating presentation, Alicia will share her experience as a three-time cancer survivor and what she’s learned about the state of clinical research from the patient perspective. Since her initial diagnosis to today, she’ll share how her journey changed the course of her career. Her focus on improving the patient experience and highlighting critical needs throughout the clinical trial ecosystem can help data management professionals find new ways to unlock value for all stakeholders.

Alicia will share how her health information and clinical trial data are still siloed and why this erodes the patient experience for all.

Without collaboration, true innovation is not possible. Alicia will inspire the audience to look for new ways to collaborate to bring efficiency and empathy to the solutions that support the industry.  That’s the essence of a moonshot – an industry wide collaboration that’s an ambitious venture to deliver profound results.

• Understand how the patient perspective can help highlight ways to improve processes and solutions to deliver a best-in-class patient experience
• Recognize the need for building a true collaborative framework to address key patient needs and how data management and solutions provide a crucial role in this work
• Envision the future of data management as an industry leading innovation hub and a core function of patient centricity

• Selecting an imaging vendor
• Decentralized clinical imaging
• Multi specialist access to imaging
• Electronic data transfer
• Importance of patient data return