Bridging the Cell and Gene Therapy Gap Between Manufacture and Supply Chain
The current understanding among sponsors of the workflow from cell collection, to manufacturing, and ultimately to the clinical site for patient administration.
OneBio® Integrated Suite
Offering Fact Sheet-OneBio® Integrated Suite
OptiForm® Total Supply
Offering Fact Sheet – OptiForm® Total Supply
Understanding the Impact of Primary Packaging Decisions on Clinical Supply Success
Explore how an experienced partner can provide invaluable guidance and offer creative solutions when selecting a primary packaging format.
Risk Mitigation in Direct-to-Patient Clinical Trials
The benefits of direct-to-patient supply to mitigate risk in decentralized studies.
Optimizing Clinical Supply for a Smoother Phase 2a to 2b Transition
The reasons behind implementing a multi-segment Phase 2 study and implications on kit design.
Proactive Clinical Supply Planning: Optimizing Strategies from Early through Late Phase
Proactive Clinical Supply Planning-Early to Late Phase
Aligning Clinical Supply Strategy with the Target Product Profile for your Clients
Management of advanced supply chain CMC collaborators and CDMO partners.
WHO, WHEN, WHERE and HOW? The Key Clinical Supply Issues Sponsors Should Consider with their CROs
The importance of project management, and key elements to consider to help keep trials on time and budget.
A Global Sponsor’s Guide to Successful Clinical Supply in Japan
Explore key aspects of Japan’s regulatory environment to consider when developing a clinical supply plan and associated timelines.
Clinical Supply Planning for Studies with Unconventional Timelines
Learn how unconventional trials impact the supply chain and the role a CDMO can play in facilitating these studies.
Planning Ahead: Using Phase 1 to Anticipate Phase 2 Clinical Supply
Learn what clinical sponsors should look for when assessing integrated services and potential providers.
Optimizing Direct-to-Patient Clinical Supply for Decentralized Clinical Trials
How adopting the decentralized trial approach introduces new challenges for companies hoping to ramp up an early phase trial or keep later stage studies going during the pandemic.
Decentralization: A Direct Approach to Clinical Trials
Benefits of decentralized trials to sponsors and patients.
Industry Perspective: Defining the Optimal Clinical Supply Strategy for Cell/Gene Therapy Studies
Insight into the current level of integration between the manufacturing and supply chain used and sought by cell/gene therapy companies.
Building a Flexible, Challenge Resistant and Patient Centric Clinical Supply Chain
Learn strategies to improve supply chain efficiency, reduce risk and respond to local, regional and global challenges.
Leveraging Effective Clinical Supply Strategies to Meet Complex Challenges in China and APAC ( Chinese )
How Catalent’s integrated and innovative model can help to ensure timely and optimal clinical supply execution in the APAC region.
Optimizing Resupply to Reduce Risk of Late Phase Delays
Learn ways that clinical supply strategies for late phase vary from early phase.
Comprehensive Clinical Supply Strategy for Compressed Timeline Trials
Strategies sponsors can enable with a supply partner in order to minimize project risk.
The APAC Advantages
Cultural considerations when planning and implementing an APAC clinical supply strategy.
Fastchain® Demand Led Supply
Summary: FastChain® demand led supply is a continuous GMP approach to secondary packaging, label printing and application, release, and regional distribution of patient kits to clinical sites based upon actual patient and site need. The FastChain® approach will…
Innovative Solutions to Meet the Complex Pharmaceutical Supply Challenges
Summary: Integrated approach from development to clinical and benefits of working with a single integrated provider.
Planning Ahead: Using Phase 1 to Anticipate Phase 2 Clinical Supply Challenges and Solutions
Summary: Utilizing an integrated solution with a single provider can help ensure a smooth transition from Phase 1 into Phase 2.
Excellence in Operating Multi-Center Clinical Trials
Summary: As the clinical development market evolves rapidly in China, a rising number of multi-national companies are initiating early phase clinical trials in China in parallel with other sponsor countries.
Discover the Latest Funding, Drug Development and Clinical Solutions Strategies
Summary: View this exclusive webcast specifically designed for pharmaceutical & biotech consultants and early stage development partners. Hear three early drug development industry experts present…
Planning Ahead: Using Phase 2 to Anticipate Phase 3 Clinical Supply Challenges and Solutions
Summary: Discover what challenges can occur in Phase 3 and how to address them in advance to limit potential setbacks.
Building a Flexible, Challenge Resistant and Patient Centric Clinical Supply Chain
Summary: Explore strategies to improve supply chain efficiency, reduce risk and respond to local, regional and global challenges.
Forecasting to Optimize Clinical Trial Supply Management
Summary: Learn about forecasting solutions for better informed decision making and contingency planning in these inherently dynamic trials.
Early Drug Development Strategies for Clinical Success
Summary: Every clinical study is different, each with its own unique characteristics and requirements. The optimal time to begin planning a clinical supply strategy is while the study…
Understanding Options in Direct-to-Patient Clinical Supply
Summary: This video explores several approaches to direct-to-patient clinical supply that are in use today and how they can be used to flexibly support today’s decentralized clinical trials.
Designing an Optimal APAC Clinical Supply Chain – What Every Sponsor Should Know
Learn how to navigate the complex clinical supply distribution landscape within this important and growing region.
From Local Trials to Across the Globe: Considerations for Managing an Effective Clinical Supply Chain in Asia
As clinical study activity continues to grow across APAC, some countries have been looking to improve upon their compliance requirements to help make the distribution of clinical supplies throughout the region more efficient.
Pragmatic Insights from Clinical Supply Management and EU Qualified Persons on How to Optimize Global Clinical Studies
Summary: After 3 years of Brexit withdrawal negotiations, the UK is officially no longer a member of the European Union. Clinical sponsors with active and planned studies in the EU…
Accelerating Timelines by Planning for Clinical Supplies in Advance
Developing a clinical supply strategy early is key to minimizing risk and avoiding delays when implementing and executing accelerated study timelines.
Clinical Trial Challenges Amid COVID-19
Summary: Due to the influx of COVID-19 related therapies being expedited into clinical testing, studies in other areas are either proceeding with heightened caution or are essentially being…
CTSuccess™
Summary: Proactive clinical supply risk evaluation and tailored strategies to support on-time study start-up for small and mid-sized sponsors…
APAC Region Distribution Considerations for Clinical Trial Supplies
Summary: The Asia-Pacific (APAC) region has become an emerging market for pharmaceutical and biotech innovation, including clinical studies. Managing a clinical supply distribution strategy within APAC…
Beyond Brexit: What Now for Clinical Supply Across Europe
Summary: After 3 years of Brexit withdrawal negotiations, the UK is officially no longer a member of the European Union. Clinical sponsors with active and planned studies in the EU…
Minimizing Bias When Blinding and Masking Drug Products
Summary: Overcoming complex blinding and masking challenges in clinical trials requires a balance of strategy and adaptability. When conducting clinical trials…
The Product Development Superhighway: Leveraging End-to-End Solutions for Market Success
Summary: Formulating drugs for optimal stability and bioavailability is fundamental to the development of new pharmaceutical products. Once developed, these products must then be delivered…
Accelerating Clinical Supply in China and Beyond
Summary: Accelerating the flow of clinical supplies both into and out of China can be accomplished using a dual-supply site model. Learn how this approach leverages both…
The Art of Recognizing Clinical Supply Risk Factors
Summary: No two studies are the same and each clinical supply project carries unique risks. Experienced supply chain managers know that certain study characteristics are often leading indicators that they can…
Demand Led Services and Clinical Supply Efficiency | Catalent in 90 Seconds
Summary: The traditional clinical supply model is a static, linear stock based approach that uses bulk storage to ship to depots based on anticipated demand. The supply for an entire clinical trial…
Catalent’s Integrated Clinical Supply Services
Summary: A short video on Catalent’s flexible and innovative clinical supply services for phase 1-4 clinical trial sponsors. We have the deep expertise, global capabilities and…
Blinding of Clinical Supplies
Summary: Catalent understands there are numerous ways to approach the various facets of blinding drugs for use in a clinical trial. Employing the right blinding strategy can…
Expediting Path to Clinic with OptiForm® Total Supply
Summary: MGB Biopharma, a biotech company based in Scotland, U.K. was developing a new class of anti-infective medicine based on Minor Groove Binder compounds…
Shortening Timelines with Clinical Trial Strategy
Summary: Biologic clinical trials can be complex with many factors to consider. Understanding your specific needs and developing a plan early on during drug development can…
How Protocol Design Drives Comparator Sourcing Cost, Timelines, Complexity and Risk
Summary: Clinical trials are conducted according to a protocol, which is the master action plan for how the study will be conducted. Clinical trial protocol design can have a significant impact on the sourcing…
How Protocol Design Drives Comparator Sourcing Cost, Timelines, Complexity and Risk
Summary: Clinical trial protocol design can have a significant impact on the commercial drug sourcing strategy for a study requiring comparators. Learn the appropriate level of detail to include in the study protocol…
Clinical Supply Services Offerings and Capabilities
Summary: As a worldwide clinical supply services leader, Catalent has the scale, expertise, and innovative solutions to improve efficiency and reduce your trial timelines.
Leveraging End-to-End Solutions for Market Success
Get insights on how contracting with a single service provider can offer significant benefits to the customer through integrated expertise between the formulation development teams, the manufacturing teams, clinical supply specialists, and the packaging teams.
Innovative & Flexible Solutions for an E2E Patient Centric, Lean Clinical Supply Chain
Summary: The trend toward crafting patient-centric clinical trials hold great promise in supporting patients’ willingness and ability to participate in important clinical research. However, for sponsors who are embracing the promise…
Implementing a Stability Strategy for Short Expiry IMPs
Summary: Different clinical trials have different supply needs and strategies. This recent Q&A article published in Pharmaceutical Technology features…
Strategies to Keep the Critical Path Clear: Understanding How Study Design Can Impact Clinical Supply Availability and Efficiency
Summary: This eBook explores the multitude of factors that can impact clinical supplies and techniques and strategies that clinical supply professionals can apply to keep clinical supplies off the critical path…
Managing Risks to Time Critical Product Imports at Clinical Supply Depots
Summary: A Catalent customer wanted to run a clinical trial in Israel and was arranging to ship their clinical trial product from a non-Catalent facility in Europe to a Catalent-managed and audited depot in Israel…
QP Perspective On Brexit
Summary: Explore how Brexit may change the working relationship between Qualified Persons (QPs) in the UK and EU through a moderated Q&A roundtable.
Countdown To Brexit: Can Your Clinical Supply Chain Pass The Brexit Pressure Test?
Summary: Developed by a cross-functional team of Catalent experts, this whitepaper is intended to help sponsors understand how the various Brexit outcome scenarios may specifically impact clinical supplies. In this paper, you will find more than 30 practical questions that you can explore internally to evaluate…
Innovative Strategies To Maintain Product Integrity In Biologic & Biosimilar Clinical Studies
Summary: Delays encountered during clinical studies can have a serious impact on competitive advantage, speed to market and the availability of lower-cost alternatives for patients. Specialized expertise in cold chain shipping and logistics are critical to avoid costly delays…
Clinical Supply Trial Perspectives: Challenges Facing Small, Mid-sized & Large BioPharma Companies
Summary: From delays in the study timeline to budget constraints and regulatory requirements, the challenges associated with management and execution of clinical supplies are many and varied.
Establishing Parameters For Success
Summary: Applying clinical supply management expertise to overcome inventory challenges for a complex, global study. A CRO customer and clinical sponsor both lacked an unblinded supply management role to oversee Interactive Response Technologies platform (IRT) supply strategies and monitor clinical supply…
Is Your Clinical Supply Playbook Ready For Phase II & Beyond?
Webinar Summary: Advancing promising investigational medicines to Phase II and beyond for the first time is an exciting time for clinical sponsors with young pipelines – and an eye opening one as well. Experience has shown that certain study characteristics can act as useful leading indicators of future clinical supply challenges…
Should Your Next Clinical Trial Use A New Supply Model?
Webinar Summary: Whether you are currently determining the best clinical supply model for an upcoming study or would like to learn more about new approaches to clinical supply this webinar will help you identify strategies to reduce supply chain risk and improve performance…
Navigating Common Clinical Supply Challenges For Asia-Pacific Regional Studies
Summary: Unlike well-established clinical trial regions, such as Europe which benefit from more harmonized regulatory requirements and quality standards and transportation networks, the APAC region is a collection of independent countries each with its own infrastructure limitations, clinical supply quality standards, regulations, and protocols…
Leveraging Forecasting Models To Optimize Clinical Trial Supply Management
Summary: Explore how to drive excellence within the forecasting process and how to utilize forecasting throughout the study to plan for study clinical supply budgets and identify potential supply-related issues before they negatively impact your study…
The Medicine Maker – More Trial, Less Error
Summary: The pressure for increased efficiency pervades the pharma industry, including the clinical trials sector, where traditional supply models can lead to overstocking, waste and higher costs. This article, originally published in “The Medicine Maker” explores if there is a more effective supply strategy…
Optimizing Your Clinical Supply Chain Strategy For Asia-Pacific Studies
Summary: Unlike Europe where clinical trial regulations are largely standardized between the EMEA member states, no such organization or harmonization exists in the APAC region, making conducting multi-country studies within the region much more complex for clinical sponsors, particularly with regards to the sourcing…
Clinical Trials Innovations
Summary: Developing, implementing, and managing a clinical trial involves coordination of multiple factors in an ever-changing environment. Recent innovations in trial design and management including a demand-led approach to drug supply, adaptive trial design, mHealth for patient-centric and site-centric trials…
Maintaining Product Integrity In Biologic & Biosimilar Clinical Studies
Summary: Specialized expertise in cold chain shipping and logistics are critical to avoid costly delays and potential for patient harm resulting from an interruption or delay in necessary clinical supply. Maintaining product integrity and reliability of supply can be especially challenging for biologic and biosimilar studies as the investigational…
Identifying & Addressing The Hidden Root Causes Of Supply Chain Inefficiency
Summary: Delayed. Out of stock. Over-budget. Unavailable…All words that clinical trial sponsors never wish to hear in reference to the impact of supply chain performance on their study. And yet, considering the critical role the supply chain plays, it has surprisingly remained largely unchanged for several decades…
Around The World In Clinical Trials: New Regulations & Country Specific Challenges
Summary: While thorough knowledge of a country’s regulatory requirements is critical, understanding both the written and unwritten regional differences and business practices that come in to play that can make the difference between clinical supplies moving successfully between countries, being detained in Customs…
Around The World In Clinical Trials: New Regulations & Country-Specific Challenges
As certain regions of the world are added to a clinical study, the logistical and regulatory challenges associated with clinical trial supply distribution can rise exponentially. While having thorough knowledge of a country’s regulatory requirements is critical, understanding both written and unwritten regional rules…
Business & Cultural Considerations For Managing The Flow Of Clinical Supplies To Asia Pacific Studies
Successfully navigating the rich and diverse Asia-Pacific business and cultural environment can prove tricky for Western study sponsors with limited experience in this region. Learn what cultural and business norms study sponsors need to be sensitive about in various countries and regions…
Questions You Need To Ask About Clinical Supply
Planning to use a CRO to support your next clinical study? Here are the top 9 questions you should always ask to help your CRO or partner of choice better understand your clinical supply needs.
Practical Considerations For Making Clinical Studies More Patient Centric
Successfully sourcing commercial products for comparative studies in an effective and efficient manner often proves far more challenging than assumed. A comprehensive plan should include insight from comparator sourcing and clinical supply management. Tight collaboration between these critical functional…
Expecting The Unexpected: Strategies For Efficient Clinical Supply Management & Forecasting
A proactive approach for effective clinical supply management is essential for reducing the risk of supply-related delays, stock-outs and excess inventory. Utilizing simulations to performing “What If” scenario planning for demand forecasting is a powerful…
Navigating Clinical Supply Challenges In Emerging Regions
The logistical and regulatory challenges associated with clinical trial supply distribution can rise exponentially when certain regions of the world are included. Underestimating the complexity of the logistics involved in the handling of sensitive and highly regulated materials such as clinical supplies has the very real potential…