Additional Available Sessions:

How supply chain sustainability will empower and optimize the way CTS strategies are planned to improve productivity and minimize costs
• Future-proofing supply chains to endure greater long-term sustainability responsibilities
• Sharing best practice for circular supply chain strategies and creating win-win business opportunities
• Adhering to sustainable practices without adding cost and risk to the supply chain
• Operational implications of striving for more sustainable shipping logistics

How has your comparator sourcing strategy updated to keep up with changes in the industry and regulatory revisions?
• Developing a risk-driven demand plan that can aptly accommodate changes in the quantity of comparators
• Finding the right provider with a global comparator network who can provide timely and accurate product assessments and insight on how long they take to source
• Single sourcing vs. decentralized sourcing to ease the demands on internal supply and logistics whilst being regulation compliant
• Appropriately weighing risk vs reward with comparator sourcing to lead to successful outcomes

Incorporating a flexible trial supply distribution strategy for decentralized trials to reduce burden on clinical supplies and move drug development forward
• Working in tandem across the trial ecosystem to better manage demands for increasingly complex clinical supply logistics in DCTs
• Ensuring timing alignment of home care practitioners and drug shipments to reduce impact on patients’ schedules and costs for biotechs
• Can we ever be appropriately equipped for adverse effects with off-site testing?
• New ways to maintain temperature integrity throughout the entirety of shipments for DCTs
• How do you control things when they’re out of your control and what can experience teach us in regards to trial supply?

Reducing the impact of increased data privacy requirements under data privacy laws on biotechs
• Managing all considerable factors when it comes to data handling
• Do the sites or vendors have a Data Privacy Officer or SOPs around data handling?
• How to review data in an efficient way
• Implications of global privacy laws, such as GDPR, on supply chain data extraction

Designing trials to demonstrate clinical efficacies and to allow for a solid and comprehensive CTS strategy to be put in place
• Marrying supply chain design and innovation: Explore how to bring together transparency and resilience to boost the effectiveness of your CTS strategy
• Promoting cross-functional synchronization when it comes to designing study
• Customizing trial designs in a more advanced way to ensure cost-effective methods for supplies manufacturing and shipping
• How to interpret preliminary data in order to choose an appropriate trial design
• Properly projecting the clinical needs and building the overage to progress your study

Confronting the complexities of personalized supplies in cell and gene therapy clinical trials and how to best manage the multifaceted process
• How can we ensure we have a robust seamless supply chain in place and have the right sort of capabilities to champion cell and gene therapy?
• What challenges do these therapies present to the supply chain and what are the key considerations for sites to be able to host them?
• Ensuring a solid raw material sourcing and selection process is in place and that your suppliers offer scalability to match growing demands
• Selecting the appropriate cold chain service providers for you: Considering storage locations, reliability of supply and online trackability

Looking at shipping and logistics from another angle: Finding an all-encompassing approach that allows us to truly confront transportation challenges
• Investing in reliable transportation partners to improve transportation challenges, especially in remote areas with poor infrastructure
• Explore best practice in close monitoring of transportation activities to guarantee timely supply delivery and minimize risk of loss or damage
• Tackling inconsistent import and export regulations for transporting clinical supplies globally and optimizing your shipping process to ensure regulatory compliance
• Effective strategies in mitigating shipping risks and reducing supply transportation costs

Navigating the import-export landscape for clinical trial supply: Managing the regulatory requirements, Hear from the Pharmaceuticals, Health & Chemicals Center, U.S. Customs & Border Control
• Overview of U.S. Customs and Border Protection’s Centers for Excellence and Expertise (CEE)
• Focus on the Pharmaceuticals, Health, and Chemicals CEE and its role in the importation process
• How industry partnerships are mutually beneficial
• Biologic import requirements
• Why is your international clinical trial shipment in customs being held?
• Developing and maintaining robust relationships with transport partners
• Knowing how to protect your drug supply chain by avoiding a surplus of unneeded drugs during the IND
• Early identification of potential logistical hurdles such as country-specific documentation needs

How are you honing your data in the supply chain to make you more efficient and achieve actionable results?
• Leveraging data to predictively build products in time to render your inventory better and less static
• Rethinking your supply strategy through data-driven decision-making capabilities
• How can we intelligently incorporate and optimize the true potential of the supply chain data?
• Adapting to an age of decentralization with live and predictive analytics

Mastering effective budgeting and management for clinical materials in a financially tight environment
• Effectively weighing up outcome of study vs cost of study to give an accurate expectation of results and pricing
• Why stricter European price controls are affecting sponsors’ willingness to invest and in turn how can the industry tackle the sharp reduction of drugs outputted
• Knowing what you don’t know: Improved strategies for predicting and calculating hidden costs as early as possible
• Aligning milestone payments with project progress and streamlining the invoicing process

Speaker Hosted Round Tables

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 as a whole. 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 lasts for 30minutes, delegates can select up to 2 roundtables.

RT 1 Adapting to change in an evolving industry Hosted by Luiz Alberto Barberini, Head of External Manufacturing, Latin America, Bayer

RT 2 Future-proofing your supply chain to maximize success, how are you doing it?

RT 3 The power of the patient voice and the patient-centric future of clinical trial supply

RT 4 The impact of direct-to-patient shipping on the future of clinical trial supply chains

Panel Discussion: Benchmarking success and assessing efficacy in avoiding dangerous pitfalls in clinical trial supply

• Take control of supply chain chaos: Preventing drug shortages through robust end-to-end visibility and streamlined workflows
• Fulfilling moral obligations to do better by patients and win the war on counterfeit products
• Why a secure network must remain mission critical: Prioritizing cybersecurity concerns throughout the supply chain to protect patients and healthcare providers
• Maintaining a resilient supply chain strategy amid macroeconomic volatility

Seats available

China’s emergence onto the market due to increased demand for low-cost medical supplies and commercial pressures: how will this impact you?

• Understanding China’s role as a key player in the clinical drug supply space
• Building a trusted supply route in unfamiliar countries and how can we best manage this?
• Choosing a supplier who has a GMP License Accreditation in China, how can you be reassured of the integrity of the production standards and differences?
• Assuring integrity in supplies and logistics


Session available