• Reiterating basics of AI and its uses in pharma
• Identification and prioritization of suitable AI and tools
• Building a holistic AI strategy: incorporating tools, ethics and data privacy
• Creating the roadmap: challenges and lessons learnt to overcome them

Speakers

Frank Richard

Vice President Medical, Heidelberg Pharma

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

Speakers

Alicia Staley

VP Patient Engagement, Medidata Dassault Systemes

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

Speakers

Cornelia Baumgartner

Head of Clinical Operations, T-CURX

• 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

Speakers

Cesare Spadoni

Founder & Chief Operating Officer, Oncoheroes Biosciences

• Feasibility figures true to delivery
• Regulatory dynamics for strategic advantages
• Collaborate with patients and physicians to enhance access to innovative therapies
• New study designs that accelerate development programs

Speakers

Dr. Claudia Hesselmann

Founder & CEO, ARENSIA Exploratory Medicine

• Site selection considerations specific to Radiopharmaceutical Therapy (RPT) clinical trials
• A sponsor’s perspective of the technical knowledge and expertise required to deliver RPT studies
• Country specific RPT clinical trial requirements and regulations
• Challenges with just-in-time supply for RPT investigational products

Speakers

Liz Emmerson

Director Clinical Operations, Blue Earth Therapeutics

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

Speakers

Sarah Westall

Solutions Specialist, Medidata

Alicia Staley

VP Patient Engagement, Medidata Dassault Systemes

Justus Harris

Patient Advocate

Helen Johansen Blanco

Chief Operating Officer, Node Pharma A/S

Hear from a representative at Science4Tech on how they are advancing access to numerous technological innovations, elevating the quality, rigor, and reliability of clinical research rooted in the scientific method.

 Science4Tech Representative

In this presentation Matt will discuss strategies to optimize the design and delivery of early phase oncology trials, including:

• Dose optimisation and dose selection in early phase oncology trials
• Adaptive designs
• Accelerated titration for early cohorts
• Backfill strategies
• Biomarker analysis integration

Speakers

Matt Cooper

Executive Director, Therapeutic Strategy Lead, Oncology, Worldwide Clinical Trials

• Creating strategies and operational processes
• Addressing challenges and complexities of cell therapy oncology trials
• Selecting fit for purpose service providers to assist

Speakers

Sarah Bischof

Head of Clinical Development, invIOs

• Considering touchpoints of how and when we can digitally reach patients
• Collating digital patient input to incorporate their voice
• Highlighting challenges and benefits of digital patient engagement

Speakers

Dr. Nicolas Schneider

Director Clinical Operations and Alliance Management, ITM Isotopen Technologien München

Project Optimus, an initiative led by the FDA’s Oncology Center of Excellence, is reshaping the landscape of oncology drug development by fundamentally altering the approach to dose optimization and dose selection. Traditionally, oncology drug trials focused on identifying the maximum tolerated dose (MTD) to ensure efficacy, often at the cost of increased toxicity. However, Project Optimus challenges this paradigm, advocating for a more nuanced approach where multiple doses are rigorously tested to find the optimal balance between efficacy, safety, and patient tolerability.

The initiative’s impact extends across various stages of drug development, from preclinical studies to pivotal Phase III trials. By emphasizing early collaboration between drug developers and the FDA, Project Optimus aims to ensure that the chosen doses not only maximize therapeutic benefit but also minimize adverse effects, thereby enhancing the overall success rate of oncology therapies.

However, this shift is not without its challenges. The need for larger, more complex trials and the incorporation of innovative trial designs, such as seamless Phase I/II studies and randomized dose-ranging trials, can increase the time and cost associated with drug development. Smaller biotech companies, in particular, may face difficulties adapting to these new requirements. Yet, the long-term benefits—more effective treatments with fewer side effects—promise to transform patient outcomes and set a new standard in oncology drug development.

Introduction

• Overview of Project Optimus and its origins within the FDA’s Oncology Center of Excellence.
• The traditional approach to dose selection in oncology (MTD-focused) and its limitations.

Key Objectives of Project Optimus

• Reforming dose optimization to focus on efficacy, safety, and tolerability.
• Encouraging early and ongoing collaboration between drug developers and the FDA.
• Integrating patient-reported outcomes (PROs) into dose-finding studies to better assess tolerability.

Impact on Early-Phase Drug Development

• Changes in Phase I and Phase II trial designs, including the move away from 3+3 dose-escalation models.
• The role of pharmacokinetic (PK) and pharmacodynamic (PD) data in dose selection.
• Case studies highlighting the successful implementation of Project Optimus guidelines (e.g., Amgen’s Lumakras, GSK’s Blenrep).

Challenges and Opportunities

• Increased trial complexity, costs, and the need for larger patient populations.
• Implications for smaller biotech companies and strategies to navigate these challenges.
• Potential long-term benefits, including improved patient outcomes and reduced trial failure rates.

The Future of Oncology Drug Development

• How Project Optimus may influence global regulatory practices.
• The evolving role of dose optimization in other therapeutic areas beyond oncology.
• Predictions for the next decade of drug development under the Project Optimus framework.

Conclusion

• Recap of the transformative impact of Project Optimus on oncology drug development.
• Final thoughts on how the industry can adapt to these changes to bring safer, more effective therapies to patients.

Speakers

Rob Berg

VP Medical Management, Syneos Health

Carol was diagnosed with Hodgkins Lymphoma in 2004 and her life and music career was all put on hold. She was repeatedly told that she would not survive, but now, in remission with a different blood type and new DNA, she is one of the most in-demand session musicians in the UK.

Carol will discuss her decade-long fight with cancer, her experiences with failed treatments, transplants and clinical trials and how she has faced fear head on and beaten the odds.

Speakers

Carol Jarvis

Patient Advocate

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

Speakers

Frank Richard

Vice President Medical, Heidelberg Pharma

Marta Perez-Noguera

Director Clinical Operations EU, Luzsana

Cornelia Baumgartner

Head of Clinical Operations, T-CURX

• 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

Speakers

Cesare Spadoni

Founder & Chief Operating Officer, Oncoheroes Biosciences

Dr. Claudia Hesselmann

Founder & CEO, ARENSIA Exploratory Medicine

Dr. Nicolas Schneider

Director Clinical Operations and Alliance Management, ITM Isotopen Technologien München

• 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

Speakers

Daniela Duffett

Senior Solutions Consultant, Suvoda

• Evaluating, predicting and understanding of the Innovator:
  • Product value, medical potential, product profile
  • Ongoing studies, IP intelligence
• Defining the details of the generic development:
  • Competition level
  • Markets, generic pricing

Speakers

Bahadir Cakmak

Director Early Portfolio & Pipeline, Sandoz

• Review current challenges that have a direct impact on site engagement and performance
• Exploration of practical solutions that will enable and elevate the voice of sites into clinical trial designs
• Case studies and examples of how a collaborative approach with sites delivers insightful study design, greater confidence of patient recruitment and strong patient retention

Speakers

Constance Jung-Stach

Head of EMEA Partnership Growth, Fortrea

Amanda Nogueira

Senior Medical Director Oncology, Fortrea

• Investing in the right people – early gap analysis
• Financial strategy leading to success
• Competitive Intelligence – market analysis & selection of indication
• Common factors of management that succeed

Speakers

Helen Johansen Blanco

Chief Operating Officer, Node Pharma A/S

• Geographic feasibility for country selection
• Benchmarking timelines, trial costs and recruitment rates
• DCT complications
• Site selection process including e-feasibility questionnaires

Speakers

Ophelia Chan

Senior Analyst, GlobalData