Running a successful clinical trial relies heavily on the management of risks within the supply chain. Risk management is an essential part of clinical trials to ensure that sponsors can generate a clear return on investment without disruptions. It’s a complex process of identification and management depending on a number of factors that can impact the effectiveness of the trial. There is no ‘one size fits all’ approach. Each clinical trial has its own complexities based on the comparator, data and stock shortages which can delay timelines and increase costs. Mistakes can prove very expensive and more importantly, put patient safety at risk.
Successful clinical trials need effective supply chain management procedures to make sure risks are identified and managed in a timely manner, so that the required medication is available at the site when needed. Taking a holistic approach to assessing and managing risks makes sure that sponsors can prevent things that will impact the trial and the data generated. There needs to be a robust methodology in place for identifying, evaluating and proactively managing the risks involved in clinical trials. Having the benefit of a global reach and multiple sources can make a tremendous difference to the options available.
So, what are the risks involved in clinical trial supplies and comparator sourcing and how can you manage these risks to ensure a successful clinical trial on a global scale?
Vanessa Dekou, PhD, Managing Director, Clinical Services International (CSI)
Dr. Vanessa Dekou has extensive experience in drug development from preclinical to registration and commercialization strategies and has secured product registration for several orphans and first-in-class drugs.
She has successfully designed and executed numerous trials all over the world. As such, Dr. Dekou understands all the challenges and requirements of supplying comparators to clinical trials and ensuring trials are delivered on time and on budget. Dr. Dekou has worked with some of the largest biopharmaceutical and biotechs to provide innovative solutions.
At CSI, Dr. Dekou is responsible for providing bespoke solutions to their clients to ensure comparator sourcing is not a rate-limiting step in the successful delivery of trials. She also works closely with pharmaceutical manufacturers to safeguard the supply chain and remain on the front line of advances in drug development. Dr. Dekou has a PhD in Cardiovascular Genetics from UCL, an MBA from Cambridge and a Masters in Market Access from University of Lyon.Message Presenter
Kotaro Yoshizawa, Chief Representative Japan-Global, Clinical Services International (CSI)
Kotaro Yoshizawa has been in investment banking businesses over 23 years and has worked with pharmaceutical manufactures, biochemicals and meditechs on numerous transactions. He started his career in Tokyo as a retail sales branch manager then expanded his expertise to wholesale and internationally in Amsterdam and London within the industry. He also worked for Sony Corporation at the global headquarters in Tokyo. During his position at Deutsche Bank AG London in the Global Market Division he supported and covered major listed Japanese Pharmaceutical companies not just in the UK and Europe but globally.
He has cultivated his career diversified in the ESG (Environmental, Social and Governance) area and organized a Japan-featuring ESG conference with the Financial Times in London in 2019. At CSI, Yoshizawa is responsible for looking after clients and supplies in the APAC region and globally if the studies require.Message Presenter
Who Should Attend?
This webinar will benefit clinical teams, and professionals in clinical supplies, logistics and outsourcing and project management, including those working within:
- Clinical Supply Team
- Comparator Sourcing Team
- Clinical Project Management
- Clinical Management
- Procurement Team
- Clinical Trial Team
- Supply Chain Department (CRO)
- Clinical Development
- Investigator Sites
- Clinical Operations
- Clinical Supplies & Investigational Supplies
- Clinical Packaging
- Clinical Labelling
- Clinical Quality Assurance/Quality Control
- Regulatory Affairs
What You Will Learn
Topics to be covered include:
- How comparators are used in different clinical trial Phases (Phase I – Phase IV)
- What are the risks associated with supply chain in each phase
- What steps to take to identify the risks
- How to proactively address and manage risks
- Why and how a partner with a global reach can mitigate risks
Clinical Services International (CSI)
Clinical Services International (CSI) is a global leader in sourcing and management of commercially-available medicines and comparators for clinical trials. Headquartered in London and with operations in UK, Germany, Japan and the USA, we provide efficient solutions and serve worldwide trials. Our longstanding experience and relationships with manufacturers enable us to provide custom-made solutions to address the most complex requirements.
We are scientist and have all worked in drug development, so we understand protocols and challenges and comparator sourcing is a value-added science-based approach rather than a commodity.
- Accelerate drug development and reduce timelines by providing a fully integrated service
- Address regulatory, quality, operational, clinical requirements
- Manage the entire supply chain and offer tailor-made solutions
- Comprehensive expertise in oncology and biosimilar products.
- Advanced technology and innovative approach
- Trusted partner of leading biopharmaceutical companies, CROs and CMOs
Experience and Expertise
- 25+ Years’ Experience in Drug Development and Clinical Trial Supplies
- Worldwide Access:
o Sourcing In Europe, USA, Latin America And Asia Pacific
- Relationships with 95+ Manufacturers:
o We Work Directly with All Big Pharmaceuticals And Generic Manufacturers
- Science Underpins Our Approach To Comparator Sourcing
- Operationally excellent