Main Conference - Day One

EVALUATING NEW OPPORTUNITIES & CHALLENGES IN SHAPING THE CLINICAL TRIAL SUPPLY CHAIN OUR PATIENTS NEED

 In his opening address to this year’s forum, chairperson Steve Jacobs surveys the contemporary challenges confronting clinical trial supply and investigates how the industry is evolving in light of these. Which challenges constitute a fundamental shift in how we must operate our supply chains and what are the steps we need to be taking now to build a platform for long term-success?

 Core focus areas to include:

•  State-Of-The-Industry Report: Where do we find ourselves after several years of disruption? How do we discern the transient impacts from those of a more permanent nature?
• Improving Collaboration & Transparency: Disruptions have increased the need for strong sponsor-vendor relationships. How must collaboration and transparency across the supply chain continue to evolve to meet rising demand?
• Meeting Rising Demands & Expectations: How are we to live up to the new standards and expectations expected of us in light of product innovation and patient requirements?
• How Do We Create A Sustainable, Engaged & Motivated Workforce? In what ways are we confronting the recruitment and retention challenges that continue to persist?

Steven Jacobs

President
Global BioPharm Solutions, LLC

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NEW PERSPECTIVES ON LEVERAGING OPERATIONAL & TECHNOLOGICAL INNOVATION TO BOLSTER SUPPLY CHAIN EFFICIENCY, MITIGATE DISRUPTION & ENSURE SUCCESS

The sheer number of disruptive events confronting the supply chain is dizzying. Mitigating the impact of these whilst also planning in an environment laced with future uncertainty remains a huge challenge.

In this extended keynote opening panel, we ask clinical trial supply chain leaders to deliver their perspective on how the operational landscape has evolved over the past 12 months and its associated impact on best practices.

 Core focus areas to include:

•  Preparing For The Unexpected: In what ways can we improve our capacity to anticipate and mitigate disruptive events? How are technological innovations supporting this?
• Doing A Practical & Tactical Risk Assessment: This has now become essential. So we investigate what the industry best practices are for accomplishing thi
• Improving Decision-Making: Breaking down silos whilst also ensuring the data on which we make our decisions is as complete and accurate as possible is critical. How can you move to a pro-active decision-making framework that allows you to make the right decision at the right time?
• Building Operational Agility: With so many short-term shocks impacting the supply chain, what does a long-term strategy for building operational agility look like in practice?

Kamal Amin

Head of Supply Management
Galderma

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Bjoern Rath

Independent Supply Chain Consultant & Sr. Economics Lecturer
GS1

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Jean Malthete

Director of Third Party and Cold Chain Management
GSK

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Ensuring patient safety in clinical trials is paramount, especially regarding drug safety and efficacy. The journey of the Investigational Medicinal Product (IMP) is complex, with multiple stops before reaching the patient, highlighting the importance of the drug supply chain. Temperature tracking devices are now standard to monitor shipments and storage conditions in real-time, improving oversight. However, clinical trial site staff still grapple with managing multiple technology systems and establishing effective communication channels with the study team. This session focuses on:

• Automated Precision for Real-Time Insights: Technology enables real-time monitoring of drug shipments and storage conditions, crucial for maintaining patient safety and drug efficacy throughout the supply chain.
• Streamlined Processes Reduce Administrative Burden: Integrating communication solutions between on-site logger technology and the Randomization and Trial Supply Management (RTSM) system reduces administrative burden, enhancing efficiency and allowing staff to prioritize patient care.
• Preventive Measures Against Human Error: The joint-solution presented serves as a robust preventive measure against human error, enhancing assurance regarding drug efficacy and patient safety by automating communication and data monitoring.

Libbi Rickenbacher

Senior Director of Product Strategy & Partnerships
4G Clinical

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Harald van Weeren

Head of Segment Management
Berlinger & Co. AG

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The pharmaceutical industry thrives on precision and reliability. This session zeroes in on the vital role real-time tracking holds in strengthening the clinical supply chain. Participants will delve into creative plans and tech breakthroughs which equip companies to actively safeguard their clinical supply chain. From the production line to distribution and beyond, this checking in real-time ensures top-notch quality, secure, and efficient clinical supply chains.

Key Learnings:

• Whole Supply Chain Visibility: Grasp how keeping tabs on things in real-time provides a full view of the clinical supply chain. This technique allows those involved to track pharmaceutical products at every move.
• Risk Mitigation and Adherence: Discover how real-time monitoring systems help reduce risks by identifying potential problems early and dealing with them promptly. This increases adherence to set rules and quality controls.
• Cutting Down on Lost Items and Wasted Drug: Keeping constant watch helps keep items from being lost or damaged.
• Better Safety for Patients: Learn how constant monitoring affects patients’ safety. It makes sure IMPs is in optimal conditions, which ensures correct treatment conditionsand lowers the chance of errors.

Ana-Zeralda Canals Hamann

Senior Clinical Trial Supplies Manager
Debiopharm

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Katrien Aerts

Senior Clinical Trial Supply Manager
Debiopharm

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Clinical trial supply chains face challenges that can lead to drug waste, high distribution costs, missed patient visits, and unintended impacts on the carbon footprint. This talk will cover how advanced solutions like improved visibility, flexible supply parameters, advanced drug optimization, and innovative technologies can revolutionize supply optimization. We'll explore: 

• Navigating Supply Challenges:  The complexities of clinical trial supply chains, including factors such as wastage due to assumption-based forecasting and planning, difficulties adjusting scenarios with real-time data,  manufacturing influences, and geopolitical tensions. 
• Clinical Supply Strategies & Solutions: Explore various strategies and tech solutions to better inventory levels. 
• Translating Technology into Tangible Outcomes: Explore the impact of data-driven decision making and simplified processes in clinical trial supply. 
• Implications: The impact and benefits of optimized clinical supply and technology solutions on the patient journey and trial risk mitigation. 

Henk Dieteren

Clinical Supply Chain Solutions Consultant
Suvoda

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FINDING NOVEL APPROACHES TO CORE CHALLENGES: BENCHMARKING SUCCESS IN OVERCOMING KEY OPERATION & STRATEGIC BARRIERS

How does it work? Choose a 45-minute discussion on a pressing clinical trial supply topic. Interact with your peers, identifying contemporary challenges and novel approaches to confronting them. Each roundtable is led by a subject matter expert.

Following the conclusion of the discussions, there will be a 30-minute feedback session, where the roundtable leaders will share the key findings that came out of their respective discussions.

The discussion groups are:

GROUP A - HOW CAN WE ADAPT SUCCESSFULLY TO THE PACE OF TECHNOLOGICAL CHANGE?

Ana-Zeralda Canal-Hamann, Senior Clinical Trial Supplies Manager, DebioPharm

GROUP B - ARE WE TRULY DOING PATIENT-CENTRICITY – AND OF YES, HOW ARE YOU DOING IT?

GROUP C - HOW CAN WE CONTAIN COST WITHOUT COMPROMISING PATIENT SUPPLY RISK?

Cinthia Travaglini, Head of Global Development - Supply Lead & Study Set Up, UCB

GROUP D - HOW CAN WE GO FURTHER IN REDUCING WASTE ACROSS THE SUPPLY CHAIN

GROUP E - HOW TO MITIGATE THE ENVIRONMENTAL IMPACT OF DIRECT-TO-PATIENT?

Costanza Carmi, Clinical Supply Lead, Chiesi

GROUP F - HOW CAN WE ENSURE WE HAVE ACCURATE & UP-TO-DATE REGULATORY INTELLIGENCE?

Nelly Conus

Digital and DCT Solutions Manager
Syneos Health

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Jeroen Gerritsen

Owner
Geronimo Consultancy

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Joerg Wania

Head of Clinical Trial Supply
Stada Arzneimittel

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Yuliyana Manolova

Head of Distribution and Clinical Trials Product Supply
Zentiva/ Zent2U

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Claudio Semeraro

Associate Director, Gene Therapy Supply Lead
UCB

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Carolien Eggink

Owner
Navigo Pharma

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Racheal Yoon

Associate Director, Clinical Trials Patient Solutions
Myonex

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TAKING COMMAND OF YOUR SUPPLY CHAIN TO GAIN CONTROL IN A WORLD OF DECENTRALISED CLINICAL TRIALS

Reducing product loss, contributing to patient retention, and minimizing patient site visits are all areas where the clinical trial supply chain can continue to drive value. In this next keynote, we explore what it means to build patient centricity into your clinical trial supply chain.

Core focus areas to include:

• Direct-to-Patient Shipping: Discover how to enable patient privacy and protect study blind in scenarios specific to decentralized trial supply chain models
• Hitting Tight Deadlines: How is technology rising to the increasing pressures we see across the supply chain and how can it assist in mitigating supply chain risks
•  Meeting The Logistics Challenge: We deliver a comprehensive overview of how technology can assist with trial, patient and drug logistics throughout the trial

During this session, we'll delve into the responsibilities of the Qualified Person (QP) within clinical packaging organizations, with a particular emphasis on assessing implications for patient safety and predicting forthcoming regulatory changes.

Key Takeaways:

• Gain insights into the multifaceted role of the Qualified Person in ensuring compliance, quality, and patient safety
• Stay updated on the latest regulatory developments impacting QP responsibilities, including labeling requirements, temperature control standards, and serialization mandates.
• Prepare for the future regulatory landscape by anticipating emerging trends, technological advancements, and potential changes in global regulatory frameworks affecting QP practices.

Simon Baker

Global Head of Programmatic
Bloomberg Media

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Mathieu Beny

Qualified Person in Clinical Trials and RP back-up
Xerimis

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The promise of cell and gene therapies is terrifically exciting. In this next keynote, we challenges of delivering a clinical trial from the lab environment into the clinical site from the perspective of an Academic Sponsor. We also discuss the clinical site perspectives of conducting clinical trials with these innovative products. 

Core focus areas to include: · 

• Bench to Bedside: The journey of manufacturing a gene therapy for a clinical trial · 
• The Patient At The Heart Of Everything: In what ways have cell and gene therapies changed the experience? What considerations are required for the clinical sites to be able to host these trials? 
• The Road Ahead: How will the expected exponential growth of these therapies continue to shape what the future clinical trial supply chain looks like in the years ahead?

Samantha Carmichael

Lead Pharmacist Clinical Trials
NHS Greater Glasgow and Clyde

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In a time where efficiency is a critical mission, innovations such as digital labelling bring solutions to control costs, risks of shortage, drug waste, CO2 emissions, inventories, and more. But do we actually know the impact innovations and decisions have on these indicators? MSD and N-SIDE have worked in the past months on assessing the impact of Digital labelling.

Join us to learn about:

• Digital labelling, its objectives, promises and implications in clinical supply chain
•  How digital labelling impacts costs, waste, sustainability, patients, and more, in clinical trials
• Going further: Processes, regulations, collaboration – How can numbers help change our industry?

Martina Marauli

Director Clinical Supply Innovation
MSD

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Amaury Jeandrain

VP of Strategy for Life Sciences
N-SIDE

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INVESTIGATING THE POTENTIAL OF ARTIFICIAL INTELLIGENCE TO TRANSFORM THE CLINICAL TRIAL SUPPLY CHAIN

 Shorter timelines. Less drug waste. Automation end-to-end. The potential benefits of artificial intelligence seem endless. But should we all be polishing up our resumés, ready to be replaced – or gearing ourselves up to leverage the potential of this technology to the max. In this next session, we cut through the myths to get to the core of how AI will likely transform the industry.

 Core focus areas to include:

•  What Do We Mean By AI? Generative AI. Machine-learning. Intelligent Automation. What do we mean by AI in clinical trial supply and what does it look like in practice?
• Assessment of Potential Benefits: We investigate where AI promises the greatest potential benefits. How close are we to achieving these benefits and what will it mean for the future potential of our supply chains?
• Digital Maturity: The adoption of new technology takes time and change management. How can we ensure that we have the skills and systems in place to successfully onboard AI technologies?
• What Role For Us? The key question: does an AI future mean we all need to be looking for new jobs? OR will we be liberated to focus on ‘higher value activity’ – and what does higher value activity look like?

Steven Jacobs

President
Global BioPharm Solutions, LLC

See Bio